Cogent Biosciences (COGT) widens Q2 loss but nears FDA decisions on bezuclastinib
Rhea-AI Filing Summary
Cogent Biosciences reported second quarter 2026 results while highlighting major regulatory and clinical milestones for bezuclastinib. The company has three New Drug Applications under review and is on track for potential FDA decisions for bezuclastinib in GIST on November 30, 2026 and in Advanced Systemic Mastocytosis on December 30, 2026. Detailed Phase 3 PEAK data in imatinib-resistant/intolerant GIST showed the bezuclastinib plus sunitinib combination reduced risk of progression or death by 50% (hazard ratio 0.50) with median progression-free survival of 16.5 months versus 9.2 months for sunitinib alone, and objective response rates of 46% versus 26%. In AdvSM, the pivotal APEX trial showed a 65% overall response rate among 68 evaluable patients.
Cogent completed hiring of a cross-functional commercial and medical field team in preparation for potential launches. As of June 30, 2026, cash, cash equivalents and marketable securities were $792.3 million, and including $73.6 million of post‑quarter ATM proceeds, management cites a pro forma cash balance of $865.9 million, expected to fund operations into late 2028. Second quarter 2026 research and development expenses were $70.8 million and general and administrative expenses were $31.8 million, leading to a net loss of $96.4 million. The company also granted options on 226,700 shares and 189,700 RSUs as inducement awards to 59 new employees.
Positive
- Bezuclastinib pivotal data support NDAs in GIST and AdvSM, including a 50% reduction in risk of progression or death and strong response rates in both indications, with U.S. FDA priority review and specific PDUFA dates disclosed.
- Strong liquidity and long runway with $792.3 million in cash, cash equivalents and marketable securities at June 30, 2026 and a cited pro forma cash balance of $865.9 million, expected to fund operations into late 2028 including potential launches.
- Commercial infrastructure in place as Cogent has hired and onboarded a nationwide, expert, cross-functional customer-facing team, positioning the company for potential bezuclastinib launch and early commercialization activities.
Negative
- Net loss expanded to $96.4 million in Q2 2026 from $73.5 million a year earlier, driven by higher R&D and G&A spending tied to pivotal trials, regulatory activities and commercial readiness.
- Operating expenses increased significantly, with R&D rising to $70.8 million and G&A to $31.8 million in Q2 2026 versus $62.2 million and $13.4 million in Q2 2025, reflecting heavier investment ahead of potential approvals.
Insights
Analyzing...
8-K Event Classification
Key Figures
Key Terms
PDUFA date regulatory
New Drug Application regulatory
hazard ratio medical
objective response medical
overall response rate medical
Inducement Plan financial
Earnings Snapshot
Management states existing cash plus ATM proceeds are expected to fund operations into late 2028, including through potential FDA approvals and early commercial launch activities.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Cogent Biosciences (COGT) key clinical results for bezuclastinib in GIST?
What efficacy did Cogent Biosciences (COGT) report for bezuclastinib in Advanced Systemic Mastocytosis?
What is Cogent Biosciences’ (COGT) cash position and runway after Q2 2026?
How did Cogent Biosciences’ (COGT) Q2 2026 expenses and net loss compare to 2025?
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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
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275 Wyman Street, 3rd Floor
Waltham, Massachusetts
(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:
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:
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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. m
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 August 10, 2026, Cogent Biosciences, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the quarter ended June 30, 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 August 10, 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: August 10, 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
Second Quarter 2026 Financial Results
On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30
Completed onboarding of expert cross-functional Cogent customer-facing team, including all field-based commercial and medical team members
Strong pro forma cash balance of $865.9 million, sufficient to fund operations into late 2028
WALTHAM, Mass. and BOULDER, Colo., August 10, 2026 – Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2026.
“The first half of 2026 has been marked by transformative milestones toward our vision of creating best-in-class therapies for patients fighting rare, mutationally driven diseases as we submitted three New Drug Applications following positive results from each of the bezuclastinib pivotal trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “We are excited to welcome the new Cogent customer facing team to the company, and supported by our strong balance sheet, we are well prepared to launch bezuclastinib and advance the standard of care for patients with GIST and Systemic Mastocytosis while continuing to invest in our broader pipeline of precision therapies for genetically defined diseases.”
Recent Business Highlights
Cogent Biosciences Integrated Business Team
Bezuclastinib in GIST
Bezuclastinib in Systemic Mastocytosis
Anticipated Upcoming Milestones
Second Quarter 2026 Financial Results
Cash Position: As of June 30, 2026, Cogent had cash, cash equivalents and marketable securities of $792.3 million. The company expects its existing cash, cash equivalents and marketable securities, with the $73.6 million gross proceeds from shares sold through the Company’s at-the-market (ATM) facility after the end of the quarter, will be sufficient to fund its operating expenses and capital expenditure requirements into late 2028, including through potential FDA approvals of bezuclastinib for GIST, NonAdvSM and AdvSM and early commercial launch activities.
R&D Expenses: Research and development expenses were $70.8 million for the second quarter of 2026 as compared to $62.2 million for the second quarter of 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company's early-stage research pipeline, and pre-approval manufacturing costs that will be capitalized following anticipated FDA approval.
R&D expenses include non-cash stock compensation expense of $8.6 million for the second quarter of 2026 as compared to $5.0 million for the second quarter of 2025.
G&A Expenses: General and administrative expenses were $31.8 million for the second quarter of 2026 as compared to $13.4 million for the second quarter of 2025. The increase was primarily driven by continued investments in commercial readiness, including personnel and infrastructure to support the anticipated launch of bezuclastinib, as well as overall organizational growth.
G&A expenses include non-cash stock compensation expense of $8.5 million for the second quarter of 2026 as compared to $4.8 million for the second quarter of 2025.
Net Loss: Net loss was $96.4 million for the second quarter of 2026 as compared to a net loss of $73.5 million for the same period of 2025.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on August 4, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to 59 new employees under the company’s 2020 Inducement Plan with grant dates of August 4, 2026 and August 10, 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 226,700 shares of Cogent common stock and (ii) 189,700 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 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 company’s expectation to receive regulatory approval of bezuclastinib later this year for both GIST patients and NonAdvSM patients; the company’s anticipated cash runway into late 2028 and the expectation that it will be sufficient to fund operations through anticipated FDA approvals of bezuclastinib for GIST, NonAdvSM and AdvSM and early commercial launch activities; the company’s level of preparation to launch bezuclastinib and advance the standard of care for patients with GIST and Systemic Mastocytosis while also continuing to invest in its broader pipeline of precision therapies for genetically defined diseases; the company’s expectation that it will present preliminary results from its “avapritinib switch” SUMMIT extension trial by the end of 2026; the potential of CGT1145 to eradicate JAK2 V617F myeloproliferative neoplasm propagating cells and induce molecular remission with improved hematologic tolerability; the company’s plans to submit INDs for both CGT1815, its novel, selective pan-KRAS(ON) inhibitor, and CGT1145, its novel, selective JAK2 V617F inhibitor; and the company’s plans to complete dose escalation for CGT4255, its 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 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 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 June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
$ |
70,811 |
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$ |
62,203 |
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$ |
146,176 |
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$ |
125,232 |
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General and administrative |
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31,827 |
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13,379 |
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60,069 |
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25,283 |
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Total operating expenses |
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102,638 |
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75,582 |
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206,245 |
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150,515 |
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Loss from operations |
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(102,638 |
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(75,582 |
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(206,245 |
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(150,515 |
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Other income: |
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Interest income |
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7,461 |
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2,373 |
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15,069 |
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5,325 |
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Interest expense |
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(1,217 |
) |
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(314 |
) |
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(2,430 |
) |
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(314 |
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Other income (expense), net |
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(11 |
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(6 |
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(151 |
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(11 |
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Total other income, net |
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6,233 |
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2,053 |
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12,488 |
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5,000 |
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Net loss |
$ |
(96,405 |
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$ |
(73,529 |
) |
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$ |
(193,757 |
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$ |
(145,515 |
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COGENT BIOSCIENCES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
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June 30, |
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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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$ |
792,300 |
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$ |
900,765 |
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Working capital |
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$ |
745,524 |
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$ |
846,402 |
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Total assets |
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$ |
834,546 |
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$ |
937,607 |
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Total liabilities |
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$ |
302,158 |
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$ |
301,236 |
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Total stockholders’ equity |
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$ |
532,388 |
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$ |
636,371 |
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Contact:
Christi Waarich
Sr. Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653