Core Points - The company announced positive results from its Phase III PEAK trial in GIST, which were shared in a press release [2] Group 1 - The webcast was hosted by Christi Waarich, Senior Director of Investor Relations, who introduced the call and highlighted the positive trial results [2][4] - The company provided a reminder that remarks made during the webcast may include forward-looking statements, particularly regarding regulatory submissions and clinical data [3]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Insights - Cogent Biosciences, Inc. (NASDAQ:COGT) stock is experiencing significant upward movement, with a trading volume of 10.95 million shares compared to the average of 1.97 million shares [1] Group 1: Clinical Trial Results - The company has reported data from its Phase 3 PEAK trial, which tested the combination of bezuclastinib and Pfizer's Sutent in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) [2] - The combination therapy achieved a median progression-free survival (mPFS) of 16.5 months, significantly higher than the 9.2 months observed with sunitinib monotherapy [3] - The objective response rate (ORR) for the combination was 46%, compared to 26% for sunitinib alone [3] Group 2: Statistical Significance and Safety - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with highly statistically significant results [4] - The estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months, and the combination was generally well tolerated without unique risks compared to sunitinib [5] Group 3: Future Plans - Cogent plans to present detailed results from the Phase 3 PEAK trial at a major medical conference in the first half of 2026 and is on track to submit a new drug application (NDA) to the FDA for bezuclastinib in GIST during the same timeframe [6] Group 4: Stock Performance - As of the latest publication, Cogent Biosciences shares increased by 124.02%, reaching a price of $33.20, marking a new 52-week high [7]

Cogent Biosciences (NasdaqGS:COGT) Update / Briefing November 10, 2025 08:00 AM ET Company ParticipantsAndrew Robbins - President and CEOChristi Waarich - Senior Director of Investor RelationsNeeta Somaiah - Department Chair of Sarcoma Medical OncologyConference Call ParticipantsAnupam Rama - AnalystChris Raymond - AnalystClara Dong - AnalystPaul Jeng - AnalystAmanda Acosta-Ruiz - AnalystSam Slutsky - AnalystOperatorMorning, and welcome to Cogent Biosciences webcast. I will now turn the call over to Christi ...

Peak Trial Results - The combination of Bezuclastinib + Sunitinib demonstrates a 50% reduction in the risk of progression or death compared to Sunitinib alone in patients with GIST [25, 47] - Median Progression-Free Survival (PFS) for Bezuclastinib + Sunitinib is 16.5 months, compared to 9.2 months for Sunitinib alone (p<0.0001) [26, 47] - Objective Response Rate (ORR) per BICR for Bezuclastinib + Sunitinib is 45.6%, compared to 25.8% for Sunitinib alone (p<0.0001) [28, 47] - Complete Response (CR) rate in the Bezuclastinib + Sunitinib arm is 6.4%, compared to 1.9% in the Sunitinib arm [28] Safety and Tolerability - The incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) is similar between the Bezuclastinib + Sunitinib and Sunitinib arms [29, 30] - Grade 3+ TRAEs occurred in 71.6% of patients in the Bezuclastinib + Sunitinib arm and 52.4% in the Sunitinib arm [29] - No TRAEs leading to death were reported in the Bezuclastinib + Sunitinib arm, while 0.5% of patients in the Sunitinib arm experienced TRAEs leading to death [29] Market and Regulatory Strategy - The company plans an NDA submission for Bezuclastinib in imatinib-resistant or intolerant GIST in the first half of 2026 based on the Peak trial results [47, 54] - An active Expanded Access Program is available, allowing immediate access to the Bezuclastinib combination for 2L patients with GIST [47, 48] - The estimated aggregate global annual sales opportunity for Bezuclastinib across indications is >$7.5 billion [57]

16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) Safety profile of bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib First positive Phase 3 trial in second- ...

Drug Development and Trials - Bezuclastinib is a highly selective tyrosine kinase inhibitor targeting the KIT D816V mutation, crucial for treating Systemic Mastocytosis (SM) and gastrointestinal stromal tumors (GIST) [87]. - The SUMMIT trial for Non-Advanced Systemic Mastocytosis (Non-AdvSM) completed enrollment with 54 patients in Part 1 and 179 patients in Part 2, demonstrating significant clinical improvements [91][92]. - In the SUMMIT Part 2 trial, bezuclastinib achieved a mean reduction of 24.3 points in total symptom score (TSS) at 24 weeks, compared to 15.4 points in the placebo group, with a placebo-adjusted improvement of 8.91 points [93]. - The APEX trial for Advanced Systemic Mastocytosis (AdvSM) completed enrollment with 58 patients in Part 2, with top-line results expected in December 2025 [95]. - As of October 11, 2024, the APEX trial reported an objective response rate (ORR) of 52%, with 61% for TKI-treatment-naïve patients and a median progression-free survival (PFS) rate of 82% at 24 months [97][98]. - The PEAK trial for GIST enrolled 413 patients, with a median progression-free survival of 10.2 months and an overall response rate of 27.5% [102][103]. - Bezuclastinib has received orphan drug designation from the FDA and EMA for both SM and GIST treatments [100][102]. - The company plans to submit its first New Drug Application (NDA) for bezuclastinib by the end of 2025 for Non-AdvSM patients [92]. Financial Performance - As of September 30, 2025, the company reported net losses of $226.4 million for the nine months ended, compared to $187.9 million for the same period in 2024 [112]. - The accumulated deficit as of September 30, 2025, reached $1,085.9 million, indicating ongoing financial challenges [112]. - Cash, cash equivalents, and marketable securities totaled $390.9 million as of September 30, 2025, expected to fund operations into 2027 [116]. - Total operating expenses for the three months ended September 30, 2025, were $83.4 million, an increase of $7.9 million (10.5%) compared to $75.4 million in the same period of 2024 [132]. - Research and development expenses for the three months ended September 30, 2025, were $69.0 million, up $5.4 million (8.5%) from $63.6 million in 2024, driven by ongoing clinical trials and increased personnel costs [133]. - General and administrative expenses for the three months ended September 30, 2025, were $14.4 million, an increase of $2.6 million (22.0%) compared to $11.8 million in 2024, primarily due to higher personnel and support costs [134]. - Net loss for the three months ended September 30, 2025, was $80.9 million, an increase of $10.3 million (14.6%) compared to a net loss of $70.6 million in 2024 [132]. - Total operating expenses for the nine months ended September 30, 2025, were $233.9 million, an increase of $31.7 million (15.7%) from $202.2 million in 2024 [138]. - Research and development expenses for the nine months ended September 30, 2025, were $194.2 million, up $23.6 million (13.8%) from $170.6 million in 2024, driven by ongoing clinical trials and increased personnel costs [139]. - General and administrative expenses for the nine months ended September 30, 2025, were $39.6 million, an increase of $8.1 million (25.6%) compared to $31.6 million in 2024 [140]. - Interest income for the nine months ended September 30, 2025, was $9.2 million, a decrease of $5.0 million (35.2%) from $14.2 million in 2024 [141]. Funding and Capital Structure - The company entered into a loan and security agreement providing for a non-dilutive term loan facility of up to $400.0 million, with the first tranche of $50.0 million fully funded as of June 30, 2025 [148]. - The company completed a public offering of 25,555,556 shares at $9.00 per share, raising approximately $215.8 million in net proceeds after expenses [149]. - As of September 30, 2025, the company had 164,155,222 shares outstanding, including 139,827,662 shares of common stock [150]. - For the nine months ended September 30, 2025, the company used $185.3 million in operating activities, primarily due to a net loss of $226.4 million [153]. - Net cash used in investing activities for the same period was $76.8 million, mainly for property and equipment purchases [155]. - Financing activities provided $289.6 million in cash, including $215.8 million from the public offering and $47.0 million from a credit facility [157]. - The company anticipates increased expenses related to clinical development and research activities, with funding needs expected to grow [159]. - The company expects to finance operations through equity offerings and debt financing, which may dilute existing ownership interests [161]. - The company has no off-balance sheet arrangements as of the reporting date [163]. Clinical Development Pipeline - The company plans to submit IND applications for CGT4255 and CGT1145 in 2026, indicating ongoing development efforts [108][111]. - CGT4859 demonstrated low nanomolar potency on WT FGFR2 and FGFR2/3 mutations, with complete regressions at 5 mg/kg PO in a mutant-driven mouse model [106]. - CGT4255 showed low nM potency against ErbB2 wild-type and oncogenic mutations, with complete regressions at 100 mg/kg PO BID in the NIH3T3 ErbB2-L755S model [108]. - CGT6297 exhibited >95% inhibition of pAKT in a H1047R PD model, outperforming alpelisib in tumor growth inhibition [109]. - CGT6737 achieved 90% PD inhibition in mouse xenograft models, demonstrating robust PK/PD and tumor growth inhibition [110]. - CGT1145 displayed JAK2 V617F cellular IC50s of 76nM, with >150-fold selectivity over JAK2 WT [111]. Adverse Events and Safety - The majority of treatment-emergent adverse events (TEAEs) in the SUMMIT trial were low grade, with serious adverse events occurring in 4.2% of patients treated with bezuclastinib [94].

Financial Position - As of September 30, 2025, cash, cash equivalents, and marketable securities were $390.9 million, up from $345.5 million as of June 30, 2025, indicating a strong cash position to fund operations into 2027[10]. - Total assets as of September 30, 2025, were $425.9 million, compared to $327.9 million as of December 31, 2024[21]. - Total stockholders' equity increased to $302.5 million as of September 30, 2025, from $256.3 million at the end of 2024[21]. Expenses - Research and development expenses for Q3 2025 were $69.0 million, compared to $63.6 million in Q3 2024, reflecting increased costs for ongoing clinical trials[11]. - General and administrative expenses rose to $14.4 million in Q3 2025 from $11.8 million in Q3 2024, primarily due to organizational growth[12]. Losses - The net loss for Q3 2025 was $80.9 million, compared to a net loss of $70.6 million for the same period in 2024[13]. Fundraising - The company successfully closed a public offering of 25,555,556 shares at $9.00 per share, generating net proceeds of $215.8 million[8]. Clinical Trials - Anticipated top-line results from the Phase 3 PEAK trial are expected in November 2025, with APEX trial results expected in December 2025[9][14]. - The company received Breakthrough Therapy Designation for bezuclastinib in NonAdvSM patients, with an NDA filing planned for year-end 2025[4]. - The company plans to initiate a Phase 1 trial for its novel ErbB2 inhibitor in November 2025 following FDA clearance[7].

Core Insights - Cogent Biosciences is approaching significant milestones with the upcoming top-line results from the Phase 3 PEAK trial in November 2025 and the APEX trial in December 2025 [1][4][13] - The company has received Breakthrough Therapy Designation for bezuclastinib, which is on track for a New Drug Application (NDA) submission for NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of 2025 [1][5][12] - Cogent has a strong cash position of $430 million, expected to fund operations through the anticipated launch of bezuclastinib and into 2027 [1][6] Recent Business Highlights - The company reported positive top-line results from the SUMMIT trial, achieving statistical significance across all primary and key secondary endpoints for NonAdvSM patients [5] - Cogent plans to present multiple abstracts at the 67th Annual Meeting of the American Society of Hematology (ASH) in December 2025, including two oral presentations on SUMMIT data [1][5][2] - The company has received FDA clearance for its Investigational New Drug (IND) submission for CGT4255, a novel ErbB2 inhibitor, with a Phase 1 trial set to begin in November [5] Financial Overview - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $390.9 million, an increase from $345.5 million as of June 30, 2025 [6] - Research and development expenses for Q3 2025 were $69.0 million, up from $63.6 million in Q3 2024, primarily due to ongoing clinical trials [7] - General and administrative expenses rose to $14.4 million in Q3 2025 from $11.8 million in Q3 2024, reflecting organizational growth [8] - The net loss for Q3 2025 was $80.9 million, compared to a net loss of $70.6 million for the same period in 2024 [9]

SUMMIT data for bezuclastinib in NonAdvSM selected for two oral presentations which will describe its best-in-class potential Novel JAK2 V617F mutant-selective inhibitor announced as Cogent’s newest preclinical program; on-track for IND in 2026 WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced three presentations featuring bezuclastin ...