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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 SEPTEMBER 30, 2025
or
☐ 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)
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Delaware |
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47-3324577 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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40 Guest Street
Boston, Massachusetts
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02135
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(Address of principal executive offices) |
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(Zip Code) |
(617) 949-2680
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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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.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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 November 7, 2025, the registrant had 78,737,736 shares of Common Stock ($0.001 par value per share) outstanding.
CUE BIOPHARMA, INC.
TABLE OF CONTENTS
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:
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the initiation, timing, progress and results of our ongoing and planned preclinical studies and any future clinical trials and our research and development programs;
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our estimates regarding expenses, future revenue, capital requirements and need for additional financing;
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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;
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our plans to develop our drug product candidates, including our prioritization of our autoimmune programs, including CUE-401 and the CUE-500 series (excluding CUE-501, which has been licensed to Boehringer Ingelheim International GmbH);
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the timing of and our ability to submit applications for, and to obtain and maintain regulatory approvals for, our drug product candidates;
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the potential advantages of our drug product candidates;
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the rate and degree of market acceptance and clinical utility of our drug product candidates, if approved;
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our estimates regarding the potential market opportunity for our drug product candidates;
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our commercialization, marketing and manufacturing capabilities and strategy;
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our intellectual property position;
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our ability to identify additional products, drug product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
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the impact of government laws and regulations, general economic and market conditions, inflation, and the imposition of new or revised global trade tariffs;
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our competitive position;
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developments relating to our competitors and our industry;
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our ability to continue as a going concern; and
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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 headings “Risk Factor Summary,” and Part II. Item 1A. “Risk Factors,” and the risk factors detailed further in Part I. Item 1A., “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 31, 2025.
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 Part II. Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q, and Part I. Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 31, 2025 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.
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Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.
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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.
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We currently do not have, and may never develop, any FDA-approved or commercialized products.
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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.
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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.
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Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials.
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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.
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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.
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We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results than our drug product candidates.
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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.
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We rely completely on third parties to manufacture our preclinical and clinical drug supplies for our drug product candidates.
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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.
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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.
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We will need substantial additional financing to support our growth and ongoing operations. Additional capital may be difficult to obtain, restrict our operations, require us to relinquish rights to our technologies or drug product candidates, encumber our assets and result in ongoing debt service cost, or result in additional dilution to our stockholders.
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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)
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|
|
September 30, 2025 |
|
|
December 31, 2024 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,701 |
|
|
$ |
22,459 |
|
Marketable securities |
|
|
6,971 |
|
|
|
— |
|
Accounts receivable |
|
|
387 |
|
|
|
945 |
|
Deposits, current portion |
|
|
1,747 |
|
|
|
929 |
|
Prepaid expenses and other current assets |
|
|
3,114 |
|
|
|
805 |
|
Foreign withholding tax receivable |
|
|
1,899 |
|
|
|
— |
|
Total current assets |
|
|
25,819 |
|
|
|
25,138 |
|
Property and equipment, net |
|
|
307 |
|
|
|
471 |
|
Operating lease right-of-use asset |
|
|
4,602 |
|
|
|
4,370 |
|
Deposits |
|
|
667 |
|
|
|
1,955 |
|
Restricted cash |
|
|
153 |
|
|
|
152 |
|
Other long-term assets |
|
|
96 |
|
|
|
105 |
|
Total assets |
|
$ |
31,644 |
|
|
$ |
32,191 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,348 |
|
|
$ |
2,823 |
|
Accrued expenses |
|
|
1,871 |
|
|
|
2,908 |
|
Research and development contract liability, current portion |
|
|
7,816 |
|
|
|
85 |
|
Operating lease liabilities, current |
|
|
2,031 |
|
|
|
3,540 |
|
Current portion of long-term debt, net |
|
|
1,458 |
|
|
|
4,333 |
|
Total current liabilities |
|
|
15,524 |
|
|
|
13,689 |
|
Operating lease liabilities, non-current |
|
|
2,684 |
|
|
|
1,003 |
|
Other long-term payable |
|
|
190 |
|
|
|
— |
|
Total liabilities |
|
$ |
18,398 |
|
|
$ |
14,692 |
|
Commitments and contingencies (Note 12) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding at September 30, 2025 and December 31, 2024 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 300,000,000 shares authorized; 77,781,743 and 61,819,101 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively |
|
|
78 |
|
|
|
62 |
|
Additional paid in capital |
|
|
383,218 |
|
|
|
359,301 |
|
Accumulated other comprehensive loss |
|
|
1 |
|
|
|
— |
|
Accumulated deficit |
|
|
(370,051 |
) |
|
|
(341,864 |
) |
Total stockholders’ equity |
|
|
13,246 |
|
|
|
17,499 |
|
Total liabilities and stockholders’ equity |
|
$ |
31,644 |
|
|
$ |
32,191 |
|
|
|
|
|
|
|
|
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
Collaboration revenue |
|
$ |
2,149 |
|
|
$ |
3,336 |
|
|
$ |
5,524 |
|
|
$ |
7,711 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
4,939 |
|
|
|
2,867 |
|
|
|
12,792 |
|
|
|
10,564 |
|
Research and development |
|
|
4,754 |
|
|
|
9,381 |
|
|
|
21,211 |
|
|
|
29,111 |
|
Loss (gain) on fixed asset disposal |
|
|
51 |
|
|
|
(97 |
) |
|
|
51 |
|
|
|
(97 |
) |
Total operating expenses |
|
|
9,744 |
|
|
|
12,151 |
|
|
|
34,054 |
|
|
|
39,578 |
|
Loss from operations |
|
|
(7,595 |
) |
|
|
(8,815 |
) |
|
|
(28,530 |
) |
|
|
(31,867 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
222 |
|
|
|
343 |
|
|
|
649 |
|
|
|
1,332 |
|
Interest expense |
|
|
(75 |
) |
|
|
(188 |
) |
|
|
(306 |
) |
|
|
(643 |
) |
Total other income, net |
|
|
147 |
|
|
|
155 |
|
|
|
343 |
|
|
|
689 |
|
Net loss |
|
$ |
(7,448 |
) |
|
$ |
(8,660 |
) |
|
$ |
(28,187 |
) |
|
$ |
(31,178 |
) |
Unrealized gain from available-for-sale securities |
|
|
1 |
|
|
|
— |
|
|
|
1 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(7,447 |
) |
|
$ |
(8,660 |
) |
|
$ |
(28,186 |
) |
|
$ |
(31,178 |
) |
Net loss per common share – basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.62 |
) |
Weighted average common shares outstanding – basic and diluted |
|
|
100,869,349 |
|
|
|
51,229,701 |
|
|
|
90,271,072 |
|
|
|
50,292,983 |
|
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2025 and 2024: |
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
Total |
|
|
|
Shares |
|
|
Par Value |
|
|
Paid-in Capital |
|
|
Comprehensive Income |
|
|
Accumulated Deficit |
|
|
Stockholders’ Equity |
|
Balance, June 30, 2024 |
|
|
48,643,316 |
|
|
$ |
48 |
|
|
$ |
345,282 |
|
|
$ |
— |
|
|
$ |
(323,708 |
) |
|
$ |
21,622 |
|
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs |
|
|
11,564,401 |
|
|
|
12 |
|
|
|
10,809 |
|
|
|
— |
|
|
|
— |
|
|
|
10,821 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,583 |
|
|
|
— |
|
|
|
— |
|
|
|
1,583 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(8,660 |
) |
|
|
(8,660 |
) |
Balance, September 30, 2024 |
|
|
60,207,717 |
|
|
$ |
60 |
|
|
$ |
357,674 |
|
|
$ |
— |
|
|
$ |
(332,368 |
) |
|
$ |
25,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2025 |
|
|
76,446,884 |
|
|
$ |
76 |
|
|
$ |
380,686 |
|
|
$ |
— |
|
|
$ |
(362,603 |
) |
|
$ |
18,159 |
|
Issuance of common stock from ATM offering, net of sales agent commissions and fees |
|
|
1,334,859 |
|
|
|
2 |
|
|
|
999 |
|
|
|
— |
|
|
|
— |
|
|
|
1,001 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,533 |
|
|
|
— |
|
|
|
— |
|
|
|
1,533 |
|
Unrealized gain from available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
|
|
|
|
|
1 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,448 |
) |
|
|
(7,448 |
) |
Balance, September 30, 2025 |
|
|
77,781,743 |
|
|
$ |
78 |
|
|
$ |
383,218 |
|
|
$ |
1 |
|
|
$ |
(370,051 |
) |
|
$ |
13,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2025 and 2024: |
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
Total |
|
|
|
Shares |
|
|
Par Value |
|
|
Paid-in Capital |
|
|
Comprehensive Income |
|
|
Accumulated Deficit |
|
|
Stockholders’ Equity |
|
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 commissions and fees |
|
|
1,428,200 |
|
|
|
1 |
|
|
|
3,353 |
|
|
|
— |
|
|
|
— |
|
|
|
3,354 |
|
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs |
|
|
11,564,401 |
|
|
|
12 |
|
|
|
10,809 |
|
|
|
— |
|
|
|
— |
|
|
|
10,821 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
5,284 |
|
|
|
— |
|
|
|
— |
|
|
|
5,284 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(31,178 |
) |
|
|
(31,178 |
) |
Balance, September 30, 2024 |
|
|
60,207,717 |
|
|
$ |
60 |
|
|
$ |
357,674 |
|
|
$ |
— |
|
|
$ |
(332,368 |
) |
|
$ |
25,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2024 |
|
|
61,819,101 |
|
|
$ |
62 |
|
|
$ |
359,301 |
|
|
$ |
— |
|
|
$ |
(341,864 |
) |
|
$ |
17,499 |
|
Issuance of common stock from ATM offering, net of sales agent commissions and fees |
|
|
2,431,862 |
|
|
|
3 |
|
|
|
1,750 |
|
|
|
— |
|
|
|
— |
|
|
|
1,753 |
|
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs |
|
|
13,530,780 |
|
|
|
13 |
|
|
|
18,033 |
|
|
|
— |
|
|
|
— |
|
|
|
18,046 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
4,134 |
|
|
|
— |
|
|
|
— |
|
|
|
4,134 |
|
Unrealized gain from available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
|
|
— |
|
|
|
1 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(28,187 |
) |
|
|
(28,187 |
) |
Balance, September 30, 2025 |
|
|
77,781,743 |
|
|
$ |
78 |
|
|
$ |
383,218 |
|
|
$ |
1 |
|
|
$ |
(370,051 |
) |
|
$ |
13,246 |
|
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)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2025 |
|
|
2024 |
|
Cash flows from operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(28,187 |
) |
|
$ |
(31,178 |
) |
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
280 |
|
|
|
299 |
|
Stock-based compensation |
|
|
4,134 |
|
|
|
5,284 |
|
Decrease in the carrying amount of right-of-use-assets |
|
|
1,994 |
|
|
|
2,289 |
|
Loss (gain) on sale of property and equipment |
|
|
51 |
|
|
|
(97 |
) |
Amortization of premium/discount on purchased securities |
|
|
(182 |
) |
|
|
— |
|
Amortization of debt issuance costs |
|
|
28 |
|
|
|
28 |
|
Accretion of final payment on term loans |
|
|
98 |
|
|
|
98 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
|
558 |
|
|
|
(1,454 |
) |
Prepaid expenses and other current assets |
|
|
(2,309 |
) |
|
|
(442 |
) |
Deposits |
|
|
470 |
|
|
|
— |
|
Foreign withholding tax receivable |
|
|
(1,899 |
) |
|
|
— |
|
Other payable |
|
|
190 |
|
|
|
— |
|
Accounts payable |
|
|
(476 |
) |
|
|
2,972 |
|
Accrued expenses |
|
|
(1,038 |
) |
|
|
(938 |
) |
Research and development contract liability |
|
|
7,731 |
|
|
|
(1,853 |
) |
Operating lease liability |
|
|
(2,054 |
) |
|
|
(2,309 |
) |
Net cash used in operating activities |
|
|
(20,611 |
) |
|
|
(27,301 |
) |
Cash flows from investing activities |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(177 |
) |
|
|
(64 |
) |
Cash received from the sale of property and equipment |
|
|
20 |
|
|
|
97 |
|
Purchases of marketable securities |
|
|
(16,288 |
) |
|
|
— |
|
Redemptions of marketable securities |
|
|
9,500 |
|
|
|
— |
|
Net cash (used in) provided by investing activities |
|
|
(6,945 |
) |
|
|
33 |
|
Cash flows from financing activities |
|
|
|
|
|
|
Proceeds from ATM offering, net of sales agent commissions and fees |
|
|
1,753 |
|
|
|
3,354 |
|
Proceeds from issuance of common stock, warrants and pre-funded warrants, net of transaction costs |
|
|
18,046 |
|
|
|
10,821 |
|
Repayment of term loans |
|
|
(3,000 |
) |
|
|
(3,000 |
) |
Net cash provided by financing activities |
|
|
16,799 |
|
|
|
11,175 |
|
Net decrease in cash, cash equivalents, and restricted cash |
|
|
(10,757 |
) |
|
|
(16,093 |
) |
Cash, cash equivalents, and restricted cash at beginning of period |
|
|
22,611 |
|
|
|
48,665 |
|
Cash, cash equivalents, and restricted cash at end of period |
|
$ |
11,854 |
|
|
$ |
32,572 |
|
Supplemental disclosures of non-cash investing and financing activities: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
198 |
|
|
$ |
547 |
|
Lease liabilities arising from obtaining right-of-use assets |
|
$ |
2,226 |
|
|
$ |
— |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
Cue Biopharma, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1.
Organization and Basis of Presentation
Cue Biopharma, Inc. (the "Company") is a clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics engineered to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer. Unlike conventional approaches that broadly activate the immune system, the Company's Immuno-STAT® platform is designed to selectively modulate disease-relevant T cells, enhancing efficacy while minimizing off-target effects. The Company believes its Immuno-STAT platform holds the promise of producing drug product candidates with the potential of establishing new standards of care in the treatment of autoimmune disease and cancer.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company is in the clinical development and preclinical research and development stages and has incurred recurring losses and negative cash flows from operations since inception. As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of $18.7 million. Effective November 6, 2025, the Company entered into a Collaboration and License Agreement with ImmunoScape Pte. Ltd. pursuant to which the Company is entitled to receive upfront payments totaling $15.0 million. Of these upfront payments, the Company is entitled to receive a total of approximately $10.0 million in the fourth quarter of 2025, of which the Company has received $5.0 million to date, and an additional $5.0 million before the first anniversary of the effective date of the agreement. For further information regarding this transaction, please refer to Note 14 Subsequent Events.
The future viability of the Company is dependent on its ability to raise additional capital to finance its operations and fund research and development costs in order to seek approval for commercialization of its drug product candidates.
The Company continues to explore raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, potential cash expenditure reduction, there is no guarantee that the Company will be successful in these mitigation efforts. The Company’s failure to access additional capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for the Company to perform the research and development activities required to develop and commercialize the Company’s drug product candidates in order to generate future revenue streams. The Company’s accumulated deficit, history of losses, negative cash flows from operations and future expected losses raises substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these financial statements.
2.
Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of September 30, 2025, and for the three and nine months ended September 30, 2025 and 2024, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and generally accepted accounting principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp., which was incorporated in the Commonwealth of Massachusetts in December 2018. In the opinion of management, these financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 31, 2025.
Interim results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025, or any future periods.
Public Offerings
In October 2021, the Company entered into an open market sale agreement (the “ATM Sales Agreement”) with Jefferies LLC ("Jefferies"), as agent, to sell shares of the Company’s common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering program. The ATM Sales Agreement will terminate upon the earliest of (a) the sale of $80 million of shares of the Company’s common stock pursuant to the ATM Sales Agreement or (b) the termination of the ATM Sales Agreement by the Company or Jefferies.
During the three and nine months ended September 30, 2025, the Company sold 1,334,859 and 2,431,862 shares of common stock under the ATM Sales Agreement for proceeds of $1.0 million and $1.8 million, net of commissions paid, but excluding transaction expenses. The Company did not sell any shares of common stock during the three months ended September 30, 2024 under the ATM Sales Agreement. During the nine months ended September 30, 2024, the Company sold 1,428,200 shares of common stock under the ATM Sales Agreement for proceeds of $3.4 million, net of commissions paid, but excluding transaction expenses. As of September 30, 2025, the Company had sold an aggregate of 11,504,093 shares of common stock under the ATM Sales Agreement for proceeds of $42.2 million, net of commissions paid, but excluding transaction expenses, since its inception.
On September 26, 2024, the Company entered into an underwriting agreement (the “2024 Underwriting Agreement”) with Oppenheimer & Co. Inc., as representative of the several underwriters named therein (collectively, the “2024 Underwriters”), relating to an underwritten public offering of (i) 11,564,401 shares (the “2024 Shares”) of the Company’s common stock, $0.001 par value per share, and accompanying common stock warrants (the “2024 Common Stock Warrants”) to purchase 2,891,100 shares of the Company’s common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants (the “2024 Pre-Funded Warrants,” and together with the 2024 Common Stock Warrants, the “2024 Warrants”) to purchase 12,435,599 shares of the Company’s common stock and accompanying 2024 Common Stock Warrants to purchase 3,108,900 shares of the Company’s common stock. All of the 2024 Shares and the 2024 Warrants were sold by the Company. Each 2024 Share was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.50, and each 2024 Pre-Funded Warrant was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.499, which is equal to the combined offering price per share of common stock and accompanying 2024 Common Stock Warrant less the $0.001 exercise price of each 2024 Pre-Funded Warrant. The Company received net proceeds from the offering of $10.8 million, after deducting underwriting discounts and commissions and offering expenses of $1.2 million, excluding any proceeds that may be received from exercise of the 2024 Warrants. At September 30, 2025, the weighted average exercise price of the 2024 Warrants was $0.50 and the weighted average contractual life was 4.0 years.
On April 14, 2025, the Company entered into an underwriting agreement (the “2025 Underwriting Agreement”) with Oppenheimer & Co. Inc., as representative of the several underwriters named therein (collectively, the “2025 Underwriters”), relating to an underwritten public offering of (i) 13,530,780 shares (the “2025 Shares”) of the Company’s common stock, $0.001 par value per share, and accompanying common stock warrants (“2025 Common Stock Warrants”) to purchase 3,382,695 shares of the Company’s common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants (the “2025 Pre-Funded Warrants,” and together with the 2025 Common Stock Warrants, the “2025 Warrants”) to purchase 11,469,216 shares of the Company’s common stock and accompanying 2025 Common Stock Warrants to purchase 2,867,304 shares of common stock. All of the 2025 Shares and 2025 Warrants were sold by the Company. Each 2025 Share was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.79, and each 2025 Pre-Funded Warrant was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.789, which is equal to the combined offering price per share of common stock and accompanying 2025 Common Stock Warrant less the $0.001 exercise price of each 2025 Pre-Funded Warrant. The 2025 Underwriters purchased (i) each 2025 Share and accompanying 2025 Common Stock Warrant from the Company pursuant to the 2025 Underwriting Agreement at a combined price of $0.7426 and (ii) each 2025 Pre-Funded Warrant and accompanying 2025 Common Stock Warrant from the Company pursuant to the 2025 Underwriting Agreement at a combined price of $0.74166. The Company received net proceeds from the offering of $18.0 million, after deducting underwriting discounts and commissions and offering expenses of $0.5 million, excluding any proceeds that may be received from exercise of the 2025 Warrants. At September 30, 2025, the weighted average exercise price of the 2025 Warrants was $0.79 and the weighted average contractual life was 4.55 years.
Consolidation
The accompanying condensed consolidated financial statements include the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp. The Company has eliminated all intercompany transactions.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include estimates related to collaboration revenue, the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and the useful life with respect to long-lived assets and intangibles. Actual results could differ from those estimates.
The Company maintains its cash balances with financial institutions in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date from the Company's deposits with these financial institutions and believes that it is not exposed to any significant credit risk on cash.
Cash and Cash Equivalents
The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company invests available cash in money market funds.
Marketable Securities
Marketable securities consist of investments with original maturities greater than ninety days and less than one year from the date of the Company's condensed consolidated balance sheets. The Company classifies all of its investments as available-for-sale securities. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. Unrealized gains and losses are recognized and determined on a specific identification basis and are included in comprehensive loss. Realized gains and losses are determined on a specific identification basis and are included in other income on the condensed consolidated statements of operations and comprehensive loss. Amortization and accretion of discounts and premiums is recorded in interest income.
The Company had $0.2 million in restricted cash deposited with a separate commercial bank to collateralize Company credit cards as of September 30, 2025 and December 31, 2024.
Property and Equipment
Property and equipment is recorded at cost. Major improvements are capitalized, while maintenance and repairs are charged to expense as incurred. Gains and losses from dispositions of property and equipment are included in income and expense when realized. Amortization of leasehold improvements is provided using the straight-line method over the shorter of the lease term or the useful life of the underlying assets. Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives:
|
|
|
Laboratory equipment |
|
5 years |
Computer equipment |
|
3 years |
Furniture and fixtures |
|
3-8 years |
The Company recognizes depreciation and amortization expense in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on how each category of property and equipment is utilized in the Company’s business activities.
Trademark
Trademark consists of the Company’s right, title and interest to the CUE BIOLOGICS Mark, and any derivative mark incorporating CUE, throughout the world, together with all associated goodwill and common law rights appurtenant thereto, including, but not limited to, any right, title and interest in any corporate name, company name, business, name, trade name, dba, domain name, or other source identifier incorporating CUE.
The Company has classified the trademark as a component of other long-term assets, having a useful life of 15 years. The Company evaluates the status of this intangible asset for amortization and impairment at each quarter end and year end reporting date. For each of the three and nine months ended September 30, 2025 and 2024, the Company recorded approximately $3,000 and $9,000, respectively, in amortization expense on a straight-line basis.
Debt Issuance Costs
Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss.
Revenue Recognition
The Company recognizes collaboration revenue under certain of the Company’s license and collaboration agreements that are within the scope of Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the expected value method.
Research and Development Expenses
Research and development expenses consist primarily of compensation costs, fees paid to consultants, outside service providers and organizations (including research institutes at universities), facility costs, and development and clinical trial costs with respect to the Company’s drug product candidates.
Research and development expenses incurred under contracts are expensed ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different pattern of performance is more appropriate. Other research and development expenses are charged to operations as incurred.
Nonrefundable advance payments are recognized as an expense as the related services are performed. The Company evaluates whether it expects the services to be rendered at each quarter end and year end reporting date. If the Company does not expect the services to be rendered, the advance payment is charged to expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the Company's condensed consolidated balance sheets. To the extent that a nonrefundable advance payment is for contracted services to be performed within 12 months from the reporting date, such advance is included in current assets; otherwise, such advance is included in non-current assets.
The Company evaluates the status of its research and development agreements and contracts, and the carrying amount of the related assets and liabilities, at each quarter end and year end reporting date, and adjusts the carrying amounts and their classification on the Company's condensed consolidated balance sheets as appropriate.
The Company is the exclusive worldwide licensee of, and has patent applications pending for, numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one or more commercially viable drug product candidates based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal fees, filing fees and other costs are charged to general and administrative expense as incurred.
Licensing Fees and Costs
Licensing fees and costs consist primarily of costs relating to the acquisition of the Company’s license agreement with the Albert Einstein College of Medicine, including related royalties, maintenance fees, milestone payments and product development costs. Licensing fees and costs are charged to research and development expense as incurred.
Long-Lived Assets
The Company reviews long-lived assets, consisting of property and equipment, for impairment when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the Company's condensed consolidated balance sheets and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs.
The Company accounts for leases under ASC 842, Leases, which requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's condensed consolidated balance sheets. Under the standard, disclosure of key information about leasing arrangements to assist users of the financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases are required.
Stock-Based Compensation
The Company periodically issues stock-based awards to officers, directors, employees, scientific and clinical advisory board members and consultants for services rendered. Such awards vest and expire according to terms established at the issuance date.
Stock-based compensation to officers, directors, employees, scientific and clinical advisory board members and consultants, including grants of employee stock options, is recognized in the financial statements based on their grant date fair values. Stock option grants, which are generally time-vested, are measured at the grant date fair value and charged to operations on a straight-line basis over the service period, which generally approximates the vesting term. The Company also grants performance-based awards periodically to officers of the Company. The Company recognizes compensation costs related to performance awards over the requisite service period if and when the Company concludes that it is probable that the performance condition will be achieved.
The fair value of stock options and restricted stock units is determined utilizing the Black-Scholes valuation model. This valuation model takes into account the exercise price of the award, as well as a variety of significant assumptions. The assumptions used to estimate the fair value of stock options include the expected term, the expected volatility of the Company's stock over the expected term, the risk-free interest rate over the expected term, and the Company's expected annual dividend yield. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. The expected dividend yield is based on the current yield at the grant date; the Company has never declared or paid dividends and has no plans to do so for the foreseeable future. As permitted by Staff Accounting Bulletin No. 107, due to the Company’s limited trading history and option activity, management utilizes the simplified method to estimate the expected term of options at the date of grant. The exercise price is determined based on the fair value of the Company's common stock at the date of grant. The Company accounts for forfeitures as they occur.
The Company recognizes the fair value of stock-based compensation in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on the type of services provided by the recipient of the equity award.
Comprehensive Income (Loss)
Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Other comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). Comprehensive income (loss) includes net income (loss) as well as changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. There were no elements of other comprehensive income (loss) in the periods presented.
Earnings (Loss) Per Share
The Company’s computation of earnings (loss) per share (“EPS”) for the respective periods includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares that would result from the exercise of outstanding stock options and warrants as if they had been exercised at the beginning of the periods presented, or issuance date, if later.
Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Basic and diluted loss per common share is the same for all periods presented because all outstanding stock options and warrants are anti-dilutive.
The Company computes EPS in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 260, Earnings per Share ("ASC 260"). Per ASC 260-10-45-13, shares issuable for little to no consideration should be included in the number of outstanding shares used for basic EPS. The FASB proposed that warrants or options exercisable for little to no cost (sometimes referred to as “penny warrants”) be included in the denominator of basic EPS (and therefore diluted EPS) once there were no further vesting conditions or contingencies associated with them. The Company included 23,904,815 and 13,967,039 pre-funded warrants in the denominator of basic EPS at September 30, 2025 and September 30, 2024, respectively.
At September 30, 2025 and 2024, the Company excluded the securities summarized below, which entitled the holders thereof to acquire shares of common stock, from its calculation of EPS, as their effect would have been anti-dilutive.
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2025 |
|
2024 |
|
Common stock warrants |
|
|
21,401,905 |
|
|
15,188,406 |
|
Common stock options |
|
|
13,777,199 |
|
|
10,611,617 |
|
Total |
|
|
35,179,104 |
|
|
25,800,023 |
|
Fair Value of Financial Instruments
The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below.
Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active exchange-traded securities and exchange-based derivatives.
Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models.
The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end.
The carrying value of financial instruments (consisting of cash, a certificate of deposit, debt, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments.
Recent Accounting Pronouncements
ASU 2023-07 - Segment Reporting
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 requires disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by these amendments and all existing segment disclosures in ASC 280, Segment Reporting. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company adopted ASU 2023-07 effective December 31, 2024.
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (the “CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company's CODM is the chief executive officer.
The Company is in the development stage, has not yet earned revenue from product sales, and has incurred recurring losses and negative cash flows from operations since inception. The Company operates as a single reporting segment, focused on developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells directly within the patient’s body. The CODM manages and allocates resources to the operations of the Company on a total company basis and therefore does not measure separate segment profit or loss. Managing and allocating resources on a total company basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development programs that are in line with the Company’s long-term strategic corporate goals. Consistent with this decision-making process, the CODM uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. All the Company’s long-lived assets are held in the United States and all the Company’s revenues since inception have been earned from collaboration agreements as none of the Company's drug product candidates have yet been approved for commercial sale. The resources utilized for any specific purpose may vary significantly and will depend on a number of factors, including, but not limited to, the Company’s research and development activities and programs, clinical testing, regulatory approval, market conditions, and changes in or revisions to the Company’s business strategy and technology development plans.
ASU 2023-09 - Income Taxes
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements.
Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures.
The Company accounts for its financial assets and liabilities using fair value measurements. The authoritative accounting guidance defines fair value, establishes a framework for measuring fair value under U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024, and indicates the level of the fair value hierarchy utilized to determine such fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of September 30, 2025 |
|
|
|
(in thousands) |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Fair Value |
|
Cash equivalents |
|
$ |
11,202 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
11,202 |
|
Marketable securities |
|
|
— |
|
|
|
6,971 |
|
|
|
— |
|
|
|
6,971 |
|
Total |
|
$ |
11,202 |
|
|
$ |
6,971 |
|
|
$ |
— |
|
|
$ |
18,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of December 31, 2024 |
|
|
|
(in thousands) |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Fair Value |
|
Cash equivalents |
|
$ |
21,813 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
21,813 |
|
Marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total |
|
$ |
21,813 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
21,813 |
|
As of September 30, 2025, the Company had $11.2 million in cash equivalents, and $7.0 million in marketable securities. The Company measures the cash equivalents that are invested in money market funds using Level 1 inputs for identical securities. The Company measures the fair value of marketable securities that are invested in U.S. Treasury securities using Level 2 inputs and primarily relies on quoted prices in active markets for similar marketable securities. As of December 31, 2024, the Company had $21.8 million in cash equivalents, and did not hold any marketable securities.
For each of the three and nine months ended September 30, 2025 and 2024 there were no transfers between Levels 1, 2 or 3.
As of September 30, 2025, the Company had $7.0 million in marketable securities. The Company did not have marketable securities at December 31, 2024. The following table presents the Company's marketable securities at September 30, 2025, and December 31, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
(In thousands) |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
U.S. Treasury Securities |
|
$ |
6,970 |
|
|
$ |
1 |
|
|
$ |
— |
|
|
$ |
6,971 |
|
|
|
$ |
6,970 |
|
|
$ |
1 |
|
|
$ |
— |
|
|
$ |
6,971 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.
Property and Equipment, Net
Property and equipment, net as of September 30, 2025 and December 31, 2024 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
|
December 31, 2024 |
|
|
|
(in thousands) |
|
Laboratory equipment |
|
$ |
3,511 |
|
|
$ |
3,785 |
|
Furniture and fixtures |
|
|
68 |
|
|
|
68 |
|
Computer equipment |
|
|
207 |
|
|
|
180 |
|
Leasehold improvements |
|
|
118 |
|
|
|
118 |
|
Total property and equipment |
|
|
3,904 |
|
|
|
4,151 |
|
Less: accumulated depreciation |
|
|
(3,597 |
) |
|
|
(3,680 |
) |
Property and equipment, net |
|
$ |
307 |
|
|
$ |
471 |
|
Depreciation expense for the three and nine months ended September 30, 2025 and 2024 was included in the condensed consolidated statements of operations and comprehensive loss as follows, and excludes trademark amortization of $3,000 and $9,000 for the three and nine months ended September 30, 2025 and 2024, respectively. The Company sold lab equipment and collected cash of $0.02 million for both the three and nine months ended September 30, 2025. The Company recorded a loss on the sale of fixed assets of $0.05 million, which is presented in other income on the condensed consolidated statements of operations and comprehensive loss. The Company sold fully depreciated lab equipment and collected cash of $0.1 million for both the three and nine months ended September 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
Nine Months Ended September 30, |
|
|
|
2025 |
|
|
2024 |
|
|
|
2025 |
|
|
2024 |
|
|
|
(in thousands) |
|
|
|
(in thousands) |
|
General and administrative |
|
$ |
8 |
|
|
$ |
4 |
|
|
|
$ |
16 |
|
|
$ |
13 |
|
Research and development |
|
|
68 |
|
|
|
93 |
|
|
|
|
255 |
|
|
|
277 |
|
Depreciation total |
|
$ |
76 |
|
|
$ |
97 |
|
|
|
$ |
271 |
|
|
$ |
290 |
|
6.
Loan with First Citizens Bank (formerly with Silicon Valley Bank)
On February 15, 2022 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”), with Silicon Valley Bank, as lender (“SVB”). The Company drew $10,000,000 in term loans under the Loan Agreement (the "Term Loans") on the Closing Date. The Loan Agreement was amended in April 2023 and October 2024.
The Term Loans bear interest at a floating rate per annum equal to the greater of (A) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.25% and (B) 5.50%. The Term Loans were interest only from the Closing Date through June 30, 2023, after which the Company is required to pay 30 equal monthly installments of principal. At September 30, 2025, the interest rate was 9.50% which is based on the prime rate plus 2.25%.
The Term Loans may be prepaid in full with payment of a 1.00% prepayment premium. Upon prepayment or repayment in full of the Term Loans, the Company will be required to pay a one-time final payment fee equal to 5.00% of the original principal amount of any funded Term Loans being repaid. This one-time final payment fee is recorded to interest expense using the effective interest method over the period of the Term Loans in the condensed consolidated statements of operations and comprehensive loss.
The Term Loans and related obligations under the Loan Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property which is subject to a negative pledge under the Loan Agreement.
The Loan Agreement, as amended, contains customary representations, warranties, events of default and covenants. In addition to the foregoing, the Company is required to have at all times on deposit in accounts of the Company maintained with SVB, unrestricted and unencumbered cash in an amount equal to the lesser of (i) 100% of the dollar value of the Company’s consolidated cash, in the aggregate, at all financial institutions and (ii) $20,000,000. On March 10, 2023, SVB was closed and the Federal Deposit Insurance Corporation (the “FDIC”) was appointed receiver for the bank. The FDIC created a successor bridge bank, and all deposits and loans of SVB were transferred to the bridge bank under a systemic risk exception approved by the United States Department of the Treasury, the Federal Reserve and the FDIC. On March 27, 2023, First Citizens Bank & Trust Company (“First Citizens Bank”), assumed all of SVB’s deposits and certain other liabilities and acquired substantially all of SVB’s loans and certain other assets from the FDIC. First Citizens Bank continues to hold the Company’s Term Loans under the same existing terms and covenants which were in place with SVB.
During the three and nine months ended September 30, 2025, the Company recognized interest expense related to the Term Loans of $0.03 million and $0.2 million, respectively, and interest expense related to accretion of the final payment of $33,000 and $98,000, respectively. During the three and nine months ended September 30, 2024, the Company recognized interest expense related to the Term Loans of $0.1 million and $0.5 million, respectively, and interest expense related to accretion of the final payment of $33,000 and $98,000, respectively. All outstanding principal and accrued and unpaid interest under the Term Loans and all other outstanding obligations with respect to the Term Loans are due and payable in full on December 1, 2025.
Debt Issuance Costs
Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss.
The Company incurred $142,000 in debt issuance costs related to the Loan Agreement at its onset. For each of the three months ended September 30, 2025 and 2024, the Company recorded $9,000 in amortization of debt issuance costs to interest expense in the condensed consolidated statements of operations and comprehensive loss. For each of the nine months ended September 30, 2025 and 2024, the Company recorded $28,000 in amortization of debt issuance costs to interest expense in the condensed consolidated statements of operations and comprehensive loss. The Company recorded less than $0.1 million to short- and long-term debt issuance costs contra-liabilities as of September 30, 2025.
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2025 |
|
|
2024 |
|
Employee and board compensation |
|
$ |
1,246 |
|
|
$ |
1,812 |
|
Contract research services |
|
|
342 |
|
|
|
773 |
|
Contract manufacturing services |
|
|
— |
|
|
|
9 |
|
Professional services |
|
|
283 |
|
|
|
314 |
|
Total |
|
$ |
1,871 |
|
|
$ |
2,908 |
|
8.
Einstein License Agreement
On January 14, 2015, the Company entered into a license agreement, as amended and restated on July 31, 2017 and as further amended on October 30, 2018, January 13, 2024, and April 10, 2025 (the “Einstein License”), with Albert Einstein College of Medicine (“Einstein”) for certain patent rights relating to the Company’s core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides.
Pursuant to the April 2025 amendment, Einstein consented to the Company’s entry into the Collaboration and License Agreement (the “BI Collaboration and License Agreement”) with Boehringer Ingelheim International GmbH (“BI”) and granted the Company the right to sublicense to BI. In addition, Einstein and the Company agreed to amend specified upstream payment obligations that may be owed to Einstein by the Company, solely in connection with the sublicense to BI.
Under the Einstein License, the Company holds an exclusive worldwide license, with the right to sublicense, import, make, have made, use, provide, offer to sell, and sell all products, processes and services that use the patents covered by the Einstein License, including certain technology received from Einstein relating thereto (the “Einstein Licensed Products”). Under the Einstein License, the Company is required to:
•
Pay royalties and amounts based on a certain percentage of proceeds, as defined in the Einstein License, from sales of Einstein Licensed Products and sublicense agreements.
•
Pay escalating annual maintenance fees, which are nonrefundable, but are creditable against the amount due to Einstein for royalties.
•
Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. Payments made upon achievement of milestones are nonrefundable and are not creditable against any other payment due to Einstein. At September 30, 2025, the Company had made aggregate payments totaling $2.14 million since inception with respect to achievement of these milestones.
•
Incur minimum product development costs until the first commercial sale of the first Einstein Licensed Product.
The Company was in compliance with its obligations under the Einstein License at September 30, 2025 and 2024.
The Einstein License expires upon the expiration of the Company’s last obligation to make royalty payments to Einstein which may be due with respect to certain Einstein Licensed Products, unless terminated earlier under the provisions thereof. The Einstein License includes certain termination provisions if the Company fails to meet its obligations thereunder.
Pursuant to the Einstein License, the Company issued to Einstein 671,572 shares of the Company’s common stock in connection with the consummation of the initial public offering of its common stock on December 27, 2017.
The Company accounts for license fees incurred in connection with the Einstein License in accordance with ASC 730, Research and Development. Please refer to Note 11 Collaboration Revenue.
9.
Stock-Based Compensation
Stock Option Valuation
For stock options requiring an assessment of value during the nine months ended September 30, 2025 and 2024, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions:
|
|
|
|
|
September 30, 2025 |
Risk-free interest rate |
|
3.90% - 4.46% |
Expected dividend yield |
|
0% |
Expected volatility |
|
86.46% - 89.38% |
Expected life |
|
5.50 to 6.72 years |
|
|
|
|
|
September 30, 2024 |
Risk-free interest rate |
|
3.83% - 4.43% |
Expected dividend yield |
|
0% |
Expected volatility |
|
36.24% - 109.86% |
Expected life |
|
5.50 to 8.91 years |
A summary of stock option activity for the nine months ended September 30, 2025 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Life (in Years) |
|
Stock options outstanding at December 31, 2024 |
|
|
10,471,724 |
|
|
$ |
5.61 |
|
|
|
7.27 |
|
Granted |
|
|
4,993,600 |
|
|
|
0.82 |
|
|
|
— |
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Cancelled |
|
|
(1,688,125 |
) |
|
|
6.83 |
|
|
|
— |
|
Stock options outstanding at September 30, 2025 |
|
|
13,777,199 |
|
|
|
3.73 |
|
|
|
7.63 |
|
Stock options exercisable at September 30, 2025 |
|
|
7,228,819 |
|
|
$ |
6.05 |
|
|
|
6.11 |
|
The aggregate intrinsic value of exercisable but unexercised in-the-money stock options at September 30, 2025 was less than $0.1 million based on a weighted average exercise price of $6.05 per share. The aggregate intrinsic value of options is calculated as the difference of the market close price of $0.72 on September 30, 2025, and the weighted average exercise price of $6.05, with a weighted average remaining contractual term of 6.11 years.
Stock-based Compensation
Stock-based compensation for the three and nine months ended September 30, 2025 and 2024 was included in the Company’s condensed consolidated statements of operations and comprehensive loss as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
(in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
General and administrative |
|
$ |
1,104 |
|
|
$ |
843 |
|
|
$ |
2,379 |
|
|
$ |
2,659 |
|
Research and development |
|
|
429 |
|
|
|
740 |
|
|
|
1,755 |
|
|
|
2,625 |
|
Total stock-based compensation |
|
$ |
1,533 |
|
|
$ |
1,583 |
|
|
$ |
4,134 |
|
|
$ |
5,284 |
|
As of September 30, 2025, total unrecognized stock-based compensation expense was $4.2 million, which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.59 years.
As of September 30, 2024, total unrecognized stock-based compensation expense was $7.2 million, which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.02 years.
During the three and nine months ended September 30, 2025, the Company granted stock options to purchase 2.9 million shares of common stock with a weighted average grant date fair value of $0.72 per share and stock options to purchase 4.9 million shares of common stock with a weighted average grant date fair value of $0.82 per share, respectively.
During the three and nine months ended September 30, 2024, the Company granted stock options to purchase 1.7 million shares of common stock with a weighted average grant date fair value of $0.69 per share and stock options to purchase 4.2 million shares of common stock with a weighted average grant date fair value of $1.42 per share, respectively.
On April 14, 2025, the Company entered into the 2025 Underwriting Agreement with Oppenheimer & Co. Inc., as representative of the 2025 Underwriters, relating to an underwritten public offering of (i) 13,530,780 shares of the Company’s common stock, $0.001 par value per share, and accompanying common stock warrants to purchase 3,382,695 shares of the Company’s common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants to purchase 11,469,216 shares of the Company’s common stock and accompanying common stock warrants to purchase 2,867,304 shares of common stock. All of the 2025 Shares and 2025 Warrants were sold by the Company. Each 2025 Share was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.79, and each 2025 Pre-Funded Warrant was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.789, which is equal to the combined offering price per share of common stock and accompanying 2025 Common Stock Warrant less the $0.001 exercise price of each 2025 Pre-Funded Warrant.
The Company received net proceeds from the offering of $18.0 million, after deducting underwriting discounts and commissions and offering expenses of $0.5 million, excluding any proceeds that may be received from exercise of the 2025 Warrants. At September 30, 2025, all of the 2025 Warrants remained outstanding.
On September 26, 2024, the Company entered into the 2024 Underwriting Agreement with Oppenheimer & Co. Inc., as representative of the 2024 Underwriters, relating to an underwritten public offering of (i) 11,564,401 shares of the Company’s common stock, $0.001 par value per share, and accompanying common stock warrants to purchase 2,891,100 shares of common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants to purchase 12,435,599 shares of common stock and accompanying common stock warrants to purchase 3,108,900 shares of common stock. All of the 2024 Shares and the 2024 Warrants were sold by the Company. Each 2024 Share was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.50, and each 2024 Pre-Funded Warrant was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.499, which is equal to the combined offering price per share of common stock and accompanying 2024 Common Stock Warrant less the $0.001 exercise price of each 2024 Pre-Funded Warrant. The Company received net proceeds from the offering of $10.8 million, after deducting underwriting discounts and commissions and offering expenses of $1.2 million, excluding any proceeds that may be received from exercise of the 2024 Warrants. At September 30, 2025, 5,963,500 of the 2024 Common Stock Warrants and 12,435,599 of the 2024 Pre-Funded Warrants remained outstanding.
On November 16, 2022, the Company issued 9,188,406 warrants with an exercise price of $3.93 and a 5-year term (the “2022 Common Stock Warrants”), and 1,531,440 pre-funded warrants at a nominal exercise price of $0.0001 per share (the “2022 Pre-Funded Warrants”). The Company recorded cash received from 7,656,966 shares of common stock, 9,188,406 2022 Common Stock Warrants and 1,531,440 2022 Pre-Funded Warrants to additional paid in capital in the amount of $27.4 million, net of placement fees of $2.6 million during the year ended December 31, 2022. At September 30, 2025, 9,188,406 of the 2022 Common Stock Warrants and zero of the 2022 Pre-Funded Warrants remained outstanding.
Each tranche of warrants was evaluated under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and the Company determined that equity classification was appropriate. The Company determined equity classification for both warrants and pre-funded warrants as they do not embody an obligation for the Company to repurchase its shares and permit the holders to receive a fixed number of shares of common stock upon exercise. Per ASC 815-40-25, the Company accounts for the warrants and pre-funded warrants as equity, as the Company does not provide the holder a fixed or guaranteed return.
The Company recognizes collaboration revenue under certain of the Company’s license or collaboration agreements that are within the scope of ASC 606. The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and if, over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company’s contracts may include options to acquire additional goods and/or services.
The terms of the Company’s arrangements with customers typically include the payment of one or more of the following: (i) non-refundable, up-front payment, and pass through costs related to research activities, (ii) development, regulatory and commercial milestone payments, (iii) future options and (iv) royalties on net sales of licensed products. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of pass through costs and milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Milestone payments that are not within the control of the Company or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, the Company reevaluates the probability of achievement of each milestone and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.
For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any development, regulatory or commercial milestones or royalty revenue resulting from any of its collaboration arrangements. Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception.
The Company allocates the transaction price to each performance obligation identified in the contract on a relative standalone selling price basis, when applicable. However, certain components of variable consideration are allocated specifically to one or more particular performance obligations in a contract to the extent both of the following criteria are met: (i) the terms of the payment relate specifically to the efforts to satisfy the performance obligation or transfer the distinct good or service and (ii) allocating the variable amount of consideration entirely to the performance obligation or the distinct good or service is consistent with the allocation objective of the standard whereby the amount allocated depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services. The Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in each contract. The key assumptions utilized in determining the standalone selling price for each performance obligation may include forecasted revenues, development timelines, estimated research and development costs, discount rates, likelihood of exercise and probabilities of technical and regulatory success.
Revenue is recognized based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good and/or service to the customer. For performance obligations that are satisfied over time, the Company recognizes revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. The Company uses input methods to measure progress toward the complete satisfaction of performance obligations satisfied over time. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. The Company measures progress toward satisfaction of the performance obligation over time as effort is expended.
Collaboration Agreement with LG Chem
On November 6, 2018, the Company entered into a Collaboration, License and Option Agreement (as amended from time to time, the “LG Chem Collaboration Agreement”), with LG Chem Ltd. (“LG Chem”) related to the development of the Company’s CUE-101 and CUE-102 Immuno-STATs focused in the field of oncology. Pursuant to the LG Chem Collaboration Agreement, the Company granted LG Chem an exclusive license to develop, manufacture and commercialize CUE-101, as well as CUE-102 Immuno-STATs that target T cells against two additional cancer antigens, in certain Asian countries (collectively, the “LG Chem Territory”).
Aside from the $6.8 million in milestone payments earned to date, the Company does not believe that any variable consideration should be included in the transaction price as of September 30, 2025. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. For the three and nine months ended September 30, 2025, the Company did not recognize any revenue related to the LG Chem Collaboration Agreement. For each of the three and nine months ended September 30, 2024, the Company recognized revenue of less than $0.1 million related to the LG Chem Collaboration Agreement. The Company did not record short or long-term research and development liabilities on its condensed consolidated balance sheets dated September 30, 2025 and 2024, as the performance obligations have been met and completed. Research and development cost sharing provisions under the agreement expired on March 31, 2022, and thereafter, the Company recognized revenue on intellectual patent filing passthrough costs in the LG Chem Territory.
On March 11, 2025, the Company and LG Chem entered into the Ninth Amendment to the LG Chem Collaboration Agreement. As of the date of the amendment, the Company regained its rights to the LG Chem Territory for the CUE-101 program which had been licensed to LG Chem, and LG Chem terminated all of its rights to the same program. Pursuant to the Ninth Amendment, the Company agreed to make future payments to LG Chem, if and when, one or more potential scenarios related to the CUE-101 program occur up to a predetermined aggregate amount. LG Chem continues to maintain its interest and rights in the CUE-102 program, targeting Wilms’ tumor 1 protein expressing cancers, pursuant to the LG Chem Collaboration Agreement.
Collaboration and Option Agreement with Ono
In February 2023, the Company entered into a strategic collaboration agreement (the "Ono Collaboration and Option Agreement") with Ono Pharmaceutical Co., Ltd. ("Ono") to further develop CUE-401. In March 2025, the Company and Ono agreed to terminate the Ono Collaboration and Option Agreement effective as of March 6, 2025. At such time, the Ono Collaboration and Option Agreement had no further force or effect with the exception of certain customary provisions which are intended to survive termination and expiration of the Ono Collaboration and Option Agreement. The Company retained all rights to CUE-401.
Under the terms of the Ono Collaboration and Option Agreement, Ono paid the Company an upfront payment and agreed to fully fund all research and development activities related to CUE-401 through a specified option period of 24 months (the “Ono Research Term”). Per the agreement, as consideration for the research and development activities performed by the Company, Ono (i) made a one-time, non-refundable, non-creditable upfront payment of $3.0 million to the Company in March 2023 and (ii) agreed to reimburse the Company for all costs incurred in conducting research, including (a) pass through costs from third party contractors and (b) full-time employee salaries capped at $2.1 million in the first 18 months of the Ono Research Term. Subsequently, the Company and Ono agreed to increase this cap for full-time employee salaries to $3.1 million.
As of the date of this report, both Ono and the Company have satisfied all of their performance obligations and made all outstanding payments required under the agreement. For the nine months ended September 30, 2025, the Company recognized revenue of $0.4 million related to the Ono Collaboration and Option Agreement. The Company did not recognize revenue for the three months ended September 30, 2025 related to the Ono Collaboration and Option Agreement. For the three and nine months ended September 30, 2024, the Company recognized revenue of $3.4 million and $7.7 million, respectively, related to the Ono Collaboration and Option Agreement. The Company did not record short or long-term research and development liabilities on its condensed consolidated balance sheet dated September 30, 2025, as the performance obligation has been met and completed. For the year ended December 31, 2024, the Company recorded short-term research and development liabilities on its consolidated balance sheets of $0.1 million.
BI Collaboration and License Agreement
On April 10, 2025, the Company entered into the BI Collaboration and License Agreement to research, develop and commercialize differentiated B cell depletion molecules, including CUE-501.
Under the terms of the BI Collaboration and License Agreement, the Company and BI will conduct collaborative research focused on CUE-501 during the BI Research Term. In addition to, or instead of, CUE-501, BI may elect, at its sole discretion, to include additional or alternative compounds targeted at B cell depletion. BI will have an exclusive, royalty-bearing, worldwide, sublicensable license, under the Company's applicable patents and know-how, to develop, manufacture and commercialize the BI Licensed Products, for all uses, and BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of BI Licensed Products at its expense. During the BI Research Term, the Company is prohibited from developing or commercializing any molecule for applications in B cell depletion.
Pursuant to the terms of the BI Collaboration and License Agreement, the Company received an upfront payment of $10.1 million in cash in the second quarter of 2025, which is net of $1.9 million of German withholding taxes that the Company is seeking to get refunded. The withholding has been recorded as a foreign withholding tax receivable at September 30, 2025 on the Company's condensed consolidated balance sheet. The Company will also be eligible to receive up to an aggregate of approximately $345.0 million in success-based research, development and commercial milestone payments, beginning with two preclinical development milestones, as well as royalty payments on net sales. The royalty payments will be subject to reduction due to patent expiration, payments made under certain licenses for third-party intellectual property and generic competition. BI has agreed to reimburse the Company for agreed upon costs incurred in conducting research during the BI Research Term, including certain pass through costs from third party contractors and full-time employee salaries.
The BI Collaboration and License Agreement will continue, on a product-by-product and country-by-country basis, until the expiration of the applicable royalty term, unless earlier terminated. BI has the right to terminate the BI Collaboration and License Agreement for any reason after a specified notice period. Each party has the right to terminate the BI Collaboration and License Agreement on account of the other party’s bankruptcy or material, uncured breach. In connection with the Company's entry into the BI Collaboration and License Agreement, the Company entered into an amendment to the Company's Einstein License whereby Einstein consented to the Company's entry into the BI Collaboration and License Agreement and granted the Company the right to sublicense to BI. In addition, the Company and Einstein agreed to amend specified upstream payment obligations that may be owed to Einstein by the Company, solely in connection with the sublicense to BI.
For the three and nine months ended September 30, 2025, the Company recognized revenue of $2.1 million and $5.1 million, respectively, related to the BI Collaboration and License Agreement. The Company recorded short-term research and development liabilities of $7.8 million on its condensed consolidated balance sheet as of September 30, 2025.
The Company considered the capitalization of contract costs under the guidance in ASC 340-40, Other Assets and Deferred Costs: Contracts with Customers, as it relates to the BI Collaboration and License Agreement. The Company capitalized license expenses of approximately $1.1 million as of September 30, 2025, paid to Einstein pursuant to the Einstein License Agreement which requires the Company to pay a percentage of sublicenses related to the Company’s patent rights for components of its core technology that is licensed from Einstein. This amount is comprised of approximately $1.1 million of capitalized license expenses related to the up-front payment received from BI in May 2025, net of accumulated amortization of approximately $0.4 million. As of September 30, 2025, $0.7 million was included in prepaid expenses and other short-term assets related to the BI Collaboration and License Agreement.
12.
Commitments and Contingencies
Einstein License Agreement
In 2015, the Company entered into the Einstein License with Einstein for certain patent rights relating to the Company’s core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides. The Company entered into an amended and restated license agreement on July 31, 2017, as amended on October 2018, which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024 and April 10, 2025.
The Company pays $0.1 million in annual maintenance license fees to Einstein, which are amortized equally throughout the year. The Company incurred less than $0.1 million in annual maintenance fees for each of the three and nine months ended September 30, 2025 and 2024.
In the second quarter of 2025, the Company paid Einstein $0.9 million in fees under the amendment to the Einstein License in relation to the BI Collaboration and License Agreement.
The Company’s remaining commitments with respect to the Einstein License are based on the attainment of future milestones. The aggregate amount of milestone payments made under the Einstein License may equal up to $1.85 million for each Einstein Licensed Product, and up to $1.85 million for each new indication of an Einstein Licensed Product. Additionally, the aggregate amount of one-time milestone payments based on cumulative sales of all Einstein Licensed Products may equal up to $5.75 million. The Company is also party to a service agreement with Einstein to support the Company’s ongoing research and development activities.
Collaboration Agreement with LG Chem
See discussion of the LG Chem Collaboration Agreement in Note 11.
Collaboration and Option Agreement with Ono
See discussion of the Ono Collaboration and Option Agreement in Note 11.
Collaboration and License Agreement with BI
See discussion of the BI Collaboration and License Agreement in Note 11.
Contingencies
The Company accrues contingent liabilities to the extent that the liability is probable and estimable. There are no accruals for contingent liabilities in the Company’s condensed consolidated financial statements.
The Company may be subject to various legal proceedings from time to time as part of its business. As of September 30, 2025, the Company was not a party to any legal proceedings or threatened legal proceedings, the adverse outcome of which, individually or in the aggregate, would have a material adverse effect on its business, financial condition or results of operations.
On March 28, 2022, the Company entered into a License Agreement (the “License”) with MIL 40G, LLC (the “Licensor”), pursuant to which the Company leases approximately 13,000 square feet of office, research and development and laboratory space located at 40 Guest Street, Boston, Massachusetts 02135 (the “Office and Laboratory Space”). The Company recognized a right of use asset of $9.1 million and an operating lease liability of $9.1 million which were recorded as of the Term Commencement Date (as defined below) related to the License. The term of the License commenced on April 15, 2022 (the “Term Commencement Date”).
On May 3, 2022, the Company entered into the First Amendment to the License with the Licensor, pursuant to which the License was expanded to include an additional room effective July 15, 2022. On July 7, 2022, the Company entered into an operating lease for additional laboratory space (the “Additional Laboratory Space”) at 40 Guest Street for the period from December 1, 2022 through December 1, 2024 (the “40G Additional Laboratory Lease”).
On November 20, 2024, the Company extended the term of the 40G Additional Laboratory Lease through July 14, 2026. The monthly rental rate for the Additional Laboratory Space is $61,519 through November 30, 2025 and $63,979 for the remainder of the term until July 14, 2026. During the year ended December 31, 2024, the Company recognized a right of use asset of $1.1 million and short-term and long-term operating lease liabilities of $0.7 million and $0.4 million, respectively, using a discount rate of 10%, which were recorded as of the term commencement date of the 40G Additional Laboratory Lease.
On June 30, 2025, the Company entered into the Second Amendment to the License with the Licensor. Pursuant to the Second Amendment, effective June 30, 2025, the monthly rental rate for the Office and Laboratory Space decreased from $235,884 to $147,546, subject to a 4% increase on April 15, 2027, and the term of the License was extended from April 14, 2026 to April 14, 2028. In addition, the Licensor agreed to provide the Company a partial credit of $44,169 for rent the Company had paid at the new monthly rental rate for the month of June 2025.
For each of the three and nine months ended September 30, 2025, the Company recorded $0.1 million in interest expense to the lease liability.
At September 30, 2025, operating lease right-of-use assets totaled $4.6 million. Corresponding operating lease liabilities totaled $4.7 million, of which $2.0 million were recorded in current liabilities, and $2.7 million were recorded in long-term liabilities on the Company’s condensed consolidated balance sheets.
As of both September 30, 2025 and December 31, 2024, security deposits of $0.6 million related to the 40G Additional Laboratory Lease were included in deposits on the Company’s consolidated balance sheets.
Future minimum lease payments under these leases at September 30, 2025 are as follows:
|
|
|
|
|
(in thousands) |
|
2025 (remaining 3 months) |
$ |
630 |
|
2026 |
|
2,228 |
|
2027 |
|
1,884 |
|
2028 |
|
559 |
|
Total lease payments |
|
5,301 |
|
Less: imputed interest |
|
(586 |
) |
Present value of lease payments |
$ |
4,715 |
|
Rent expense of $0.6 million and $2.3 million was included in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025, respectively. Rent expense of $0.9 million and $2.6 million was included in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024, respectively.
The weighted average remaining lease term and discount rate related to the Company's leases were as follows:
|
|
|
|
|
|
|
|
|
September 30, 2025 |
|
|
December 31, 2024 |
|
Weighted average remaining lease term (years) |
|
2.33 |
|
|
|
1.35 |
|
Weighted average discount rate |
|
9.78 |
% |
|
|
6.85 |
% |
On November 6, 2025, ImmunoScape Pte. Ltd. (“IMSCP”) exercised its option (the “Option”) to obtain licenses to research, develop and commercialize molecules from the Company's CUE-100 series, including CUE-101 and CUE-102, subject to certain exclusions (the licensed series of molecules, the “Licensed Program”), for all oncology indications pursuant to a Collaboration and License Agreement, effective November 6, 2025, between the Company and IMSCP (the “Collaboration and License Agreement”). The licenses include a co-exclusive development license for five years or, if longer, for so long as IMSCP has a specified number of CUE-100 series molecules under active development and, pursuant to which, the Company retains non-exclusive research rights to support its other programs (the “co-exclusive development license”). The licenses also include an exclusive commercial license to IMSCP for any CUE-100 series molecule that IMSCP advances to IND-enabling studies while the co-exclusive development license is in effect. The Licensed Program will be further developed and potentially commercialized by IMSCP. The Option was exercised pursuant to an Option Agreement between the Company and IMSCP, dated October 22, 2025 (the “Option Agreement”). In connection with entry into the Option Agreement and IMSCP’s exercise of the Option, the Company received an aggregate of $5.0 million in the fourth quarter of 2025. Pursuant to the Collaboration and License Agreement, the Company is entitled to receive (a) equity of IMSCP equal to 40% of the issued and outstanding equity of IMSCP and additional equity, in the form of warrants, upon certain dilution events in the future, (b) a time-based payment of $5.0 million in or prior to December 2025, (c) an additional time-based payment of $5.0 million before the first anniversary of the effective date of the Collaboration and License Agreement, (d) high single-digit royalties on global net sales and (e) low- to mid-double digit royalties from sublicensing royalties and income. The Collaboration and License Agreement includes customary termination provisions, including IMSCP’s ability to terminate the agreement in its entirety on 60 days’ advanced written notice to the Company.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations of Cue Biopharma, Inc. and its subsidiary (“Cue Biopharma”, “we”, “us”, “our” or the “Company”) should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 31, 2025, or the 2024 Annual Report.
Overview
We are a clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics engineered to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer. Unlike conventional approaches that broadly activate the immune system, our Immuno-STAT® platform is designed to selectively modulate disease-relevant T cells, enhancing efficacy while minimizing off-target effects. We believe our Immuno-STAT platform holds the promise of producing drug product candidates with the potential of establishing new standards of care in the treatment of autoimmune disease and cancer. Our programs include, but are not limited to, drug product candidates designed to:
•
CUE-400 series (Autoimmune Diseases): Exploit transforming growth factor beta (TGF-β) and Interleukin 2 (IL2) signaling to induce an anti-inflammatory process, with a novel and unique mechanism to not only foster proliferation of regulatory T cells (Tregs) but also induce Tregs from T effector cells with the potential of restoring immune balance and functional immune tolerance (e.g., CUE-401 for autoimmune conditions).
•
CUE-500 series (Targeted Cell Depletion): Redirect anti-viral killer T cells to target and eliminate defined pathogenic cells (e.g., CUE-501 for autoimmune B cell depletion, which has been licensed to Boehringer Ingelheim International GmbH).
•
CUE-100 series (Oncology): Selectively activate and expand tumor-specific T cells (e.g., CUE-101 for HPV+ cancers and CUE-102 for Wilms’ tumor 1 protein (WT1), expressing cancers, both of which have been licensed to ImmunoScape Pte. Ltd. for development in oncology indications).
We aim to leverage our differentiated platform to establish new standards of care, forge strategic partnerships, and accelerate clinical development.
As represented in the following image, the Immuno-STAT framework is engineered to be highly flexible and modular, potentially enabling us to deploy the same or similar core functional elements to restore immune balance across diverse therapeutic approaches.
Immuno-STAT Platform Pipeline of Assets for Restoration of Immune Balance In autoimmune disease, Tregs are the master regulators of maintaining immune homeostasis, or balance, and health.

CUE-401
Autoreactive T cells, referred to as T effector cells (Teff cells), are reactive against “self” proteins and foster inflammation and induce chronic tissue damage. Tregs are important to maintaining immune balance in that they possess the ability to dampen and control the Teff cells.
Our lead candidate, CUE-401, is a preclinical, bifunctional fusion protein designed to promote immune tolerance by modulating key components of the immune system, including the induction of newly formed Tregs (iTregs) from Teff cells, as well as expansion of existing or natural regulatory T cells (nTregs). Through the co-activity of engineered variants of TGF-β and IL-2, CUE-401 has the therapeutic potential to re-establish immune balance and induce tolerance across a range of T cell mediated autoimmune and inflammatory diseases.
CUE-401 has been engineered to harness the capacity of TGF-β to re-establish immune balance combined with the complementary signaling of IL-2, to provide an anti-inflammatory environment, as well as Treg induction and expansion for what we believe will provide long-lasting tolerance, which is considered to be the ultimate goal of treating autoimmune disease.
CUE-401, our first-in-class, bifunctional molecule integrating a masked TGF-ß with our clinically validated, attenuated IL-2 variant, is designed to address multiple hurdles to fully exploit the therapeutic potential of an immunology master switch. This novel design provides for “conditional binding” to avoid off target activity and has generated highly differentiated data in multiple preclinical autoimmune animal disease models.
In these preclinical animal models, CUE-401 behaves as a master switch to reduce inflammation as well as convert autoreactive effector T cells into iTregs, which express FoxP3, the hallmark transcription factor that characterizes stable Tregs. These findings suggest that CUE-401 acts by establishing a “tolerance positive feedback loop” that not only increases nonspecific Treg populations but also reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific to the disease-causing autoantigens.
We believe these results, along with advances in the manufacturing of CUE-401, have substantially reduced the risk profile for the development of this program and we have selected a lead candidate molecule. Scale-up manufacturing and other IND-enabling studies for CUE-401 are presently ongoing. We are preparing to file an investigational new drug (IND) application in the second quarter of 2026. We have selected atopic dermatitis as our lead indication for our Phase 1b trial for CUE-401. We anticipate receiving human safety data in the second half of 2026 and human proof-of-concept data in the second half of 2027. These early clinical trial results are anticipated to provide mechanistic evidence and validation further supporting the underlying premise of establishing immune balance and inducing durable immune tolerance, which could represent a potential breakthrough as a new standard of care in multiple high-value autoimmune disease indications.
CUE-500 Series
The CUE-500 series has been developed to enable targeted anti-viral T cell-mediated depletion of pathogenic cell types, including autoreactive B cells. We believe these biologics have the potential to achieve immune balance in autoimmune patients and are significantly differentiated from other competing approaches such as bifunctional antibody drug conjugates, pan-T cell engagers, IL-2 muteins, TNFR2 agonists, and CAR-T therapies.
The CUE-500 series represents a novel approach to selectively target disease-causing cells by redirecting existing anti-viral memory T cells to target and deplete such disease-causing cells. CUE-501, for which we entered into a collaboration and license agreement with Boehringer Ingelheim International GmbH (BI) in April 2025, is being developed to target and deplete autoimmune disease-causing B cells, in patients with autoimmune disease caused by autoreactive, pathogenic B cells. Targeted B cell depletion is widely recognized in the industry as a clinically validated and important approach for the treatment of B cell mediated autoimmune and inflammatory diseases, and we believe the selective mechanism of action exploiting the anti-viral memory T cell repertoire will provide highly effective killing of the targeted cells while preventing or substantially reducing the side effect profile often experienced with competing approaches.
Due to its modularity, we believe that the CUE-500 series has therapeutic potential across multiple disease areas. The mode of redirecting a defined population of already existing anti-viral T cells may apply to many pathogenic cell types readily addressed by swapping different cell-targeting antibody domains into the CUE-500 series framework.
We believe the preclinical data generated to date for CUE-401 and the CUE-500 series demonstrates the intended mechanistic effect of these novel approaches for the potential treatment of autoimmune disease, and each represent potential breakthrough therapeutic opportunities for significant patient populations and potential near-term value creation opportunities for our shareholders.
CUE-100 Series
Historically, we primarily focused our resources on the development of our CUE-100 series for oncology, namely the CUE-101 and CUE-102 drug product candidates, which are representative of our approach to selectively activate targeted CD8+ T cells against cancer, both of which have been licensed to ImmunoScape Pte. Ltd.
While we are prioritizing CUE-401, we are preparing study reports for the CUE-101 and CUE-102 trials. A total of 80 patients were dosed in the CUE-101 Phase 1b open-label study investigating CUE-101 in the treatment of HPV+ recurrent metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), in second line and beyond in patients as a monotherapy, and as a first line therapy in combination with pembrolizumab (KEYTRUDA®). All patient dosing has been completed and post-dose safety follow-up is ongoing for one study patient. Database lock preparations are ongoing with lock expected in the fourth quarter of 2025. In addition, we are enabling an investigator sponsored trial to evaluate CUE-101 as neoadjuvant therapy in locally advanced HPV+ HNSCC.
Additionally, a total of 42 patients were dosed in the CUE-102 Phase 1b clinical trial investigating CUE-102 as a monotherapy in late line R/M WT1+ colorectal, gastric, ovarian, and pancreatic cancer. All patient dosing and post-dose safety follow-up has been completed. Database lock preparations are ongoing with lock expected in the fourth quarter of 2025. In addition, we are enabling an investigator sponsored Phase 1b, open-label study to evaluate CUE-102 in recurrent glioblastoma (rGBM) with the first patient dosed in August 2025.
Key data highlights (data cutoff date of September 17, 2025) from the open-label Phase 1b study of CUE-101 in HPV+ R/M HNSCC include:
•
Overall response rate (ORR) of 50% (2 complete responses and 10 partial responses) in treatment-naïve patients treated with CUE-101 and KEYTRUDA with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with KEYTRUDA alone.
•
12-month overall survival (OS) of 88% compared to 57% with KEYTRUDA alone in the historical KEYNOTE-048 trial, representing an unprecedented reduction in the risk of death (hazard ratio of 0.23) compared to historical data.
•
Median OS of 32.7 months compared to 12.3 months in the historical KEYNOTE-048 trial.
•
ORR of 50% in patients, including 50% with low PD-L1 expression (CPS 1-19).
Plan of Operation
Our approach to developing precision immunotherapies has yielded a growing portfolio of novel proteins with the potential to address multiple unmet needs across autoimmune disease and cancer. We believe that our science is derisked with clinical tolerability and activity from our Phase 1 clinical trials of CUE-101 and CUE-102, with the potential for significant market opportunities. As a result of our insights and learnings from our growing body of supportive data, we believe our corresponding strategic plans position us well to optimize shareholder value.
We intend to maximize this value by focusing on the development of CUE-401, for which we are preparing to file an IND application in the second quarter of 2026. We have also successfully established collaborations across our pipeline, such as our strategic collaboration and license agreements with BI for the development of CUE-501, and ImmunoScape Pte. Ltd. for the development of our CUE-100 series.
As a development-stage company, the majority of our business activities to date have been, and our planned future activities will be, devoted to furthering research and development of our drug product candidates.
Events that Raise Substantial Doubt About Our Ability to Continue as a Going Concern
We will need to raise additional capital to fund our future operations and remain as a going concern. We expect to finance our future cash needs through a combination of equity offerings, collaborations, and other strategic alliances. Volatility in capital markets and general economic conditions in the U.S. may be a significant obstacle to raising the required funds and, as a result, we may be unable to secure the necessary funding on acceptable terms. This raises substantial doubt about our ability to continue as a going concern. For a further discussion of factors that raise substantial doubt about our ability to continue as a going concern, please see “– Liquidity and Capital Resources – Funding Requirements” and Part II. Item 1A, “Risk Factors” herein.
Critical Accounting Estimates and Significant Judgments
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments, including those described below, on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, we believe that the estimates, assumptions and judgments involved in the accounting policies described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our 2024 Annual Report have the greatest potential impact on our financial statements, so we consider those estimates, assumptions and judgments to be our critical accounting policies and estimates. There were no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2025.
Recent Accounting Pronouncements and Adopted Standards
A discussion of recent accounting pronouncements is included in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Significant Contracts and Agreements Related to Research and Development Activities
Einstein License Agreement
On January 14, 2015, we entered into a license agreement, as amended and restated on July 31, 2017, and as further amended on October 30, 2018, January 13, 2024 and April 10, 2025, or the Einstein License, with Albert Einstein College of Medicine, or Einstein, for certain patent rights, or the Patents, relating to our core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides.
We hold an exclusive worldwide license, with the right to sublicense, import, make, have made, use, provide, offer to sell, and sell all products, processes and services that use the Patents, including certain technology received from Einstein related thereto, which we refer to as the Einstein Licensed Products. Under the Einstein License, we are required to:
•
Pay royalties and amounts based on a certain percentage of proceeds, as defined in the Einstein License, from sales of Einstein Licensed Products and sublicense agreements.
•
Pay escalating annual maintenance fees, which are non-refundable, but are creditable against the amount due to Einstein for royalties.
•
Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. As of September 30, 2025, two of these milestones had been achieved, as we had filed an IND application in 2019, and initiated an investigator sponsored Phase 1b neoadjuvant clinical trial for CUE-101 in locally advanced HNSCC in 2021.
•
Incur minimum product development costs per year and meet certain diligence obligations until the first commercial sale of the first Einstein Licensed Product.
On April 10, 2025, we entered into an amendment to the Einstein License. Pursuant to the amendment, Einstein consented to our entry into the BI Collaboration and License Agreement and granted us the right to sublicense to BI. In addition, we and Einstein agreed to amend specified upstream payment obligations that may be owed to Einstein by us, solely in connection with the sublicense to BI. In the second quarter of 2025, we paid Einstein $0.9 million in fees in relation to the amendment to this license with Einstein.
As of September 30, 2025, we were in compliance with our obligations under the Einstein License.
We account for the costs incurred in connection with the Einstein License in accordance with Accounting Standards Codification 730, Research and Development.
We pay $0.1 million in annual maintenance license fees to Einstein, which are amortized equally throughout the year. We incurred less than $0.1 million in annual maintenance fees for each of the three and nine months ended September 30, 2025 and 2024. Such costs are included in research and development costs in our condensed consolidated statements of operations and comprehensive loss.
Collaboration Agreement with LG Chem
On November 6, 2018, we entered into a Collaboration, License and Option Agreement, and as amended from time to time, or the LG Chem Collaboration Agreement, with LG Chem Ltd., or LG Chem, pertaining to the development of CUE-101 and CUE-102 Immuno-STATs focused in the field of oncology.
Pursuant to the LG Chem Collaboration Agreement, we granted LG Chem an exclusive license to develop, manufacture and commercialize CUE-101, as well as CUE-102 Immuno-STATs that target T cells against two additional cancer antigens in certain Asian countries, which we refer to collectively as the LG Chem Territory.
On March 11, 2025, we and LG Chem entered into the Ninth Amendment to the LG Chem Collaboration Agreement, or the Ninth Amendment. As of the date of the Ninth Amendment, we regained our rights to the LG Chem Territory for the CUE-101 program, which had been licensed to LG Chem, and LG Chem terminated all of its rights to the same program. Pursuant to the Ninth Amendment, we agreed to make future payments to LG Chem, if and when one or more potential scenarios related to the CUE-101 program occur, up to a predetermined aggregate amount. LG Chem continues to maintain its interest and rights in the CUE-102 program, targeting WT1 expressing cancers, pursuant to the LG Chem Collaboration Agreement.
We did not recognize any revenue related to the LG Chem Collaboration Agreement for the three and nine months ended September 30, 2025. For each of the three and nine months ended September 30, 2024 we recognized revenue of less than $0.1 million related to the LG Chem Collaboration Agreement. As of September 30, 2025, we had recorded $20.0 million in collaboration revenue related to this agreement since the agreement was entered into. The majority of the research phase of the LG Chem Collaboration Agreement was completed by March 31, 2022.
Collaboration and Option Agreement with Ono
In February 2023, we entered into a strategic collaboration agreement, or the Ono Collaboration and Option Agreement, with Ono Pharmaceutical Co., Ltd., or Ono, to further develop CUE-401. In March 2025, we and Ono agreed to terminate the Ono Collaboration and Option Agreement, effective as of March 6, 2025. At such time, the Ono Collaboration and Option Agreement had no further force or effect with the exception of certain customary provisions which are intended to survive termination and expiration of the Ono Collaboration and Option Agreement.
We retained all rights to CUE-401.
Under the terms of the Ono Collaboration and Option Agreement, Ono paid us an upfront payment and agreed to fully fund all research and development activities related to CUE-401 through a specified option period of 24 months, or the Ono Research Term. Per the agreement, as consideration for the research and development activities performed by us, Ono (i) made a one-time, non-refundable, non-creditable upfront payment of $3.0 million to us in March 2023, and (ii) agreed to reimburse us for all costs incurred in conducting research, including (a) pass through costs from third party contractors and (b) full time employee salaries capped at $2.1 million in the first 18 months of the Ono Research Term. Subsequently, we and Ono agreed to increase this cap for full-time employee salaries to $3.1 million.
As of the date of this report, both we and Ono have satisfied all of our respective performance obligations and made all outstanding payments required under the agreement. For the nine months ended September 30, 2025, we recognized revenue of $0.4 million related to the Ono Collaboration and Option Agreement. We did not recognize revenue for the three months ended September 30, 2025 related to the Ono Collaboration and Option Agreement. For each of the three and nine months ended September 30, 2024, we recognized revenue of $3.4 million and $7.7 million, respectively, related to the Ono Collaboration and Option Agreement. We did not record short or long-term research and development liabilities on our condensed consolidated balance sheet as of September 30, 2025, as the performance obligation has been met and completed. For the year ended December 31, 2024, we recorded short-term research and development liabilities on our consolidated balance sheets of $0.1 million.
BI Collaboration and License Agreement
On April 10, 2025, we entered into a Collaboration and License Agreement with BI, or the BI Collaboration and License Agreement, to research, develop and commercialize differentiated B cell depletion molecules, including CUE-501.
Under the terms of the BI Collaboration and License Agreement, we and BI will conduct collaborative research focused on CUE-501 during a four-year period or, if earlier, the completion of activities under the research plans, or the BI Research Term. In addition to, or instead of, CUE-501, BI may elect, at its sole discretion, to include additional or alternative compounds targeted at B cell depletion. BI will have an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize such compounds and their derivatives, or BI Licensed Products, for all uses, and BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of BI Licensed Products at its expense. During the BI Research Term, we are prohibited from developing or commercializing any molecule for applications in B cell depletion.
Pursuant to the terms of the BI Collaboration and License Agreement, we received an upfront payment of $10.1 million in cash in the second quarter of 2025, which is net of $1.9 million of German withholding taxes that we are seeking to get refunded. We will also be eligible to receive up to an aggregate of approximately $345.0 million in success-based research, development and commercial milestone payments, beginning with two preclinical development milestones, as well as royalty payments on net sales. The royalty payments will be subject to reduction due to patent expiration, payments made under certain licenses for third-party intellectual property and generic competition. BI has agreed to reimburse us for agreed upon costs incurred in conducting research during the BI Research term, including certain pass through costs from third party contractors and full time employee salaries.
The BI Collaboration and License Agreement will continue, on a product-by-product and country-by-country basis, until the expiration of the applicable royalty term, unless earlier terminated. BI has the right to terminate the BI Collaboration and License Agreement for any reason after a specified notice period. Each party has the right to terminate the BI Collaboration and License Agreement on account of the other party’s bankruptcy or material, uncured breach. In connection with our entry into the BI Collaboration and License Agreement, we entered into an amendment to our Einstein License whereby Einstein consented to our entry into the BI Collaboration and License Agreement and granted us the right to sublicense to BI. In addition, we and Einstein agreed to amend specified upstream payment obligations that may be owed to Einstein by us, solely in connection with the sublicense to BI.
For the three and nine months ended September 30, 2025, we recognized revenue of $2.1 million and $5.1 million, respectively, related to the BI Collaboration and License Agreement. We recorded short-term research and development liabilities of $7.8 million on our condensed consolidated balance sheet dated September 30, 2025.
ImmunoScape Collaboration and License Agreement
On November 6, 2025, ImmunoScape Pte. Ltd. (“IMSCP”) exercised its option (the “Option”) to obtain licenses to research, develop and commercialize molecules from the CUE-100 series, including CUE-101 and CUE-102, subject to certain exclusions (the licensed series of molecules, the “Licensed Program”), for all oncology indications pursuant to a Collaboration and License Agreement, effective November 6, 2025, with IMSCP. The licenses include a co-exclusive development license for five years or, if longer, for so long as IMSCP has a specified number of CUE-100 series molecules under active development and, pursuant to which, we retain non-exclusive research rights to support its other programs (the “co-exclusive development license”). The licenses also include an exclusive commercial license to IMSCP for any CUE-100 series molecule that IMSCP advances to IND-enabling studies while the co-exclusive development license is in effect. The Licensed Program will be further developed and potentially commercialized by IMSCP. The Option was exercised pursuant to an Option Agreement between us and IMSCP, dated October 22, 2025 (the “Option Agreement”). In connection with entry into the Option Agreement and IMSCP’s exercise of the Option, we received an aggregate of $5.0 million in the fourth quarter of 2025.
Pursuant to the Collaboration and License Agreement, we are entitled to receive (a) equity of IMSCP equal to 40% of the issued and outstanding equity of IMSCP and additional equity, in the form of warrants, upon certain dilution events in the future, (b) a time-based payment of $5.0 million in or prior to December 2025, (c) an additional time-based payment of $5.0 million before the first anniversary of the effective date of the Collaboration and License Agreement, (d) high single-digit royalties on global net sales and (e) low- to mid-double digit royalties from sublicensing royalties and income. The Collaboration and License Agreement includes customary termination provisions, including IMSCP’s ability to terminate the agreement in its entirety on 60 days’ advanced written notice to us.
Components of Results of Operations
Collaboration Revenue
We have not yet generated commercial revenue from product sales. To date, we have generated revenue from collaboration agreements with BI, IMSCP, LG Chem, Ono (which terminated in March 2025), and Merck Sharp & Dohme Corp. (which terminated in December 2022). Our collaboration revenue may vary from period to period depending on the progress of our work in connection with our collaboration agreements.
Research and Development Expenses
Research and development expenses consist primarily of compensation costs, fees paid to consultants, outside service providers and organizations (including research institutes at universities), facility costs, and development and clinical trial costs with respect to our drug product candidates. We utilize our employee and infrastructure resources across multiple research and development programs, and do not track these costs by project. We believe the attempted allocation of these costs by project would be arbitrary and not meaningful.
Research and development expenses incurred under contracts are expensed ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different pattern of performance is more appropriate. Other research and development expenses are charged to operations as incurred.
Nonrefundable advance payments are recognized as an expense as the related services are performed. We evaluate whether we expect the services to be rendered at each quarter end and year end reporting date. If we do not expect the services to be rendered, the advance payment is recorded as expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the balance sheet. To the extent that a nonrefundable advance payment is for contracted services to be performed within 12 months from the reporting date, such advance is included in current assets; otherwise, such advance is included in non-current assets.
We evaluate the status of our research and development agreements and contracts, and the carrying amount of the related assets and liabilities, at each quarter end and year end reporting date, and adjust the carrying amounts and their classification on the balance sheet as appropriate.
The following table summarizes our research and development expenses by category for the nine months ended September 30, 2025 and 2024 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2025 |
|
|
2024 |
|
|
Employee compensation |
|
$ |
7.7 |
|
|
$ |
9.6 |
|
|
Clinical trial costs |
|
|
3.1 |
|
|
|
5.9 |
|
|
Facilities and overhead |
|
|
3.8 |
|
|
|
3.9 |
|
|
Contract manufacturing costs |
|
|
3.9 |
|
|
|
4.7 |
|
|
Lab costs |
|
|
0.6 |
|
|
|
0.8 |
|
|
Professional fees |
|
|
2.1 |
|
|
|
4.2 |
|
|
Total |
|
$ |
21.2 |
|
|
$ |
29.1 |
|
|
The following table summarizes our research and development expenses by category for the three months ended September 30, 2025 and 2024 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2025 |
|
|
2024 |
|
|
Employee compensation |
|
$ |
2.2 |
|
|
$ |
2.7 |
|
|
Clinical trial costs |
|
|
0.3 |
|
|
|
1.4 |
|
|
Facilities and overhead |
|
|
1.3 |
|
|
|
1.3 |
|
|
Contract manufacturing costs |
|
|
0.2 |
|
|
|
1.2 |
|
|
Lab costs |
|
|
0.1 |
|
|
|
0.2 |
|
|
Professional fees |
|
|
0.7 |
|
|
|
2.6 |
|
|
Total |
|
$ |
4.8 |
|
|
$ |
9.4 |
|
|
General and Administrative Expenses
General and administrative expenses consist of salaries and related expenses for executive, legal, finance, human resources, information technology and administrative personnel, as well as professional fees, insurance costs, and other general corporate expenses. We expect general and administrative expenses to remain consistent in future periods as we continue to incur expenses related to our operation as a public company, which requires our ongoing compliance with certain laws and regulations.
Interest Income
We earn interest income from cash invested in money market funds.
Interest Expense
We incur interest expense from borrowings under our Loan and Security Agreement, as amended, or the Loan Agreement, with Silicon Valley Bank, a division of First Citizens Bank & Trust Company, or SVB.
Results of Operations
Three and Nine Months Ended September 30, 2025 and 2024
Our condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, as discussed herein, are presented below in thousands.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
Collaboration revenue |
|
$ |
2,149 |
|
|
$ |
3,336 |
|
|
$ |
5,524 |
|
|
$ |
7,711 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
4,939 |
|
|
|
2,867 |
|
|
|
12,792 |
|
|
|
10,564 |
|
Research and development |
|
|
4,754 |
|
|
|
9,381 |
|
|
|
21,211 |
|
|
|
29,111 |
|
Loss (gain) on fixed asset disposal |
|
|
51 |
|
|
|
(97 |
) |
|
|
51 |
|
|
|
(97 |
) |
Total operating expenses |
|
|
9,744 |
|
|
|
12,151 |
|
|
|
34,054 |
|
|
|
39,578 |
|
Loss from operations |
|
|
(7,595 |
) |
|
|
(8,815 |
) |
|
|
(28,530 |
) |
|
|
(31,867 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
222 |
|
|
|
343 |
|
|
|
649 |
|
|
|
1,332 |
|
Interest expense |
|
|
(75 |
) |
|
|
(188 |
) |
|
|
(306 |
) |
|
|
(643 |
) |
Total other income, net |
|
|
147 |
|
|
|
155 |
|
|
|
343 |
|
|
|
689 |
|
Net loss |
|
$ |
(7,448 |
) |
|
$ |
(8,660 |
) |
|
$ |
(28,187 |
) |
|
$ |
(31,178 |
) |
Collaboration Revenue
Collaboration revenue decreased by $1.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was due to less revenue earned during the three months ended September 30, 2025 from our BI Collaboration and License Agreement compared to revenue earned during the three months ended September 30, 2024 from our Ono Collaboration and Option Agreement due to the timing of activities pursuant to the respective agreements.
Collaboration revenue decreased by $2.2 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to less revenue earned during the nine months ended September 30, 2025 from our BI Collaboration and License Agreement compared to revenue earned during the nine months ended September 30, 2024 from our Ono Collaboration and Option Agreement due to the timing of activities pursuant to the respective agreements.
General and Administrative Expenses
General and administrative expenses increased by $2.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The increase was primarily due to a one-time employee severance accrual in September of 2025, as well as an increase in professional fees.
General and administrative expenses increased by $2.2 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The increase was primarily due to an increase in professional fees and a one-time employee severance payment, partially offset by a decrease in stock-based compensation.
Research and Development Expenses
Research and development expenses decreased by $4.6 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series, as well as decreases in employee compensation, which includes stock-based compensation.
Research and development expenses decreased by $7.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series, as well as decreases in employee compensation, which includes stock-based compensation.
Interest Income
Interest income decreased by $0.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.
Interest income decreased by $0.7 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.
Interest Expense
Interest expense decreased by $0.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.
Interest expense decreased by $0.3 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.
Liquidity and Capital Resources
We have financed our working capital requirements primarily through private and public offerings of equity securities, cash received from BI, IMSCP, LG Chem, Ono, and Merck Sharp & Dohme Corp. under collaboration agreements, and borrowings under the Loan Agreement.
The amounts that we actually spend for any specific purpose may vary significantly and will depend on a number of factors, including, but not limited to, our research and development activities and programs, clinical testing, regulatory approval, market conditions, and changes in or revisions to our business strategy and technology development plans.
On May 9, 2023, we filed a registration statement on Form S-3, which was declared effective on May 26, 2023 (File No. 333-271786), to register for sale from time to time up to $300 million of our common stock, preferred stock, debt securities, warrants, subscription rights and/or units in one or more offerings.
In October 2021, we entered into an open market sale agreement, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, as agent, to sell shares of our common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering program. The ATM Sales Agreement will terminate upon the earliest of (a) the sale of $80 million of shares of our common stock pursuant to the ATM Sales Agreement or (b) the termination of the ATM Sales Agreement by us or Jefferies. During the three months ended September 30, 2025, we sold 1,334,859 shares of common stock under the ATM Sales Agreement for proceeds of $1.0 million, net of commissions paid, but excluding transaction expenses. During the three months ended September 30, 2024, there were no sales under the ATM Sales Agreement. During the nine months ended September 30, 2025, we sold 2,431,862 shares of common stock under the ATM Sales Agreement for proceeds of $1.8 million, net of commissions paid, but excluding transaction expenses. During the nine months ended September 30, 2024, we sold 1,428,200 shares of common stock under the ATM Sales Agreement for proceeds of $3.4 million, net of commissions paid, but excluding transaction expenses. As of September 30, 2025, we had sold an aggregate of 11,504,093 shares of common stock under the ATM Sales Agreement for proceeds of $42.2 million, net of commissions paid, but excluding transaction expenses, since its inception.
On February 15, 2022, we entered into the Loan Agreement, pursuant to which we have borrowed $10.0 million. The Loan Agreement was amended in April 2023 and October 2024. The term loans under the Loan Agreement, or the Term Loans, bear interest at a floating rate per annum equal to the greater of (A) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.25% and (B) 5.50%. On the first calendar day of each month, we will be required to make monthly interest payments and commencing on June 30, 2023, we began repayment of the Term Loans in (i) 30 consecutive installments of principal plus monthly payments of accrued interest if the additional term loans are not advanced and (ii) 24 months if the additional term loans are advanced. All outstanding principal and accrued and unpaid interest under the Term Loans and all other outstanding obligations with respect to the Term Loans are due and payable in full on December 1, 2025.
The Loan Agreement permits voluntary prepayment of all, but not less than all, of the Term Loans, subject to a prepayment premium except if the facility is refinanced with another First Citizens Bank facility. Such prepayment premium would be 1.00% of the principal amount of the Term Loans. Upon prepayment or repayment in full of the Term Loans, we will be required to pay a one-time final payment fee equal to 5.00% of the original principal amount of any funded Term Loans being repaid. The Loan Agreement, as amended, also requires us to have at all times on deposit in our accounts maintained with SVB, unrestricted and unencumbered cash in an amount equal to the lesser of (i) 100% of the dollar value of our consolidated cash, in the aggregate, at all financial institutions, and (ii) $20,000,000.
On March 10, 2023, SVB was closed and the Federal Deposit Insurance Company, or FDIC, was appointed receiver for the bank. The FDIC created a successor bridge bank, and all deposits of SVB were transferred to the bridge bank under a systemic risk exception approved by the U.S. Department of the Treasury, the Federal Reserve and the FDIC. On March 27, 2023, First Citizens Bank assumed all of SVB’s deposits and certain other liabilities and acquired substantially all of SVB’s loans and certain other assets from the FDIC. First Citizens Bank continues to hold our Term Loans under the same existing terms and covenants which were in place with SVB.
On September 26, 2024, we entered into an underwriting agreement, or the 2024 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2024 Underwriters, relating to an underwritten public offering of (i) 11,564,401 shares, or the 2024 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the2024 Common Stock Warrants, to purchase 2,891,100 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2024 Pre-Funded Warrants, to purchase 12,435,599 shares of our common stock and accompanying 2024 Common Stock Warrants to purchase 3,108,900 shares of common stock. All of the 2024 Shares, the 2024 Pre-Funded Warrants and the 2024 Common Stock Warrants were sold by us. Each 2024 Share was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.50, and each 2024 Pre-Funded Warrant was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.499, which is equal to the combined offering price per share of common stock and accompanying 2024 Common Stock Warrant less the $0.001 exercise price of each 2024 Pre-Funded Warrant. The 2024 Underwriters purchased (i) each 2024 Share and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.47 and (ii) each 2024 Pre-Funded Warrant and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.46906. We recorded net proceeds from the offering of $10.8 million, after deducting underwriting discounts and commissions and offering expenses of $1.2 million, excluding any proceeds that may be received from exercise of the 2024 Common Stock Warrants and the 2024 Pre-Funded Warrants.
On April 14, 2025, we entered into an underwriting agreement, or the 2025 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2025 Underwriters, relating to an underwritten public offering of (i) 13,530,780 shares, or the 2025 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the 2025 Common Stock Warrants to purchase 3,382,695 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2025 Pre-Funded Warrants, to purchase 11,469,216 shares of our common stock and accompanying 2025 Common Stock Warrants to purchase 2,867,304 shares of common stock. All of the 2025 Shares, the 2025 Pre-Funded Warrants and the 2025 Common Stock Warrants were sold by us. Each 2025 Share was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.79, and each 2025 Pre-Funded Warrant was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.789, which is equal to the combined offering price per share of common stock and accompanying 2025 Common Stock Warrant less the $0.001 exercise price of each 2025 Pre-Funded Warrant. The 2025 Underwriters purchased (i) each 2025 Share and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.7426 and (ii) each 2025 Pre-Funded Warrant and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.74166. We received net proceeds from the offering of approximately $18.0 million, after deducting underwriting discounts and commissions and offering expenses of $0.5 million excluding any proceeds that may be received from exercise of the 2025 Common Stock Warrants and the 2025 Pre-Funded Warrants.
Cash Flows
Based on our current plans and forecasted expenses, we believe our existing cash, cash equivalents and marketable securities as of September 30, 2025, as well as the upfront payments we have received and are entitled to receive from IMSCP, will enable us to fund our operations into the third quarter of 2026. However, we will need to raise substantial additional capital to fund our future operations and remain as a going concern. We expect to finance our future cash needs through a combination of equity offerings, collaborations, and other strategic alliances. Volatility in capital markets and general economic conditions in the United States may be a significant obstacle to raising the required funds and, as a result, we may be unable to secure the necessary funding on acceptable terms. This raises substantial doubt about our ability to continue as a going concern.
The following table summarizes our changes in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2025 and 2024 in thousands:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2025 |
|
|
2024 |
|
Net cash provided by (used in): |
|
|
|
|
|
|
Operating activities |
|
$ |
(20,611 |
) |
|
$ |
(27,301 |
) |
Investing activities |
|
|
(6,945 |
) |
|
|
33 |
|
Financing activities |
|
|
16,799 |
|
|
|
11,175 |
|
Net change in cash, cash equivalents, and restricted cash |
|
$ |
(10,757 |
) |
|
$ |
(16,093 |
) |
Operating Activities
Net cash used in operating activities totaled $20.6 million for the nine months ended September 30, 2025 compared to $27.3 million for the nine months ended September 30, 2024. The decrease of $6.7 million was primarily due to decreases in cash outflows from changes in accounts payable, prepaid expense and other current assets, partially offset by increases from changes in research and development contract liabilities.
Investing Activities
Net cash used in investing activities totaled $6.9 million for the nine months ended September 30, 2025 compared to net cash provided by investing activities of less than $0.1 million during the nine months ended September 30, 2024. The increase of $7.0 million in cash used was primarily due to purchases of marketable securities during the nine months ended September 30, 2025.
Financing Activities
Net cash provided by financing activities totaled $16.8 million for the nine months ended September 30, 2025 compared to $11.2 million for the nine months ended September 30, 2024. The increase of $5.6 million was due to proceeds received from our underwriting agreement entered into in April 2025, as well as sales under our ATM Sales Agreement during the nine months ended September 30, 2025.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our Immuno-STAT platform and continue ongoing and initiate new clinical trials of and seek marketing approval for our drug product candidates. In addition, we expect to incur additional costs associated with operating as a public company. Our expenses will also increase if, and as, we:
•
continue the preclinical development of CUE-401 and the CUE-500 series (excluding CUE-501, which has been licensed to BI);
•
continue to assess maturing clinical data of our CUE-100 series, including CUE-101 and CUE-102, which we have deprioritized and which have been licensed to IMSCP for development in oncology indications;
•
leverage our autoimmune and cancer programs to advance our other drug product candidates into preclinical and clinical development;
•
seek regulatory approvals for any drug product candidates for which we successfully complete clinical trials;
•
seek to discover and develop additional drug product candidates;
•
establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any drug product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
•
expand our manufacturing, quality, operational, financial and management systems, including personnel to support these functions;
•
maintain, expand and protect our intellectual property portfolio;
•
acquire or in-license other drug product candidates and technologies; and
•
incur additional legal, accounting and other expenses in operating as a public company.
Under Accounting Standards Update, or ASU, 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40), or, ASC 205-40, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the financial statements are issued. Under ASC 205-40, this evaluation initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. We currently believe that our existing cash, cash equivalents and marketable securities, as of September 30, 2025, along with the upfront payments we have received and are entitled to receive from IMSCP will allow us to fund operations into the third quarter of 2026. As a result, we have determined that this cash runway of less than 12 months from the date of issuance of our financial statements included in this Quarterly Report on Form 10-Q, along with our accumulated deficit, history of losses, and future expected losses meet the ASC 205-40 standard for raising substantial doubt about our ability to continue as a going concern within one year of the issuance date of our financial statements included in this Quarterly Report on Form 10-Q.
While we have plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, and cash expenditure reduction, there is no guarantee that we will be successful in these mitigation efforts.
We will need to raise additional capital or incur additional indebtedness to continue to fund our operations in the near term. Our ability to raise additional funds will depend on financial, economic and market conditions, many of which are outside of our control, and we may be unable to raise financing when needed, or on terms favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market drug product candidates that we would otherwise prefer to develop and market ourselves, which could adversely affect our business prospects, and we may be unable to continue our operations. Because of numerous risks and uncertainties associated with the research, development and commercialization of our drug product candidates, we are unable to estimate the exact amount of our working capital requirements. Factors that may affect our planned future capital requirements and accelerate our need for additional working capital include the following:
•
the progress, timing, scope and costs of our clinical trials, including the ability to timely enroll patients in our ongoing, planned and any future clinical trials;
•
the outcome, timing and cost of regulatory approvals by the FDA and other comparable regulatory authorities, including the potential that the FDA or other comparable regulatory authorities may require that we perform more studies than those that we currently expect;
•
the number and characteristics of drug product candidates that we may in-license and develop;
•
our ability to successfully commercialize our drug product candidates, if approved;
•
the amount of sales and other revenues from drug product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party reimbursement;
•
selling and marketing costs associated with our potential products, including the cost and timing of expanding our marketing and sales capabilities;
•
the terms and timing of any potential future collaborations, licensing or other arrangements that we may establish;
•
cash requirements of any future acquisitions and/or the development of other drug product candidates;
•
the costs of operating as a public company;
•
the cost and timing of completion of commercial-scale, outsourced manufacturing activities;
•
the time and cost necessary to respond to technological and market developments;
•
the impact of government laws and regulations, general economic and market conditions, inflation, and the imposition of new or revised global trade tariffs;
•
any disputes which may occur between us and our employees, collaborators, including Einstein, LG Chem, BI and IMSCP, or other prospective business partners; and
•
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
A change in the outcome of any of these or other variables with respect to the development of any of our drug product candidates could significantly change the costs and timing associated with the development of that drug product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties and grants from organizations and foundations. If we raise additional funds by selling shares of our common stock or other equity-linked securities, the ownership interest of our current stockholders will be diluted. New investors may demand rights, preferences or privileges senior to those of existing holders of our common stock. If we issue debt securities, we may be required to grant security interests in our assets, could have substantial debt service obligations, and lenders may have a senior position (compared to stockholders) in any potential future bankruptcy or liquidation.
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. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or drug product candidates or to grant licenses on terms that may not be acceptable to us. Additionally, corporate collaboration and licensing arrangements may require us to incur non-recurring and other charges, give up certain rights relating to our intellectual property and research and development activities, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, issue debt which may require liens on our assets and which will increase our monthly expense obligations, or disrupt our management and business.
If we are unable to raise additional capital when needed, we may be required to curtail the development of our technology or materially curtail or reduce our operations. We could be forced to sell or dispose of our rights or assets. Any inability to raise adequate funds on commercially reasonable terms could have a material adverse effect on our business, results of operation and financial condition, including the possibility that a lack of funds could cause our business to fail, dissolve and liquidate with little or no return to investors.
Principal Commitments
There have been no material changes to our contractual obligations and commitments as described in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our 2024 Annual Report. Additional information regarding the BI Collaboration and License Agreement, the amendment to our Einstein License, and the second amendment to our License Agreement with MIL 40G, LLC, may be found in Notes 11 and 13 to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide the information required by this Item 3.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We are responsible for maintaining disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, or the Exchange Act. Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act, our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective as of September 30, 2025, the end of the period covered by this report.
Inherent Limitations on Effectiveness of Controls
Our management, including our principal executive officer and our principal financial officer, do not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of control effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings.
ITEM 1A. RISK FACTORS
We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. In evaluating us and our business, you should carefully consider the following risks, the information included in this Quarterly Report on Form 10-Q and in other documents we file with the SEC and the risk factors previously disclosed in Part I. Item 1A, “Risk Factors” of our 2024 Annual Report.
Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.
We have incurred significant losses since our inception and have never generated revenue or profit from product sales, and it is possible we will never generate revenue or profit from product sales. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $18.7 million. Based on our current operating plans, and the upfront payments we have received and are entitled to receive from IMSCP, we believe we will have sufficient funds to meet our obligations into the third quarter of 2026. However, we will need to raise substantial additional capital to fund our future operations. There can be no assurance that we will be able to obtain additional funding, including through a combination of equity offerings, collaborations, and other strategic alliances, or other sources on acceptable terms, if at all. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which dilution may be significant. We cannot guarantee that we will be able to obtain any or sufficient additional funding or that such funding, if available, will be obtainable on terms satisfactory to us. In the event that we are unable to obtain any or sufficient additional funding, there can be no assurance that we will be able to continue as a going concern, and we will be forced to delay, reduce or discontinue our product development programs or consider other various strategic alternatives.
Moreover, these factors raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If existing or potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.
Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
This past spring, the Trump Administration initiated a series of tariff-related actions against U.S. trading partners. On April 2, 2025, the President issued an Executive Order announcing a “baseline” reciprocal tariff of 10% on all U.S. trading partners effective April 5, 2025, and higher individualized reciprocal tariffs on 57 countries (with certain product exemptions for pharmaceutical-related products, among others). Previously, the administration had imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement, or USMCA, and tariffs equaling 20% on China. In response, several countries threatened retaliatory measures, including Canada and China, which then imposed retaliatory tariffs. Prior to when the country-specific reciprocal tariffs were scheduled to take effect, the administration delayed the effective date of such tariffs for all countries except China to August 1, 2025. Later, the U.S. and China reached a framework agreement that ultimately resulted in the suspension of the higher reciprocal tariffs on China until November 11, 2025. Since the April announcement, several countries including, the European Union, Japan, South Korea and the United Kingdom, among others, have reached deals with the U.S. that include reduced tariff rates to varying levels and other measures. On July 31, 2025, the President issued an executive order detailing new reciprocal tariff rates for individual countries that took effect on August 7, 2025. The new reciprocal rates, which are consistent with the rates reflected in the trade deals already announced, range from 10% to 41%. The new rates do not apply to Canada, China, Mexico and a few other countries. For China, the 10% baseline reciprocal tariff announced in April remains in effect, in addition to a minimum of an additional 20%. Regarding Canada and Mexico, the rate remains 25% for goods that are not covered by the USMCA for Mexico and, effective August 1, 2025, was increased to 35% on imports from Canada that are not covered by the USMCA. Sustained uncertainty about, or the further escalation of, trade and political tensions between the U.S.
and China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S. based companies, including retaliatory restrictions that hinder or potentially inhibit our ability to rely on CMOs and other service providers that operate in China. Certain countries have reached agreements with the U.S. that cap pharmaceutical tariffs at 15%. These include the European Union, Japan, South Korea and the United Kingdom.
Separately, in April 2025, the U.S. Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S. national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. On September 25, 2025, via a post on Truth Social, the President announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S. would face a 100% tariff. At the same time, the President indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S. Thereafter, the President delayed the October 1st effective date of the tariffs on branded or patented pharmaceutical products announcing that the administration had now “begun preparing” tariffs on manufacturers that don’t build in the U.S. or enter into a most-favored-nation (MFN) drug pricing agreement with the Trump Administration.
As a result of changes in tariffs that have been announced and/or implemented, and the underlying uncertainty currently surrounding international trade, we could experience a negative impact to our costs of materials and production processes, and supply chain disruptions and delays as a result of any new tariff policies or trade restrictions. If we are unable to obtain necessary raw materials or product components in sufficient quantity and in a timely manner due to disruptions in the global supply chain caused by macroeconomic events and conditions, the development, testing and clinical trials of our product candidates may be delayed or infeasible, and regulatory approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business. We cannot yet predict the effect of the recently imposed U.S. tariffs on imports, or the extent to which other countries will impose quotas, duties, tariffs, taxes or other similar restrictions upon imports or exports in the future, nor can we predict future trade policy or the terms of any renegotiated trade agreements and their impact on our business.
Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.
Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at any time, which could affect our business or financial condition, including causing potentially adverse impacts to our effective tax rate, tax liabilities, and cash tax obligations. For example, the Inflation Reduction Act, or IRA, was signed into law in August 2022, and the One Big Beautiful Bill Act, or OBBBA, was signed into law in July 2025. The IRA introduced new tax provisions, including a one percent excise tax imposed on certain stock repurchases by publicly traded companies. The one percent excise tax generally applies to any acquisition of stock by the publicly traded company (or certain of its affiliates) from a stockholder of the company in exchange for money or other property (other than stock of the company itself), subject to a de minimis exception. Thus, the excise tax could apply to certain transactions that are not traditional stock repurchases. The OBBBA contains numerous tax provisions that we are currently in the process of evaluating, and which may significantly affect our business or financial condition. The recent changes under the OBBBA include tax rate extensions and changes to the business interest deduction limitation, the expensing of domestic research and development expenditures (in contrast to the continued capitalization and amortization of foreign research and development expenditures), the bonus depreciation deduction rules, and the international tax framework. Regulatory guidance under the IRA, the OBBBA, and other tax-related legislation is and continues to be forthcoming, and such guidance could ultimately increase or lessen the impact of these laws on our business and financial condition. In addition, it is uncertain if and to what extent various states will conform to changes to federal tax legislation.
If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
We are required to comply with the continued listing requirements of the Nasdaq Stock Market LLC, or Nasdaq, including, among other things, maintaining a minimum closing bid price of at least $1.00 per share, or the Minimum Bid Requirement, or shares of our common stock may be subject to delisting, which would have a material adverse effect on our business.
On May 12, 2025, we received a deficiency letter, or the Notice, from the Listing Qualifications Department, or the Staff, of Nasdaq indicating that we failed to comply with the Minimum Bid Requirement. The Notice had no immediate effect on the listing of our common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had an initial period of 180 calendar days (which expired on November 10, 2025) to regain compliance with the Minimum Bid Requirement.
Thereafter, on November 11, 2025, we received a written notice from the Staff granting us an additional 180 calendar day compliance period (until May 11, 2026), or the Second Compliance Period, to regain compliance with the Minimum Bid Requirement.
We intend to actively monitor the closing bid price of our common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. If at any time during the Second Compliance Period the closing bid price of our common stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Staff will provide us with written confirmation of compliance and the matter will be closed, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). We have provided written notice to Nasdaq of our intention to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary. If we fail to regain compliance with the Minimum Bid Requirement, by effecting a reverse stock split or otherwise, our common stock may be delisted. This potential delisting, and any other potential delisting, of our common stock could have a material adverse effect on the market for, and liquidity and price of, our common stock and would adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting from Nasdaq could also have other negative results, including, without limitation, the potential loss of confidence by investors, customers and employees and fewer business development opportunities. Any delisting of our common stock from Nasdaq would also make it more difficult for our stockholders to sell their shares of our common stock in the public market.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
(a)
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
On May 12, 2025, we received a deficiency letter, or the Notice, from the Listing Qualifications Department, or the Staff, of Nasdaq indicating that we failed to comply with the Nasdaq continued listing requirement to maintain a minimum closing bid price of at least $1.00 per share, or the Minimum Bid Requirement. The Notice had no immediate effect on the listing of our common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had an initial period of 180 calendar days (which expired on November 10, 2025) to regain compliance with the Minimum Bid Requirement.
Thereafter, on November 11, 2025, we received a written notice from the Staff granting us an additional 180 calendar day compliance period (until May 11, 2026), or the Second Compliance Period, to regain compliance with the Minimum Bid Requirement.
We intend to actively monitor the closing bid price of our common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. If at any time during the Second Compliance Period the closing bid price of our common stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Staff will provide us with written confirmation of compliance and the matter will be closed, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). We have provided written notice to Nasdaq of our intention to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary.
(c) Director and Officer Trading Arrangements
None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.
ITEM 6. EXHIBITS
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Incorporated by Reference |
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Exhibit
Number
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Exhibit Description |
Filed
Herewith
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Form |
Exhibit |
Filing Date |
Registration/File No. |
10.1# |
Executive Employment Agreement, dated September 28, 2025, between the Registrant and Usman Azam |
X
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10.2# |
Separation and Release of Claims Agreement, dated September 27, 2025, between the Registrant and Daniel Passeri |
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10.3# |
Advisor Agreement, dated September 27, 2025, between the Registrant and Daniel Passeri |
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31.1 |
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 |
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32.1 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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101.SCH |
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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104 |
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, has been formatted in Inline XBRL. |
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# Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
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.
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Cue Biopharma, Inc. |
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Dated: November 12, 2025 |
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By: |
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/s/ Usman Azam |
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Usman Azam
President and Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer)
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EX-10.1
2
cue-ex10_1.htm
OZ EMPLOYMENT AGREEMENT
EX-10.1
Exhibit 10.1
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
CUE BIOPHARMA, INC.
EXECUTIVE EMPLOYMENT AGREEMENT
This Executive Employment Agreement (the “Agreement”) is made by and between Cue Biopharma, Inc., a Delaware corporation (“Cue” or the “Company”), and Usman Azam, M.D.
(“Executive,” and together with Cue, the “Parties”).
WHEREAS, the Company and Executive desire to enter into this Agreement to set forth the conditions under which the Executive is to be employed by the Company.
NOW, THEREFORE, in consideration of the foregoing, of the mutual promises contained herein and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
(a)
As of the Effective Date, Cue shall employ the Executive as President and Chief Executive Officer (“President and CEO”) and the Executive shall have such duties and authority commensurate with the position and such other duties commensurate with the positions that may be assigned by the Board of Directors of Cue (the “Board”).
(b)
Executive shall report directly to the Chairman of the Board.
(c)
Executive, upon being duly elected, shall also serve as a member of the Board or as an officer or director of any Affiliate (as defined below) for no additional compensation
(d)
Executive shall devote all of Executive’s business time, energy, judgment, knowledge and skill and Executive’s best efforts to the performance of Executive’s duties with Cue, provided that the foregoing shall not prevent Executive from (i) participating in charitable, civic, educational, professional, community or industry affairs or (ii) managing Executive’s passive personal investments, so long as such activities in the aggregate do not interfere or conflict with Executive’s duties hereunder or create a potential business or fiduciary conflict.
2.
EFFECTIVE DATE and TERM.
This Agreement shall have an Effective Date that begins on September 29th, 2025, (the “Effective Date”) and continues in effect for no less than two years and, unless terminated sooner as herein provided, shall continue on a year-to-year basis after the Initial Term (each year, a “Renewal Term,” and each Renewal Term together with the Initial Term, the “Term”). If either Party elects
not to renew this Agreement, that Party must give a written notice of non-renewal to the other Party at least 30 days before the expiration of the then-current Initial Term or Renewal Term. In the event that one Party provides the other with a notice of non-renewal pursuant to this Section 2, no further automatic extensions shall occur and this Agreement shall terminate at the end of the then-existing Initial Term or Renewal Term, as applicable, and any such non-renewal shall be deemed to be a termination of Executive’s employment by Cue without Cause and Executive shall be entitled to receive the payments set forth in Section 8(c) below.
3.
BASE SALARY. During Executive’s employment with the Company, Cue shall initially pay the Executive a base salary (“Base Salary”) of $620,000 annually, payable in accordance with the regular payroll practices of Cue. The Base Salary shall be subject to all applicable taxes and withholdings. In addition, the Base Salary shall be subject to periodic review and may be adjusted from time to time by the Company, provided however, that the Base Salary shall not be reduced during the Term unless mutually agreed by the Parties.
4.
ANNUAL BONUS. Executive shall be eligible to receive an annual incentive bonus (the “Annual Bonus”), subject to achievement of key performance indicators for Cue, with the level of achievement, the key performance indicators, and actual amount of the Annual Bonus determined by the Compensation Committee of the Board or its delegate (the “Committee”) in its sole discretion. Executive’s target Annual Bonus for each calendar year shall be up to fifty percent (50%) of the Base Salary. Any Annual Bonus awarded to the Executive shall be paid by the Company as scheduled by management, provided that no Annual Bonus shall be considered earned until the Board makes all necessary determinations with respect to the Annual Bonus.
5.
STOCK OPTIONS. As consideration for the noncompetition restrictions referenced in Section 10(b), on the Effective Date, Executive shall be granted an Option (as defined in the Cue Biopharma, Inc. 2025 Stock Incentive Plan (the “Plan”)) to purchase 2,250,000 shares of Cue’s Common Stock (the “Option”). The exercise price per share of the Option shall be equal to the Fair Market Value (as defined in the Plan) of a share of Common Stock as of the Grant Date (as defined in the Plan). The Option shall have a term that expires ten years from the Grant Date. The Option shall be subject to the terms and conditions applicable to Options granted under the Plan and the applicable Award Agreement (as defined in the Plan), and the terms of the Award Agreement, shall not be inconsistent with this Agreement (provided that in the event of any conflict between this Agreement and the Plan the terms of the Plan shall control). The Option shall become vested and exercisable based upon continuous Service (as that term is defined in the Plan) with respect to 1,875,000 shares in 48 monthly installments of 39,062.50 shares beginning on the first anniversary of the Grant Date, and the Option shall become vested and exercisable with respect to an additional 375,000 shares if, prior to the first anniversary of the Grant Date, the Company [**].
(a)
BENEFIT PLANS. During the Executive’s employment with Cue, Executive shall be eligible to participate, in accordance with and subject to any terms and conditions thereof, any employee benefit plans that Cue has adopted or may adopt, maintains or contributes to for the benefit of its employees generally, except to the extent such plans are duplicative of the benefits otherwise provided to Executive hereunder.
Executive’s participation shall be subject to the applicable plan documents and generally applicable Cue policies. Notwithstanding the foregoing, Cue may modify or terminate any employee benefit plan at any time.
(b)
HOLIDAYS/PERSONAL TIME OFF/SICK TIME. During the Executive’s employment with Cue, the Executive shall be eligible for the public holidays on which the business of the Company is officially closed in accordance with the Company’s holiday policy. During the Term, Executive shall be entitled to paid vacation time in accordance with Cue’s policy applicable to senior management employees as in effect from time to time. Finally, the Executive shall be entitled to one week (5 business days) of personal and sick days each year, which may be used for doctor appointments, religious observances, personal matters, and all other reasons permitted for personal and sick days as set forth in the Company’s Employee Handbook.
(c) BUSINESS EXPENSES. Upon presentation of reasonable substantiation and documentation as Cue may require from time to time, Executive shall be reimbursed in accordance with Cue’s expense reimbursement policy, for all reasonable out-of-pocket business expenses incurred and paid by Executive during his employment with the Company and in connection with the performance of Executive’s duties hereunder.
(d) INDEMNIFICATION AND INSURANCE. The Company shall provide the Executive with indemnification, the advancement of expenses and insurance coverage to the fullest extent provided under the Company’s bylaws and to the fullest extent provided to other C-Suite executives of the Company.
7.
TERMINATION. Executive’s employment under this Agreement shall terminate on the first to occur of the following:
(a)
DISABILITY. Upon 30 days’ prior written notice by Cue to Executive of termination due to Disability while a Disability exists. “Disability” shall mean Executive is unable to perform the essential duties of Executive’s position by reason of a medically determinable physical or mental impairment that is potentially permanent in character or that can be expected to last for a continuous period of not less than 12 months from the start of such Disability.
(b)
DEATH. Automatically upon the death of Executive.
(c)
CAUSE. Immediately upon written notice by Cue to Executive of a termination for Cause. “Cause” shall mean a good faith determination by the Board of:
(i)
the commission of any act by Executive constituting financial dishonesty against Cue or its Affiliates, which act would be chargeable as a felony under applicable law;
(ii)
Executive’s engaging in any other act of fraud, intentional and material misrepresentation, moral turpitude, illegality, discrimination, harassment, or retaliation that would (a) materially adversely affect the business or the reputation of Cue or any of its Affiliates with their respective current or prospective customers, suppliers, lenders or other third parties with whom such entity does or might do business or (b) expose Cue or any of its Affiliates to a risk of civil or criminal legal damages, liabilities or penalties; the repeated and material failure by Executive to follow the reasonable and lawful directives of the CEO or the Board;
(iv)
any material misconduct, material and willful violation of Cue’s or its Affiliates’ written policies applicable to Executive, or willful and deliberate breach of duty by Executive in connection with the business affairs of Cue or its Affiliates; or
(v)
Executive’s material breach of this Agreement.
Executive shall be given written notice detailing the specific Cause event and a period of 10 days following Executive’s receipt of such notice to cure such event (if susceptible to cure, as determined by the Board) to the reasonable satisfaction of the Board. Notwithstanding anything to the contrary contained herein, Executive’s right to cure as set forth in the preceding sentence shall not apply if there are habitual or repeated breaches by Executive. A termination for Cause shall be deemed to include a determination by the Board or its designee following Executive’s termination of service that circumstances existing prior to such termination would have entitled Cue to have terminated Executive for Cause, in which case Executive shall be treated as a Bad Leaver in accordance with Section 10(g). All rights Executive has or may have under this Agreement (including as set forth in Section 10(d) below) shall be suspended automatically during the pendency of any investigation by the Board or its designee, or during any negotiations between the Board or its designee and Executive, regarding any actual or alleged act or omission by Executive of the type described in this definition of Cause. For purposes of the foregoing, no act, or failure to act or refusal to act, on the part of Executive shall be considered “willful” unless it is done, or omitted to be done, by Executive in bad faith or without reasonable belief that Executive’s action or omission was in the best interests of Cue.
(d)
GOOD REASON. Upon written notice by Executive to Cue of a termination for Good Reason. “Good Reason” shall mean the occurrence of any of the following events, without the consent of Executive, unless such events are fully corrected in all material respects by Cue within 30 days following written notification by Executive to Cue of the occurrence of one of the events:
(i) a material diminution in Executive’s Base Salary or Annual Bonus opportunity in a manner that is not applied proportionately to all other senior executive officers of the Company;
(ii) a material diminution in Executive’s authority, responsibilities or duties set forth in Section 1 above, other than temporarily while physically or mentally incapacitated, as required by applicable law;
(iii) a relocation of Executive’s primary work location by more than 50 miles from its then current location (unless mutually agreed);
(iv) a requirement that Executive report to anyone other than the Chairman of the Board or the Board; or
(v) a material breach by Cue of a material term of this Agreement.
Executive shall provide Cue with a written notice detailing the specific circumstances alleged to constitute Good Reason within 30 days after the first occurrence of such circumstances, and actually terminate employment within 30 days following the expiration of Cue’s 30-day cure period described above (subject to the Company’s correction of the grounds for Good Reason within such cure period). Otherwise, any claim of such circumstances as Good Reason shall be deemed irrevocably waived by Executive.
(e)
WITHOUT CAUSE. Immediately upon written notice by Cue to Executive of an involuntary termination without Cause (other than for death or Disability).
(f)
VOLUNTARY TERMINATION. Upon 60 days’ prior written notice by Executive to Cue of Executive’s voluntary termination of employment without Good Reason (which Cue may make effective earlier than any notice date).
(g)
EXPIRATION OF TERM. Immediately upon expiration of the Term as set forth in Section 2 (unless such term has been extended in writing by the Parties).
8.
CONSEQUENCES OF TERMINATION.
(a)
DEATH/DISABILITY. In the event that Executive’s employment ends on account of Executive’s death or Disability, Executive or Executive’s estate, as the case may be, shall be entitled to the following (with the amounts due under Sections 8(a)(i) through 8(a)(iv) below to be paid within 60 days following termination of employment, or such earlier date as may be required by applicable law):
(i)
any unpaid Base Salary through the date of termination;
(ii)
any Annual Bonus for the year prior to the year in which such termination occurs that is earned but unpaid prior to the date of termination, to be paid pro-rata for the period of time from the start of the year to the date of termination from employment (or, if applicable, to the start of the Disability), paid when annual bonuses are paid to actively employed employees of Cue;
(iii)
reimbursement for any unreimbursed business expenses incurred through the date of termination; and
(iv)
all other payments, benefits or fringe benefits to which Executive shall be entitled under the terms of any applicable compensation arrangement or benefit, equity or fringe benefit plan or program or grant (collectively, Sections 8(a)(i) through 8(a)(v) hereof shall be hereafter referred to as the “Accrued Benefits”).
(b)
TERMINATION FOR CAUSE; UPON RESIGNATION WITHOUT GOOD REASON; UPON EXPIRATION OF TERM. If Executive’s employment is terminated (i) by Cue for Cause; (ii) by Executive without Good Reason; or (iii) upon expiration of the Term, Cue shall pay to Executive within 60 days following termination of employment, or such earlier date as may be required by applicable law:
(i)
any unpaid Base Salary through the date of termination;
(ii)
reimbursement for any unreimbursed business expenses incurred through the date of termination; and
(iii)
all other payments, benefits or fringe benefits to which Executive shall be entitled under the terms of any applicable compensation arrangement or benefit, equity or fringe benefit plan or program or grant.
(c)
TERMINATION WITHOUT CAUSE OR RESIGNATION FOR GOOD REASON. If Executive’s employment by Cue is terminated (i) by Cue other than for Cause, for Executive’s death or Disability, or upon expiration of the Term, or (ii) by Executive for Good Reason, Cue shall pay or provide Executive the following:
(ii)
subject to Executive’s compliance with Section 9 below and Executive’s continued compliance with Section 10 below, and subject to Section 20, a lump sum cash severance payment in an amount equal to the sum of 12 months of Base Salary plus the target Annual Bonus for the year of termination, prorated based on the number of days that Executive is employed in such year through the date of termination, with such lump sum payable on the first payroll date of Cue that occurs more than 60 days after Executive’s termination or resignation (collectively, the “Severance Amount”); and;
(iii)
subject to Executive’s compliance with Section 9 below and Executive’s continued compliance with Section 10 below, if Executive elects COBRA coverage for health and/or dental insurance in a timely manner, the Company shall pay the monthly premium payments for such timely elected coverage (consistent with what was in place at termination) when each premium is due until the earliest of the following: (i) twelve months from termination; (ii) the expiration of the Term; (iii) the date Executive obtains new employment that offers health and/or dental insurance that is reasonably comparable to that offered by the Company; or (iv) the date COBRA continuation coverage would otherwise terminate in accordance with the provisions of COBRA.
Payments and benefits provided under this Section 8(c) shall be in lieu of any termination or severance payments or benefits to which Executive may be eligible under any of the plans, policies or programs of Cue or any similar state statute or regulation. Should Executive die prior to the payment of the Severance Amount, the Severance Amount shall be paid to the heirs or estate of Executive in accordance with the schedule set forth herein.
(d)
OTHER OBLIGATIONS. Upon any termination of Executive’s employment with Cue, Executive shall automatically be deemed to have resigned from any and all other positions the Executive then holds as an officer, director or fiduciary of Cue and any other entity that is part of the same consolidated group as Cue or in which capacity Executive serves at the direction of or as a result of Executive’s position with Cue; and Executive shall, within 10 days of such termination, take all actions as may be necessary under applicable law or requested by Cue to effect any such resignations.
(e)
EXCLUSIVE REMEDY. The amounts payable to Executive following termination of employment hereunder pursuant to Sections 8(a), (b) and (c) above shall be in full and complete satisfaction of Executive’s rights under this Agreement and any other claims that Executive may have in respect of Executive’s employment with Cue or any of its Affiliates, and Executive acknowledges that such amounts are fair and reasonable, and are Executive’s sole and exclusive remedy, in lieu of all other remedies at law or in equity, with respect to the termination of Executive’s employment hereunder or any breach of this Agreement.
(f)
NO MITIGATION OR OFFSET. Executive shall not be required to seek or accept other employment or otherwise to mitigate damages as a condition to the receipt of benefits pursuant to this Section 8, and amounts payable pursuant to this Section 8 shall not be offset or reduced by any amounts received by Executive from other sources.
(g)
NO WAIVER OF ERISA-RELATED RIGHTS. Nothing in this Agreement shall be construed to be a waiver by Executive of any benefits accrued for or due to Executive under any employee benefit plan (as such term is defined in the Employee Retirement Income Security Act of 1974, as amended) maintained by Cue, if any, except that Executive shall not be entitled to any severance benefits pursuant to any severance plan or program of Cue other than as provided herein.
(h)
CLAWBACK. All awards, amounts or benefits received or outstanding under this Agreement shall be subject to clawback, cancellation, recoupment, rescission, payback, reduction or other similar action in accordance with the terms of any applicable law related to such actions, as may be in effect from time to time. Cue may take such actions as may be necessary to effectuate any provision of applicable law relating to clawback, cancellation, recoupment, rescission, payback or reduction of compensation, whether adopted before or after the Effective Date, without further consideration or action.
9.
RELEASE. Any and all amounts payable and benefits or additional rights, beyond the Accrued Benefits, provided pursuant to this Agreement following termination from employment shall only be payable if Executive delivers to Cue and does not revoke a general release of claims in favor of Cue in a form to be provided by Cue (which will include, at a minimum, a release of all releasable claims, non-disparagement and cooperation obligations, reaffirmation of Executive’s continuing obligations under this Agreement or the Non-Competition Agreement, and an agreement not to compete with the Company for twelve (12) months following Executive’s separation from employment). Such release shall be furnished to Executive within two business days after Executive’s date of termination, and must become irrevocable within 60 days following termination (or such shorter period as requested by Cue).
10.
RESTRICTIVE COVENANTS.
(i)
COMPANY INFORMATION. At all times during the Term and thereafter, Executive shall hold in strictest confidence, and shall not use, except in connection with the performance of Executive’s duties, and shall not disclose to any person or entity, any Confidential Information of Cue.
“Confidential Information” means any Cue proprietary or confidential information, technical data, trade secrets or know-how, including research, product plans, products, services, customer lists and customers, markets, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, marketing, distribution and sales methods and systems, sales and profit figures, finances and other business information disclosed to Executive by Cue, either directly or indirectly in writing, orally or by drawings or inspection of documents or other tangible property. However, Confidential Information does not include any of the foregoing items which has become publicly known and made generally available through no wrongful act of Executive.
(ii)
EXECUTIVE-RESTRICTED INFORMATION. During the Term, Executive shall not improperly use or disclose any proprietary or confidential information or trade secrets of any person or entity with whom Executive has an agreement or duty to keep such information or secrets confidential.
(iii) THIRD PARTY INFORMATION. Executive recognizes that Cue has received and in the future shall receive from third parties their confidential or proprietary information subject to a duty on Cue’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. At all times during the Term and thereafter, Executive shall hold in strictest confidence, and shall not use, except in connection with the Performance of Executive’s duties, and shall not disclose to any person or entity except in connection with the Performance of Executive’s duties and consistent with Cue’s agreement with such third party, such third party confidential or proprietary information, and shall not use it except as necessary in performing Executive’s duties, consistent with Cue’s agreement with such third party.
(b)
CONFIDENTIAL INFORMATION, INVENTION ASSIGNMENT AND NONSOLICITATION. Executive acknowledges and agrees that his employment with the Company is contingent upon his signing and adhering to the Employee Confidential Information, Invention Assignment, And Non-Solicitation Agreement in the form attached as Attachment A. Executive expressly acknowledges that Executive’s eligibility for the Option set forth in Section 5 is contingent upon his agreement to adhere to the non-competition provisions set forth in the Non-Competition and Non-Solicitation Agreement, and that such consideration was mutually agreed upon with the Company and is fair and reasonable in exchange for Executive’s compliance with the non-competition obligations.
(c)
NONDISPARAGEMENT. During the Executive’s employment with Cue and at all times thereafter, Executive shall not make negative comments or otherwise disparage Cue or any company or other trade or business that “controls,” is “controlled by” or is “under common control with,” Cue within the meaning of Rule 405 of Regulation C under the Securities Act, including any “subsidiary corporation” of Cue within the meaning of Section 424(f) of the Internal Revenue Code of 1986 (“Affiliates”) or any of their officers, directors, managers, employees, consultants, equity holders, agents or products. The foregoing shall not be violated by truthful statements (i) in accordance with Section 10(i) below; (ii) in response to legal process, required governmental testimony or filings or administrative or arbitral proceedings (including depositions in connection with such proceedings) or (iii) made in the course of Executive discharging Executive’s duties for Cue.
(d)
COOPERATION. Upon the receipt of reasonable notice from Cue, while employed by Cue and for two (2) years thereafter, Executive shall respond and provide information with regard to matters in which Executive has knowledge as a result of Executive’s employment with Cue, and shall provide reasonable assistance to Cue, its Affiliates and their respective representatives in defense of any claims that may be made against Cue or its Affiliates, and shall assist Cue and its Affiliates in the prosecution of any claims that may be made by Cue or its Affiliates, to the extent that such claims may relate to the period of Executive’s employment with Cue (collectively, the “Claims”). Executive shall promptly inform Cue if Executive becomes aware of any lawsuits involving Claims that may be filed or threatened against Cue or its Affiliates. Executive also shall promptly inform Cue (to the extent that Executive is legally permitted to do so) if Executive is asked to assist in any investigation of Cue or its Affiliates (or their actions) or another party attempts to obtain information or documents from Executive (other than in connection with any litigation or other proceeding in which Executive is a party-in- opposition) with respect to matters Executive believes in good faith to relate to any investigation of Cue or its Affiliates, in each case, regardless of whether a lawsuit or other proceeding has then been filed against Cue or its Affiliates with respect to such investigation, and shall not do so unless legally required. During the pendency of any litigation or other proceeding involving Claims, Executive shall not communicate with anyone (other than Executive’s attorneys and tax and/or financial advisors and except to the extent either permitted by Section 10(i) below or that Executive determines in good faith is necessary in connection with the Performance of Executive’s duties hereunder) with respect to the facts or subject matter of any pending or potential litigation or regulatory or administrative proceeding involving Cue or any of its Affiliates without getting the prior written consent of Cue. Upon presentation of appropriate documentation, Cue shall pay or reimburse Executive for all reasonable counsel fees, out-of-pocket travel, duplicating or telephonic expenses incurred by Executive in accordance with Cue’s applicable policies in complying with this Section 10(d), and Executive shall be compensated by Cue at a reasonable hourly rate for assistance given after the end of the Term; provided, however, that Executive shall not be paid for any time spent testifying in any arbitration, trial, administrative hearing or other proceeding.
(e)
OWNERSHIP OF INFORMATION, IDEAS, CONCEPTS, IMPROVEMENTS, DISCOVERIES AND INVENTIONS, AND ALL ORIGINAL WORKS OF AUTHORSHIP.
(i)
As between the Parties, all information, ideas, concepts, improvements, discoveries and inventions, whether patentable or not, which are conceived, made, developed or acquired by Executive or which are disclosed or made known to Executive, individually or in conjunction with others, during the Term and which relate to Cue’s business, products or services (including all such information relating to corporate opportunities, research, financial and sales data, pricing and trading terms, evaluations, opinions, interpretations, acquisition prospects, the identity of clients or customers or their requirements, the identity of key contacts within the client or customers’ organizations or within the organization of acquisition prospects, or marketing and merchandising techniques, prospective names and marks) are and shall be the sole and exclusive property of Cue. Moreover, all drawings, memoranda, notes, records, files, correspondence, manuals, models, specifications, computer programs, maps and all other writings or materials of any type embodying any of such information, ideas, concepts, improvements, discoveries and inventions are and shall be the sole and exclusive property of Cue.
(ii)
In particular, Executive hereby specifically assigns and transfers to Cue all of Executive’s worldwide right, title and interest in and to all such information, ideas, concepts, improvements, discoveries or inventions, and any United States or foreign applications for patents, inventor’s certificates or other industrial rights that may be filed thereon, and applications for registration of such names and marks. During the Term and thereafter, Executive shall assist Cue and its nominee at all times in the protection of such information, ideas, concepts, improvements, discoveries or inventions, both in the United States and all foreign countries, including the execution of all lawful oaths and all assignment documents requested by Cue or its nominee in connection with the preparation, prosecution, issuance or enforcement of any applications for United States or foreign letters patent, and any application for the registration of such names and marks.
(iii)
Moreover, if during the Term, Executive creates any original work of authorship fixed in any tangible medium of expression which is the subject matter of copyright (such as reports, videotapes, written presentations, computer programs, drawings, maps, architectural renditions, models, manuals, brochures or the like) relating to Cue’s business, products or services, whether such work is created solely by Executive or jointly with others, Cue shall be deemed the author of such work if the work is prepared by Executive in the scope of Executive’s employment; or, if the work is not prepared by Executive within the scope of Executive’s employment but is specially ordered by Cue as a contribution to a collective work, as a part of any written or audiovisual work, as a translation, as a supplementary work, as a compilation or as an instructional text, then the work shall be considered to be work made for hire and Cue shall be the author of the work. In the event such work is neither prepared by Executive within the scope of Executive’s employment or is not a work specially ordered and deemed to be a work made for hire, then Executive shall assign, and by these presents, does assign, to Cue all of Executive’s worldwide right, title and interest in and to such work and all rights of copyright therein. Both during the Term and thereafter, Executive shall assist Cue and its nominee, at any time, in the protection of Cue’s worldwide right, title and interest in and to the work and all rights of copyright therein, including the execution of all formal assignment documents requested by Cue or its nominee and the execution of all lawful oaths and applications for registration of copyright in the United States and foreign countries; provided, however, that Executive shall be compensated by Cue at a reasonable hourly rate for assistance given after the end of the Term.
(iv)
Notwithstanding the foregoing provisions of this Section 10(e), Cue hereby notifies Executive that the provisions of this Section 10(e) shall not apply to any inventions for which no equipment, supplies, facility, Confidential Information or trade secret information of Cue was used and which were developed entirely on Executive’s own time, unless (A) the invention relates (1) to the business or technology of Cue, or (2) to actual or demonstrably anticipated research or development of Cue, or (B) the invention results from any work performed by Executive for Cue.
(f)
RETURN OF COMPANY PROPERTY. On the date of Executive’s termination of employment with Cue for any reason (or at any time prior thereto at Cue’s request), Executive shall return all property belonging to Cue or its Affiliates (including any Cue or Affiliate-provided laptops, computers, cell phones, wireless electronic mail devices or other equipment, or documents or property belonging to Cue or an Affiliate).
(g)
EFFECT OF EXECUTIVE BECOMING A BAD LEAVER. Notwithstanding any provision of this Agreement to the contrary, if (i) Executive breaches any of the applicable covenants set forth in this Agreement at any time during the period commencing on the Effective Date and ending 12 months after Executive’s termination of employment with Cue for any reason and (ii) Executive fails to cure such breach within 10 days of the effective date of written notice of such breach given by Cue, then Executive shall be deemed a “Bad Leaver.” If Executive is or becomes a Bad Leaver, then (i) any severance being paid to Executive pursuant to this Agreement or otherwise shall immediately cease upon commencement of such action and (ii) Executive shall be liable to repay to Cue any severance previously paid to Executive by Cue, less $100 to serve as consideration for the release described in Section 9 above.
(h)
TOLLING. If Executive violates any of the terms of the non-disclosure and non-solicitation covenants articulated herein, the obligation at issue shall run from the first date on which Executive ceases to be in violation of such obligation.
(i)
SCOPE OF DISCLOSURE RESTRICTIONS. Executive acknowledges that nothing in this Agreement prohibits him from communicating with government agencies about possible violations of federal, state, or local laws or otherwise providing information to government agencies, filing a complaint with government agencies, or participating in government agency investigations or proceedings. Executive further understands that he is not required to notify Cue of any such communications; provided, however, that nothing herein authorizes the disclosure of information Executive obtained through a communication that was subject to the attorney-client privilege. Further, notwithstanding his confidentiality and nondisclosure obligations, Executive understands that she is hereby advised as follows pursuant to the Defend Trade Secrets Act: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except pursuant to court order.”
11.
EQUITABLE RELIEF AND OTHER REMEDIES. Executive acknowledges that Cue’s remedies at law for a breach or threatened breach of any of the provisions of Section 10 above would be inadequate and in the event of such a breach or threatened breach, in addition to any remedies at law, Cue, without posting any bond, shall be entitled to seek to obtain equitable relief in the form of specific performance, a temporary restraining order, a temporary or permanent injunction or any other equitable remedy that may then be available, without the necessity of showing actual monetary damages or the posting of a bond or other security.
12.
NO ASSIGNMENTS. This Agreement is personal to each of the Parties. Except as provided in this Section 12, neither Party may assign or delegate any rights or obligations hereunder without first obtaining the written consent of the other Party. Cue may assign this Agreement to any of its Affiliates or to any successor to all or substantially all of the business and/or assets of Cue, provided that Cue shall require such Affiliate or successor to expressly assume and agree to perform this Agreement in the same manner and to the same extent that Cue would be required to perform it if no such succession had taken place.
As used in this Agreement, “Cue” and the “Company” shall mean Cue and any Affiliate or successor to its business and/or assets that assumes and agrees to perform the duties and obligations of Cue under this Agreement by operation of law or otherwise.
13.
NOTICE. Any notice that either Party may be required or permitted to give to the other shall be in writing and may be delivered personally, by electronic mail or via a postal service, postage prepaid, to such electronic mail or postal address and directed to such person as Cue may notify Executive from time to time; and to Executive at Executive’s electronic mail or postal address as shown on the records of Cue from time to time, or at such other electronic mail or postal address as Executive, by notice to Cue, may designate in writing from time to time.
14.
SECTION HEADINGS; INCONSISTENCY. The section headings used in this Agreement are included solely for convenience and shall not affect, or be used in connection with, the interpretation of this Agreement. In the event of any inconsistency between the terms of this Agreement and any form, award, plan or policy of Cue, the terms of this Agreement shall govern and control.
15.
SEVERABILITY. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement or any action in any other jurisdiction, but this Agreement shall be reformed, construed and enforced in such jurisdiction.
16.
COUNTERPARTS. This Agreement may be executed in several counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument.
17.
APPLICABLE LAW; CHOICE OF VENUE AND CONSENT TO JURISDICTION; SERVICE OF PROCESS; WAIVER OF JURY TRIAL.
(a)
All questions concerning the construction, validity and interpretation of this Agreement and the Performance of the obligations imposed by this Agreement shall be governed by the internal laws of the Commonwealth of Massachusetts applicable to agreements made and wholly to be performed in such state without regard to conflicts of law provisions of any jurisdiction.
(b)
For purposes of resolving any dispute that arises directly or indirectly from the relationship of the Parties evidenced by this Agreement, the Parties hereby submit to and consent to the exclusive jurisdiction of the Commonwealth of Massachusetts and further agree that any related litigation shall be conducted solely in the courts of Suffolk County, Massachusetts or the federal courts for the United States for the District of Massachusetts in Suffolk County, where this Agreement is made and/or to be performed, and no other courts.
(c)
Each Party may be served with process in any manner permitted under State of Massachusetts law, or by United States registered or certified mail, return receipt requested.
(d)
BY EXECUTION OF THIS AGREEMENT, THE PARTIES ARE WAIVING ANY RIGHT TO TRIAL BY JURY IN CONNECTION WITH ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF OR BASED ON THIS AGREEMENT.
18.
MISCELLANEOUS. No provision of this Agreement may be modified, waived or discharged unless such waiver, modification or discharge is agreed to in writing and signed by Executive and such officer or director as may be designated by Cue. No waiver by either Party at any time of any breach by the other Party of, or compliance with, any condition or provision of this Agreement to be performed by such other Party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. This Agreement together with all exhibits hereto sets forth the entire agreement of the Parties in respect of the subject matter contained herein and supersedes any and all prior agreements or understandings between Executive and Cue or its Affiliates with respect to the subject matter hereof. No agreements or representations, oral or otherwise, express or implied, with respect to the subject matter hereof, have been made by either Party that are not expressly set forth in this Agreement.
19.
REPRESENTATIONS. Executive represents and warrants to Cue that (a) Executive has the legal right to enter into this Agreement and to perform all of the obligations on Executive’s part to be performed hereunder in accordance with its terms, and (b) Executive is not a party to any agreement or understanding, written or oral, and is not subject to any restriction, which, in either case, could prevent Executive from entering into this Agreement or performing all of Executive’s duties and obligations hereunder.
(a)
WITHHOLDING. Any and all amounts payable under this Agreement or otherwise shall be subject to, and Cue may withhold from such amounts, any federal, state, local or other taxes as may be required to be withheld pursuant to any applicable law or regulation.
(b)
SECTION 409A COMPLIANCE.
(i)
The intent of the Parties is that payments and benefits under this Agreement be exempt from (to the extent possible) or compliant with Section 409A (“Section 409A”) of the Internal Revenue Code of 1986 and the regulations and guidance promulgated thereunder, as amended (collectively, the “Code”) and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted accordingly. To the extent that any provision hereof is modified in order to comply with Section 409A, such modification shall be made in good faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to the Parties of the applicable provision without violating the provisions of Section 409A. In no event shall Cue be liable for any additional tax, interest or penalty that may be imposed on Executive by Section 409A or damages for failing to comply with Section 409A.
A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits that constitute “nonqualified deferred compensation” under Section 409A upon or following a termination of employment unless such termination is also a “separation from service” within die meaning of Section 409A and, for purposes of any such provision of this Agreement, references to a “termination,” “termination of employment” or like terms shall mean “separation from service.” Notwithstanding anything to the contrary in this Agreement, if Executive is deemed on the date of termination to be a “specified employee” under Section 409A, then with regard to any payment or the provision of any benefit that is considered “nonqualified deferred compensation” under Section 409A payable on account of a “separation from service,” such payment or benefit shall not be made or provided until the earlier of (A) the expiration of the six-month period measured from the date of such “separation from service” of Executive, and (B) the date of Executive’s death, to the extent required under Section 409A. Upon the expiration of the foregoing delay period, all payments and benefits delayed pursuant to this Section 20(b)(ii) (whether they would have otherwise been payable in a single sum or in installments in the absence of such delay) shall be paid or reimbursed to Executive in a lump sum on the first business day following the six-month period, and any remaining payments and benefits due under this Agreement shall be paid or provided in accordance with the normal payment dates specified for them herein.
(iii)
To the extent that reimbursements or other in-kind benefits under this Agreement constitute “nonqualified deferred compensation” for purposes of Section 409A, (A) all expenses or other reimbursements hereunder shall be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred by Executive, (B) any right to reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit and (C) no such reimbursement, expenses eligible for reimbursement or in-kind benefits provided in any taxable year shall in any way affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year.
(iv)
For purposes of Section 409A, Executive’s right to receive any installment payments pursuant to this Agreement shall be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement specifies a payment period with reference to a number of days, the actual date of payment within the specified period shall be at the sole discretion of the Board.
(v)
Notwithstanding any other provision of this Agreement to the contrary, in no event shall any payment under this Agreement that constitutes “nonqualified deferred compensation” for purposes of Section 409A be subject to offset by any other amount unless otherwise permitted by Section 409A.
(c)
MODIFICATION OF PAYMENTS. In the event it shall be determined that any payment, right or distribution by Cue or any other person or entity to or for the benefit of Executive pursuant to the terms of this Agreement or otherwise, in connection with, or arising out of, Executive’s employment with Cue or a change in ownership or effective control of Cue or a substantial portion of its assets (a “Payment”) is a “parachute payment” within the meaning of Code Section 280G on account of the aggregate value of the Payments due to Executive being equal to or greater than three times the “base amount,” as defined in Code Section 280G (the “Parachute Threshold”), so that Executive would be subject to the excise tax imposed by Code Section 4999 (the “Excise Tax”) and the net after-tax benefit that Executive would receive by reducing the Payments to the Parachute Threshold is greater than the net after-tax benefit Executive would receive if the full amount of the Payments were paid to Executive, then the Payments payable to Executive shall be reduced (but not below zero) so that the Payments due to Executive do not exceed the amount of the Parachute Threshold, reducing first any Payments under Section 8 above.
BY SIGNING THIS AGREEMENT BELOW, EXECUTIVE ACKNOWLEDGES THAT EXECUTIVE:
(1) HAS READ AND UNDERSTOOD THE ENTIRE AGREEMENT;
(2) HAS HAD THE OPPORTUNITY TO ASK QUESTIONS AND CONSULT COUNSEL OR OTHER ADVISORS ABOUT THE AGREEMENT’S TERMS; AND
(3) AGREES TO BE BOUND BY THE AGREEMENT.
IN WITNESS WHEREOF, Cue has caused this Agreement to be executed in its name and on its behalf, and Executive acknowledges understanding and acceptance of, and agrees to, the terms of this Agreement, all as of the Effective Date.
CUE BIOPHARMA, INC.
/s/ Pasha Sarraf /s/ Usman Azam
Print Name: Pasha Sarraf, M.D. Print Name: Usman Azam, M.D,
Title: Chairman Title: President and CEO This Separation and Release of Claims Agreement (the “Agreement”) is made as of the Agreement Effective Date (as defined below) by and between Cue Biopharma, Inc. (the “Company”) and Daniel Passeri (“Executive”) (together, the “Parties”).
EX-10.2
3
cue-ex10_2.htm
DAN P SEPARATION
EX-10.2
Exhibit 10.2
SEPARATION AND RELEASE OF CLAIMS AGREEMENT
WHEREAS, the Company and Executive are parties to a Third Amended and Restated Executive Employment Agreement dated March 4, 2021, as amended by the Employment Agreement Amendment and Consent dated July 24, 2024 (together, the “Employment Agreement”), pursuant to which Executive serves as the Company’s Chief Executive Officer;
WHEREAS, Executive’s last day of employment with the Company will be September 29, 2025 (the “Separation Date”);
WHEREAS, the Parties wish to establish mutually agreeable terms for Executive’s separation from the Company; and
WHEREAS, the Parties agree that the benefits and rights set forth in this Agreement shall be the exclusive benefits and rights due Executive.
NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1.
Separation; Resignation – As of the Separation Date, Executive’s employment will end. In connection with Executive’s separation from employment, all salary payments from the Company will cease as of the Separation Date and any benefits Executive had as of the Separation Date under benefit plans, programs, or practices of the Company will terminate, except as required by federal or state law. Executive hereby acknowledges and agrees that, pursuant to Section 9(c) of the Employment Agreement, as of the Separation Date he shall automatically be deemed to have resigned from all positions he holds as an officer, director or fiduciary of the Company and any other entity that is part of the same consolidated group as the Company or in which capacity Executive serves at the direction of or as a result of his position with the Company. Executive further acknowledges and agrees that he will, within 10 days following the Separation Date, take all actions as may be necessary under applicable law or requested by the Company to effect such resignations.
2.
Severance Benefits – Provided Executive (a) signs and returns this Agreement and the Advisor Agreement (as defined in Section 2(d) below) no later than the Return Date (as defined in Section 11 below), (b) does not revoke his acceptance of this Agreement during the Revocation Period (as defined in Section 11 below), and (c) abides by all of his obligations in this Agreement, the Company will, in exchange for Executive’s commitments and obligations set forth herein and therein, provide Executive with the following severance benefits (the “Severance Benefits”):
a.
Severance Pay – The Company will pay to Executive $838,750, less all applicable taxes and withholdings, as severance pay (which amount constitutes (x) a pro-rated (based on the Separation Date) amount of Executive’s target 2025 Annual Bonus (as defined in the Employment Agreement), plus (y) 12 months of Executive’s Base Salary (as defined in the Employment Agreement). This severance pay will be paid in one lump sum in the Company’s first regular payroll cycle that follows the 60-day anniversary of the Separation Date.
b.
COBRA Benefits – Should Executive be eligible for and timely elect to continue receiving group health insurance coverage under the law known as COBRA, the Company will, commencing on the Separation Date and continuing until the earliest of (x) 18 months following the Separation Date, (y) the date Executive obtains new employment that offers health and/or dental insurance that is reasonably comparable to that offered by the Company, and (z) the date COBRA continuation coverage would otherwise terminate in accordance with the provisions of COBRA (as applicable, the “COBRA Payment Period”), pay the full premiums for such coverage.
c.
Equity Acceleration; Exercise Period – The Company will provide Executive with those equity acceleration and extended exercise benefits as are set forth in Section 9(c)(iv) of the Employment Agreement, pursuant to the terms and conditions thereof.
d.
Strategic Advisor Engagement – The Company will engage Executive following the Separation Date as a Strategic Advisor pursuant to the terms and conditions set forth in the Advisor Agreement attached hereto as Attachment A (the “Advisor Agreement”). This engagement will be deemed to have commenced as of the day immediately following the Separation Date.
Executive acknowledges that the Severance Benefits exceed the Company’s obligations under the Employment Agreement, and that he will not be eligible for, nor shall he have a right to receive, any payments or benefits from the Company following the Separation Date other than as set forth in this Section 2. Executive further acknowledges that his right to receive and retain the Severance Benefits is contingent upon his timely and full compliance with all of his obligations set forth in this Agreement.
3.
Release of Claims – In exchange for Executive’s eligibility to receive the Severance Benefits, which Executive acknowledges he would not otherwise be entitled to receive, Executive hereby fully, forever, irrevocably and unconditionally releases, remises and discharges the Company, its past and present affiliates, joint employers (including any professional employer organization or employer of record), subsidiaries, parent companies, predecessors, and successors, and all of their respective past and present officers, directors, stockholders, partners, members, employees, agents, representatives, plan administrators, attorneys, insurers and fiduciaries (each in their individual and corporate capacities) (collectively, the “Released Parties”) from any and all claims, charges, complaints, demands, actions, causes of action, suits, rights, debts, sums of money, costs, accounts, reckonings, covenants, contracts, agreements, promises, doings, omissions, damages, executions, obligations, liabilities, and expenses (including attorneys’ fees and costs), of every kind and nature that he ever had or now has against any or all of the Released Parties, whether known or unknown, including, but not limited to, any and all claims arising out of or relating to Executive’s employment with and/or separation from the Company, including, but not limited to, all claims under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq., the Americans With Disabilities Act of 1990, 42 U.S.C. § 12101 et seq., the Age Discrimination in Employment Act (“ADEA”), 29 U.S.C. § 621 et seq., the Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. § 2000ff et seq., the Family and Medical Leave Act, 29 U.S.C. § 2601 et seq., the Worker Adjustment and Retraining Notification Act (“WARN”), 29 U.S.C. § 2101 et seq., the Rehabilitation Act of 1973, 29 U.S.C. § 701 et seq., Executive Order 11246, Executive Order 11141, the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq., and the Employee Retirement Income Security Act of 1974 (“ERISA”), 29 U.S.C. § 1001 et seq., all as amended; all claims arising out of the Massachusetts Fair Employment Practices Act, Mass.
Gen. Laws ch. 151B, § 1 et seq., the Massachusetts Civil Rights Act, Mass. Gen. Laws ch. 12, §§ 11H and 11I, the Massachusetts Equal Rights Act, Mass. Gen. Laws. ch. 93, § 102, Mass. Gen. Laws ch. 214, § 1C (Massachusetts right to be free from sexual harassment law), the Massachusetts Labor and Industries Act, Mass. Gen. Laws ch. 149, § 1 et seq., Mass. Gen. Laws ch. 214, § 1B (Massachusetts right of privacy law), the Massachusetts Parental Leave Act, Mass. Gen. Laws ch. 149, § 105D, the Massachusetts Paid Family and Medical Leave Act, Mass. Gen. Laws ch. 175m, § 1, et seq., the Massachusetts Earned Sick Time Law, Mass. Gen. Laws ch. 149, § 148c, and the Massachusetts Small Necessities Leave Act, Mass. Gen. Laws ch. 149, § 52D, all as amended; all rights and claims under the Massachusetts Wage Act, Mass. Gen. Laws ch. 149, § 148 et seq., as amended (Massachusetts law regarding payment of wages and overtime), including any rights or claims thereunder to unpaid wages, including overtime, bonuses, commissions, and accrued, unused vacation time; all common law claims including, but not limited to, actions in defamation, intentional infliction of emotional distress, misrepresentation, fraud, wrongful discharge, and breach of contract (including, without limitation, all claims arising out of or related to the Employment Agreement); all claims to any unvested ownership interest in the Company, its subsidiaries or any of its affiliates, contractual or otherwise; all state and federal whistleblower claims to the maximum extent permitted by law; and any claim or damage arising out of Executive’s employment with and/or separation from the Company (including a claim for retaliation) under any common law theory or any federal, state or local statute or ordinance not expressly referenced above. Notwithstanding the foregoing, nothing in this release of claims or in this Agreement shall be deemed to prohibit Executive from filing a charge with, or participating in any investigation or proceeding before, any local, state or federal government agency, including, without limitation, the EEOC or a state or local fair employment practices agency. Executive retains the right to participate in any such action but not the right to recover money damages or other individual legal or equitable relief awarded by any such governmental agency, including any payment, benefit, or attorneys’ fees, and hereby waives any right or claim to any such relief; provided, however, that nothing herein shall bar or impede in any way Executive’s ability to seek or receive a monetary incentive award from any governmental agency or regulatory authority in connection with information provided to the governmental agency or regulatory authority.
a.
Confidentiality – Except for Permitted Disclosures (as set forth in Section 4(b) below), Executive agrees to maintain as confidential and not to disclose the terms of this Agreement and the contents of the negotiations and discussions resulting in this Agreement.
b.
Permitted Disclosures – Nothing in this Agreement, including Section 4(a) above, or elsewhere (including in the Employment Agreement or the Non-Competition Agreement defined below) prohibits or restricts Executive from communicating with, or voluntarily providing information he believes indicates possible or actual violations of the law to, local, state or federal government agencies, any legislative body, law enforcement, or any self-regulatory organization (including but not limited to the Securities and Exchange Commission). Executive is not required to notify the Company of any such communications or disclosures. Further, notwithstanding Executive’s confidentiality and nondisclosure obligations, he is hereby advised as follows pursuant to the Defend Trade Secrets Act: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.
An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except pursuant to court order.”
5.
Continuing Obligations; Non-Competition Restriction –
a.
Reaffirmation of Continuing Obligations. Executive acknowledges and reaffirms his continuing obligations to the Company as set forth in Section 11 of the Employment Agreement, which Section 11 and the obligations therein remain in full force and effect following the Separation Date in accordance with the terms of Section 11. Executive further acknowledges and reaffirms his continuing obligations as set forth in the Non-Competition Agreement attached to the Employment Agreement as Attachment A (the “Non-Competition Agreement”), which Non-Competition Agreement and the obligations therein also remain in full force and effect.
b.
Non-Competition Restriction. Further, and as an express condition of Executive’s eligibility to receive the Severance Benefits, Executive agrees that, during the Restricted Period (as defined below), Executive will not, in the geographic area where the Company does business, has done business, or plans to do business as of the Separation Date, directly or indirectly, whether as an owner, partner, officer, director, employee, Advisor, investor, lender or otherwise, except as the passive holder of not more than 1% of the outstanding stock of a publicly-held company, engage or assist others in engaging in any business or enterprise that is competitive with the Company’s business, including but not limited to any business or enterprise that researches, develops, manufactures, markets, licenses, sells or provides any product or service that competes with any product or service researched, developed, manufactured, marketed, licensed, sold or provided, or planned to be researched, developed, manufactured, marketed, licensed, sold or provided by the Company. For purposes hereof, “Restricted Period” means the period commencing on the Separation Date and continuing until the twelve (12)-month anniversary of the Separation Date, unless Executive breaches a fiduciary duty to the Company or unlawfully takes, physically or electronically, any property belonging to the Company, in which event the Restricted Period shall be twenty-four (24) months following the Separation Date. If any restriction set forth in this Section 5(b) is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range or activities or geographic area as to which it may be enforceable.
6.
Return of Company Property – Executive confirms that he has returned to the Company all keys, files, records (and copies thereof), Company identification, and any other Company owned property in his possession or control other than his Company-provided computer and cellphone, which he may retain during the Advisory Period (as defined in the Advisor Agreement). Executive further confirms that he has left intact all, and has otherwise not destroyed, deleted, or made inaccessible to the Company any, electronic Company documents, including, but not limited to, those that he developed or helped to develop during his employment, and that other than those documents that remain on his Company-provided computer and cellphone, he has not (a) retained any copies in any form or media; (b) maintained access to any copies in any form, media, or location; (c) stored any copies in any physical or electronic locations that are not readily accessible or known to the Company or that remain accessible to him; or (d) sent, given, or made accessible any copies to any persons or entities that the Company has not authorized to receive such electronic or hard copies.
Executive further confirms that he has cancelled all accounts for his benefit, if any, in the Company’s name, including but not limited to, credit cards, telephone charge cards, cellular phone accounts, and computer accounts.
7.
Business Expenses and Final Compensation – Executive acknowledges that he has been reimbursed by the Company for all business expenses incurred in conjunction with the performance of his employment and that no other reimbursements are owed to him. Executive further acknowledges that he has received payment in full for all services rendered in conjunction with his employment by the Company, including payment for all wages, bonuses, commissions, and accrued but unused vacation time, and that no other compensation is owed to him except as provided herein.
8.
Amendment and Waiver – This Agreement shall be binding upon the Parties and may not be modified in any manner, except by an instrument in writing of concurrent or subsequent date signed by duly authorized representatives of the Parties. This Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective agents, assigns, heirs, executors, administrators, personal representatives, and successors. No delay or omission by either Party in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar to or waiver of any right on any other occasion.
9.
Validity – Should any provision of this Agreement be declared or be determined by any court of competent jurisdiction to be illegal or invalid, the validity of the remaining parts, terms or provisions shall not be affected thereby and said illegal or invalid part, term or provision shall be deemed not to be a part of this Agreement.
10.
Nature of Agreement – The Parties understand and agree that this Agreement is a separation and release of claims agreement and that nothing herein constitutes an admission of liability or wrongdoing on the part of the Company or any of the other Released Parties.
11.
Time for Consideration and Revocation – Executive acknowledges that he was initially presented with this Agreement on September 27, 2025 (the “Receipt Date”). Executive understands that he will not be eligible to receive the Severance Benefits unless he (a) signs and returns this Agreement and the Advisor Agreement no later than the close of business on October 20, 2025 (the “Return Date”), and (b) does not revoke his acceptance of this Agreement during the seven (7) business day period after signing it (the “Revocation Period”). This Agreement will become effective and enforceable on the day after the Revocation Period has expired without revocation (the “Agreement Effective Date”).
12.
Acknowledgements – Executive acknowledges that he has been given at least twenty-one (21) days to consider this Agreement (the “Consideration Period”), and that the Company is hereby advising him to consult with an attorney of his own choosing prior to signing this Agreement. Executive further acknowledges and agrees that any changes made to this Agreement following the Receipt Date, whether material or immaterial, shall not re-start or affect in any manner the Consideration Period. Executive understands that he may revoke his acceptance of this Agreement during the Revocation Period by notifying in writing the Company signatory of this Agreement, and this Agreement shall not be effective or enforceable unless and until the Revocation Period expires without Executive’s revocation.
Executive understands and agrees that by entering into this Agreement he is waiving any and all rights or claims he might have under the Age Discrimination in Employment Act, as amended by the Older Workers Benefit Protection Act, and that he has received consideration beyond that to which he was previously entitled.
13.
Voluntary Assent – Executive affirms that no other promises or agreements of any kind have been made to or with Executive by any person or entity whatsoever to cause him to sign this Agreement or the Advisor Agreement, and that he fully understands the meaning and intent of this Agreement and the Advisor Agreement and has had the opportunity to be represented by counsel of his own choosing.
14.
Governing Law; Forum; Jury Trial Waiver – This Agreement shall be interpreted and construed by the laws of the Commonwealth of Massachusetts, without regard to conflict of laws provisions. Executive hereby irrevocably submits to and acknowledges and recognizes the jurisdiction of the courts of the Commonwealth of Massachusetts, or if appropriate, a federal court located in Massachusetts (which courts, for purposes of this Agreement, are the only courts of competent jurisdiction), over any suit, action or other proceeding arising out of, under or in connection with this Agreement or the subject matter hereof. Executive further hereby irrevocably waives any right to a trial by jury in any action, suit or other legal proceeding arising under or relating to any provision of this Agreement.
15.
Entire Agreement – This Agreement contains and constitutes the entire understanding and agreement between the Parties hereto with respect to Executive’s separation of employment from the Company, severance benefits, and the settlement of claims against the Released Parties, and cancels all previous oral and written negotiations, agreements, commitments and writings in connection therewith.
16.
Tax Acknowledgement; Clawback – In connection with the Severance Benefits provided to Executive pursuant to this Agreement, the Company shall withhold and remit to the tax authorities the amounts required under applicable law, and Executive shall be responsible for all applicable taxes with respect to such Severance Benefits under applicable law. Executive acknowledges that he is not relying upon the advice or representation of the Company with respect to the tax treatment of any of the Severance Benefits. Executive acknowledges and agrees that he remains subject to the clawback provision of Section 9(h) of the Employment Agreement.
17.
Counterparts – This Agreement may be executed in two counterparts, each of which shall be deemed to be an original, but both of which together will constitute one and the same Agreement. Facsimile, electronic, and PDF signatures shall be deemed to be of equal force and effect as originals.
[Remainder of page intentionally left blank]
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date(s) written below.
CUE BIOPHARMA, INC.
By: /s/ Pasha Sarraf Date: 9/27/2025
Name: Pasha Sarraf, MD, PhD
Title: Chair, Board of Directors
I hereby agree to the terms and conditions set forth above. I have carefully read this Agreement, understand the contents herein, freely and voluntarily assent to all of the terms and conditions hereof, and sign my name of my own free act. I intend that this Agreement will become a binding agreement between me and the Company if I do not revoke my acceptance in seven (7) business days.
DANIEL PASSERI
/s/ Daniel Passeri Date: 9/27/2025
ATTACHMENT A
Incorporated by reference to Exhibit 10.3 of this Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2025 Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential.
EX-10.3
4
cue-ex10_3.htm
ADVISOR AGREEMENT
EX-10.3
Exhibit 10.3
Double asterisks denote omissions.
ATTACHMENT A
Advisor Agreement
This Advisor Agreement (the “Agreement”) is entered into as of 9/27/2025 by and between Cue Biopharma, Inc. (the “Company”), and Daniel Passeri (the “Advisor”), and is deemed effective as of the day immediately following the Separation Date (hereinafter, the “Advisor Effective Date”). Capitalized terms used but not defined herein have the meanings set forth in the Agreement to which this Agreement is attached as Attachment A (the “Separation Agreement”).
WHEREAS, the Advisor has knowledge regarding the Company and certain on-going matters pertaining to the Company; and
WHEREAS, the Company desires to have the benefit of the Advisor’s knowledge and familiarity, and the Advisor desires to provide strategic advisor services to the Company, all as hereinafter provided in this Agreement.
NOW, THEREFORE, in consideration of the promises and mutual agreements hereinafter set forth, the sufficiency of which are hereby acknowledged, the Company and the Advisor hereby agree as follows:
a.
Services; Performance. The Advisor shall, from time to time and on an as-requested basis, render to the Company services pertaining to providing the Company with strategic advice and assistance, including by advising the Company’s new Chief Executive Officer (the “Services”). The Advisor shall perform the Services in a professional manner and consistent with the highest industry standards. The Advisor shall devote such hours as may reasonably be required for satisfactory performance of the Services, though it is not anticipated that the Advisor will devote more than 10 hours per month of Services hereunder. The Advisor shall comply with all rules, procedures and standards promulgated from time to time by the Company with respect to the Advisor’s access to and use of the Company’s property, information, equipment and facilities in the course of the Advisor’s provision of Services hereunder.
a.
Strategic Advisor Grant. The Company shall grant to the Advisor, subject to the approval of the Company’s Board of Directors, a non-statutory option grant under the Company’s 2025 Stock Incentive Plan for the purchase of up to 375,000 shares of common stock of the Company at a price per share equal to the fair market value of the Company’s common stock at the time of approval (the “Strategic Advisor Grant”). The Strategic Advisor Grant will vest in its entirety if (x) on or before the six (6)-month anniversary of the Advisor Effective Date (the “Outside Date”) the Company [**], and (y) the Advisor continues to perform Services for the Company [**] (the “Vesting Contingency”). If the Vesting Contingency occurs, the Strategic Advisor Grant will vest in its entirety and become exercisable as of the occurrence date. If the Vesting Contingency does not occur, the Strategic Advisor Grant will remain unvested in its entirety and be forfeited as of the earlier of (x) the Outside Date, and (y) the date on which the Advisor ceases to perform services for the Company.
b.
Continued Equity Vesting. During the Advisory Period (as defined below), all of the Advisor’s outstanding and unvested equity awards (the “Equity Awards”) will continue to vest and be exercisable in accordance with the terms of the applicable equity award agreements and the Company’s 2016 Omnibus Incentive Plan.
c.
No Employee Benefits. The Advisor’s relationship with the Company will be that of an independent contractor, and the Advisor shall not, in connection with this relationship, be entitled to any benefits, coverages or privileges, including, without limitation, health insurance, social security, unemployment, workers compensation, or pension payments, made available to employees of the Company.
a.
Advisory Period. Subject to the terms and conditions hereinafter set forth, the term of this Agreement shall, provided the Advisor has timely entered into the Separation Agreement, be deemed to have commenced on the Advisor Effective Date and shall continue until the six (6)-month anniversary of the Advisor Effective Date (the “Expiration Date”); provided, however, that the Expiration Date may be extended to such later date as may mutually be agreed upon by the parties hereto, as evidenced in a written agreement signed by both parties, and this Agreement and the Advisor’s engagement may earlier be terminated pursuant to the termination provisions set forth below (the period during which this Agreement remains in effect, the “Advisory Period”). The Advisory Period shall automatically terminate prior to the Expiration Date upon the death, physical incapacitation or mental incompetence of the Advisor or, if the Advisor revokes his acceptance of the Separation Agreement, upon the date of such revocation. The Advisory Period may further be terminated at any time after the Advisor Effective Date in the following manner: (i) by the Company at any time immediately upon written notice if the Advisor has materially breached this Agreement, the Separation Agreement, or any of the agreements or obligations referenced in the Separation Agreement; (ii) by the Advisor at any time immediately upon written notice if the Company has materially breached this Agreement or the Separation Agreement; (iii) at any time upon the mutual written consent of the parties hereto; or (iv) by either party for any reason upon thirty (30) days’ prior written notice to the other party, provided that the Company shall in no event terminate the Advisory Period pursuant to this Section 3(a)(iv) prior to the six (6)-month anniversary of the Advisor Effective Date.
b.
Effects of Termination. In the event of any termination of the Advisory Period under this Section 3, vesting of the Equity Grants will cease immediately and the Strategic Advisor Grant, if unvested as of such date, will remain unvested and be forfeited.
4.
Independent Contractor. The Advisor shall not, as of the Advisor Effective Date or at any time during the Advisory Period, be deemed an employee of the Company. The Advisor’s status and relationship with the Company shall be that of an independent contractor and Advisor. The Advisor is not authorized to assume or create any obligation or responsibility, express or implied, on behalf of, or in the name of, the Company or to bind the Company in any manner. Nothing herein shall create, expressly or by implication, a partnership, joint venture or other association between the parties. The Advisor shall be solely responsible for payment of any taxes arising from the consideration to be provided to the Advisor pursuant to this Agreement and the Advisor agrees that the Company shall have no obligation or liability with respect to such taxes.
5.
Confidential Information.
a. The Advisor acknowledges that the Advisor’s relationship with the Company is one of high trust and confidence and that in the course of the Services, the Company intends to provide the Advisor with information, including Confidential Information (as defined below). Except as otherwise permitted by Section 5(c) below, the Advisor agrees to hold in strictest confidence and not to disclose any Confidential Information, other than any disclosure that is necessary to perform the Services or is authorized in writing by the Company. Except as otherwise permitted by Section 5(c) below, the Advisor agrees not to use Confidential Information except for the benefit of the Company. The Advisor agrees not to make copies of Confidential Information except in pursuit of his performance of the Services. The Advisor agrees that these obligations apply to Confidential Information (i) in any form or media, whether available now or invented hereafter, (ii) whether tangible or intangible, and (iii) whether Generated (as defined below) by the Advisor or others.
b. For purposes of this Agreement, “Confidential Information” means private, secret or confidential information, data, material or other know-how, whether tangible or intangible, that relates to the business, or the financial, scientific or technological affairs, of the Company, of any subsidiary or other affiliate of the Company or a third party with whom the Company does, has done or may do business, and includes, without limitation, Inventions (as defined below), discoveries, ideas, inventions, products, product improvements, product enhancements, processes, methods, techniques, formulas, compositions, compounds, negotiation strategies and positions, projects, developments, plans (including, without limitation, business and marketing plans), research data, clinical data, financial data (including, without limitation, sales costs, profits, pricing methods), personnel data of employees or consultants of the Company, computer programs (including software used pursuant to a license agreement), login credentials, customer, prospect and supplier lists, and contacts at or knowledge of customers or prospective customers of the Company. The Advisor agrees that Confidential Information includes information that is Generated by any artificial intelligence system, even if such information is not protectable by copyright or patentable. Notwithstanding anything to the contrary herein, Confidential Information shall not be interpreted to include information that (i) the Company has released to the general public, (ii) has become known to the public or in the Company’s industry without any violation by the Advisor of this Agreement, or (iii) has been provided or become known to the Advisor through disclosure by a source, other than the Company, that has the legal right to disclose such information without any obligation of confidentiality and without breaching any obligation of confidentiality.
c. Nothing in this Agreement or elsewhere restricts the Advisor’s right to communicate with or voluntarily provide information that the Advisor believes indicates possible or actual violations of the law to local, state or federal government agencies, any legislative body, law enforcement, or any self-regulatory organization (including but not limited to the Securities and Exchange Commission). The Advisor understands that he is not required to notify the Company of any such communications. Without limiting the foregoing, notwithstanding the Advisor’s confidentiality and nondisclosure obligations, the Company hereby provides the Advisor notice of his immunity rights pursuant to the federal Defend Trade Secrets Act of 2016, which provides in relevant part as follows: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except pursuant to court order.”
a. “Invention” means any discovery, idea, invention, improvement, enhancement, process, method, technique, software, work of authorship or other development, whether or not patentable, protectable by copyright or otherwise protectable by any intellectual property right. “Generated” means created, made, conceived, reduced to practice, authored or otherwise generated.
b. The Advisor will make full and prompt disclosure to the Company of each Invention which is Generated by him or under his direction, whether alone or jointly with others, while performing the Services, whether or not during normal working hours or on the premises of the Company (collectively, “Company Inventions”). The Advisor hereby assigns to the Company all of his right, title and interest in and to all Company Inventions and all related patents, patent applications, copyrights and copyright applications; provided, however, that the foregoing assignment shall not apply to Company Inventions which both (1) do not relate to the business or research and development conducted or planned to be conducted by the Company or its affiliates at the time such Company Invention is created, made, conceived or reduced to practice, and (2) are made and conceived by the Advisor not during normal working hours, not on the Company’s premises and not using the Company’s or its affiliates’ tools, devices, equipment or Confidential Information. The Advisor also hereby waives all claims to moral rights in any Company Inventions and acknowledges that each original work of authorship which is made by the Advisor (solely or jointly with others) within the scope of the Agreement and which is protectable by copyright is a “work made for hire,” as that term is defined in the United States Copyright Act.
7.
Notice. Any notice required or desired to be given shall be governed solely by this paragraph. Notice shall be deemed given only upon (a) mailing of any letter or instrument by overnight delivery with a reputable carrier or by registered mail, return receipt requested, postage prepaid by the sender, or (b) personal delivery.
8.
Miscellaneous. This Agreement, together with the Separation Agreement, constitutes the entire understanding of the parties hereto with respect to the matters contained herein and supersedes all proposals and agreements, written or oral, and all other communications between the parties relating to the subject matter of this Agreement. For the avoidance of doubt, nothing herein supersedes the Separation Agreement. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts without regard to its conflict of laws rules. The headings contained in this Agreement are for the convenience of the parties and are not to be construed as a substantive provision hereof. This Agreement may not be modified or amended except in writing signed or executed by the Advisor and the Company. In the event any provision of this Agreement is held to be unenforceable or invalid, such unenforceability or invalidity shall not affect any other provisions of this Agreement and such other provisions shall remain in full force and effect. If any provision of this Agreement is held to be excessively broad, it shall be reformed and construed by limiting and reducing it so as to be enforceable to the maximum extent permitted by law. This Agreement shall be binding upon, and inure to the benefit of, both parties hereto and their respective successors and assigns, including any corporation with or into which the Company may be merged or which may succeed to its assets or business; provided, however, that the responsibility for actual performance of the Services may not be assigned or delegated by the Advisor to any other person or entity.
This Agreement may be executed in counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the day and year first above written.
COMPANY:
CUE BIOPHARMA, INC.
/s/ Pasha Sarraf
Name: Pasha Sarraf, MD, PhD
Title: Chair, Board of Directors
ADVISOR:
/s/ Daniel Passeri Daniel Passeri I, Usman Azam, certify that:
EX-31.1
5
cue-ex31_1.htm
SOX 302 CERT
EX-31.1
EXHIBIT 31.1
CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
1.
I have reviewed this Quarterly Report on Form 10-Q of Cue Biopharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 12, 2025
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/s/ Usman Azam |
Name: Usman Azam |
Title: President and Chief Executive Officer |
(Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer) |
EX-32.1
6
cue-ex32_1.htm
SOX 906 CERT
EX-32.1
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report on Form 10-Q of Cue Biopharma, Inc. (the “Company”) for the period ended September 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Usman Azam, President and Chief Executive Officer of the Company certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to my knowledge that:
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Usman Azam |
|
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Name: Usman Azam |
|
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Title: President and Chief Executive Officer |
|
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(Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer) |
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Date: November 12, 2025 |
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