WALTHAM, Mass. and BOULDER, Colo., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that on September 25, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to 10 new employees under the company’s 2020 Inducement Plan with a grant date of September 29, 2025. The ...

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].

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]

Core Insights - Bezuclastinib has shown significant clinical benefits in treating patients with non-advanced systemic mastocytosis (NonAdvSM), achieving a statistically significant mean change in total symptom score (TSS) at 24 weeks compared to placebo [1][2][3] - The drug demonstrated a substantial reduction in serum tryptase levels, with 87.4% of patients experiencing at least a 50% reduction, contrasting with 0% in the placebo group [1][2] - Bezuclastinib is expected to submit a New Drug Application (NDA) to the FDA by the end of 2025, supported by a strong financial position with $237 million in cash and access to an additional $350 million [1][2][6] Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a mean reduction of 24.3 points in TSS for the bezuclastinib group versus 15.4 points for placebo, resulting in a placebo-adjusted improvement of 8.91 points (p=0.0002) [2][3] - All key secondary endpoints also showed statistically significant improvements, including a ≥50% reduction in serum tryptase (p<0.0001) and other measures of mast cell burden [3][4] Safety and Tolerability - Bezuclastinib exhibited a favorable safety profile, with the majority of treatment-emergent adverse events (TEAEs) being low grade; 98.3% in the bezuclastinib arm compared to 88.3% in the placebo arm [4][5] - Common TEAEs included hair color change (69.5% vs. 5.0% placebo), altered taste (23.7% vs. 0%), and nausea (22.0% vs. 13.3%) [4][5] Future Plans - Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year and is on track to share pivotal trial results from the PEAK and APEX trials in the second half of 2025 [1][6][5]

Company Announcement - Cogent Biosciences, Inc. will present at the Jefferies Global Healthcare Conference on June 5, 2025, at 7:35 a.m. ET [1] - A live webcast of the presentation will be available on the Investors & Media page of Cogent's website, with a replay accessible approximately two hours after the event and archived for 30 days [2] Inducement Grants - On May 19, 2025, Cogent's Compensation Committee approved "inducement" equity awards for five new employees under the 2020 Inducement Plan, with a grant date of May 27, 2025 [3] - The total awards consist of nonqualified options to purchase 127,000 shares of Cogent common stock, with a 10-year term and an exercise price equal to the closing price on the grant date [3] - The options will vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting in equal monthly installments over the following 36 months, contingent on continued employment [3] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its most advanced clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [4] - The KIT D816V mutation is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST), which rely on oncogenic KIT signaling [4] - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [4]

Core Insights - Cogent Biosciences, Inc. presented preclinical data from four pipeline programs at the AACR 2025 Annual Meeting, highlighting its focus on developing precision therapies for genetically defined diseases [1][2] Pipeline Programs - The first program involves a potent KRAS (ON) inhibitor that shows selectivity for mutant KRAS over HRAS and NRAS, achieving 90% tumor growth inhibition in a mouse model with a 30 mg/kg oral dose [2][3] - The second program features CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor, which demonstrates efficacy against PI3K helical mutations and broad cellular profiling across resistant cell lines [3][4] - The third program is CGT4859, a reversible and selective FGFR2/3 inhibitor that shows superior target coverage of resistance mutations and demonstrated complete tumor regressions in a model at doses greater than 2.5 mg/kg [5][6][7] - The fourth program is CGT4255, an EGFR-sparing, pan-mutant HER2 inhibitor with potential best-in-class brain penetration, showing high oral bioavailability and stability in human blood [8] Leadership Changes - Cogent announced the appointment of Ray Frost as Senior Vice President of Market Access and Adam Boyd, Ph.D., as Senior Vice President of Corporate Strategy, both bringing extensive industry experience [10][11][12] Inducement Grants - The company approved inducement equity awards for new employees, including Mr. Frost and Dr. Boyd, totaling nonqualified options to purchase 446,000 shares of common stock [13] Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with its most advanced clinical program targeting the KIT D816V mutation associated with systemic mastocytosis and gastrointestinal stromal tumors [14]

Core Insights - Cogent Biosciences, Inc. announced four preclinical poster presentations at the 2025 AACR Annual Meeting, showcasing its focus on precision therapies for genetically defined diseases [1][2] Group 1: Poster Presentations - The first poster details a potent KRAS (ON) inhibitor selective for mutant KRAS over HRAS and NRAS, scheduled for presentation on April 30, 2025 [2] - The second poster presents CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor, to be showcased on April 28, 2025 [2] - The third poster features CGT4859, a reversible and selective FGFR2/3 inhibitor with superior target coverage of resistance mutations, presented on April 29, 2025 [2] - The fourth poster introduces CGT4255, an EGFR sparing, pan-mutant HER2 candidate with potential best-in-class brain penetration, also scheduled for April 29, 2025 [2] Group 2: Inducement Grant - The Compensation Committee of Cogent's Board approved an inducement equity award for a new employee, consisting of a nonqualified option to purchase 9,700 shares of common stock, with a 10-year term and a 4-year vesting schedule [3] Group 3: Company Overview - 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][5] - The company is also advancing a Phase 1 study of its novel FGFR2 inhibitor and developing a portfolio of targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [5]

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]