Core Insights - Cogent Biosciences, Inc. announced that the FDA granted Breakthrough Therapy Designation for bezuclastinib in treating NonAdvanced Systemic Mastocytosis (NonAdvSM) and Smoldering Systemic Mastocytosis, highlighting the unmet medical need in these patient populations [1][2] - The company plans to submit a New Drug Application (NDA) for bezuclastinib by the end of 2025, following positive results from the SUMMIT trial [1][2] - The Breakthrough Therapy Designation allows for Priority Review and supports the company's planned commercial launch of bezuclastinib [2][3] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [5] - The company is also developing therapies targeting mutations in FGFR2, ErbB2, PI3Ka, and KRAS, indicating a broad pipeline aimed at serious, genetically driven diseases [5] Upcoming Milestones - Cogent plans to report top-line results from the Phase 3 PEAK trial in Gastrointestinal Stromal Tumors (GIST) patients in November 2025 and from the APEX trial in Advanced Systemic Mastocytosis (AdvSM) patients in December 2025 [4]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

Core Insights - Cogent Biosciences, Inc. announced the approval of inducement equity awards for 10 new employees as part of its 2020 Inducement Plan, in compliance with Nasdaq corporate governance rules [1][2] Group 1: Inducement Equity Awards - The Compensation Committee approved nonqualified options to purchase a total of 299,200 shares of Cogent common stock for the new employees [2] - Each option has a 10-year term with an exercise price equal to the closing price on the grant date, and a four-year vesting schedule [2] 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 [3] - Bezuclastinib targets the KIT D816V mutation, which is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors (GIST) [3] - 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 [3]

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]

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].

[Introduction to the Underwriting Agreement](index=1&type=section&id=Introduction) This section outlines the proposed issuance and sale of common stock by Cogent Biosciences, Inc. and the roles of the underwriting representatives - Cogent Biosciences, Inc. proposes to issue and sell **22,222,223 shares** of common stock ('Firm Shares') and an additional **3,333,333 shares** ('Additional Shares') if the Underwriters exercise their option[1](index=1&type=chunk) - **J.P. Morgan Securities LLC, Leerink Partners LLC, and Guggenheim Securities, LLC** are acting as representatives for the Underwriters[1](index=1&type=chunk) - The Company has filed an **automatic shelf registration statement on Form S-3** with the SEC, including a prospectus for the securities[1](index=1&type=chunk) - Key terms like 'Registration Statement,' 'Prospectus,' 'Time of Sale Prospectus,' and 'free writing prospectus' are defined, including documents incorporated by reference[2](index=2&type=chunk)[3](index=3&type=chunk) [1. Representations and Warranties](index=2&type=section&id=1.%20Representations%20and%20Warranties) The Company provides assurances regarding its legal, financial, and operational status, including SEC filings, corporate authority, and regulatory compliance [1.1. Securities Filings and Disclosure Accuracy](index=2&type=section&id=1.1.%20Securities%20Filings%20and%20Disclosure%20Accuracy) The Company represents that its SEC filings, including the Registration Statement, Prospectus, Time of Sale Prospectus, and any free writing prospectuses, comply materially with applicable laws and regulations, are free from material misstatements or omissions, and that the Company is a 'well-known seasoned issuer' Statistical and forward-looking data are also affirmed for reliability and proper disclosure - The Registration Statement is an '**automatic shelf registration statement**' and became automatically effective upon filing; no stop order is in effect or threatened[4](index=4&type=chunk) - Each document incorporated by reference, the Registration Statement, the Prospectus, and the Time of Sale Prospectus, complied or will comply materially with the Securities Act and Exchange Act, and do not contain untrue statements or omissions of material fact[5](index=5&type=chunk)[6](index=6&type=chunk)[20](index=20&type=chunk)[60](index=60&type=chunk) - The Company is not an 'ineligible issuer' and is a '**well-known seasoned issuer**'; all required free writing prospectuses have been or will be filed and comply materially with the Securities Act[7](index=7&type=chunk) - All statistical, demographic, and market-related data in the filings are based on reliable and accurate sources Forward-looking statements are included in good faith with a reasonable basis and accompanied by meaningful cautionary statements[64](index=64&type=chunk)[66](index=66&type=chunk) [1.2. Corporate Status and Authority](index=3&type=section&id=1.2.%20Corporate%20Status%20and%20Authority) The Company and its subsidiaries are duly incorporated, validly existing, and in good standing, possessing the necessary corporate power and qualifications to conduct their business The Agreement is duly authorized, and all capital stock, including the Shares being offered, is properly authorized, validly issued, fully paid, and non-assessable - The Company is duly incorporated, validly existing, in good standing under Delaware law, and has the corporate power and authority to own its property and conduct its business[8](index=8&type=chunk) - Each subsidiary is duly incorporated, validly existing, in good standing, and its issued capital stock is duly authorized, validly issued, fully paid, non-assessable, and owned directly by the Company, free and clear of all liens[9](index=9&type=chunk) - This Agreement has been duly authorized, executed, and delivered by the Company[10](index=10&type=chunk) - The Shares have been duly authorized and, when issued and delivered, will be validly issued, fully paid, and non-assessable, without being subject to any preemptive or similar rights[13](index=13&type=chunk) [1.3. Compliance with Laws and Regulations](index=4&type=section&id=1.3.%20Compliance%20with%20Laws%20and%20Regulations) The Company asserts its material compliance with a wide array of laws and regulations, including those governing environmental protection, anti-corruption, anti-money laundering, sanctions, healthcare, and data privacy (HIPAA, GDPR) It also confirms that the offering will not contravene any applicable laws or corporate documents - The execution and delivery of the Agreement and the issuance of Shares will not contravene applicable law, the Company's organizational documents, or material agreements, and no governmental consents are required (except Blue Sky laws)[14](index=14&type=chunk) - The Company and its subsidiaries are in compliance with Environmental Laws, possess all required permits, and have no material environmental liabilities[22](index=22&type=chunk)[23](index=23&type=chunk) - The Company, its subsidiaries, and affiliates comply with applicable anti-corruption laws and Anti-Money Laundering Laws, and will not use offering proceeds in violation of such laws or Sanctions[25](index=25&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk) - The Company and its subsidiaries are in material compliance with all Applicable Laws (including those related to product candidates), possess all material Authorizations, and have conducted preclinical and clinical trials in material compliance with accepted scientific standards and laws[37](index=37&type=chunk)[39](index=39&type=chunk) - The Company and its subsidiaries are in material compliance with all applicable state and federal data privacy and security laws and regulations, including HIPAA and GDPR, and have implemented commercially reasonable controls for IT Systems and Personal Data[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) [1.4. Financial Information and Controls](index=11&type=section&id=1.4.%20Financial%20Information%20and%20Controls) The Company affirms that its consolidated financial statements fairly present its financial position in accordance with GAAP and SEC requirements It also confirms the maintenance of effective internal accounting controls and disclosure controls, and compliance with tax filing and payment obligations - **PricewaterhouseCoopers LLP** is an independent public accountant as required by the Securities Act and Commission rules[47](index=47&type=chunk) - The consolidated financial statements present fairly the financial position and results, comply materially with the Securities Act, and are prepared in conformity with GAAP (with exceptions for unaudited interim statements)[48](index=48&type=chunk)[50](index=50&type=chunk) - The Company and its subsidiaries maintain internal accounting controls sufficient to provide reasonable assurance over financial reporting and asset accountability, with no material weaknesses or changes since the most recent audited fiscal year (except as disclosed)[51](index=51&type=chunk) - The Company maintains effective disclosure controls and procedures designed to comply with Exchange Act requirements[52](index=52&type=chunk) - All required federal, state, local, and foreign tax returns have been filed or extended, and all taxes paid (except for good faith contests with GAAP reserves or non-material failures)[55](index=55&type=chunk)[56](index=56&type=chunk) [1.5. Business Operations and Assets](index=8&type=section&id=1.5.%20Business%20Operations%20and%20Assets) The Company represents that it holds good and marketable title to its material personal property and valid leases for real property It also confirms ownership or valid licenses for all material intellectual property, compliance with labor laws, adequate insurance coverage, and possession of necessary regulatory permits for its business operations - The Company does not own real property but has good and marketable title to all material personal property, free and clear of liens (except as described or non-material) Leased real property is held under valid, subsisting, and enforceable leases[33](index=33&type=chunk) - The Company and its subsidiaries own or have valid licenses for all material Intellectual Property used in their business, and such IP is valid, enforceable, and subsisting (except as disclosed) There are no material infringement claims or challenges to IP rights[34](index=34&type=chunk) - All patent and patent applications owned or licensed by the Company have been duly filed, prosecuted, and maintained in all material respects[36](index=36&type=chunk) - No material labor dispute exists or is imminent, and there are no threatened labor disturbances from principal suppliers, manufacturers, or contractors that would have a material adverse effect[42](index=42&type=chunk) - The Company and its subsidiaries are insured by financially responsible insurers against prudent and customary losses and risks, and possess all necessary regulatory certificates, authorizations, and permits[45](index=45&type=chunk)[46](index=46&type=chunk) [1.6. Other Representations](index=5&type=section&id=1.6.%20Other%20Representations) This section includes various other representations, such as the absence of material adverse changes since the Time of Sale Prospectus, no significant pending legal proceedings, no recent stock sales outside of employee plans, no securities ratings, and compliance with Nasdaq listing requirements It also confirms no market manipulation activities and proper disclosure of related-party transactions - There has been no material adverse change or development in the Company's condition, earnings, business, management, prospects, or operations since the Time of Sale Prospectus[18](index=18&type=chunk) - No material legal or governmental proceedings are pending or threatened against the Company or its subsidiaries (except as described or non-material)[19](index=19&type=chunk) - Subsequent to the dates of information in the filings, no material liabilities or transactions have occurred, no stock repurchases (except for employee/consultant departures), no non-ordinary dividends, and no material changes in capital stock or debt (except as described)[31](index=31&type=chunk) - The Company has not sold, issued, or distributed any Common Stock in the six-month period preceding the agreement, other than shares issued pursuant to employee benefit plans or outstanding options/warrants[53](index=53&type=chunk) - The Shares are listed on the **Nasdaq Global Select Market**, and the Company is in compliance with all applicable listing requirements[57](index=57&type=chunk) - The Company has not taken any action designed to stabilize or manipulate the price of the Shares or any reference security, or to violate Regulation M[61](index=61&type=chunk) [2. Agreements to Sell and Purchase](index=15&type=section&id=2.%20Agreements%20to%20Sell%20and%20Purchase) This section details the Company's agreement to sell Firm Shares to the Underwriters and the option for Additional Shares - The Company agrees to sell **22,222,223 Firm Shares** to the Underwriters at a Purchase Price of **$8.46 per share**[70](index=70&type=chunk) - The Underwriters have an option to purchase up to an additional **3,333,333 shares** ('Additional Shares') at the Purchase Price[71](index=71&type=chunk) - The option can be exercised in whole or in part by written notice within 30 days after the agreement date ('Option Period')[71](index=71&type=chunk) [3. Terms of Public Offering](index=16&type=section&id=3.%20Terms%20of%20Public%20Offering) This section specifies the initial public offering price per share and the concession offered to dealers - The Shares are to be offered to the public initially at a price of **$9.00 per Firm Share**[73](index=73&type=chunk) - A concession not exceeding **$0.324 per Firm Share** will be offered to certain dealers selected by the Representatives[73](index=73&type=chunk) [4. Payment and Delivery](index=16&type=section&id=4.%20Payment%20and%20Delivery) This section outlines the payment schedule and delivery procedures for the Firm Shares and any Additional Shares - Payment for Firm Shares will be made on **July 10, 2025** ('Closing Date'), or a designated date not later than **July 24, 2025**, in immediately available funds[74](index=74&type=chunk) - Payment for any Additional Shares will be made on the specified 'Option Closing Date,' not later than **August 8, 2025**[74](index=74&type=chunk) - Shares will be delivered to the Representatives, registered as requested, with transfer taxes paid, against payment of the Purchase Price[75](index=75&type=chunk) [5. Conditions to the Underwriters' Obligations](index=16&type=section&id=5.%20Conditions%20to%20the%20Underwriters'%20Obligations) The Underwriters' obligations are contingent upon the accuracy of the Company's representations, the absence of adverse changes, and receipt of legal and financial documentation - The Underwriters' obligations are subject to the accuracy of the Company's representations and warranties as of the agreement date and Closing Date, and the effectiveness of the Registration Statement[76](index=76&type=chunk) - No stop order suspending the Registration Statement's effectiveness shall be in effect, and no material adverse change in the Company's condition, earnings, business, prospects, or operations shall have occurred since the Time of Sale Prospectus that makes marketing impracticable[77](index=77&type=chunk)[78](index=78&type=chunk) - The Underwriters must receive various legal opinions and negative assurance letters from Company counsel (Gibson, Dunn & Crutcher LLP, Goodwin Procter LLP) and Underwriters' counsel (Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.)[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - Receipt of 'comfort letters' from **PricewaterhouseCoopers LLP** and certificates from the Company's executive officer and CFO confirming representations, compliance, and financial information accuracy is required[79](index=79&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk) - Lock-up agreements with certain shareholders, officers, and directors must be in full force and effect[87](index=87&type=chunk) [6. Covenants of the Company](index=19&type=section&id=6.%20Covenants%20of%20the%20Company) The Company commits to various actions, including SEC filing updates, expense payments, and restrictions on stock sales during a lock-up period - The Company covenants to furnish copies of all SEC filings and amendments to the Representatives, and to promptly advise them of any significant developments related to the Registration Statement or Prospectus[91](index=91&type=chunk)[92](index=92&type=chunk)[99](index=99&type=chunk) - The Company will prepare and furnish amendments or supplements to the Time of Sale Prospectus or Prospectus if necessary to prevent misleading statements or ensure compliance with applicable law[95](index=95&type=chunk)[96](index=96&type=chunk) - The Company agrees to pay all expenses incident to the performance of its obligations under the Agreement, including legal, accounting, printing, transfer, listing, and road show costs (with specific limits for Underwriters' counsel fees)[102](index=102&type=chunk)[103](index=103&type=chunk) - During a **60-day 'Restricted Period'** after the Prospectus date, the Company will not offer, sell, or transfer Common Stock or convertible securities, or file related registration statements, without the Representatives' prior written consent[106](index=106&type=chunk) - Exceptions to the lock-up include sales under the agreement, exercise of existing options/warrants, S-8 filings, sales under existing 'at the market' programs (with conditions), and issuances for M&A or strategic transactions (up to **5% of outstanding shares**, with lock-up for recipients)[107](index=107&type=chunk) [7. Covenants of the Underwriters](index=23&type=section&id=7.%20Covenants%20of%20the%20Underwriters) Each Underwriter agrees not to take actions that would necessitate additional free writing prospectus filings by the Company - Each Underwriter covenants not to take any action that would require the Company to file a free writing prospectus under Rule 433(d) that would otherwise not be required[108](index=108&type=chunk) [8. Indemnity and Contribution](index=24&type=section&id=8.%20Indemnity%20and%20Contribution) This section establishes mutual indemnification obligations between the Company and Underwriters for offering document liabilities, with provisions for contribution - The Company agrees to indemnify the Underwriters (and their controlling persons, affiliates, directors, officers) against losses arising from untrue statements or omissions of material fact in the offering documents, except for information furnished by the Underwriters[109](index=109&type=chunk) - Each Underwriter severally agrees to indemnify the Company (and its directors, officers, controlling persons) for losses arising from untrue statements or omissions based on information specifically furnished by that Underwriter for use in the offering documents[110](index=110&type=chunk) - Procedures for notification, retention of counsel, payment of legal fees, and settlement of proceedings are outlined[111](index=111&type=chunk) - If indemnification is unavailable or insufficient, parties will contribute to losses based on relative benefits received from the offering or relative fault, considering factors like intent, knowledge, and opportunity to correct[112](index=112&type=chunk)[113](index=113&type=chunk) - The Underwriters' contribution obligations are several, not joint, and capped at the public offering price of the shares underwritten by them These provisions survive the termination of the agreement and any investigations[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [9. Termination](index=26&type=section&id=9.%20Termination) The Underwriters may terminate the agreement under specific adverse market, trading, or geopolitical conditions prior to the Closing Date - The Underwriters may terminate the Agreement if, prior to the Closing Date, certain adverse events occur, including: (i) suspension or material limitation of trading on major exchanges, (ii) suspension of Company securities trading, (iii) material disruption in securities settlement services, (iv) a moratorium on commercial banking activities, or (v) any outbreak of hostilities, change in financial markets, or calamity/crisis making the offering impracticable or inadvisable[116](index=116&type=chunk) [10. Effectiveness; Defaulting Underwriters](index=27&type=section&id=10.%20Effectiveness%3B%20Defaulting%20Underwriters) The agreement becomes effective upon execution, with provisions for handling defaulting Underwriters and Company reimbursement for termination due to non-compliance - The Agreement becomes effective upon execution and delivery by the parties[118](index=118&type=chunk) - If defaulting Underwriters fail to purchase shares, non-defaulting Underwriters may be obligated to purchase their proportional share if the default is not more than **one-tenth** of the total shares[119](index=119&type=chunk) - If the default exceeds **one-tenth** and no satisfactory arrangements are made within **36 hours**, the Agreement may terminate without liability for non-defaulting Underwriters or the Company[119](index=119&type=chunk) - The Company will reimburse Underwriters for out-of-pocket expenses if the Agreement is terminated due to the Company's non-compliance or inability to perform its obligations[120](index=120&type=chunk) [11. Entire Agreement](index=28&type=section&id=11.%20Entire%20Agreement) This agreement constitutes the complete understanding between the Company and Underwriters, clarifying their arm's-length relationship and absence of fiduciary duties - This Agreement, along with any contemporaneous and prior written agreements related to the offering, constitutes the entire agreement between the Company and the Underwriters[122](index=122&type=chunk) - The Company acknowledges that the Underwriters act at arm's length, are not agents, owe no fiduciary duties, and are not providing legal, tax, investment, accounting, or regulatory advice[123](index=123&type=chunk) - The Company waives any claims against the Underwriters arising from an alleged breach of fiduciary duty[123](index=123&type=chunk) [12. Counterparts](index=28&type=section&id=12.%20Counterparts) The agreement may be executed in multiple counterparts, with electronic delivery and signatures deemed valid - The Agreement may be signed in two or more counterparts, each considered an original[124](index=124&type=chunk) - Delivery of executed counterparts by facsimile or electronic mail (including electronic signatures) is deemed duly and validly delivered[124](index=124&type=chunk) [13. Applicable Law](index=28&type=section&id=13.%20Applicable%20Law) The agreement and related disputes are governed by the internal laws of the State of New York - This Agreement and any related claims or disputes shall be governed by and construed in accordance with the internal laws of the **State of New York**[125](index=125&type=chunk) [14. Waiver of Jury Trial](index=28&type=section&id=14.%20Waiver%20of%20Jury%20Trial) All parties irrevocably waive their right to a jury trial for any disputes arising from this agreement - Each of the parties irrevocably waives any right to trial by jury in any suit or proceeding arising out of or relating to this Agreement[125](index=125&type=chunk) [15. Consent to Jurisdiction](index=28&type=section&id=15.%20Consent%20to%20Jurisdiction) The parties agree to the exclusive jurisdiction of federal and New York State courts in Manhattan for any legal proceedings - Any legal suit, action, or proceeding arising from the Agreement shall be instituted in the federal courts of the United States or the courts of the **State of New York** located in the City and County of New York, Borough of Manhattan[126](index=126&type=chunk) - The parties irrevocably submit to the exclusive jurisdiction of these courts and waive any objection to venue or inconvenient forum[126](index=126&type=chunk) [16. Headings](index=29&type=section&id=16.%20Headings) Section headings are for reference only and do not form part of the agreement's substantive content - The headings of the sections of this Agreement are for convenience of reference only and shall not be deemed a part of this Agreement[128](index=128&type=chunk) [17. Persons Entitled to Benefit of Agreement](index=29&type=section&id=17.%20Persons%20Entitled%20to%20Benefit%20of%20Agreement) The agreement benefits the parties and their successors, but no other persons, including share purchasers, have rights under it - This Agreement shall inure to the benefit of and be binding upon the parties, their respective successors, and the officers, directors, controlling persons, and affiliates referred to herein[129](index=129&type=chunk) - No other person, including purchasers of Shares from any Underwriter, is intended to have any legal or equitable right, remedy, or claim under this Agreement[129](index=129&type=chunk) [18. Survival](index=29&type=section&id=18.%20Survival) Indemnities, contribution rights, representations, warranties, and agreements survive the delivery and payment for shares, remaining in effect despite termination or investigation - The respective indemnities, rights of contribution, representations, warranties, and agreements of the Company and the Underwriters shall survive the delivery of and payment for the Shares[130](index=130&type=chunk) - These provisions shall remain in full force and effect regardless of any termination of this Agreement or any investigation[130](index=130&type=chunk) [19. Compliance with USA Patriot Act](index=29&type=section&id=19.%20Compliance%20with%20USA%20Patriot%20Act) Underwriters are required to obtain and verify client identification information in accordance with the USA Patriot Act - In accordance with the **USA Patriot Act**, the Underwriters are required to obtain, verify, and record information that identifies their respective clients, including the Company[131](index=131&type=chunk) [20. Notices](index=29&type=section&id=20.%20Notices) All communications under the agreement must be in writing and are effective upon receipt, with specific contact details provided - All communications under the Agreement must be in writing and are effective only upon receipt[132](index=132&type=chunk) - Specific contact information, including addresses and attention lines, is provided for notices to the Underwriters (J.P. Morgan, Leerink, Guggenheim) and the Company (Cogent Biosciences, Inc.)[132](index=132&type=chunk) [21. Recognition of the U.S. Special Resolution Regimes](index=30&type=section&id=21.%20Recognition%20of%20the%20U.S.%20Special%20Resolution%20Regimes) This section addresses the applicability of U.S. Special Resolution Regimes to Underwriters, limiting default rights under such regimes - If an Underwriter (defined as a 'Covered Entity') becomes subject to a **U.S. Special Resolution Regime**, the transfer of this Agreement and any related interests/obligations will be effective as if governed by U.S. law[134](index=134&type=chunk) - Default Rights against a Covered Entity Underwriter or its BHC Act Affiliate are limited to the extent exercisable under the **U.S. Special Resolution Regime**[135](index=135&type=chunk) - Definitions for 'BHC Act Affiliate,' 'Covered Entity,' 'Default Right,' and '**U.S. Special Resolution Regime**' are provided[136](index=136&type=chunk) [Signatures](index=31&type=section&id=Signatures) This section contains the formal execution and acceptance of the Underwriting Agreement by the Company and the Underwriters - The Agreement is signed by **John Green, Chief Financial Officer of Cogent Biosciences, Inc.**[138](index=138&type=chunk) - The Agreement is accepted by **Benjamin Burdett (J.P. Morgan Securities LLC), Jon Civitarese (Leerink Partners LLC), and Shiv Taylor (Guggenheim Securities, LLC)** on behalf of themselves and the several Underwriters[138](index=138&type=chunk) [Schedule I: Underwriters and Firm Shares](index=32&type=section&id=Schedule%20I) This schedule details the specific allocation of Firm Shares to be purchased by each Underwriter Number of Firm Shares To Be Purchased by Each Underwriter | Underwriter | Number of Firm Shares | | :---------- | :-------------------- | | J.P. Morgan Securities LLC | 9,777,778 | | Leerink Partners LLC | 6,666,667 | | Guggenheim Securities, LLC | 4,444,445 | | LifeSci Capital LLC | 1,333,333 | | **Total** | **22,222,223** | [Schedule II: Time of Sale Prospectus Information](index=33&type=section&id=Schedule%20II) This schedule provides key offering parameters, including the preliminary prospectus date, public price, and share counts - The preliminary prospectus is dated **July 8, 2025**[142](index=142&type=chunk) - The price per Share to the public is **$9.00**[142](index=142&type=chunk) - The number of Firm Shares offered is **22,222,223**[142](index=142&type=chunk) - The Underwriters' option to purchase Additional Shares is **3,333,333**[142](index=142&type=chunk) [Exhibit A: Form of Lock-Up Letter](index=34&type=section&id=Exhibit%20A) This exhibit presents the form of the lock-up agreement restricting insiders from selling shares for a specified period post-offering - The lock-up letter is intended to induce the Underwriters to continue their efforts in connection with the Public Offering[144](index=144&type=chunk) - During a '**Restricted Period**' of **60 days** after the final prospectus supplement date, the undersigned agrees not to offer, sell, or transfer Common Stock or related securities, or enter into swaps that transfer economic consequences of ownership, without the Representatives' prior written consent[144](index=144&type=chunk) - Key exceptions to the lock-up include shares acquired in the Public Offering or open market, bona fide gifts, distributions to affiliates/family (with donee lock-up), transfers by will, exercise of existing options/warrants (underlying stock remains locked up), transfers by operation of law, repurchases by the Company upon employment termination, establishment of Rule 10b5-1 plans (no transfers during Restricted Period), cashless exercises for tax withholding, and transfers in connection with a Board-approved Change of Control transaction[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - The undersigned also agrees not to demand or exercise any registration rights during the Restricted Period and consents to stop transfer instructions[148](index=148&type=chunk) - The lock-up agreement is irrevocable and binding, but automatically terminates under specific conditions, such as the Public Offering not proceeding or the Underwriting Agreement not being executed by **July 31, 2025**[149](index=149&type=chunk)[150](index=150&type=chunk)