Cogent Biosciences (NASDAQ: COGT) posts 2025 loss but ends year with $901M cash runway
Rhea-AI Filing Summary
Cogent Biosciences reported fourth quarter and full year 2025 results alongside major clinical and regulatory progress for its lead drug bezuclastinib. The company ended 2025 with $900.8 million in cash, cash equivalents and marketable securities and expects this to fund operations into 2028.
Cogent completed three positive pivotal trials in 2025, including the Phase 3 PEAK study in second-line GIST, where bezuclastinib plus sunitinib achieved 16.5 months median progression-free survival versus 9.2 months for sunitinib alone and a higher objective response rate. Positive SUMMIT and APEX data in systemic mastocytosis supported an NDA submission and additional planned filings.
Operating expenses rose as development and commercial preparations accelerated. Research and development expenses reached $269.8 million in 2025 and general and administrative expenses were $63.6 million. Net loss for 2025 widened to $328.9 million, reflecting heavier investment ahead of planned NDAs and an anticipated bezuclastinib launch in the second half of 2026.
Positive
- Multiple positive pivotal trials for bezuclastinib: PEAK Phase 3 in second-line GIST showed 16.5 months median progression-free survival versus 9.2 months for sunitinib alone and higher objective response rates, while SUMMIT and APEX trials in systemic mastocytosis also reported strong efficacy signals.
- Robust capital position and extended runway: Cash, cash equivalents and marketable securities of $900.8 million as of December 31, 2025, supported by approximately $546.8 million in November 2025 offerings, are expected to fund operations into 2028 as Cogent prepares for commercial launch.
- Clear regulatory path toward commercialization: An NDA based on SUMMIT has been submitted, PEAK NDA is being completed under Real‑Time Oncology Review with Breakthrough Therapy Designation, and APEX NDA submission is planned for the first half of 2026, supporting a targeted bezuclastinib launch in the second half of 2026.
Negative
- None.
Insights
Cogent paired strong Phase 3 data and multiple NDAs with a large cash runway.
Cogent Biosciences delivered three positive pivotal readouts for bezuclastinib in 2025, most notably the PEAK trial in second-line GIST showing longer median progression-free survival and higher response rates versus sunitinib alone. SUMMIT and APEX data in systemic mastocytosis support current and planned NDA submissions.
The balance sheet strengthened markedly, with cash, cash equivalents and marketable securities of
R&D spending of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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 February 17, 2026, Cogent Biosciences, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the year ended December 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference in its entirety.
The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press release issued by Cogent Biosciences, Inc. on February 17, 2026, furnished herewith. |
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104 |
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The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL. |
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.
Date: February 17, 2026 |
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COGENT BIOSCIENCES, INC. |
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By: |
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/s/ John Green |
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John Green |
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Chief Financial Officer |
Exhibit 99.1
Cogent Biosciences Reports Recent Business Highlights and
Fourth Quarter and Full Year 2025 Financial Results
WALTHAM, Mass. and BOULDER, Colo., February 17, 2026 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025.
“Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value-creating regulatory catalysts underway,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have submitted our SUMMIT NDA for bezuclastinib in patients with NonAdvSM, initiated our PEAK NDA under the FDA’s RTOR program for bezuclastinib in patients with second-line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib’s best-in-class potential across KIT-mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026.”
Recent Company Highlights
Projected Near-Term Milestones
Bezuclastinib
Pipeline
Bezuclastinib - Expanded Access Program
Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy
Upcoming Investor Conference
Fourth Quarter and Full Year 2025 Financial Results
Cash and Cash Equivalents: As of December 31, 2025, Cogent had cash, cash equivalents and marketable securities of $900.8 million. Fourth quarter cash usage was driven largely by non-recurring items, including the repayment of $54.8 million of long-term debt and approximately $38.5 million of one-time, performance-based equity compensation.
R&D Expenses: Research and development expenses were $75.6 million for the fourth quarter of 2025 and $269.8 million for the year ended December 31, 2025, as compared to $62.0 million for the fourth quarter of 2024 and $232.7 million for the year ended December 31, 2024. The change was driven by the continued development of bezuclastinib across three pivotal trials, including costs associated with the completed and planned NDA filings, as well as the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $7.5 million for the fourth quarter of 2025 and $23.1 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $19.0 million for the year ended December 31, 2024.
G&A Expenses: General and administrative expenses were $23.9 million for the fourth quarter of 2025 and $63.6 million for the year ended December 31, 2025, as compared to $11.7 million for the fourth quarter of 2024 and $43.3 million for the year ended December 31, 2024. The increase was primarily due to the growth of the organization and activities related to the anticipated commercial launch of bezuclastinib. G&A expenses include non-cash stock compensation expense of $8.3 million for the fourth quarter of 2025 and $23.0 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $20.8 million for the year ended December 31, 2024.
Net Loss: Net loss was $102.5 million for the fourth quarter of 2025 and $328.9 million for the year ended December 31, 2025, as compared to a net loss of $67.9 million for the fourth quarter of 2024 and $255.9 million for the year ended December 31, 2024.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on February 11, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to twelve new employees under the company’s 2020 Inducement Plan with grant dates of February 11, 2026 and February 16, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 59,300 shares of Cogent common stock and (ii) 47,000 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.
About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving Systemic Mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced Gastrointestinal Stromal Tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Ka, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: plans to submit an NDA for bezuclastinib in patients with AdvSM in the first half of 2026; plans to complete the submission of an NDA for bezuclastinib in combination with sunitinib in patients with GIST in April 2026; the anticipated cash runway into 2028; bezuclastinib’s best-in-class potential across KIT-mutant driven diseases; plans to finish building a commercial organization and to launch bezuclastinib in the second half of 2026; the potential best-in-class profile of the company’s JAK2 V617F inhibitor; the expectation for FDA to accept the company’s NDA for bezuclastinib in NonAdvSM in February 2026; plans to present additional clinical data from the PEAK and APEX trials at major medical meetings during the first half of 2026; and plans to submit INDs and present data on the company’s pre-clinical and early clinical stage candidates. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date the date hereof.
COGENT BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
(unaudited)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
$ |
75,559 |
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$ |
62,045 |
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$ |
269,780 |
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$ |
232,658 |
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General and administrative |
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23,934 |
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11,689 |
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63,583 |
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43,281 |
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Total operating expenses |
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99,493 |
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73,734 |
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333,363 |
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275,939 |
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Loss from operations |
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(99,493 |
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(73,734 |
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(333,363 |
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(275,939 |
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Other income: |
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Interest income |
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5,477 |
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3,859 |
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14,689 |
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18,088 |
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Interest expense |
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(1,289 |
) |
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— |
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(3,062 |
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— |
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Loss on debt extinguishment |
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(7,181 |
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— |
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(7,181 |
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— |
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Other income (expense), net |
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(6 |
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1,948 |
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(20 |
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1,992 |
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Total other income, net |
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(2,999 |
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5,807 |
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4,426 |
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20,080 |
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Net loss |
$ |
(102,492 |
) |
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$ |
(67,927 |
) |
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$ |
(328,937 |
) |
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$ |
(255,859 |
) |
COGENT BIOSCIENCES, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
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December 31, |
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December 31, |
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2025 |
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2024 |
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Cash, cash equivalents and marketable securities |
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$ |
900,765 |
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$ |
287,077 |
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Working capital |
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$ |
846,402 |
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$ |
240,762 |
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Total assets |
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$ |
937,607 |
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$ |
327,898 |
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Total liabilities |
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$ |
301,236 |
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$ |
71,612 |
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Total stockholders’ equity |
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$ |
636,371 |
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$ |
256,286 |
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Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
FAQ
How much cash does Cogent Biosciences (COGT) have, and how long will it last?
What were Cogent Biosciences’ (COGT) 2025 research and development and net loss figures?
What key results did Cogent Biosciences report from the PEAK Phase 3 GIST trial?
Which regulatory filings for bezuclastinib is Cogent Biosciences planning or has submitted?
How did Cogent Biosciences strengthen its balance sheet in late 2025?
What other pipeline assets beyond bezuclastinib is Cogent Biosciences developing?
Filing Exhibits & Attachments
2 documentsPress Releases
