10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

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

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024

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

FOR THE TRANSITION PERIOD FROM TO

Commission file number: 001-38327

Cue Biopharma, Inc.

(Exact name of registrant as specified in its charter)


Delaware		47-3324577
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

40 Guest Street Boston, Massachusetts		02135
(Address of principal executive offices)		(Zip Code)

(617) 949-2680

(Registrant’s telephone number, including area code)

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	Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer		Accelerated filer	

Non-accelerated filer	☒	Smaller reporting company	☒

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes  No

As of May 6, 2024, the registrant had 48,643,316 shares of Common Stock ($0.001 par value per share) outstanding.

CUE BIOPHARMA, INC.

TABLE OF CONTENTS


PART I. FINANCIAL INFORMATION
	Item 1. Financial Statements (Unaudited)	6
	Condensed Consolidated Balance Sheets	6
	Condensed Consolidated Statements of Operations and Comprehensive Loss	7
	Condensed Consolidated Statements of Stockholders’ Equity	8
	Condensed Consolidated Statements of Cash Flows	9
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	10
	Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
	Item 3. Quantitative and Qualitative Disclosures about Market Risk	41
	Item 4. Controls and Procedures	41
PART II. OTHER INFORMATION
	Item 1. Legal Proceedings	42
	Item 1A. Risk Factors	42
	Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	42
	Item 3. Defaults Upon Senior Securities	42
	Item 4. Mine Safety Disclosures	42
	Item 5. Other Information	42
	Item 6. Exhibits	43

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q 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. 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 fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

•

the initiation, timing, progress and results of our ongoing and planned preclinical studies and clinical trials and our research and development programs;

•

our estimates regarding expenses, future revenue, capital requirements and need for additional financing;

•

our expectations regarding our ability to fund our projected operating requirements with our existing cash resources and the period in which we expect that such cash resources will enable us to fund such operating requirements;

•

our plans to develop our drug product candidates;

•

the timing of and our ability to submit applications for, and to obtain and maintain regulatory approvals for, our drug product candidates;

•

the potential advantages of our drug product candidates;

•

the rate and degree of market acceptance and clinical utility of our drug product candidates, if approved;

•

our estimates regarding the potential market opportunity for our drug product candidates;

•

our commercialization, marketing and manufacturing capabilities and strategy;

•

our intellectual property position;

•

our ability to identify additional products, drug product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;

•

the impact of government laws and regulations;

•

our competitive position;

•

developments relating to our competitors and our industry;

•

our ability to continue as a going concern; and

•

our ability to maintain and establish collaborations or obtain additional funding.

Forward-looking statements are neither historical 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 the factors discussed below under the heading “Risk Factor Summary,” and the risk factors detailed further in Item 1A., “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023.

This report includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties as well as our own estimates. All of the market data used in this report involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our drug product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.

Any forward-looking statement made by us in this Quarterly Report on Form 10-Q 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.

RISK FACTOR SUMMARY

Investment in our securities involves risk. You should carefully consider the following summary of what we believe to be the principal risks facing our business, in addition to the risks described more fully in Item 1A, “Risk Factors” of Part I of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 28, 2024 and other information included in this report. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations.

If any of the following risks occurs, our business, financial condition and results of operations and future growth prospects could be materially and adversely affected, and the actual outcomes of matters as to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements.

•

We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses, and may never achieve or maintain profitability.

•

We currently do not have, and may never develop, any FDA-approved or commercialized products.

•

We are substantially dependent on the success of our drug product candidates, only two of which are currently being tested in clinical trials, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidates.

•

We have limited experience in conducting clinical trials and no history of commercializing biologic products, which may make it difficult to evaluate the prospects for our future viability.

•

Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials.

•

We plan to continue to seek collaborations or strategic alliances. However, we may not be able to establish such relationships, and relationships we have established may not provide the expected benefits.

•

Our collaboration agreement with LG Chem contains exclusivity provisions that restrict our research and development activities.

•

We may not be successful in our efforts to identify additional drug product candidates. Due to our limited resources and access to capital, we must prioritize the development of certain drug product candidates; these decisions may prove to be wrong and may adversely affect our business.

•

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

•

We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to successfully complete development of, obtain regulatory approval for, or commercialize our drug product candidates and our business could be substantially harmed.

•

We rely completely on third parties to manufacture our preclinical and clinical drug supplies for our drug product candidates.

•

If we or our licensor(s) are unable to protect our or its intellectual property, then our financial condition, results of operations and the value of our technology and potential products could be adversely affected.

•

Even if we, or any collaborators we may have, obtain marketing approvals for any of our drug product candidates, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.

•

We will need substantial additional financing to support our growth and ongoing operations.

•

Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.

•

We have a loan agreement that requires us to meet certain operating covenants and place restrictions on our operating and financial flexibility.

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Cue Biopharma, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)


	March 31, 2024			December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents	$	41,029		$	48,514
Accounts receivable		1,400			1,698
Prepaid expenses and other current assets		2,240			1,242
Total current assets		44,669			51,454
Property and equipment, net		754			795
Operating lease right-of-use assets		5,573			6,323
Deposits		2,690			2,690
Restricted cash		151			151
Other long-term assets		114			117
Total assets	$	53,951		$	61,530
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	3,919		$	3,501
Accrued expenses		5,208			4,137
Research and development contract liability, current portion		1,790			2,112
Operating lease liabilities, current		3,210			3,368
Current portion of long-term debt, net		3,963			3,963
Total current liabilities		18,090			17,081
Operating lease liabilities, non-current		2,579			3,162
Long-term debt, net		3,244			4,202
Total liabilities	$	23,913		$	24,445
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding at March 31, 2024 and December 31, 2023		—			—
Common stock, $0.001 par value; 100,000,000 shares authorized; 48,643,316 and 47,215,116 shares issued and outstanding, at March 31, 2024 and December 31, 2023, respectively		48			47
Additional paid in capital		343,527			338,228
Accumulated deficit		(313,537	)		(301,190	)
Total stockholders’ equity		30,038			37,085
Total liabilities and stockholders’ equity	$	53,951		$	61,530

The accompanying notes are an integral part of these condensed consolidated financial statements.

Cue Biopharma, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended March 31,
	2024			2023
Collaboration revenue	$	1,717		$	187
Operating expenses:
General and administrative		4,186			4,176
Research and development		10,199			9,391
Total operating expenses		14,385			13,567
Loss from operations		(12,668	)		(13,380	)
Other income (expense):
Interest income		562			641
Interest expense		(241	)		(370	)
Total other income (expense), net		321			271
Net loss	$	(12,347	)	$	(13,109	)
Unrealized gain from available-for-sale securities		—			57
Comprehensive loss	$	(12,347	)	$	(13,052	)
Net loss per common share – basic and diluted	$	(0.25	)	$	(0.29	)
Weighted average common shares outstanding – basic and diluted		49,466,711			44,652,353

The accompanying notes are an integral part of these condensed consolidated financial statements.

Cue Biopharma, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share and per share amounts)



	Common Stock				Additional		Accumulated Other						Total
	Shares		Par Value		Paid-in Capital		Comprehensive Income (Loss)			Accumulated Deficit			Stockholders’ Equity
Balance, December 31, 2022		43,042,548	$	43	$	316,192	$	(96	)	$	(250,456	)	$	65,683
Stock-based compensation		—		—		1,998		—			—			1,998
Exercise of stock options		135,602		—		388		—			—			388
Unrealized gain from available-for-sale securities		—		—		—		57			—			57
Net loss		—		—		—		—			(13,109	)		(13,109	)
Balance, March 31, 2023		43,178,150	$	43	$	318,578	$	(39	)	$	(263,565	)	$	55,017

Balance, December 31, 2023		47,215,116	$	47	$	338,228	$	—		$	(301,190	)	$	37,085
Issuance of common stock from ATM offering, net of sales agent commission and fees		1,428,200		1		3,353		—			—			3,354
Stock-based compensation		—		—		1,946		—			—			1,946
Net loss		—		—		—		—			(12,347	)		(12,347	)
Balance, March 31, 2024		48,643,316	$	48	$	343,527	$	—		$	(313,537	)	$	30,038

The accompanying notes are an integral part of these condensed consolidated financial statements.

Cue Biopharma, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)


	Three Months Ended March 31,
	2024			2023
Cash flows from operating activities
Net loss	$	(12,347	)	$	(13,109	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization		99			177
Stock-based compensation		1,946			1,998
Decrease in the carrying amount of right-of-use-assets		750			703
Gain on sale of property and equipment		—			(2	)
Amortization of premium/discount on purchased securities		—			(149	)
Amortization of debt issuance costs		9			9
Accretion of final payment on term loan		33			33
Changes in operating assets and liabilities:
Accounts receivable		298			(139	)
Prepaid expenses and other current assets		(998	)		(1,518	)
Deposits		—			139
Accounts payable		418			(580	)
Accrued expenses		1,071			(709	)
Research and development contract liability		(322	)		2,966
Operating lease liability		(741	)		(652	)
Net cash used in operating activities		(9,784	)		(10,833	)
Cash flows from investing activities
Purchases of property and equipment		(55	)		—
Cash received from the sale of property and equipment		—			2
Redemption of marketable securities

SEC Form 10-Q filed by Cue Biopharma Inc.