• Top-line results from SUMMIT trial in NonAdvSM patients expected July 2025 • APEX trial enrollment in AdvSM patients complete; top-line results expected in 2H 2025 • Top-line results from PEAK trial in 2nd-line GIST patients expected by end of 2025 • $312 million sufficient to fund operations well past clinical readouts, into late 2026; includes gross proceeds from ATM sale in February 2025 WALTHAM, Mass. and BOULDER, Colo., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biot ...

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]

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]

Core Points - Cogent Biosciences, Inc. is a biotechnology company focused on developing precision therapies for genetically defined diseases [3] - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025 [1] - The most advanced clinical program is bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [3] - Bezuclastinib is designed to treat systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST) [3] - Cogent is also developing a portfolio of targeted therapies for mutations in FGFR2, ErbB2, PI3Kα, and KRAS [3] Company Information - Cogent Biosciences is headquartered in Waltham, MA, and Boulder, CO [3] - The company provides a live webcast of its presentations on its Investors & Media page [2] - A replay of the webcast will be available for 30 days after the event [2] Contact Information - Christi Waarich is the Senior Director of Investor Relations [4] - Contact details include email: christi.waarich@cogentbio.com and phone: 617-830-1653 [4]

Drug Development and Trials - Bezuclastinib is being developed for Advanced Systemic Mastocytosis (AdvSM) and Non-Advanced Systemic Mastocytosis (Non-AdvSM), with a median survival of less than 3.5 years for AdvSM patients[56]. - The SUMMIT trial for Non-AdvSM completed enrollment in Q3 2023 with 54 patients, and Part 2 is expected to enroll 159 patients, with top-line results anticipated in H2 2025[57]. - In SUMMIT Part 1b, 100% of patients with baseline tryptase ≥20ng/mL achieved <20ng/mL at week 12, compared to 0% in the placebo group[57]. - The APEX trial for AdvSM reported an objective response rate (ORR) of 52% as of September 25, 2023, with a 56% ORR for TKI-treatment-naïve patients[58]. - The PEAK trial for GIST enrolled 413 patients, with a median progression-free survival (mPFS) of 10.2 months and an ORR of 27.5%[60]. - Bezuclastinib has received orphan drug designation from the FDA and EMA for both Mastocytosis and GIST[59][60]. - The SUMMIT Part 1b showed a 51% mean improvement in overall symptom severity for bezuclastinib compared to 18% for placebo[57]. - The majority of treatment-emergent adverse events in clinical trials were low-grade and reversible, with no serious adverse events reported in the SUMMIT trial[57][60]. - The company initiated a Phase 1 study of CGT4859 in patients with FGFR2 mutations, with preliminary results expected in 2025[63]. - CGT4255 demonstrated low nM potency against ErbB2 wild-type and oncogenic mutations with over 100-fold selectivity over wild-type EGFR[64]. - CGT6297, a PI3Kα inhibitor, showed low nM potency in H1047R mutant PI3K cell lines and superior efficacy compared to Alpelisib in preclinical models[66]. - The company is developing a potent KRAS inhibitor, CGT6737, which demonstrated 90% PD inhibition in mouse xenograft models[67]. - The company plans to initiate IND-enabling studies for CGT4255 in mid-2024 and for CGT6297 in 2025[64][66]. Financial Performance - The company reported a net loss of $187.9 million for the nine months ended September 30, 2024, compared to a net loss of $138.0 million for the same period in 2023, with an accumulated deficit of $791.6 million as of September 30, 2024[68]. - The company expects to incur significant expenses and operating losses for at least the next several years, particularly related to ongoing clinical trials and product development[68]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities of $345.5 million, expected to fund operations through late 2026[70]. - Total operating expenses for the three months ended September 30, 2024, were $75.4 million, an increase of $15.8 million (26.6%) compared to $59.6 million for the same period in 2023[75]. - Research and development expenses for the three months ended September 30, 2024, were $63.6 million, up $13.5 million (26.9%) from $50.1 million in 2023, driven by higher costs associated with bezuclastinib and increased personnel costs[76][77]. - Net loss for the three months ended September 30, 2024, was $70.6 million, compared to a net loss of $55.4 million for the same period in 2023, reflecting an increase of $15.2 million (27.5%) in losses[75]. - For the nine months ended September 30, 2024, total operating expenses were $202.2 million, an increase of $52.3 million (34.9%) from $149.9 million in 2023[81]. - Research and development expenses for the nine months ended September 30, 2024, totaled $170.6 million, up $45.6 million (36.5%) from $125.0 million in 2023, primarily due to increased costs for bezuclastinib and personnel[83][84]. - Interest income for the nine months ended September 30, 2024, was $14.2 million, compared to $9.2 million in 2023, reflecting an increase of $5.0 million (54.3%) due to higher invested balances[85]. - Other income, net for the nine months ended September 30, 2024, was less than $0.1 million, a decrease of $0.9 million compared to $1.0 million in 2023, primarily due to the expiration of a sublease[86]. - The change in fair value of the CVR liability for the nine months ended September 30, 2024, was nil, compared to a decrease of $1.7 million in 2023, as the CVRs expired on August 6, 2023[87]. - The company has incurred significant operating losses since inception and does not expect to generate revenue from product sales for several years[88]. Funding and Capital Raising - The company filed a shelf registration statement allowing the sale of up to $300.0 million in various securities, with a specific Sales Agreement for $75.0 million in common stock through Guggenheim Securities[89]. - The company completed a public offering of 17,899,698 shares at $8.25 per share, raising approximately $161.9 million in net proceeds[89]. - A subsequent public offering in June 2023 raised approximately $161.8 million from 14,375,000 shares sold at $12.00 per share[89]. - A private placement on February 16, 2024, generated net proceeds of approximately $213.4 million from the sale of 17,717,997 shares at $7.50 each and 12,280 shares of Series B Preferred Stock[89]. - The company expects expenses to increase as it advances clinical development and research activities, with funding requirements dependent on various operational factors[95]. - The company anticipates needing additional funding to support ongoing research and development programs, with potential dilution of existing ownership interests if equity is raised[97]. Operational Insights - The company has focused significant resources on establishing its intellectual property portfolio and conducting R&D since its inception in 2014[68]. - The company anticipates an increase in general and administrative expenses due to expansion of operations to support ongoing discovery and clinical activities[73]. - Operating activities used $147.2 million in cash during the nine months ended September 30, 2024, primarily due to a net loss of $187.9 million[91]. - Net cash provided by financing activities was $214.4 million for the nine months ended September 30, 2024, compared to $163.5 million in the same period of 2023[94]. - The company has no off-balance sheet arrangements and no material changes in critical accounting policies were reported[99][98].

Clinical Trials - Top-line results from the registration-directed SUMMIT, PEAK, and APEX trials are expected in 2025[1] - Enrollment in the Phase 3 PEAK trial for GIST patients was completed with a total of 413 patients, focusing on median progression-free survival (mPFS) as the primary endpoint[3] - A Phase 1 trial for CGT-4859, a reversible FGFR2 inhibitor, was initiated, with preliminary results expected in 2025[6] - The company plans to present updated clinical data from SUMMIT and APEX at the ASH annual meeting in December 2024[5] - Anticipated milestones include completing enrollment in SUMMIT Part 2 in Q1 2025 and delivering top-line results from PEAK by the end of 2025[10] Financial Performance - Research and development expenses for Q3 2024 were $63.6 million, up from $50.1 million in Q3 2023, reflecting increased costs associated with trial enrollments[14] - General and administrative expenses for Q3 2024 were $11.8 million, compared to $9.5 million in Q3 2023, primarily due to organizational growth[15] - Net loss for Q3 2024 was $70.6 million, compared to a net loss of $55.4 million for the same period in 2023[16] - Cash position as of September 30, 2024, was $345.5 million, down from $389.9 million as of June 30, 2024, sufficient to fund operations into late 2026[13] - Total assets as of September 30, 2024, were $384.0 million, compared to $313.4 million as of December 31, 2023[21]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 Par Value COGT The Nasdaq Global Select Market 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...