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 (Date of Earliest Event Reported): May 19, 2020

 

 

Cue Biopharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-38327		47-3324577
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)
21 Erie St., Cambridge, Massachusetts				02139
(Address of principal executive offices)				(Zip Code)

(Registrant’s telephone number, including area code): (617) 949-2680

(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		CUE		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 19, 2020, Cue Biopharma, Inc. announced its financial results for the quarter ended March 31, 2020. A copy of the press release is being furnished as Exhibit 99 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and Exhibit 99 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01

Financial Statements and Exhibits

The exhibits required to be filed as a part of this Current Report on Form 8-K are listed below and incorporated herein by reference

 

Exhibit No.		Exhibit Description
99		Press release, dated May 19, 2020, issued by Cue Biopharma, Inc., furnished herewith.

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 thereunto duly authorized.

 

		Cue Biopharma, Inc.
Date: May 19, 2020		By:		/s/ Daniel R. Passeri
		Name:		Daniel R. Passeri
		Title:		Chief Executive Officer

Exhibit 99

 

Cue Biopharma Reports First Quarter 2020 Results, Updates of CUE-101 Phase 1 Dose Escalation Study and Recent Business Highlights

CAMBRIDGE, Mass., May 19, 2020 — Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, provided a business update for the first quarter 2020.

“We have successfully maintained momentum in meeting our business goals and clinical trial objectives for the first quarter and early second quarter of 2020, despite the rapid onset of COVID-19 and the many challenges it has presented,” said Daniel Passeri, chief executive officer of Cue Biopharma. “I am grateful for the dedication of the Cue Biopharma team during this pandemic as we continue to work together and safely execute on our mission of bringing novel therapies to patients with serious diseases.”

According to Kerri-Ann Millar, vice president of finance and principal financial and accounting officer of Cue Biopharma, “We successfully navigated the beginning of the pandemic and finished the first quarter of 2020 in a solid financial position which was further strengthened by the successful deployment of an ATM facility in April that enabled us to boost our cash position by an additional $34.3 million.”

First-Quarter 2020 Financial Results

The Company reported collaboration revenue of approximately $0.9 million and $0.4 million for the three months ended March 31, 2020 and 2019, respectively.

Research and development expenses were $9.9 million and $8.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in research and development expenses of $1.5 million was primarily due to clinical trial costs related to our on-going CUE-101 mono-therapy trial that was initiated in the latter part of the third quarter of 2019. During the first quarter of 2020, we initiated the manufacturing of CUE-101 to supply our recently announced combination trial of CUE-101 with Merck’s KEYTRUDA^® which also contributed to the increase in research and development costs.

 

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General and administrative expenses were $3.9 million and $3.4 million for the three months ended March 31, 2020 and 2019, respectively. The increase in general and administrative expense of $0.5 million was primarily due to an increase in stock-based compensation expense and legal and accounting fees incurred in the first quarter of 2020 as compared to the same period in 2019.

Recent News & Business Updates

 

•

Extended cash runway through an ATM equity offering sales agreement for aggregate proceeds of $34.3 million, net of commissions paid, with Stifel, who acted as sales agent. As of April 30, 2020, the Company had sold 1,824,901 shares of common stock under the sales agreement.

 

•

Completed our first analysis of clinical biomarker samples from the CUE-101 Phase 1 clinical trial and the early data provides favorable insights into clinical metrics that bolster our confidence in CUE-101 and our entire IL-2-based CUE-100 series.

 

•

Completed a clinical collaboration agreement with Merck in April 2020 to evaluate the combination of CUE-101 with Merck’s KEYTRUDA®, an anti-PD-1 biologic agent, as a first-line therapy in patients with advanced HPV16+ head and neck cancer in a planned dose-escalation Phase 1 study to be called KEYNOTE-A78.

 

		Three Months Ended March 31,
		2020				2019
Collaboration revenue		$	900			$	370
Operating expenses:
General and administrative			3,989				3,444
Research and development			9,906				8,353
Total operating expenses			13,895				11,797
Loss from operations			(12,995	)			(11,427	)
Other income:
Interest income			203				114
Other income / (expense) net			(26	)			46
Net Loss			$ (12,818)				$ (11,267)
Net loss per common share – basic and diluted			$ (0.48)				$ (0.54)
Weighted average common shares outstanding – basic and diluted			26,570				20,718

 

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Cue Biopharma, Inc.

Selected Consolidated Balance Sheet Data

(in thousands)

 

		March 31, 2020				December 31, 2019
Cash and cash equivalents			23,432				44,290
Marketable securities			25,298				15,120
Total current assets			51,190				61,025
Working Capital			39,100				49,370
Total assets			60,649				71,605
Total Stockholders’ equity			45,236				54,584

About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. The company’s proprietary Immuno-STAT^™ (Selective Targeting and Alteration of T cells) platform is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

Headquartered in Cambridge, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology treatments.

For more information, visit www.cuebio.com and follow us on Twitter https://twitter.com/CueBiopharma.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding anticipated results of our drug development efforts, including study results, and our expectations regarding regulatory developments and expected future operating results. Forward-looking statements are neither historical

 

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facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, our limited operating history, limited cash and a history of losses; our ability to achieve profitability; potential setbacks in our research and development efforts including negative or inconclusive results from our preclinical studies, our ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for our product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on our operations and clinical trials; negative or inconclusive results from our clinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in our clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; our reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; our ability to obtain adequate financing to fund our business operations in the future; ; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact

Ashley R. Robinson

LifeSci Advisors

arr@lifesciadvisors.com

Media Contact

Alison Chen

LifeSci Communications

achen@lifescicomms.com

 

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