UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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: 001-38443 COGENT BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

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 tremen ...

SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meetingStrong financial position with $9 ...

Core Insights - Cogent Biosciences, Inc. is set to present multiple posters on bezuclastinib results from the SUMMIT trial for NonAdvanced Systemic Mastocytosis at the 2026 AAAAI Annual Meeting [1][2] Group 1: Upcoming Presentations - The posters will cover various aspects of bezuclastinib, including expanded results from the Phase 2 SUMMIT trial, evaluation of bone formation marker changes, patient experiences, symptom burden improvement, and results in subgroups with unmet needs [3] Group 2: Drug Development and Regulatory Status - In December 2025, Cogent submitted a New Drug Application for bezuclastinib to the FDA, based on positive clinical data from the SUMMIT trial and following its Breakthrough Therapy Designation [2] - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is significant in systemic mastocytosis and other related conditions [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases and has an ongoing Phase 1 study of a novel FGFR2/3 inhibitor [4][5]

Core Insights - A significant insider sale of 3,500,000 shares by Fairmount Funds Management LLC occurred despite Cogent Biosciences achieving its best annual performance in 2025, raising questions about the motivations behind the sale [1][6]. Transaction Summary - Fairmount Funds Management LLC sold 3,500,000 shares for approximately $127.4 million, reducing its indirect holdings by 38.87% to 5,503,418 shares [2][3]. - The shares were sold at a reported price of $36.40, which was lower than the closing price of $39.53 on the same day [3]. Company Overview - Cogent Biosciences, based in Massachusetts, is a clinical-stage biotechnology company focused on targeted therapies for rare, genetically driven diseases, with a market capitalization of $5.46 billion and a net income of -$294.37 million [4][5]. - The company's stock experienced a remarkable 286.13% price increase over the past year, with a notable rise of approximately 342% in 2025 [4][6]. Investor Implications - The sale of shares by Fairmount Funds Management, which generated over $120 million, may indicate profit-taking following substantial stock gains, although the specific motivations remain unclear [6]. - Fairmount Funds continues to hold approximately 67,414 units of Series A Convertible Preferred Stock, which could convert to about 16.85 million common shares, subject to ownership limits [7][8].

Core Insights - Pfizer Inc. shares are experiencing an increase due to a price forecast raise by Cantor Fitzgerald from $24 to $27, despite a decline in the broader healthcare sector [1] Recent Developments Supporting Pfizer - Pfizer has entered a non-exclusive licensing agreement with Novavax Inc. for the Matrix-M adjuvant technology, which includes a $30 million upfront payment and potential milestones totaling up to $500 million [2] - Pfizer's drug Sutent, used for gastrointestinal stromal tumors, has received FDA Breakthrough Therapy Designation in combination with Cogent Biosciences' bezuclastinib, showing a 50% reduction in disease progression risk [3] Leadership Commentary - Pfizer CEO Albert Bourla highlighted at the World Economic Forum that reduced funding for U.S. universities is weakening America's position in global health research, with Chinese institutions now holding about 80% of top-tier positions in health research rankings [4] Earnings & Analyst Outlook - Investors are anticipating the next earnings report scheduled for February 3 [5] Benzinga Edge Rankings - Pfizer shares were up 2.14% at $26.43, with an EPS estimate of $0.57 (down from $0.63 YoY) and a revenue estimate of $16.83 billion (down from $17.76 billion YoY) [6] - The company has a P/E ratio of 15.0x, indicating fair valuation, and is trading at a premium relative to peers with a value score of 34.84 [6] - The balance sheet remains healthy with a quality score of 54.07, but the stock is underperforming the broader market with a momentum score of 29.54 [6]

Core Insights - Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for bezuclastinib in combination with sunitinib for patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST) [2][3] - The company plans to submit the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) program, aiming for completion by April 2026 [1][3] Clinical Trial Results - The PEAK trial demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - Median progression-free survival (mPFS) was reported as 16.5 months for the bezuclastinib combination versus 9.2 months for sunitinib monotherapy [2] Future Plans - Cogent intends to present full results from the PEAK trial at a major medical meeting in the first half of 2026 [4] - The company expects to initiate a Phase 2 trial in mid-2026 to investigate the bezuclastinib and sunitinib combination for first-line GIST patients with exon 9 mutations [4] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [5] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [5]

Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Future Plans and Trials - Cogent is expected to initiate the RTOR process immediately, with the completion of the NDA submission anticipated in April 2026 [1][4] - Full results from the PEAK trial will be presented at a major medical meeting in the first half of 2026 [5] - A Phase 2 trial is expected to begin in mid-2026 to investigate the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to or have recently started treatment with imatinib [5] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of novel targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Safety and Future Plans - The bezuclastinib combination was generally well tolerated, with no unique risks observed compared to the known safety profile of sunitinib [3] - Cogent plans to present full results from the PEAK trial at a major medical meeting in the first half of 2026 and will initiate a Phase 2 trial in mid-2026 for first-line GIST patients with exon 9 mutations [5][8] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

Core Insights - The presentation is part of the 44th Annual JPMorgan Healthcare Conference, featuring Cogent Biosciences and its CEO, Andy Robbins [1] - The focus of the discussion is on the future of Cogent, particularly looking ahead to developments in 2026 and beyond [3] Company Overview - Cogent's lead asset, bezuclastinib, is a potent and selective KIT mutant inhibitor [3] - In 2025, Cogent reported positive results from three pivotal trials for bezuclastinib, marking a significant year for the company and its patients [3]