Bezuclastinib NDAs and cash into 2028 at Cogent Biosciences (NASDAQ: COGT)
Rhea-AI Filing Summary
Cogent Biosciences reported a first quarter 2026 net loss of $97.4 million, wider than the prior year as it ramps research and commercial activities. Total operating expenses rose to $103.6 million, driven by higher R&D and general and administrative spending tied to pipeline progress and launch preparation.
The company ended March 31, 2026 with $866.4 million in cash, cash equivalents and marketable securities and expects this to fund operations into 2028, including potential commercialization of bezuclastinib in systemic mastocytosis and GIST. Cogent has multiple NDAs for bezuclastinib under FDA review, including a GIST filing accepted under the Real-Time Oncology Review program and an NDA for non-advanced systemic mastocytosis with a PDUFA target action date of December 30, 2026, and is planning for dual launches pending approvals.
Positive
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Insights
Losses widened as Cogent builds for potential 2026 bezuclastinib launches, backed by a large cash runway.
Cogent Biosciences reported Q1 2026 operating expenses of $103.6 million and a net loss of $97.4 million, reflecting heavier investment in bezuclastinib and early-stage programs. R&D and G&A both increased year over year as the company advances multiple clinical and preclinical assets.
Cash, cash equivalents and marketable securities were $866.4 million as of March 31, 2026, and management expects this to fund operations into 2028, including commercialization efforts in systemic mastocytosis and GIST. This provides substantial runway through key regulatory events and potential launches.
Pipeline momentum is notable: two NDAs for bezuclastinib are already under FDA review, the GIST NDA was filed under the Real-Time Oncology Review program, and the non-advanced systemic mastocytosis NDA carries a PDUFA target action date of December 30, 2026. Additional planned INDs and early-phase trials broaden the portfolio, though ultimate value depends on regulatory outcomes and clinical data disclosed at forums such as the 2026 ASCO and AAAAI meetings.
8-K Event Classification
Key Figures
Key Terms
New Drug Application (NDA) regulatory
Real-Time Oncology Review (RTOR) program regulatory
Breakthrough Therapy Designation regulatory
Prescription Drug User Fee Act (PDUFA) target action date regulatory
at-the-market (ATM) stock offering financial
Expanded Access Programs (EAPs) regulatory
Earnings Snapshot
The company expects existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements into 2028, including commercialization of bezuclastinib in systemic mastocytosis and GIST.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 5, 2026, Cogent Biosciences, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the three months ended March 31, 2026. 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
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Description |
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99.1 |
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Press release issued by Cogent Biosciences, Inc. on May 5, 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: May 5, 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 First Quarter 2026 Financial Results
WALTHAM, Mass. and BOULDER, Colo., May 5, 2026 – Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026.
“2026 is shaping up to be a pivotal year for Cogent,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have two NDAs for bezuclastinib under FDA review and expect to submit a third in the first half of this year. These milestones highlight the breadth of bezuclastinib’s potential across GIST and KIT-driven diseases. With a strong balance sheet, we are focused on completing our commercial build and preparing for multiple potential launches.”
Recent Business Highlights
Upcoming 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. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy
Upcoming Investor Conference
First Quarter 2026 Financial Results
Cash and Cash Equivalents: As of March 31, 2026, cash, cash equivalents and marketable securities were $866.4 million, which includes net proceeds of $45.7 million from shares recently sold under the Company’s at-the-market (ATM) stock offering as well as non-recurring payments totaling $18.0 million related to annual performance-based bonus compensation and a milestone payment to Plexxikon. Based on our current plans, we expect our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, including the commercialization of bezuclastinib in SM and GIST.
R&D Expenses: Research and development expenses were $75.4 million for the first quarter of 2026 compared to $63.0 million for the first quarter of 2025. The increase was driven by increased early-stage, preclinical and discovery programs as we advance our pipeline of programs into Phase 1 clinical trials and IND-enabling studies, and includes one-time costs associated with the wind down of the FGFR clinical program. R&D expenses include non-cash stock compensation expense of $8.9 million for the first quarter of 2026 as compared to $5.3 million for the first quarter of 2025.
G&A Expenses: General and administrative expenses were $28.2 million for the first quarter of 2026 compared to $11.9 million for the first quarter of 2025. 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 $8.0 million for the first quarter of 2026 as compared to $4.8 million for the first quarter of 2025.
Net Loss: Net loss was $97.4 million for the first quarter of 2026 compared to a net loss of $72.0 million for the first quarter of 2025.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on April 29, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to seven new employees under the company’s 2020 Inducement Plan with a grant date of April 29, 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 62,600 shares of Cogent common stock and (ii) 48,600 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. 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, PI3Kα, 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: the anticipated commercial launches of bezuclastinib in SM and GIST starting in the second half of 2026; the anticipated cash runway into 2028; the expectation to submit an NDA for bezuclastinib in patients with AdvSM in the first half of 2026; anticipated presentations of clinical data from PEAK and APEX; plans to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib; plans to submit INDs for CGT1815, the company’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, the company’s novel, selective JAK2 V617F inhibitor; and plans to complete dose escalation studies for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor. 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 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 Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings 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 subsequent to the date hereof.
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
(unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
$ |
75,365 |
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$ |
63,029 |
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General and administrative |
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28,242 |
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11,904 |
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Total operating expenses |
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103,607 |
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74,933 |
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Loss from operations |
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(103,607 |
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(74,933 |
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Other income: |
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Interest income |
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7,608 |
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2,952 |
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Interest expense |
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(1,213 |
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— |
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Other income (expense), net |
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(140 |
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(5 |
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Total other income, net |
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6,255 |
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2,947 |
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Net loss |
$ |
(97,352 |
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$ |
(71,986 |
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COGENT BIOSCIENCES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Cash, cash equivalents and marketable securities |
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$ |
866,378 |
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$ |
900,765 |
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Working capital |
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$ |
819,822 |
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$ |
846,402 |
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Total assets |
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$ |
903,006 |
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$ |
937,607 |
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Total liabilities |
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$ |
295,313 |
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$ |
301,236 |
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Total stockholders’ equity |
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$ |
607,693 |
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$ |
636,371 |
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Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653