Core Insights - Cogent Biosciences announced expanded clinical results from the SUMMIT trial evaluating bezuclastinib for nonadvanced systemic mastocytosis, showing a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, with 88% of patients achieving at least a 50% reduction in TSS [1][6] Group 1: Clinical Trial Results - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study involving patients with nonadvanced systemic mastocytosis, with results focusing on those who received 100 mg bezuclastinib for at least 48 weeks [3] - Updated clinical data indicate a 63% reduction from baseline in the most severe symptom at 48 weeks, and quality of life improved to mild as early as week four, sustained through 48 weeks as measured by the Mastocytosis Quality-of-Life scale [6] Group 2: Safety and Patient Outcomes - The median duration of bezuclastinib treatment was 56 weeks for active patients and 40 weeks for placebo patients who crossed over to the Open Label Extension [4] - Most treatment-emergent adverse events were low grade and reversible, with common events including hair discoloration and transaminase elevations, all of which were asymptomatic and reversible [4] Group 3: Future Plans - Top-line results from SUMMIT Part 2 are expected in July 2025, with the company aiming to make bezuclastinib available to all nonadvanced systemic mastocytosis patients as quickly as possible [2][8]

OR 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, 2024 ☐ 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 https://files.reportify.cc/m Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2024 Financial Results Top-line results from SUMMIT trial in NonAdvSM patients expected July 2025 Bezuclastinib – Gastrointestinal Stromal Tumors (GIST) • Report top-line results by the end of 2025 from the pivotal Phase 3 PEAK trial. PEAK is a global, blinded, randomized clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with ...

Core Insights - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with a significant emphasis on bezuclastinib, a selective tyrosine kinase inhibitor targeting systemic mastocytosis and gastrointestinal stromal tumors [2][16] Business Highlights - The company plans to report data from three pivotal clinical trials for bezuclastinib in 2025, with a New Drug Application (NDA) submission expected by the end of 2025 [2][4] - As of December 31, 2024, Cogent had cash and cash equivalents of $287.1 million, which is projected to fund operations into late 2026 [10][19] - Research and development expenses for Q4 2024 were $62.0 million, up from $48.7 million in Q4 2023, driven by the development of bezuclastinib and other pipeline projects [11][18] Clinical Trial Updates - The SUMMIT trial for nonadvanced systemic mastocytosis (NonAdvSM) showed a 56% mean improvement in Total Symptom Score (TSS) at 24 weeks, with 76% of patients achieving over 50% reduction from baseline [5] - The APEX trial for advanced systemic mastocytosis (AdvSM) reported a 52% overall response rate (ORR) per mIWG criteria, with 83% ORR for patients receiving 100 mg BID [5] - The PEAK trial for gastrointestinal stromal tumors (GIST) is expected to report top-line results by the end of 2025 [7] Pipeline Developments - Cogent is advancing a potent and selective KRAS inhibitor, CGT6737, which demonstrated significant activity against KRAS mutations [5] - The company is also developing CGT6297, a potent allosteric inhibitor of PI3Kα, which showed high oral bioavailability and efficacy in animal models [5] Financial Performance - The net loss for Q4 2024 was $67.9 million, compared to a net loss of $54.4 million in Q4 2023, with total operating expenses for the year reaching $275.9 million [14][18] - General and administrative expenses increased to $11.7 million in Q4 2024 from $9.5 million in Q4 2023, reflecting organizational growth [12][18]

Group 1 - Cogent Biosciences, Inc. (COGT) is a notable stock in the Medical sector, currently ranked 2 in the Zacks Sector Rank, which evaluates the average Zacks Rank of individual stocks within the sector [2][3] - The Zacks Consensus Estimate for COGT's full-year earnings has increased by 2.6% over the past quarter, indicating a positive trend in analyst sentiment and earnings outlook [4] - COGT has achieved a year-to-date performance increase of approximately 12.3%, significantly outperforming the average gain of 5.3% in the Medical sector [4] Group 2 - Cogent Biosciences, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 510 companies and is currently ranked 65 in the Zacks Industry Rank [6] - Stocks in the Medical - Biomedical and Genetics industry have gained about 2.9% year-to-date, showcasing COGT's superior performance within this group [6] - Another outperforming stock in the Medical sector is Cardiol Therapeutics Inc. (CRDL), which has increased by 7% year-to-date, with a consensus EPS estimate rise of 12.5% over the past three months [5][7]

Core Insights - Cogent Biosciences, Inc. is set to present a poster on bezuclastinib at the 2025 AAAAI Annual Meeting, focusing on its efficacy and safety in patients with Non-Advanced Systemic Mastocytosis [1][3] Company Overview - Cogent Biosciences specializes in developing precision therapies for genetically defined diseases, with bezuclastinib being its most advanced clinical program [4] - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is linked to systemic mastocytosis and other cancers [4] - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [4] Presentation Details - The poster presentation titled "Efficacy and Safety Results of Adult Patients with NonAdvanced Systemic Mastocytosis Receiving Bezuclastinib 100 mg in the Ongoing Summit Trial" will take place on March 1, 2025 [3] - The session will highlight the benefits of long-term use of 100mg bezuclastinib over at least 48 weeks [2] - The presentation is scheduled for 9:45am – 10:45am PT at the San Diego Convention Center [3]

Cogent Biosciences Inc (COGT) Conference Summary Company Overview - Cogent Biosciences is focused on developing small molecule targeted agents for rare genetically driven diseases, with its lead asset being bezuclasanib, a selective KIT mutant inhibitor [5][4]. Key Points on Bezuclasanib - Bezuclasanib is currently in three pivotal studies set to read out in 2025: - SUMMIT study for non-advanced systemic mastocytosis (July 2025) - APEC study for advanced systemic mastocytosis (second half of 2025) - PEAK trial for gastrointestinal stromal tumor patients (end of 2025) [5][6]. - Bezuclasanib is differentiated from other KIT inhibitors, particularly Avapritinib, in two main ways: - It is about 10 times more selective for mutant KIT over wild type and does not target other kinases, reducing tolerability challenges [9][10]. - It has minimal penetration into CNS tissue, avoiding cognitive issues associated with other drugs [10][11]. Market Opportunity - The non-advanced systemic mastocytosis market is estimated to be a $4 billion total available market, with bezuclasanib expected to address unmet needs for symptomatic control [14][12]. - Blueprint's Avapritinib achieved approximately $500 million in first-year sales, indicating strong demand for treatments in this space [13][14]. Clinical Data and Safety Profile - Phase one data showed a nearly 56% improvement in total symptom score reduction at 24 weeks, with almost 90% of patients achieving at least a 50% improvement [17][18]. - Bezuclasanib has a benign safety profile, with reversible and asymptomatic transaminase elevations being the primary concern, unlike Avapritinib, which has reported neuropsychiatric events and fatalities associated with cerebral hemorrhage [22][24][25][26]. Formulation and Development - The formulation of bezuclasanib was changed to reduce pill burden and improve bioavailability, with no risk in translating Phase one data to pivotal studies [27][28]. - SUMMIT PART two is designed similarly to the PIONEER study, allowing patients who have previously been treated with Avapritinib [31][32]. Advanced Systemic Mastocytosis (ASM) and GIST Opportunities - The ASM population represents about 10% of the total mastocytosis market, estimated at $300 million to $400 million [38]. - In GIST treatment, bezuclasanib is expected to provide coverage for all known resistance mutations when combined with SUTENT, potentially leading to longer progression-free survival [41][43]. Conclusion - The upcoming pivotal trial readouts in 2025 are critical for Cogent Biosciences, with bezuclasanib positioned as a promising treatment option in the rare disease market, particularly for systemic mastocytosis and gastrointestinal stromal tumors [5][6][48].

Core Insights - Cogent Biosciences, Inc. is participating in the Guggenheim SMID Cap Biotech Conference on February 5, 2025, at 9:30 a.m. ET [1] - The company focuses on developing precision therapies for genetically defined diseases, with its most advanced clinical program being bezuclastinib, a selective tyrosine kinase inhibitor [3] Company Overview - Cogent Biosciences is based in Waltham, MA, and Boulder, CO, and is dedicated to creating targeted therapies for serious diseases driven by genetic mutations [3] - The company is currently conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [3] Event Information - A live webcast of the conference participation can be accessed on Cogent's Investors & Media page, with a replay available for 30 days post-event [2]

Company Overview - Cogent Biosciences (NASDAQ: COGT) is a clinical-stage biotech company focused on genetically defined diseases, with its lead candidate Bezuclastinib [1] - Bezuclastinib is currently in 3 ongoing late-stage trials targeting AdvSM, non-AdvSM, and GIST [1] Clinical Trials - The company's success hinges on the outcomes of its 3 late-stage trials for Bezuclastinib [1] Author Background - The author, Myriam Hernandez Alvarez, holds multiple degrees including a Ph.D. in computer applications and collaborates professionally with Edgar Torres H [1]

Core Insights - Cogent Biosciences anticipates 2025 to be a transformational year, with plans to report top-line results from three registration-directed studies of bezuclastinib and submit its first New Drug Application (NDA) by the end of the year [2][9] Milestones for 2025 - The company plans to report top-line results from the SUMMIT trial for Non-Advanced Systemic Mastocytosis (NonAdvSM) in July 2025 [8][9] - Top-line results from the pivotal Phase 3 PEAK trial for gastrointestinal stromal tumors (GIST) are expected by the end of 2025 [4][9] - The APEX trial for Advanced Systemic Mastocytosis (AdvSM) will report results in the second half of 2025 [9] - An Expanded Access Program (EAP) for bezuclastinib will be initiated in Q1 2025 for eligible SM and GIST patients [5] Pipeline Development - The ongoing Phase 1 trial of CGT4859, a selective FGFR2 inhibitor, aims to explore safety and tolerability in patients with FGFR mutations [6] - The company plans to submit IND applications for CGT4255, a selective ErbB2 inhibitor, and CGT6737, a potent allosteric inhibitor of PI3Kα, during 2025 [7][10] Financial Position - Cogent Biosciences has a strong balance sheet, positioning the company well for its transition into a commercial-stage entity [2]