Company Overview - Cogent Biosciences is focused on the discovery, development, and commercialization of targeted therapies for patients with rare genetically driven diseases [2] - The company's lead asset is bezuclastinib, a selective potent KIT inhibitor aimed at treating diseases driven by mutations in the KIT gene [3] Product and Clinical Trials - Bezuclastinib targets patients with mastocytosis, which is divided into advanced and non-advanced forms, as well as gastrointestinal stromal tumors [3] - The company has initiated pivotal studies across three patient populations, with the SUMMIT study being the first to report positive data in the non-advanced systemic mastocytosis population [4] - The SUMMIT study results indicate the potency and favorable safety profile of bezuclastinib [4]

Summary of Cogent Biosciences Conference Call Company Overview - **Company**: Cogent Biosciences - **Focus**: Discovery, development, and commercialization of targeted therapies for rare genetically driven diseases - **Lead Asset**: Bezuclastinib, a selective potent KIT inhibitor for diseases driven by mutations in the KIT gene, particularly mastocytosis and gastrointestinal stromal tumors (GIST) [3][4] Key Points Product Development and Trials - **Pivotal Trials**: - Summit study for non-advanced systemic mastocytosis has shown positive data, leading to an expected FDA submission in 2026 [4] - Other pivotal trials (PEAK for GIST and APEX for advanced mastocytosis) are set to read out later in 2025 [4] - **Portfolio Expansion**: Cogent is developing early-stage programs targeting FGFR, ERB2, PI3K, and KRAS [5] Mechanism of Action - **Targeting KIT**: Bezuclastinib is designed for high potency and selectivity, avoiding off-target effects common in other KIT inhibitors [7][10] - **Differentiation**: Unlike avapritinib, bezuclastinib does not penetrate the central nervous system, reducing side effects [9][10] Disease Insights - **Mastocytosis**: - Advanced form leads to significant mortality, while non-advanced form results in morbidity with symptoms affecting quality of life [11][12] - Symptoms include skin issues, fatigue, and anxiety, with a significant number of patients undiagnosed [14][16] - **Market Dynamics**: Avapritinib has provided some symptomatic relief but often fails to achieve full resolution of symptoms, leaving patients seeking better options [19][20] Clinical Data and Efficacy - **Summit Part II Data**: Bezuclastinib demonstrated a statistically significant improvement over placebo, with nearly 90% of patients showing a greater than 50% reduction in serum tryptase levels [21][23] - **Symptom Resolution**: Faster and deeper symptomatic improvement compared to low-dose avapritinib [22][23] Safety Profile - **Liver Function**: No significant liver toxicity observed in pivotal trials, with only lab abnormalities reported [29][30] - **Side Effects**: Bezuclastinib has a safety profile similar to placebo, with manageable side effects such as hair color changes [31] Advanced Mastocytosis and GIST - **Advanced Mastocytosis**: Bezuclastinib may allow concurrent treatment with therapies for associated hematologic neoplasms due to its lower hematologic toxicity [40][41] - **GIST Strategy**: Bezuclastinib is being tested in combination with sunitinib to cover all known KIT mutations, addressing previous failures in monotherapy trials [46][49] Market Potential - **Patient Population**: Approximately 75% of advanced mastocytosis patients have associated hematologic neoplasms, expanding the potential market for bezuclastinib [43] - **Future Trials**: Upcoming data from the APEX study and combination trials with sunitinib are anticipated to provide further insights into efficacy and safety [45][54] Conclusion Cogent Biosciences is positioned to make significant advancements in the treatment of rare genetically driven diseases, particularly through the development of bezuclastinib, which shows promise in efficacy and safety compared to existing therapies. The upcoming trial results and FDA submissions will be critical in determining the future market landscape for these treatments.

Group 1 - Cogent Biosciences, Inc. announced participation in the Citi Biopharma Back to School Conference on September 3, 2025, at 9:00 a.m. ET [1] - A live webcast of the event will be available on Cogent's Investors & Media page, with a replay accessible for 30 days post-event [2] - The Compensation Committee approved inducement equity awards for two new employees, granting nonqualified options to purchase 54,500 shares of common stock, with a 10-year term and a four-year vesting schedule [3] Group 2 - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program, bezuclastinib, targeting the KIT D816V mutation linked to systemic mastocytosis and advanced gastrointestinal stromal tumors [4] - The company is also conducting a Phase 1 study of a novel FGFR2/3 inhibitor and developing targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [4] - Cogent is headquartered in Waltham, MA, and Boulder, CO, and provides updates on its website and social media platforms [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 incorporatio ...

Anticipated Upcoming Milestones Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary ...

Core Viewpoint - Cogent Biosciences, Inc. has successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at a price of $9.00 per share, raising approximately $230 million in gross proceeds [1][2]. Group 1: Offering Details - The offering included 3,333,333 shares from the underwriters' option to purchase additional shares [1] - The net proceeds will be utilized for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2]. - J.P. Morgan, Leerink Partners, and Guggenheim Securities served as joint book-running managers for the offering [2]. Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6].

Exhibit 1.1 COGENT BIOSCIENCES, INC. 22,222,223 Shares of Common Stock UNDERWRITING AGREEMENT July 8, 2025 J.P. MORGAN SECURITIES LLC LEERINK PARTNERS LLC GUGGENHEIM SECURITIES, LLC As Representatives of the several Underwriters c/o J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 c/o Leerink Partners LLC 53 State Street, 40th Floor Boston, Massachusetts 02109 c/o Guggenheim Securities, LLC 330 Madison Avenue New York, New York 10017 Ladies and Gentlemen: Cogent Biosciences, Inc., a De ...

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] Group 2 - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] - The analyst has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3]

Core Viewpoint - Cogent Biosciences, Inc. has announced a public offering of 22,222,223 shares of common stock at a price of $9.00 per share, aiming to raise approximately $200 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 3,333,333 shares on the same terms [1]. - The expected closing date for the offering is around July 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the development, regulatory, and commercial preparation activities related to bezuclastinib and other product candidates [2]. - Funds will also support the planned commercial launch of bezuclastinib, along with working capital and general corporate purposes [2]. Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5]. - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is associated with systemic mastocytosis and advanced gastrointestinal stromal tumors [5]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [5].

Core Viewpoint - Cogent Biosciences, Inc. has initiated an underwritten public offering of $150 million in common stock, with an additional option for underwriters to purchase up to $22.5 million more [1][2] Group 1: Offering Details - The offering is subject to market conditions and there is no assurance regarding its completion or the final terms [1] - The net proceeds will be used for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2] - J.P. Morgan, Leerink Partners, and Guggenheim Securities are acting as joint book-running managers for the offering [2] Group 2: Regulatory Information - The securities will be offered under an automatic shelf registration statement filed with the SEC on February 10, 2023 [3] - A preliminary prospectus supplement will be filed with the SEC detailing the terms of the offering [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5] - Bezuclastinib is designed to inhibit the KIT D816V mutation, which is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors [5] - The company is also developing a portfolio of targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [5]