Cue Biopharma (CUE) posts 2025 results and $15M ImmunoScape pact
Rhea-AI Filing Summary
Cue Biopharma reported significantly higher collaboration revenue for 2025, driven by a new strategic collaboration and license agreement with ImmunoScape. Collaboration revenue rose to $21.9 million in the fourth quarter from $1.6 million a year earlier and to $27.5 million for the full year from $9.3 million in 2024, leading to fourth quarter net income of $1.6 million and a reduced full-year net loss of $26.6 million compared with $40.7 million in 2024.
The ImmunoScape agreement provides total upfront payments of $15 million, of which Cue received $9.5 million (net of withholding taxes) in the fourth quarter of 2025 and is entitled to an additional $5 million in November 2026, plus a 40% equity stake and eligibility for high-single digit royalties. The company advanced its lead autoimmune candidate CUE-401 toward IND readiness, reporting preclinical toxicology and pharmacology data in which CUE-401 was well tolerated with no adverse events observed and presenting supportive in vivo and in vitro data at a major immune regulation meeting. As of December 31, 2025, Cue Biopharma had $27.1 million in cash and cash equivalents, while continuing to operate at a full-year loss.
Positive
- None.
Negative
- Going concern and funding risk: The company’s own risk disclosures note limited cash, a history of losses, and a current going concern determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months without obtaining additional financing.
Insights
Revenue inflection from ImmunoScape deal offsets losses but going concern risk remains highlighted.
Cue Biopharma’s 2025 results show a sharp revenue step-up, largely from the ImmunoScape collaboration. Collaboration revenue increased to
Operating structure is still loss-making, with a full-year net loss of
The ImmunoScape agreement adds non-dilutive value via
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|||
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
|
|
(Zip Code) |
(Address of principal executive offices) |
|
|
(
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading |
|
Name of each exchange |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. |
Results of Operations and Financial Condition.
|
On March 16, 2026, Cue Biopharma, Inc. issued a press release announcing financial results for the quarter and year ended December 31, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits:
|
|
|
Exhibit |
|
Description |
|
|
|
99.1 |
|
Press Release dated March 16, 2026 |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
Cue Biopharma, Inc. |
||
|
|
|
|
|||
Date: March 16, 2026 |
|
|
|
By: |
|
/s/ Usman Azam |
|
|
|
|
Name: Usman Azam |
||
|
|
|
|
Title: President and Chief Executive Officer |
||
Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
CUE-401 is the Company’s lead asset for the treatment of autoimmune and inflammatory diseases
BOSTON, Mass., March 16, 2026-- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, today reported fourth quarter and full year 2025 financial results.
“During the fourth quarter and throughout the full year 2025, the Company successfully met its strategic development goals and objectives that demonstrated significant progress towards establishing potential first-in-class and best-in-class assets for patients suffering with autoimmune diseases,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “With these strategic deliverables and continued progress to date, we believe we are well positioned to further advance our differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address major unmet needs in autoimmune disease treatment.”
Business Highlights
Fourth Quarter 2025 Financial Results
The Company reported collaboration revenue of $21.9 million and $1.6 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue recognized from the collaboration and license agreement with ImmunoScape in the fourth quarter of 2025.
Research and development expenses were $16.5 million and $7.2 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in drug substance manufacturing and lab costs for CUE-401, an increase from one-time acquired acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.
General and administrative expenses were $3.5 million and $4.0 million for the three months ended December 31, 2025 and 2024, respectively. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, partially offset by an increase in severance expense paid to our former chief executive officer as well as an increase in professional fees related to the review, negotiation, and preparation of the collaboration and license agreement with ImmunoScape.
Full Year 2025 Financial Results
The Company reported collaboration revenue of $27.5 million and $9.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue earned from our collaboration and license agreement entered into with ImmunoScape in the fourth quarter of 2025.
Research and development expenses were $37.7 million and $36.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to one-time acquired
in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, an increase in drug substance manufacturing and lab costs for CUE-401, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.
General and administrative expenses were $16.2 million and $14.6 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees, which included fees incurred for the review, negotiation, and preparation of our 2025 collaboration and license agreements and an increase in severance paid to our former chief executive officer, partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount.
As of December 31, 2025, the Company had $27.1 million in cash and cash equivalents.
Cue Biopharma, Inc. |
Consolidated Statements of Operations and Comprehensive Income (Loss) |
(In thousands, except share and per share amounts) |
|
|
Three Months Ended December 31, |
|
|
Years Ended December 31, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Collaboration revenue |
|
$ |
21,942 |
|
|
$ |
1,576 |
|
|
$ |
27,466 |
|
|
$ |
9,287 |
|
Operating expenses (income): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
3,452 |
|
|
|
4,021 |
|
|
|
16,244 |
|
|
|
14,585 |
|
Research and development |
|
|
16,532 |
|
|
|
7,184 |
|
|
|
37,743 |
|
|
|
36,295 |
|
(Gain) loss on fixed asset disposal |
|
|
(20 |
) |
|
|
4 |
|
|
|
31 |
|
|
|
(93 |
) |
Total operating expenses |
|
|
19,964 |
|
|
|
11,209 |
|
|
|
54,018 |
|
|
|
50,787 |
|
Income (loss) from operations |
|
|
1,978 |
|
|
|
(9,633 |
) |
|
|
(26,552 |
) |
|
|
(41,500 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
158 |
|
|
|
290 |
|
|
|
807 |
|
|
|
1,622 |
|
Interest expense |
|
|
(51 |
) |
|
|
(153 |
) |
|
|
(357 |
) |
|
|
(796 |
) |
Total other income, net |
|
|
107 |
|
|
|
137 |
|
|
|
450 |
|
|
|
826 |
|
Income (loss) before provision for income taxes |
|
|
2,085 |
|
|
|
(9,496 |
) |
|
|
(26,102 |
) |
|
|
(40,674 |
) |
Provision for income taxes |
|
|
(500 |
) |
|
|
— |
|
|
|
(500 |
) |
|
|
— |
|
Net income (loss) |
|
$ |
1,585 |
|
|
$ |
(9,496 |
) |
|
$ |
(26,602 |
) |
|
$ |
(40,674 |
) |
Unrealized loss from available-for-sale securities |
|
|
(1 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
Comprehensive income (loss) |
|
$ |
1,584 |
|
|
$ |
(9,496 |
) |
|
$ |
(26,602 |
) |
|
$ |
(40,674 |
) |
Net income (loss) per common share – basic |
|
$ |
0.01 |
|
|
$ |
(0.13 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.72 |
) |
Net income (loss) per common share – diluted |
|
$ |
0.01 |
|
|
$ |
(0.13 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.72 |
) |
Weighted average common shares outstanding – basic |
|
|
107,988,413 |
|
|
|
74,238,329 |
|
|
|
94,731,768 |
|
|
|
56,328,348 |
|
Weighted average common shares outstanding – diluted |
|
|
110,512,936 |
|
|
|
74,238,329 |
|
|
|
94,731,768 |
|
|
|
56,328,348 |
|
Cue Biopharma, Inc.
Consolidated Balance Sheets
(In thousands)
|
|
|
|
|
|
|
||
|
|
December 31, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
27,136 |
|
|
$ |
22,459 |
|
Other assets |
|
|
15,076 |
|
|
|
9,732 |
|
Total assets |
|
$ |
42,212 |
|
|
$ |
32,191 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
||
Liabilities |
|
$ |
15,780 |
|
|
$ |
14,692 |
|
Stockholders' equity |
|
|
26,432 |
|
|
|
17,499 |
|
Total Liabilities and stockholders’ equity |
|
$ |
42,212 |
|
|
$ |
32,191 |
|
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically both as a regulator of proinflammatory mechanisms, and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. It is a highly innovative, tolerogenic bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic.
Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.
For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment; the company’s belief that CUE-401 has the therapeutic potential to restore immune balance for the treatment of autoimmune and inflammatory diseases; the company’s business strategies, plans and prospects; the potential benefits of the therapeutic approach to be developed pursuant to the collaboration and license agreement with ImmunoScape and receipt of upfront payments pursuant to such agreement[; and the company’s plans to host a virtual R&D day event and the timing thereof]. Forward-looking statements, which are based on certain assumptions and
describe the company’s 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,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain its collaboration with ImmunoScape; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (FDA) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
FAQ
How did Cue Biopharma (CUE) perform financially in the fourth quarter of 2025?
What were Cue Biopharma’s full-year 2025 revenues and net loss?
What are the key terms of Cue Biopharma’s collaboration with ImmunoScape?
How much cash did Cue Biopharma (CUE) have at December 31, 2025?
What progress did Cue Biopharma report on its lead asset CUE-401?
What were Cue Biopharma’s 2025 research and development and administrative expenses?
Filing Exhibits & Attachments
2 documentsPress Releases
