WALTHAM, Mass. and BOULDER, Colo., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced updated preclinical data from the company’s potent and selective pan KRAS(ON) inhibitor in a poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston, MA, October 22-26, 2025.  “We are excited today to s ...

Core Insights - Cogent Biosciences, Inc. presented updated preclinical data on its pan KRAS(ON) inhibitor at the 2025 AACR-NCI-EORTC International Conference, indicating a potential best-in-class profile for its lead molecule [1][2] Group 1: Product Development - The pan KRAS(ON) program aims to file an Investigational New Drug (IND) application with the FDA in 2026 [2] - The presented data highlights the KRAS(ON/OFF) inhibitor CGT1263, which shows selectivity for mutant KRAS over HRAS and NRAS, with picomolar activity across various KRAS mutant cell lines [3] - CGT1815, the prodrug of CGT1263, is designed to enhance human pharmacokinetic performance, demonstrating superior efficacy in tumor growth inhibition studies compared to RMC-6236 [3] Group 2: 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 company is also conducting a Phase 1 study of a novel FGFR2/3 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [4]

Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis planned for presentation at upcoming scientific conference this yearNDA submission for bezuclastinib planned by YE 2025 WALTHAM, Mass. and BOULDER, Colo., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Ad ...

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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]

[Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements reflecting current views on operations and financial performance, subject to risks that may cause actual results to differ materially - This report contains forward-looking statements reflecting current views on operations and financial performance, subject to known and unknown risks and uncertainties that may cause actual results to differ materially[7](index=7&type=chunk) - Key factors causing actual results to differ include impacts of raising additional capital, product development success, clinical trial duration, regulatory approval for bezuclastinib, and funding availability[8](index=8&type=chunk)[10](index=10&type=chunk) [PART I—FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, providing a snapshot of financial position and performance [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Total Assets | $274,817 | $327,898 | | Total Liabilities | $119,781 | $71,612 | | Total Stockholders' Equity | $155,036 | $256,286 | | Cash and cash equivalents | $127,598 | $98,165 | | Short-term marketable securities | $110,250 | $188,912 | | Long-term debt, net | $43,949 | $— | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Research and development | $62,203 | $54,294 | $125,232 | $106,999 | | General and administrative | $13,379 | $10,093 | $25,283 | $19,792 | | Total operating expenses | $75,582 | $64,387 | $150,515 | $126,791 | | Net loss | $(73,529) | $(58,950) | $(145,515) | $(117,298) | | Net loss per share, common stock (basic and diluted) | $(0.53) | $(0.43) | $(1.05) | $(0.91) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) - Total stockholders' equity **decreased from $256.3 million** at December 31, 2024, to **$155.0 million** at June 30, 2025[16](index=16&type=chunk)[20](index=20&type=chunk) - Issuance of common stock under the ATM program generated net proceeds of **$24.25 million** for the six months ended June 30, 2025[20](index=20&type=chunk) - Stock-based compensation expense was **$19.724 million** for the six months ended June 30, 2025, and **$19.405 million** for the six months ended June 30, 2024[20](index=20&type=chunk)[21](index=21&type=chunk)[62](index=62&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(121,053) | $(95,230) | | Net cash provided by (used in) investing activities | $78,289 | $(83,581) | | Net cash provided by financing activities | $72,197 | $213,801 | | Net increase in cash, cash equivalents and restricted cash | $29,433 | $34,990 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Nature of the Business and Basis of Presentation](index=12&type=section&id=Note%201.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) - Cogent Biosciences is a clinical-stage biotechnology company developing precision therapies for genetically defined diseases, with **bezuclastinib** as its most advanced program[25](index=25&type=chunk)[87](index=87&type=chunk) - The company has incurred recurring losses since inception, with a net loss of **$145.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$1,005.0 million**[27](index=27&type=chunk) - Current cash, cash equivalents, and marketable securities are expected to fund operations for at least the next 12 months, but additional funding will be required through equity offerings, debt financings, or collaborations[27](index=27&type=chunk)[28](index=28&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=13&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - Financial statements are prepared in conformity with GAAP, with management making estimates and assumptions, particularly for research and development expenses and stock-based awards[29](index=29&type=chunk)[32](index=32&type=chunk) - Marketable securities are classified as available-for-sale and carried at fair value, with unrealized gains and losses included in other comprehensive income[33](index=33&type=chunk) - The company is evaluating the impact of new FASB ASUs on income tax disclosures (ASU 2023-09, effective after December 15, 2024) and income statement expense disaggregation (ASU 2024-03, effective after December 15, 2026)[34](index=34&type=chunk)[35](index=35&type=chunk) [Note 3. Marketable Securities and Fair Value of Financial Assets and Liabilities](index=15&type=section&id=Note%203.%20Marketable%20Securities%20and%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Amortized Cost | $110,237 | $188,465 | | Fair Value | $110,250 | $188,912 | | Gross Unrealized Gains | $30 | $451 | | Gross Unrealized Losses | $(17) | $(4) | - As of June 30, 2025, the company held nine securities in an unrealized loss position for less than twelve months, totaling **$68.3 million** in fair value, with no impairments recorded due to intent and ability to hold until recovery[37](index=37&type=chunk) - Cash equivalents (money market funds) are classified as Level 1, and marketable securities (U.S. Treasury bills and notes) are classified as Level 2 in the fair value hierarchy[38](index=38&type=chunk) [Note 4. Accrued Expenses and Other Current Liabilities](index=16&type=section&id=Note%204.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------ | :----------------------------- | :------------------------------- | | Accrued employee compensation and benefits | $8,130 | $12,259 | | Accrued external research and development expense | $19,011 | $19,957 | | Accrued external manufacturing costs | $6,629 | $6,548 | | Accrued professional and consulting services | $5,096 | $2,995 | | Other | $1,273 | $373 | | **Total** | **$40,139** | **$42,132** | [Note 5. Preferred Stock, Series A and Series B Non-Voting Convertible Preferred Stock and Common Stock](index=16&type=section&id=Note%205.%20Preferred%20Stock%2C%20Series%20A%20and%20Series%20B%20Non-Voting%20Convertible%20Preferred%20Stock%20and%20Common%20Stock) - As of June 30, 2025, **67,414 shares of Series A Preferred Stock** (convertible into **16,853,500 common shares**) and **6,868 shares of Series B Preferred Stock** (convertible into **6,868,000 common shares**) remain outstanding[48](index=48&type=chunk)[149](index=149&type=chunk) - The company sold **2,587,992 common shares** under its ATM program for net proceeds of approximately **$24.3 million** as of June 30, 2025[51](index=51&type=chunk)[144](index=144&type=chunk) - A private placement in February 2024 generated approximately **$213.3 million** in net proceeds from the sale of common stock and Series B Preferred Stock[45](index=45&type=chunk)[53](index=53&type=chunk)[146](index=146&type=chunk) [Note 6. Stock-Based Compensation](index=18&type=section&id=Note%206.%20Stock-Based%20Compensation) | Type of Award | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Time-based stock options | $7,374 | $7,586 | $15,065 | $14,944 | | Employee stock purchase plan | $149 | $161 | $298 | $322 | | Time-based restricted stock units | $57 | $57 | $113 | $96 | | Performance-based restricted stock units | $2,136 | $2,208 | $4,248 | $4,043 | | **Total** | **$9,716** | **$10,012** | **$19,724** | **$19,405** | - Total unrecognized compensation cost for unvested time-based stock options and restricted stock units was **$63.8 million** and **$0.1 million**, respectively, as of June 30, 2025[62](index=62&type=chunk) - Unrecognized compensation cost for Executive PSUs was **$6.2 million** (based on maximum achievement), expected to be recognized over a weighted average period of **0.6 years**[63](index=63&type=chunk) [Note 7. Commitments and Contingencies](index=20&type=section&id=Note%207.%20Commitments%20and%20Contingencies) - Under the Plexxikon License Agreement for bezuclastinib, the company is obligated to pay up to **$7.5 million** in clinical milestones and **$25.0 million** in regulatory milestones, plus tiered royalties on net sales[64](index=64&type=chunk)[65](index=65&type=chunk) - **$5.0 million** in regulatory milestone payments may become payable within the next twelve months[64](index=64&type=chunk) - The company is not currently party to any material legal proceedings and has not incurred any material costs from indemnification agreements[67](index=67&type=chunk)[68](index=68&type=chunk) [Note 8. Net Loss per Share](index=21&type=section&id=Note%208.%20Net%20Loss%20per%20Share) - Net loss per common share (basic and diluted) was **$(0.53)** for the three months ended June 30, 2025, and **$(1.05)** for the six months ended June 30, 2025[18](index=18&type=chunk)[70](index=70&type=chunk)[72](index=72&type=chunk) - Potential dilutive securities (stock options, performance-based restricted stock units, time-based restricted stock units) were excluded from diluted net loss per share computation due to their anti-dilutive effect[72](index=72&type=chunk) - Outstanding pre-funded warrants are included in the computation of basic and diluted net loss per share due to their negligible exercise price and immediate exercisability[72](index=72&type=chunk) [Note 9. Retirement Plan](index=22&type=section&id=Note%209.%20Retirement%20Plan) - The company's 401(k) Plan allows for discretionary matching contributions of **100% of the first 4%** of elective contributions, which vest immediately[73](index=73&type=chunk) | Period | Contributions (in thousands) | | :------------------------------- | :--------------------------- | | Three months ended June 30, 2025 | $0.4 | | Three months ended June 30, 2024 | $0.4 | | Six months ended June 30, 2025 | $1.2 | | Six months ended June 30, 2024 | $0.9 | [Note 10. Segment Information](index=22&type=section&id=Note%2010.%20Segment%20Information) - Cogent Biosciences manages operations as a single operating segment, with the CEO evaluating performance based on consolidated net loss[74](index=74&type=chunk) - All of the company's tangible assets are held in the United States[74](index=74&type=chunk) | Period | Segment Net Loss (in thousands) | | :------------------------------- | :------------------------------ | | Three months ended June 30, 2025 | $73,529 | | Three months ended June 30, 2024 | $58,950 | | Six months ended June 30, 2025 | $145,515 | | Six months ended June 30, 2024 | $117,298 | [Note 11. Debt](index=23&type=section&id=Note%2011.%20Debt) - On June 11, 2025, the company entered into a **$400.0 million** non-dilutive term loan facility, with a first tranche of **$50.0 million** fully funded on the closing date[77](index=77&type=chunk) - Future tranches are subject to milestones: **$25.0 million** for positive SUMMIT data (available July 2025), **$75.0 million** for positive PEAK data, **$50.0 million** for **$85.0 million** net product revenue by June 30, 2027, and **$200.0 million** by mutual agreement[77](index=77&type=chunk) - The Credit Facility matures on **June 1, 2030**, bears interest at **4.75%** plus the greater of one-month SOFR or **4.15%**, and requires interest-only payments until **June 1, 2028** (potentially deferred to June 1, 2029)[78](index=78&type=chunk) | Metric | June 30, 2025 (in thousands) | | :-------------------------------- | :--------------------------- | | Principal amount | $50,000 | | Unamortized debt discount and issuance costs | $(6,051) | | **Long-term debt, net** | **$43,949** | [Note 12. Subsequent Events](index=25&type=section&id=Note%2012.%20Subsequent%20Events) - On July 10, 2025, the company completed an underwritten public offering of **25,555,556 common shares** at **$9.00 per share**, generating approximately **$215.8 million** in net proceeds[84](index=84&type=chunk)[148](index=148&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition and results, covering business overview, performance analysis, liquidity, capital resources, critical accounting estimates, and future funding requirements [Overview (Business Description & Pipeline)](index=26&type=section&id=Overview) - **Bezuclastinib (CGT9486)** is the most advanced program, a highly selective KIT inhibitor for Systemic Mastocytosis (SM) and GIST, with Orphan Drug Designation from FDA and EMA[87](index=87&type=chunk)[91](index=91&type=chunk)[104](index=104&type=chunk) - Positive top-line results from the **SUMMIT Phase 2 trial** for Non-AdvSM were announced in July 2025, showing statistically significant improvements in TSS and serum tryptase reduction, with plans for NDA submission by the end of 2025[94](index=94&type=chunk)[95](index=95&type=chunk) - The **APEX Phase 2 trial** for AdvSM completed enrollment in Q1 2025, with top-line results expected in H2 2025; Part 1 data showed a **52% ORR** and **82% PFS rate** at 24 months[97](index=97&type=chunk)[99](index=99&type=chunk) - The **PEAK Phase 3 trial** for GIST (bezuclastinib + sunitinib) completed enrollment in Q3 2024, with top-line results expected in H2 2025; lead-in data showed a median PFS of **19.4 months** in second-line GIST patients[104](index=104&type=chunk)[105](index=105&type=chunk) - The company is advancing **CGT4859** (FGFR2/3 inhibitor) in Phase 1, and preclinical programs for ErbB2, PI3Kα, and KRAS inhibitors, with IND submissions planned for ErbB2 and PI3Kα in 2025[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) [Financial Operations Overview](index=30&type=section&id=Financial%20Operations%20Overview) - Since inception in 2014, the company has focused significant resources on intellectual property, R&D, manufacturing, staffing, and capital raising, with no approved products or product sales revenue to date[113](index=113&type=chunk) - Net losses were **$145.5 million** for the six months ended June 30, 2025, compared to **$117.3 million** for the same period in 2024, with an accumulated deficit of **$1,005.0 million**[113](index=113&type=chunk) - Significant increases in expenses and capital requirements are expected due to advancing clinical trials, developing new product candidates, expanding intellectual property, hiring personnel, establishing manufacturing, and seeking regulatory approvals[113](index=113&type=chunk) [Results of Operations (Comparison of the Three Months Ended June 30, 2025 and 2024)](index=35&type=section&id=Results%20of%20Operations%20%28Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024%29) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------- | | Research and development | $62,203 | $54,294 | $7,909 | | General and administrative | $13,379 | $10,093 | $3,286 | | Total operating expenses | $75,582 | $64,387 | $11,195 | | Net loss | $(73,529) | $(58,950) | $(14,579) | | Interest income | $2,373 | $5,393 | $(3,020) | | Interest expense | $(314) | $— | $(314) | - The increase in R&D expenses was driven by the continued development of **bezuclastinib** and progression of early-stage programs, along with higher personnel costs[132](index=132&type=chunk) - General and administrative expenses increased due to organizational growth and commercial readiness activities[133](index=133&type=chunk) [Results of Operations (Comparison of the Six Months Ended June 30, 2025 and 2024)](index=36&type=section&id=Results%20of%20Operations%20%28Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024%29) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Research and development | $125,232 | $106,999 | $18,233 | | General and administrative | $25,283 | $19,792 | $5,491 | | Total operating expenses | $150,515 | $126,791 | $23,724 | | Net loss | $(145,515) | $(117,298) | $(28,217) | | Interest income | $5,325 | $9,450 | $(4,125) | | Interest expense | $(314) | $— | $(314) | - R&D expenses increased by **$18.2 million**, primarily due to early-stage programs and higher personnel costs, while bezuclastinib-related direct external R&D expenses slightly decreased[138](index=138&type=chunk) - General and administrative expenses rose by **$5.5 million** due to organizational growth and commercial readiness activities[139](index=139&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has historically funded operations through public offerings, private placements, debt issuance, and collaborative agreements, having incurred significant operating losses and limited revenue[143](index=143&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$237.8 million**[150](index=150&type=chunk) - Recent financing activities include **$24.3 million** net from ATM sales (as of June 30, 2025), **$213.3 million** net from a February 2024 private placement, and a **$50.0 million** first tranche from a **$400.0 million** term loan facility in June 2025[144](index=144&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - A subsequent public offering in July 2025 generated approximately **$215.8 million** in net proceeds[148](index=148&type=chunk) [Cash Flows](index=39&type=section&id=Cash%20Flows) | Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(121,053) | $(95,230) | | Net cash provided by (used in) investing activities | $78,289 | $(83,581) | | Net cash provided by financing activities | $72,197 | $213,801 | | Net increase in cash, cash equivalents and restricted cash | $29,433 | $34,990 | - Operating activities used **$121.1 million** in cash in H1 2025, primarily due to net loss, partially offset by non-cash charges and changes in operating assets/liabilities[152](index=152&type=chunk) - Investing activities provided **$78.3 million** in cash in H1 2025, mainly from marketable securities maturities/sales, a shift from H1 2024 which used **$83.6 million**[154](index=154&type=chunk)[155](index=155&type=chunk) - Financing activities provided **$72.2 million** in cash in H1 2025, primarily from the Credit Facility and ATM common stock issuance, compared to **$213.8 million** in H1 2024 from the private placement[156](index=156&type=chunk)[157](index=157&type=chunk) [Funding Requirements](index=40&type=section&id=Funding%20Requirements) - Existing cash, cash equivalents, marketable securities, and July 2025 public offering proceeds are expected to fund operating expenses and capital expenditures into 2027, including potential FDA approval for Non-AdvSM and early commercial launch activities[158](index=158&type=chunk) - Additional funding will be required to complete ongoing R&D programs, likely through equity offerings, debt financings (including the Credit Facility), collaborations, or licensing arrangements[159](index=159&type=chunk) - Failure to raise additional funds could lead to delays, reductions, or termination of research, product development, or future commercialization efforts, or granting rights to drug candidates the company would prefer to develop and market itself[159](index=159&type=chunk) [Critical Accounting Estimates](index=40&type=section&id=Critical%20Accounting%20Estimates) - No material changes in critical accounting policies occurred during the three months ended June 30, 2025, compared to those described in the Annual Report on Form 10-K[160](index=160&type=chunk) [Off-Balance Sheet Arrangements](index=40&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have, and does not currently have, any off-balance sheet arrangements as defined by SEC rules[161](index=161&type=chunk) [Contractual Obligations and Commitments](index=42&type=section&id=Contractual%20Obligations%20and%20Commitments) - Material cash requirements, including capital expenditure commitments, are described in Note 7 (Commitments and Contingencies) and Note 11 (Debt) to the condensed consolidated financial statements[163](index=163&type=chunk) [Recently Issued Accounting Pronouncements](index=42&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - Information on recently issued accounting pronouncements impacting the company's financial position and results of operations is disclosed in Note 2 to the condensed consolidated financial statements[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, specifically interest rate risk related to its new term loan facility - The company's **$50.0 million** outstanding debt under the Loan and Security Agreement (as of June 30, 2025) exposes it to interest rate risk, as the interest rate is tied to the one-month term Secured Overnight Financing Rate (SOFR)[167](index=167&type=chunk) - For every **100 basis point increase** in interest rates, the company would incur approximately **$0.5 million** of additional annual interest expense based on the amount outstanding as of June 30, 2025[167](index=167&type=chunk) - The company does not currently engage in hedging transactions to manage its exposure to interest rate risk, but higher interest expense would be partially offset by higher earnings on cash and marketable securities[167](index=167&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[169](index=169&type=chunk) - No change in internal control over financial reporting occurred during the three months ended June 30, 2025, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[170](index=170&type=chunk) [PART II—OTHER INFORMATION](index=44&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, though it may face various claims in the ordinary course of business - The company is not currently subject to any material legal proceedings[173](index=173&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors from the Annual Report on Form 10-K, detailing risks associated with the new Loan and Security Agreement, including covenants, milestone-dependent borrowing, and default impacts - The Loan and Security Agreement requires the company to meet certain operating and financial covenants and places restrictions on its operating and financial flexibility[175](index=175&type=chunk)[176](index=176&type=chunk) - The amount the company may borrow under the Loan and Security Agreement is subject to the achievement of certain clinical, regulatory, and financial milestones, which may not be achieved[177](index=177&type=chunk) - An event of default under the Loan and Security Agreement could accelerate the repayment of outstanding indebtedness, potentially harming the business and financial condition if sufficient cash or assets are unavailable[179](index=179&type=chunk) [Item 2. Recent Sales of Unregistered Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%20and%20Use%20of%20Proceeds) No recent sales of unregistered securities were reported in this section - No recent sales of unregistered securities were reported[181](index=181&type=chunk) [Item 3. Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current financial reporting - This item is not applicable[182](index=182&type=chunk) [Item 4. Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations or disclosures - This item is not applicable[183](index=183&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025 - No director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025[184](index=184&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Fourth Restated Certificate of Incorporation, Loan and Security Agreement, and various certifications - The report includes exhibits such as the Fourth Restated Certificate of Incorporation, the Loan and Security Agreement, and certifications from the Principal Executive and Financial Officers[185](index=185&type=chunk) [Signatures](index=47&type=section&id=Signatures) This section contains the signatures of the President, Chief Executive Officer, and Chief Financial Officer, certifying the report - The report is signed by Andrew Robbins, President and Chief Executive Officer, and John Green, Chief Financial Officer, on August 5, 2025[192](index=192&type=chunk)

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]