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 ...

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]

Core Insights - Cogent Biosciences reported positive top-line results from the SUMMIT trial for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints [1][5] - The company is on track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in the second half of 2025 [1][12] - Cogent has $453 million in pro-forma cash, sufficient to fund operations through the anticipated launch and into 2027, including proceeds from a $230 million public offering in July 2025 [1][6] Recent Business Highlights - The SUMMIT trial demonstrated a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002), with a mean reduction of 24.3 points in the bezuclastinib arm compared to 15.4 points in the placebo arm [5] - 87.4% of bezuclastinib-treated patients had a ≥50% reduction in serum tryptase, compared to no patients in the control arm (p<0.0001) [5] - The majority of treatment-emergent adverse events (TEAEs) were of low grade, with serious AEs occurring in 4.2% of patients treated with bezuclastinib [5] Financial Overview - As of June 30, 2025, Cogent had cash, cash equivalents, and marketable securities of $237.8 million, which, along with net proceeds from the public offering, is expected to fund operations into 2027 [6][15] - Research and development expenses for Q2 2025 were $62.2 million, up from $54.3 million in Q2 2024, primarily due to ongoing clinical trials [7] - General and administrative expenses increased to $13.4 million in Q2 2025 from $10.1 million in Q2 2024, attributed to organizational growth [8] Net Loss - The net loss for Q2 2025 was $73.5 million, compared to a net loss of $59.0 million for the same period in 2024 [9][14] Upcoming Milestones - The company anticipates reporting top-line results from the PEAK and APEX trials in the second half of 2025 and plans to submit its first New Drug Application (NDA) by the end of 2025 [12][13] - The anticipated commercial launch of bezuclastinib is expected in 2026 [13] Inducement Grants - On July 30, 2025, the Compensation Committee approved equity awards to six new employees under the company's 2020 Inducement Plan, totaling nonqualified options to purchase 172,450 shares of common stock [10] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program targeting the KIT D816V mutation [11]

Investment Rating - The report indicates a positive investment outlook for the hereditary angioedema (HAE) treatment sector, particularly following the approval of the first oral on-demand treatment, sebetralstat [14][21]. Core Insights - The report highlights the urgent need for effective HAE treatments due to the high risk of life-threatening episodes, with nearly half of HAE patients facing potential asphyxiation [10][16]. - Sebetralstat, approved by the FDA, is noted for its rapid onset of action, achieving near-complete inhibition of plasma kallikrein within 15 minutes of administration [21]. - The KONFIDENT trial results demonstrate that sebetralstat significantly reduces symptom relief time compared to placebo, with median relief times of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose [20][21]. Summary by Sections Section 1: HAE Overview - HAE is characterized by recurrent episodes of angioedema without urticaria, with a prevalence of approximately 1.5 per 100,000 individuals [7]. - The disease can lead to severe complications, including laryngeal edema, which has a mortality rate of up to 40% among patients [7][10]. Section 2: Current Treatment Landscape - Existing treatments include long-term preventive therapies (LTP) and on-demand treatments for acute episodes [10][11]. - The global HAE drug market reached $2.9 billion in 2022, with $2 billion attributed to long-term prevention and $900 million to acute on-demand treatments [13]. Section 3: Sebetralstat Approval and Efficacy - Sebetralstat is the first oral on-demand treatment for HAE, approved on July 7, 2025, and is expected to address unmet needs in the treatment landscape [21]. - The KONFIDENT trial, involving 136 patients across 20 countries, confirmed the efficacy and safety of sebetralstat, showing significant improvements in symptom relief and severity reduction compared to placebo [21]. Section 4: Future Developments - Pharvaris is developing deucrictibant, a competitive oral antagonist for HAE, with promising Phase II trial results indicating effective management of HAE attacks [26]. - The report anticipates further advancements in HAE treatments, with ongoing clinical trials expected to yield additional data in the coming years [26].

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 - Shares of Cogent Biosciences (COGT) increased by 23.4% following the positive results from a late-stage study of bezuclastinib for treating non-advanced systemic mastocytosis (SM) patients [1][7]. Study Results - The phase III SUMMIT study met all primary and key secondary endpoints, showing significant improvements in the treatment of SM patients with bezuclastinib compared to placebo [2][9]. - Bezuclastinib treatment resulted in a mean total symptom score (TSS) reduction of 24.3 points at 24 weeks, compared to a 15.4-point reduction in the placebo group, leading to a placebo-adjusted improvement of 8.91 points [8]. - 87.4% of patients treated with bezuclastinib experienced a ≥50% reduction in serum tryptase levels, a key biomarker, while no patients in the placebo group achieved this [9]. Safety and Tolerability - Bezuclastinib was reported to be well-tolerated with a favorable safety profile, indicating its potential for chronic use in this patient population [10]. Future Plans - Cogent Biosciences plans to submit a new drug application to the FDA for bezuclastinib by the end of 2025, aiming to establish it as a new standard of care for non-advanced SM [11]. - The company is also evaluating bezuclastinib for advanced SM and gastrointestinal stromal tumors in separate pivotal studies, with top-line data expected in the second half of 2025 [12]. Market Performance - Year-to-date, Cogent Biosciences shares have increased by 19.9%, outperforming the industry, which saw a decline of 1.9% [4].