424B3 1 d28678d424b3.htm 424B3 424B3
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Filed Pursuant to Rule 424(b)(3)
Registration No. 333-252232

LOGO              LOGO

MERGER PROPOSED—YOUR VOTE IS VERY IMPORTANT

To Our Stockholders:

On behalf of the boards of directors of NantKwest, Inc. and ImmunityBio, Inc., we are pleased to enclose the accompanying joint proxy and consent solicitation statement/prospectus relating to the proposed combination of NantKwest and ImmunityBio.

On December 21, 2020, NantKwest and ImmunityBio entered into a merger agreement providing for the combination of the two companies to create a leading immunotherapy and cell therapy company focused on oncology and infectious disease. The combination will be implemented by means of a merger of a NantKwest subsidiary with and into ImmunityBio, resulting in ImmunityBio becoming a wholly-owned subsidiary of NantKwest. In connection with the closing of the merger, the combined company will assume the ImmunityBio name and shares of common stock of the combined company are expected to be listed on the NASDAQ Global Select Market under the symbol “IBRX”.

Dr. Patrick Soon-Shiong, Executive Chairman of NantKwest and Chairman and Chief Executive Officer of ImmunityBio, will serve as the Executive Chairman of the combined company. Richard Adcock, the Chief Executive Officer of NantKwest, will serve as the Chief Executive Officer of the combined company.

In the merger, NantKwest will issue to the stockholders of ImmunityBio 0.8190 of a share of its common stock, par value $0.0001 per share, for each outstanding share of ImmunityBio common stock. The newly issued shares will represent approximately 72% of the outstanding shares of the combined company on a fully diluted basis immediately following the merger.

In light of the fact that Dr. Soon-Shiong serves as the Chairman and Chief Executive Officer of ImmunityBio and he and his affiliates beneficially own approximately 88.9% of the outstanding shares of ImmunityBio common stock, the NantKwest board of directors formed a special committee of independent directors to evaluate the proposed merger and to make a recommendation to the NantKwest board of directors. Acting upon the recommendation of the NantKwest special committee, the NantKwest board of directors (other than Dr. Soon-Shiong and Barry J. Simon, M.D., President and Chief Administrative Officer of NantKwest, both of whom recused themselves from deliberations regarding the merger) declared the merger agreement and the transactions contemplated by the merger agreement advisable, approved and adopted the merger agreement and the transactions contemplated by the merger agreement, and recommends that the NantKwest stockholders vote “FOR” the proposals to be presented at a special meeting of the stockholders of NantKwest seeking approval of the issuance of shares to security holders of ImmunityBio as contemplated by the merger agreement and approval of the merger. The proposal seeking approval of the merger requires the affirmative vote of holders of a majority of the outstanding shares of NantKwest common stock as of January 29, 2021, not held by Dr. Soon-Shiong and his affiliates Cambridge Equities, LP and Chan Soon-Shiong Family Foundation or any of their respective controlled affiliates or any of the directors or executive officers of NantKwest or ImmunityBio.

This document is a proxy statement being provided to NantKwest stockholders in connection with the solicitation of their votes in favor of the proposals to be presented at the NantKwest special meeting. It is also a prospectus relating to the shares of NantKwest common stock to be issued to the ImmunityBio stockholders in the merger and a consent solicitation statement for ImmunityBio to solicit written consents from its stockholders for the adoption of the merger agreement. This document contains answers to frequently asked questions and a summary of the important terms of the merger, the merger agreement and related transactions, followed by a more detailed discussion.


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Your vote on or consent to these matters is very important, regardless of the number of shares that you own. We ask NantKwest stockholders to please submit a proxy to have their shares voted in advance of the NantKwest special meeting by using one of the proxy voting methods described in the accompanying joint proxy and consent solicitation statement/prospectus. In addition, we ask ImmunityBio stockholders to please complete the enclosed written consent as soon as possible and return it promptly to ImmunityBio by one of the means described in the accompanying joint proxy and consent solicitation statement/prospectus.

The obligations of NantKwest and ImmunityBio to complete the merger are subject to the satisfaction or waiver of several conditions set forth in the merger agreement, which is included as Annex A to the accompanying joint proxy and consent solicitation statement/prospectus. Please carefully read this entire document, including “Risk Factors” beginning on page 24, for a discussion of the risks relevant to the merger and the combined company.

We are excited about the opportunities the merger brings to both NantKwest stockholders and ImmunityBio stockholders, and we thank you for your consideration and continued support.

Sincerely,

 

LOGO   LOGO   LOGO

Michael Blaszyk

Chairman of Special Committee

of the Board of Directors

NantKwest, Inc.

 

Patrick Soon-Shiong,

MBBCh., FRCS (C), FACS

Executive Chairman

NantKwest, Inc.

Chairman and Chief Executive Officer

ImmunityBio, Inc.

 

Richard Adcock

Chief Executive Officer

NantKwest, Inc.

Neither the Securities and Exchange Commission nor any state securities regulatory authority has approved or disapproved of the merger or the securities to be issued under this joint proxy and consent solicitation statement/prospectus or has passed upon the adequacy or accuracy of the disclosure in this joint proxy and consent solicitation statement/prospectus. Any representation to the contrary is a criminal offense.

The date of the accompanying joint proxy and consent solicitation statement/prospectus is February 2, 2021, and it is first being mailed or otherwise delivered to NantKwest stockholders and ImmunityBio stockholders on or about February 5, 2021.


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LOGO

NantKwest, Inc.

3530 John Hopkins Court

San Diego, California 92121

(858) 633-0300

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

To the Stockholders of NantKwest, Inc.:

A special meeting of the stockholders of NantKwest, Inc. (“NantKwest”) will be held exclusively online via a live audio webcast at www.proxypush.com/NK on March 8, 2021 at 9:30 a.m., Pacific Time. You are invited to attend and vote your shares at the special meeting so long as you register to attend the special meeting at www.proxydocs.com/NK prior to the registration deadline of 2:00 p.m. Pacific Time on March 4, 2021. There is no physical location for the special meeting. The special meeting is being held for the following purposes:

 

  1.

To consider and vote on a proposal to approve the issuance of shares of common stock, par value $0.0001 per share, of NantKwest (the “NantKwest common stock”) to security holders of ImmunityBio, Inc. (“ImmunityBio”) as contemplated by the Agreement and Plan of Merger, dated as of December 21, 2020 (the “merger agreement”), by and among NantKwest, Nectarine Merger Sub, Inc., a wholly owned subsidiary of NantKwest (“Merger Sub”), and ImmunityBio, attached as Annex A to this joint proxy and consent solicitation statement/prospectus (the “stock issuance proposal”).

 

  2.

To consider and vote on a proposal to approve the merger contemplated by the merger agreement (the “merger proposal”).

 

  3.

To approve the adjournment of the NantKwest special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the stock issuance proposal or the merger proposal (the “adjournment proposal”).

Only holders of record of NantKwest common stock at the close of business on January 29, 2021 (the “NantKwest record date”), will be entitled to notice of and to vote at the special meeting.

In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into a voting agreement with Dr. Patrick Soon-Shiong and certain of his affiliates who collectively owned and are entitled to vote approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to vote their shares of NantKwest common stock in favor of the stock issuance proposal and the adjournment proposal. Because their shares represent more than a majority of shares of NantKwest common stock issued and outstanding as of the NantKwest record date, their vote will ensure the requisite vote will be received to approve such proposals.

The merger proposal requires for approval the affirmative vote of holders of a majority of the outstanding shares of NantKwest common stock as of the NantKwest record date not held by Dr. Soon-Shiong and his affiliates Cambridge Equities, LP and Chan Soon-Shiong Family Foundation or any of their controlled affiliates or any of the directors or executive officers of NantKwest or ImmunityBio.

Your vote is very important! Please vote by telephone, Internet at www.proxypush.com/NK or by completing, signing, dating and returning the enclosed proxy card, whether or not you expect to virtually attend the special meeting, so that your shares of NantKwest common stock may be represented at the special meeting if


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you are unable to virtually attend and vote electronically. Holders of NantKwest common stock of record and beneficial owners will be able to vote their shares electronically at the virtual special meeting. Submitting a vote before the special meeting will not preclude you from voting your shares electronically at the virtual special meeting should you decide to virtually attend. For specific instructions on how to participate in and vote your shares at the virtual special meeting, please refer to the section entitled “Questions and Answers about the Special Meeting and Consent Solicitation—Questions and Answers about the NantKwest Special Meeting” beginning on page 2 of the joint proxy and consent solicitation statement/prospectus.

BY ORDER OF THE NANTKWEST BOARD OF DIRECTORS,

 

LOGO
STEVEN YANG

General Counsel and Corporate Secretary

San Diego, California


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LOGO

ImmunityBio, Inc.

9920 Jefferson Boulevard

Culver City, California 90232

(310) 883-1300

NOTICE OF SOLICITATION OF WRITTEN CONSENT

To the Stockholders of ImmunityBio, Inc.:

The accompanying joint proxy and consent solicitation statement/prospectus is being delivered on behalf of the board of directors (the “ImmunityBio board”) of ImmunityBio, Inc. (“ImmunityBio”), to request that holders of ImmunityBio’s common stock, par value $0.001 (the “ImmunityBio common stock”), as of the close of business on the ImmunityBio record date (as defined below) execute and return written consents to approve the adoption of the Agreement and Plan of Merger, dated as of December 21, 2020, by and among NantKwest, Inc. (“NantKwest”), Nectarine Merger Sub, Inc., a wholly owned subsidiary of NantKwest (“Merger Sub”), and ImmunityBio attached as Annex A to this joint proxy and consent solicitation statement/prospectus (the “merger agreement”).

Pursuant to the merger agreement, Merger Sub will merge with and into ImmunityBio, with ImmunityBio continuing as the surviving corporation and a direct wholly owned subsidiary of NantKwest (the “merger”). In the merger, ImmunityBio stockholders will receive 0.8190 of a share of common stock, par value $0.0001 per share, of NantKwest for each outstanding share of ImmunityBio common stock they own. After the closing of the merger, the combined company shares will be listed on the NASDAQ Global Select Market and are expected to trade under the symbol “IBRX”.

The ImmunityBio board has fixed the close of business on January 29, 2021 as the record date for the consent solicitation.

This joint proxy and consent solicitation statement/prospectus describes the merger and the actions to be taken in connection with the merger and provides additional information about the parties involved. Please give this information your careful attention.

In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into a voting agreement with Dr. Patrick Soon-Shiong and certain of his affiliates who collectively own and are entitled to vote approximately 88.9% of the outstanding shares of ImmunityBio common stock. Pursuant to the voting agreement, those stockholders agreed, among other things, to execute consents in favor of the adoption of the merger agreement and the transactions contemplated thereby within two business days of the date upon which the registration statement to which this accompanying joint proxy and consent solicitation statement/prospectus relates is declared effective. Because their shares represent more than a majority of the shares of ImmunityBio common stock issued and outstanding, their consents represent the requisite consents necessary for the adoption by the ImmunityBio stockholders of the merger agreement and the transactions contemplated thereby.

Your consent is very important! Please complete, date and sign the written consent furnished with the accompanying joint proxy and consent solicitation statement/prospectus and return it promptly to ImmunityBio by one of the means described in the section entitled “Questions and Answers about the Special Meeting and Consent Solicitation—Questions and Answers about ImmunityBio’s Consent Solicitation” beginning on page 6 of this joint proxy and consent solicitation statement/prospectus.

BY ORDER OF THE IMMUNITYBIO BOARD OF DIRECTORS,

 

LOGO     
CHARLES KIM

General Counsel and Corporate Secretary

Culver City, California


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ADDITIONAL INFORMATION

This joint proxy and consent solicitation statement/prospectus incorporates by reference important business and financial information about NantKwest from documents filed with the Securities and Exchange Commission (the “SEC”) that are not included in or delivered with this joint proxy and consent solicitation statement/prospectus. You can obtain any of the documents filed with or furnished to the SEC by NantKwest at no cost from the SEC’s website maintained at http://www.sec.gov. You can also find information about NantKwest and ImmunityBio by visiting NantKwest’s website at www.nantkwest.com or ImmunityBio’s website at www.immunitybio.com. Information contained on these websites does not constitute part of this joint proxy and consent solicitation statement/prospectus.

You may also request copies of documents incorporated by reference into this joint proxy and consent solicitation statement/prospectus, without charge upon your written or oral request by contacting NantKwest at the address or by telephone as specified below:

For NantKwest stockholders:

NantKwest, Inc.

Attn: Investor Relations

3530 John Hopkins Court

San Diego, California 92121

(858) 633-0300

MacKenzie Partners, Inc.

1407 Broadway, 27th Floor

New York, NY 10018

Stockholders may call toll free:

(800) 322-2885

Banks and Brokers may call collect:

(212) 929-5500

If you would like to request any documents, please do so by March 1, 2021, in order to receive them before the NantKwest special meeting.

For a more detailed description of the information incorporated by reference into this joint proxy and consent solicitation statement/prospectus and how you may obtain it, please see “Where You Can Find More Information” on page 321 of this joint proxy and consent solicitation statement/prospectus.


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ABOUT THIS JOINT PROXY AND CONSENT SOLICITATION STATEMENT/PROSPECTUS

This joint proxy and consent solicitation statement/prospectus, which forms part of a registration statement on Form S-4 filed by NantKwest with the SEC, constitutes a prospectus of NantKwest under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of the NantKwest common stock to be issued to ImmunityBio stockholders in the proposed merger pursuant to which a subsidiary of NantKwest will merge with and into ImmunityBio with ImmunityBio continuing as the surviving corporation and a direct wholly owned subsidiary of NantKwest, as more fully described herein. This joint proxy and consent solicitation statement/prospectus also constitutes a proxy statement for NantKwest and a consent solicitation statement for ImmunityBio. In addition, it constitutes a notice of meeting with respect to the NantKwest special meeting and a notice of written consent solicitation of ImmunityBio stockholders.

You should rely only on the information contained in, or incorporated by reference into, this joint proxy and consent solicitation statement/prospectus. No one has been authorized to provide you with information that is different from that contained in, or incorporated by reference into, this joint proxy and consent solicitation statement/prospectus. This joint proxy and consent solicitation statement/prospectus is dated February 2, 2021, and you should assume that the information in this joint proxy and consent solicitation statement/prospectus is accurate only as of such date. You should assume that the information incorporated by reference into this joint proxy and consent solicitation statement/prospectus is accurate as of the date of such incorporated document. Neither the mailing or delivery of this joint proxy and consent solicitation statement/prospectus to NantKwest stockholders and ImmunityBio stockholders nor the issuance of shares of NantKwest common stock in connection with the merger will create any implication to the contrary.

This document does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, or the solicitation of a proxy or consent, in any jurisdiction to or from any person to whom it is unlawful to make any such offer or solicitation in such jurisdiction.


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GLOSSARY

The following terms have the following meanings in this joint proxy and consent solicitation statement/prospectus (unless otherwise noted or the context otherwise requires):

 

   

“bylaws” means, with respect to NantKwest, the Amended and Restated Bylaws of NantKwest and, with respect to ImmunityBio, the Amended and Restated Bylaws of ImmunityBio, in each case as amended;

 

   

“certificate of incorporation” means, with respect to NantKwest, the Amended and Restated Certificate of Incorporation of NantKwest and, with respect to ImmunityBio, the Amended and Restated Certificate of Incorporation of ImmunityBio, in each case as amended;

 

   

“closing date” means the date on which the effective time occurs;

 

   

“combined company” means ImmunityBio and NantKwest on a combined basis following the effective time;

 

   

“dissenting shares” means shares of ImmunityBio common stock held by a holder who has properly exercised (and has not effectively withdrawn or lost) his, her or its appraisal rights under Section 262 of the Delaware General Corporation Law;

 

   

“effective time” means the effective time of the merger;

 

   

“exchange ratio” means the ratio of 0.8190 shares of NantKwest common stock to be issued to the ImmunityBio stockholders in the merger per issued and outstanding share of ImmunityBio common stock;

 

   

“fully diluted basis” means, in the references in this document to the percentage ownership on a fully diluted basis of the shares of the combined company to be owned by ImmunityBio stockholders and/or NantKwest stockholders, as applicable, upon consummation of the merger, the fully diluted number of shares of the combined company calculated treating as vested shares all restricted stock units of ImmunityBio and NantKwest expected to be outstanding as of closing, whether or not they will then be vested, treating as exercisable an outstanding warrant to purchase shares of common stock of ImmunityBio held by an affiliate of Dr. Patrick Soon-Shiong that will only become exercisable if a certain performance condition not yet satisfied is satisfied, and treating as exercisable all outstanding options of ImmunityBio and NantKwest, whether or not vested, but with the number of shares represented by such warrant and options determined using the treasury stock method using the closing share price for the NantKwest common stock of $10.26 on December 18, 2020, the last trading day before the announcement of the proposed merger and with all shares, restricted stock units, options and warrants of ImmunityBio assumed to be converted into equivalent securities of the combined company at the exchange ratio and in the case of warrants and options with the relevant adjustment to their strike price. The fully diluted number of shares of the combined company does not for this purpose take into account any shares of NantKwest, ImmunityBio or the combined company that may be issued in connection with any future capital raising transaction that may occur prior to and/or, in the case of the combined company, after the closing of the merger or any shares potentially issuable upon settlement of the contingent value rights previously issued by ImmunityBio.

 

   

“GAAP” means accounting principles generally accepted in the United States of America;

 

   

“ImmunityBio” means ImmunityBio, Inc., a Delaware corporation;

 

   

“ImmunityBio board” means the ImmunityBio board of directors;

 

   

“ImmunityBio common stock” means the common stock, par value $0.001 per share, of ImmunityBio;

 

   

“ImmunityBio stockholders” means the holders of ImmunityBio common stock;

 

   

“merger” means the merger of Merger Sub with and into ImmunityBio pursuant to the merger agreement, with ImmunityBio surviving the merger as the surviving corporation and a wholly owned subsidiary of NantKwest;

 

   

“merger agreement” means the Agreement and Plan of Merger, dated as of December 21, 2020, by and among NantKwest, Merger Sub and ImmunityBio, as amended from time to time;


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“merger consideration” means the right to receive 0.8190 newly issued shares of NantKwest common stock;

 

   

“Merger Sub” means Nectarine Merger Sub, Inc., a Delaware corporation and direct wholly owned subsidiary of NantKwest;

 

   

“NantKwest” means NantKwest, Inc., a Delaware corporation;

 

   

“NantKwest board” means the NantKwest board of directors;

 

   

“NantKwest common stock” means the common stock, par value $0.0001 per share, of NantKwest;

 

   

“NantKwest special committee” means the special committee of independent and disinterested directors of NantKwest formed by the NantKwest board to, among other things, evaluate and negotiate the terms and conditions of the merger and to make a recommendation to the NantKwest board regarding the merger;

 

   

“NantKwest special meeting” means the meeting of the NantKwest stockholders in connection with the merger, as it may be adjourned or postponed from time to time;

 

   

“NantKwest stockholders” means the holders of NantKwest common stock;

 

   

“outside date” means September 20, 2021; and

 

   

“surviving corporation” means ImmunityBio as the surviving entity of the merger.

All currency amounts referenced in this joint proxy and consent solicitation statement/prospectus are in U.S. dollars.


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QUESTIONS AND ANSWERS ABOUT THE SPECIAL MEETING AND CONSENT SOLICITATION

     1  

SUMMARY

     10  

The Parties

     10  

NantKwest Special Meeting

     10  

ImmunityBio Solicitation of Written Consents

     12  

The Merger

     12  

Merger Consideration

     12  

Recommendations of the NantKwest Special Committee and the NantKwest Board of Directors; Reasons for the Merger

     13  

Recommendation of the ImmunityBio Board of Directors and Reasons for the Merger

     13  

Opinion of the Financial Advisor to the NantKwest Special Committee

     13  

Board of Directors and Management of the Combined Company Following Completion of the Merger

     14  

Ownership of the Combined Company after the Merger

     14  

Interests of Certain NantKwest Directors and Executive Officers in the Merger

     14  

Interests of Certain ImmunityBio Directors and Executive Officers in the Merger

     15  

Material U.S. Federal Income Tax Consequences

     15  

Accounting Treatment of the Merger

     15  

Federal Securities Law Consequences

     15  

Regulatory Approvals

     16  

NASDAQ Listing of Combined Company Stock

     16  

Appraisal Rights or Dissenters’ Rights

     16  

Overview of the Merger Agreement

     16  

Overview of the Voting Agreements

     20  

Market Price Data and Dividend Information

     21  

Risk Factors

     22  

RISK FACTORS

     24  

Risks Relating to the Merger

     24  

Risks Relating to the Combined Company Following the Merger

     26  

Risks Related to Government Regulation

     70  

Risks Related to Intellectual Property

     86  

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

     98  

NANTKWEST SPECIAL MEETING

     100  

THE NANTKWEST PROPOSALS

     107  

NantKwest Proposal 1: The NantKwest Stock Issuance Proposal

     107  

NantKwest Proposal 2: The NantKwest Merger Proposal

     108  

NantKwest Proposal 3: The NantKwest Adjournment Proposal

     109  

IMMUNITYBIO SOLICITATION OF WRITTEN CONSENTS

     110  

THE MERGER

     112  

General Information

     112  

Background of the Merger

     112  

Recommendations of the NantKwest Special Committee and the NantKwest Board of Directors; Reasons for the Merger

     126  

Recommendation of the ImmunityBio Board of Directors and Reasons for the Merger

     132  

Opinion of the Financial Advisor to the NantKwest Special Committee

     134  

Certain Unaudited Prospective Financial and Operating Information

     142  

Board of Directors and Management of the Combined Company Following Completion of the Merger

     152  

Ownership of the Combined Company after the Merger

     154  

Interests of Certain NantKwest Directors and Executive Officers in the Merger

     154  

Interests of Certain ImmunityBio Directors and Executive Officers in the Merger

     156  

 

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Material U.S. Federal Income Tax Consequences

     157  

Accounting Treatment of the Merger

     157  

Federal Securities Law Consequences

     157  

Regulatory Approvals

     157  

Exchange of Shares

     158  

NASDAQ Listing of Combined Company Stock

     158  

Appraisal Rights or Dissenters’ Rights

     158  

THE MERGER AGREEMENT AND VOTING AGREEMENTS

     162  

Description of the Merger Agreement

     162  

Description of the Voting Agreements

     183  

MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES

     185  

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

     188  

BUSINESS OF IMMUNITYBIO

     197  

Overview

     197  

Our History

     198  

Our Platform

     199  

Our Pipeline

     204  

Employees

     246  

Manufacturing

     247  

License and Collaboration Agreements

     248  

Competition

     258  

Government Regulation

     259  

Facilities

     274  

Legal Proceedings

     275  

MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OF IMMUNITYBIO

     279  

Overview

     279  

Components of Our Results of Operations

     280  

Results of Operations

     282  

Liquidity and Capital Resources; Plan of Operations

     287  

Contractual Obligations and Commitments

     291  

Off-Balance Sheet Arrangements

     291  

Critical Accounting Policies and Significant Judgments and Estimates

     291  

Contingencies

     295  

Recent Accounting Pronouncements

     295  

Quantitative and Qualitative Disclosures about Market Risk

     295  

IMMUNITYBIO EXECUTIVE COMPENSATION

     296  

Summary Compensation Table

     296  

Outstanding Equity Awards at Fiscal Year-End

     296  

Employment Arrangements with Our Named Executive Officers

     297  

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS OF IMMUNITYBIO

     298  

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT OF IMMUNITYBIO

     307  

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT OF NANTKWEST

     309  

COMPARISON OF STOCKHOLDER RIGHTS

     310  

Comparison of Stockholder Rights

     310  

PROPOSALS OF STOCKHOLDERS FOR NANTKWEST’S 2021 ANNUAL MEETING

     317  

LEGAL MATTERS

     318  

EXPERTS

     319  

NantKwest, Inc.

     319  

ImmunityBio, Inc.

     319  

 

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QUESTIONS AND ANSWERS ABOUT THE SPECIAL MEETING AND CONSENT SOLICITATION

The following questions and answers are intended to address briefly some commonly asked questions regarding the merger and the NantKwest special meeting and certain procedures for ImmunityBio stockholders to deliver their written consents. These questions and answers may not address all questions that may be important to you as a NantKwest stockholder or an ImmunityBio stockholder. To better understand these matters, and for a description of the legal terms governing the merger, you should carefully read this entire joint proxy and consent solicitation statement/prospectus, including the annexes, as well as the documents that have been incorporated by reference into this joint proxy and consent solicitation statement/prospectus. See “Where You Can Find More Information” beginning on page 321. NantKwest and ImmunityBio are each first mailing this joint proxy and consent solicitation statement/prospectus to their respective stockholders on or about February 5, 2021.

QUESTIONS AND ANSWERS ABOUT THE MERGER

 

Q:

What is the merger, and why am I receiving this document?

 

A:

On December 21, 2020, NantKwest and ImmunityBio entered into a merger agreement providing for the combination of the two companies to create a leading immunotherapy and cell therapy company focused on oncology and infectious disease. The combination will be implemented by means of a merger of a NantKwest subsidiary with and into ImmunityBio, resulting in ImmunityBio becoming a wholly-owned subsidiary of NantKwest. In connection with the closing of the merger, the combined company will assume the ImmunityBio name, and following the closing, its shares of common stock will be listed on the NASDAQ Global Select Market (the “NASDAQ”) and are expected to trade under the symbol “IBRX”.

NantKwest will hold the NantKwest special meeting to, among other things, obtain the approvals of NantKwest stockholders required to complete the merger, and NantKwest stockholders are receiving this document to help them decide how to vote their shares of NantKwest common stock with respect to the matters to be considered at the NantKwest special meeting. The merger cannot be completed unless NantKwest’s stockholders approve at the NantKwest special meeting a proposal to issue common stock in connection with the merger and a proposal in favor of the merger. ImmunityBio is also providing this document to its stockholders to solicit written consent to adopt the merger agreement. A copy of the merger agreement is attached to this joint proxy and consent solicitation statement/prospectus as Annex A. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Conditions to Completion of the Merger” beginning on page 178.

We urge you to read carefully this joint proxy and consent solicitation statement/prospectus, including the Annexes and the other documents referred to herein, in their entirety.

 

Q:

What will ImmunityBio stockholders receive in the merger?

 

A:

If the merger is completed, each share of ImmunityBio common stock issued and outstanding immediately prior to the effective time of the merger (other than shares directly owned by ImmunityBio as treasury stock or dissenting shares) will be converted into the right to receive 0.8190 shares of NantKwest common stock. Upon consummation of the merger, ImmunityBio stockholders will own approximately 72% of the outstanding shares of the combined company and NantKwest stockholders will own approximately 28% of the outstanding shares of the combined company, in each case, on a fully diluted basis. NantKwest, ImmunityBio and/or the combined company intend to issue additional shares in connection with one or more capital raising transactions that may occur prior to and/or, in the case of the combined company, after the closing of the merger. The percentages above do not take into account any such future shares issuances; any such shares issuances would proportionately reduce the percentage ownership of the existing NantKwest and ImmunityBio stockholders in the combined company.

 

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Q:

When do you expect the merger to be completed?

 

A:

It is currently anticipated that the merger will be consummated promptly following the NantKwest special meeting, which is set for March 8, 2021; however, the meeting could be adjourned or postponed, as described herein. Moreover, neither NantKwest nor ImmunityBio can assure you of when or if the merger will be completed and it is possible that factors outside of the control of both companies could result in the merger being completed at a different time or not at all. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Conditions to Completion of the Merger” beginning on page 178.

 

Q:

What happens if the merger is not completed?

 

A:

If the merger is not completed, NantKwest and ImmunityBio will remain separate companies. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Termination of the Merger Agreement” and “Risk Factors” beginning on page 179 and page 24, respectively.

QUESTIONS AND ANSWERS ABOUT THE NANTKWEST SPECIAL MEETING

 

Q:

When and where is the NantKwest special meeting?

 

A:

The NantKwest special meeting will be held at 9:30 a.m., Pacific Time, on March 8, 2021, in virtual format. NantKwest stockholders may attend, vote and examine the list of NantKwest stockholders entitled to vote at the NantKwest special meeting by visiting www.proxypush.com/NK. NantKwest stockholders may attend the NantKwest special meeting by registering in advance prior to the registration deadline of 2:00 p.m. Pacific Time on March 4, 2021 at www.proxydocs.com/NK and entering the control number found on their proxy card. In light of public health concerns regarding the COVID-19 pandemic, the NantKwest special meeting will be held in virtual meeting format only. You will not be able to attend the NantKwest special meeting physically.

 

Q:

What am I being asked to vote on and why is this approval necessary?

 

A:

The stockholders of NantKwest are being asked to vote on the following:

 

  1.

A proposal to issue shares of NantKwest common stock to ImmunityBio stockholders as contemplated by the merger agreement (the “stock issuance”, and this proposal, the “stock issuance proposal”).

 

  2.

A proposal to approve the merger (the “merger proposal”).

 

  3.

A proposal to approve the adjournment of the NantKwest special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the stock issuance proposal or the merger proposal (the “adjournment proposal”).

NantKwest will hold the NantKwest special meeting to consider and vote upon these proposals. This joint proxy and consent solicitation statement/prospectus contains important information about the proposed merger and the other matters to be acted upon at the NantKwest special meeting.

Consummation of the merger is conditioned on approval of each of the merger proposal and the stock issuance proposal, subject to the terms of the merger agreement.

The vote of NantKwest stockholders is important. NantKwest stockholders are encouraged to vote as soon as possible after carefully reviewing this joint proxy and consent solicitation statement/prospectus.

 

Q:

What constitutes a quorum at the NantKwest special meeting?

 

A:

A majority of the voting power of the NantKwest common stock issued, outstanding and entitled to vote, present in person (which would include presence at a virtual meeting) or represented by proxy, is necessary

 

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  to constitute a quorum. Abstentions and broker non-votes will be counted as present and entitled to vote for purposes of determining a quorum. However, because all proposals at the NantKwest special meeting are expected to be non-routine, NantKwest does not expect to receive any broker non-votes (which are shares of NantKwest common stock held by brokers, banks or other nominees with respect to which the broker, bank or other nominee is not instructed by the beneficial owner of such shares how to vote on a particular proposal and the broker, bank or other nominee does not have discretionary voting power on such proposal). In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the NantKwest voting agreement with the NantKwest significant stockholders who collectively owned approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to be present at the NantKwest special meeting in person (which would include presence at a virtual meeting) or by proxy. As such, a quorum at the NantKwest special meeting is expected to be present.

 

Q:

What vote is required to approve each proposal at the NantKwest special meeting?

 

A:

The stock issuance proposal: Per the NASDAQ rules, the affirmative vote of a majority of the votes cast by the stockholders present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting is required to approve the stock issuance proposal. As described above, in connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the NantKwest voting agreement with Dr. Patrick Soon-Shiong and his affiliates Cambridge Equities, LP and Chan Soon-Shiong Family Foundation (collectively, the “NantKwest significant stockholders”) who collectively owned and are entitled to vote approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, the NantKwest significant stockholders agreed, among other things, to vote their shares of NantKwest common stock in favor of the stock issuance proposal. Because their shares represent more than a majority of shares of NantKwest common stock issued and outstanding, their vote will ensure the requisite vote will be received to approve the stock issuance proposal.

The merger proposal: The affirmative vote of holders of a majority of all of the outstanding shares of NantKwest common stock as of the NantKwest record date, other than shares of NantKwest common stock held by the NantKwest significant stockholders or any of their respective controlled affiliates or any directors or executive officers of NantKwest or ImmunityBio is required to approve the merger proposal. If such majority of the minority of NantKwest stockholders fails to approve the merger proposal, the merger will not occur.

The adjournment proposal: The affirmative vote of a majority of the voting power of the shares of NantKwest common stock present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting and entitled to vote on the proposal is required to approve the adjournment proposal. Votes by the NantKwest significant stockholders in favor of the adjournment proposal will constitute the required stockholder approval for the adjournment proposal. The vote on the adjournment proposal is a vote separate and apart from the votes to approve the stock issuance proposal and the merger proposal. NantKwest does not intend to call a vote on this proposal if the stock issuance proposal and the merger proposal are approved at the NantKwest special meeting. The merger is not conditioned on the approval of the adjournment proposal.

 

Q:

What do I need to do now?

 

A:

NantKwest urges you to read carefully and consider the information contained in this joint proxy and consent solicitation statement/prospectus, including the Annexes and the other documents referred to herein, and to consider how the merger will affect you as a NantKwest stockholder. NantKwest stockholders should then vote as soon as possible in accordance with the instructions provided in this joint proxy and consent solicitation statement/prospectus and on the enclosed proxy card.

 

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Q:

How do I vote?

 

A:

After reading and carefully considering the information contained in this joint proxy and consent solicitation statement/prospectus, a NantKwest stockholder may submit a proxy or voting instructions for its shares of NantKwest common stock before the NantKwest special meeting in one of the following ways:

 

   

By Internet. If you are a registered owner of shares of NantKwest common stock, use the Internet to submit your proxy instructions and for the electronic delivery of information at any time before the NantKwest special meeting. Have the proxy card accompanying this joint proxy and consent solicitation statement/prospectus in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form. If your shares are held in “street name” in a stock brokerage account or by a broker, bank or other nominee, you must provide the record holder of your shares with instructions on how to vote your shares. The availability of Internet voting for beneficial owners holding shares of NantKwest common stock in “street name” will depend on the voting process of your broker, bank or other nominee. If you are a beneficial owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

 

   

By Phone. If you are a registered owner of shares of NantKwest common stock, use any touch-tone telephone to dial 866-249-5381 to submit your proxy instructions at any time before the NantKwest special meeting. Have your proxy card in hand when you call and then follow the instructions. If you submit a proxy by telephone, do not return your proxy card or voting instructions. The availability of telephone voting for beneficial owners holding shares of NantKwest common stock in “street name” will depend on the voting process of your broker, bank or other nominee. If you are an owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

 

   

By Mail. Mark, sign and date your proxy card and return it in the postage-paid envelope we have provided. If you are a beneficial owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

In addition, NantKwest stockholders may vote at the NantKwest special meeting, which will be conducted exclusively online via live audio webcast at www.proxypush.com/NK starting at 9:30 a.m., Pacific Time, on March 8, 2021. If NantKwest stockholders wish to ask a question to directors and/or members of management, please note that such questions must be submitted in advance of the NantKwest special meeting. To submit a question, mark the box on the proxy card when registering to attend the NantKwest special meeting and submit your written question or submit a question at www.proxydocs.com/NK after logging in with your control number. You will also be able to vote your shares electronically at the NantKwest special meeting by going to www.proxydocs.com/NK and registering in advance of 2:00 p.m. Pacific Time on March 4, 2021 and entering your control number, which is included on the proxy card that you received. Because the NantKwest special meeting is completely virtual and being conducted online via live audio webcast, stockholders will not be able to attend the meeting in person (which would include presence at a virtual meeting). Note that if your shares are held in the name of your broker, bank or other nominee and you wish to vote in person at the NantKwest special meeting, you must contact your broker, bank or other nominee and request a document called a “legal proxy.” You must submit this legal proxy in order to vote in person (which would include presence at a virtual meeting), and you must also register in advance as described above.

 

Q:

If my shares are held in “street name” by a broker, bank or other nominee, will my broker, bank or other nominee vote my shares for me?

 

A:

If your shares are held in “street name” in a stock brokerage account or by a broker, bank or other nominee, you must provide your broker, bank or other nominee with instructions on how to vote your shares. Please follow the voting instructions in the materials provided by your broker, bank or other nominee.

 

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Brokers who hold shares in “street name” for a beneficial owner of those shares typically have the authority to vote in their discretion on “routine” proposals when they have not received instructions from beneficial owners. However, brokers are not permitted to exercise their voting discretion with respect to the approval of matters that are “non-routine” without specific instructions from the beneficial owner. All proposals to be voted on at the NantKwest special meeting are expected to be “non-routine.”

If you are a NantKwest stockholder holding your shares in “street name” and you do not instruct your broker, bank or other nominee on how to vote your shares, your broker, bank or other nominee will not vote your shares on the stock issuance proposal, merger proposal or the adjournment proposal. The failure to instruct your broker, bank or other nominee on how to vote your shares will have no effect on the vote count for the stock issuance proposal or the adjournment proposal, but will have the same effect as a vote against the merger proposal.

 

Q:

What if I attend the NantKwest special meeting and abstain or do not vote?

 

A:

At the NantKwest special meeting:

 

  1.

Abstentions will not be counted as votes cast on the stock issuance proposal and therefore will have no effect on the outcome of the stock issuance proposal. Because the stock issuance proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the NantKwest stock issuance proposal and will not be able to vote on the stock issuance proposal without receiving specific voting instructions from the beneficial owner. The failure of a beneficial owner to provide voting instructions to its broker, bank or other nominee will result in the applicable shares not being counted in determining the votes cast in connection with the stock issuance proposal, and will therefore have no effect on the outcome of the stock issuance proposal.

 

  2.

Abstentions and shares deemed not in attendance at the NantKwest special meeting, whether due to a record holder’s failure to vote or a “street name” holder’s failure to provide any voting instructions to such holder’s broker, bank or other nominee, will have the same effect as a vote “AGAINST” the merger proposal. Because the merger proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the merger proposal and will not be able to vote on the merger proposal without receiving specific voting instructions from the beneficial owner.

 

  3.

Abstentions with respect to the adjournment proposal also will have the effect of a vote “AGAINST” such proposal. Because the adjournment proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the adjournment proposal and will not be able to vote on the adjournment proposal without receiving specific voting instructions from the beneficial owner.

In addition, the votes approving the stock issuance proposal required to be cast by the NantKwest significant stockholders pursuant to the NantKwest voting agreement will constitute the required stockholder approval for the stock issuance proposal, and their votes in favor of the adjournment proposal will constitute the required stockholder approval for the adjournment proposal. Therefore, a failure of any other NantKwest stockholder to vote to approve the stock issuance proposal or the adjournment proposal is not expected to have any effect on the approval of the stock issuance proposal or the adjournment proposal.

 

Q:

What will happen if I return my proxy card without indicating how to vote?

 

A:

If you sign and return your proxy card (or provide proxy instructions by means of the Internet or telephone) without indicating your vote on any particular proposal, the NantKwest common stock represented by your proxy will be voted as recommended by the NantKwest board with respect to that proposal.

 

Q:

May I change my vote after I have mailed my signed proxy card?

 

A:

Yes. NantKwest stockholders may send a later-dated, signed proxy card to P.O. Box 8016, Cary, NC 27512, so that it is received prior to the vote at the NantKwest special meeting or attend the NantKwest special

 

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  meeting in person (which would consist of presence at a virtual meeting) and vote. NantKwest stockholders also may revoke their proxy by sending a notice of revocation to P.O. Box 8016, Cary, NC 27512, which must be received prior to the vote at the NantKwest special meeting.

If you attend the NantKwest special meeting and vote online, any votes that you previously submitted — whether via the Internet, by telephone or by mail — will be revoked and superseded by the vote that you cast at the NantKwest special meeting.

 

Q:

What happens if I fail to take action with respect to the NantKwest special meeting?

 

A:

If you fail to take any action with respect to the NantKwest special meeting and the merger is approved by stockholders and consummated, you will be a stockholder of the combined company. If you fail to take any action with respect to the NantKwest special meeting and the merger is not approved, you will continue to be a stockholder of NantKwest.

 

Q:

What should I do if I receive more than one set of voting materials?

 

A:

NantKwest stockholders may receive more than one set of voting materials, including multiple copies of this joint proxy and consent solicitation statement/prospectus and multiple proxy cards or voting instruction cards. For example, if you hold your shares in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold shares. If you are a holder of record and your shares are registered in more than one name, you will receive more than one proxy card. Please complete, sign, date and return each proxy card and voting instruction card that you receive (or vote by means of Internet or telephone) in order to cast a vote with respect to all of your shares of NantKwest common stock.

 

Q:

Who can help answer my questions?

 

A:

If you have questions about the merger or if you need additional copies of the joint proxy and consent solicitation statement/prospectus or the enclosed proxy card you should contact: MacKenzie Partners, Inc. toll-free at 800-322-2885 or collect at 212-929-5500.

You may also obtain additional information about NantKwest from documents filed with the SEC by following the instructions in the section entitled “Where You Can Find More Information” on page 321.

QUESTIONS AND ANSWERS ABOUT IMMUNITYBIO’S CONSENT SOLICITATION

 

Q:

Did the ImmunityBio board approve the merger agreement?

 

A:

Yes. Following a review of the merger agreement and of the negotiations between ImmunityBio, NantKwest and their respective representatives with respect to the merger agreement, the ImmunityBio board, including its independent director, unanimously approved and declared advisable the merger agreement and the merger, upon the terms and conditions set forth in the merger agreement, and unanimously determined that the merger agreement and the merger are in the best interests of ImmunityBio and its stockholders. See “The Merger—Recommendation of the ImmunityBio Board of Directors and Reasons for the Merger” beginning on page 132.

 

Q:

What am I being asked to approve?

 

A:

ImmunityBio stockholders are being asked to approve the proposal to adopt the merger agreement and the transactions contemplated thereby (the “ImmunityBio merger proposal”).

 

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Q:

What is the recommendation of the ImmunityBio board?

 

A:

The ImmunityBio board, including its independent director, unanimously recommends that the ImmunityBio stockholders approve the ImmunityBio merger proposal.

 

Q:

Who is entitled to give a written consent for ImmunityBio?

 

A:

The record date for determining the holders of ImmunityBio common stock entitled to execute and deliver written consents with respect to this solicitation is January 29, 2021, the ImmunityBio record date. ImmunityBio stockholders on the ImmunityBio record date will be entitled to give or withhold a consent using the written consent furnished with this joint proxy and consent solicitation statement/prospectus.

 

Q:

What approval is required by ImmunityBio stockholders to adopt the merger agreement?

 

A:

The approval of the ImmunityBio merger proposal requires the affirmative vote or consent of the holders of a majority of the voting power of the outstanding shares of ImmunityBio common stock (the “ImmunityBio stockholder approval”).

In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into a voting agreement (the “ImmunityBio voting agreement”) with Dr. Patrick Soon-Shiong and certain of his affiliates who, collectively, own approximately 88.9% of the outstanding shares of ImmunityBio common stock. Pursuant to the ImmunityBio voting agreement, those stockholders agreed, among other things, to execute consents in favor of the adoption of the merger agreement and the transactions contemplated thereby within two business days of the date upon which the registration statement to which this joint proxy and consent solicitation statement/prospectus relates is declared effective. Because their shares represent more than a majority of the shares of ImmunityBio common stock issued and outstanding, their consents represent the requisite consents necessary for the adoption by the ImmunityBio stockholders of the merger agreement and the transactions contemplated thereby. See “The Merger Agreement and Voting Agreements—Description of the Voting Agreements—The ImmunityBio Voting Agreement” on page 184 for additional information.

 

Q:

How can I return my written consent?

 

A:

If you hold shares of ImmunityBio common stock as of the close of business on the ImmunityBio record date and you wish to give your written consent, you must fill out the enclosed written consent, date and sign it, and promptly return it to ImmunityBio. Once you have completed, dated and signed the written consent, you may deliver it to ImmunityBio by emailing a .pdf copy to NKMergerVote@immunitybio.com or by mailing your written consent to 2040 East Mariposa Avenue, El Segundo, California 90245. ImmunityBio will not call or convene any meeting of its stockholders in connection with the approval of the ImmunityBio merger proposal. ImmunityBio stockholders should not send stock certificates with their written consents.

 

Q:

What happens if I do not return my written consent?

 

A:

If you hold shares of ImmunityBio common stock as of the ImmunityBio record date and you do not return your written consent, it will have the same effect as a vote against the ImmunityBio merger proposal. However, the execution and delivery of written consents by Dr. Patrick Soon-Shiong and certain of his affiliates pursuant to the ImmunityBio voting agreement will constitute the ImmunityBio stockholder approval at the time of such delivery. Therefore, a failure of any other ImmunityBio stockholder to deliver a written consent is not expected to have any effect on the approval of the ImmunityBio merger proposal.

 

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Q:

What happens if I return my written consent but do not indicate a decision with respect to the proposal?

 

A:

If you hold shares of ImmunityBio common stock as of the ImmunityBio record date and you return a signed written consent without indicating your decision on the ImmunityBio merger proposal, you will have given your consent to approve such proposal.

 

Q:

Can I change or revoke my written consent?

 

A:

Yes. You may change or revoke your consent at any time before the closing of the merger. If you wish to change or revoke your consent, you may do so by sending in a new written consent with a later date by one of the means described in the section entitled “ImmunityBio Solicitation of Written Consents—Submission of Written Consents” on page 110.

 

Q:

What do I need to do now?

 

A:

ImmunityBio urges you to read carefully and consider the information contained in this joint proxy and consent solicitation statement/prospectus, including the Annexes and the other documents referred to herein, and to consider how the merger will affect you as a stockholder of ImmunityBio. The ImmunityBio board, including its independent director, unanimously recommends that all ImmunityBio stockholders approve the ImmunityBio merger proposal by executing and returning to ImmunityBio the written consent furnished with this joint proxy and consent solicitation statement/prospectus as soon as possible and no later than the consent deadline.

 

Q:

What will happen to my existing share of ImmunityBio common stock in the merger?

 

A:

At the effective time of the merger, your shares of ImmunityBio common stock will no longer represent an ownership interest in ImmunityBio, as each share of ImmunityBio common stock issued and outstanding immediately prior to the effective time (other than any cancelled shares or dissenting shares) will be cancelled and automatically converted into the right to receive 0.8190 of a share of NantKwest common stock, with any cash amount payable in respect of fractional shares of NantKwest common stock. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Merger Consideration” on page 163.

 

Q:

Do I have appraisal rights if I object to the merger?

 

A:

Yes. ImmunityBio stockholders have appraisal rights in connection with the merger under the Delaware General Corporation Law (the “DGCL”). See the section entitled “The Merger—Appraisal Rights or Dissenters’ Rights” on page 158.

 

Q:

Should I send my stock certificates to ImmunityBio now?

 

A:

No. Do not send in your certificates now. After the transaction is completed, a letter of transmittal and written instructions for the surrender of ImmunityBio stock certificates or electronic certificates, as applicable, will be mailed to ImmunityBio stockholders.

 

Q:

Who can help answer my questions?

 

A:

If you have questions about the transaction or the process for returning your written consent, or if you need additional copies of this joint proxy and consent solicitation statement/prospectus or a replacement written consent, please contact ImmunityBio, Inc. at NKMergerVote@immunitybio.com.

 

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Q:

What are the U.S. federal income tax consequences of the merger to U.S. Holders of ImmunityBio common stock?

 

A:

NantKwest and ImmunityBio intend that the merger qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”). It is a condition to ImmunityBio’s obligation to complete the merger that ImmunityBio receive an opinion from Fried, Frank, Harris, Shriver & Jacobson LLP (“Fried Frank”) or another nationally recognized law firm reasonably acceptable to ImmunityBio, to the effect that the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. If the merger qualifies as a reorganization for U.S. federal income tax purposes, U.S. Holders (as defined below in “Material U.S. Federal Income Tax Consequences”) of ImmunityBio common stock generally will not recognize any gain or loss for U.S. federal income tax purposes upon the exchange of shares of ImmunityBio common stock for shares of NantKwest common stock in the merger.

Please review the information set forth in the section entitled “Material U.S. Federal Income Tax Consequences” on page 185 for a more complete description of the material U.S. federal income tax consequences of the merger. The tax consequences to you of the merger will depend on your particular facts and circumstances. Please consult your own tax advisors as to the specific tax consequences to you of the merger.

 

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SUMMARY

The following summary highlights selected information described in more detail elsewhere in this joint proxy and consent solicitation statement/prospectus and the documents incorporated by reference into this joint proxy and consent solicitation statement/prospectus and may not contain all the information that may be important to you. To understand the merger and the matters being voted on by NantKwest stockholders at the NantKwest special meeting and ImmunityBio stockholders by written consent more fully, and to obtain a more complete description of the legal terms of the merger agreement and the agreements related thereto, you should carefully read this entire document, including the annexes and the documents incorporated by reference herein and to which NantKwest and ImmunityBio refer you. Each item in this summary includes a page reference directing you to a more complete description of that topic. See “Where You Can Find More Information”.

The Parties

NantKwest, Inc.

NantKwest is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. NantKwest is a Delaware corporation, and its common stock has been listed and traded on the NASDAQ under the ticker symbol “NK”. NantKwest’s principal executive office is located at 3530 John Hopkins Court, San Diego, California 92121, and its telephone number is (858) 633-0300. Additional information about NantKwest is included in documents incorporated by reference in this joint proxy and consent solicitation statement/prospectus. See “Where You Can Find More Information” beginning on page 321.

ImmunityBio, Inc.

ImmunityBio is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. ImmunityBio’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory”. ImmunityBio is a Delaware corporation. ImmunityBio’s principal executive office is located at 9920 Jefferson Boulevard, Culver City, California 90232, and its telephone number is (310) 883-1300. Additional information about ImmunityBio is included in this joint proxy and consent solicitation statement/prospectus. See “Business of ImmunityBio” beginning on page 197.

Nectarine Merger Sub, Inc.

Merger Sub, a direct wholly-owned subsidiary of NantKwest, is a Delaware corporation formed on December 17, 2020, for the purpose of effecting the merger. Merger Sub has not conducted any activities other than those incidental to its formation and the matters contemplated by the merger agreement.

NantKwest Special Meeting (See page 100)

The NantKwest special meeting will be conducted exclusively online via live audio webcast at www.proxypush.com/NK starting at 9:30 a.m., Pacific Time, on March 8, 2021. You will be able to attend the NantKwest special meeting online and vote your shares electronically at the NantKwest special meeting by registering in advance prior to the deadline of 2:00 p.m. Pacific Time on March 4, 2021 at www.proxydocs.com/NK and entering your control number, which is included on the proxy card that you received. Because the NantKwest special meeting is completely virtual and being conducted online via live audio webcast, stockholders will not be able to attend the meeting in person.



 

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At the NantKwest special meeting, NantKwest stockholders will be asked to consider and vote upon the following items:

 

  1.

Stock issuance proposal: to approve the issuance of shares of NantKwest common stock to security holders of ImmunityBio as contemplated by the merger agreement, a copy of which is attached as Annex A to this joint proxy and consent solicitation statement/prospectus;

 

  2.

Merger proposal: to approve the merger contemplated by the merger agreement; and

 

  3.

Adjournment proposal: to approve the adjournment of the NantKwest special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the stock issuance proposal or the merger proposal.

Only NantKwest stockholders who held NantKwest common stock of record as of the close of business on January 29, 2021, the NantKwest record date, are entitled to vote at the NantKwest special meeting or any adjournments or postponements thereof. Each stockholder shall be entitled to one vote for each share of NantKwest common stock held by such stockholder.

In order for business to be conducted at the NantKwest special meeting, a quorum must be present. At the NantKwest special meeting, a majority of the voting power of the stock issued, outstanding and entitled to vote, present in person (which would include presence at a virtual meeting) or represented by proxy, is necessary to constitute a quorum. Abstentions and broker non-votes will be counted as present and entitled to vote for purposes of determining a quorum. However, because all proposals at the NantKwest special meeting are expected to be non-routine, NantKwest does not expect to receive any broker non-votes (which are shares of NantKwest common stock held by brokers, banks or other nominees with respect to which the broker, bank or other nominee is not instructed by the beneficial owner of such shares how to vote on a particular proposal and the broker, bank or other nominee does not have discretionary voting power on such proposal).

Approval of the stock issuance proposal requires the affirmative vote of a majority of the votes cast by the stockholders present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting.

Approval of the merger proposal requires the affirmative vote of holders of a majority of all of the outstanding shares of NantKwest common stock as of the NantKwest record date, other than shares of NantKwest common stock held by the NantKwest significant stockholders or any of their respective controlled affiliates or any directors or executive officers of NantKwest or ImmunityBio.

Approval of the adjournment proposal requires the affirmative vote of a majority of the voting power of the shares of NantKwest common stock present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting and entitled to vote on the proposal.

Abstentions or a NantKwest stockholder’s failure to vote will not be counted as votes cast on the stock issuance proposal and therefore will have no effect on the outcome of the stock issuance proposal; however, an abstention or failure to vote with respect to the merger proposal will have the same effect as a vote “AGAINST” such proposal and an abstention or failure to vote with respect to the adjournment proposal by a NantKwest stockholder present in person or represented by proxy at the NantKwest special meeting and entitled to vote on the proposal will have the same effect as a vote “AGAINST” such proposal.

As of January 29, 2021, the directors and executive officers of NantKwest and their respective affiliates own approximately, in the aggregate, 73,725,413 shares of NantKwest common stock, or approximately 67.63% of the voting power of the issued and outstanding shares of NantKwest common stock.



 

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ImmunityBio Solicitation of Written Consents (See page 110)

ImmunityBio stockholders are being asked to adopt and approve the ImmunityBio merger proposal by executing and delivering the written consent furnished with this joint proxy and consent solicitation statement/prospectus.

Only ImmunityBio stockholders of record as of the close of business on January 29, 2021, the ImmunityBio record date, will be entitled to execute and deliver a written consent. Each holder of ImmunityBio common stock is entitled to one vote for each share of ImmunityBio common stock held as of the ImmunityBio record date.

The approval of the ImmunityBio merger proposal requires the affirmative vote or consent of the holders of a majority of the voting power of the outstanding shares of ImmunityBio common stock. An ImmunityBio stockholder’s failure to return such stockholder’s consent will have a same effect as a vote against the ImmunityBio merger proposal.

As of January 29, 2021, directors and executive officers of ImmunityBio and their affiliates beneficially owned and were entitled to vote 296,963,072 shares of ImmunityBio common stock, representing approximately 88.9% of the ImmunityBio common stock outstanding on that date.

The Merger (See page 112)

Under the terms and subject to the conditions set forth in the merger agreement, at the effective time, Merger Sub will merge with and into ImmunityBio and the separate corporate existence of Merger Sub shall thereupon cease. ImmunityBio will survive the merger as the surviving corporation and a direct wholly-owned subsidiary of NantKwest. Prior to the closing of the merger, the NantKwest board shall take all action necessary, including approving amendments to its certificate of incorporation and bylaws as necessary, to change its name to “ImmunityBio, Inc.”, which will be the name of the combined company, effective as of the effective time.

Upon consummation of the merger, on a fully diluted basis, ImmunityBio stockholders and NantKwest stockholders will own approximately 72% and 28%, respectively, of the outstanding shares of common stock of the combined company. Shares of NantKwest common stock currently trade on the NASDAQ under the symbol “NK,” and shares of ImmunityBio common stock are not publicly traded. Following the consummation of the merger, shares of common stock of the combined company will be listed on the NASDAQ and are expected to trade under the symbol “IBRX”.

Merger Consideration (See page 163)

As a result of the merger, at the effective time, each share of ImmunityBio common stock that is issued and outstanding immediately prior to the effective time (other than (i) shares of ImmunityBio common stock owned directly by ImmunityBio as treasury stock or otherwise owned by ImmunityBio, NantKwest or any other direct or indirect wholly owned subsidiary of NantKwest and (ii) dissenting shares) will be converted automatically at the effective time into the right to receive 0.8190 newly issued shares of NantKwest common stock.

If the exchange ratio would result in an ImmunityBio stockholder being entitled to receive a fraction of a share of NantKwest common stock, such ImmunityBio stockholder will receive cash from NantKwest in lieu of such fractional interest in an amount determined by multiplying (i) the amount of the fractional share interest in a share of NantKwest common stock to which such holder is entitled under the merger agreement and (ii) the volume weighted average price for a share of NantKwest common stock on the NASDAQ (as reported by Bloomberg or, if not reported thereby, in another authoritative source mutually selected by NantKwest and ImmunityBio) for the three consecutive trading days ending on (and including) the third trading day immediately prior to the closing date.



 

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Recommendation of the NantKwest Board of Directors and Reasons for the Merger (See page 126)

At a meeting held on December 20, 2020, the NantKwest board (other than Dr. Soon-Shiong and Barry J. Simon, M.D., President and Chief Administrative Officer of NantKwest, both of whom recused themselves from deliberations regarding the proposed transaction with ImmunityBio), acting upon the recommendation of the NantKwest special committee, (1) declared the merger agreement, and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approved and adopted the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, (3) directed that the stock issuance be submitted to the NantKwest stockholders for approval and the merger agreement and the transactions contemplated by the merger agreement, including the merger, be submitted to the NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) for approval by such holders, and (4) resolved to recommend that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger. The NantKwest board, acting upon the recommendation of the NantKwest special committee, recommends that NantKwest stockholders vote “FOR” each of the proposals to be considered at the NantKwest special meeting and described in this joint proxy and consent solicitation statement/prospectus.

For a description of the various factors considered by the NantKwest special committee and the NantKwest board in their determination to recommend, authorize, approve, and declare advisable the merger agreement, the merger, the stock issuance and the other transactions contemplated by the merger agreement, see the section titled “The Merger—Recommendation of the NantKwest Special Committee and NantKwest Board of Directors; Reasons for the Merger” beginning on page 126.

Recommendation of the ImmunityBio Board of Directors and Reasons for the Merger (See page 132)

After consideration, the ImmunityBio board (including the independent director of the ImmunityBio board) adopted resolutions determining that the merger agreement, the merger contemplated by the merger agreement and the other transactions contemplated by the merger agreement were advisable and in the best interests of ImmunityBio and its stockholders, adopting and approving the merger agreement and the transactions contemplated thereby, including the merger, and directing that the merger agreement be submitted to the holders of ImmunityBio common stock for consideration. The ImmunityBio board (including the independent director of the ImmunityBio board) recommends that the holders of ImmunityBio common stock adopt and approve the merger agreement and the transactions contemplated thereby, including the merger, by executing and delivering the written consent furnished with this joint proxy and consent solicitation statement/prospectus.

For a description of the various factors considered by the ImmunityBio board in reaching its decision to adopt the merger agreement and approve the merger and the other transactions contemplated by the merger agreement, see the section titled “The Merger—Recommendation of the ImmunityBio Board of Directors and Reasons for the Merger” beginning on page 132.

Opinion of the Financial Advisor to the NantKwest Special Committee (See page 134 and Annex B)

The NantKwest special committee engaged Barclays Capital Inc. to act as its financial advisor in connection with a potential strategic transaction with ImmunityBio. On December 20, 2020, Barclays rendered its oral opinion (which was subsequently confirmed in writing) to the NantKwest special committee that, as of such date and based upon and subject to the qualifications, limitations and assumptions stated in its opinion, the exchange ratio to be paid by NantKwest was fair, from a financial point of view, to NantKwest.



 

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The full text of Barclays’ written opinion, dated as of December 20, 2020, is attached as Annex B to this joint proxy and consent solicitation statement/prospectus. Barclays’ written opinion sets forth, among other things, the assumptions made, procedures followed, factors considered and limitations upon the review undertaken by Barclays in rendering its opinion. You are encouraged to read the opinion carefully in its entirety.

For more information, see the section titled “The Merger—Opinion of the Financial Advisor to the NantKwest Special Committee” beginning on page 134 and the full text of the written opinion of Barclays attached as Annex B to this joint proxy and consent solicitation statement/prospectus.

Board of Directors and Management of the Combined Company Following Completion of the Merger (See page 152)

Upon completion of the merger, the current directors of NantKwest are expected to continue as directors of the combined company, other than for changes as may be publicly announced by NantKwest in the future. Additionally, under the merger agreement, the NantKwest board shall take all action necessary so that, as of immediately following the effective time, up to three (3) individuals designated by ImmunityBio prior to closing shall be appointed as directors of NantKwest and the size of the NantKwest board shall be increased as necessary to include such individuals. Each such individual shall be reasonably acceptable to the Nominating and Corporate Governance Committee of the NantKwest board.

Dr. Patrick Soon-Shiong, the current Executive Chairman of NantKwest, will continue as the Executive Chairman of the board of directors of the combined company. Richard Adcock, the current Chief Executive Officer of NantKwest, will continue as the Chief Executive Officer of the combined company. Additionally, David Sachs, who currently serves as the Chief Financial Officer of ImmunityBio, will be appointed as Chief Financial Officer of the combined company.

Ownership of the Combined Company after the Merger (See page 154)

Based on the exchange ratio of 0.8190, on a fully diluted basis, NantKwest stockholders as of immediately prior to the merger will hold, in the aggregate, approximately 28% of the outstanding shares of common stock of the combined company immediately following the merger, and ImmunityBio stockholders as of immediately prior to the merger will hold, in the aggregate, approximately 72% of the outstanding shares of common stock of the combined company immediately following the merger. NantKwest, ImmunityBio and/or the combined company intend to issue additional shares in connection with one or more capital raising transactions that may occur prior to and/or, in the case of the combined company after the closing of the merger. The percentages above do not take into account any such future shares issuances; any such shares issuances would proportionately reduce the percentage ownership of the existing NantKwest and ImmunityBio stockholders in the combined company.

It is estimated that, immediately following the closing date, Dr. Soon-Shiong and his affiliates will beneficially own, in the aggregate, approximately 82% of the outstanding shares of common stock of the combined company, without taking into account any additional shares that may be issued in connection with one or more capital raising transactions.

Interests of Certain NantKwest Directors and Executive Officers in the Merger (See page 154)

In considering the recommendation of the NantKwest special committee and the NantKwest board, NantKwest stockholders should be aware that certain of NantKwest’s directors and executive officers have interests in the merger that may be different from, or in addition to, those of NantKwest’s stockholders generally. In addition to Dr. Patrick Soon-Shiong’s ownership interests in NantKwest and ImmunityBio, as described below, each member of the NantKwest special committee will receive compensation in accordance with NantKwest’s Outside Director Compensation Policy in recognition of their responsibilities and the commitment



 

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of time required to serve in such capacity. The NantKwest special committee and the NantKwest board were aware of these interests and considered them, among other matters, prior to providing their respective approvals and recommendations with respect to the merger agreement and the transactions contemplated thereby.

Interests of Certain ImmunityBio Directors and Executive Officers in the Merger (See page 156)

In considering the recommendation of the ImmunityBio board, ImmunityBio stockholders should be aware that the executive officers and directors of ImmunityBio have interests in the merger that may be different from, or in addition to, those of ImmunityBio stockholders generally. In particular, Dr. Patrick Soon-Shiong, ImmunityBio’s Chairman and Chief Executive Officer, who together with his affiliates beneficially own approximately 88.9% of the outstanding ImmunityBio common stock, also serves as the Executive Chairman of NantKwest and together with his affiliates beneficially own approximately 64.6% of the outstanding shares of NantKwest common stock as of the NantKwest record date. An affiliate of Dr. Soon-Shiong also holds a warrant to purchase 2,000,000 shares of ImmunityBio common stock if a certain performance condition is satisfied. As noted above, immediately following the closing date, Dr. Soon-Shiong and his affiliates will beneficially own, in the aggregate, approximately 82% of the issued and outstanding shares of common stock of the combined company and the warrant held by an affiliate of Dr. Soon-Shiong will entitle the affiliate to purchase 1,638,000 shares of common stock of the combined company if the performance condition is satisfied. Additionally, pursuant to the ImmunityBio voting agreement, NantKwest agreed that the ImmunityBio significant stockholders (as defined below) will be entitled to registration rights in respect of the shares of common stock of the combined company issued to the ImmunityBio significant stockholders in the merger under a registration rights agreement in effect between NantKwest and Cambridge Equities, LP, an affiliate of Dr. Soon-Shiong. The ImmunityBio board (including the independent director of ImmunityBio) was aware of and considered these interests, among other matters, in evaluating the merger agreement and the merger, in approving the merger agreement, and in recommending the merger agreement and the transactions contemplated thereby.

Material U.S. Federal Income Tax Consequences (See page 157)

NantKwest and ImmunityBio intend that the merger qualify as a “reorganization” within the meaning of Section 368(a) of the Code. It is a condition to ImmunityBio’s obligation to complete the merger that ImmunityBio receive an opinion from Fried Frank or another nationally recognized law firm reasonably acceptable to ImmunityBio, to the effect that the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. If the merger qualifies as a reorganization, U.S. Holders (as defined below in “The Merger—Material U.S. Federal Income Tax Consequences”) of ImmunityBio common stock generally will not recognize any gain or loss for U.S. federal income tax purposes upon the exchange of ImmunityBio common stock for NantKwest common stock in the merger.

Please review the information set forth in the section entitled “Material U.S. Federal Income Tax Consequences” on page 185 for a more complete description of the material U.S. federal income tax consequences of the merger.

Accounting Treatment of the Merger (See page 157)

The merger is expected to be accounted for as a transfer between entities under common control. Therefore, in the merger, the net assets of NantKwest will be combined with those of ImmunityBio at their historical carrying amounts and the companies will be presented on a combined basis for historical periods because they were under common control for all periods presented.

Federal Securities Law Consequences (See page 157)

All shares of NantKwest common stock received by ImmunityBio stockholders upon consummation of the merger will be freely tradable without restriction under the Securities Act, except that NantKwest common stock



 

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received in the merger by persons who become affiliates of the combined company for purposes of Rule 144 under the Securities Act may be transferred by them only pursuant to Rule 144, or as otherwise permitted under the Securities Act.

Regulatory Approvals (See page 157)

In the United States, NantKwest must comply with applicable federal and state securities laws and the rules and regulations of the NASDAQ in connection with the issuance of shares of NantKwest common stock to ImmunityBio stockholders in connection with the transactions contemplated by the merger agreement and the filing of this registration statement/prospectus with the SEC. Neither NantKwest nor ImmunityBio is required to obtain any regulatory approval from antitrust authorities to consummate the transactions contemplated by the merger agreement.

Certain ImmunityBio stockholders who as a result of the merger will hold shares of common stock of the combined company with a value in excess of $94 million may, unless exempt, be subject to the filing and waiting period requirements of the HSR Act (as defined below). Compliance with the applicable HSR Act procedures could delay the acquisition of shares of common stock of the combined company by affected ImmunityBio stockholders.

NASDAQ Listing of Combined Company Stock (See page 158)

The merger agreement obligates NantKwest to use its reasonable best efforts to cause (i) the shares of NantKwest common stock to be issued in the merger, (ii) the shares of NantKwest common stock issuable upon exercise or settlement of the ImmunityBio equity awards or ImmunityBio warrant (each as defined below) after the effective time and (iii) the shares of NantKwest common stock potentially issuable after the effective time pursuant to the contingent value rights issued by ImmunityBio in connection with a previously completed acquisition by ImmunityBio, to be approved for listing on the NASDAQ, subject to official notice of issuance, prior to the closing date. Following the merger, shares of common stock of the combined company will be listed on the NASDAQ and are expected to trade under the symbol “IBRX”.

Appraisal Rights or Dissenters’ Rights (See page 158)

Under Delaware law, NantKwest stockholders are not entitled to appraisal rights or dissenters’ rights in connection with the issuance of shares of NantKwest common stock as contemplated by the merger agreement.

However, ImmunityBio stockholders who do not consent to the adoption of the merger agreement will be entitled to exercise appraisal rights under Section 262 of the DGCL, with respect to their shares of ImmunityBio common stock, in connection with the merger if they take certain actions and meet certain conditions set forth in Section 262 of the DGCL. Failure to comply with Section 262 of the DGCL may result in an ImmunityBio stockholder waiving, or being unable to exercise, appraisal rights.

For more information regarding appraisal rights, please see “The Merger—Appraisal Rights or Dissenters’ Rights” beginning on page 158 of this joint proxy and consent solicitation statement/prospectus and the full text of Section 262 of the DGCL, attached as Annex C to this joint proxy and consent solicitation statement/prospectus.

Overview of the Merger Agreement (See page 162)

Conditions to Completion of the Merger (See page 178)

As more fully described in this joint proxy and consent solicitation statement/prospectus and as set forth in the merger agreement, the closing of the merger depends on a number of conditions being satisfied or waived (except with respect to the approval by NantKwest stockholders of the stock issuance proposal, the merger



 

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proposal and the approval by ImmunityBio stockholders of the ImmunityBio merger proposal, which are not waivable). These conditions include:

 

   

approval of the merger by:

 

   

holders of a majority of the outstanding shares of ImmunityBio common stock by action by written consent; and

 

   

holders of a majority of the outstanding shares of NantKwest common stock as of the NantKwest record date (excluding all shares of NantKwest common stock beneficially owned by any of the NantKwest significant stockholders or any of their respective controlled affiliates or by any of the directors or executive officers of NantKwest or ImmunityBio).

 

   

approval of the stock issuance proposal by at least a majority of the votes cast by the stockholders present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting;

 

   

absence of any applicable law or order being in effect restraining, enjoining, making illegal or otherwise prohibiting consummation of the merger or the NantKwest stock issuance;

 

   

the effectiveness of the registration statement for the shares of NantKwest common stock to be issued in the merger (of which this joint proxy and consent solicitation statement/prospectus forms a part) and the absence of any stop order or similar restraining order by the SEC suspending that effectiveness;

 

   

the shares of NantKwest common stock to be issued to the ImmunityBio stockholders in the merger being authorized for listing on the NASDAQ, subject to official notice of issuance;

 

   

the accuracy of each party’s representations and warranties in the merger agreement (generally subject to a material adverse effect, materiality or de minimis standard) as of the date of the merger agreement and as of the closing date of the merger and the receipt by each party of a certificate from an executive officer of the other party certifying that this condition has been satisfied; and

 

   

the performance in all material respects by each party of the covenants and agreements required to be performed by it under the merger agreement and the receipt by each party of a certificate from an executive officer of the other party certifying that this condition has been satisfied.

The obligation of ImmunityBio to effect the merger is also subject to the satisfaction, or waiver by ImmunityBio, at or prior to the effective time of the following additional condition:

 

   

receipt of an opinion from Fried Frank, counsel to ImmunityBio, or another nationally recognized law firm reasonably satisfactory to ImmunityBio, dated as of the closing date, to the effect that the merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code.

Neither NantKwest nor ImmunityBio can be certain when, or if, the conditions to the merger will be satisfied or waived, or that the merger will be completed.

No Solicitation; Change of Recommendations (See page 170)

As more fully described in this joint proxy and consent solicitation statement/prospectus and as set forth in the merger agreement, NantKwest and ImmunityBio have agreed, subject to certain exceptions, among other things:

 

   

not to initiate, solicit or knowingly encourage or facilitate any inquiries or the making of any proposal or offer that constitutes, or would be reasonably expected to lead to, any alternative acquisition proposal; and



 

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not to engage in, continue or otherwise participate in any discussions or negotiations regarding, or that would be reasonably expected to lead to, any alternative acquisition proposal, or provide any nonpublic information or data to any entity in connection with any of the foregoing actions.

For a more detailed discussion on NantKwest and ImmunityBio and the ability of their boards of directors to consider other proposals, please see “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—No Solicitation; Change of Recommendations” on page 170.

Termination of the Merger Agreement (See page 179)

NantKwest and ImmunityBio may mutually agree in writing to terminate the merger agreement before consummating the merger, even after approval of the stock issuance proposal or merger proposal by the NantKwest stockholders or approval of the ImmunityBio merger proposal by the ImmunityBio stockholders have been obtained.

In addition, either NantKwest or ImmunityBio may terminate the merger agreement if:

 

   

the closing of the merger has not occurred by the outside date; provided that such right to terminate the merger agreement will not be available to any party whose breach of its representations and warranties set forth in the merger agreement or whose failure to fulfill any of such party’s obligations under the merger agreement was a principal cause of or primarily resulted in the failure of the merger to be consummated by the outside date;

 

   

any order permanently restraining, enjoining or otherwise prohibiting consummation of the merger shall become final and non-appealable or any law shall have been enacted, entered, enforced or deemed applicable to the merger that prohibits, makes illegal or enjoins the consummation of the merger; provided that such right to terminate the merger agreement will not be available to any party whose failure to fulfill such party’s obligation to use its reasonable best efforts pursuant to the merger agreement was the principal cause of such judgment, order, injunction, rule, law, decree or other action; or

 

   

approval of the stock issuance proposal or the merger proposal shall not have been obtained at the NantKwest special meeting duly convened for such purpose or at any adjournment, recess or postponement thereof.

In addition, the merger agreement may be terminated at any time before the effective time under the following circumstances:

 

   

by NantKwest:

 

   

if the ImmunityBio board changes its recommendation in favor of the merger;

 

   

if there has been a breach of any representation, warranty, covenant or agreement made by ImmunityBio in the merger agreement, any such representation or warranty shall have become untrue after the date of the merger agreement or ImmunityBio shall have failed to perform in all material respects all obligations required to be performed by it under the merger agreement and, in each case, is not cured within the earlier of (i) 30 days after written notice thereof is given by NantKwest to ImmunityBio and (ii) one business day before the outside date; provided, however, that NantKwest shall not have the right to terminate the merger agreement pursuant to this bullet if NantKwest is then in breach of the merger agreement such that NantKwest has breached any representation, warranty, covenant or agreement made by NantKwest in the merger agreement, any such representation or warranty shall have become untrue after the date of the merger agreement or NantKwest shall have failed to perform in all material respects all obligations required to be performed by it under the merger agreement;



 

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at any time prior to the approval of the stock issuance proposal or the merger proposal, in order to enter into an alternative acquisition agreement providing for a NantKwest superior proposal; provided, that the right to terminate the merger agreement for this reason will not be available unless substantially concurrently with or prior to (and as a condition to) such termination, (i) NantKwest pays to ImmunityBio a termination fee and (ii) NantKwest duly executes and delivers a definitive agreement with respect to such NantKwest superior proposal to the counterparty thereto; or

 

   

if the ImmunityBio stockholder approval shall not have been obtained within two business days after the registration statement for the shares of NantKwest common stock to be issued in the merger (of which this joint proxy and consent solicitation statement/prospectus forms a part) shall have been declared effective.

 

   

by ImmunityBio:

 

   

if the NantKwest special committee (or the NantKwest board acting upon the recommendation change of the NantKwest special committee) changes its recommendation in favor of the stock issuance and merger;

 

   

there has been a breach of any representation, warranty, covenant or agreement made by NantKwest or Merger Sub in the merger agreement, any such representation or warranty shall have become untrue after the date of the merger agreement or NantKwest or Merger Sub shall have failed to perform in all material respects all obligations required to be performed by it under the merger agreement and, in each case, is not cured within the earlier of (i) 30 days after written notice thereof is given by ImmunityBio to NantKwest and (ii) one business day before the outside date; provided, however, that ImmunityBio shall not have the right to terminate the merger agreement pursuant to this bullet if ImmunityBio is then in breach of the merger agreement such that ImmunityBio has breached any representation, warranty, covenant or agreement made by ImmunityBio in the merger agreement, any such representation or warranty shall have become untrue after the date of the merger agreement or ImmunityBio shall have failed to perform in all material respects all obligations required to be performed by it under the merger agreement; or

 

   

at any time prior to the time the ImmunityBio stockholder approval of the merger is obtained, in order to enter into an alternative acquisition agreement providing for an ImmunityBio superior proposal; provided, that the right to terminate the merger agreement for this reason will not be available unless substantially concurrently with or prior to (and as a condition to) such termination, (i) ImmunityBio pays to NantKwest a termination fee and (ii) ImmunityBio duly executes and delivers a definitive agreement with respect to such ImmunityBio superior proposal to the counterparty thereto.

Termination Fees (See page 181)

Termination Fees Payable by NantKwest

The merger agreement requires NantKwest to pay ImmunityBio a termination fee of $34,070,000 if:

 

   

the merger agreement is terminated by NantKwest in order to enter into an alternative acquisition agreement providing for a NantKwest superior proposal;

 

   

the merger agreement is terminated by ImmunityBio due to an adverse recommendation change by the NantKwest special committee (or the NantKwest board acting at upon the recommendation of the NantKwest special committee); or

 

   

(A) the merger agreement is terminated by either ImmunityBio or NantKwest because (I) approval of the merger proposal has not been obtained and (B) (I) a bona fide NantKwest acquisition proposal shall



 

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have been (1) made known to the NantKwest special committee or publicly made or disclosed and (2) not withdrawn (which withdrawal shall be public if such NantKwest acquisition proposal has been publicly made or disclosed) prior to the date of the NantKwest special meeting and (II) concurrently with or within twelve months of such termination, NantKwest shall have consummated a NantKwest acquisition proposal or entered into a definitive alternative acquisition agreement relating to a NantKwest acquisition proposal that is subsequently consummated (whether or not, in each case, such NantKwest acquisition proposal is the same one as the NantKwest acquisition proposal referred to above under (B)(I)).

In no event shall NantKwest be required to pay the termination fee on more than one occasion.

Termination Fees Payable by ImmunityBio

The merger agreement requires ImmunityBio to pay NantKwest a termination fee of $87,610,000 if:

 

   

the merger agreement is terminated by ImmunityBio to enter into an alternative acquisition agreement in respect of an ImmunityBio superior proposal;

 

   

the merger agreement is terminated by NantKwest due to an adverse recommendation change by the ImmunityBio board; or

 

   

(A) the merger agreement is terminated by NantKwest because the ImmunityBio stockholder approval was not obtained two business days after the registration statement (of which this joint proxy and consent solicitation statement/prospectus forms a part) was declared effective and (B) (I) a bona fide ImmunityBio acquisition proposal shall have been (1) made known to ImmunityBio or publicly made or disclosed and (2) not withdrawn (which withdrawal shall be public if such ImmunityBio acquisition proposal has been publicly made or disclosed) prior to the time of termination of the merger agreement and (II) concurrently with or within twelve months of such termination, ImmunityBio shall have consummated an ImmunityBio acquisition proposal or entered into an alternative acquisition agreement relating to an ImmunityBio acquisition proposal that is subsequently consummated (whether or not, in each case, such ImmunityBio acquisition proposal is the same one as the ImmunityBio acquisition proposal referred to above under (B)(I)).

In no event shall ImmunityBio be required to pay the termination fee on more than one occasion.

Overview of the Voting Agreements (See page 183)

In connection with the execution of the merger agreement, the NantKwest significant stockholders entered into the NantKwest voting agreement. Pursuant to the NantKwest voting agreement, each NantKwest significant stockholder agreed during the term of such agreement to, among other things, upon the terms and subject to the conditions therein, vote all of their shares of NantKwest common stock beneficially owned by them in favor of the stock issuance and any other actions presented to the NantKwest stockholders that are necessary or desirable to consummate the transactions contemplated by the merger agreement, and against (i) any action, proposal, agreement, transaction or proposed transaction that would reasonably be expected to result in a breach in any material respect of any obligation of (A) NantKwest, as set forth in the merger agreement, or (B) such NantKwest significant stockholders, as set forth in the NantKwest voting agreement and (ii) against any other action, proposal, agreement or transaction or proposed transaction, in each case, that would reasonably be expected to, prevent or materially delay the merger, the stock issuance or any of the other transactions contemplated by the merger agreement. The NantKwest voting agreement will have no impact on the requirement to obtain approval of the merger by holders of a majority of the outstanding shares of NantKwest common stock as of the NantKwest record date (excluding all shares of NantKwest common stock beneficially owned by any of the NantKwest significant stockholders or any of their respective controlled affiliates or by any of the directors or executive officers of NantKwest or ImmunityBio).



 

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In connection with the execution of the merger agreement, Dr. Soon-Shiong and certain of his affiliates who hold shares of ImmunityBio common stock (collectively, the “ImmunityBio significant stockholders”) entered into a voting agreement with ImmunityBio and NantKwest (the “ImmunityBio voting agreement,” and together with the NantKwest voting agreement, the “voting agreements”). Pursuant to the ImmunityBio voting agreement, each ImmunityBio significant stockholder agreed during the term of such agreement to deliver to ImmunityBio a written consent in respect of all shares of ImmunityBio common stock over which such ImmunityBio significant stockholder then has the right to vote (or direct the voting of) in favor of the adoption of the merger agreement and the approval of the transactions contemplated by the merger agreement, not later than two business days after the registration statement for the shares of NantKwest common stock to be issued in the merger (of which this joint proxy and consent solicitation statement/prospectus forms a part) is declared effective by the SEC; and vote all of their shares of ImmunityBio common stock beneficially owned by them against (i) any action, proposal, agreement, transaction or proposed transaction that would reasonably be expected to result in a breach in any material respect of any obligation of (A) ImmunityBio, as set forth in the merger agreement, or (B) such ImmunityBio significant stockholders, as set forth in the voting agreement; and (ii) any other action, proposal, agreement or transaction or proposed transaction, in each case, that would reasonably be expected to prevent or materially delay the merger or any of the other transactions contemplated by the merger agreement. Additionally, pursuant to the ImmunityBio voting agreement, NantKwest agreed that the ImmunityBio significant stockholders will be entitled to registration rights in respect of the shares of common stock of the combined company issued to the ImmunityBio significant stockholders in the merger under a registration rights agreement in effect between NantKwest and Cambridge Equities, LP, an affiliate of Dr. Soon-Shiong.

The voting agreements automatically terminate without any further action required by any person upon the earliest to occur of (i) the termination of the merger agreement in accordance with its terms, (ii) the effective time, (iii) any amendment to the merger agreement that would materially affect the rights of any NantKwest significant stockholder or ImmunityBio significant stockholder, as applicable, with respect to the shares of NantKwest common stock or ImmunityBio common stock that are subject to the applicable voting agreement without the prior written consent of such NantKwest or ImmunityBio significant stockholder, as applicable, and (iv) upon the mutual written agreement of each NantKwest significant stockholder or each ImmunityBio significant stockholder party to the voting agreement, as applicable, ImmunityBio and NantKwest.

Market Price Data and Dividend Information

Shares of NantKwest common stock are traded on the NASDAQ Global Select Market under the symbol “NK”. ImmunityBio is a private company and shares of ImmunityBio common stock are not publicly traded. The following table sets forth, for the periods indicated, the range of high and low intraday sales prices for NantKwest common stock on the NASDAQ. The sales prices are as reported in published financial sources.

 

     NantKwest, Inc.
Common Stock
 
     High      Low  

Fiscal 2019

     

Quarter ended March 31, 2019

   $ 1.87      $ 1.03  

Quarter ended June 30, 2019

   $ 1.65      $ 0.95  

Quarter ended September 30, 2019

   $ 1.55      $ 1.01  

Quarter ended December 31, 2019

   $ 4.89      $ 1.05  

Fiscal 2020

     

Quarter ended March 31, 2020

   $ 9.90      $ 2.60  

Quarter ended June 30, 2020

   $ 13.11      $ 2.52  

Quarter ended September 30, 2020

   $ 15.70      $ 6.03  

Quarter ended December 31, 2020

   $ 19.37      $ 6.80  


 

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The closing price of NantKwest common stock on December 18, 2020, the full trading day immediately prior to the public announcement of the merger on December 21, 2020, as reported on the NASDAQ, was $10.26 per share. The closing price of NantKwest common stock on February 1, 2021, the latest practicable trading day before the date of this joint proxy and consent solicitation statement/prospectus, as reported on the NASDAQ, was $20.18 per share.

Because the market price of NantKwest common stock is subject to fluctuation, the market value of the shares of NantKwest common stock that ImmunityBio stockholders will be entitled to receive in the merger may increase or decrease. In connection with the closing of the merger, the combined company will assume the ImmunityBio name, and following the closing, shares of the combined company will be listed on the NASDAQ and are expected to be traded under the symbol “IBRX”.

As of January 29, 2021, NantKwest had approximately 29 holders of record of its common stock, and ImmunityBio had approximately 300 holders of record of its common stock. For further information, see the sections titled “Security Ownership of Certain Beneficial Owners and Management of ImmunityBio” and “Security Ownership of Certain Beneficial Owners and Management of NantKwest” in this joint proxy and consent solicitation statement/prospectus.

Neither NantKwest nor ImmunityBio has ever paid a dividend with respect to the shares of NantKwest common stock or ImmunityBio common stock, respectively.

Risk Factors (See page 24)

Before voting at the NantKwest special meeting or submitting a written consent pursuant to the ImmunityBio consent solicitation, you should carefully consider all of the information contained in or incorporated by reference into this joint proxy and consent solicitation statement/prospectus. In particular, you should consider the specific risk factors in the section titled “Risk Factors” beginning on page 24 of this joint proxy and consent solicitation statement/prospectus, which include, among others, the following risks:    

 

   

The exchange ratio will not be adjusted based on the market price of NantKwest common stock so the merger consideration at the closing may have a greater or lesser value than at the time the merger agreement was signed;

 

   

The consummation of the merger is subject to a number of conditions and if those conditions are not satisfied or waived, the merger agreement may be terminated in accordance with its terms and the merger may not be completed;

 

   

Although NantKwest and ImmunityBio expect that the merger will result in synergies and other benefits, those synergies and benefits may not be realized or may not be realized within the expected time frame;

 

   

Both NantKwest and ImmunityBio have a history of operating losses and the combined company expects to continue to incur operating losses and may never be profitable;

 

   

The limited operating history of NantKwest and ImmunityBio, and the biotechnology industry in which the combined company will operate, make it difficult to evaluate the combined company’s business plan and prospects;

 

   

The combined company will be substantially dependent on the success of its product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval or be successfully commercialized;

 

   

The combined company may use its financial and human resources to pursue a particular type of treatment, or treatment for a particular type of disease, and fail to capitalize on programs or treatment



 

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of other types of cancer or infectious diseases that may be more profitable or for which there is a greater likelihood of success;

 

   

The combined company may develop product candidates in combination with other therapies, which exposes it to additional risks;

 

   

It may take longer and cost more to complete the combined company’s clinical trials than it projects, or the combined company may not be able to complete them at all;

 

   

The U.S. Food and Drug Administration (“FDA”) regulatory approval process is lengthy and time-consuming, and the combined company may experience significant delays in the clinical development and regulatory approval of its product candidates;

 

   

The combined company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates, which would prevent or delay regulatory approval and commercialization;

 

   

The combined company’s business could be adversely affected by the effects of health epidemics, pandemics or contagious diseases, including the recent pandemic of the disease caused by the novel coronavirus SARS-CoV-2 or COVID-19, in regions where it or third parties on which it relies have significant manufacturing facilities, concentrations of clinical trial sites or other business operations;

 

   

The combined company will be heavily dependent on its senior management, particularly Dr. Soon-Shiong, and although Dr. Soon-Shiong focuses heavily on ImmunityBio and NantKwest matters and is highly active in their management, he does devote a significant amount of his time to a number of different endeavors and companies; any loss of a member of the combined company’s senior management team in the future, even if only temporary, could harm its business;

 

   

If the combined company is unable to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, it may not be able to compete effectively or operate profitably;

 

   

The use of the combined company’s technology and product candidates could potentially conflict with the rights of others, and third-party claims of intellectual property infringement, misappropriation or other violation against the combined company, its licensors or its collaborators may prevent or delay the development and commercialization of its product candidates and technologies;

 

   

The combined company’s rights to develop and commercialize its product candidates and technologies will be subject, in part, to the terms and conditions of licenses granted to it by others;

 

   

Dr. Soon-Shiong, the executive chairman and principal stockholder of the combined company, has significant interests in other companies which may conflict with the interests of the combined company;

 

   

Dr. Soon-Shiong and entities affiliated with him will collectively own a significant majority of the combined company’s common stock (as of immediately following the closing of the merger, approximately 79.2% of the shares of the combined company’s common stock outstanding as well as a warrant to purchase an additional 1,638,000 shares of the combined company’s common stock that may become exercisable subject to the satisfaction of certain performance conditions), and will be in a position to control actions that require stockholder approval; and

 

   

As of December 31, 2020, ImmunityBio had $254.6 million in related party debt owed to entities controlled by Dr. Soon-Shiong and may incur up to an additional $40.0 million of such debt prior to the closing. This debt will remain outstanding in accordance with its terms following the closing of the merger.



 

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RISK FACTORS

In addition to the other information included or incorporated by reference in this joint proxy and consent solicitation statement/prospectus, including the matters addressed in “Cautionary Statement Regarding Forward-Looking Statements”, you should carefully consider the following risks before deciding how to vote. In addition, you should read and carefully consider the risks associated with each of NantKwest and its businesses. These risks can be found in NantKwest’s Annual Reports on Form 10-K for the year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q, each of which is filed with the SEC and incorporated by reference into this joint proxy and consent solicitation statement/prospectus. For further information regarding the documents incorporated into this joint proxy and consent solicitation statement/prospectus by reference, please see the section titled “Where You Can Find More Information”. Realization of any of the risks described below, any of the events described under “Cautionary Statement Regarding Forward-Looking Statements” or any of the risks or events described in the documents incorporated by reference could have a material adverse effect on NantKwest’s, ImmunityBio’s or the combined company’s businesses, financial condition, cash flows and results of operations.

For the purposes of this section, references to “we”, “us”, “our” and other similar references shall mean the combined company or its management, as the context requires.

Risks Relating to the Merger

The consummation of the merger is subject to a number of conditions and if those conditions are not satisfied or waived, the merger agreement may be terminated in accordance with its terms and the merger may not be completed.

The merger agreement is subject to a number of conditions which must be fulfilled in order to complete the merger. Those conditions include, among others, the approval of the merger by a majority of the outstanding shares of NantKwest common stock as of the NantKwest record date (excluding all shares of NantKwest common stock beneficially owned by any of the NantKwest significant stockholders or any of their respective controlled affiliates or by any of the directors or executive officers of NantKwest or ImmunityBio), absence of orders prohibiting completion of the merger, effectiveness of the registration statement of which this joint proxy and consent solicitation statement/prospectus is a part, approval of the shares of common stock to be issued to ImmunityBio stockholders for listing on the NASDAQ and the performance by both parties of their covenants and agreements. These conditions to the closing of the merger may not be fulfilled in a timely manner or at all, and, accordingly, the merger may not be completed. In addition, the parties can mutually decide to terminate the merger agreement at any time, before or after stockholder approval, or NantKwest or ImmunityBio may elect to terminate the merger agreement in certain other circumstances. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Termination of the Merger Agreement” beginning on page 179.

Termination of the merger agreement could negatively impact ImmunityBio and NantKwest.

If the merger is not completed for any reason, including as a result of NantKwest stockholders declining to approve the proposals required to effect the merger, the ongoing businesses of ImmunityBio and NantKwest may be adversely impacted and, without realizing any of the anticipated benefits of completing the merger, ImmunityBio and NantKwest would be subject to a number of risks, including the following: (i) NantKwest may experience negative reactions from the financial markets, including negative impacts on its stock price (including to the extent that the current market price reflects a market assumption that the merger will be completed); (ii) ImmunityBio and NantKwest may experience negative reactions from their employees and others doing business with ImmunityBio or NantKwest; (iii) ImmunityBio and NantKwest will have incurred substantial expenses and will be required to pay certain costs relating to the merger, whether or not the merger is completed; and (iv) since the merger agreement restricts the conduct of ImmunityBio’s and NantKwest’s businesses prior to completion of

 

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the merger, each of ImmunityBio and NantKwest may not have been able to take certain actions during the pendency of the merger that would have benefitted it as an independent company, and the opportunity to take such actions may no longer be available (see the section entitled “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Conduct of Business Pending the Merger” beginning on page 168 of this joint proxy and consent solicitation statement/prospectus for a description of the restrictive covenants applicable to ImmunityBio and NantKwest).

ImmunityBio and NantKwest will be subject to business uncertainties and contractual restrictions while the merger is pending.

Uncertainty about the effect of the merger on employees and others doing business with ImmunityBio or NantKwest may have an adverse effect on ImmunityBio and NantKwest. These uncertainties may impair both companies’ ability to attract, retain and motivate key personnel until the merger is completed. Retention of certain employees may be challenging during the pendency of the merger as certain employees may experience uncertainty about their future roles. If key employees depart because of issues relating to the uncertainty and difficulty of integration or a desire not to remain with the business, the operations of the combined company following the merger could be negatively impacted.

NantKwest and ImmunityBio will incur transaction costs in connection with the merger.

Each of NantKwest and ImmunityBio has incurred and expects that it will incur significant, non-recurring costs in connection with consummating the merger. NantKwest and ImmunityBio may also incur additional costs to retain key employees. NantKwest and ImmunityBio will also incur significant legal, financial advisor, accounting, banking and consulting fees, SEC filing fees, printing and mailing fees and other costs associated with the merger. NantKwest and ImmunityBio estimate that they will incur $20.5 million in aggregate transaction costs. Some of these costs are payable regardless of whether the merger is completed.

Because the market price of shares of NantKwest’s common stock will fluctuate, ImmunityBio’s stockholders cannot be sure of the value of the merger consideration they will receive.

The ImmunityBio stockholders will receive in the merger for each ImmunityBio share a fixed exchange ratio of 0.8190 of a share of NantKwest common stock; it is not a number of shares with a particular fixed market value. See “The Merger Agreement and Voting Agreements—Description of the Merger Agreement—Merger Consideration” beginning on page 163. The market value of the combined company’s common stock at the effective time of the merger may vary significantly from the values of NantKwest common stock on the date of this document. Because the merger consideration is fixed and will not be adjusted to reflect any changes in the market value of shares of NantKwest’s common stock, the market value of the shares of NantKwest common stock issued in connection with the merger may be higher or lower than the values of those shares on earlier dates Accordingly, at the time of providing written consent to the ImmunityBio merger proposal, ImmunityBio stockholders will not know or be able to calculate the market value of the shares of NantKwest’s common stock they would receive upon the completion of the merger. Stock price changes may result from a variety of factors, including changes in the business, operations or prospects of NantKwest or ImmunityBio, regulatory considerations, and general business, market, industry or economic conditions. Many of these factors are outside of the control of NantKwest and ImmunityBio.

The unaudited pro forma condensed combined financial information included in this joint proxy and consent solicitation statement/prospectus is preliminary and the actual financial condition and results of operations after the merger may differ materially.

The unaudited pro forma financial information included in this joint proxy and consent solicitation statement/prospectus is presented for illustrative purposes only and is not necessarily indicative of what our actual financial position or results of operations would have been had the merger been completed on the date(s) indicated. Moreover, the pro forma adjustments are preliminary and based upon available information and certain

 

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assumptions and estimates that NantKwest and ImmunityBio currently believe are reasonable, but are subject to further revision as additional information becomes available and additional analyses are performed. Differences between the preliminary estimates reflected in the unaudited pro forma financial information and the final merger accounting, expected to be completed after the closing of the merger, will occur and these differences could have a material impact on the unaudited pro forma condensed combined financial statements and the combined company’s future results of operations and financial position. The actual amounts recorded as of the completion of the merger may differ materially from the information presented in the unaudited pro forma condensed combined financial statements. See “Unaudited Pro Forma Condensed Combined Financial Information” beginning on page 188.

ImmunityBio’s stockholders will have their rights as stockholders governed by the combined company’s organizational documents.

As a result of the completion of the merger, holders of shares of ImmunityBio common stock may become holders of shares of the combined company’s common stock, which will be governed by the combined company’s organizational documents. As a result, there will be differences between the rights currently enjoyed by ImmunityBio stockholders and the rights that ImmunityBio stockholders who become stockholders of the combined company will have as stockholders of the combined company. See “Comparison of Stockholders’ Rights” beginning on page 310.

NantKwest and ImmunityBio may be targets of securities class action and derivative lawsuits which could result in substantial costs and may delay or prevent the merger from being completed.

Securities class action lawsuits and derivative lawsuits are often brought against companies that have entered into merger agreements. Even if the lawsuits are without merit, defending against these claims could result in substantial costs and divert management time and resources. An adverse judgment could result in monetary damages, which could have a negative impact on NantKwest’s and ImmunityBio’s respective liquidity and financial condition. Additionally, if a plaintiff is successful in obtaining an injunction prohibiting completion of the merger, then that injunction may delay or prevent the merger from being completed, which may adversely affect NantKwest’s and ImmunityBio’s respective business, financial position and results of operations.

Risks Relating to the Combined Company Following the Merger

The market price of the combined company’s common stock could fluctuate significantly.

There have been periods of time when the U.S. securities markets have experienced significant price fluctuations. These price fluctuations may be day-to-day or they may last for extended periods of time. Significant price fluctuations in the securities markets as a whole may cause the market price of the combined company’s common stock to be volatile and subject to wide fluctuations. Historically, ImmunityBio has been a privately held company without an active market for its shares, and its current stockholders may seek liquidity following the closing of the transaction. The trading volume of the combined company’s common stock may fluctuate and cause significant price variations to occur. Additional factors that could cause fluctuations in, or have a material adverse effect on, the stock price or trading volume of the combined company’s common stock include:

 

   

general market and economic conditions, including market conditions in the biotechnology and pharmaceutical industries;

 

   

results of clinical trials and preclinical studies of the combined company’s product candidates, or those of the combined company’s competitors or the combined company’s existing or future collaborators;

 

   

actions taken by regulatory agencies with respect to the combined company’s product candidates, clinical studies, manufacturing process or sales and marketing terms;

 

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disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain patent protection for its technologies;

 

   

actual or expected variations in quarterly operating results;

 

   

differences between actual operating results and those expected by investors and analysts;

 

   

sales of common stock by current ImmunityBio stockholders looking to liquidate in the public market;

 

   

changes in recommendations by securities analysts;

 

   

operations and stock performance of competitors;

 

   

accounting charges, including charges relating to the impairment of goodwill;

 

   

significant acquisitions or strategic alliances by the combined company or by competitors; and

 

   

recruitment or departure of key personnel.

There can be no assurance that the stock price of the combined company’s common stock will not fluctuate or decline significantly in the future. In addition, the stock market in general can experience considerable price and volume fluctuations that may be unrelated to the combined company’s performance.

The market price for the combined company’s common stock following the closing may be affected by factors different from those that historically have affected or currently affect NantKwest’s common stock.

Upon the closing, NantKwest and ImmunityBio stockholders will hold shares of the combined company’s common stock. The combined company’s business and financial position will differ from the respective business and financial positions of NantKwest and ImmunityBio before the closing and, accordingly, the results of operations of the combined company will be affected by some factors that are different from those currently affecting the results of operations of NantKwest and those currently affecting the results of operations of ImmunityBio, as separate companies. Accordingly, the market price and performance of the combined company’s common stock is likely to be different from the performance of NantKwest common stock in the absence of the merger. In addition, general fluctuations in stock markets could have a material adverse effect on the market for, or liquidity of, the combined company’s common stock, regardless of the combined company’s actual operating performance. For a discussion of the business of ImmunityBio, see “Business of ImmunityBio” and for a discussion of the business of NantKwest and some important factors to consider in connection therewith, see the documents incorporated by reference into this joint proxy and consent solicitation statement/prospectus and referred to under the section entitled “Where You Can Find More Information.”

Dr. Soon-Shiong, our executive chairman and our principal stockholder, has significant interests in other companies which may conflict with our interests.

Our executive chairman, Dr. Soon-Shiong, is the founder of NantWorks, LLC (“NantWorks”). The various NantWorks companies are currently exploring opportunities in the immunotherapy, oncology, infectious disease and inflammatory disease fields. In particular, NantKwest and ImmunityBio have agreements with a number of related parties that provide services, technology and equipment for use in their efforts to develop their product pipelines. Dr. Soon-Shiong holds a controlling interest, either directly or indirectly, in these entities. Consequently, Dr. Soon-Shiong’s interests may not be aligned with our other stockholders and he may from time to time be incentivized to take certain actions that benefit his other interests and that our other stockholders do not view as being in their interest as investors in our company. In addition, other companies affiliated with Dr. Soon-Shiong may compete with us for business opportunities or, in the future, develop products that are competitive with ours (including products in other therapeutic fields which we may target in the future). Moreover, even if they do not directly relate to us, actions taken by Dr. Soon-Shiong and the companies with which he is involved could impact us.

 

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NantKwest and ImmunityBio are also pursuing supply arrangements for various investigational agents controlled by affiliates to be used in their clinical trials. If Dr. Soon-Shiong were to cease his affiliation with us or NantWorks, these entities may be unwilling to continue these relationships with us on commercially reasonable terms, or at all, and as a result may impede our ability to control the supply chain for our combination therapies. These collaboration agreements do not typically specify how sales will be apportioned between the parties upon successful commercialization of the product. As a result, we cannot guarantee that we will receive a percentage of the revenues that is at least proportional to the costs that we will incur in commercializing the product candidate.

Furthermore, in 2015, each of NantKwest and ImmunityBio entered into shared services agreements with NantWorks, pursuant to which NantWorks and its affiliates provide corporate, general and administrative and other support services to NantKwest, ImmunityBio and their respective subsidiaries. If Dr. Soon-Shiong was to cease his affiliation with us or with NantWorks, we may be unable to establish or maintain this relationship with NantWorks on a commercially reasonable basis, if at all. As a result, we could experience a lack of business continuity due to loss of historical and institutional knowledge and a lack of familiarity of new employees and/or new service providers with business processes, operating requirements, policies and procedures, and we may incur additional costs as new employees and/or service providers gain necessary experience. In addition, the loss of the services of NantWorks might significantly delay or prevent the development of our product candidates or achievement of other business objectives by diverting management’s attention to transition matters and identification of suitable replacements, if any, and could have a material adverse effect on our business and results of operations.

Dr. Patrick Soon-Shiong, through his voting control of the combined company, will be in a position to control actions that require stockholder approval.

Dr. Soon-Shiong, through his direct and indirect ownership of the combined company’s common stock, will have voting control of the combined company. Immediately following the closing, Dr. Soon-Shiong and certain of his affiliates are expected to beneficially own approximately 82% of the shares of the combined company’s common stock outstanding. Additionally, an affiliate of Dr. Soon-Shiong will hold a warrant to purchase an additional 1,638,000 shares of combined company common stock that will become exercisable if certain performance conditions are satisfied. Dr. Soon-Shiong also indirectly holds 139,768,338 contingent value rights (“CVRs”) issued to the former stockholders of Altor BioScience Corporation (succeeded by Altor BioScience LLC) (“Altor”) in connection with ImmunityBio’s acquisition of Altor. After the completion of the merger, if the underlying conditions for payment are met, the CVRs become payable in cash or shares of our common stock or any combination as the holder elects. Dr. Soon-Shiong has elected to receive shares of our common stock for all of the CVRs. Dr. Soon-Shiong will serve as Executive Chairman of the board of directors of the combined company following the closing.

Dr. Soon-Shiong will be in a position to control the outcome of corporate actions that require, or may be accomplished by, stockholder approval, including amending the bylaws of the combined company, the election or removal of directors and transactions involving a change of control. Dr. Soon-Shiong’s concentrated ownership could limit the ability of the remaining stockholders of the combined company to influence corporate matters, and the interests of Dr. Soon-Shiong may not coincide with the combined company’s interests or the interests of its remaining stockholders. In addition, entities affiliated with Dr. Soon-Shiong held promissory notes representing $254.6 million in indebtedness of ImmunityBio as of December 31, 2020, which debt will remain outstanding in accordance with its terms following the closing of the merger.

Although NantKwest and ImmunityBio expect that the merger will result in synergies and other benefits, those synergies and benefits may not be realized or may not be realized within the expected time frame.

The ability of NantKwest and ImmunityBio to realize the anticipated benefits of the merger will depend, to a large extent, on our ability to integrate NantKwest’s and ImmunityBio’s businesses in a manner that facilitates growth opportunities and achieves the projected synergies identified by each company without adversely

 

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affecting current revenues and investments in future growth. Even if we are able to integrate the two companies successfully, the anticipated benefits of the merger, including the expected synergies, may not be realized fully or at all or may take longer to realize than expected.

NantKwest’s and ImmunityBio’s businesses may not be integrated successfully or such integration may be more difficult, time consuming or costly than expected. Operating costs, customer loss and business disruption, including difficulties in maintaining relationships with employees, customers, suppliers or vendors, may be greater than expected following the merger. Revenues following the merger may be lower than expected.

The combination of two businesses is complex, costly and time-consuming and may divert significant management attention and resources to combining NantKwest’s and ImmunityBio’s business practices and operations. This process may disrupt NantKwest’s and ImmunityBio’s businesses. The failure to meet the challenges involved in combining the two businesses and to realize the anticipated benefits of the merger could cause an interruption of, or a loss of momentum in, the activities of the combined company and could adversely affect the results of operations of the combined company. The overall combination of NantKwest’s and ImmunityBio’s businesses may also result in material unanticipated problems, expenses, liabilities, competitive responses, and loss of customer and other business relationships. The difficulties of combining the operations of the companies include, among others:

 

   

the diversion of management attention to integration matters;

 

   

difficulties in integrating operations and systems, including intellectual property and communications systems, administrative and information technology infrastructure and financial reporting and internal control systems;

 

   

challenges in conforming standards, controls, procedures and accounting and other policies, business cultures and compensation structures between the two companies;

 

   

difficulties in integrating employees and attracting and retaining key personnel, including talent;

 

   

challenges in retaining existing, and obtaining suppliers and employees;

 

   

difficulties in achieving anticipated cost savings, synergies, accretion targets, business opportunities, financing plans and growth prospects from the combination;

 

   

difficulties in managing the expanded operations of a significantly larger and more complex company;

 

   

contingent liabilities that are larger than expected; and

 

   

potential unknown liabilities, adverse consequences and unforeseen increased expenses associated with the merger.

Many of these factors are outside of the control of NantKwest and ImmunityBio and will be outside the control of the combined company, and any one of them could result in lower revenues, higher costs and diversion of management time and energy, which could materially impact the business, financial condition and results of operations of the combined company. In addition, even if the operations of the businesses of NantKwest and ImmunityBio are integrated successfully, the full benefits of the merger may not be realized, including, among others, the synergies or growth opportunities that are expected. These benefits may not be achieved within the anticipated time frame or at all. Further, additional unanticipated costs may be incurred in the integration of the businesses of NantKwest and ImmunityBio. All of these factors could negatively impact the price of the combined company’s common stock following the merger. As a result, it cannot be assured that the combination of NantKwest and ImmunityBio will result in the realization of the full benefits expected from the merger within the anticipated time frames or at all. Accordingly, holders of the combined company’s common stock following the consummation of the merger may experience a loss as a result of a decline in the market price of such common stock. In addition, a decline in the market price of our common stock following the consummation of the merger could adversely affect the combined company’s ability to issue additional securities and to obtain additional financing in the future.

 

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Both NantKwest and ImmunityBio have a history of operating losses and we expect to continue to incur losses and may never be profitable.

Both NantKwest and ImmunityBio are biopharmaceutical companies with broad portfolios of product candidates at various stages of development. Neither ImmunityBio nor NantKwest have any products approved for commercial sale or for which marketing approval has been sought, although ImmunityBio has generated limited revenues from license agreements and grant programs as well as from product sales of its proprietary GMP-in-a-Box bioreactors and related consumables associated with such equipment.

We expect to incur significant expenses as we seek to expand our business, including in connection with conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, seeking regulatory approvals and, upon successful receipt of FDA approval, commercializing our products. We will also incur costs as we hire additional personnel and increase our manufacturing capabilities, including the lease or purchase of a facility for the manufacturing of our product candidates for ongoing and future clinical trials and, upon potential receipt of FDA approval, for our initial commercialization activities. Moreover, the combined company does not expect to have any significant product sales or revenue for a number of years. These losses have had an adverse impact on the stockholders’ equity and working capital of NantKwest and ImmunityBio and, as these operating losses continue to increase significantly in the future due to such expenditures, will continue to have an adverse effect on the combined company’s stockholders’ equity and working capital. Because of the numerous risks and uncertainties associated with our product development efforts, we are unable to predict when the combined company may become profitable, if at all. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

Our ability to achieve profitability in the future is dependent upon obtaining regulatory approvals for our product candidates and successfully commercializing our product candidates alone or with third parties. However, our operations may not be profitable even if one or more of our product candidates under development are successfully developed and produced and thereafter commercialized.

The limited operating history of NantKwest and ImmunityBio, and the biotechnology industry in which the combined company will operate, make it difficult to evaluate the combined company’s business plan and prospects.

Each of NantKwest and ImmunityBio have only a limited operating history on which a decision to invest in the combined company can be based and against which we can test the plans and assumptions in our business plan. The future of the combined company is dependent upon its ability to implement its business plan, as that business plan may be modified from time to time by the combined company’s management and board of directors. Investors therefore cannot evaluate the likelihood of our success.

The combined company will face the problems, expenses, difficulties, complications and delays normally associated with a pre-commercial biotechnology company, many of which are beyond its control. Accordingly, the combined company’s prospects should be considered in light of the risks, expenses and difficulties frequently encountered in the establishment of a new business developing technologies in an industry that is characterized by a number of market entrants and intense competition. Because of our size and limited resources, we may not possess the ability to successfully overcome many of the risks and uncertainties frequently encountered by pre-commercial companies involved in the rapidly evolving field of immunotherapy. If our research and development efforts are successful, we may also face the risks associated with the shift from development to commercialization of new products based on innovative technologies. There can be no assurance that we will be successful in developing our business.

 

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We will be substantially dependent on the success of our product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval or be successfully commercialized.

Other than ImmunityBio’s proprietary GMP-in-a-Box bioreactors, NantKwest and ImmunityBio currently have no products approved for commercial sale or for which regulatory approval to market has been sought. ImmunityBio has invested a significant portion of its efforts and financial resources in the development of its main product candidates, Anktiva, aldoxorubicin and human adenovirus serotype 5 (“hAd5”) vaccine candidates. The combined company expects to invest heavily in these product candidates as well as in NantKwest’s existing product candidates and in any future product candidates that the combined company may develop. The combined company’s business depends entirely on the successful development, regulatory approval and commercialization of such product candidates, each of which may never occur. The combined company’s ability to generate revenues in the future is substantially dependent on its ability to develop, obtain regulatory approval for, and then successfully commercialize, its product candidates. NantKwest and ImmunityBio currently generate no meaningful revenues from the sale of any product candidates, and the combined company may never be able to develop or commercialize a product.

Our product candidates will require additional clinical and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before the combined company can generate any revenues from product sales. We cannot assure you that we will meet our timelines for current or future clinical trials, which may be delayed or not completed for a number of reasons, including the negative impact of the COVID-19 pandemic.

We will not be permitted to market or promote any of our product candidates before it receives regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates or regulatory approval that will allow us to successfully commercialize our product candidates. If we do not receive FDA or comparable foreign regulatory approval with the necessary conditions to allow successful commercialization, and then successfully commercialize our product candidates, we will not be able to generate revenues from those product candidates in the United States or elsewhere in the foreseeable future, or at all. Any significant delays in obtaining approval for and commercializing our product candidates will have a material adverse impact on our business and financial condition.

ImmunityBio has not previously submitted a Biologics License Application (“BLA”) for any biologics product candidates, or a New Drug Application (“NDA”) for any small molecule product candidates or similar marketing application to the FDA or comparable foreign authorities, for any product candidate, and the combined company cannot be certain that any current product candidates of ImmunityBio or NantKwest or any future product candidates of the combined company will be successful in clinical trials or receive regulatory approval. Furthermore, although we do not expect to submit a BLA and/or NDA with comparisons to existing or more established therapies, and we do not expect the FDA to base its determination with respect to product approval on such comparisons, the FDA may factor these comparisons into its decision whether to approve Anktiva. The FDA may also consider approvals of competing products, which may alter the treatment landscape concurrently with their review of the combined company’s BLA and/or NDA filings, and which may lead to changes in the FDA’s review requirements that have been previously communicated to us and our interpretation thereof, including changes to requirements for clinical data or clinical trial design. Such changes could delay approval or necessitate withdrawal of our BLA and/or NDA filings.

Our product candidates will be susceptible to the risks of failure inherent at any stage of product development, including the appearance of unexpected adverse events or failure to achieve primary endpoints in clinical trials. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials.

 

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If approved for marketing by applicable regulatory authorities, our ability to generate revenues from our product candidates will depend on our ability to:

 

   

price our product candidates competitively such that third-party and government reimbursement leads to broad product adoption;

 

   

prepare a broad network of clinical sites for administration of our product;

 

   

create market demand for our product candidates through our own marketing and sales activities, and any other arrangements to promote these product candidates that we may otherwise establish;

 

   

receive regulatory approval for the targeted patient population(s) and claims that are necessary or desirable for successful marketing;

 

   

manufacture product candidates through contract manufacturing organizations (“CMOs”) or in our own, or our affiliates’, manufacturing facilities in sufficient quantities and at acceptable quality and manufacturing cost to meet commercial demand at launch and thereafter;

 

   

establish and maintain agreements with wholesalers, distributors, pharmacies, and group purchasing organizations on commercially reasonable terms;

 

   

obtain, maintain, protect and enforce patent and other intellectual property protection and regulatory exclusivity for our product candidates;

 

   

successfully commercialize any of our product candidates that receive regulatory approval;

 

   

maintain compliance with applicable laws, regulations, and guidance specific to commercialization including interactions with health care professionals, patient advocacy groups, and communication of health care economic information to payors and formularies;

 

   

achieve market acceptance of our product candidates by patients, the medical community, and third-party payors;

 

   

achieve appropriate reimbursement for our product candidates;

 

   

maintain a distribution and logistics network capable of product storage within our specifications and regulatory guidelines, and further capable of timely product delivery to commercial clinical sites;

 

   

effectively compete with other therapies or competitors; and

 

   

following launch, assure that our product will be used as directed and that additional unexpected safety risks will not arise.

Additionally, our ability to generate revenues from our combination therapy products will also depend on the availability of the other therapies with which our products are intended to be used. For example, ImmunityBio has in the past experienced, and may in the future experience, challenges obtaining sufficient quantities of bacillus Calmette-Guérin (“BCG”) for some of its clinical trials involving Anktiva due to global shortages. There can be no assurance that the combined company will be able to source adequate supplies of BCG to continue these clinical trials in a timely fashion or at all, and in the future there may be other supply-related challenges that delay or prevent patient enrollment and continued progress on our clinical trials. For more information, see “—Our clinical trials may not be initiated or completed when we expect and we may be required to conduct additional clinical trials or modify current or future clinical trials based on feedback we receive from the FDA.

We may use our financial and human resources to pursue a particular type of treatment, or treatment for a particular type of disease, and fail to capitalize on programs or treatment of other types of cancer or infectious diseases that may be more profitable or for which there is a greater likelihood of success.

Because we have limited resources, we will have to choose to pursue and fund the development of specific types of treatment, or treatment for a specific type of disease, and may forego or delay pursuit of opportunities

 

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with other programs, investigational medicines or treatment for other types of diseases, which could later prove to have greater commercial potential. Moreover, given the rapidly evolving competitive landscape and the time it takes to advance a product through clinical development, an incorrect decision to pursue a particular type of treatment or disease may have a material adverse effect on our results of operations and negatively impact our future clinical strategies. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs for investigational medicines or clinical trials may not yield any commercially viable products. If we do not accurately evaluate and anticipate the commercial potential or target market for a particular type of treatment or disease, we may choose to spend our limited resources on a particular treatment, or treatment for a particular type of cancer, and then later learn that another type of treatment or disease that we previously decided not to pursue would have been more advantageous. We may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

We may develop product candidates in combination with other therapies, which exposes us to additional risks.

We may develop product candidates in combination with one or more other therapies. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities outside of the United States could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies. If the therapies we use in combination with our product candidates are replaced as the standard of care for the indications we choose for any of our product candidates, the FDA or comparable foreign regulatory authorities may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.

We also may choose to evaluate product candidates in combination with one or more therapies that have not yet been approved for marketing by the FDA or comparable foreign regulatory authorities. We will not be able to market and sell any product candidate we develop in combination with an unapproved therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product. In addition, unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDA approval. If the FDA or comparable foreign regulatory authorities do not approve these other drugs or revoke their approval of, or if safety, efficacy, quality, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with our product candidate we develop, we may be unable to obtain approval of or market such combination therapy.

It may take longer and cost more to complete our clinical trials than we project, or we may not be able to complete them at all.

For budgeting and planning purposes, we have projected the date for the commencement of future trials, and continuation and completion of NantKwest’s and ImmunityBio’s ongoing clinical trials. However, a number of factors, including scheduling conflicts with participating clinicians and clinical institutions, and difficulties in identifying and enrolling patients who meet trial eligibility criteria, may cause significant delays. Our clinical trials may also experience delays related to the COVID-19 pandemic; for more information, see “—Our business could be adversely affected by the effects of health epidemics, pandemics or contagious diseases, including the recent pandemic of the disease caused by the novel coronavirus SARS-CoV-2 or COVID-19, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.” We may not commence or complete clinical trials involving any of our product candidates as projected or may not conduct them successfully.

We may, however, experience difficulties in patient enrollment in our clinical trials for a variety of reasons. Our ability to enroll or treat patients in our other studies, or the duration or costs of those studies, could be

 

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affected by multiple factors, including, preliminary clinical results, which may include efficacy and safety results from ImmunityBio’s and NantKwest’s ongoing Phase II trials, but may not be reflected in the final analyses of these trials. Although preliminary data from ImmunityBio’s Phase I trials were generally positive, that data may not necessarily be representative of interim or final results, as new patients are cycled through the applicable treatment regimes. As the trials continue, the investigators may prioritize patients with more progressed forms of cancer than the initial patient population, based on the success or perceived success of that initial population. Patients with more progressed forms of cancer may be less responsive to treatment, and accordingly, interim efficacy data may show a decline in patient response rate or other assessment metrics. As the trials continue, investigators may shift their approach to the patient population, which may ultimately result in a decline in both interim and final efficacy data from the preliminary data, or conversely, an increase in final efficacy data following a decline in the interim efficacy data, as patients with more progressed forms of cancer are cycled out of the trials and replaced by patients with less advanced forms of cancer. This opportunity for investigator selection bias in our trials as a result of open-label design may not be adequately handled and may cause a decline in or distortion of clinical trial data from our preliminary results. Depending on the outcome of our studies, we may need to conduct one or more follow-up or supporting studies in order to successfully develop our product candidates for FDA approval. Many companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier development, and we cannot be certain that we will not face such setbacks.

Furthermore, the timely completion of clinical trials in accordance with their protocols will depend, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion, including the ability of us or our collaborators to conduct clinical trials under the constraints of the COVID-19 pandemic. In addition, we expect that our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Accordingly, we cannot guarantee that our trials will progress as planned or as scheduled. Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.

We expect to rely on medical institutions, academic institutions or contract research organizations (“CROs”) to conduct, supervise or monitor some or all aspects of clinical trials involving our product candidates. We will have less control over the timing and other aspects of these clinical trials than if we conducted them entirely on our own. See “—NantKwest and ImmunityBio have limited experience conducting clinical trials and have relied and will rely on third parties and related parties to conduct many of our preclinical studies and clinical trials. Any failure by a third party, related party, or by us to conduct the clinical trials according to Good Clinical Practice (GCP) regulations, and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.” If we fail to commence or complete, or experience delays in, any of our planned clinical trials, our stock price and our ability to conduct our business as currently planned could be harmed.

We currently anticipate that we will have to rely on our CMOs or partners to manufacture our product candidates for some of our clinical trials. If they fail to commence or complete, or experience delays in, manufacturing our product candidates, our planned clinical trials will be delayed, which will adversely affect our stock price and our ability to conduct our business as currently planned.

Our clinical trial costs may be higher than for more conventional therapeutic technologies or drug products.

Because NantKwest’s and ImmunityBio’s product candidates include, and we expect our product candidates to include, candidates based on advanced therapy technologies, we expect that they will require extensive research and development and have substantial manufacturing costs. In addition, costs to treat patients and to treat potential side effects that may result from our product candidates can be significant. Some clinical trial sites

 

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may not bill, or obtain coverage from Medicare, Medicaid, or other third-party payors for some or all of these costs for patients enrolled in our clinical trials, and clinical trial sites outside of the United States may not reimburse for costs typically covered by third-party payors in the United States, and as a result we may be required by those trial sites to pay such costs. Accordingly, our clinical trial costs are likely to be significantly higher per patient than those of more conventional therapeutic technologies or drug products.

Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.

The clinical trials of our product candidates will be, and the manufacturing and marketing of our product candidates will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective, or safe, pure and potent, for use in each target indication. Because most of our product candidates will be subject to regulation as biological drug products, we will need to demonstrate that they are safe, pure, and potent for use in their target indications. For small molecule product candidates, we will need to demonstrate that they are safe and effective for their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. The risk/benefit profile required for product licensure will vary depending on these factors and may include not only the ability to show tumor shrinkage, but also adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival. For example, response rates from the use of our product candidates may not be sufficient to obtain regulatory approval unless we can also show an adequate duration of response. Regulatory authorities may ultimately disagree with our chosen endpoints or may find that our studies or study results do not support product approval. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates with small patient populations may not be predictive of the results of later-stage clinical trials or the results once the applicable clinical trials are completed. Additionally, early clinical trials may not produce data that support further development of our product candidates and regulatory authorities may not allow continued clinical development of our product candidates. Preliminary, single cohort or top-line results from clinical trials may not be representative of the final study results. The results of studies in one set of patients or line of treatment may not be predictive of those obtained in another and the results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Preclinical studies may also reveal unfavorable product candidate characteristics, including safety concerns.

There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. NantKwest’s and ImmunityBio’s current and our future clinical trial results may not be successful. Moreover, should there be a flaw in a clinical trial or cross-site variation that are not properly addressed, it may not become apparent until the clinical trial is well advanced or until data from different sites become available. For example, NantKwest’s and ImmunityBio’s current

 

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clinical trials are, and we expect our clinical trials to be, conducted at multiple sites in different geographies, with different levels of experience and expertise by medical professionals, and these professionals may make mistakes or introduce site-specific variation that could have an impact on clinical trials by disqualifying patients or impacting patient ability to continue in a study or on the clinical data. Further, because we currently plan to test our product candidates for use with other oncology products, the design, implementation and interpretation of the clinical trials necessary for marketing approval may be more complex than if we were developing our product candidates alone.

In addition, even if such trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

ImmunityBio has reported preliminary results for clinical trials of its product candidates, including Anktiva. These preliminary results, which include assessments of efficacy, are subject to substantial risk of change due to small sample sizes and may change as patients are evaluated or as additional patients are enrolled in these clinical trials. These outcomes may be unfavorable, deviate from ImmunityBio’s earlier reports, and/or delay or prevent regulatory approval or commercialization of our product candidates, including candidates for which we have reported preliminary efficacy results.

Further, certain of our hypotheses regarding the potential benefits of our product candidates compared to alternative therapies and treatments are based on cross-trial comparisons of results that were not derived from head-to-head clinical trials. Such clinical trial data may not be directly comparable due to differences in study protocols, conditions and patient populations. Accordingly, these cross-trial comparisons may not be reliable predictors of the relative efficacy or other benefits of our product candidates compared to other product candidates that may have been approved previously.

Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which are based on preliminary analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also may make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available.

From time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could

 

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impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

NantKwest and ImmunityBio have limited experience conducting clinical trials and have relied and will rely on third parties and related parties to conduct many of our preclinical studies and clinical trials. Any failure by a third party, related party, or by us to conduct the clinical trials according to Good Clinical Practice (“GCP”) regulations, and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.

Historically NantKwest and ImmunityBio have been, and in the future the combined company may be, heavily reliant on third parties to conduct their clinical trials. NantKwest and ImmunityBio have a limited history of conducting clinical trials and have no experience as a company in filing and supporting the applications necessary to gain marketing approvals. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety, purity, and potency, or efficacy, for that indication. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, applicable regulatory authorities.

Large-scale clinical trials require significant financial and management resources, and reliance on third-party clinical investigators, CROs, CMOs, if used, partners or consultants. Relying on third-party clinical investigators, CROs or CMOs may force us to encounter delays and challenges that are outside of our control. We may not be able to demonstrate sufficient comparability between products manufactured at different facilities to allow for inclusion of the clinical results from patients treated with products from these different facilities, in our product registrations. Further, if we use CMOs, they may not be able to manufacture Anktiva or our other product candidates or otherwise fulfill their obligations to us because of interruptions to their business, including the loss of their key staff or interruptions to their raw material supply.

Our reliance on these third parties for development activities will reduce our control over these activities. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable trial protocol and legal, regulatory and scientific standards, and our reliance on CROs, clinical trial sites, and other third parties does not relieve us of these responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with Good Laboratory Practice (“GLP”) regulations, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with GCP for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these requirements through periodic inspections (including pre-approval inspections once a BLA or NDA is filed with the FDA) of trial sponsors, clinical investigators, trial sites and certain third parties including CMOs. If we, our CROs, clinical trial sites, or other third parties fail to comply with applicable GCP or other regulatory requirements, we or they may be subject to enforcement or other legal actions, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations.

Our clinical trials will need to be conducted with product candidates that were produced under current Good Manufacturing Practices (“cGMP”) regulations. Our failure to comply or our CMOs’ failure to comply with these

 

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regulations may require us to repeat clinical trials, which would delay the regulatory approval process. We also are required to register certain clinical trials and post the results of certain completed clinical trials on a government sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so could result in enforcement actions and adverse publicity.

NantKwest and ImmunityBio rely, and the combined company expects to rely, on other third parties to manufacture, package, label and ship their product candidates for the clinical trials that they conduct. Any performance failure on the part of these third parties could delay clinical development or marketing approval of our product candidates or commercialization of our product candidates, if approved, producing additional losses and depriving us of potential product revenues.

In addition, we will be required to report certain financial interests of our third-party investigators if these relationships exceed certain financial thresholds or meet other criteria. In the past, Immuno-Oncology Clinic, Inc. (the “Clinic”) has conducted, and in the future the Clinic may conduct, clinical trials involving ImmunityBio’s and NantKwest’s product candidates. NantWorks is a collection of healthcare and technology companies that is controlled, and a majority of which is owned, by the Executive Chairman of the combined company, Dr. Soon-Shiong, and provides certain administrative services (and has loaned money) to the Clinic. ImmunityBio and NantKwest are conducting ongoing clinical trials and single patient investigational new drug (“spIND”) applications that may include the use of Anktiva, aldoxorubicin or product candidates enabled by our adenovirus, or Ad, technologies. The FDA or comparable foreign regulatory authorities may question the integrity of the data from those clinical trials conducted by investigators that are determined to have conflicts of interest.

Our CROs, clinical trial sites and other third parties may also have relationships with other entities, some of which may be our competitors, for whom they may also be conducting clinical trials or other therapeutic development activities that could harm our competitive position. In addition, these third parties are not our employees, and except for remedies available to us under our agreements with them, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and preclinical programs. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our trial protocols, regulatory requirements or for other reasons, our trials may need to be repeated, extended, delayed or terminated, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates or we or they may be subject to regulatory enforcement actions. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. To the extent we are unable to successfully identify and manage the performance of third-party service providers in the future, our business may be materially and adversely affected.

Our reliance on third parties can also present intellectual property-related risks. For example, collaborators may not properly obtain, maintain, enforce or defend intellectual property or proprietary rights relating to our product candidates or technology or may use our proprietary information in such a way as to expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity and enforceability of our intellectual property. Collaborators may also own or co-own intellectual property covering our product candidates or technology that results from our collaboration with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property or such product candidates or technology. Collaborators may also gain access to our trade secrets or formulations and impact our ability to commercialize proprietary technology. We may also need the cooperation of our collaborators to enforce or defend any intellectual property we contribute to or that arises out of our collaborations, which may not be provided to us.

If any of our relationships with these third parties terminate, we may not be able to enter into alternative arrangements or do so on commercially reasonable terms. Switching or adding additional contractors involves

 

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additional cost and time and requires management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays could occur, which could compromise our ability to meet our desired development timelines. In addition, if an agreement with any of our collaborators terminates, our access to technology and intellectual property licensed to us by that collaborator may be restricted or terminate entirely, which may delay our continued development of our product candidates utilizing the collaborator’s technology or intellectual property or require us to stop development of those product candidates completely.

ImmunityBio’s and NantKwest’s relative lack of experience conducting clinical trials may contribute to their planned clinical trials not beginning or completing on time, if at all. In addition, ImmunityBio and NantKwest have entered into agreements with the Clinic, a related party, to continue to conduct and oversee certain of its clinical trials. Large-scale clinical trials will require significant additional resources and reliance on CROs, clinical investigators or consultants. Consequently, our reliance on outside parties may introduce delays beyond our control. Our CROs, the Clinic and other third parties must communicate and coordinate with one another in order for our trials to be successful. Additionally, our CROs, the Clinic and other third parties may also have relationships with other commercial entities, some of which may compete with us. If our CROs, the Clinic or other third parties conducting our clinical trials do not perform their contractual duties or regulatory obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical trial protocols, GCP or other regulatory requirements or for any other reason, we may need to conduct additional clinical trials or enter into new arrangements with alternative CROs, clinical investigators or other third parties. We may be unable to enter into arrangements with alternative CROs on commercially reasonable terms, or at all.

We, the Clinic and the third parties upon which we intend to rely for conducting our clinical trials are required to comply with GCP. GCP are regulations and guidelines enforced by regulatory authorities around the world, through periodic inspections, for products in clinical development. If we or these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and have to be repeated, and our submission of marketing applications may be delayed or the regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We are subject to the risk that, upon inspection, a regulatory authority will determine that any of our clinical trials fails to comply or failed to comply with applicable GCP regulations. In addition, our clinical trials must be conducted with material produced under GMP and/or Good Tissue Practice (“GTP”) regulations, which are enforced by regulatory authorities. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be significantly impacted if our CROs, the Clinic, clinical investigators or other third parties violate federal or state healthcare fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

We also anticipate that part of our strategy for pursuing the wide range of indications potentially addressed by Anktiva will involve further investigator-initiated clinical trials. While these trials generally provide us with valuable clinical data that can inform our future development strategy in a cost-efficient manner, we generally have less control over not only the conduct but also the design of these clinical trials. Third-party investigators may design clinical trials involving our product candidates with clinical endpoints that are more difficult to achieve or in other ways that increase the risk of negative clinical trial results compared to clinical trials we may design on our own. Negative results in investigator-initiated clinical trials, regardless of how the clinical trial was designed or conducted, could have a material adverse effect on our prospects and the perception of our product candidates.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. In addition, in the past, the Clinic has conducted clinical trials involving NantKwest’s and ImmunityBio’s product candidates, and in the future the Clinic may conduct, clinical trials involving our product candidates. NantWorks, which is controlled by, and a

 

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majority of which is owned by, the Executive Chairman of the combined company, Dr. Soon-Shiong, provides certain administrative services (and has loaned money) to the Clinic. Under certain circumstances, we may be required to report some of these relationships to the FDA. The FDA may conclude that a financial relationship between us, the Clinic and/or a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of regulatory approval of one or more of our product candidates.

Our clinical trials may not be initiated or completed when we expect and we may be required to conduct additional clinical trials or modify current or future clinical trials based on feedback we receive from the FDA.

Clinical testing is expensive, time consuming and subject to uncertainty. We cannot guarantee that any current or future clinical trials will be conducted as planned or completed on schedule, if at all, or that any of the combined company’s product candidates will receive regulatory approval. ImmunityBio previously initiated clinical trials in patients with bladder cancer and in other indications, sometimes in collaboration with third parties. The combined company plans to initiate trials in new indications, and new cohorts in existing trials. Even as these trials progress, issues may arise that could require us to suspend or terminate such clinical trials or could cause the results of one cohort to differ from a prior cohort. For example, we may experience slower than anticipated enrollment in our clinical trials, which may consequently delay our BLA and/or NDA filing timelines or permit competitors to obtain approvals that may alter our BLA and/or NDA filing strategy. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical trials may not be successful.

Events that may prevent successful or timely initiation or completion of clinical development or product approval include:

 

   

regulators or Institutional Review Boards (“IRBs”) may not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or regulators or IRBs may require that we modify or amend our clinical trial protocols;

 

   

delays in reaching a consensus or inability to obtain agreement with the FDA or comparable foreign regulatory authorities on trial design or eligibility criteria for patient enrollment;

 

   

the FDA or comparable foreign regulatory authorities may disagree with our intended indications, trial design or our interpretation of data from preclinical studies and clinical trials or find that a product candidate’s benefits do not outweigh its safety risks;

 

   

the FDA or comparable foreign regulatory authorities may not accept data from trials with clinical trial sites in foreign countries;

 

   

the FDA may not allow us to use the clinical trial data from a research institution to support an investigational new drug (“IND”) if we cannot demonstrate the comparability of our product candidates with the product candidate used by the relevant research institution in its clinical trials;

 

   

delays in or failure to reach an agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

 

   

imposition of a temporary or permanent clinical hold, such as the clinical hold on the Phase II/III clinical trial for ImmunityBio’s hAd5 COVID-19 vaccine candidate pending modifications to the protocol and FDA’s review of additional information, including of immunogenicity and safety data from the Phase I portion of the study, or the temporary hold previously experienced in ImmunityBio’s 2014 clinical study relating to aldoxorubicin; although this temporary clinical hold involved a single death of a compassionate use patient, since that time, aldoxorubicin has been administered in multiple Phase II clinical trials and a Phase III clinical trial with no further clinical holds;

 

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suspensions or terminations by regulatory agencies, IRBs, or us for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the product candidate, or due to findings of undesirable effects caused by a biologically or mechanistically similar therapeutic or therapeutic candidate;

 

   

delays in adding new investigators or clinical trial sites, or withdrawal of clinical trial sites from a trial;

 

   

failure by our CROs, clinical trial sites or patients, or other third parties, or us to adhere to clinical trial requirements, including regulatory, contractual or protocol requirements;

 

   

failure to perform in accordance with the GCP requirements, or applicable regulatory guidelines in other countries;

 

   

occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

 

   

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols to regulatory authorities and IRBs, and which may cause delays in our development programs, or changes to regulatory review times;

 

   

there may be regulatory questions or disagreements regarding interpretations of data and results, or new information may emerge regarding our product candidates;

 

   

changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;

 

   

the cost of clinical trials of our product candidates being greater than we anticipate, or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA upon the filing of a BLA or NDA;

 

   

clinical trials of our product candidates producing negative or inconclusive results may fail to provide sufficient data and information to support product approval, or our trials may fail to reach the necessary level of statistical or clinical significance, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials, or preclinical studies, or abandon product development programs;

 

   

interruption of, or delays in receiving, supplies of our product candidates or other drugs or components of our therapies due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

 

   

early results from our clinical trials of our product candidates may be negatively affected by changes in efficacy measures such as overall response rate and duration of response as more patients are enrolled in our clinical trials or as new cohorts of our clinical trials are tested, and overall response rate and duration of response may be negatively affected by the inclusion of unconfirmed responses in preliminary results that we report if such responses are not later confirmed;

 

   

we may not be able to demonstrate that a product candidate provides an advantage over current standards of care or current or future competitive therapies in development;

 

   

there may be changes to the therapeutics or their regulatory status which we are administering in combination with our product candidates;

 

   

the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or our manufacturing facilities for clinical and future commercial supplies;

 

   

the FDA or comparable regulatory authorities may take longer than we anticipate making a decision on our product candidates;

 

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transfer of our manufacturing processes to our CMOs or other larger-scale facilities operated by a CMO or by us and delays or failure by our CMOs or us to make any necessary changes to such manufacturing process;

 

   

our use of different manufacturing processes within our clinical trials, and any effects that may result from the use of different processes on the clinical data that we have reported and will report in the future;

 

   

delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing, including as a result of any quality issues associated with the contract manufacturer;

 

   

delays and additional costs associated with business disruptions, new regulatory requirements, social distancing and other restrictions imposed by governmental or regulatory agencies and clinical trial sites due to the COVID-19 pandemic, which may include enrollment delays or failures to follow trial protocols; and

 

   

obtaining sufficient supply of therapies that may be used in combination with our molecular agents or as comparative agents in clinical trials.

ImmunityBio is conducting its Phase II trial of Anktiva in combination with BCG in BCG unresponsive patients with non-muscle invasive bladder cancer, (“NMIBC”) in both carcinoma in situ (“CIS”) and papillary forms. Due to BCG shortages, delays were encountered in patient enrollment. As of December, 2020, ImmunityBio has completed its planned enrollment in the BCG unresponsive CIS cohort. ImmunityBio has enrolled patients who have received a lower dosage of BCG therapy before enrollment in its trial as a result of BCG shortages. During the period of shortages, ImmunityBio has also enrolled patients who have received a lower dosage of BCG therapy before enrollment in the trial due to the global shortage of BCG; for example, some patients received the recommended number of doses, but the amount per dose was one-third of recommended strength. All patients, without exception, received the number of BCG doses consistent with FDA guidance, and no less than approximately 90% of patients enrolled in the trial as of December, 2020 have received the amount of BCG recommended by the American Urological Association before enrolling in the trial.

The FDA agreed with ImmunityBio’s modification of the study design to allow enrollment of patients who have received a less than adequate dose of BCG as first line therapy. These patients received the full dose of BCG + Anktiva during the trial; however, such patients should not be considered BCG unresponsive. The disposition of such patients in the assessment of ImmunityBio’s trial results to support approval of Anktiva in BCG unresponsive CIS NMIBC patients will be determined by the FDA during their review. ImmunityBio may consider enrolling additional patients before BLA submission, and the labeling will reflect the enrolled patient population and will also be determined by the FDA during their review.

We also may conduct clinical and preclinical research in collaboration with other academic, pharmaceutical, biotechnology and biologics entities in which we combine our technologies with those of our collaborators. Such collaborations may be subject to additional delays because of the management of the trials, contract negotiations, the need to obtain agreement from multiple parties and the necessity of obtaining additional approvals for therapeutics used in the combination trials. These combination therapies will require additional testing and clinical trials will require additional FDA regulatory approval and will increase our future cost of expenses.

Any inability to successfully complete preclinical and clinical development could result in additional costs to the combined company or impair our ability to generate revenues. In addition, if we make manufacturing changes to our product candidates, we may be required to, or we may elect to, conduct additional trials to bridge our modified product candidates to earlier versions. These changes may require FDA approval or notification and may not have their desired effect. The FDA may also not accept data from prior versions of the product to support an application, delaying our clinical trials or programs or necessitating additional clinical trials or preclinical studies. We may find that this change has unintended consequences that necessitates additional

 

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development and manufacturing work, additional clinical and preclinical studies, or that results in refusal to file or non-approval of a BLA and/or NDA.

Clinical trial delays could shorten any periods during which our product candidates have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical studies, clinical trials or other research. The number and types of preclinical studies and clinical trials that will be required for regulatory approval also vary depending on the product candidate, the disease or condition that the product candidate is designed to address and the regulations applicable to any particular product candidate. Approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It is possible that any product candidates we may seek to develop in the future will never obtain the appropriate regulatory approvals necessary for us or any future collaborators to commence product sales. Any delay in completing development or obtaining, or failing to obtain, required approvals could also materially adversely affect our ability or that of any of our collaborators to generate revenues from any such product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities and receipt of necessary marketing approvals could be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients, who remain in the trial until its conclusion. We may experience difficulties or delays in patient enrollment in our clinical trials for a variety of reasons, including:

 

   

the size and nature of the patient population;

 

   

the severity of the disease under investigation;

 

   

the patient eligibility criteria defined in the protocol;

 

   

the size of the study population required for analysis of the trial’s primary endpoints;

 

   

the proximity of patients to trial sites;

 

   

our ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

   

the efforts to facilitate timely enrollment in clinical trials and the effectiveness of recruiting publicity;

 

   

the patient referral practices of physicians;

 

   

the number of patients required for clinical trials of our product candidates may be larger than we anticipate or enrollment in these clinical trials may be slower than we anticipate, potentially affecting our timelines for approval of our product candidates;

 

   

patients that enroll in our studies may misrepresent their eligibility or may otherwise not comply with the clinical trial protocol, resulting in the need to drop such patients from the study or clinical trial, increase the needed enrollment size for the study or clinical trial or extend the study’s or clinical trial’s duration;

 

   

competing clinical trials for similar therapies or other new therapeutics not involving cell-based immunotherapy;

 

   

clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating;

 

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clinical investigators enrolling patients who do not meet the enrollment criteria, requiring the inclusion of additional patients in the clinical trial;

 

   

approval of new indications for existing therapies or approval of new therapies in general;

 

   

our ability to obtain and maintain patient consents;

 

   

the impact of the current COVID-19 pandemic or other material adverse events, which may affect the conduct of a clinical trial, including by slowing potential enrollment or reducing the number of eligible patients for clinical trials; and

 

   

the risk that patients enrolled in clinical trials will not complete a clinical trial, return for post-treatment follow-up, or follow the required study procedures. For instance, patients, including patients in any control groups, may withdraw from the clinical trial if they are not experiencing improvement in their underlying disease or condition. Withdrawal of patients from our clinical trials may compromise the quality of our data.

In addition, we expect that our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Because the number of qualified clinical investigators is limited, we may need to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer and/or viral disease treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and approved immunotherapies, rather than enroll patients in any future clinical trial.

Amendments to our clinical protocols may affect enrollment in, or results of, our trials, including amendments we have made to further define the patient population to be studied.

Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment or small population size may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.

Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

Results of our trials could reveal a high and unacceptable severity and prevalence of side effects, adverse events or unexpected characteristics. Undesirable side effects caused by our product candidates could cause us, IRBs, Drug Safety Monitoring Boards (“DSMBs”) or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. Even if we were to receive product approval, such approval could be contingent on inclusion of unfavorable information in our product labeling, such as limitations on the indicated uses for which the products may be marketed or distributed, a label with significant safety warnings, including boxed warnings, contraindications, and precautions, a label without statements necessary or desirable for successful commercialization, or requirements for costly post marketing testing and surveillance, or other requirements, including a Risk Evaluation and Mitigation Strategy (“REMS”) to monitor the safety or efficacy of the products, and in turn prevent us from commercializing and generating revenues from the sale of our current or future product candidates.

If unacceptable toxicities or side effects arise in the development of our product candidates, we, an IRB, DSMB or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials, order our

 

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clinical trials to be placed on clinical hold, or deny approval of our product candidates for any or all targeted indications. The FDA or comparable foreign regulatory authorities may also require additional data, clinical, or preclinical studies should unacceptable toxicities arise. We may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk/benefit perspective. Toxicities associated with our trials and product candidates may also negatively impact our ability to conduct clinical trials using tumor-infiltrating lymphocyte (“TIL”) therapy in larger patient populations, such as in patients that have not yet been treated with other therapies or have not yet progressed on other therapies.

Treatment-emergent adverse events could also affect patient recruitment or the ability of enrolled subjects to complete our trials or result in potential product liability claims. ImmunityBio has observed that certain events associated with its product candidates may include, for example, injection site pain and reaction, fatigue, nausea, vomiting, diarrhea, mucositis, abdominal pain, anorexia, chills, pyrexia, arthralgia, limb edema, myelosuppression (neutropenia, thrombocytopenia, and anemia) and hypoalbuminemia. Combination immunotherapy that includes ImmunityBio’s current product candidates may be associated with more frequent adverse events or additional adverse events, such as esophagitis, stomatitis, epistaxis, weight loss, headache, alopecia, night sweats, peripheral neuropathy, and death. In addition, these serious adverse effects may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from our product candidate are not normally encountered in the general patient population and by medical personnel. Any of these occurrences may harm our business, financial condition and prospects significantly.

The manufacture of our product candidates is complex, and we may encounter difficulties in production, particularly with respect to process development, quality control, or scaling-up of our manufacturing capabilities. If we or our related parties, or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

NantKwest’s and ImmunityBio’s current product candidates include predominately biologics, vectors, small molecules and decentralized, advanced cell therapies. The manufacture of these product candidates involves complex processes, especially for our biologics, vectors and cell therapy product candidates, which are complex, highly regulated and subject to multiple risks. As a result of the complexities, the cost to manufacture biologics, vectors and cell therapies is generally higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. If microbial, viral, environmental or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

Currently, NantKwest’s and ImmunityBio’s product candidates are manufactured using processes developed or modified by NantKwest or ImmunityBio, their respective affiliates or by their third-party research institution collaborators that the combined company may not intend to use for more advanced clinical trials or commercialization. As a result of these challenges, we may experience delays in our clinical development and/or commercialization plans. We may ultimately be unable to reduce the cost of goods for our product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized.

Currently NantKwest’s and ImmunityBio’s product candidates are manufactured by NantKwest, in partnership with ImmunityBio, or by CMOs. The combined company may use third-party CMOs or some of its related parties to manufacture its product candidates. Our product candidates may compete with other products and product candidates for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If our CMOs should cease manufacturing for us, we would experience delays in obtaining sufficient quantities of our

 

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product candidates for clinical trials and, if approved, commercial supply. Further, our CMOs may breach, terminate, or not renew these agreements. If we were to need to find alternative manufacturing facilities it would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. The commercial terms of any new arrangement could be less favorable than our existing arrangements and the expenses relating to the transfer of necessary technology and processes could be significant.

Reliance on third-party manufacturers entails exposure to risks to which we would not be subject if we manufactured the product candidate ourselves, including:

 

   

inability to negotiate manufacturing and quality agreements with third parties under commercially reasonable terms;

 

   

reduced day-to-day control over the manufacturing process for our product candidates as a result of using third-party manufacturers for all aspects of manufacturing activities;

 

   

reduced control over the protection of our trade secrets, know-how and other proprietary information from misappropriation or inadvertent disclosure or from being used in such a way as to expose us to potential litigation;

 

   

termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that may be costly or damaging to us or result in delays in the development or commercialization of our product candidates; and

 

   

disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier.

The manufacture of cell therapy products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of cell therapy products often encounter difficulties in production, particularly in scaling up initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel and compliance with strictly enforced federal, state, local and foreign regulations.

Moreover, any problems or delays the combined company or its CMOs experience in preparing for commercial scale manufacturing of a product candidate may result in a delay in the FDA approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and could adversely affect our business. Furthermore, if we or our commercial manufacturers fail to deliver the required commercial quantities of our product candidates on a timely basis and at reasonable costs, we would likely be unable to meet demand for our products and we would lose potential revenues.

In addition, the manufacturing process and facilities for any products that we may develop are subject to FDA and foreign regulatory authority approval processes, and we or our CMOs will need to meet all applicable FDA and foreign regulatory authority requirements, including cGMP, on an ongoing basis. The cGMP requirements include quality control, quality assurance and the maintenance of records and documentation. The FDA and other regulatory authorities enforce these requirements through facility inspections. Manufacturing facilities must submit to pre-approval inspections by the FDA that will be conducted after we submit our marketing applications, including our BLAs and NDAs, to the FDA. Manufacturers are also subject to continuing FDA and other regulatory authority inspections following marketing approval. Further, we and our third-party CMOs must supply all necessary chemistry, manufacturing and quality control documentation in support of a BLA or NDA on a timely basis. There is no guarantee that we or our CMOs will be able to successfully pass all aspects of a pre-approval inspection by the FDA or other foreign regulatory authorities.

As product candidates progress through preclinical and clinical trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing

 

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methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates, if approved, and generate revenues.

Our or our CMOs’ manufacturing facilities may be unable to comply with our specifications, cGMP, and with other FDA, state, and foreign regulatory requirements. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of product candidates that may not be detectable in final product testing. If we or our CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, or in accordance with the strict regulatory requirements, we may not obtain or maintain the approvals we need to commercialize such products. Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Deviations from manufacturing requirements may further require remedial measures that may be costly and/or time-consuming for us or a third party to implement and may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.

Even to the extent we use CMOs, we are ultimately responsible for the manufacture of our products, if approved, and product candidates. A failure to comply with these requirements may result in regulatory enforcement actions against our manufacturers or us, including fines and civil and criminal penalties, which could result in imprisonment, suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues with the biologic, refusal to permit the import or export of the products, product seizure, detention, or recall, operating restrictions, suits under the federal civil False Claims Act (“FCA”) corporate integrity agreements, consent decrees, or withdrawal of product approval.

Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.

Cell-based therapies and biologics rely on the availability of reagents, specialized equipment and other specialty materials, which may not be available to the combined company on acceptable terms or at all. For some of these reagents, equipment and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products, if approved.

Manufacturing our product candidates will require many reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. NantKwest and ImmunityBio currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product candidates. Some of these suppliers may not have the capacity to support clinical trials and commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. NantKwest and ImmunityBio also do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key materials and equipment to support clinical or commercial manufacturing.

 

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For some of these reagents, equipment and materials, NantKwest and ImmunityBio rely and we may in the future rely on sole source vendors or a limited number of vendors. An inability to continue to source product from any of these suppliers, which could be due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

As the combined company seeks to develop and scale its manufacturing process, we expect that we will need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on our business. Even if we are able to alter our process so as to use other materials or equipment, such a change may lead to a delay in our clinical development and/or commercialization plans. If such a change occurs for a product candidate that is already in clinical testing, the change may require us to perform both ex vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials.

We will be unable to commercialize our product candidates if our trials are not successful.

NantKwest’s and ImmunityBio’s research and development programs are each at an early stage. We must demonstrate our product candidates’ safety and efficacy in humans through extensive clinical testing. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our product candidates, including but not limited to the following:

 

   

safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials;

 

   

after reviewing test results, we or our collaborators may abandon projects that we might previously have believed to be promising;

 

   

we, our collaborators or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;

 

   

the standard of care may change as the result of new technology or therapies in our target clinical indications, precluding regulatory approval or limited commercial use if approved;

 

   

the effects our potential products have may not be the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved;

 

   

manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity; and

 

   

regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements.

Clinical testing is very expensive, can take many years and the outcome is uncertain. It could take as much as 12 months or more before we learn the results from any clinical trial using Anktiva, aldoxorubicin, Ad and yeast technologies or other therapy. The data collected from our clinical trials may not be sufficient to support approval by the FDA of ImmunityBio’s Anktiva product candidate for the treatment of bladder cancer or of other therapies, including our hAd5 COVID-19 vaccine candidate. The clinical trials for our product candidates under development may not be completed on schedule and the FDA may not ultimately approve any of our product candidates for commercial sale. If we fail to adequately demonstrate the safety and efficacy of any product candidate under development, we may not receive regulatory approval for those product candidates, which would prevent us from generating revenues or achieving profitability.

 

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Even if ImmunityBio’s lead product candidate, Anktiva, is approved and commercialized, the combined company may not become profitable.

ImmunityBio’s lead product candidate, Anktiva, is initially targeting a small population of patients that suffer from bladder cancer, lung cancer and metastatic pancreatic cancer, when used as a combination therapy. Even if the FDA approves this candidate for these indications, and even if the combined company obtains significant market share for it, because the potential target population may be small, we may never achieve profitability without obtaining regulatory approval for additional indications. The FDA often approves new therapies initially only for use in patients with relapsed or refractory metastatic disease, which may limit our patient population.

Additionally, ImmunityBio has issued CVRs to the former stockholders of Altor BioScience Corporation (succeeded by Altor BioScience LLC) (“Altor”) in connection with its acquisition of Altor. These CVRs become payable upon the attainment of certain regulatory and sales milestones related to Anktiva. The former Altor stockholders have the ability to choose to receive these payments either in cash, in an equivalent value of our common stock or in a combination of both cash and stock at the time such payments are due, except that Dr. Soon-Shiong and his related party, as prior stockholders of Altor, have irrevocably elected to receive all payments in respect of their CVRs in the form of our common stock. Such CVR payments to Dr. Soon-Shiong and his related party aggregate to approximately $279.5 million. The combined company may, however, still be required to pay the other prior Altor stockholders up to $164.2 million for the CVRs relating to the regulatory milestone and up to $164.2 million for the CVRs relating to the sales milestone should they choose to have these CVRs paid in cash instead of common stock. If this were to occur, the combined company may need to seek additional sources of capital and we may not be able to achieve profitability or positive cash flow. We plan to collaborate with governmental, academic and corporate partners, including affiliates, to improve and develop Anktiva, hAd5 and other therapies for new indications for use in combination with other therapies and to improve and develop the combined company’s other product candidates, which may expose us to additional risks, or we may not realize the benefits of such collaborations.

In addition to its own research and process development efforts, the combined company will seek to collaborate with government, academic research institutions and corporate partners, including its affiliates, to improve manufacturing of ImmunityBio’s existing product candidates, including Anktiva, hAd5 and yeast technologies, and to develop Anktiva and other therapies for new indications.

Because some of our collaborations are conducted at outside laboratories, and we do not have complete control over how the studies are conducted or reported or over the manufacturing methods used to manufacture ImmunityBio’s Anktiva product candidate, the results of such studies, which we may use as the basis for our conclusions, projections or decisions with respect to NantKwest’s and ImmunityBio’s current or our future product candidates, may be incorrect or unreliable, or may have a negative impact on us if the results of such studies are imputed to our product candidates or proposed indications, even if such imputation is improper. Additionally, we may use third-party data to analyze, reach conclusions or make predictions or decisions with respect to our product candidates that may be incomplete, inaccurate or otherwise unreliable.

Further, collaborations involving our product candidates will be subject to numerous risks, which may include the following:

 

   

collaborators, including their related or affiliated companies, may be entitled to receive exclusive rights for or involving our products;

 

   

collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

 

   

collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization of our product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products,

 

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availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

 

   

collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

 

   

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;

 

   

a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;

 

   

collaborators may not properly maintain, defend or enforce our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

 

   

disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources (see “—If conflicts arise between the combined company and its collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.”);

 

   

collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;

 

   

if an agreement with any collaborator terminates, our access to technology and intellectual property licensed to us by that collaborator may be restricted or terminate entirely, which may delay our continued development of our product candidates utilizing the collaborator’s technology or intellectual property or require us to stop development of those product candidates completely; and

 

   

collaborators may own or co-own intellectual property covering our product candidates or technology that results from our collaborating with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property.

As a result, if we enter into collaboration agreements and strategic partnerships or license our product candidates, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. Additionally, exclusive rights that we may grant in connection with collaboration agreements may limit our ability to enter into new or additional collaboration agreements or strategic partnerships if we experience issues with existing collaborations. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenues or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

NantKwest’s and ImmunityBio’s efforts to develop, manufacture and market COVID-19 therapeutics will require additional personnel who will require training, which may cause some of our employees to reallocate their time from other duties which could in turn cause delays in clinical supply of our other product candidates or trials.

In August 2020, ImmunityBio and NantKwest entered into a collaboration agreement to pursue collaborative joint development, manufacturing and marketing of certain COVID-19 therapeutics and vaccines. NantKwest and ImmunityBio have been planning for the development of COVID-19-related product candidates. NantKwest and ImmunityBio have repurposed some of their personnel overseeing quality, clinical operations and

 

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manufacturing of their oncology product candidates to support their COVID-19 efforts and the combined company plans to hire additional staff to support the COVID-19 efforts, which will increase its expenses. If our personnel fail to remain focused on our oncology or other infectious disease drug candidates or the services of employees that may have shifted to the COVID-19 efforts are not adequately covered by other employees, or new personnel that we plan to hire to support the COVID-19 efforts require extensive training, the combined company’s current oncology operations may be adversely impacted.

If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.

If conflicts arise between our corporate or academic collaborators or strategic partners and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Some of NantKwest’s and ImmunityBio’s existing academic collaborators and strategic partners are conducting multiple product development efforts within each area that is the subject of the collaboration with NantKwest or ImmunityBio. Such collaborators or strategic partners may develop, either alone or with others, products that are competitive with the product candidates that are the subject of these collaborations. Competing product candidates, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of our collaborator’s or partner’s support for our product candidates.

Some of our future collaborators or strategic partners could also become our competitors in the future. Our collaborators or strategic partners could develop competing products, preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely or fail to devote sufficient resources to the development and commercialization of our product candidates. For example, in May 2019, Sorrento Therapeutics, Inc. (“Sorrento”) with which ImmunityBio jointly established a new entity called Immunotherapy NANTibody, LLC (“NANTibody”) as a stand-alone biotechnology company, commenced litigation against ImmunityBio and certain of its officers and directors, alleging that ImmunityBio improperly caused NANTibody to acquire IgDraSol, Inc. (“IgDraSol”) and in January 2020 and April 2020, Sorrento sent letters purporting to terminate an exclusive license agreement with ImmunityBio and an exclusive license agreement with NANTibody. Additionally, in July 2020, ImmunityBio received a Request for Arbitration before the International Chamber of Commerce, International Court of Arbitration, served by Shenzhen Beike Biotechnology Co. Ltd. (“Beike”) asserting breach of contract under ImmunityBio’s subsidiary Altor’s license agreement with them. For more information regarding these disputes, see “Business of ImmunityBio—Legal Proceedings.” Any of these developments could harm our product development efforts.

We will need additional financing to fund our operations and complete the development and commercialization of our various product candidates, and if we are unable to obtain such financing, we may be unable to complete the development and commercialization of our product candidates. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

NantKwest’s and ImmunityBio’s operations have consumed substantial amounts of cash since inception. As of September 30, 2020, NantKwest had an accumulated deficit of $722.4 million and ImmunityBio had an accumulated deficit of $822.7 million. In addition, research and development and operating costs have also been substantial and are expected to increase. A significant portion of ImmunityBio’s funding had been in the form of promissory notes representing $254.6 million in indebtedness as of December 31, 2020 held by entities affiliated with Dr. Soon-Shiong with a maturity date of September 30, 2025, which debt will remain outstanding in accordance with its terms following the closing of the merger.

As of September 30, 2020, NantKwest had cash, cash equivalents and marketable securities of $89.0 million and ImmunityBio had cash, cash equivalents and marketable securities of $61.7 million. In order to complete the development of our current product candidates, and in order to implement our business plan, we anticipate that

 

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we will have to spend more than the funds currently available to us. Furthermore, changing circumstances may cause us to increase our spending significantly faster than we currently anticipate, and we may require additional capital for the further development and commercialization of our product candidates and may need to raise additional funds sooner if we choose to expand more rapidly than we presently anticipate. Moreover, our fixed expenses such as rent and other contractual commitments, including those for our research collaborations, are substantial and are expected to increase in the future.

We will need to obtain additional financing to fund our future operations, including completing the development and commercialization of our product candidates. Our future funding requirements will depend on many factors, including, but not limited to:

 

   

progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture ImmunityBio’s main product candidate, Anktiva, and other therapies for the treatment of patients in our ongoing, planned and potential future clinical trials;

 

   

time and cost necessary to obtain regulatory approvals that may be required by regulatory authorities to execute clinical trials;

 

   

our ability to successfully commercialize any product candidates, if approved;

 

   

our ability to have clinical and commercial product successfully manufactured consistent with FDA and European Medicines Agency regulations;

 

   

amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;

 

   

sales and marketing costs associated with commercializing any product candidates, if approved, including the cost and timing of building our marketing and sales capabilities;

 

   

cost of building, staffing and validating our own manufacturing facility in the United States;

 

   

terms and timing of our current and any potential future collaborations, CVRs, milestones, royalties, licensing or other arrangements that we have established or may establish;

 

   

cash requirements of any future acquisitions or the development of other product candidates;

 

   

time and cost necessary to respond to technological, regulatory, political and market developments;

 

   

costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and

 

   

costs associated with any potential business or product acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish.

Unless and until we can generate a sufficient amount of revenues, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. In that connection, NantKwest, ImmunityBio and/or the combined company intend to issue additional shares in connection with one or more future capital raising transactions that may occur prior to and/or, in the case of the combined company, after the closing of the merger. Additional funds may not be available when we seek to raise capital or need funds on terms that are acceptable to us, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely

 

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affect your rights as a stockholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us.

The combined company’s substantial debt could adversely affect our cash flows and limit our flexibility to raise additional capital.

ImmunityBio has, and the combined company will have, a significant amount of debt and may need to incur additional debt to support our growth. As of December 31, 2020, the total indebtedness of ImmunityBio was $254.6 million consisting of related party promissory notes, all held by entities affiliated with Dr. Soon-Shiong with a maturity date of September 30, 2025. The merger agreement also permits ImmunityBio to incur up to an additional $40 million in principal amount of debt prior to the closing. This debt will remain outstanding in accordance with its terms following the closing of the merger. As of December 31, 2020, NantKwest had no indebtedness.

Our substantial amount of debt could have important consequences and could:

 

   

require us to dedicate a substantial portion of our cash and cash equivalents to make interest and principal payments on our debt, reducing the availability of our cash and cash equivalents and cash flow from operations to fund future capital expenditures, working capital, execution of our strategy and other general corporate requirements;

 

   

increase our cost of borrowing and even limit our ability to access additional debt to fund future growth;

 

   

increase our vulnerability to general adverse economic and industry conditions and adverse changes in governmental regulations;

 

   

limit our flexibility in planning for, or reacting to, changes in our business and industry, which may place us at a competitive disadvantage compared with our competitors; and

 

   

limit our ability to borrow additional funds, even when necessary to maintain adequate liquidity, which would also limit our ability to further expand our business.

The occurrence of any of the foregoing factors could have a material adverse effect on our business, results of operations and financial condition.

We may also need to refinance a portion of our outstanding debt as it matures. We may not be able to refinance existing debt or the terms of any refinancing may not be as favorable as the terms of our existing debt. Furthermore, if prevailing interest rates or other factors at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to that refinanced indebtedness would increase. These risks could materially adversely affect our financial condition, cash flows and results of operations.

Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations

In general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses or tax credits, or NOLs or credits, to offset future taxable income or taxes. For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. We have not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant

 

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complexity and cost associated with such a study. If we have experienced a change of control, as defined by Section 382, at any time since inception (including as a result of the merger), utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. In addition, our NOLs or credits may also be impaired under state law. Accordingly, we may not be able to utilize a material portion of our NOLs or credits.

Changes in tax law could adversely affect our business and financial condition.

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the IRS and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us and our stockholders. In recent years, many such changes have been made and changes are likely to continue to occur in the future. For example, the Tax Cuts and Jobs Act (the “TCJA”) was enacted in 2017 and significantly reformed the Code. The TCJA, among other things, contained significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, a limitation of the tax deduction for net interest expense to 30% of adjusted earnings (except for certain small businesses), a limitation of the deduction for net operating losses to 80% of current year taxable income and an elimination of net operating loss carrybacks (though any net operating losses generated in taxable years beginning after December 31, 2017 may be carried forward indefinitely), and the modification or repeal of many business deductions and credits. Additionally, on March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act was enacted, which, among other things, suspends the 80% limitation on the deduction for net operating losses in taxable years beginning before January 1, 2021, permits a 5-year carryback of net operating losses arising in taxable years beginning after December 31, 2017 and before January 1, 2021, and generally caps the limitation on the deduction for net interest expense at 50% of adjusted taxable income for taxable years beginning in 2019 and 2020. It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in the combined company’s or the combined company’s stockholders’ tax liability or require changes in the manner in which the combined company operates in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

Our transfer pricing policies may be subject to challenge by the IRS or other taxing authorities.

The intercompany relationships of NantKwest and ImmunityBio are subject to complex transfer pricing regulations administered by taxing authorities in various jurisdictions. The relevant taxing authorities may disagree with our determinations as to the value of assets sold or acquired or income and expenses attributable to specific jurisdictions. If such a disagreement were to occur, and our position were not sustained, we could be required to pay additional taxes, interest and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations. We believe that our financial statements reflect adequate reserves to cover such a contingency, but there can be no assurances in that regard.

We may become subject to tax examinations of our tax returns by the Internal Revenue Service, or the IRS, and other domestic and foreign tax authorities. An adverse outcome of any such audit or examination by the IRS or other tax authority could have a material adverse effect on our operating results and financial condition.

We may become subject to regular review and audit by the IRS and other tax authorities in various domestic and foreign jurisdictions. As a result, we may in the future receive assessments in multiple jurisdictions on various tax-related assertions. Taxing authorities may in the future challenge our tax positions and methodologies on various matters, including our positions regarding the collection of sales and use taxes, the determination and

 

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payment of value added taxes and the jurisdictions in which we are subject to taxes, which could expose us to additional taxes. We regularly assess the likelihood of adverse outcomes resulting from future tax examinations to determine the adequacy of our provision for income taxes. These assessments can require considerable estimates and judgments. The calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax laws and regulations in a variety of jurisdictions. There can be no assurance that our tax positions and methodologies or calculation of our tax liabilities are accurate or that the outcomes from ongoing and future tax examinations will not have an adverse effect on our operating results and financial condition.

We will be subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays; even if we obtain regulatory approval for some of our product candidates, those products may still face regulatory difficulties.

Our potential products, cell processing and manufacturing activities will be subject to comprehensive regulation by the FDA in the United States and by comparable authorities in other countries. The process of obtaining FDA and other required regulatory approvals, including foreign approvals, is expensive and often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved. In addition, regulatory agencies may lack experience with our technologies and products, which may lengthen the regulatory review process, increase our development costs and delay or prevent their commercialization.

No fusion protein or cell therapy using Anktiva has been approved for marketing by the FDA. Consequently, there is no precedent for the successful commercialization of products based on ImmunityBio’s or NantKwest’s technologies. In addition, ImmunityBio has had only limited experience in filing and pursuing applications necessary to gain regulatory approvals, which may impede our ability to obtain timely FDA approvals, if at all. Neither NantKwest nor ImmunityBio has yet sought FDA approval for any adaptive cell therapy product. We will not be able to commercialize any of our potential products until we obtain FDA approval, and so any delay in obtaining, or inability to obtain, FDA approval would harm our business.

If we violate regulatory requirements at any stage, whether before or after marketing approval is obtained, we may face a number of regulatory consequences, including refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, modification of promotional materials or labeling, provision of corrective information, imposition of post-market requirements, including the need for additional testing, imposition of distribution or other restrictions under a REMS, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, FDA debarment, injunctions, fines, consent decrees, corporate integrity agreements, debarment from receiving government contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement, or civil or criminal penalties, including fines and imprisonment, and adverse publicity, among other adverse consequences. Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our product candidates. We may also be required to undertake post-marketing trials. In addition, if we or others identify side effects after any of our therapies are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn, and reformulation of our product candidates may be required.

Our projections regarding the market opportunities for our product candidates may not be accurate, and the actual market for our products, if approved, may be smaller than we estimate.

We do not have verifiable internal marketing data regarding the potential size of the commercial market for our product candidates, nor have we obtained current independent marketing surveys to verify the potential size of the commercial markets for our current product candidates or any future product candidates. Since our current product candidates and any future product candidates will represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. Accordingly, we may spend significant capital trying to obtain approval for product candidates that

 

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have an uncertain commercial market. Our projections of both the number of people who have the cancers or viral diseases we are targeting, as well as the subset of people with these diseases who are in a position to receive second- or third- line therapy, and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research by third parties, and may prove to be incorrect. Further, new studies or approvals of new therapeutics may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates and may also be limited by the cost of our treatments and the reimbursement of those treatment costs by third-party payors. For instance, we expect Anktiva to initially target a small patient population that suffers from bladder cancer. Even if we obtain significant market share for our product candidates, because the potential target populations may be small, we may never achieve profitability without obtaining regulatory approval for additional indications.

Because NantKwest’s and ImmunityBio’s current product candidates represent, and our other potential product candidates will represent novel approaches to the treatment of disease, there are many uncertainties regarding the development, the market acceptance, third-party reimbursement coverage and the commercial potential of our product candidates.

Human immunotherapy products are a new category of therapeutics. Because this is a relatively new and expanding area of novel therapeutic interventions, there are many uncertainties related to development, marketing, reimbursement and the commercial potential for our product candidates. There can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy products, or that the data generated in these trials will be acceptable to the FDA to support marketing approval. The FDA may take longer than usual to come to a decision on any BLA and/or NDA that we submit and may ultimately determine that there is not enough data, information, or experience with our product candidates to support an approval decision. The FDA may also require that we conduct additional post-marketing studies or implement risk management programs, such as REMS, until more experience with our product candidates is obtained. Finally, after increased usage, we may find that our product candidates do not have the intended effect, do not work with other combination therapies or have unanticipated side effects, potentially jeopardizing initial or continuing regulatory approval and commercial prospects.

We may also find that the manufacture of our product candidates is more difficult than anticipated, resulting in an inability to produce a sufficient amount of our product candidates for our clinical trials or, if approved, commercial supply. Moreover, because of the complexity and novelty of our manufacturing process, there are only a limited number of manufacturers who have the capability of producing our product candidates. Should any of our contract manufacturers no longer produce our product candidates, it may take us significant time to find a replacement, if we are able to find a replacement at all.

There is no assurance that the approaches offered by our product candidates will gain broad acceptance among doctors or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for proposed product candidates. The market for any products that we successfully develop will also depend on the cost of the product. We do not yet have sufficient information to reliably estimate what it will cost to commercially manufacture our current product candidates, and the actual cost to manufacture these products could materially and adversely affect the commercial viability of these products. Our goal is to reduce the cost of manufacturing and providing our therapies. However, unless we can reduce those costs to an acceptable amount, we may never be able to develop a commercially viable product. If we do not successfully develop and commercialize products based upon our approach or find suitable and economical sources for materials used in the production of our potential products, we will not become profitable, which would materially and adversely affect the value of our common stock.

 

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ImmunityBio’s Anktiva therapies and our other therapies may be provided to patients in combination with other agents provided by third parties or our affiliates. The cost of such combination therapy may increase the overall cost of therapy and may result in issues regarding the allocation of reimbursements between our therapy and the other agents, all of which may affect our ability to obtain reimbursement coverage for the combination therapy from governmental or private third-party medical insurers.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. Large judgements have also been awarded in class action lawsuits based on therapeutics that had unanticipated side effects. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

   

decreased demand for our products, if approved;

 

   

injury to our reputation;

 

   

withdrawal of clinical trial participants or sites and potential termination of clinical trial sites or entire clinical programs;

 

   

initiation of investigations by regulators, refusal to approve marketing applications or supplements, and withdrawal or limitation of product approvals;

 

   

costs to defend litigation;

 

   

a diversion of management’s time and our resources;

 

   

substantial monetary awards to trial participants or patients;

 

   

product recalls, withdrawals or labeling, marketing or promotional restrictions;

 

   

loss of revenues;

 

   

significant negative media attention;

 

   

decrease in the price of our stock and overall value of our company;

 

   

exhaustion of our available insurance coverage and our capital resources; or

 

   

the inability to commercialize our product candidates.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we may develop, alone or with corporate collaborators. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. While ImmunityBio has obtained clinical trial insurance for its Phase II clinical trials, ImmunityBio may have to pay amounts awarded by a court or negotiated in a settlement that exceed its coverage limitations or that are not covered by our insurance, and ImmunityBio may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

 

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Due to the significant resources required for the development of our product candidates, and depending on our ability to access capital, we must prioritize among many different opportunities. Moreover, we may expend our limited resources on programs that do not yield successful product candidates and not on indications that may be more profitable or for which there is a greater likelihood of success.

The combined company will not have sufficient resources to pursue development of all or even a substantial portion of the potential opportunities that we believe will be afforded to us by our product candidates. Because we have limited resources and access to capital to fund our operations, our management must make significant prioritization decisions as to which product candidates and indications to pursue and how much of our resources to allocate to each. Our management must also evaluate the benefits of developing in-licensed or jointly owned technologies, which in some circumstances we may be contractually obligated to pursue, relative to developing other product candidates, indications or programs. Our management has broad discretion to suspend, scale down, or discontinue any or all of these development efforts, or to initiate new programs to treat other diseases. If we select and commit resources to opportunities that we are unable to successfully develop, or we forego more promising opportunities, our business, financial condition and results of operations will be adversely affected.

We will face significant competition from other biotechnology and pharmaceutical companies and from non-profit institutions.

Competition in the field of cancer and viral infectious disease therapy is intense and is accentuated by the rapid pace of technological development. Research and discoveries by others may result in breakthroughs which may render our product candidates obsolete even before they generate any revenues. There are products that are approved and currently under development by others that could compete with the product candidates that we are developing. Many of our potential competitors have substantially greater research and development capabilities and approval, manufacturing, marketing, financial and managerial resources and experience than we do. Our competitors may:

 

   

develop safer, more convenient or more effective immunotherapies and other therapeutic products;

 

   

develop therapies that are less expensive or have better reimbursement from private or public payors;

 

   

reach the market more rapidly, reducing the potential sales of our product candidates; or

 

   

establish superior proprietary positions.

We will focus our efforts on oncological and infectious disease indications that are difficult to treat and with large unmet needs, and we believe our platforms will be broadly applicable across multiple tumor types and infections. Based on the breadth and depth of our platforms, we believe our competitors will range from large pharmaceutical companies to emerging novel biotechnology companies.

From an oncology perspective, we have different competitors based on modality. In the NK and T cells activation modality, we primarily compete with large pharmaceutical companies marketing checkpoint inhibitors including AstraZeneca PLC, or AstraZeneca, Bristol-Myers Squibb Company, or BMS, GlaxoSmithKline plc, or GSK, Merck & Co., Inc., or Merck, Pfizer Inc., or Pfizer, and Roche Holding AG, or Roche. The potential exists for some of these large pharmaceutical companies to seek collaboration for combination of Anktiva with their marketed checkpoint. Also, in the NK and T cell activation modality, we will compete with immunotherapy fusion protein companies developing similar approaches including Nektar Therapeutics, Neoleukin Therapeutics, Inc. Novartis International AG, Roche, Sanofi S.A., and in the context of NMIBC, FerGene, Inc., Merck and Sesen Bio, Inc.

In the tumoricidal macrophage activation modality, we will compete with various chemotherapeutic agents, including Abraxane, doxorubicin and paclitaxel/Taxol, as well as an antibody drug conjugate produced by Immunomedics, Inc., or Immunomedics.

In the T cell memory modality, we also compete with cell therapy and chimeric antigen receptor T-cell, or CAR-T cell, based companies including Allogene Therapeutics Inc., CRISPR Therapeutics AG, Fate

 

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Therapeutics, Inc., Forty Seven, Inc., or Forty Seven (which was acquired by Gilead Sciences, Inc. in April 2020), Intellia Therapeutics, Inc., Iovance Biotherapeutics, Inc. and Legend Biotech Corporation.

From an infectious disease perspective, we will compete with Abbott Laboratories Inc., or Abbott Laboratories, BMS, Gilead Sciences, Inc., or Gilead and GSK, in the field of human immunodeficiency virus, or HIV. In the field of COVID-19, we will compete with Altimmune, Inc., AstraZeneca, BioNTech SE/Pfizer, CanSinoBio Biologics Inc., or CanSinoBio, GSK, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc., Vaxart, Inc., or Vaxart and with many other new competitors that are emerging frequently.

Many of these companies and our other current and potential competitors have substantially greater research and development capabilities and financial, scientific, regulatory, manufacturing, marketing, sales, human resources, and experience than we do. Many of our competitors have several therapeutic products that have already been developed, approved and successfully commercialized, or are in the process of obtaining regulatory approval for their therapeutic products in the United States and internationally. Our competitors may obtain regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in competitors establishing a strong market position before we are able to enter the market.

Universities and public and private research institutions in the United States and Europe are also potential competitors. While these universities and public and private research institutions primarily have educational objectives, they may develop proprietary technologies that lead to other FDA approved therapies or that secure patent protection that we may need for the development of our technologies and product candidates and that can be licensed or sold to other parties, including our competitors.

ImmunityBio’s lead product candidate, Anktiva, is a potential therapy for the treatment of bladder cancer and (1) when used in combination with checkpoint inhibitors, lung cancer, and (2) when used in combination with NK cells, metastatic pancreatic cancer and triple negative breast cancer, or TNBC. Currently, there are numerous companies that are developing various alternate treatments for bladder, pancreatic and breast cancer, including patients that have progressed after prior treatment with checkpoint inhibitors and chemotherapy. For example, Nektar Therapeutics is currently developing an immunotherapy treatment for muscle-invasive bladder cancer using an IL-2 agonist and is in Phase III clinical trials. Accordingly, Anktiva faces significant competition in the bladder, lung, pancreatic and breast cancer treatment space from multiple companies. Even if we obtain regulatory approval for Anktiva, the availability and price of our competitors’ products could limit the demand and the price we are able to charge for our therapies. We may not be able to implement our business plan if the acceptance of our product candidates is inhibited by price competition or the reluctance of physicians to switch from other methods of treatment to our product, or if physicians switch to other new therapies, drugs or biologic products or choose to reserve our product candidates for use in limited circumstances.

In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and/or enforceability of our patents or other intellectual property relating to our competitors’ products, and our competitors may allege that our product candidates infringe, misappropriate or otherwise violate their intellectual property. See “—Risks Related to Intellectual Property.”

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

 

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Public opinion and scrutiny of immunotherapy approaches may impact public perception of the combined company and product candidates, or may adversely affect our ability to conduct our business and our business plans.

ImmunityBio uses relatively novel technologies involving the Anktiva, aldoxorubicin, hAd5 and yeast technologies and cell-based therapies and NantKwest’s platform utilizes a relatively novel technology involving the genetic modification of human cells and utilization of those modified cells in other individuals. Public perception may be influenced by claims, such as claims that our technologies are unsafe, unethical or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to cell-based immunotherapy in general could result in greater government regulation and stricter labeling requirements of immunotherapy products, including any of our product candidates, and could cause a decrease in the demand for any products we may develop. Adverse public attitudes may adversely impact our ability to enroll clinical trials. Moreover, our success will depend upon physicians specializing in the treatment of those diseases that our product candidates target prescribing, and their patients being willing to receive, treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop. Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.

Development of a product candidate intended for use in combination with an already approved product may present more or different challenges than development of a product candidate for use as a single agent.

ImmunityBio is currently developing Anktiva for use along with NantKwest’s natural killer cell platform. ImmunityBio is also studying Anktiva therapy along with other product candidates, such as aldoxorubicin and hAd5 product candidates. The development of product candidates for use in combination with another product may present challenges. For example, the FDA may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of these trials could show that any positive results are attributable to the already approved product. Moreover, following product approval, the FDA may require that products used in conjunction with each other be cross labeled for combined use. To the extent that we do not have rights to already approved products, this may require us to work with another company to satisfy such a requirement. Moreover, developments related to the already approved products may impact our clinical trials for the combination as well as our commercial prospects should we receive marketing approval. Such developments may include changes to the approved product’s safety or efficacy profile, changes to the availability of the approved product, and changes to the standard of care.

A Fast Track designation, Breakthrough Therapy designation or other designation to facilitate product candidate development may not lead to faster development or a faster regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

ImmunityBio has received, and the combined company may seek in the future, Fast Track or Breakthrough Therapy designation for current or future product candidates. Receipt of a designation to facilitate product candidate development is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for a designation, the FDA may disagree. In any event, the receipt of such a designation for a product candidate may not result in a faster development process, review or approval compared to product candidates considered for approval under conventional FDA procedures and does not assure ultimate marketing approval by the FDA. In addition, the FDA may later decide that the product candidates no longer meet the designation conditions.

 

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As a condition of approval, the FDA may require that we implement various post-marketing requirements and conduct post-marketing studies, any of which would require a substantial investment of time, effort, and money, and which may limit our commercial prospects.

As a condition of biologic licensing, the FDA is authorized to require that sponsors of approved BLAs implement various post-market requirements, including REMS and Phase IV trials. For example, when the FDA approved Novartis’ Kymriah in August 2017, a CAR-T cell therapy for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (“ALL”) that is refractory or in second or later relapse, the FDA required significant post-marketing commitments, including a Phase IV trial, revalidation of a test method, and a substantial REMS program that included, among other requirements, the certification of hospitals and their associated clinics that dispense Kymriah, which certification includes a number of requirements, the implementation of a Kymriah training program and limited distribution only to certified hospitals and their associated clinics. If we receive approval of our product candidates, the FDA may determine that similar or additional or more burdensome post-approval requirements are necessary to ensure that our product candidates are safe, pure and potent. To the extent that we are required to establish and implement any post-approval requirements, we will likely need to invest a significant amount of time, effort and money. Such post-approval requirements may also limit the commercial prospects of our product candidates.

We may be unable to establish effective marketing and sales capabilities or enter into agreements with third parties or related parties to market and sell our product candidates, if they are approved, and as a result, we may be unable to generate product revenues.

NantKwest and ImmunityBio currently do not have a commercial infrastructure for the marketing, sale and distribution of their products. If approved, in order to commercialize our product candidates, we must build our marketing, sales and distribution capabilities or make arrangements with third parties to perform these services, which will take time and require significant financial expenditures and we may not be successful in doing so. There are risks involved with establishing our own marketing and sales capabilities. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have incurred these commercialization expenses prematurely or unnecessarily. These efforts may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. Even if we are able to effectively establish a sales force and develop a marketing and sales infrastructure, our sales force and marketing teams may not be successful in commercializing our current or future product candidates. To the extent we rely on third parties to commercialize any products for which we obtain regulatory approval, we would have less control over their sales efforts and could be held liable if they failed to comply with applicable legal or regulatory requirements.

NantKwest and ImmunityBio each have little to no prior experience in the marketing, sale, and distribution of biopharmaceutical products, and there are significant risks involved in the building and managing of a commercial infrastructure. The establishment and development of commercial capabilities, including a comprehensive healthcare compliance program, to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to successfully develop this capability. We, or our collaborators, will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, manage and retain medical affairs, marketing, sales and commercial support personnel. In the event we are unable to develop a commercial infrastructure, we may not be able to commercialize our current or future product candidates, which would limit our ability to generate product revenues. Factors that may inhibit our efforts to commercialize our current or future product candidates and generate product revenues include:

 

   

if the COVID-19 pandemic continues or reoccurs it may negatively impact our ability to establish commercial operations, educate and interact with healthcare professionals, and successfully launch our product on a timely basis;

 

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the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe our current or future product candidates;

 

   

our inability to effectively oversee a geographically dispersed sales and marketing team;

 

   

the costs and time associated with the initial and ongoing training of sales and marketing personnel on legal and regulatory compliance matters and monitoring their actions;

 

   

an inability to secure adequate coverage and reimbursement by government and private health plans;

 

   

the clinical indications for which the products are approved and the claims that we may make for the products;

 

   

limitations or warnings, including distribution or use restrictions, contained in the products’ approved labeling;

 

   

any distribution and use restrictions imposed by the FDA or to which we agree as part of a mandatory REMS or voluntary risk management plan;

 

   

liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements;

 

   

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

 

   

unforeseen costs and expenses associated with creating an independent sales and marketing organization or engaging a contract sales organization.

If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.

Neither NantKwest nor ImmunityBio has ever commercialized a product candidate for any indication. Even if our product candidates are approved by the appropriate regulatory authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors and others in the medical community. If any product candidate for which we obtain regulatory approval does not gain an adequate level of market acceptance, we may not generate significant product revenues or become profitable. Market acceptance of our product candidates by the medical community, patients and third-party payors will depend on a number of factors, some of which are beyond our control. For example, physicians are often reluctant to switch their patients, and patients may be reluctant to switch from, existing therapies even when new and potentially more effective or safer treatments enter the market.

Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful. If any of our product candidates is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of any of our product candidates will depend on a number of factors, including:

 

   

the continued safety and efficacy of our product candidates;

 

   

the prevalence and severity of adverse events associated with such product candidates;

 

   

the clinical indications for which the products are approved and the approved claims that we may make for the products;

 

   

limitations or warnings contained in the product’s FDA-approved labeling, including potential limitations or warnings for such products that may be more restrictive than other competitive products;

 

   

changes in the standard of care for the targeted indications for such product candidates;

 

   

the relative difficulty of administration of such product candidates;

 

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cost of treatment versus economic and clinical benefit in relation to alternative treatments or therapies;

 

   

the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid;

 

   

the extent and strength of our marketing and distribution of such product candidates;

 

   

the safety, efficacy and other potential advantages over, and availability of, alternative treatments already used or that may later be approved for any of our intended indications;

 

   

distribution and use restrictions imposed by the FDA with respect to such product candidates or to which we agree as part of a mandatory REMS or voluntary risk management plan;

 

   

the timing of market introduction of such product candidates, as well as competitive products;

 

   

our ability to offer such product candidates for sale at competitive prices;

 

   

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

 

   

the extent and strength of our third-party manufacturer and supplier support;

 

   

the approval of other new products for the same indications;

 

   

adverse publicity about the product or favorable publicity about competitive products; and

 

   

potential product liability claims.

Our efforts to educate the medical community and third-party payors as to the benefits of our product candidates may require significant resources and may never be successful. Even if the medical community accepts that our product candidates are safe and effective for their approved indications, physicians and patients may not immediately be receptive to such product candidates and may be slow to adopt them as an accepted treatment of the approved indications. If our current or future product candidates are approved but do not achieve an adequate level of acceptance among physicians, patients, and third-party payors, we may not generate meaningful revenues from our product candidates, in which case we would not expect to become profitable.

Our product candidates may face competition sooner than anticipated.

The enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created an abbreviated pathway for the approval of biosimilar and interchangeable biological products. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product. Under the BPCIA, the FDA cannot make an approval of an application for a biosimilar product effective until 12 years after the original branded product was approved under a BLA. Certain changes, however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest or other related entity do not qualify for the 12-year exclusivity period.

Our product candidates may qualify for the BPCIA’s 12-year period of exclusivity. However, there is a risk that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated. Additionally, this period of regulatory exclusivity does not block companies pursuing regulatory approval via their own traditional BLA, rather than via the abbreviated pathway. Changes may also be made to this exclusivity period as a result of future legislation as there have been ongoing efforts to reduce the period of exclusivity. Even if we receive a period of BPCIA exclusivity for our first licensed product, if subsequent products do not include a modification to the structure of the product that impacts safety, purity, or potency, we may not receive additional periods of exclusivity for those products. Moreover, the extent to which a biosimilar, once approved, will be substituted for

 

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any one of our reference product candidates in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. Medicare Part B encourages use of biosimilars by paying the provider the same percentage of the reference product average sale price as a mark-up, regardless of which product is reimbursed. It is also possible that payors will give reimbursement preference to biosimilars even over reference biologics absent a determination of interchangeability.

For our small molecular product candidates, if qualified, the regulatory exclusivity period is less than for our biologic product candidates. The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of a NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application or a 505(b)(2) NDA submitted by another company for a generic version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for a NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug. As such, we may face competition from generic versions of our small molecule product candidates, which will negatively impact our long-term business prospects and marketing opportunities.

We will need to obtain FDA approval of any proposed branded product names, and any failure or delay associated with such approval may adversely affect our business.

Any name the combined company intends to use for its product candidates in the United States will require approval from the FDA regardless of whether we have secured a formal trademark registration from the U.S. Patent and Trademark Office (“USPTO”). The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. The FDA may also object to a product name if it believes the name inappropriately implies medical claims or contributes to an overstatement of efficacy. If the FDA objects to any of our proposed product names, we may be required to adopt alternative names for our product candidates. If we adopt alternative names, we would lose the benefit of any existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe or otherwise violate the existing rights of third parties, and be acceptable to the FDA. We may be unable to build a successful brand identity for a new product name in a timely manner or at all, which would limit our ability to commercialize our product candidates.

We will be dependent on information technology, systems, infrastructure and data. Our internal computer systems, or those used by our CROs, CMOs, clinical sites or other contractors or consultants, may fail or suffer security breaches.

We will be dependent upon information technology systems, infrastructure and data. In the ordinary course of our business, we will directly or indirectly collect, store and transmit sensitive data, including intellectual property, confidential information, preclinical and clinical trial data, proprietary business information, personal data and personally identifiable health information of our clinical trial subjects and employees, in our data centers and on our networks, or on those of third parties. The secure processing, maintenance and transmission of this information is critical to our operations. The multitude and complexity of our computer systems and those of our CROs, CMOs, clinical sites or other contractors or consultants make them inherently vulnerable to service interruption or destruction, malicious intrusion and random attack. Data privacy or security breaches by third parties, employees, contractors or others may pose a risk that sensitive data, including our intellectual property, trade secrets or personal information of our employees, patients, or other business partners may be exposed to unauthorized persons or to the public.

 

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Despite the implementation of security measures, our internal computer systems and those of our CROs, CMOs, clinical sites and other contractors and consultants are vulnerable to failure or damage from computer viruses and other malware, employee error, unauthorized and authorized access or other cybersecurity attacks, natural disasters, terrorism, war, fire and telecommunication and electrical failures. Cyberattacks are increasing in their frequency, sophistication and intensity. The techniques used by cyber criminals change frequently, may not be recognized until launched and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations or hostile foreign governments or agencies. Cyberattacks could include the deployment of harmful malware, denial-of-service, social engineering and other means to affect service reliability and threaten data confidentiality, integrity and availability. While NantKwest, ImmunityBio and their shared services partner, NantWorks, have invested, and continue to invest, in the protection of their data and information technology infrastructure, there can be no assurance that their efforts, or the efforts of their partners, vendors, CROs, CMOs, clinical sites and other contractors and consultants will prevent service interruptions, or identify breaches in our or their systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in financial, legal, business or reputational harm to us. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyberattacks and other related breaches.

If any such event were to occur and cause interruptions in our operations, it could result in a disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing clinical trials for a product candidate could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data, or may limit our ability to effectively execute a product recall, if required. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of any product candidates could be delayed. Any such event could also result in legal claims or proceedings, liability under laws that protect the privacy of personal information and significant regulatory penalties, and damage to our reputation and a loss of confidence in us and our ability to conduct clinical trials, which could delay the clinical development of our product candidates.

Our business could be adversely affected by the effects of health epidemics, pandemics or contagious diseases, including the recent pandemic of the disease caused by the novel coronavirus SARS-CoV-2 or COVID-19, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.

Outbreaks of epidemic, pandemic or contagious diseases, such as the COVID-19 pandemic, may significantly disrupt our operations and adversely affect our business, financial condition and results of operations. In March 2020, the World Health Organization (“WHO”) declared the outbreak of the COVID-19 pandemic as the novel coronavirus continues to spread throughout the world. The spread of this pandemic has caused significant volatility and uncertainty in the United States and international markets and has resulted in increased risks to our operations. The COVID-19 pandemic could materially affect our operations, including at our headquarters and at our manufacturing facilities, which are currently subject to state executive orders and shelter-in-place orders, and at our clinical trial sites, as well as the business or operations of our other manufacturers, CROs, CMOs, clinical sites or other third parties with whom we conduct business.

Executive orders have been issued by state and local governments in California and elsewhere, and states of emergency have been declared at the state and local level in most jurisdictions throughout the United States. Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to the COVID-19 pandemic or other infectious diseases could impact our personnel or personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain. We are monitoring a number of risks related to this pandemic, including the following:

 

   

Financial: While to date, the financial impact to the businesses of NantKwest and ImmunityBio has not been material, we anticipate that the pandemic could have an adverse financial impact in the short-term

 

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and potentially beyond. As a result of slower patient enrollment, we may not be able to complete our clinical trials as planned or in a timely manner. We expect to continue spending on research and development in the third quarter of 2020 and beyond, and we could also have unexpected expenses related to the pandemic. The short-term continued expenses, as well as the overall uncertainty and disruption caused by the pandemic, will likely cause a delay in our ability to commercialize a product and adversely impact our financial results.

 

   

Supply Chain: While to date neither NantKwest nor ImmunityBio have experienced significant disruptions in their respective supply chains and distribution channels, an extended duration of this pandemic could result in disruptions in the future. For example, quarantines, shelter-in-place and similar government orders, travel restrictions and health impacts of the COVID-19 pandemic, could impact the availability or productivity of personnel at third-party laboratory supply manufacturers, distributors, freight carriers and other necessary components of our supply chain. In addition, there may be unfavorable changes in the availability or cost of raw materials, intermediates and other materials necessary for production, which may result in disruptions in our supply chain and adversely affect our ability to have manufactured certain product candidates for clinical supply.

 

   

Clinical Trials: This pandemic has not significantly impacted the business or financial results of NantKwest or ImmunityBio during the first and second quarters of 2020, however, it is likely to adversely affect certain of our clinical trials, including our ability to initiate and complete our clinical trials within the anticipated timelines. Due to site and participant availability during the pandemic, new subject enrollment is expected to slow, at least in the short-term, for most of our clinical trials. For ongoing trials, we have seen an increasing number of clinical trial sites imposing restrictions on patient visits to limit risks of possible COVID-19 exposure, and we may experience issues with participant compliance with clinical trial protocols as a result of quarantines, travel restrictions and interruptions to healthcare services. The current pressures on medical systems and the prioritization of healthcare resources toward the COVID-19 pandemic have also resulted in interruptions in data collection and submissions for certain clinical trials and delayed starts for certain planned studies. As a result, our anticipated filing and marketing timelines may be adversely impacted.

 

   

Overall Economic and Capital Markets Environment: The impact of the COVID-19 pandemic could result in a prolonged recession or depression in the United States or globally that could harm the banking system, limit demand for all products and services and cause other seen and unforeseen events and circumstances, all of which could negatively impact us. The continued spread of COVID-19 has led to and could continue to lead to severe disruption and volatility in the United States and global capital markets, which could result in a decline in stock price, increase our cost of capital and adversely affect our ability to access the capital markets in the future. In addition, trading prices on the public stock market have been highly volatile as a result of the COVID-19 pandemic.

 

   

Regulatory Reviews: The operations of the FDA or other regulatory agencies may be adversely affected. In response to COVID-19, federal, state and local governments are issuing new rules, regulations, orders and advisories on a regular basis. These government actions can impact us, our members and our suppliers. There is also the possibility that we may experience delays with obtaining approvals for our IND applications, BLAs, and/or NDAs.

Our failure to comply with state, national and/or international data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.

There are numerous laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy laws apply more broadly than the Health Insurance Portability and Accountability Act (“HIPAA”) and associated regulations. For example, California recently enacted legislation—the California Consumer Privacy Act (“CCPA”)—which went into effect on January 1, 2020. The CCPA, among other things, creates new data privacy and security obligations for covered companies

 

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and provides new privacy rights to California consumers, including the right to opt out of certain disclosures of their information. The CCPA also provides for civil penalties as well as a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes limited exceptions, including for certain information collected as part of clinical trials as specified in the law, it may regulate or impact our processing of personal information depending on the context. The California Attorney General has not yet issued final regulations implementing the CCPA, and it remains unclear what language such regulations will contain, or how the statute and regulations will be interpreted.

There are also various laws and regulations in other jurisdictions relating to privacy and security. For example, European Union (“EU”) member states and other foreign jurisdictions, including Switzerland, have adopted data protection laws and regulations which impose significant compliance obligations on us. Moreover, the EU Data Protection Directive, which formerly governed the collection, processing and other use of personal health or other data in the EU, was replaced with the EU General Data Protection Regulation (“GDPR”) in May 2018. The GDPR, which is wide-ranging in scope and applies extraterritorially, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to such individuals, the security and confidentiality of the personal data, data breach notification, the adoption of appropriate privacy governance, including policies, procedures, training and audits, and the use of third-party processors in connection with the processing of personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EU, including to the United States, provides an enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global revenues of the noncompliant entity, whichever is greater. The GDPR requirements apply not only to third-party transactions, but also to transfers of information between us and our subsidiaries, including employee information.

Complying with these numerous, complex and often changing regulations is expensive and difficult, and failure to comply with any privacy laws or data security laws or any security incident or breach involving the misappropriation, loss or other unauthorized processing, use or disclosure of sensitive or confidential patient, consumer or other personal information, whether by us, one of our CROs or business associates or another third party, could adversely affect our business, financial condition and results of operations, including but not limited to: investigation costs; material fines and penalties; compensatory, special, punitive and statutory damages; litigation; consent orders regarding our privacy and security practices; requirements that we provide notices, credit monitoring services and/or credit restoration services or other relevant services to impacted individuals; adverse actions against our licenses to do business; reputational damage; and injunctive relief. The recent implementation of the CCPA and GDPR has increased our responsibility and liability in relation to personal data that we process, including in clinical trials, and we may in the future be required to put in place additional mechanisms to ensure compliance with the CCPA, GDPR and other applicable laws and regulations, which could divert management’s attention and increase our cost of doing business. In addition, new regulation or legislative actions regarding data privacy and security (together with applicable industry standards) may increase our costs of doing business. In this regard, we expect that there will continue to be new proposed laws, regulations and industry standards relating to privacy and data protection in the United States, the EU and other jurisdictions, and we cannot determine the impact such future laws, regulations and standards may have on our business.

We cannot assure you that our CROs or other third-party service providers with access to our or our customers’, suppliers’, trial patients’ and employees’ personally identifiable and other sensitive or confidential information in relation to which we are responsible will not breach contractual obligations imposed by us, or that they will not experience data security breaches, which could have a corresponding effect on our business, including putting us in breach of our obligations under privacy laws and regulations and/or which could in turn adversely affect our business, results of operations and financial condition. We cannot assure you that our contractual measures and our own privacy and security-related safeguards will protect us from the risks associated with the third-party processing, use, storage and transmission of such information. Any of the foregoing could have a material adverse effect on the combined company’s business, financial condition, results of operations and prospects.

 

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We will be heavily dependent on our senior management, particularly Dr. Soon-Shiong, our Executive Chairman, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business.

If we lose members of our senior management for a short or an extended time, we may not be able to find appropriate replacements on a timely basis, and our business could be adversely affected. NantKwest’s and ImmunityBio’s existing operations and our future development depend to a significant extent upon the performance and active participation of certain key individuals, particularly Dr. Soon-Shiong, our Executive Chairman. Although Dr. Soon-Shiong focuses heavily on matters related to ImmunityBio and NantKwest and is highly active in their management, he does devote a significant amount of his time to a number of different endeavors and companies, including NantHealth, Inc., NantMedia Holdings, LLC (which operates the Los Angeles Times and the San Diego Union-Tribune) and NantWorks, which is a collection of multiple companies in the healthcare and technology space. The risks related to our dependence upon Dr. Soon-Shiong are particularly acute given his ownership percentage, the commercial and other relationships that we have with entities affiliated with him, his role in our company and his public reputation. We may also be dependent on additional funding from Dr. Soon-Shiong and his affiliates, which may not be available when needed and which he is under no obligation to provide. If we were to lose the services of Dr. Soon-Shiong for a short or an extended time, for any reason, including, for example, due to the contraction of COVID-19, we may not be able to find appropriate replacements on a timely basis and our financial condition and results of operations could be materially adversely affected.

Competition for qualified personnel in the biotechnology and pharmaceuticals industry is intense due to the limited number of individuals who possess the skills and experience required. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided, and plan to continue providing, equity incentive awards that vest over time. The value to employees of equity incentive awards that vest over time may be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice. We face significant competition for employees, particularly scientific personnel, from other biopharmaceutical companies, which include both publicly traded and privately held companies, and we may not be able to hire new employees quickly enough to meet our needs. We do not have employment agreements with our key employees and all of our employees are hired on an “at-will” basis, which means that any of our employees could leave our employment at any time, with or without notice. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. We may not be able to attract and retain quality personnel on acceptable terms, or at all, which may cause our business and operating results to suffer.

We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.

Our operations will be dependent upon the services of our executives and our employees who are engaged in research and development. The loss of the services of our executive officers or senior research personnel could delay our product development programs and our research and development efforts. In order to develop our business in accordance with our business plan, we will have to hire additional qualified personnel, including in the areas of research, manufacturing, clinical trials management, regulatory affairs, and sales and marketing. We are continuing our efforts to recruit and hire the necessary employees to support our planned operations in the near term. However, competition for qualified employees among companies in the biotechnology and biopharmaceutical industry is intense, and no assurance can be given that we will be able attract, hire, retain and motivate the highly skilled employees that we need. Future growth will impose significant added responsibilities on members of management, including:

 

   

identifying, recruiting, integrating, maintaining, and motivating additional employees;

 

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managing our internal development efforts effectively, including the clinical and FDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and

 

   

improving our operational, financial and management controls, reporting systems, and procedures.

Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

NantKwest and ImmunityBio currently rely, and for the foreseeable future we expect to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality, compliance or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, if at all.

If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development, and commercialization goals on a timely basis, or at all.

If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

We may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

 

   

increased operating expenses and cash requirements;

 

   

the assumption of additional indebtedness or contingent liabilities;

 

   

the issuance of our equity securities;

 

   

assimilation of operations, intellectual property and products of an acquired company or product, including difficulties associated with integrating new personnel;

 

   

the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

 

   

retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;

 

   

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and

 

   

our inability to generate revenues from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

Depending on the size and nature of future strategic acquisitions, we may acquire assets or businesses that require us to raise additional capital or to operate or manage businesses in which we have limited experience.

 

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Making larger acquisitions that require us to raise additional capital to fund the acquisition will expose us to the risks associated with capital raising activities. Acquiring and thereafter operating larger new businesses will also increase our management, operating and reporting costs and burdens. In addition, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.

We expect to rely on third parties to perform many essential services for any products that we commercialize, including services related to distribution, government price reporting, customer service, accounts receivable management, cash collection and adverse event reporting. If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize our current or future product candidates will be significantly impacted and we may be subject to regulatory sanctions.

We expect to retain third-party service providers to perform a variety of functions related to the sale of our current or future product candidates, key aspects of which will be out of our direct control. These service providers may provide key services related to distribution, customer service, accounts receivable management, and cash collection. If we retain a service provider, we would substantially rely on it as well as other third-party providers that perform services for us, including entrusting our inventories of products to their care and handling. If these third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines or otherwise do not carry out their contractual duties to us, or encounter physical or natural damage at their facilities, our ability to deliver product to meet commercial demand would be significantly impaired and we may be subject to regulatory enforcement action.

In addition, we may engage in the future with third parties to perform various other services for us relating to adverse event reporting, safety database management, fulfillment of requests for medical information regarding our product candidates and related services. If the quality or accuracy of the data maintained by these service providers is insufficient, or these third parties otherwise fail to comply with regulatory requirements related to adverse event reporting, we could be subject to regulatory sanctions.

Additionally, we may contract in the future with a third party to calculate and report pricing information mandated by various government programs. If a third party fails to timely report or adjust prices as required or errs in calculating government pricing information from transactional data in our financial records, it could impact our discount and rebate liability, and potentially subject us to regulatory sanctions or FCA lawsuits.

Risks Related to Government Regulation

The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.

Neither NantKwest nor ImmunityBio has previously submitted a BLA or NDA to the FDA, or similar approval filings to comparable foreign authorities. BLAs and NDAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and efficacy for NDAs, or safety, purity and potency for BLAs, for each desired indication. Additionally, the patient population is defined per the discussion with the FDA as patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which include many of the more advanced patients enrolled to date. Our current beliefs regarding the registration pathway for the Anktiva product candidate are based on our interpretation of ImmunityBio’s communications with the FDA to date and its efforts to address such communications, which may be incorrect. Further, enrollment in our trials may need to be further adjusted based on future feedback from the FDA or other regulatory agency input. The revised protocol which further defines the patient population to include more advanced patients in the study, may have an adverse effect on the results reported to date, changes to implement an independent review committee and assay validation and implementation, and the data within this

 

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study may not ultimately be supportive of product approval, all of which could result in significant delays to our currently anticipated timeline for development and approval of our product candidates or prevent their approval entirely.

We may also experience delays, including delays arising from the need to increase enrollment, in completing planned clinical trials for a variety of reasons, including delays related to:

 

   

the availability of financial resources to commence and complete the planned trials;

 

   

reaching agreement on acceptable contract terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 

   

obtaining approval at each clinical trial site by an IRB or central IRB;

 

   

recruiting suitable patients to participate in a trial;

 

   

having patients complete a trial or return for post-treatment follow-up;

 

   

clinical trial sites deviating from trial protocol or dropping out of a trial;

 

   

adding new clinical trial sites;

 

   

manufacturing sufficient quantities of qualified materials under cGMP and applying them on a subject by subject basis for use in clinical trials; or

 

   

timely implementing or validating changes to our manufacturing or quality control processes and methods needed to address FDA feedback.

We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted by the FDA or other regulatory authorities, or recommended for suspension or termination by DSMBs due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenues will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenues.

Results for any patient who receives compassionate use access to our product candidates should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial, and cannot be used to establish safety or efficacy for regulatory approval.

NantKwest and ImmunityBio often receive requests for compassionate use access to our investigational drugs by patients that do not meet the entry criteria for enrollment into our clinical trials. Generally, patients requesting compassionate use have no other treatment alternatives for life threatening conditions. We will evaluate each compassionate use request on an individual basis, and in some cases grant access to our investigational product candidates outside of our sponsored clinical trials if a physician certifies the patient they are treating is critically ill and does not meet the entry criteria for one of our open clinical trials. Individual patient results from compassionate use access may not be used to support submission of a regulatory application, may not support approval of a product candidate and should not be considered to be indicative of results from

 

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any on-going or future well-controlled clinical trial. Before we can seek regulatory approval for any of our product candidates, we must demonstrate in well-controlled clinical trials statistically significant evidence that the product candidate is both safe and effective for the indication we are seeking approval. The results of our compassionate use program may not be used to establish safety or efficacy or regulatory approval.

The clinical and commercial utility of our product candidates are uncertain and may never be realized.

NantKwest’s and ImmunityBio’s current product candidates are in the early stages of development. NantKwest and ImmunityBio currently have ongoing clinical trials to evaluate their respective product candidates. Success in early clinical trials does not ensure that large-scale clinical trials will be successful nor does it predict final results. In addition, we will not be able to treat patients if we cannot manufacture a sufficient quantity of Anktiva or therapies that meet our minimum specifications. In addition, Anktiva and many of our other product candidates have only been tested in a small number of patients. Results from these clinical trials may not necessarily be indicative of the safety and tolerability or efficacy of our product candidates as we expand into larger clinical trials.

We may not ultimately be able to provide the FDA with substantial clinical evidence to support a claim of safety, purity and potency sufficient to enable the FDA to approve our product candidate for any indication. This may be because later clinical trials fail to reproduce favorable data obtained in earlier clinical trials, because the FDA disagrees with how we interpret the data from these clinical trials or because the FDA does not accept these therapeutic effects as valid endpoints in pivotal clinical trials necessary for market approval. We will also need to demonstrate that our product candidates are safe. We do not have data on possible harmful long-term effects of our product candidates and do not expect to have this data in the near future. As a result, our ability to generate clinical safety and effectiveness data sufficient to support submission of a marketing application or commercialization of our product candidates is uncertain and is subject to significant risk.

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

In order to market and sell our product candidates outside the United States, we or our third-party collaborators may be required to obtain separate marketing approvals and comply with numerous and varying regulatory requirements. Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval policies and requirements may vary among jurisdictions. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product candidates is also subject to approval. We or our collaborators may not be able to file for regulatory approval of our product candidates in international jurisdictions or obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

 

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A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.

We plan to seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:

 

   

differing regulatory requirements in foreign countries;

 

   

unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

 

   

economic weakness, including inflation, or political instability in particular foreign economies and markets;

 

   

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

 

   

foreign taxes, including withholding of payroll taxes;

 

   

foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

 

   

difficulties staffing and managing foreign operations;

 

   

workforce uncertainty in countries where labor unrest is more common than in the United States;

 

   

differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls;

 

   

potential liability under the Foreign Corrupt Practices Act of 1977, or the FCPA, or comparable foreign regulations;

 

   

challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

 

   

production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

 

   

the impact of public health epidemics on the global economy, such as the coronavirus pandemic currently having an impact throughout the world; and

 

   

business interruptions resulting from geo-political actions, including war and terrorism.

These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations.

Neither NantKwest nor ImmunityBio have ever commercialized a product candidate before and we may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.

Neither NantKwest nor ImmunityBio have ever commercialized a product candidate, and neither company currently has any therapeutic sales force, marketing or distribution capabilities. To achieve commercial success for the product candidates, which we may license to others, we will rely on the assistance and guidance of those collaborators. For product candidates for which we retain commercialization rights and marketing approval, we will have to develop our own sales, marketing and supply organization or outsource these activities to a third party.

 

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Factors that may affect our ability to commercialize our product candidates, if approved, on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, developing adequate educational and marketing programs to increase public acceptance of our approved product candidates, ensuring regulatory compliance of our company, employees and third parties under applicable healthcare laws and other unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing organization will be expensive and time-consuming and could delay the launch of our product candidates upon approval. We may not be able to build an effective sales and marketing organization. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may not generate revenues from them or be able to reach or sustain profitability.

We are, and if we receive regulatory approval of our product candidates, will continue to be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA may also require post-approval Phase IV trials. Moreover, the FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval. If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates, they may withdraw approval, require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. Any such restrictions could limit sales of the product.

In addition, we, our contractors, and our collaborators are and will remain responsible for FDA compliance, including requirements related to product design, testing, clinical trials and preclinical studies approval, manufacturing processes and quality, labeling, packaging, distribution, adverse event and deviation reporting, storage, advertising, marketing, promotion, sale, import, export, submissions of safety and other post-marketing information and reports such as deviation reports, registration, product listing, annual user fees, and recordkeeping for our product candidates. We and any of our collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with regulatory requirements. Application holders must further notify the FDA, and depending on the nature of the change, obtain FDA pre- approval for product and manufacturing changes. The cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, that the product is less effective than previously thought, problems with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 

   

restrictions on the marketing, distribution, or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

 

   

restrictions on the labeling of our product candidates, including required additional warnings, such as black box warnings, contraindications, precautions, and restrictions on the approved indication or use;

 

   

modifications to promotional pieces;

 

   

changes to product labeling or the way the product is administered;

 

   

liability for harm caused to patients or subjects;

 

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fines, restitution, disgorgement, warning letters, untitled letters, or holds on or termination of clinical trials;

 

   

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

 

   

product seizure or detention, or refusal to permit the import or export of our product candidates;

 

   

injunctions or the imposition of civil or criminal penalties, including imprisonment;

 

   

FDA debarment, debarment from government contracts, and refusal of future orders under existing contracts, exclusion from federal healthcare programs, consent decrees, or corporate integrity agreements;

 

   

regulatory authority issuance of safety alerts, Dear Healthcare Provider letters, press releases, or other communications containing warnings or other safety information about the biologic;

 

   

reputational harm; or

 

   

the product becoming less competitive.

Any of these events could further have other material and adverse effects on our operations and business and could adversely impact our stock price and could significantly harm our business, financial condition, results of operations, and prospects.

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, be subject to other regulatory enforcement action, and we may not achieve or sustain profitability.

ImmunityBio’s GMP-in-a-Box will be regulated by the FDA as a medical device, and regulatory compliance for medical devices is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.

The FDA and similar agencies regulate medical devices. Complying with these regulations is costly, time-consuming, complex and uncertain. For instance, before a new medical device, or a new intended use for an existing device, can be marketed in the United States, a company must first submit and receive either 510(k) clearance or pre-marketing approval from the FDA, unless an exemption applies.

FDA regulations and regulations of similar agencies are wide-ranging and include, among other things, oversight of:

 

   

product design, development, manufacture (including suppliers) and testing;

 

   

laboratory and preclinical studies and clinical trials;

 

   

product safety and effectiveness;

 

   

product labeling;

 

   

product storage and shipping;

 

   

record keeping;

 

   

pre-market clearance or approval;

 

   

marketing, advertising and promotion;

 

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product sales and distribution;

 

   

product changes;

 

   

product recalls; and

 

   

post-market surveillance and reporting of deaths or serious injuries and certain malfunctions.

Medical devices regulated by the FDA are subject to general controls which include: registration with the FDA; listing commercially distributed products with the FDA; complying with cGMP under Quality Systems Regulations; filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation; assuring that device labeling complies with device labeling requirements; reporting certain device field removals and corrections to the FDA; and obtaining pre-market notification 510(k) clearance for devices prior to marketing. Some devices known as 510(k)-exempt devices can be marketed without prior marketing-clearance or approval from the FDA. In addition to the general controls, some Class II medical devices are also subject to special controls, including adherence to a particular guidance document and compliance with the performance standard. Instead of obtaining 510(k) clearance, most Class III devices are subject to pre-market approval, or PMA.

The FDA can also refuse to clear or approve pre-market applications for any medical device we develop. Any enforcement action by the FDA and other comparable non- U.S. regulatory agencies could have a material adverse effect on our business, financial condition and results of operations. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following actions:

 

   

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

 

   

unanticipated expenditures to address or defend such actions;

 

   

customer notifications for repair, replacement or refunds;

 

   

recall, detention or seizure of our products;

 

   

operating restrictions or partial suspension or total shutdown of production;

 

   

refusing or delaying our requests for 510(k) clearance or PMA approval of new products or modified products;

 

   

operating restrictions;

 

   

withdrawing 510(k) clearances or PMA approvals that have already been granted;

 

   

refusal to grant export approval for our products; or

 

   

criminal prosecution.

If any of these events were to occur, it would have a material and adverse effect on our business, financial condition and results of operations. We may not be able to obtain the necessary clearances or approvals or may be unduly delayed in doing so, for any medical device products we develop, which could harm our business. Furthermore, even if we are granted regulatory clearances or approvals for any medical device products, they may include significant limitations on the indicated uses for the product, which may limit the market for the product. The FDA also regulates the advertising and promotion of medical devices to ensure that the claims are consistent with their regulatory clearances or approvals, that there are adequate and reasonable data to substantiate the claims and that the promotional labeling and advertising is neither false nor misleading in any respect. If the FDA determines that any of our advertising or promotional claims are misleading, not substantiated or not permissible, we may be subject to enforcement actions, including warning letters, and we may be required to revise our promotional claims and make other corrections or restitutions.

 

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Any medical device products we develop will be subject to extensive regulation by the FDA and non- U.S. regulatory agencies. Further, all of our potential medical device products and material modifications will be subject to extensive regulation and clearance or approval from the FDA and non- U.S. regulatory agencies prior to commercial sale and distribution as well as after clearance or approval. Failure to comply with applicable U.S. requirements regarding, for example, promoting, manufacturing, or labeling our medical device products, may subject us to a variety of administrative or judicial actions and sanctions, such as Form 483 observations, warning letters, untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution. If any of our medical device products cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

We will be subject to governmental export and import controls that could impair our ability to compete in international markets due to licensing requirements and subject us to liability if we are not in compliance with applicable laws. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.

Our product candidates will be subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls. Exports of our product candidates and solutions outside of the United States must be made in compliance with these laws and regulations. If we fail to comply with these laws and regulations, we and certain of our employees could be subject to substantial civil or criminal penalties, including the possible loss of export or import privileges; fines, which may be imposed on us and responsible employees or managers; and, in extreme cases, the incarceration of responsible employees or managers.

In addition, changes in our product candidates or solutions or changes in applicable export or import laws and regulations may create delays in the introduction, provision, or sale of our product candidates and solutions in international markets, prevent customers from using our product candidates and solutions or, in some cases, prevent the export or import of our product candidates and solutions to certain countries, governments or persons altogether. Any limitations on our ability to export, provide, or sell our product candidates and solutions could adversely affect our business, financial condition and results of operations.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.

We are subject to the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. §201, the U.S. Travel Act, the USA PATRIOT Act and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. NantKwest and ImmunityBio have each used CROs abroad for clinical trials. In addition, we may engage third-party intermediaries to sell our product candidates and solutions abroad once we enter a commercialization phase for our product candidates and/or to obtain necessary permits, licenses, and other regulatory approvals. We or our third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities. We can be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

NantKwest adopted an anti-corruption policy in connection with the consummation of the IPO of its common stock in July 2015. The anti-corruption policy mandates compliance with the FCPA and other anti-

 

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corruption laws applicable to NantKwest’s business throughout the world. However, there can be no assurance that our employees and third-party intermediaries will comply with this policy or such anti-corruption laws. Non-compliance with anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other investigations, or other enforcement actions. If such actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor, which can result in added costs and administrative burdens.

If we fail to comply with environmental, health, and safety laws and regulations, including regulations governing the handling, storage or disposal of hazardous materials, we could become subject to fines or penalties or incur costs that could harm our business.

We will be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous materials, including chemicals, biological materials and infectious agents. Our operations also may produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We will not be able to eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from any use by us of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although we will maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health, and safety laws and regulations. These current or future laws and regulations may impair our research, development, or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the FDA, the Securities and Exchange Commission, or the SEC, and other government agencies on which our operations may rely is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA,

 

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SEC and other government employees and stop critical activities. In response to the COVID-19 pandemic, the FDA recently announced that it will continue to postpone domestic and foreign routine surveillance inspections due to COVID-19. While the FDA indicated that it will consider alternative methods for inspections and could exercise discretion on a case-by-case basis to approve products based on a desk review, if a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could potentially impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

If we fail to comply with federal and state healthcare and promotional laws, including fraud and abuse and information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, and prospects could be adversely affected.

As a biopharmaceutical companies, NantKwest and ImmunityBio are, and the combined company will be, subject to many federal and state healthcare laws, including the federal Anti-Kickback Statute, or AKS, the FCA, the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the federal Physician Payment Sunshine Act, the Veterans Health Care Act of 1992, HIPAA (as amended by the Health Information Technology for Economics and Clinical Health Act), the FCPA, the Patient Protection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act), or the ACA, and similar state laws. Even though we do not make referrals of healthcare services or bill directly to Medicare, Medicaid, or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. If we do not comply with all applicable fraud and abuse laws, we may be subject to healthcare fraud and abuse enforcement by both the federal government and the states in which we conduct our business.

Laws and regulations require calculation and reporting of complex pricing information for prescription drugs, and compliance will require us to invest in significant resources and develop a price reporting infrastructure, or depend on third parties to compute and report our drug pricing. Pricing reported to the Centers for Medicare and Medicaid Services, or CMS, must be certified. Non-compliant activities expose us to FCA risk if they result in overcharging agencies, underpaying rebates to agencies, or causing agencies to overpay providers.

If we or our operations are found to be in violation of any federal or state healthcare law, or any other governmental regulations that apply to us, we may be subject to penalties, including civil, criminal, and administrative penalties, damages, fines, disgorgement, debarment from government contracts, refusal of orders under existing contracts, exclusion from participation in U.S. federal or state health care programs, corporate integrity agreements and the curtailment or restructuring of our operations, any of which could materially adversely affect our ability to operate our business and our financial results. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, is found not to be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including but not limited to, exclusions from participation in government healthcare programs, which could also materially affect our business.

In particular, if we are found to have impermissibly promoted any of our product candidates, we may become subject to significant liability and government fines. We, and any of our collaborators, must comply with requirements concerning advertising and promotion for any of our product candidates for which we or they obtain marketing approval. Promotional communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing review by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys general, members of Congress, and the public. When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved. If we are not able to obtain FDA approval for desired uses or indications for our product candidates, we may not market or

 

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promote our product candidates for those indications and uses, referred to as off-label uses, and our business may be adversely affected. We further must be able to sufficiently substantiate any claims that we make for our product candidates including claims comparing our product candidates to other companies’ products and must abide by the FDA’s strict requirements regarding the content of promotion and advertising.

While physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications and uses that are not specifically approved by the FDA. These off-label uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authorities do, however, restrict communications by biopharmaceutical companies concerning off-label use.

The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Thus, we and any of our collaborators will not be able to promote any products we develop for indications or uses for which they are not approved.

In the United States, engaging in the impermissible promotion of our products, following approval, for off-label uses can also subject us to false claims and other litigation under federal and state statutes, including fraud and abuse and consumer protection laws, which can lead to civil and criminal penalties and fines, agreements with governmental authorities that materially restrict the manner in which we promote or distribute therapeutic products and do business through, for example, corporate integrity agreements, suspension or exclusion from participation in federal and state healthcare programs, and debarment from government contracts and refusal of future orders under existing contracts. These false claims statutes include the FCA, which allows any individual to bring a lawsuit against a biopharmaceutical company on behalf of the federal government alleging submission of false or fraudulent claims or causing others to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid. If the government decides to intervene and prevails in the lawsuit, the individual will share in the proceeds from any fines or settlement funds. If the government declines to intervene, the individual may pursue the case alone. These FCA lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth, leading to several substantial civil and criminal settlements, up to $3.0 billion, pertaining to certain sales practices and promoting off-label uses. In addition, FCA lawsuits may expose manufacturers to follow-on claims by private payors based on fraudulent marketing practices. This growth in litigation has increased the risk that a biopharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal and civil penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state healthcare programs. If we or our future collaborators do not lawfully promote our approved products, if any, we may become subject to such litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial condition, results of operations and prospects.

Although an effective compliance program can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated. Moreover, achieving and sustaining compliance with applicable federal and state fraud laws may prove costly. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

 

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Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates profitably.

In both domestic and foreign markets, sales of our product candidates, if approved, depend on the availability of coverage and adequate reimbursement from third-party payors. Such third-party payors include government health programs such as Medicare and Medicaid, managed care providers, private health insurers and other organizations. In addition, because our product candidates represent new approaches to the treatment of cancer, we cannot accurately estimate the potential revenues from our product candidates.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance.

Government authorities and third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. If reimbursement is not available, or is available only to limited levels, our product candidates may be competitively disadvantaged, and we, or our collaborators, may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us, or our collaborators, to establish or maintain a market share sufficient to realize a sufficient return on our or their investments. Alternatively, securing favorable reimbursement terms may require us to compromise pricing and prevent us from realizing an adequate margin over cost. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:

 

   

a covered benefit under its health plan;

 

   

safe, effective and medically necessary;

 

   

appropriate for the specific patient;

 

   

cost-effective; and

 

   

neither experimental nor investigational.

Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our product candidates. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Moreover, the factors noted above have continued to be the focus of policy and regulatory debate that has, thus far, shown the potential for movement towards permanent policy changes; this trend is likely to continue, and may result in more or less favorable impacts on pricing. Patients are unlikely to use our product candidates unless coverage is provided, and reimbursement is adequate to cover a significant portion of the cost of our product candidates.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

Prices paid for a drug also vary depending on the class of trade. Prices charged to government customers are subject to price controls, including ceilings, and private institutions obtain discounts through group purchasing organizations. Net prices for drugs may be further reduced by mandatory discounts or rebates required by

 

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government healthcare programs and demanded by private payors. It is also not uncommon for market conditions to warrant multiple discounts to different customers on the same unit, such as purchase discounts to institutional care providers and rebates to the health plans that pay them, which reduces the net realization on the original sale.

In addition, federal programs impose penalties on manufacturers of drugs marketed under an NDA or BLA, in the form of mandatory additional rebates and/or discounts if commercial prices increase at a rate greater than the Consumer Price Index-Urban, and these rebates and/or discounts, which can be substantial, may impact our ability to raise commercial prices. Regulatory authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability or that of our collaborators to sell our product candidates profitably. These payors may not view our products, if any, as cost-effective, and coverage and reimbursement may not be available to our customers, or those of our collaborators, or may not be sufficient to allow our products, if any, to be marketed on a competitive basis. Cost control initiatives could cause us, or our collaborators, to decrease, discount, or rebate a portion of the price we, or they, might establish for products, which could result in lower than anticipated product revenues. If the realized prices for our product candidates, if any, decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement, our prospects for revenues and profitability will suffer. Moreover, the recent and ongoing series of congressional hearings relating to drug pricing has presented heightened attention to the biopharmaceutical industry, creating the potential for political and public pressure, while the potential for resulting legislative or policy changes presents uncertainty.

Assuming coverage is approved, the resulting reimbursement payment rates might not be adequate. If payors subject our product candidates to maximum payment amounts or impose limitations that make it difficult to obtain reimbursement, providers may choose to use therapies which are less expensive when compared to our product candidates. Additionally, if payors require high copayments, beneficiaries may decline prescriptions and seek alternative therapies. We may need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of any future products to the satisfaction of hospitals and other target customers and their third-party payors. Such studies might require us to commit a significant amount of management time and financial and other resources. Our future products might not ultimately be considered cost-effective. Adequate third-party coverage and reimbursement might not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, third-party payors are requiring higher levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged. We, and our collaborators, cannot be sure that coverage will be available for any product candidate that we, or they, commercialize and, if available, that the reimbursement rates will be adequate. Further, the net reimbursement for drug products may be subject to additional reductions if there are changes to laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any of our product candidates for which we obtain marketing approval could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products, and our overall financial condition.

There have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

 

   

the demand for our product candidates, if we obtain regulatory approval;

 

   

our ability to set a price that we believe is fair for our product candidates;

 

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our ability to generate revenues and achieve or maintain profitability;

 

   

the level of taxes that we are required to pay; and

 

   

the availability of capital.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability. A particular challenge for our product candidates arises from the fact that they will primarily be used in an inpatient setting. Inpatient reimbursement generally relies on stringent packaging rules that may mean that there is no separate payment for our product candidates. Additionally, data used to set the payment rates for inpatient admissions is usually several years old and would not take into account all of the additional therapy costs associated with the administration of our product candidates. If special rules are not created for reimbursement for immunotherapy treatments such as our product candidates, hospitals might not receive enough reimbursement to cover their costs of treatment, which will have a negative effect on their adoption of our product candidates.

We are subject to new legislation, regulatory proposals, and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our product candidates, obtain collaborators, and raise capital.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect our ability, or the ability of our collaborators, to profitably sell any products for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we, or our collaborators, may receive for any approved products.

Since enactment of the ACA in 2010, in both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our product candidates profitably. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect on April 1, 2013 and were to remain in effect until 2029 unless additional Congressional action is taken. The CARES Act, which was signed into law on March 27, 2020, designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030, in order to offset the added expense of the 2020 cancellation. In January 2013, the American Taxpayer Relief Act of 2012, or ATRA, was approved which, among other things, reduced Medicare payments to several providers, with primary focus on the hospital outpatient setting and ancillary services, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. On January 20, 2017, the new administration signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices, and, for that reason, some final regulations have yet to take effect. In December 2017, Congress repealed the individual mandate for health insurance required by the ACA and could consider further legislation to repeal other elements of the ACA. At the end of 2017, CMS promulgated regulations that reduce the amount paid to hospitals for outpatient drugs purchased under the 340B program, and some states have enacted transparency laws requiring manufacturers to report information on drug prices and price increases. On December 14, 2018, the U.S. District Court for the Northern District of Texas struck down

 

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the ACA, deeming it unconstitutional given that Congress repealed the individual mandate in 2017; on July 9, 2019, the U.S. Court of Appeals for the Fifth Circuit heard arguments on appeal in this matter. On December 18, 2019, the Fifth Circuit ruled that the ACA’s individual mandate is unconstitutional given that the Tax Act eliminated the tax penalty associated with the individual mandate. In concluding that the individual mandate is unconstitutional, the question remains whether, or how much of, the rest of the ACA is severable from that constitutional defect. The Fifth Circuit further remanded the case to the U.S. District Court for the Northern District of Texas to further analyze whether the other provisions of the ACA are severable as they currently exist under the law. On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari to review this case, although it is unclear when or how the U.S. Supreme Court will rule. It is also unclear how other efforts to challenge, repeal or replace the ACA will impact the ACA or our business. We will continue to evaluate the effect that the ACA and its possible repeal and replacement has on our business. Complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive, resulting in a material adverse effect on our business.

Additional federal and state healthcare reform measures may be adopted in the future that may result in more rigorous coverage criteria, increased regulatory burdens and operating costs, decreased revenues from our biopharmaceutical product candidates, decreased potential returns from our development efforts, and additional downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenues, attain profitability or commercialize our product candidates.

Legislative and regulatory proposals may also be made to expand post-approval requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance, or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

In addition, there have been a number of other policy, legislative and regulatory proposals aimed at changing the pharmaceutical industry. For instance, on May 11, 2018, the current administration presented its “Blueprint” to lower drug prices and reduce out of pocket costs of drugs, as well as additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, and incentivize manufacturers to lower the list price of their products. Although some proposals related to the administration’s Blueprint may require additional authorization to become effective, may ultimately be withdrawn, or may face challenges in the courts, Congress and the administration have indicated that they will continue to seek new legislative and administrative measures to control drug costs, including by addressing the role of pharmacy benefit managers in the supply chain. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The ACA and any further changes in the law or regulatory framework that reduce our revenues or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In international markets, reimbursement and health care payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In some countries, particularly

 

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the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. There can be no assurance that our product candidates will be considered cost-effective by third-party payors, that an adequate level of reimbursement will be available, or that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our product candidates profitably. If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to: comply with the laws of the FDA and other similar foreign regulatory bodies, provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws, or report financial information or data accurately or to disclose unauthorized activities to us. If we obtain FDA approval of any of our product candidates and begin commercializing those product candidates in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

It is not always possible to identify and deter misconduct or other improper activities by our employees or third parties that we engage for our business operations, including independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our, or our employees’, consultants’, collaborators’, contractors’, or vendors’ business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, compliance agreements, withdrawal of product approvals, and curtailment of our operations, among other things, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

 

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Risks Related to Intellectual Property

If we are unable to obtain, maintain, protect and enforce patent protection and other proprietary rights for our product candidates and technologies, we may not be able to compete effectively or operate profitably.

Our success is dependent in large part on our obtaining, maintaining, protecting and enforcing patents and other proprietary rights in the United States and other countries with respect to our product candidates and technology and on our ability to avoid infringing the intellectual property and other proprietary rights of others. Certain of NantKwest’s and ImmunityBio’s intellectual property rights are licensed from other entities, and as such the preparation and prosecution of any such patents and patent applications was not performed by us or under our control. Furthermore, patent law relating to the scope of claims in the biotechnology field in which we operate is still evolving and, consequently, patent positions in our industry may not be as strong as in other more well-established fields. The patent positions of biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date.

The issuance of a patent is not conclusive as to its validity or enforceability and it is uncertain how much protection, if any, will be provided by our patents, including if they are challenged in court or in other proceedings, such as re-examinations or oppositions, which may be brought in the United States or foreign jurisdictions to challenge the validity of a patent. A third party may challenge the validity or enforceability of a patent after its issuance. It is possible that a competitor may successfully challenge our patents or that a challenge will result in limiting their coverage. Moreover, the cost of litigation to uphold the validity of patents and to prevent infringement can be substantial. If the outcome of litigation is adverse to us, third parties may be able to use our patented invention without payment to us. Moreover, it is possible that competitors may infringe our patents or successfully avoid the patented technology through design innovation. To stop these activities, we may need to file a lawsuit. These lawsuits are expensive and would consume time and other resources, even if we were successful in stopping the violation of our patent rights. In addition, there is a risk that a court would decide that our patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of our patents were upheld, a court would refuse to stop the other party on the grounds that its activities are not covered by, that is, do not infringe, our patents.

Should third parties file patent applications, or be issued patents claiming technology also used or claimed by our licensor(s) or by us in any future patent application, we may be required to participate in interference proceedings in the USPTO to determine priority of invention for those patents or patent applications that are subject to the first-to-invent law in the United States, or may be required to participate in derivation proceedings in the USPTO for those patents or patent applications that are subject to the first-inventor-to-file law in the United States. We may be required to participate in such interference or derivation proceedings involving our issued patents and pending applications. We may be required to cease using the technology or to license rights from prevailing third parties as a result of an unfavorable outcome in an interference proceeding or derivation proceeding. A prevailing party in that case may not offer us a license on commercially acceptable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.

Changes in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our owned and licensed patents. With respect to both in-licensed and owned intellectual property, we cannot predict whether the patent applications we and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors or other third parties.

 

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The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. Although we enter into nondisclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable over the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in any of our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.

If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our owned or in-licensed pending and future patent applications may not result in patents being issued which protect ImmunityBio’s Anktiva or hAd5 product candidates or other technologies or which effectively prevent others from commercializing competitive technologies and product candidates.

Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own or in-license may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether ImmunityBio’s Anktiva or hAd5 product candidates or other technologies will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition, results of operations and growth prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. We or our licensors may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings or other similar proceedings challenging our owned or licensed patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our owned or in-licensed patent rights, allow third parties to commercialize ImmunityBio’s Anktiva or hAd5 product candidates or other technologies and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, we, or one of our licensors, may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our or our licensor’s priority of invention or other features of patentability with respect to our owned or in-licensed patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others

 

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from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of ImmunityBio’s Anktiva or hAd5 product candidates and other technologies. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us. If we or our collaborators are unsuccessful in any such proceeding or other priority or inventorship dispute, we may be required to obtain and maintain licenses from third parties, including parties involved in any such interference proceedings or other priority or inventorship disputes. Such licenses may not be available on commercially reasonable terms or at all, or may be non-exclusive. If we are unable to obtain and maintain such licenses, we may need to cease the development, manufacture, and commercialization of one or more of the product candidates we may develop. The loss of exclusivity or the narrowing of our owned and licensed patent claims could limit our ability to stop others from using or commercializing similar or identical technology and products.

In addition, given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

Some of our owned and in-licensed patents and patent applications are, and may in the future be, co-owned with third parties. In addition, certain of our licensors co-own the patents and patent applications we in-license with other third parties with whom we do not have a direct relationship. Our exclusive rights to certain of these patents and patent applications are dependent, in part, on inter-institutional or other operating agreements between the joint owners of such patents and patent applications, who are not parties to our license agreements. If our licensors do not have exclusive control of the grant of licenses under any such third-party co-owners’ interest in such patents or patent applications or we are otherwise unable to secure such exclusive rights, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects.

We may be involved in lawsuits to protect or enforce our patents or other intellectual property or the patents or other intellectual property of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors and other third parties may infringe, misappropriate or otherwise violate our patents or other intellectual property or the patents or other intellectual property of our licensors. In addition, our patents or the patents of our licensors also may become involved in inventorship, priority or validity disputes. To counter infringement or other unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceeding could put one or more of our owed or licensed patents at risk of being invalidated, held unenforceable, or interpreted narrowly, and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially

 

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increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

Issued patents covering our technology and product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.

If we or one of our licensors initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or other technologies, the defendant could counterclaim that the patent is invalid and/or unenforceable or that we infringe their patents. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or other applicable body, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial. Some of our competitors may be better able to sustain the costs of such litigation or other proceeding because they have substantially greater resources. Such proceedings could result in revocation or cancellation of, or amendment to, our patents in such a way that they no longer cover our product candidates or technologies. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our licensor, our or our licensor’s patent counsel and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business, financial condition, results of operations and prospects.

The use of our technology and product candidates could potentially conflict with the rights of others, and third-party claims of intellectual property infringement, misappropriation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our product candidates and technologies.

Our commercial success depends in part on our, our licensors’ and our collaborators’ ability to avoid infringing, misappropriating and otherwise violating the patents and other intellectual property rights of third parties. There is a substantial amount of complex litigation involving patents and other intellectual property rights in the biopharmaceutical industry. Our potential competitors or other parties may have, develop or acquire patent or other intellectual property rights that they could assert against us. If they do so, then we may be required to alter our product candidates, pay licensing fees or cease our development and commercialization activities with respect to the applicable product candidates or technologies. If our product candidates conflict with patent or other intellectual property rights of others, such parties could bring legal actions against us or our collaborators, licensees, suppliers or customers, claiming damages and seeking to enjoin manufacturing, use and marketing of the affected products.

Although ImmunityBio has conducted freedom-to-operate, or FTO, analyses of the patent landscape with respect to its lead product candidates and continues to undertake FTO analyses of its manufacturing processes, its

 

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lead Anktiva product candidate, and contemplated future processes and products, because patent applications do not publish for 18 months, and because the claims of patent applications can change over time, no FTO analysis can be considered exhaustive. We may not be aware of patents that have already been issued and that a competitor or other third party might assert are infringed by our current or future product candidates or technologies. It is also possible that we could be found to have infringed patents owned by third parties of which we are aware, but which we do not believe are relevant to our product candidates or technologies. In addition, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates or technologies may infringe. Furthermore, patent and other intellectual property rights in biotechnology remains an evolving area with many risks and uncertainties. As such, we may not be able to ensure that we can market our product candidates without conflict with the rights of others.

If intellectual property-related legal actions asserted against us are successful, in addition to any potential liability for damages (including treble damages and attorneys’ fees for willful infringement), we could be enjoined from, or required to obtain a license to continue, manufacturing, promoting the use of or marketing the affected products. We may not prevail in any legal action and a required license under the applicable patent or other intellectual property may not be available on acceptable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. We also could be required to redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, and may impact our reputation. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we can because of greater financial resources. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of a patent. The USPTO and various foreign governmental patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. In certain circumstances, we rely on our licensors to pay these fees and take the necessary actions to comply with these requirements. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market with similar or identical products or technology, which would have a material adverse impact on our business, financial condition, results of operations and prospects.

 

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Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other immunotherapy and biopharmaceutical companies, our success is dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 2011, the United States transitioned to a first-to-file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either file any patent application related to our product candidates or other technologies or invent any of the inventions claimed in our or our licensor’s patents or patent applications. The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent applications and the enforcement or defense of our owned or in-licensed issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Additionally, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. While we do not believe that any of the patents owned or licensed by us will be found invalid based on the foregoing, we cannot predict how future decisions by Congress, the federal courts or the USPTO may impact the value of our patents.

Our rights to develop and commercialize our product candidates and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.

We will rely on licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development of aldoxorubicin and products enabled by our yeast, including Tarmogen, technologies. For example, in July 2017, ImmunityBio entered into an exclusive license agreement with CytRx Corporation, or CytRx, pursuant to which it received an exclusive license to certain of CytRx’s intellectual property relating to aldoxorubicin, in January 2020 ImmunityBio entered into an exclusive license agreement with GlobeImmune, Inc., or GlobeImmune, pursuant to which ImmunityBio obtained an exclusive license to certain of GlobeImmune’s intellectual property relating to their Tarmogen platform to complement our proprietary yeast technology, and in August 2020, ImmunityBio entered into an exclusive license agreement with iosBio Ltd., formerly named Stabilitech Biopharma Ltd., or iosBio, pursuant to which iosBio granted ImmunityBio an exclusive license to certain of iosBio’s intellectual property rights relating to the SARS-CoV-2

 

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and successor vaccine candidates (and, in connection with such license, ImmunityBio granted iosBio a non-exclusive license relating to its adenovirus constructs for the prevention and treatment of shingles and other infectious disease targets to be mutually agreed by the parties in good faith). For more information regarding the arrangements with CytRx, GlobeImmune and iosBio, see “Business of ImmunityBio—License and Collaboration Agreements.”

License agreements may not provide exclusive rights to use certain licensed intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and product candidates in the future. As a result, we may not be able to prevent competitors or other third parties from developing and commercializing competitive products that also utilizes technology that we have in-licensed.

In addition, subject to the terms of any such license agreements, we do not have the right to control the preparation, filing, prosecution and maintenance, and we may not have the right to control the enforcement, and defense of patents and patent applications covering the technology that we license from third parties. We cannot be certain that our in-licensed or out-licensed patents and patent applications that are controlled by our licensors or licensees will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of our business. If our licensors or licensees fail to prosecute, maintain, enforce, and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, our right to develop and commercialize Anktiva and any of our product candidates that are subject of such licensed rights could be adversely affected, and we may not be able to prevent competitors from making, using and selling competing products. In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties. For example, certain of ImmunityBio’s in-licensed intellectual property was funded in part by the U.S. government. As a result, the U.S. government may have certain rights to such intellectual property. When new technologies are developed with U.S. government funding, the U.S. government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the U.S. government to use the invention or to have others use the invention on its behalf. The U.S. government’s rights may also permit it to disclose the funded inventions and technology to third parties and to exercise march-in rights to use or allow third parties to use the technology we have licensed that was developed using U.S. government funding. The U.S. government may exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, or because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States in certain circumstances and if this requirement is not waived. Any exercise by the U.S. government of such rights or by any third party of its reserved rights could have a material adverse effect on our competitive position, business, financial condition, results of operations and growth prospects.

If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.

NantKwest and ImmunityBio have each entered into license agreements with third parties and may need to obtain additional licenses from others to advance our research or allow commercialization of our product candidates. It is possible that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we

 

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may be unable to develop or commercialize the affected product candidates or continue to utilize our existing technology, which could harm our business, financial condition, results of operations and growth prospects significantly. We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing methods, product candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.

In addition, each of NantKwest’s and ImmunityBio’s license agreements, and we expect our future agreements, will impose various development, diligence, commercialization, and other obligations on us. Certain of our license agreements also require us to meet development timelines, or to exercise commercially reasonable efforts to develop and commercialize licensed products, in order to maintain the licenses. In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commercialization of certain of our product candidates or of Anktiva. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and growth prospects.

Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:

 

   

the scope of rights granted under the license agreement and other interpretation-related issues;

 

   

the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

   

the sublicensing of patent and other rights under our collaborative development relationships;

 

   

our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

 

   

the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

 

   

the priority of invention of patented technology.

In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and growth prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations and growth prospects.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the

 

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United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of third parties or claims asserting ownership of what we regard as our own intellectual property.

NantKwest and ImmunityBio have received confidential and proprietary information from third parties and their employees and contractors. In addition, we plan to employ and contract with individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed the trade secrets or other confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend against or pursue these claims. Even if we are successful in resolving these claims, litigation could result in substantial cost and be a distraction to our management and employees.

In addition, while it is our policy to require our employees, consultants and independent contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.

 

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We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties.

An element of our intellectual property strategy is to license intellectual property rights and technologies from third parties and/or our affiliates. Other parties, including our competitors or our affiliates, may have patents and have filed and are likely filing patent applications potentially relevant to our business. In order to avoid infringing these patents, we may find it necessary or prudent to obtain licenses to such patents from such parties. In addition, with respect to any patents we co-own with other parties—including our affiliates—we may require licenses to such co-owners’ interest to such patents. The licensing or acquisition of intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. No assurance can be given that we will be successful in licensing any additional rights or technologies from third parties and/or our affiliates. Our inability to license the rights and technologies that we have identified, or that we may in the future identify, could have a material adverse impact on our ability to complete the development of our product candidates or to develop additional product candidates. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Failure to obtain any necessary rights or licenses may detrimentally affect our planned development of our current or future additional product candidates and could increase the cost, and extend the timelines associated with our development, of such other products, and we may have to abandon development of the relevant program or product candidate. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.

Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our owned or in-licensed U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar extensions as compensation for patent term lost during regulatory review processes are also available in certain foreign countries and territories, such as in Europe under a Supplementary Patent Certificate. However, we may not be granted an extension in the United States and/or foreign countries and territories because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is shorter than what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and growth prospects could be materially harmed.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or

 

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co- inventor. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing Anktiva, product candidates or other technologies. Litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to ImmunityBio’s Anktiva product candidates and other technologies. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for Anktiva, Ad and yeast technologies and other product candidates and other technologies, we also rely on trade secrets and confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information and to maintain our competitive position. Trade secrets and know-how can be difficult to protect. We expect our trade secrets and know-how to over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to industry scientific positions.

We seek to protect these trade secrets and other proprietary technology, in part, by entering into nondisclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants as well as train our employees not to bring or use proprietary information or technology from former employers to us or in their work, and remind former employees when they leave their employment of their confidentiality obligations. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. Despite our efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely harmed.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights

 

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or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

 

   

others may be able to make products that are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents that we license or may own;

 

   

we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or own now or in the future;

 

   

we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

 

   

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

 

   

it is possible that our current or future pending owned or licensed patent applications will not lead to issued patents;

 

   

issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;

 

   

our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

 

   

we may not develop additional proprietary technologies that are patentable;

 

   

the patents of others may harm our business; and

 

   

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

 

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This joint proxy and consent solicitation statement/prospectus, and the documents to which NantKwest and ImmunityBio refer you within this joint proxy and consent solicitation statement/prospectus, as well as oral statements made or to be made by NantKwest and ImmunityBio, include “forward-looking statements” within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act, and the United States Private Securities Litigation Reform Act of 1995, as amended. All statements, other than statements of historical fact, included in this joint proxy and consent solicitation statement/prospectus, including those that address activities, events or developments that NantKwest or ImmunityBio expects, believes or anticipates will or may occur in the future, are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the merger, the expected timetable for completing the merger, the anticipated results, effects, benefits and synergies of the merger, pro forma descriptions of the combined company and its operations, integration and transition plans, synergies, opportunities, and anticipated future performance and any other statements regarding NantKwest’s or ImmunityBio’s future expectations, beliefs, plans, objectives, financial conditions, assumptions, or future events or performance that are not historical facts. Words such as “estimate,” “project,” “predict,” “believe,” “expect,” “anticipate,” “potential,” “create,” “intend,” “should,” “could,” “would,” “may,” “might,” “foresee,” “plan,” “will,” “guidance,” “outlook,” “future,” “assume,” “forecast,” “focus,” “target,” “continue,” or the negative of such terms or other variations thereof and words and terms of similar substance used in connection with any discussion of future plans, actions, or events identify forward-looking statements. However, the absence of these words does not mean that the statements are not forward-looking.

NantKwest and ImmunityBio caution investors that any forward-looking statements are subject to known and unknown risks and uncertainties, many of which are outside NantKwest’s and ImmunityBio’s control, and which may cause actual results and future trends to differ materially from those matters expressed in, or implied or projected by, such forward-looking statements, which speak only as of the date of this joint proxy and consent solicitation statement/prospectus. Investors are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties that could cause actual results to differ from those described in forward-looking statements include the following:

 

   

the merger agreement may be terminated in accordance with its terms and the merger may not be completed;

 

   

NantKwest stockholders may not approve the merger proposal;

 

   

the parties may not be able to satisfy the conditions to the completion of the merger in a timely manner or at all;

 

   

NantKwest and ImmunityBio may incur significant transaction and other costs in connection with the merger in excess of those anticipated by NantKwest or ImmunityBio;

 

   

the combined company may fail to realize anticipated synergies or other benefits expected from the merger in the timeframe expected or at all;

 

   

the ultimate timing, outcome and results of integrating the operations of NantKwest and ImmunityBio and the risk that NantKwest’s and ImmunityBio’s businesses may not be integrated successfully;

 

   

the effect of the merger and their announcement and/or completion on NantKwest’s and ImmunityBio’s business or employee relationships;

 

   

the risk related to disruption of management time from ongoing business operations due to the merger;

 

   

the merger may disrupt current plans and operations that may harm NantKwest’s and ImmunityBio’s respective businesses;

 

   

the effects of the business combination on NantKwest and ImmunityBio, including the combined company’s future financial condition, results of operations, strategy, credit ratings and plans;

 

   

changes in capital markets and the ability of the combined company to finance operations;

 

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unexpected costs, charges or expenses may result from the merger;

 

   

each of NantKwest, ImmunityBio and the combined company may be unable to continue or timely complete its planned preclinical and clinical development of its development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions;

 

   

any litigation relating to the merger;

 

   

risks to NantKwest’s and ImmunityBio’s operations generally, including the impact of a widespread outbreak of an illness, such as the COVID-19 pandemic, and the other risks, contingencies and uncertainties applicable to NantKwest and ImmunityBio disclosed in NantKwest’s other filings with the SEC incorporated herein by reference; and

 

   

the uncertainty of the value of the merger consideration due to the fixed exchange ratio and potential fluctuation in the market price of NantKwest common stock.

The foregoing list of factors is not exhaustive. For further discussion of these and other risks, contingencies, and uncertainties applicable to NantKwest and ImmunityBio, please see “Risk Factors” in this joint proxy and consent solicitation statement/prospectus as well as NantKwest’s other filings with the SEC incorporated herein by reference. Please see “Where You Can Find More Information” for more information about the SEC filings incorporated by reference into this joint proxy and consent solicitation statement/prospectus.

All subsequent written or oral forward-looking statements attributable to NantKwest, ImmunityBio or any person acting on its or their behalf are expressly qualified in their entirety by the cautionary statements contained in this section. All forward-looking statements speak only as of the date they are made and are based on information available at that time. Neither NantKwest nor ImmunityBio assumes any obligation to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements were made or to reflect the occurrence of unanticipated events except as required by federal securities laws. As forward-looking statements involve significant risks and uncertainties, caution should be exercised against placing undue reliance on such statements.

 

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NANTKWEST SPECIAL MEETING

Date, Time and Place of the NantKwest Special Meeting

The NantKwest special meeting will be conducted exclusively online via live audio webcast at www.proxypush.com/NK starting at 9:30 a.m., Pacific Time, on March 8, 2021. NantKwest stockholders will be able to attend the NantKwest special meeting online, and vote their shares electronically at the NantKwest special meeting by going to www.proxydocs.com/NK and registering in advance prior to the registration deadline of 2:00 p.m. Pacific Time on March 4, 2021 and entering their control number, which is included on the proxy card that they received. Because the NantKwest special meeting is completely virtual and being conducted online via live audio webcast, stockholders will not be able to attend the meeting in person. If NantKwest stockholders wish to ask a question to directors and/or members of management in attendance at the NantKwest special meeting, please note that such questions must be submitted in advance of the NantKwest special meeting. To submit a question, mark the box on the proxy card when registering to attend the NantKwest special meeting and submit your written question or submit a question at www.proxydocs.com/NK after logging in with your control number.

On or about February 5, 2021, NantKwest commenced mailing this joint proxy and consent solicitation statement/prospectus and the enclosed form of proxy card to its stockholders entitled to notice and to vote at the NantKwest special meeting.

Purpose of the NantKwest Special Meeting

At the NantKwest special meeting, NantKwest stockholders will be asked to consider and vote upon the following items:

 

  1.

a proposal to approve the issuance of shares of NantKwest common stock to security holders of ImmunityBio as contemplated by the merger agreement, a copy of which is attached as Annex A to this joint proxy and consent solicitation statement/prospectus (the “stock issuance proposal”);

 

  2.

a proposal to approve the merger contemplated by the merger agreement (the “merger proposal”); and

 

  3.

a proposal to approve the adjournment of the NantKwest special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the stock issuance proposal or the merger proposal (the “adjournment proposal”).

No other business will be acted upon at the NantKwest special meeting.

NantKwest Record Date and Quorum

Record Date

The NantKwest board has fixed the close of business on January 29, 2021 as the record date for determining the NantKwest stockholders entitled to receive notice of and to vote at the NantKwest special meeting.

On the NantKwest record date, NantKwest’s outstanding capital stock consisted of 108,997,270 shares of NantKwest common stock, which was held by approximately 29 holders of record. Each stockholder shall be entitled to one vote for each share of NantKwest common stock held by such stockholder.

Quorum

At the NantKwest special meeting, a majority of the voting power of the stock issued, outstanding and entitled to vote, present in person (which would include presence at a virtual meeting) or represented by proxy, is necessary to constitute a quorum. Abstentions and broker non-votes will be counted as present and entitled to

 

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vote for purposes of determining a quorum. However, because all proposals at the NantKwest special meeting are expected to be non-routine, NantKwest does not expect to receive any broker non-votes (which are shares of NantKwest common stock held by brokers, banks or other nominees with respect to which the broker, bank or other nominee is not instructed by the beneficial owner of such shares how to vote on a particular proposal and the broker, bank or other nominee does not have discretionary voting power on such proposal).

In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the NantKwest voting agreement with the NantKwest significant stockholders who collectively owned and are entitled to vote approximately 64.4% of the outstanding shares of NantKwest common stock as of the record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to be present at the NantKwest special meeting in person (which would include presence at a virtual meeting) or by proxy. As such, a quorum at the NantKwest special meeting is expected to be present.

Required Vote

Required Vote to Approve the NantKwest Stock Issuance Proposal

Per the NASDAQ rules, approval of the stock issuance proposal requires the affirmative vote of a majority of the votes cast by the stockholders present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting. As described above, in connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the NantKwest voting agreement with the NantKwest significant stockholders who collectively owned and are entitled to vote approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to vote their shares of NantKwest common stock in favor of the stock issuance proposal. Because their shares represent more than a majority of shares of NantKwest common stock issued and outstanding, their vote will ensure the requisite vote will be received to approve the stock issuance proposal.

Required Vote to Approve the NantKwest Merger Proposal

Approval of the merger proposal requires the affirmative vote of holders of a majority of all of the outstanding shares of NantKwest common stock as of the NantKwest record date, other than shares of NantKwest common stock held by the NantKwest significant stockholders or any of their respective controlled affiliates or any directors or executive officers of NantKwest or ImmunityBio. If such majority of the minority of NantKwest stockholders fails to approve the merger proposal, the merger will not occur.

Required Vote to Approve the NantKwest Adjournment Proposal

Approval of the adjournment proposal requires the affirmative vote of a majority of the voting power of the shares of NantKwest common stock present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting and entitled to vote on the proposal. Votes by the NantKwest significant stockholders in favor of the adjournment proposal will constitute the required stockholder approval for the adjournment proposal. The vote on the adjournment proposal is a vote separate and apart from the votes to approve the stock issuance proposal and the merger proposal. NantKwest does not intend to call a vote on this proposal if the stock issuance proposal and the merger proposal are approved at the NantKwest special meeting. The merger is not conditioned on the approval of the adjournment proposal.

Treatment of Abstentions; Failure to Vote

At the NantKwest special meeting:

 

  1.

Abstentions will not be counted as votes cast on the stock issuance proposal and therefore will have no effect on the outcome of the stock issuance proposal. Because the stock issuance proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the

 

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  NantKwest stock issuance proposal and will not be able to vote on the stock issuance proposal without receiving specific voting instructions from the beneficial owner. The failure of a beneficial owner to provide voting instructions to its broker, bank or other nominee will result in the applicable shares not being counted in determining the votes cast in connection with the stock issuance proposal, and will therefore have no effect on the outcome of the stock issuance proposal.

 

  2.

Abstentions and shares deemed not in attendance at the NantKwest special meeting, whether due to a record holder’s failure to vote or a “street name” holder’s failure to provide any voting instructions to such holder’s broker, bank or other nominee, will have the same effect as a vote “AGAINST” the merger proposal. Because the merger proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the merger proposal and will not be able to vote on the merger proposal without receiving specific voting instructions from the beneficial owner.

 

  3.

Abstentions with respect to the adjournment proposal also will have the effect of a vote “AGAINST” such proposal. Because the adjournment proposal is non-routine, brokers, banks and other nominees do not have discretionary authority to vote on the adjournment proposal and will not be able to vote on the adjournment proposal without receiving specific voting instructions from the beneficial owner.

In addition, the votes approving the stock issuance proposal required to be cast by the NantKwest significant stockholders pursuant to the NantKwest voting agreement will constitute the required stockholder approval for the stock issuance proposal, and their votes in favor of the adjournment proposal will constitute the required stockholder approval for the adjournment proposal. Therefore, a failure of any other NantKwest stockholder to vote to approve the stock issuance proposal or the adjournment proposal is not expected to have any effect on the approval of the stock issuance proposal or the adjournment proposal.

Recommendations of the NantKwest Special Committee and the NantKwest Board of Directors

The NantKwest special committee consists of Michael D. Blaszyk and Cheryl L. Cohen. The NantKwest board determined that each of Mr. Blaszyk and Ms. Cohen was independent and disinterested with respect to the potential transaction with ImmunityBio and other strategic alternatives available to NantKwest. At a meeting held on December 20, 2020, the NantKwest special committee unanimously determined that it was fair to and in the best interests of NantKwest and its stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest or ImmunityBio) for NantKwest to enter into the merger agreement and declared the merger agreement, and the transactions contemplated by the merger agreement, advisable, and resolved to recommend that the NantKwest board (1) declare the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approve and adopt the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, and (3) recommend that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates or the directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger.

At a meeting held on December 20, 2020, the NantKwest board (other than Dr. Soon-Shiong and Barry J. Simon, M.D., President and Chief Administrative Officer of NantKwest, both of whom recused themselves from deliberations regarding the merger), acting upon the recommendation of the NantKwest special committee, (1) declared the merger agreement, and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approved and adopted the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, (3) directed that the stock issuance be submitted to the NantKwest stockholders for approval and the merger agreement and the transactions contemplated by the merger agreement, including the merger, be submitted to the NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates or the directors and executive officers of NantKwest and ImmunityBio) for approval by such holders, and (4) resolved to recommend

 

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that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates or the directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger.

For a discussion of the factors considered by the NantKwest special committee and the NantKwest board in their evaluation of the merger, see “The Merger—Recommendation of the NantKwest Special Committee and the NantKwest Board of Directors; Reasons for the Merger” beginning on page 126.

Consummation of the merger is conditioned on approval of the stock issuance proposal and the merger proposal, but is not conditioned on the approval of the adjournment proposal.

Voting by NantKwest’s Directors, Executive Officers and Significant Stockholders

In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into a voting agreement with the NantKwest significant stockholders who collectively own approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to vote their shares of NantKwest common stock in favor of the stock issuance proposal and the adjournment proposal. Because their shares represent more than a majority of shares of NantKwest common stock issued and outstanding, their vote will ensure that the requisite vote will be received to approve such proposals.

The NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio will be excluded from the vote on the merger proposal. As of the NantKwest record date, such persons beneficially owned shares of NantKwest common stock representing approximately 67.63% of the outstanding shares of NantKwest common stock.

Voting; Proxies

After reading and carefully considering the information contained in this joint proxy and consent solicitation statement/prospectus, a NantKwest stockholder may submit a proxy or voting instructions for its shares of NantKwest common stock before the NantKwest special meeting in one of the following ways:

 

   

By Internet. If you are a registered owner of shares of NantKwest common stock, use the Internet to submit your proxy instructions and for the electronic delivery of information up until 9:30 a.m., Pacific Time, on March 8, 2021. Have the proxy card accompanying this joint proxy and consent solicitation statement/prospectus in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form. If your shares are held in “street name” in a stock brokerage account or by a broker, bank or other nominee, you must provide the record holder of your shares with instructions on how to vote your shares. The availability of Internet voting for beneficial owners holding shares of NantKwest common stock in “street name” will depend on the voting process of your broker, bank or other nominee. If you are a beneficial owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

 

   

By Phone. If you are a registered owner of shares of NantKwest common stock, use any touch-tone telephone to dial 866-249-5381 to submit your proxy instructions up until 9:30 a.m., Pacific Time, on March 8, 2021. Have your proxy card in hand when you call and then follow the instructions. If you submit a proxy by telephone, do not return your proxy card or voting instructions. The availability of telephone voting for beneficial owners holding shares of NantKwest common stock in “street name” will depend on the voting process of your broker, bank or other nominee. If you are an owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

 

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By Mail. Mark, sign and date your proxy card and return it in the postage-paid envelope we have provided. If you are a beneficial owner of shares of NantKwest common stock held in “street name,” please follow the voting instructions in the materials you receive from your broker, bank or other nominee.

In addition, all NantKwest stockholders may vote in person (which would consist of presence at a virtual meeting) at the NantKwest special meeting. Note that if your shares are held in the name of your broker, bank or other nominee and you wish to vote in person at the NantKwest special meeting, you must contact your broker, bank or other nominee and request a document called a “legal proxy.” You must submit this legal proxy in order to vote in person.

Even if you plan to attend the NantKwest special meeting virtually, we recommend that you also submit your proxy card or vote by telephone or via the Internet by the applicable deadline so that your vote will be counted if you later decide not to virtually attend the meeting. When the accompanying proxy card is returned properly executed, the shares of NantKwest common stock represented by it will be voted at the NantKwest special meeting in accordance with the instructions contained on the proxy card. If you sign and return your proxy card or voting instruction form without indicating how to vote on any particular proposal, the shares of NantKwest common stock represented by your proxy will be voted “FOR” each such proposal in accordance with the recommendation of the NantKwest board.

If you attend the NantKwest special meeting and vote online, any votes that you previously submitted — whether via the Internet, by telephone or by mail — will be revoked and superseded by the vote that you cast at the NantKwest special meeting.

EVERY NANTKWEST STOCKHOLDER’S VOTE IS IMPORTANT. ACCORDINGLY, EACH NANTKWEST STOCKHOLDER SHOULD SUBMIT HIS, HER OR ITS PROXY VIA THE INTERNET OR BY TELEPHONE, OR SIGN, DATE AND RETURN THE ENCLOSED PROXY CARD, WHETHER OR NOT THE NANTKWEST STOCKHOLDER PLANS TO ATTEND THE NANTKWEST SPECIAL MEETING.

Shares Held in “Street Name”

If your shares of NantKwest common stock are held in “street name” through a broker, bank or other nominee, you must instruct such broker, bank or other nominee on how to vote the shares by following the instructions that the broker, bank or other nominee provides you along with this joint proxy and consent solicitation statement/prospectus. Your broker, bank or other nominee, as applicable, may have an earlier deadline by which you must provide instructions to it as to how to vote your shares of NantKwest common stock, so you should read carefully the materials provided to you by your broker, bank or other nominee.

You may not vote shares of NantKwest common stock held in “street name” by returning a proxy card directly to NantKwest or by voting at the NantKwest special meeting if you attend virtually unless you obtain and submit a properly executed “legal proxy” from your broker, bank or other nominee.

With respect to shares of NantKwest common stock held in street name, your broker, bank or other nominee generally has the discretionary authority to vote uninstructed shares on “routine” matters, but cannot vote such uninstructed shares on “non-routine” matters. A “broker non-vote” will occur if your broker, bank or other nominee cannot vote your shares of NantKwest common stock on a particular matter because it has not received instructions from you and does not have discretionary voting authority on that matter or because your broker, bank or other nominee chooses not to vote on a matter for which it does have discretionary voting authority.

 

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All of the proposals at the NantKwest special meeting are expected to be treated as non-routine. Accordingly, if brokers, banks or other nominees do not receive specific voting instructions from the beneficial owner of shares of NantKwest common stock, they may not vote such shares with respect to the stock issuance proposal, the merger proposal or the adjournment proposal. Therefore, if your shares of NantKwest common stock are held in “street name” and you do not instruct your broker, bank or other nominee on how to vote your shares:

 

  1.

your broker, bank or other nominee may not vote your shares on the stock issuance proposal, which will not count as a vote cast on such proposal;

 

  2.

your broker, bank or other nominee may not vote your shares on the merger proposal, which will have the same effect as a vote “AGAINST” such proposal; and

 

  3.

your broker, bank or other nominee may not vote your shares on the adjournment proposal, which will not count as a vote cast on such proposal.

If your shares of NantKwest common stock are held in “street name” and you do not instruct your broker, bank or other nominee on how to vote your shares with respect to any of the NantKwest proposals, your shares will not be counted toward determining whether a quorum is present.

Revocability of Proxies and Changes to a NantKwest Stockholder’s Vote

Any proxy may be revoked at any time before it is exercised by (1) sending a written notice of revocation to Steven Yang, Corporate Secretary, at NantKwest, Inc., 3530 John Hopkins Court, San Diego, California 92121, Attention: Corporate Secretary, (2) attending the NantKwest special meeting and voting virtually or (3) properly completing and executing a later dated proxy and delivering it to the Corporate Secretary of NantKwest at the address listed above at or before the NantKwest special meeting. Stockholders of NantKwest may also revoke their proxy by entering a new vote over the Internet or by telephone at any time before the NantKwest special meeting.

If you are a NantKwest stockholder whose shares of NantKwest common stock are held in “street name” by a broker, bank or other nominee, you may revoke your proxy or voting instructions and vote your shares at the NantKwest special meeting if you attend virtually only in accordance with applicable rules and procedures as employed by your broker, bank or other nominee or by obtaining a “legal proxy” from your broker, bank or other nominee. If your shares are held in an account at a broker, bank or other nominee, you must follow the directions you receive from your broker, bank or other nominee in order to change or revoke your proxy or voting instructions and should contact your broker, bank or other nominee to do so.

Virtually attending the NantKwest special meeting will NOT automatically revoke a proxy that was submitted through the Internet or by telephone or mail. You must vote at the NantKwest special meeting to change your vote.

Solicitation of NantKwest Proxies

The cost of solicitation of proxies from NantKwest stockholders will be borne by NantKwest. NantKwest will reimburse brokerage firms and other custodians, nominees and fiduciaries for reasonable expenses incurred by them in sending proxy materials to the beneficial owners of shares of NantKwest common stock. NantKwest has retained a professional proxy solicitation firm, MacKenzie Partners, Inc., to assist in the solicitation of proxies. NantKwest will bear the costs of the fees for the proxy solicitation agent, which are not expected to exceed $15,000, excluding out-of-pocket expenses. In addition to solicitations by mail, NantKwest’s directors, officers and regular employees may solicit proxies personally or by telephone without additional compensation.

 

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Attending the NantKwest Special Meeting

In light of public health concerns regarding the COVID-19 pandemic, the NantKwest special meeting will be conducted exclusively via live audio webcast starting at 9:30 a.m., Pacific Time, on March 8, 2021. You will be able to attend the NantKwest special meeting online and vote your shares electronically at the NantKwest special meeting by going to www.proxypush.com/NK. You may attend the NantKwest special meeting by registering in advance prior to the registration deadline of 2:00 p.m. Pacific Time on March 4, 2021 at www.proxydocs.com/NK and entering your control number, which is included on the proxy card that you received. Because the NantKwest special meeting is completely virtual and being conducted via live audio webcast, stockholders will not be able to attend the meeting in person.

Stockholders participating in the special meeting will be in a listen-only mode and will not be able to speak during the live audio webcast. If NantKwest stockholders wish to ask a question to directors and/or members of management in attendance at the NantKwest special meeting, please note that such questions must be submitted in advance of the NantKwest special meeting. To submit a question, mark the box on the proxy card when registering to attend the meeting and submit your written question or submit a question at www.proxydocs.com/NK after logging in with your control number.

Adjournments

Pursuant to the NantKwest bylaws, if a quorum is not present, the NantKwest special meeting may be adjourned by either (1) the chairperson of the meeting, or (2) the stockholders entitled to vote at the meeting, present in person (which would include presence at a virtual meeting) or represented by proxy. The chairperson of the meeting has the authority to adjourn a meeting of the stockholders in all other events. At such adjourned meeting at which a quorum is present or represented, any business may be transacted that might have been transacted at the meeting as originally noticed.

When a meeting is adjourned to another time or place, unless the NantKwest bylaws otherwise require, notice need not be given of the adjourned meeting if the time, place, if any, thereof, and the means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such adjourned meeting are announced at the meeting at which the adjournment is taken. At the adjourned meeting, NantKwest may transact any business which might have been transacted at the original meeting. If the adjournment is for more than 30 days, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. If after the adjournment a new record date for stockholders entitled to vote is fixed for the adjourned meeting, the NantKwest board will fix a new record date for notice of such adjourned meeting, and shall give notice of the adjourned meeting to each stockholder of record entitled to vote at such adjourned meeting as of the record date fixed for notice of such adjourned meeting.

Other Business

No other matters are intended to be brought before the NantKwest special meeting by NantKwest.

Assistance

If you need assistance in completing your proxy card or have questions regarding the NantKwest special meeting, please contact MacKenzie Partners, Inc., the proxy solicitation agent for NantKwest, toll-free at 800-322-2885 or collect at 212-929-5500.

 

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THE NANTKWEST PROPOSALS

NantKwest Proposal 1: The NantKwest Stock Issuance Proposal

NantKwest is asking its stockholders to approve the issuance of shares of NantKwest common stock to security holders of ImmunityBio as contemplated by the merger agreement. In the merger, NantKwest will issue to the stockholders of ImmunityBio 0.8190 of a share of NantKwest common stock for each outstanding share of ImmunityBio common stock as of immediately prior to the effective time and also will assume the ImmunityBio equity awards and the ImmunityBio warrant. Upon consummation of the merger, on a fully diluted basis, ImmunityBio stockholders will own approximately 72% of the outstanding shares of common stock of the combined company and NantKwest stockholders will own approximately 28% of the outstanding shares of common stock of the combined company, not taking into account any shares of NantKwest or ImmunityBio that may be issued in any capital raising transaction that may occur prior to closing of the merger. Approval of this proposal will constitute approval of the issuance of shares of NantKwest common stock in the merger in respect of any ImmunityBio shares issued prior to closing and the issuance of shares of NantKwest common stock to holders of equity awards issued under ImmunityBio’s equity incentive plan (which will become equity awards of NantKwest in connection with the merger) upon exercise or settlement of those awards, to the holder of the ImmunityBio warrant (which will become a warrant for shares of NantKwest common stock in connection with the merger), and to holders of CVRs issued by ImmunityBio prior to the merger in the event of the settlement of any such CVRs for shares after the merger.

The terms of, reasons for and other aspects of the merger agreement, the merger and the issuance of NantKwest common stock to security holders of ImmunityBio as contemplated by the merger agreement are described in detail in the other sections of this joint proxy and consent solicitation statement/prospectus. NantKwest stockholders should carefully read this joint proxy and consent solicitation statement/prospectus in its entirety, including the annexes and exhibits, for more detailed information concerning the merger agreement and the merger. In particular, NantKwest stockholders are directed to the merger agreement, which is attached as Annex A to this joint proxy and consent solicitation statement/prospectus.

Under Nasdaq rules, a company is required to obtain stockholder approval prior to the issuance of shares of common stock if the number of shares of common stock to be issued is, or will be upon issuance, equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of the common stock, or any director, officer or substantial shareholder (as defined under Nasdaq rules) of the company has a 5% or greater interest (or such persons collectively have a 10% or greater interest), directly or indirectly, in the company or assets to be acquired or in the consideration to be paid in the transaction and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in the outstanding common stock of 5% or more. Accordingly, NantKwest is seeking the approval of NantKwest stockholders for the issuance of shares of NantKwest common stock to security holders of ImmunityBio as contemplated by the merger agreement.

In addition, Nasdaq rules also require a company listed on Nasdaq to obtain stockholder approval prior to an issuance of securities that will result in a “change of control” of the company. Nasdaq has not adopted any rule as to what constitutes a change of control for this purpose; however, Nasdaq has previously indicated that the acquisition of, or right to acquire, by a single investor or affiliated investor group, as little as 20% of the common stock (or securities convertible into or exercisable for common stock) or voting power of an issuer could constitute a change of control. If the merger is deemed a change of control under Nasdaq rules, then the approval of NantKwest stockholders of the issuance of shares of NantKwest common stock as contemplated by the merger agreement will constitute the approval of such change of control.

In the event the stock issuance proposal is approved by NantKwest stockholders, but the merger agreement is terminated (without the merger being completed) prior to the issuance of shares of NantKwest common stock pursuant to the merger agreement, NantKwest will not issue any shares of NantKwest common stock as a result of the approval of the stock issuance proposal.

 

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Consummation of the merger is conditioned on approval of the stock issuance proposal, subject to the terms of the merger agreement.

Vote Required; Recommendation

Approval of the stock issuance proposal requires the affirmative vote of a majority of the votes cast by the stockholders present virtually or represented by proxy at the NantKwest special meeting. As described above, in connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the NantKwest voting agreement with Dr. Patrick Soon-Shiong and certain of his affiliates who collectively own approximately 64.4% of the outstanding shares of NantKwest common stock as of the NantKwest record date. Pursuant to the NantKwest voting agreement, those stockholders agreed, among other things, to vote their shares of NantKwest common stock in favor of the stock issuance proposal. Because their shares represent more than a majority of shares of NantKwest common stock issued and outstanding, their vote will ensure the requisite vote will be received to approve the stock issuance proposal.

The NantKwest board, upon recommendation of the NantKwest special committee, recommends that NantKwest stockholders vote “FOR” the stock issuance proposal.

NantKwest Proposal 2: The NantKwest Merger Proposal

NantKwest is asking its stockholders to approve the merger contemplated by the merger agreement pursuant to which Merger Sub will merge with and into ImmunityBio, with ImmunityBio surviving the merger as the surviving corporation and a direct wholly-owned subsidiary of NantKwest. If the merger is completed, each share of ImmunityBio common stock issued and outstanding immediately prior to the effective time of the merger (other than shares directly owned by ImmunityBio as treasury stock or dissenting shares) will be converted into the right to receive 0.8190 of a share of NantKwest common stock. Upon consummation of the merger, on a fully diluted basis, ImmunityBio stockholders will own approximately 72% of the outstanding shares of the combined company and NantKwest stockholders will own approximately 28% of the outstanding shares of the combined company, not taking into account any shares of NantKwest or ImmunityBio that may be issued in any capital raising transaction that may occur prior to closing of the merger. In connection with the closing of the merger, the combined company will assume the ImmunityBio name, and following the closing will be listed on the NASDAQ and are expected to be traded under the symbol “IBRX”.

The terms of, reasons for and other aspects of the merger agreement, the merger and the issuance of NantKwest common stock are described in detail in the other sections of this joint proxy and consent solicitation statement/prospectus. NantKwest stockholders should carefully read this joint proxy and consent solicitation statement/prospectus in its entirety, including the annexes and exhibits, for more detailed information concerning the merger agreement and the merger. In particular, NantKwest stockholders are directed to the merger agreement, which is attached as Annex A to this joint proxy and consent solicitation statement/prospectus.

Consummation of the merger is conditioned on approval of the merger proposal, subject to the terms of the merger agreement.

Vote Required; Recommendation

Approval of the merger proposal requires the affirmative vote of holders of a majority of all of the outstanding shares of NantKwest common stock as of the record date, other than shares of NantKwest common stock held by the NantKwest significant stockholders or any of their respective controlled affiliates or any directors or executive officers of NantKwest or ImmunityBio. If such majority of the minority of NantKwest stockholders fails to approve the merger proposal, the merger will not occur.

The NantKwest board, upon the recommendation of the special committee, recommends that NantKwest stockholders vote “FOR” the merger proposal.

 

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NantKwest Proposal 3: The NantKwest Adjournment Proposal

NantKwest is asking its stockholders to approve the adjournment of the NantKwest special meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for, or otherwise in connection with, the approval of the stock issuance proposal or the merger proposal. The merger agreement provides that the NantKwest special meeting will not be adjourned to a date that is more than 45 days after the date for which the NantKwest special meeting was originally scheduled without the prior written consent of ImmunityBio (such consent not to be unreasonably withheld, conditioned or delayed).

Consummation of the merger is not conditioned on approval of the adjournment proposal.

Vote Required; Recommendation

Approval of the adjournment proposal requires the affirmative vote of a majority of the voting power of the shares of NantKwest common stock present in person (which would include presence at a virtual meeting) or represented by proxy at the NantKwest special meeting and entitled to vote on the proposal.

The NantKwest board, upon recommendation of the NantKwest special committee, recommends that NantKwest stockholders vote “FOR” the adjournment proposal.

 

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IMMUNITYBIO SOLICITATION OF WRITTEN CONSENTS

Purpose of the Consent Solicitation; Recommendation of the ImmunityBio Board of Directors

The ImmunityBio board is providing this joint proxy and consent solicitation statement/prospectus to ImmunityBio stockholders. ImmunityBio stockholders are being asked to adopt and approve the ImmunityBio merger proposal by executing and delivering the written consent furnished with this joint proxy and consent solicitation statement/prospectus.

After consideration, the ImmunityBio board (including its independent director) unanimously approved and declared advisable the merger agreement and the merger, upon the terms and conditions set forth in the merger agreement, and unanimously determined that the merger agreement and the transactions contemplated thereby are in the best interests of ImmunityBio and its stockholders. The ImmunityBio board (including its independent director) unanimously recommends that ImmunityBio stockholders approve the ImmunityBio merger proposal.

ImmunityBio Stockholders Entitled to Consent

Only ImmunityBio stockholders of record as of the close of business on January 29, 2021, the ImmunityBio record date, will be entitled to execute and deliver a written consent. As of the close of business on the ImmunityBio record date, there were 334,164,092 shares of ImmunityBio common stock outstanding and entitled to execute and deliver written consents with respect to the ImmunityBio merger proposal. Each holder of ImmunityBio common stock is entitled to one vote for each share of ImmunityBio common stock held as of the ImmunityBio record date.

Written Consents; Required Written Consents

The approval of the ImmunityBio merger proposal requires the affirmative vote or consent of the holders of a majority of the voting power of the outstanding shares of ImmunityBio common stock. In connection with the execution of the merger agreement, NantKwest and ImmunityBio have entered into the ImmunityBio voting agreement with the ImmunityBio significant stockholders, who collectively own and are entitled to vote approximately 88.9% of the outstanding shares of ImmunityBio common stock as of the date of the merger agreement, pursuant to which such stockholders agreed, among other things, to vote their shares of ImmunityBio common stock in favor of adoption of the merger agreement and the transactions contemplated thereby as promptly as practicable, and in any event within two business days after the registration statement, of which this joint proxy and consent solicitation statement/prospectus forms a part, is declared effective by the SEC.

Submission of Written Consents

You may consent to the ImmunityBio merger proposal with respect to your shares of ImmunityBio common stock by completing, dating and signing the written consent enclosed with this joint proxy and consent solicitation statement/prospectus and returning it to ImmunityBio before the merger.

If you hold shares of ImmunityBio common stock as of the close of business on the ImmunityBio record date and you wish to give your written consent, you must fill out the enclosed written consent, date and sign it, and promptly return it to ImmunityBio. Once you have completed, dated and signed the written consent, you may deliver it to ImmunityBio by emailing a .pdf copy to NKMergerVote@immunitybio.com or by mailing your written consent to 2040 East Mariposa Avenue, El Segundo, California 90245.

ImmunityBio stockholders should not send stock certificates with their written consents. After the merger is completed, a letter of transmittal and written instructions for the surrender of ImmunityBio stock certificates will be mailed to ImmunityBio stockholders. Do not send in your certificates now.

Executing Written Consents; Revocation of Written Consents

You may execute a written consent to approve the ImmunityBio merger proposal (which is equivalent to a vote for such proposal), or disapprove, or abstain from consenting with respect to, the ImmunityBio merger

 

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proposal (which is equivalent to a vote against such proposal). If you do not return your written consent, it will have the same effect as a vote against the ImmunityBio merger proposal. If you are a record holder of shares of ImmunityBio common stock and you return a signed written consent without indicating your decision on the ImmunityBio merger proposal, you will have given your consent to approve such proposal.

Your consent to the ImmunityBio merger proposal may be changed or revoked at any time before the consent deadline; however, such change or revocation is not expected to have any effect, as the delivery of the written consents contemplated by the ImmunityBio voting agreement will constitute the ImmunityBio stockholder approval at the time of such delivery. If you wish to change or revoke your consent before the consent deadline, you may do so by sending a new written consent with a later date or by delivering a notice of revocation, in either case by emailing a .pdf copy to NKMergerVote@immunitybio.com or by mailing your written consent to 2040 East Mariposa Avenue, El Segundo, California 90245.

Due to the obligations of the ImmunityBio significant stockholders under the ImmunityBio voting agreement, a failure of any other ImmunityBio stockholder to deliver a written consent, or any change or revocation of a previously delivered written consent by any other ImmunityBio stockholder, is not expected to have any effect on the approval of the ImmunityBio merger proposal.

Solicitation of Written Consents; Expenses

The expense of printing and mailing these consent solicitation materials is being borne equally by ImmunityBio and NantKwest. Officers and employees of ImmunityBio may solicit consents by telephone and personally, in addition to solicitation by mail. These persons will receive their regular compensation but no special compensation for soliciting consents.

 

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THE MERGER

This section of the joint proxy and consent solicitation statement/prospectus describes the material aspects of the proposed merger. This section may not contain all of the information that is important to you. You should carefully read this entire joint proxy and consent solicitation statement/prospectus and the documents incorporated by reference into this joint proxy and consent solicitation statement/prospectus, including the full text of the merger agreement, a copy of which is attached to this joint proxy and consent solicitation statement/prospectus as Annex A, for a more complete understanding of the proposed merger and the transactions related thereto. In addition, important business and financial information about NantKwest is included in or incorporated by reference into this joint proxy and consent solicitation statement/prospectus. Please see “Where You Can Find More Information”.

General Information

Under the terms and subject to the conditions set forth in the merger agreement, at the effective time, Merger Sub will merge with and into ImmunityBio and the separate corporate existence of Merger Sub shall thereupon cease. ImmunityBio will survive the merger as the surviving corporation and a direct wholly-owned subsidiary of NantKwest. Prior to the closing of the merger, the NantKwest board shall take all action necessary, including approving amendments to its certificate of incorporation and bylaws as necessary, to change its name to “ImmunityBio, Inc.”, which will be the name of the combined company, effective as of the effective time.

Upon consummation of the merger, on a fully diluted basis, ImmunityBio stockholders and NantKwest stockholders will own approximately 72% and 28%, respectively, of the outstanding shares of common stock of the combined company. Shares of NantKwest common stock currently trade on the NASDAQ under the symbol “NK,” and shares of ImmunityBio common stock are not publicly traded.

NantKwest, ImmunityBio and/or the combined company intend to issue additional shares in connection with one or more future capital raising transactions that may occur prior to and/or, in the case of the combined company, after the closing of the merger. The percentages above do not take into account any such future shares issuances; any such shares issuances would proportionately reduce the percentage ownership of the existing NantKwest and ImmunityBio stockholders in the combined company. Following the consummation of the merger, shares of common stock of the combined company will be listed on the NASDAQ and are expected to trade under the symbol “IBRX”.

Background of the Merger

The following chronology summarizes the key meetings and events that led to the signing of the merger agreement. The following chronology does not purport to catalogue every conversation among the NantKwest special committee, the NantKwest board, the ImmunityBio board, or their respective representatives and other parties.

NantKwest is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and infectious diseases. ImmunityBio is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. Dr. Patrick Soon-Shiong and certain of his affiliates collectively own in excess of a majority of the outstanding common stock of each of NantKwest and ImmunityBio. The boards of directors and management of NantKwest and ImmunityBio each regularly review and assess the operations, performance, prospects and strategic direction of their respective companies. As part of this review, each such board regularly evaluates and considers a variety of possible financial and strategic opportunities to enhance stockholder value as part of the long-term business plan of the respective company, including, among other things, the exploration of possible financing, acquisitions, divestitures, licensing and collaboration transactions, and other strategic alternatives.

 

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In August 2016, NantKwest entered into an exclusive Co-Development Agreement with Altor BioScience, LLC, a wholly owned subsidiary of ImmunityBio. Under the Co-Development Agreement, the parties agreed to exclusively collaborate on the development of certain therapeutic applications combining NantKwest’s proprietary NK cells with Altor’s N-801 and/or N-803 products with respect to certain technologies and intellectual property rights as may be agreed between the parties for the purpose of jointly developing therapeutic applications of certain effector cell lines. NantKwest and ImmunityBio are currently partners with respect to late-stage clinical development programs for a number of indications (including pancreatic cancer, triple negative breast cancer, non-small cell lung cancer, and merkel cell carcinoma), as well as, most recently, clinical programs for COVID-19. Given the on-going collaboration between NantKwest and ImmunityBio and their joint clinical programs, the NantKwest board has periodically discussed the potential strategic benefit of combining the two companies.

On January 29, 2020, during a regularly-scheduled meeting, the NantKwest board discussed financing strategies for NantKwest and, as part of that discussion, the potential consideration of a strategic transaction with ImmunityBio if the ImmunityBio board were to propose such a transaction. Following such discussion, the NantKwest board determined to form a special committee consisting of independent and disinterested directors to review and evaluate the advisability of a potential strategic transaction between NantKwest and ImmunityBio. Dr. Soon-Shiong indicated to the special committee that he had no interest in selling any shares of NantKwest common stock that he or his affiliates owned as part of an alternative transaction. The special committee, after interviews with potential advisors, engaged Goodwin Procter LLP as independent counsel to the special committee (“Goodwin”), Barclays Capital Inc. as independent financial advisor to the special committee (“Barclays”), and Health Advances LLC, an independent industry consultant (the “Consultant”), to assist the special committee in evaluating the product pipelines of both NantKwest and ImmunityBio and the preparation and/or review of financial projections and synergies related to a potential transaction given the conflicts of interest of the NantKwest management team presented by a potential strategic transaction between NantKwest and ImmunityBio. The decision to engage each such advisor was based on, among other things, such advisor’s qualifications, experience and reputation and the absence of conflicts on the part of such advisor. Following engagement of its advisors through May 2020, the special committee held meetings with its advisors and engaged in preliminary discussions regarding the advisability of a potential strategic transaction between NantKwest and ImmunityBio. During this period, neither party made a proposal regarding a potential transaction or pricing or potential ownership split with respect to a transaction.

On April 14, 2020, NantKwest and ImmunityBio jointly announced that they were in active discussions with the U.S. Food and Drug Administration for vaccines and therapeutics to combat COVID-19.

On May 20, 2020, Dr. Soon-Shiong informed the special committee that he was considering various financing alternatives for each of NantKwest and ImmunityBio, particularly in light of their recently announced collaboration regarding the development of potential COVID-19 therapeutics and/or vaccines and the respective financing needs of the two companies. Dr. Soon-Shiong indicated that ImmunityBio would not at that time propose a potential strategic transaction between NantKwest and ImmunityBio. Thereafter, on June 10, 2020, the NantKwest board formally dissolved the special committee and in connection therewith, the special committee terminated the engagement of its advisors.

On June 29, 2020, NantKwest closed a public offering of shares of its common stock for aggregate gross proceeds of approximately $90.7 million. The offering consisted of the sale of 8,521,500 shares of NantKwest common stock, including the sale of 4,811,500 shares of common stock at a price to the public of $9.50 per share and 3,710,000 shares of common stock at a price of $12.12 per share to Dr. Soon-Shiong, which price per share was equal to the “market value” of the NantKwest common stock immediately preceding the entry into the related underwriting agreement in accordance with NASDAQ rules.

On August 24, 2020, NantKwest and ImmunityBio announced that they had signed a definitive agreement to pursue collaborative joint development, manufacturing and marketing of certain COVID-19 therapeutics and vaccines.

 

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On October 13, 2020, the NantKwest board held a regularly-scheduled meeting at which all of the directors and representatives of Wilson Sonsini Goodrich & Rosati, P.C., the Company’s outside counsel (“Wilson Sonsini”), were present. During this meeting, the NantKwest board again discussed financing strategies for NantKwest and, as part of that discussion, the potential consideration of a strategic transaction with ImmunityBio if the ImmunityBio board were to propose such a transaction. The members of the NantKwest board other than Dr. Soon-Shiong discussed the possibility of a potential strategic transaction with ImmunityBio. The discussion included that the formation of a committee consisting of only independent and disinterested directors to consider such a matter and then, if a transaction were ultimately pursued, obtaining approval from a majority of the minority stockholders was recommended for this type of transaction. Following discussion, the NantKwest board, including Dr. Soon-Shiong, determined to proceed in this manner with respect to the consideration of a potential transaction with ImmunityBio, including to form a special committee consisting of certain directors of NantKwest who were independent and disinterested with respect to the potential transaction and other strategic alternatives available to NantKwest, and obtaining a majority of the minority stockholder vote with respect to any such transaction. The NantKwest board, with the assistance of the Wilson Sonsini representatives, discussed the independence and disinterestedness of potential special committee members, including disclosure by members of the NantKwest board of facts that might impact the NantKwest board’s consideration of potential members for such a special committee. The NantKwest board then selected Michael D. Blaszyk and Cheryl L. Cohen, both of whom are members of the related party transaction committee of the NantKwest board, to serve on the NantKwest special committee, with Mr. Blaszyk acting as chairperson (the “Chair”). In making this selection, the NantKwest board considered Mr. Blaszyk’s service as an independent director of NantHealth, Inc., a publicly-traded company that is an affiliate of Dr. Soon-Shiong, and his prior service as an independent director of certain other companies affiliated with Dr. Soon-Shiong, and determined that such service did not present a conflict with respect to a potential strategic transaction with ImmunityBio. The resolutions unanimously adopted by the NantKwest board authorized the NantKwest special committee to, among other things, (1) review and evaluate the advisability of the potential transaction, (2) identify, review and evaluate alternatives to the potential transaction available to NantKwest, including, without limitation, NantKwest’s stand-alone business prospects, (3) recommend, reject or seek to modify the terms of the potential transaction or any other such alternative, (4) if the NantKwest special committee considers it advisable or appropriate, negotiate the price, structure, form, terms and conditions of the potential transaction or any alternative thereto and the form, terms and conditions of any definitive agreements in connection therewith, (5) determine whether the potential transaction or any alternative thereto is fair to, and in the best interests of, NantKwest and its stockholders, (6) obtain any necessary or desirable advice, assistance and opinions from financial advisors or other advisors, consultants and agents, (7) recommend to the full NantKwest board what action, if any, should be taken by NantKwest with respect to the potential transaction or any alternative thereto, (8) do all things that may, in the judgment of its members, be deemed necessary, appropriate or advisable to assist the NantKwest special committee in carrying out its responsibilities in connection with or with respect to the potential transaction or any alternative thereto and (9) provide reports or recommendations to the NantKwest board in regard to such matters at such times as the NantKwest special committee deems appropriate and consistent with its activities. In addition, the resolutions provided that the NantKwest board shall not propose or recommend a potential transaction for approval by NantKwest stockholders or otherwise approve the potential transaction without a prior favorable recommendation of such transaction by the NantKwest special committee. The resolutions, which served as a charter for the NantKwest special committee, also authorized the NantKwest special committee, at its sole discretion, to interview, select and retain, at NantKwest’s expense, such legal counsel, financial and other advisors, consultants and agents as it may deem appropriate, in its sole discretion, in the exercise of its power and authority, and also authorized and directed the officers, agents and employees of NantKwest and its subsidiaries to cooperate with and assist the NantKwest special committee and its legal counsel, financial and other advisors, consultants and agents in all respects, and to provide and furnish to the NantKwest special committee and its legal counsel, financial and other advisors, consultants and agents all information and documents that the NantKwest special committee and its advisors requested with respect to the evaluation and negotiation of the potential transaction or any alternative thereto.

 

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Following this meeting of the NantKwest board, the NantKwest special committee contacted Goodwin, Barclays and the Consultant with respect to serving as independent advisors to the newly-formed committee, and thereafter, the NantKwest special committee interviewed each of the former advisors and determined to engage them as independent advisors to the committee. The Chair also had a telephone conversation with Dr. Soon-Shiong, and the representatives of Barclays had telephone conversations with representatives of Goldman Sachs & Co., one of ImmunityBio’s financial advisors (“Goldman Sachs”), regarding the work that the NantKwest special committee would expect to undertake to be in a position to evaluate any potential offer that may be made by ImmunityBio.

On October 20, 2020, NantKwest and ImmunityBio entered into a mutual non-disclosure agreement in order to facilitate conversations regarding a potential strategic transaction and the sharing of due diligence materials between the parties. The agreement did not include a standstill provision.

On October 21, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, the Chair reported on his recent conversation with Dr. Soon-Shiong and the representatives of Barclays reported on their recent conversations with Goldman Sachs. Representatives of Goodwin reviewed the directors’ fiduciary duties in this context. The members of the NantKwest special committee discussed their understanding that obtaining stockholder approval from a majority of the minority stockholders if a transaction were ultimately pursued was consistent with the discussions of the NantKwest board at its October 13th meeting, such that they would not need to consider any offer from ImmunityBio that didn’t include such a majority of the minority approval. The meeting participants then discussed the process for conducting due diligence and producing financial projections for each of NantKwest and ImmunityBio in order to aid the NantKwest special committee’s consideration and evaluation of a potential strategic transaction with ImmunityBio in the event that ImmunityBio decided to make an offer, as well as any available alternatives to such a transaction, including continuing as a stand-alone company. It was noted that, because of the controlling position that Dr. Soon-Shiong and his affiliates hold in NantKwest and his stated unwillingness to sell such shares, it would not be feasible to solicit third-party proposals to acquire NantKwest. The NantKwest special committee determined that it would request due diligence materials from management of both NantKwest and ImmunityBio. The meeting participants also discussed various workstreams and a preliminary timeline for these workstreams.

On October 22, 2020, representatives of Barclays had a telephone conversation with representatives of Goldman Sachs to request certain preliminary due diligence items regarding ImmunityBio and a presentation from ImmunityBio’s senior management with respect to ImmunityBio’s business, clinical programs and development pipeline.

On October 24, 2020, ImmunityBio provided access to a virtual data room to the NantKwest special committee and its advisors, which contained certain preliminary due diligence materials regarding ImmunityBio. Thereafter, ImmunityBio shared additional confidential information regarding ImmunityBio’s business with the NantKwest special committee and its advisors, and representatives of Barclays, the Consultant and Goodwin had a number of telephone conversations regarding such due diligence process with representatives of Goldman Sachs and Fried, Frank, Harris, Shriver & Jacobson LLP, outside counsel to ImmunityBio (“Fried Frank”), respectively.

On October 26, 2020, the members of the NantKwest special committee had a meeting with members of senior management of NantKwest at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays and the Consultant reviewed with NantKwest management certain preliminary due diligence requests regarding NantKwest. Thereafter, the NantKwest management began sharing the requested information regarding NantKwest’s business with the NantKwest special committee and its advisors.

On October 27, 2020, representatives of Goldman Sachs provided Barclays with a due diligence request list regarding NantKwest. Thereafter, at the direction of the NantKwest special committee, NantKwest shared confidential information regarding NantKwest’s business with ImmunityBio and its advisors, and representatives

 

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of Barclays and Goodwin had a number of telephone conversations regarding such due diligence process with representatives of Goldman Sachs and Fried Frank, respectively.

On October 28, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays reported on their recent conversations with representatives of Goldman Sachs regarding the due diligence process with respect to ImmunityBio, and reviewed with the NantKwest special committee the due diligence request list regarding NantKwest that had been provided by representatives of Goldman Sachs. Following review of the list, the NantKwest special committee authorized Barclays to share the list with NantKwest senior management and coordinate the delivery of such materials to ImmunityBio. The meeting participants also reviewed the capital structure of ImmunityBio as outlined in the preliminary due diligence materials provided by ImmunityBio. The NantKwest special committee also reviewed and provided input to Barclays regarding the proposed agenda for the management presentation to be provided by ImmunityBio on the following day, and the representatives of each of Barclays and the Consultant provided an update on the status and scope of their respective workstreams.

In addition, on October 28, 2020, ImmunityBio provided the NantKwest special committee and its advisors with expanded access to the virtual data room in order to perform further financial and legal due diligence regarding ImmunityBio. Following such access to the virtual data room, the advisors to the NantKwest special committee provided supplemental due diligence request lists to ImmunityBio and its representatives and such parties had a number of conference calls to discuss items on such due diligence request lists.

On October 29, 2020, ImmunityBio’s senior management team, including Dr. Soon-Shiong, provided a presentation to the NantKwest special committee and its advisors regarding ImmunityBio’s business, including its clinical programs and development pipeline, material partnerships and collaborations, and expected capital needs, and the business rationale and potential synergies for a possible strategic transaction between NantKwest and ImmunityBio.

On November 2, 2020, representatives of Barclays had a telephone conversation with representatives of Goldman Sachs to discuss ImmunityBio’s capital structure and expected capital requirements.

On November 3, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives from each of Barclays and the Consultant provided an update on the status and scope of their respective workstreams, including a report by the representatives of Barclays regarding their recent conversation with representatives of Goldman Sachs.

Also on November 3, 2020, NantKwest senior management provided preliminary financial projections for NantKwest to Barclays and the Consultant as requested by the NantKwest special committee to facilitate its due diligence, but did not present those preliminary financial projections to the NantKwest special committee. These preliminary financial projections reflected an aspirational business case for NantKwest and a set of preliminary assumptions regarding pricing, patient criteria, dosing, market penetration, peak net sales, including sales outside of the United States, estimates of cost of goods sold and other expenses, and other inputs upon which NantKwest senior management continued to work. During this period, representatives of Barclays and the Consultant had a number of conference calls with members of NantKwest senior management to discuss the preliminary financial projections, including the related methodology and underlying assumptions.

On November 5, 2020, the NantKwest special committee held a meeting at which a representative of Goodwin was present. At this meeting, the NantKwest special committee discussed the formal engagement of Barclays as the financial advisor to the committee. The representative from Goodwin reviewed with the NantKwest special committee the terms of the proposed engagement letter with Barclays which were substantially the same as the terms that had been previously negotiated in early 2020, as well as the updated relationship disclosure provided by Barclays with respect to NantKwest and Dr. Soon-Shiong and his controlled affiliates, including ImmunityBio. Following such review, the NantKwest special committee determined that it was advisable to engage Barclays as its financial advisor. The NantKwest special committee also approved the

 

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formal engagement of the Consultant following review of the terms of the proposed engagement and confirmation by the Consultant that it did not have any relationships that would present conflicts of interest or otherwise limit its engagement. The decision of the NantKwest special committee to approve the engagement of each of Barclays and the Consultant was based on, among other things, their respective qualifications, industry experience, familiarity with NantKwest given their engagement by the prior special committee to consider a similar transaction, and absence of conflicts.

On November 11, 2020, the NantKwest special committee held a meeting at which representatives of Goodwin were present. At this meeting, the representatives of Goodwin updated the members of the NantKwest special committee on the due diligence process, and the meeting participants engaged in a discussion regarding timing for such process.

On November 13, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays reviewed the preliminary financial projections that had been provided by NantKwest senior management, including certain underlying assumptions. Among other things, the meeting participants discussed management’s preliminary view of certain cost estimates and the assumptions regarding the recent COVID-19 clinical programs being conducted by NantKwest in collaboration with ImmunityBio. The representatives of Barclays also reported on their recent conversations with NantKwest senior management regarding the preliminary financial projections. In addition, representatives of the Consultant provided an update regarding their work in preparing financial projections for NantKwest and related due diligence items.

From November 13, 2020 through November 24, 2020, the Chair had telephone calls with Dr. Soon-Shiong, and the financial and legal advisors to the NantKwest special committee had telephone calls with their respective counterparts, in each case to discuss the due diligence process.

On November 24, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays and Goodwin reported on their recent conversations with Goldman Sachs and Fried Frank, respectively, regarding the due diligence process. The meeting participants also discussed timing expectations for the due diligence process. The representatives of Barclays provided an update regarding NantKwest management’s preliminary financial projections, and representatives of the Consultant provided an update regarding their work in preparing financial projections for NantKwest. In addition, the meeting participants discussed the proposed responses to ImmunityBio’s due diligence request list regarding NantKwest. Following the meeting, representatives of Barclays coordinated the delivery of the due diligence responses to ImmunityBio and its advisors.

Later on November 24, 2020, representatives of Barclays, Goldman Sachs, Goodwin and Fried Frank had a conference call to discuss due diligence matters.

On November 25, 2020, the ImmunityBio board held a meeting at which members of management and representatives of each of Goldman Sachs and Lazard Frères & Co. LLC, another financial advisor to ImmunityBio (“Lazard”), were present. At this meeting, the ImmunityBio board reviewed the preliminary, non-risk adjusted financial projections that had been provided by ImmunityBio senior management, including certain underlying assumptions. The meeting participants discussed management’s preliminary view of the financial projections for the clinical programs being conducted by ImmunityBio, and after discussion, the ImmunityBio board authorized its financial advisors to share the financial projections with the NantKwest special committee and its advisors.

On November 26, 2020, in connection with the evaluation of ImmunityBio by the NantKwest special committee, ImmunityBio made available to the NantKwest special committee and its advisors preliminary, non-risk adjusted financial projections regarding the potential future performance of ImmunityBio on a stand-alone basis. Thereafter, representatives of Barclays and the Consultant had a number of conference calls with members of ImmunityBio senior management and its financial advisors to discuss the financial projections, including the related methodology and underlying assumptions.

 

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On December 1, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays and the Consultant discussed with the members of the NantKwest special committee the ImmunityBio management projections, including the financial projections for the clinical programs being conducted by ImmunityBio in collaboration with NantKwest and related assumptions. The representatives of Barclays also reported on their recent conversation with ImmunityBio senior management and Goldman Sachs regarding the ImmunityBio management projections. The meeting participants also discussed the status of the due diligence process.

On December 1 and 2, 2020, the NantKwest special committee and its advisors participated in conference calls with NantKwest senior management to discuss the ImmunityBio management projections and the clinical programs being conducted by NantKwest in collaboration with ImmunityBio. Following the December 2nd call, the NantKwest special committee convened to discuss these conversations with representatives of Barclays, the Consultant and Goodwin.

On December 3, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, the representatives of Barclays provided an update regarding NantKwest management’s preliminary financial projections, and representatives of the Consultant provided an update regarding their work in preparing financial projections for NantKwest and ImmunityBio. In addition, the meeting participants discussed the proposed agenda for the mutual due diligence session to be held on the following day.

On December 4, 2020, the NantKwest special committee and representatives of its advisors, members of senior management of NantKwest, members of senior management of ImmunityBio, and representatives of ImmunityBio’s advisors held a mutual due diligence session to discuss the respective businesses of NantKwest and ImmunityBio across various functional areas.

On December 5, 2020, Dr. Soon-Shiong contacted the Chair via telephone and inquired as to the status of the NantKwest special committee’s financial and legal due diligence. The Chair indicated that the NantKwest special committee continued to conduct its due diligence review of NantKwest and ImmunityBio and would not be prepared at that time to evaluate any potential offer that may be made by ImmunityBio.

Also on December 5, 2020, a representative of Goldman Sachs contacted a representative of Barclays to inform Barclays that ImmunityBio had received positive data concerning its non-muscle invasive bladder cancer program, for which further detail would be provided.

In addition, on December 5, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, the Chair reported on his telephone call with Dr. Soon-Shiong earlier in the day and potential timing for completion of the due diligence process. A representative from Barclays also reported on his recent conversation with Goldman Sachs regarding the positive data concerning ImmunityBio’s non-muscle invasive bladder cancer program.

On December 6, 2020, representatives of Goldman Sachs supplied representatives of Barclays with an ImmunityBio presentation describing positive data from the first cohort of ImmunityBio’s pivotal Phase 2/3 trial (QUILT 3.032) for non-muscle invasive bladder cancer in high risk carcinoma in situ (CIS) disease (which is referred to as the “ImmunityBio bladder cancer data”).

Later on December 6, 2020, representatives of Barclays and the Consultant, members of NantKwest senior management, members of ImmunityBio senior management, and representatives of Goldman Sachs had a conference call to discuss the ImmunityBio bladder cancer data and due diligence matters.

On December 8, 2020, ImmunityBio made available to the NantKwest special committee and its advisors a revised set of non-risk adjusted financial projections regarding ImmunityBio that included revised assumptions regarding certain pricing and expense estimates after further consideration by ImmunityBio management (see the section below entitled “The Merger—Certain Unaudited Prospective Financial and Operating Information” for more information regarding the “ImmunityBio management projections”).

 

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Also on December 8, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays and the Consultant provided an update from the recent conference call with ImmunityBio senior management and Goldman Sachs regarding the ImmunityBio bladder cancer data. The representatives of Barclays also provided an update regarding NantKwest management’s preliminary financial projections, and representatives of the Consultant provided an update regarding their work in preparing financial projections for NantKwest and ImmunityBio. The meeting participants also had a preliminary discussion regarding potential synergies that may be presented by a transaction between NantKwest and ImmunityBio.

On December 10, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays provided an update regarding NantKwest management’s preliminary financial projections and the work of the Consultant in preparing financial projections for NantKwest and ImmunityBio. Following discussion, representatives of the Consultant joined the meeting and reviewed with the NantKwest special committee the Consultant’s preliminary financial projections for NantKwest and ImmunityBio, including the related methodology, inputs and underlying assumptions. Representatives of the Consultant also compared the inputs and assumptions used in their preliminary financial projections with those of ImmunityBio management and NantKwest management. The NantKwest special committee discussed with the Consultant certain preliminary assumptions underlying the financial projections, including pricing and cost of goods sold and other expense estimates. After the Consultant departed the meeting, the NantKwest special committee discussed the Consultant’s preliminary financial projections and potential probabilities of success for the respective clinical programs included in the projections.

On December 11 and 16, 2020, the NantKwest special committee received reports on the due diligence process regarding ImmunityBio.

Later on December 11, 2020, the NantKwest special committee held a meeting at which members of senior management of NantKwest and representatives of Barclays and Goodwin were present. At this meeting, members of NantKwest senior management presented certain financial projections regarding the potential future performance of NantKwest on a stand-alone basis (see the section below entitled “The Merger—Certain Unaudited Prospective Financial and Operating Information” for further information regarding the “NantKwest management projections”). The members of the NantKwest special committee discussed the financial projections with management, the underlying assumptions, and the risks related to achievement of the financial projections. In executive session, the NantKwest special committee continued its discussion of such financial projections and NantKwest’s prospects and challenges as a stand-alone company, and also reviewed the inputs and assumptions used in the Consultant’s preliminary financial projections as compared to those used by NantKwest management.

On December 13, 2020, the NantKwest special committee held a meeting at which representatives of Barclays, the Consultant and Goodwin were present. At this meeting, representatives of Barclays and the Consultant discussed preliminary financial projections prepared by the Consultant with respect to each of NantKwest and ImmunityBio, including the related methodology and underlying assumptions (see the section entitled “The MergerCertain Unaudited Prospective Financial and Operating Information” for further information regarding the non-risk adjusted financial projections prepared by the Consultant described as the “NantKwest consultant projections” and the “ImmunityBio consultant projections”). After the Consultant departed the meeting, the NantKwest special committee discussed the Consultant’s preliminary financial projections and potential risk adjustments to such projections to reflect the probabilities of success of the clinical programs of NantKwest and ImmunityBio reflected in such preliminary financial projections. The NantKwest special committee then determined to apply risk adjustments reflecting the NantKwest special committee’s view of the probabilities of success of the clinical programs of NantKwest and ImmunityBio (which reflected probability of success percentages five percentage points above the levels suggested by the Consultant) after considering a number of inputs, including: (1) the financial projections for NantKwest prepared by NantKwest senior management, which were less aggressive than management’s preliminary financial projections but continued to reflect optimism for the business, and the NantKwest special committee’s discussions with

 

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NantKwest senior management regarding such projections; (2) the financial projections for ImmunityBio prepared by ImmunityBio management and the results of the due diligence review of ImmunityBio by the NantKwest special committee and its advisors; (3) the financial projections prepared by the Consultant for each of NantKwest and ImmunityBio and the NantKwest special committee’s discussions with representatives of the Consultant regarding such projections, which Consultant projections were more conservative with respect to certain underlying assumptions than the financial projections prepared by the respective management teams; and (4) the NantKwest special committee’s knowledge and understanding of NantKwest’s business and future prospects, including the clinical programs being conducted by NantKwest in collaboration with ImmunityBio. The meeting participants also discussed the status of the due diligence process.

On December 14, 2020, representatives of Barclays and Goldman Sachs had a conference call to discuss the status of the NantKwest special committee’s due diligence process.

On December 15, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays updated the NantKwest special committee on their recent call with Goldman Sachs and the due diligence review of certain contractual obligations that could require ImmunityBio to make future milestone or similar payments, including the contingent value rights issued by ImmunityBio in connection with its acquisition of Altor BioScience. The meeting participants also discussed the status of the due diligence process.

On December 16, 2020, the Chair and Dr. Soon-Shiong, and the representatives of Barclays and Goldman Sachs, each had a telephone conversation during which they discussed the status of the NantKwest special committee’s due diligence process.

On December 17, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays updated the NantKwest special committee on their recent call with Goldman Sachs. After representatives of the Consultant joined the meeting, representatives of Barclays reviewed the financial projections and related assumptions for each of NantKwest and ImmunityBio prepared by the Consultant with the risk adjustments discussed at the December 13th meeting of the NantKwest special committee (see the section entitled “The MergerCertain Unaudited Prospective Financial and Operating Information” for further information regarding the “risk adjusted NantKwest projections” and the “risk adjusted ImmunityBio projections”). Representatives of Barclays also discussed with the NantKwest special committee a preliminary synergy analysis with respect to a potential strategic transaction between NantKwest and ImmunityBio (see the section entitled “The MergerCertain Unaudited Prospective Financial and Operating Information” for further information regarding the “estimated synergies”). The NantKwest special committee instructed Barclays to utilize the risk adjusted financial projections and synergy analysis discussed at the meeting for purposes of preparing a preliminary financial analysis of a potential strategic transaction with ImmunityBio. Given that the NantKwest special committee was expecting to complete its due diligence process by the following day, the NantKwest special committee also authorized the representatives of Barclays to have an initial conversation with Goldman Sachs regarding potential ownership splits between the ImmunityBio and NantKwest stockholders in the event that ImmunityBio determined to submit an offer for a combination between the two companies.

Also on December 17, 2020, representatives of Barclays and Goldman Sachs had a telephone call during which the representatives of Barclays conveyed that the NantKwest special committee expected to complete its due diligence review of NantKwest and ImmunityBio on the following day. The representatives of Barclays and Goldman Sachs had a conversation during which a representative of Goldman Sachs suggested that any offer ImmunityBio was to submit would likely reflect a 80% / 20% ownership split for the combined company in favor of the ImmunityBio stockholders. The representative from Barclays noted that there were differing views on relative value, as the ownership percentage for the NantKwest stockholders was expected to be meaningfully into the thirties.

 

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On December 18, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays updated the NantKwest special committee on their recent call with Goldman Sachs. The representatives of Barclays then reviewed a preliminary financial analysis with respect to a potential strategic transaction between NantKwest and ImmunityBio. The meeting participants also discussed the strategic rationale for a potential transaction, the pro forma capitalization of a potential combined company, and the capital needs of both NantKwest and ImmunityBio, including the potential for the combined company to obtain third-party financing if a transaction were to be completed.

Also on December 18, 2020, the ImmunityBio board met to discuss the potential submission of a non-binding offer for a stock-for-stock combination between NantKwest and ImmunityBio. Representatives of Goldman Sachs, Lazard and Fried Frank were present at the meeting. Representatives of Goldman Sachs and Lazard discussed with the ImmunityBio board potential exchange ratios (i.e., number of shares of NantKwest to be issued for each ImmunityBio share) for a proposal for a potential strategic transaction between NantKwest and ImmunityBio. A representative of Fried Frank discussed with the ImmunityBio board its duties in connection with a proposed transaction as well as potential legal terms of a transaction. Thereafter, the members of the ImmunityBio board discussed and the board unanimously approved the submission by ImmunityBio to NantKwest of a non-binding offer for a strategic combination of NantKwest and ImmunityBio in which ImmunityBio stockholders would receive 1.2 shares of NantKwest common stock for each share of ImmunityBio. The ImmunityBio board authorized management of ImmunityBio, including Dr. Soon-Shiong, and ImmunityBio’s advisors to seek to negotiate a potential transaction with the NantKwest special committee, including the exchange ratio, for consideration by the ImmunityBio board.

Later on December 18, 2020, ImmunityBio submitted to NantKwest a letter containing a non-binding offer for a stock-for-stock combination of NantKwest and ImmunityBio, in which ImmunityBio stockholders would receive 1.2 shares of NantKwest common stock for each share of ImmunityBio owned (which Barclays subsequently calculated as representing an approximately 79% / 21% ownership split of the combined company on a fully diluted basis in favor of the ImmunityBio stockholders). The letter indicated that (1) ImmunityBio would only proceed with the proposed transaction if it was approved by the NantKwest special committee and favorably recommended to the full NantKwest board and NantKwest stockholders, and (2) the proposed transaction would be subject to a non-waivable condition requiring a majority of the minority stockholder approval. The letter also confirmed that Dr. Soon-Shiong, in his capacity as a stockholder of NantKwest, had no interest in selling any shares of NantKwest common stock that he or his affiliates owned nor would he expect, in his capacity as a NantKwest stockholder, to vote in favor of any alternative sale, merger or similar transaction involving NantKwest. In addition, the letter indicated that, if the special committee or NantKwest’s public stockholders determined not to approve a proposed combination with ImmunityBio, that determination would not adversely affect Dr. Soon-Shiong’s or ImmunityBio’s future relationship with NantKwest, and that Dr. Soon-Shiong intended to remain a supportive, long-term stockholder of NantKwest. Prior to this point, neither party had made a proposal regarding a potential transaction or pricing or potential ownership split with respect to a transaction. Following delivery of the letter, Dr. Soon-Shiong contacted the Chair to confirm receipt of the offer letter and to discuss potential next steps.

Also on December 18, 2020, Fried Frank sent to Goodwin drafts of a potential merger agreement and voting agreements among NantKwest, ImmunityBio and Dr. Soon-Shiong and his affiliates that own shares of NantKwest common stock and/or shares of ImmunityBio common stock. Consistent with the offer letter, the draft merger agreement contained a requirement that consummation of the proposed transaction be conditioned upon the approval of holders of a majority of the outstanding shares of NantKwest common stock not held by Dr. Soon-Shiong, Cambridge Equities, LP or Chan Soon-Shiong Family Foundation or any of their controlled affiliates or any of the directors or executive officers of NantKwest or ImmunityBio. ImmunityBio’s initial draft of the merger agreement also included the right for ImmunityBio to add directors to the combined company board in connection with the closing of the proposed transaction; however, such directors were not identified prior to signing of the merger agreement and there were no discussions with the members of the NantKwest special committee regarding their future roles or compensation as directors of the combined company. Following

 

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receipt of the draft merger agreement, the members of the NantKwest special committee had a meeting with representatives of Goodwin to discuss the proposed terms and conditions.

Following receipt of the ImmunityBio offer, on December 18, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, the NantKwest special committee discussed ImmunityBio’s offer and the relative ownership split proposed by ImmunityBio. After discussion, the NantKwest special committee authorized Barclays to respond to Goldman Sachs that (1) ImmunityBio’s offer was inadequate, (2) improved economic terms from ImmunityBio would be required for further discussions regarding a potential transaction, and (3) the NantKwest special committee was unwilling to make a counterproposal at that time. The NantKwest special committee also determined that the Chair should communicate the same message directly to Dr. Soon-Shiong. In addition, the NantKwest special committee discussed Dr. Soon-Shiong’s disclosure obligations due to his status as a significant stockholder of NantKwest, the market uncertainties if the offer were publicly disclosed, and the potential benefits to NantKwest’s unaffiliated stockholders of negotiating the terms of a potential transaction with ImmunityBio on a confidential basis prior to public disclosure of the offer. Thereafter, the NantKwest special committee authorized Goodwin to prepare a revised draft of the merger agreement and related documents to be negotiated with Fried Frank in the event that ImmunityBio were to offer improved economic terms.

Following the meeting of the NantKwest special committee, the Chair had a telephone conversation with Dr. Soon-Shiong, and the representatives of Barclays contacted the representatives of Goldman Sachs, to communicate the NantKwest special committee’s response to ImmunityBio’s offer. Thereafter, the NantKwest special committee convened to discuss these conversations and potential negotiating strategies with representatives of Barclays and Goodwin.

Later on December 18, 2020, ImmunityBio sent a revised, non-binding offer to the NantKwest special committee for a stock-for-stock combination of NantKwest and ImmunityBio, in which ImmunityBio stockholders would receive 1.1 shares of NantKwest common stock for each share of ImmunityBio owned (which Barclays subsequently calculated as representing an approximately 77.5% / 22.5% ownership split of the combined company on a fully diluted basis in favor of the ImmunityBio stockholders). Following receipt of the revised offer, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, the NantKwest special committee discussed ImmunityBio’s revised offer and the relative ownership split proposed by ImmunityBio, and the NantKwest special committee again determined that ImmunityBio’s offer was inadequate. After discussion of potential negotiating strategies, the NantKwest special committee directed the representatives of Barclays to contact Goldman Sachs to communicate that ImmunityBio’s revised offer was inadequate and that the NantKwest special committee expected the ownership percentage for the NantKwest stockholders to be meaningfully into the thirties. Following the meeting, representatives of Barclays contacted the representatives of Goldman Sachs on behalf of the NantKwest special committee to relay the committee’s response to ImmunityBio’s revised offer.

Early in the day on December 19, 2020, the Chair and Dr. Soon-Shiong, and the advisors to the NantKwest special committee and ImmunityBio, had telephone conversations during which the Chair and the advisors to the NantKwest special committee reiterated that ImmunityBio’s revised offer was inadequate and that improved economic terms from ImmunityBio would be required for further discussions regarding a potential transaction.

Later on December 19, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, the Chair and the advisors to the special committee reported on their recent conversations, and the meeting participants discussed potential negotiating strategies and next steps.

Following the meeting of the NantKwest special committee, on December 19, 2020, representatives of Barclays had a conference call with representatives of Goldman Sachs to discuss the potential ownership split in the combined company between the NantKwest and ImmunityBio stockholders and the apparent differences in

 

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the parties’ views as to relative value. During this call, the representatives of Goldman Sachs requested access to the financial projections for NantKwest being used by the NantKwest special committee. Thereafter, the NantKwest special committee convened with representatives of Barclays and Goodwin present to discuss Barclays’ conversation with Goldman Sachs and potential negotiating strategies. At this meeting, the NantKwest special committee determined not to provide ImmunityBio with access to the financial projections for NantKwest because, based on Barclays’ conversation with Goldman Sachs, the difference in the parties’ proposed relative ownership percentages appeared to be related to the parties’ respective views on the value of ImmunityBio. In addition, it was noted that a meaningful source of the difference could be related to ImmunityBio’s clinical program for non-muscle invasive bladder cancer. Thereafter, the representatives of Barclays contacted the representatives of Goldman Sachs on behalf of the NantKwest special committee to communicate the committee’s response. During this call, representatives of Goldman Sachs did not indicate whether or not an improved offer from ImmunityBio would be forthcoming.

Later on December 19, 2020, the NantKwest special committee held another meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays reported on their recent conversation with Goldman Sachs, and the meeting participants discussed potential negotiating strategies and next steps. At the conclusion of this discussion, and after further consideration of the potential benefits of a combination between NantKwest and ImmunityBio, the NantKwest special committee determined to propose an ownership split for the combined company of 70% / 30% on a fully diluted basis in favor of the ImmunityBio stockholders.

During the evening of December 19, 2020, there was a series of telephone conversations between the Chair and Dr. Soon-Shiong to discuss the potential ownership split. First, Dr. Soon-Shiong contacted the Chair to discuss the 77.5% / 22.5% ownership split on a fully diluted basis that had been proposed by ImmunityBio and indicated that ImmunityBio might not move forward with a transaction at a higher ownership percentage for the NantKwest stockholders. The Chair informed Dr. Soon-Shiong that the NantKwest special committee was not in favor of proceeding with a transaction on that basis and proposed an ownership split, on a fully diluted basis, for the combined company of 70% / 30% in favor of the ImmunityBio stockholders. Thereafter, Dr. Soon-Shiong contacted the Chair and offered on behalf of ImmunityBio a 73% / 27% ownership split on a fully diluted basis, which proposal the Chair rejected on behalf of the NantKwest special committee. In a further conversation, Dr. Soon-Shiong offered on behalf of ImmunityBio a 72% / 28% ownership split on a fully diluted basis in favor of the ImmunityBio stockholders (which Barclays subsequently calculated as representing an exchange ratio of 0.8190), which he told the Chair was ImmunityBio’s last, best and final offer. During these conversations, Dr. Soon-Shiong suggested that the NantKwest special committee and its advisors were not ascribing appropriate value to ImmunityBio’s clinical program for non-muscle invasive bladder cancer.

Following these conversations, the NantKwest special committee convened with representatives of Barclays and Goodwin present to discuss the Chair’s conversations with Dr. Soon-Shiong. At this meeting, the participants discussed ImmunityBio’s offer of 28% ownership of the combined company by NantKwest stockholders on a fully diluted basis and the characterization of such offer by Dr. Soon-Shiong as ImmunityBio’s last, best and final offer. After discussion, and given that the disconnect in relative value between the parties appeared to relate to the parties’ respective views on the value of ImmunityBio, the NantKwest special committee requested that its advisors have a further discussion with ImmunityBio and its advisors regarding the value of ImmunityBio and, in particular, its clinical program for non-muscle invasive bladder cancer, which the NantKwest special committee believed might provide additional value to a potential combined company.

Later on December 19, 2020, representatives of Barclays and Goodwin had a conference call with members of senior management of ImmunityBio, including Dr. Soon-Shiong, and representatives of Fried Frank to discuss ImmunityBio’s clinical program for non-muscle invasive bladder cancer. During this call, the representatives of ImmunityBio provided the representatives of Barclays and Goodwin with further information regarding this clinical program, including information regarding discussions in which ImmunityBio had previously engaged with a global pharmaceutical company related to the terms of a possible third-party license arrangement with respect to ImmunityBio’s product candidate for non-muscle invasive bladder cancer. Such discussions, which

 

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occurred in late 2019 and prior to receipt of the ImmunityBio bladder cancer data, had been terminated. The terms that had been discussed between the parties included an upfront payment, significant potential payments with respect to the achievement of certain development and sales milestones, and tiered royalty payments based on worldwide net sales. Following that call, Barclays reviewed the information provided by representatives of ImmunityBio on the call and as follow-up due diligence materials, and discussed these items with the Consultant to consider the appropriate assumptions for modeling purposes that the NantKwest special committee could potentially incorporate within the risk adjusted projections for ImmunityBio based on this information.

On December 19 and 20, 2020, Goodwin and Fried Frank exchanged multiple drafts of the merger agreement and voting agreements and engaged in discussions on various issues related to such agreements, including with respect to the scope of each party’s representations and warranties, interim operating covenants, conditions to closing and each party’s termination rights, including the situations in which a termination fee or expense reimbursement would be payable by a party. Goodwin and Fried Frank also exchanged drafts of the disclosure schedules for the merger agreement and engaged in discussions on various issues related to such schedules.

On December 20, 2020, the NantKwest special committee held a meeting at which representatives of Barclays and Goodwin were present. At this meeting, representatives of Barclays and Goodwin reported to the NantKwest special committee on the conference call with ImmunityBio and its advisors regarding ImmunityBio’s clinical program for non-muscle invasive bladder cancer. The meeting participants considered the potential impact on the valuation of ImmunityBio if the relevant clinical program was analyzed assuming a partnership arrangement with a global pharmaceutical company on similar terms to those that had been previously discussed by ImmunityBio. After further discussion, and for the purpose of evaluating the proposed merger and the relative value of the two companies, the NantKwest special committee requested that Barclays review the assumptions that could be incorporated into its financial analysis to reflect a potential scenario in which, in lieu of direct sales, ImmunityBio would enter into a partnering arrangement with respect to its clinical program for non-muscle invasive bladder cancer. Following review of such assumptions with the representatives of Barclays, the NantKwest special committee directed Barclays to incorporate such assumptions into the risk adjusted financial projections for ImmunityBio and to use such updated financial projections (see the section entitled “The MergerCertain Unaudited Prospective Financial and Operating Information” for further information regarding the “risk adjusted ImmunityBio projections”) for purposes of its financial analysis of the proposed transaction between NantKwest and ImmunityBio.

On December 20, 2020, the ImmunityBio board met to discuss a potential transaction with NantKwest at an exchange ratio of 0.8190 of a share of NantKwest for each outstanding share of ImmunityBio representing a 72% / 28% ownership split on a fully diluted basis in favor of the ImmunityBio stockholders. Representatives of Goldman Sachs, Lazard and Fried Frank were present at the meeting and discussed with the members of the ImmunityBio board the terms of the transaction. A representative of Fried Frank discussed with the ImmunityBio board its duties in connection with the proposed transaction. Thereafter, by unanimous vote, the ImmunityBio board (including its independent director), (1) declared that the merger agreement and the transactions contemplated thereby (including the merger) were fair to, and in the best interests of, ImmunityBio and the ImmunityBio stockholders, (2) approved and declared advisable the merger agreement and the transactions contemplated by the merger agreement (including the merger), and (3) recommended that the ImmunityBio stockholders approve and adopt the merger agreement and the transactions contemplated by the merger agreement (including the merger).

Later on December 20, 2020, the NantKwest special committee held a meeting to discuss the terms of the proposed strategic transaction with ImmunityBio, with representatives of Barclays and Goodwin present. Representatives of Goodwin reviewed the directors’ fiduciary duties in connection with the proposed transaction. Representatives of Goodwin then summarized for the NantKwest special committee the terms of the proposed merger agreement and voting agreements. Representatives of Barclays then reviewed and discussed with the NantKwest special committee Barclays’ financial analysis of the exchange ratio, which included a discounted cash flow analysis resulting in a range of implied equity ownership on a fully diluted basis in the combined

 

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company for the NantKwest stockholders of 23.8% to 36.0% and a breakeven relative contribution percentage on a fully diluted basis in a range of 26.5% to 27.8% for NantKwest with respect to the pro forma combined company (including synergies). Barclays noted that, without the impact of the assumptions regarding an assumed non-muscle invasive bladder cancer license, the discounted cash flow analysis would have resulted in a range of implied equity ownership on a fully diluted basis in the combined company for the NantKwest stockholders of 24.3% to 37.5% and a breakeven relative contribution percentage on a fully diluted basis in a range of 27.6% to 28.4% for NantKwest with respect to the pro forma combined company (including synergies). After discussion, representatives of Barclays rendered to the NantKwest special committee an oral opinion, which was subsequently confirmed by delivery of a written opinion dated such date that, as of such date and based upon and subject to various assumptions made, procedures followed, matters considered, and qualifications and limitations upon the review undertaken in preparing its opinion, the exchange ratio was fair, from a financial point of view, to NantKwest. For a detailed discussion of Barclays’ opinion, see below in the section entitled “The Merger—Opinion of the Financial Advisor to the NantKwest Special Committee.” After discussion, the NantKwest special committee unanimously determined that it was fair to and in the best interests of NantKwest and its stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) for NantKwest to enter into the merger agreement and declared the merger agreement, and the transactions contemplated by the merger agreement, advisable, and resolved to recommend that the NantKwest board (1) declare the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approve and adopt the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, and (3) recommend that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger.

Also on December 20, 2020, following the meeting of the NantKwest special committee, a meeting of the NantKwest board was convened with representatives of Barclays and Goodwin present. The attendee directors were Mr. Blaszyk, Ms. Cohen, Frederick W. Driscoll and John C. Thomas, Jr. Dr. Soon-Shiong and Barry J. Simon, M.D., President and Chief Administrative Officer of NantKwest, recused themselves from deliberations regarding the proposed strategic transaction with ImmunityBio and did not attend the meeting. Representatives of Goodwin, in their capacity as legal advisor to the NantKwest special committee, reviewed the directors’ fiduciary duties in connection with the proposed transaction. Representatives of Goodwin and Barclays and the members of the NantKwest special committee then provided a report of the NantKwest special committee’s evaluation of the proposed transaction, including the various proposals made by ImmunityBio prior to its final proposal. Representatives of Goodwin then provided the NantKwest special committee’s recommendation with respect to the merger agreement and the proposed transaction, as well as a review of the terms of the proposed merger agreement and voting agreements. A discussion then followed among the assembled NantKwest board members with regard to the terms of the merger agreement and the voting agreements and the proposed transaction. After discussion, the NantKwest board, acting upon the recommendation of the NantKwest special committee, (1) declared the merger agreement, and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approved and adopted the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, (3) directed that the stock issuance be submitted to the NantKwest stockholders for approval and the merger agreement and the transactions contemplated by the merger agreement, including the merger, be submitted to the NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) for approval by such holders, and (4) resolved to recommend that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger.

 

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Following the meeting of the NantKwest board, on December 21, 2020, NantKwest and ImmunityBio executed the merger agreement, and the parties thereto executed the voting agreements.

Later on the morning of December  21, 2020, NantKwest and ImmunityBio issued a joint press release announcing the execution of the merger agreement.

Recommendations of the NantKwest Special Committee and the NantKwest Board of Directors; Reasons for the Merger

On October 13, 2020, the NantKwest board adopted resolutions establishing the NantKwest special committee. The NantKwest special committee consists of Michael D. Blaszyk and Cheryl L. Cohen. The NantKwest board determined that each of Mr. Blaszyk and Ms. Cohen was independent and disinterested with respect to the potential transaction with ImmunityBio and other strategic alternatives available to NantKwest. Pursuant to the resolutions of the NantKwest board, the NantKwest special committee was authorized to, among other things, (1) review and evaluate the advisability of the potential transaction, (2) identify, review and evaluate alternatives to the potential transaction available to NantKwest, including, without limitation, NantKwest’s stand-alone business prospects, (3) recommend, reject or seek to modify the terms of the potential transaction or any other such alternative, (4) if the NantKwest special committee considers it advisable or appropriate, negotiate the price, structure, form, terms and conditions of the potential transaction or any alternative thereto and the form, terms and conditions of any definitive agreements in connection therewith, (5) determine whether the potential transaction or any alternative thereto is fair to, and in the best interests of, NantKwest and its stockholders, (6) obtain any necessary or desirable advice, assistance and opinions from financial advisors or other advisors, consultants and agents, (7) recommend to the full NantKwest board what action, if any, should be taken by NantKwest with respect to the potential transaction or any alternative thereto, (8) do all things that may, in the judgment of its members, be deemed necessary, appropriate or advisable to assist the NantKwest special committee in carrying out its responsibilities in connection with or with respect to the potential transaction or any alternative thereto and (9) provide reports or recommendations to the NantKwest board in regard to such matters at such times as the NantKwest special committee deems appropriate and consistent with its activities. In addition, the resolutions provided that the NantKwest board shall not propose or recommend a potential transaction for approval by NantKwest stockholders or otherwise approve the potential transaction without a prior favorable recommendation of such transaction by the NantKwest special committee. The resolutions also authorized the NantKwest special committee, at its sole discretion, to interview, select and retain, at NantKwest’s expense, such legal counsel, financial and other advisors, consultants and agents as it may deem appropriate, in its sole discretion, in the exercise of its power and authority, and also authorized and directed the officers, agents and employees of NantKwest and its subsidiaries to cooperate with and assist the NantKwest special committee and its legal counsel, financial and other advisors, consultants and agents in all respects, and to provide and furnish to the NantKwest special committee and its legal counsel, financial and other advisors, consultants and agents all information and documents that the NantKwest special committee and its advisors requested with respect to the evaluation and negotiation of the potential transaction or any alternative thereto.

NantKwest Special Committee

At a meeting held on December 20, 2020, the NantKwest special committee unanimously determined that it was fair to and in the best interests of NantKwest and its stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the directors and executive officers of NantKwest and ImmunityBio) for NantKwest to enter into the merger agreement and declared the merger agreement, and the transactions contemplated by the merger agreement, advisable, and resolved to recommend that the NantKwest board (1) declare the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, advisable, (2) approve and adopt the merger agreement and the transactions contemplated by the merger agreement, including the merger and the stock issuance, and (3) recommend that NantKwest stockholders vote to approve the stock issuance and that NantKwest stockholders (other than the NantKwest significant stockholders and any of their respective controlled affiliates and the

 

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directors and executive officers of NantKwest and ImmunityBio) vote to approve the merger agreement and the transactions contemplated by the merger agreement, including the merger.

In arriving at this determination and recommendation, the NantKwest special committee reviewed and discussed a significant amount of information (including information from NantKwest management and ImmunityBio management) and consulted with its independent legal and financial advisors and an independent industry consultant. The following are some of the significant factors that supported its determination and recommendation (these factors are presented below in no particular order and were neither ranked nor weighted in any particular manner by the NantKwest special committee):

 

   

its knowledge and understanding of NantKwest’s business, operations, assets and liabilities, financial condition, strategy and future prospects and challenges as a stand-alone company;

 

   

the information obtained in its discussions with ImmunityBio’s management, in consultation with the NantKwest special committee’s advisors, regarding ImmunityBio’s business, operations, assets and liabilities, financial condition, strategy and future prospects, and the results of the NantKwest special committee’s due diligence review of ImmunityBio;

 

   

the fact that NantKwest and ImmunityBio are already collaboration partners with respect to a number of clinical programs and the combined company would bring together phase II / III clinical trials across oncology and infectious disease that use combined immunotherapy platforms;

 

   

the risks associated with developing and commercializing NantKwest’s product candidates without the additional strategic resources and infrastructure that the proposed merger with ImmunityBio would provide;

 

   

the fact that the merger would remove complexity arising from the existing relationships between NantKwest and ImmunityBio, including the combined clinical programs and shared services, thereby allowing investor focus on the core business and simplifying the commercialization and marketing of future products;

 

   

NantKwest’s need for additional capital in order to complete the clinical development of its product candidates and potentially commercialize these product candidates, as well as fund its other ongoing operations, and the potential for the combined company to obtain third-party financing following the merger;

 

   

the expected synergies (taking into account that NantKwest and ImmunityBio have combined clinical programs and otherwise utilize shared services) and other financial benefits of the merger;

 

   

the fact that NantKwest stockholders will own approximately 28% of the combined company on a fully diluted basis following completion of the merger and will continue to participate in potential appreciation in the equity value of the combined company;

 

   

the arm’s-length negotiations with ImmunityBio which, among other things, resulted in a lower exchange ratio than set forth in ImmunityBio’s initial proposal and the revision of terms in the merger agreement to be more favorable to NantKwest and its unaffiliated stockholders than initially proposed by ImmunityBio;

 

   

the benefits that NantKwest was able to obtain as a result of the NantKwest special committee’s negotiations with ImmunityBio and the belief of the NantKwest special committee that this was the most favorable exchange ratio to which ImmunityBio would be willing to agree;

 

   

the NantKwest special committee’s belief that the transactions contemplated by the merger agreement have a high likelihood of being completed in a timely manner based on, among other things, (1) the limited number and nature of the conditions to the completion of the merger agreement, (2) the fact that Dr. Soon-Shiong and certain of his affiliates are subject to the voting agreements, and (3) the ability of NantKwest, pursuant to the merger agreement, to seek specific performance to prevent breaches of the merger agreement by ImmunityBio and to specifically enforce the terms of the merger agreement;

 

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the review by the NantKwest special committee with its independent financial and legal advisors of, and advice received from such advisors on, the structure of the contemplated transactions and the financial and other terms of the merger agreement and the other agreements entered into in connection with the merger, including with respect to deal protection, conditionality, termination rights and the likelihood of consummating the merger;

 

   

the financial analysis presented by Barclays to the NantKwest special committee and the opinion of Barclays rendered to the NantKwest special committee on December 20, 2020, which was subsequently confirmed by delivery of a written opinion dated such date that, as of such date and based upon and subject to the assumptions made, procedures followed, matters considered, and qualifications and limitations upon the review undertaken by Barclays in preparing its opinion, the exchange ratio was fair, from a financial point of view, to NantKwest, as more fully described below under the section entitled “The Merger—Opinion of the Financial Advisor to the NantKwest Special Committee;”

 

   

the fact that Dr. Soon-Shiong, who beneficially owns approximately 64.6% of the outstanding shares of NantKwest common stock, had expressed that he was not interested in selling his interest in NantKwest, and any alternative acquisition of NantKwest was not feasible without the cooperation and consent of Dr. Soon-Shiong;

 

   

the following procedural safeguards to ensure the fairness of the transactions contemplated by the merger agreement and to permit the NantKwest special committee to represent the interests of the NantKwest stockholders (other than Dr. Soon-Shiong and his affiliates):

 

   

the NantKwest special committee consists solely of directors of NantKwest who are independent directors and who are not officers or employees of NantKwest, and who do not otherwise have a conflict of interest or lack independence with respect to the transactions contemplated by the merger agreement; the NantKwest special committee was advised in the review, evaluation and negotiation of the transactions contemplated by the merger agreement by independent legal and financial advisors; and the NantKwest special committee engaged an independent industry consultant to assist the NantKwest special committee in evaluating the product pipelines of both NantKwest and ImmunityBio and the preparation and/or review of financial projections and synergies related to a potential transaction;

 

   

the members of the NantKwest special committee will not personally benefit from the consummation of the transactions contemplated by the merger agreement in a manner different from the NantKwest stockholders (other than Dr. Soon-Shiong and his affiliates), except for indemnification and continuing directors and officers liability insurance coverage and the receipt of customary fees for service on the NantKwest special committee as described in the section entitled “The Merger—Interests of Certain NantKwest Directors and Executive Officers in the Merger—NantKwest Special Committee Compensation;”

 

   

the resolutions of the NantKwest board referring consideration of the potential transaction with ImmunityBio to the NantKwest special committee, and confirming the NantKwest special committee’s authority to perform its duties in accordance with such resolutions in connection with the potential transaction with ImmunityBio, including, without limitation, evaluating, negotiating and/or rejecting, as the NantKwest special committee deemed appropriate, the terms of any transaction with ImmunityBio;

 

   

pursuant to the terms of the merger agreement, NantKwest may take the following actions only with the prior approval of the NantKwest special committee: (1) amending, restating, modifying or otherwise changing any provision of the merger agreement; (2) waiving any right under the merger agreement or extending the time for the performance of any obligation of ImmunityBio thereunder; (3) terminating the merger agreement; (4) taking any action under the merger agreement that expressly requires the approval of the NantKwest special committee; (5) making any decision or determination, or taking any action under or with respect to the merger agreement or the transactions contemplated thereby that would reasonably be expected to be, or is required to

 

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be, approved, authorized, ratified