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]

Core Insights - Cogent Biosciences has secured a debt financing facility of up to $400 million to support its growth strategy, including the anticipated launch of bezuclastinib in 2026 [1][2] - The company is on track to report results from three pivotal trials in 2025, starting with the SUMMIT trial results in July [1][4] Financing Details - An initial tranche of $50 million was drawn at closing, with an additional $100 million available in 2025 based on successful data readouts from SUMMIT and PEAK trials [3] - A further $50 million can be accessed upon achieving early commercial success after the bezuclastinib launch, with the remaining $200 million available through mutual agreement [3] Clinical Trials - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study focused on patients with NonAdvSM, with results expected in July 2025 [4] - The APEX trial, an open-label study in patients with AdvSM, is set to release results in the second half of 2025, while the PEAK trial results are expected before the end of 2025 [4] Company Overview - Cogent Biosciences specializes in developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6] - The company is also advancing a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6]

Clinical Programs & Catalysts - Cogent Biosciences has multiple clinical and preclinical programs with upcoming catalysts, including top-line results for Bezuclastinib in AdvSM expected in July 2025, NonAdvSM in 2H 2025, and GIST by EOY 2025 [7, 8, 11] - The company is conducting a registration-directed study of Bezuclastinib in NonAdvSM with 179 patients, using a 24-week MS2D2 primary endpoint [11] - A registration-directed study of Bezuclastinib monotherapy is underway in AdvSM with 58 patients, using ORR as the primary endpoint [11] - PEAK Part 2 is a global Phase 3 trial of Bezuclastinib in 2nd-line GIST, with top-line results expected by the end of 2025 [8] Financial Position - As of Q1 2025, Cogent Biosciences has $245.7 million, expected to fund operations into late 2026 [9] Market Opportunity - The aggregate US annual sales opportunity for Bezuclastinib across AdvSM, NonAdvSM, and GIST is greater than $3 billion with limited competition [12] - The US annual market opportunity for NonAdvSM is estimated at $2 billion, with differentiated symptom improvement potentially leading to market leadership [11] - The US annual market opportunity for 2nd-line GIST is estimated at over $1 billion, with limited competition [11] - The US annual market opportunity for AdvSM is estimated at $300 million, with differentiated safety/tolerability results potentially leading to market leadership [11] Competitive Landscape - Cogent believes Bezuclastinib offers a best-in-class KIT inhibitor opportunity with minimal late-stage competitive activity [10, 13, 30] Safety and Efficacy - In ISM patients, only 25% of Ayvakit patients achieved clinically meaningful improvement [18] - In PIONEER Part 2, low-dose Ayvakit (25 mg once daily) was associated with an improved safety profile, with 13% experiencing eye edema and dizziness [19]

WALTHAM, Mass. and BOULDER, Colo., May 29, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its presentation at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 7:35 a.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours afte ...

Core Viewpoint - Cogent Biosciences, Inc. (COGT) shows significant upside potential with a mean price target of $16.64, indicating a 224.4% increase from the current price of $5.13 [1] Price Targets and Analyst Consensus - The average of 11 short-term price targets ranges from a low of $7 to a high of $24, with a standard deviation of $5.28, suggesting variability in analyst estimates [2] - The lowest estimate indicates a 36.5% increase, while the most optimistic estimate points to a 367.8% upside [2] - A low standard deviation indicates a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Analyst Optimism - Analysts are optimistic about COGT's earnings prospects, as indicated by a positive trend in earnings estimate revisions [4][11] - The Zacks Consensus Estimate for the current year has increased by 3% over the past month, with one estimate going higher and no negative revisions [12] - COGT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

Drug Development - Bezuclastinib is being developed for Non-Advanced Systemic Mastocytosis (Non-AdvSM), Advanced Systemic Mastocytosis (AdvSM), and gastrointestinal stromal tumors (GIST) with FDA orphan drug designation granted for Mastocytosis[78]. - The SUMMIT trial for Non-AdvSM completed enrollment in Q3 2023 with 54 patients, and Part 2 completed enrollment in Q4 2024 with 179 patients, with top-line results expected in July 2025[80]. - In the SUMMIT trial, 89% of patients achieved >50% decrease in serum tryptase by week 4, and 95% achieved serum tryptase levels <20 ng/ml by week 24[83]. - The APEX trial for AdvSM completed enrollment in Q1 2025 with 58 patients, and top-line results are expected in the second half of 2025[86]. - In the APEX trial, an objective response rate (ORR) of 52% was achieved, with 94% of patients showing a ≥50% reduction in serum tryptase levels[88][89]. - The PEAK trial for GIST enrolled 413 patients, with top-line results expected by the end of 2025; the median progression-free survival (mPFS) was 10.2 months in all patients[92]. - The combination of bezuclastinib and sunitinib resulted in a disease control rate of 80% in all patients and 100% in second-line patients with prior imatinib only[93]. Financial Performance - The company reported a net loss of $72.0 million for the three months ended March 31, 2025, compared to a net loss of $58.3 million for the same period in 2024, with an accumulated deficit of $931.5 million as of March 31, 2025[102]. - Total operating expenses for the three months ended March 31, 2025, were $74.9 million, an increase of $12.5 million compared to $62.4 million in the same period of 2024[120]. - Research and development expenses increased by $10.3 million to $63.0 million for the three months ended March 31, 2025, driven by the development of bezuclastinib and early-stage programs[121]. - General and administrative expenses rose to $11.9 million for the three months ended March 31, 2025, compared to $9.7 million in 2024, primarily due to higher personnel costs[122]. - Net loss for the three months ended March 31, 2025, was $72.0 million, compared to a net loss of $58.3 million in the same period of 2024, reflecting an increase of $13.7 million[120]. - Net cash used in operating activities for the three months ended March 31, 2025, was $66.5 million, compared to $52.5 million in 2024[131]. - Net cash provided by financing activities was $25.0 million for the three months ended March 31, 2025, compared to $214.1 million in the same period of 2024[135]. Funding and Financial Strategy - The company has cash, cash equivalents, and marketable securities totaling $245.7 million, expected to fund operations through late 2026[106]. - The company expects to require additional funding to support ongoing research and development programs[138]. - The company has established a strategy to finance operations through equity offerings, debt financings, and collaborations, as it does not expect to generate revenue from product sales in the near term[104]. - The company has U.S. federal and state net operating loss carryforwards of $268.1 million and $128.7 million, respectively, which may offset future taxable income[116]. - The company has recorded a full valuation allowance against its net deferred tax assets at each balance sheet date[118]. Intellectual Property - The company has an exclusive license agreement with Plexxikon Inc. with potential milestone payments totaling up to $32.5 million based on clinical and regulatory achievements[96]. - The patent protection for bezuclastinib extends through 2033, with potential extensions through a new patent application filed in 2023 for the optimized formulation[96]. Research and Development Pipeline - The company is actively enrolling patients in a Phase 1 study of CGT4859, targeting tumors with FGFR2 and FGFR3 mutations, including advanced cholangiocarcinoma[97]. - CGT4255 demonstrated low nM potency against ErbB2 wild-type and oncogenic mutations with over 100-fold selectivity over wild-type EGFR, and complete regressions were observed at a dose of 100 mg/kg[99]. - CGT6297, a PI3Kα inhibitor, showed >95% inhibition of pAKT in a H1047R PD model, with superior efficacy compared to alpelisib in tumor growth inhibition models[100]. - The company is developing a potent KRAS inhibitor, CGT9109, which demonstrated >90% pERK inhibition and robust tumor regression in KRASG12D tumor-bearing mouse models[101]. - The company plans to submit an IND application for CGT4255 in 2025 and for CGT6297 in the same year[99][100]. - The company anticipates significant increases in research and development expenses due to ongoing clinical and preclinical activities[109].

Financial Performance - Net loss for Q1 2025 was $72.0 million, up from a net loss of $58.3 million in Q1 2024[9] - Total operating expenses for Q1 2025 were $74.9 million, compared to $62.4 million in Q1 2024[13] - Total stockholders' equity decreased to $219.0 million as of March 31, 2025, from $256.3 million at the end of 2024[14] Cash Position - Cogent Biosciences ended Q1 2025 with $245.7 million in cash, sufficient to fund operations into late 2026[1] - Cash, cash equivalents, and marketable securities decreased from $287.1 million at the end of 2024 to $245.7 million at the end of Q1 2025[14] - The company sold shares under its at-the-market stock offering for net proceeds of $24.3 million during the quarter[6] Research and Development - Research and development expenses increased to $63.0 million in Q1 2025 from $52.7 million in Q1 2024, reflecting ongoing clinical trials[7] General and Administrative Expenses - General and administrative expenses rose to $11.9 million in Q1 2025 compared to $9.7 million in Q1 2024, primarily due to organizational growth[8] Clinical Trials and Results - The company expects to report top-line results from the SUMMIT trial in July 2025, APEX in the second half of 2025, and PEAK by the end of 2025[5] - Bezuclastinib demonstrated a 65% mean improvement in Total Symptom Score at 48 weeks, with 88% of patients achieving at least a 50% reduction[5]

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]

WALTHAM, Mass. and BOULDER, Colo., March 25, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced four preclinical poster presentations at the upcoming 2025 AACR Annual Meeting being held in Chicago, IL April 25-30, 2025. Poster Details Title: Identification of a potent KRAS (ON) inhibitor with selectivity for mutant KRAS over HRAS and NRASSession Category: ChemistrySession Title: ...

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