Document
false0001370053 0001370053 2020-05-06 2020-05-06
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report: May 6, 2020
(Date of earliest event reported)

ANAPTYSBIO, INC.
(Exact Name of Registrant as Specified in Its Charter)

Delaware
001-37985
20-3828755
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
            
10421 Pacific Center Court, Suite 200
San Diego, CA 92121
(Address of Principal Executive Offices, and Zip Code)

(858) 362-6295
(Registrant’s Telephone Number, Including Area Code)

Not Applicable
(Former name or former address, if changed since last report.)


Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)
☐Pre‑commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b))
☐Pre‑commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per share
ANAB
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02.
Results of Operations and Financial Condition.
On May 6, 2020, AnaptysBio, Inc. (“AnaptysBio”) issued a press release announcing its financial results for the three months ended March 31, 2020. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibit 99.01 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.01 shall not be incorporated by reference into any registration statement or other document filed by AnaptysBio with the Securities and Exchange Commission, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number
 
Description of Exhibit
99.1
 
104
 
Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document).




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

                   
 
AnaptysBio, Inc.
Date: May 6, 2020
By:
/s/ Eric Loumeau
 
 
Name: Eric Loumeau
 
 
Title: Interim Chief Financial Officer and General Counsel



 
 Exhibit


AnaptysBio Announces First Quarter 2020 Financial Results and
Provides Pipeline Updates
•
Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in Third Quarter of 2020, Decided to Over-Enroll Trial Due to COVID-19
•
Additional Topline Data from GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Second Half of 2020
•
Topline Data from POPLAR Phase 2 Clinical Trial of ANB019 Monotherapy in Palmoplantar Pustulosis on Track for Second Half of 2020
•
IND Cleared For Company’s Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, and Phase 1 Trial Initiation Anticipated in First Half of 2020
•
US BLA and EU MAA for Dostarlimab, Our PD-1 Antagonist Antibody Partnered With GlaxoSmithKline (GSK), in Endometrial Cancer Accepted by the FDA and the EMA, Respectively
SAN DIEGO, May 6, 2020 - AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the first quarter ended March 31, 2020 and provided pipeline updates.

“Our wholly-owned pipeline continues to advance with three Phase 2 clinical trial readouts anticipated in the remainder of 2020,” said Hamza Suria, president and chief executive officer of AnaptysBio. “AnaptysBio’s capital-efficient business model has resulted in the advancement of 7 internally-generated antibodies to the clinic to date, and we anticipate continued discovery and development of novel antibodies in the upcoming future. We also look forward to significant revenues associated with regulatory filing related milestone payment and future royalties upon FDA approval of dostarlimab under our GSK partnership later this year.”

Etokimab (ANB020 Anti-IL-33) Program
•
AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. We have over-enrolled this trial beyond the first 100 patients to compensate for lost patient visits due to the COVID-19 pandemic, and hence anticipate interim top-line data from this trial to be available in the third quarter of 2020.
•
As previously announced, the Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until results are available from the ECLIPSE trial.

ANB019 (Anti-IL-36 Receptor) Program
•
In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal. The Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during the second half of 2020.




•
The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.
•
Enrollment of the GALLOP and POPLAR trials has been enhanced by expanding clinical sites and geographies involved. While the Company does not believe that the aforementioned timelines are materially impacted by the COVID-19 pandemic at this point, some of the sites involved in the GALLOP and POPLAR trials have been affected by the COVID-19 pandemic, and the Company will continue to monitor the situation over the upcoming months.
ANB030 (Anti-PD-1 Agonist) Program
•
ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented. Our Investigational New Drug Application (IND) for ANB030 has been cleared by the FDA and we plan to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
ANB032 (Anti-BTLA Modulator) Program
•
Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the second half of 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK
•
In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with GSK, for the treatment of endometrial cancer. AnaptysBio received a $10.0 million cash milestone payment upon this acceptance, and anticipates an additional $20.0 million cash milestone upon first FDA approval of dostarlimab during 2020. Also in the first quarter of 2020, the EMA accepted GSK’s Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer, for which AnaptysBio has earned a $5.0 million milestone payment. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.
First Quarter Financial Results
•
Cash, cash equivalents and investments totaled $412.7 million as of March 31, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $15.8 million. The decrease relates primarily to cash used for operating activities.
•
Collaboration revenue was $15.0 million for the three months ended March 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab, compared to zero for the three months ended March 31, 2019.
•
Research and development expenses were $21.0 for the three months ended March 31, 2020, compared to $20.6 million for the three months ended March 31, 2019. The increase was due primarily to continued advancement of the Company’s preclinical programs.




•
General and administrative expenses were $4.3 million for the three months ended March 31, 2020, compared to $4.1 million for the three months ended March 31, 2019. The increase was due primarily to personnel-related expenses, including share-based compensation.
•
Net loss was $8.3 million for the three months ended March 31, 2020, or a net loss per share of $0.30, compared to a net loss of $22.1 million for the three months ended March 31, 2019, or a net loss per share of $0.82.
Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be approximately $60.0 million, and that its cash, cash equivalents and investments will fund its current operating plan at least into 2023.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with GSK, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab’s Phase 2 clinical trial in adult patients with CRSwNP and ANB019’s Phase 2 clinical trials in GPP and PPP, the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, the timing of a regulatory strategy update for GPP, the timing of initiation of a Phase 1 clinical trial for ANB030, the timing of an IND filing for ANB032, the milestones and royalty payments to be received under the GSK partnership, and our projected 2020 cash burn and cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contact:




Eric Loumeau
AnaptysBio, Inc.
858.732.0179
eloumeau@anaptysbio.com




ANAPTYSBIO, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value)
 
March 31, 2020
 
December 31, 2019
 
(unaudited)
 
 
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
165,317

 
$
171,017

Receivable from collaborative partners
5,000

 
—

Short-term investments
197,166

 
203,210

Prepaid expenses and other current assets
3,572

 
3,506

Total current assets
371,055

 
377,733

Property and equipment, net
1,610

 
1,618

Long-term investments
50,215

 
54,305

Other long-term assets
1,293

 
1,481

Restricted cash
60

 
60

Total assets
$
424,233

 
$
435,197

LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
8,571

 
$
16,237

Accrued expenses
13,781

 
11,052

Notes payable, current portion
—

 
1,375

Other current liabilities
898

 
871

Total current liabilities
23,250

 
29,535

Other long-term liabilities
419

 
654

Stockholders’ equity:
 
 
 
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at March 31, 2020 and December 31, 2019, respectively
—

 
—

Common stock, $0.001 par value, 500,000 shares authorized, 27,277 shares and 27,255 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
27

 
27

Additional paid in capital
651,680

 
648,669

Accumulated other comprehensive income
1,145

 
338

Accumulated deficit
(252,288
)
 
(244,026
)
Total stockholders’ equity
400,564

 
405,008

Total liabilities and stockholders’ equity
$
424,233

 
$
435,197





ANAPTYSBIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
 
Three Months Ended
March 31,
 
2020
 
2019
Collaboration revenue
$
15,000

 
$
—

Operating expenses:
 
 
—

Research and development
20,968

 
20,631

General and administrative
4,285

 
4,141

Total operating expenses
25,253

 
24,772

Loss from operations
(10,253
)
 
(24,772
)
Other income (expense), net:
 
 
 
Interest expense
—

 
(320
)
Interest income
1,897

 
2,988

Other income, net
94

 
7

Total other income (expense), net
1,991

 
2,675

Loss before income taxes
(8,262
)
 
(22,097
)
Provision for income taxes
—

 
19

Net loss
(8,262
)
 
(22,078
)
Other comprehensive income:
 
 
 
Unrealized income on available for sale securities, net of tax of $0 and $115, respectively
807

 
427

Comprehensive loss
$
(7,455
)
 
$
(21,651
)
Net loss per common share:
 
 
 
      Basic and diluted
$
(0.30
)
 
$
(0.82
)
Weighted-average number of shares outstanding:
 
 
 
      Basic and diluted
27,264

 
26,981




v3.20.1
Cover Page
May 06, 2020
Cover page.  
Document Type 8-K
Document Period End Date May 06, 2020
Entity Registrant Name ANAPTYSBIO, INC
Entity Incorporation, State or Country Code DE
Entity File Number 001-37985
Entity Tax Identification Number 20-3828755
Entity Address, Address Line One 10421 Pacific Center Court
Entity Address, Address Line Two Suite 200
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92121
City Area Code 858
Local Phone Number 362-6295
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol ANAB
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001370053
Amendment Flag false