"I have been impressed with Cogent's rapid progress developing bezuclastinib in multiple patient populations," said Mr. Pinnow. "I look forward to building a capable commercial team ahead of Cogent's first potential product launch, and to working across the organization to help bring bezuclastinib to patients." Mr. Pinnow has 25 years of global and U.S. commercial experience, including multiple product launches as well as new product planning, sales and acquisitions. Mr. Pinnow joins Cogent from Pfizer, whe ...

Item 6. Exhibits. 3.2 10.2(1) 32.1*† Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 104* The cover page for the Company's Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101 SIGNATURES Date: May 7, 2024 By: /s/ John Green John Green Chief Financial Officer (Principal Accounting and Financial Officer) PART II—OTHER INFORMATION Item 1. Legal Proceedings. We are not cu ...

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025 Exhibit 99.1 Ended 1Q 2024 with $435.7 million in cash, suf icient to fund operations into 2027 "Our team made important progress in the first quarter," said Andrew Robbins, the Company's President and Chief Executive Officer. "Based on the emerging clinical results demonstrating the potential of bezuclastinib in both systemic mastocytosis and GIST patients, we have ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38443 COGENT BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 46-5308248 (State or other jurisdicti ...

Exhibit 99.1 Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results SUMMIT Part 2 registration-directed study of bezuclastinb in NonAdvSM patients initiated and actively enrolling at 40 sites globally; once-daily 100 mg selected as RP2D; topline results expected by YE 2025 PEAK Phase 3 study of bezuclastinib + sunitinib in 2nd-line GIST patients on track to complete enrollment by end of 2024; topline results expected by YE 2025 APEX Part 2 registration- ...

Pro-forma cash, cash equivalents and marketable securities expected to fund the Company into 2027 and through clinical readouts from ongoing SUMMIT, PEAK and APEX registration-directed trials Cogent to host investor webcast at 8:00 a.m. ET on February 23 to review the SUMMIT Part 1b data with bezuclastinib at AAAAI annual meeting WALTHAM, Mass. and BOULDER, Colo., Feb. 14, 2024 (GLOBE NEWSWIRE) --  Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38443 | --- | --- | --- | --- | --- | --- | |----------------|--------|-------|---------------------------------------------- ...

Common Stock, $0.001 Par Value COGT The Nasdaq Global Select Market (Mark One) OR | --- | --- | --- | |------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------| | Delaware | Cogent Biosciences, Inc. (Exact name of registrant as specified in its charter) \n | 46-5308248 | | (State or other incorporation or | jurisdiction of (I.R.S. organization) Identification | Emplo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38443 Cogent Biosciences, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporati ...

Part I [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Cogent Biosciences develops precision therapies, with lead candidate bezuclastinib for SM and GIST, and other pipeline programs under regulatory oversight [Bezuclastinib Program](index=8&type=section&id=Bezuclastinib%20Program) Bezuclastinib, a selective KIT inhibitor with a best-in-class profile, is being evaluated in three active clinical trials for SM and GIST - Bezuclastinib is designed as a selective Type I inhibitor targeting KIT receptor tyrosine kinase mutations, demonstrating potency comparable to FDA-approved inhibitors but with greater selectivity and limited blood-brain-barrier penetration in preclinical studies[32](index=32&type=chunk) - The company has initiated three clinical trials—APEX (AdvSM), SUMMIT (Non-AdvSM), and PEAK (GIST)—to evaluate the safety and efficacy of bezuclastinib, all of which are actively recruiting patients[14](index=14&type=chunk) Bezuclastinib Selectivity Profile | Compound | PDGFRa | PDGFRB | CSF1R | FLT3 | KDR | |---|---|---|---|---|---| | Bezuclastinib | >10,000 | >10,000 | >10,000 | >1000 | >1000 | | Avapritinib | 53 | 10 | 249 | 305 | >1000 | [Research Programs](index=15&type=section&id=Research%20Programs) The research team is expanding the pipeline with novel small molecule inhibitors for FGFR2 and ErbB2 mutations, with clinical trials expected in 2024 - The research team is developing a next-generation FGFR2 inhibitor designed to retain potency against resistance mutations while sparing FGFR1, potentially avoiding common toxicities like hyperphosphatemia[62](index=62&type=chunk) - A novel ErbB2 mutant program is also underway, focusing on providing broad mutant coverage in various solid tumors while sparing wild-type EGFR engagement[114](index=114&type=chunk) - Cogent anticipates initiating clinical trials for both the FGFR2 and ErbB2 programs in 2024[88](index=88&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) Cogent protects its technology through in-licensed patents for bezuclastinib, with exclusivity extending to 2033-2034, potentially to 2043 with new formulations - The company's intellectual property strategy relies on in-licensed patents from Plexxikon, know-how, and trade secrets[89](index=89&type=chunk) - Issued U.S. patents covering bezuclastinib and its therapeutic uses are expected to expire in 2033 and 2034. A provisional patent application for a new formulation filed in 2022 could provide exclusivity through at least 2043[116](index=116&type=chunk) [Competition](index=17&type=section&id=Competition) Cogent faces intense competition in SM and GIST from larger pharmaceutical companies with greater resources and established therapies - In the AdvSM market, Cogent competes with approved drugs like avapritinib (Blueprint) and midostaurin (Novartis). For Non-AdvSM, there are no currently approved drugs, but Blueprint's avapritinib is under FDA review[97](index=97&type=chunk) - In GIST, the competitive landscape includes established therapies such as imatinib, sunitinib, regorafenib, and ripretinib, as well as drug candidates from companies like Celldex, Deciphera, and Theseus Pharmaceuticals[126](index=126&type=chunk) - Many competitors have significantly greater financial resources and expertise in R&D, manufacturing, clinical trials, and marketing[123](index=123&type=chunk) [Government Regulation](index=18&type=section&id=Government%20Regulation) Operations are extensively regulated by U.S. and EU authorities, requiring lengthy approval processes and ongoing compliance with strict post-market requirements - Drug development in the U.S. requires a multi-step process including preclinical studies, an Investigational New Drug (IND) application, and three phases of human clinical trials before submitting a New Drug Application (NDA) to the FDA[101](index=101&type=chunk) - In the European Union, marketing authorization can be obtained through centralized or decentralized procedures, with the EMA's CHMP playing a key role. The new Clinical Trials Regulation (CTR) aims to streamline the trial application process via a centralized EU portal[203](index=203&type=chunk)[178](index=178&type=chunk) - Both U.S. and EU regulations impose strict post-approval requirements, including adherence to Good Manufacturing Practices (cGMP), pharmacovigilance, and restrictions on off-label promotion[141](index=141&type=chunk)[214](index=214&type=chunk)[246](index=246&type=chunk) - The company's primary focus is on developing **bezuclastinib**, a selective tyrosine kinase inhibitor, to treat genetically defined diseases like Systemic Mastocytosis (SM) and Gastrointestinal Stromal Tumors (GIST) by targeting KIT mutations[396](index=396&type=chunk) - Cogent's strategy includes exploring bezuclastinib's utility in Advanced SM (AdvSM), Non-Advanced SM (Non-AdvSM), and GIST, while preparing for potential commercialization and advancing its preclinical programs for FGFR2 and ErbB2[30](index=30&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including bezuclastinib program failure, intense competition, reliance on third parties, regulatory hurdles, IP protection, and significant funding needs [Risks Related to Discovery and Development of Our Drug Candidates](index=39&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Drug%20Candidates) Success hinges on bezuclastinib, facing risks of clinical trial failure, adverse side effects, intense competition, and challenges in patient enrollment - The business is highly dependent on the success of the bezuclastinib program, which may not succeed in its ongoing APEX, SUMMIT, and PEAK clinical trials or obtain regulatory approval[299](index=299&type=chunk)[275](index=275&type=chunk) - The company faces significant competition from well-established biotechnology and pharmaceutical companies with greater financial resources and expertise[277](index=277&type=chunk)[303](index=303&type=chunk) - Unacceptable side effects identified during development could lead to the abandonment or limitation of drug candidates[276](index=276&type=chunk)[301](index=301&type=chunk) [Risks Related to Our Reliance on Third Parties](index=43&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Extensive reliance on third-party CROs and single-source CMOs for bezuclastinib manufacturing poses significant risks to development and supply - The company depends on third-party CROs and medical institutions to conduct clinical trials, giving it less direct control over timing and execution[320](index=320&type=chunk)[337](index=337&type=chunk) - Cogent relies on third-party CMOs for manufacturing and does not own its own facilities, increasing the risk of supply shortages, cost issues, and quality control problems[323](index=323&type=chunk)[339](index=339&type=chunk) - The API and drug product for bezuclastinib are supplied by single-source suppliers, and the loss of any of these could significantly harm the business[342](index=342&type=chunk)[326](index=326&type=chunk) [Risks Related to Our Intellectual Property](index=47&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) IP protection, largely in-licensed for bezuclastinib, faces risks of challenge, invalidation, infringement claims, and license termination - The company's efforts to protect its proprietary technology may not be adequate, potentially allowing competitors to erode its market position[38](index=38&type=chunk)[173](index=173&type=chunk) - Cogent is dependent on its license agreement with Plexxikon for bezuclastinib; termination of this agreement would cause the loss of significant rights and harm the business[42](index=42&type=chunk)[43](index=43&type=chunk) - The company may face third-party claims of intellectual property infringement, which could prevent or delay product development and lead to substantial damages or royalty payments[46](index=46&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=51&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of net losses, requires substantial additional funding, and faces limitations on using NOLs due to prior ownership changes - The company has incurred net losses every year since inception and expects to continue incurring losses, consuming substantial cash for R&D and clinical development[346](index=346&type=chunk)[353](index=353&type=chunk) - Substantial additional funding is required to complete development and commercialization. Failure to raise capital may force the company to delay or scale back operations[152](index=152&type=chunk)[345](index=345&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards is subject to an annual limitation under Section 382 due to a prior ownership change, which resulted in the write-off of some deferred tax assets[348](index=348&type=chunk)[355](index=355&type=chunk) [Item 2. Properties](index=53&type=section&id=Item%202.%20Properties) Cogent Biosciences leases corporate headquarters in Waltham, a research facility in Boulder, and a partially subleased former headquarters in Cambridge - The company subleases approximately **17,749 square feet** of office space in Waltham, Massachusetts for its corporate headquarters, with the lease expiring in September 2026[402](index=402&type=chunk) - A **44,657 square feet** office and laboratory space is leased in Boulder, Colorado, housing research and administrative personnel under a 12-year lease term[674](index=674&type=chunk) - The former headquarters in Cambridge, Massachusetts, approximately **33,500 square feet**, is under a lease expiring in April 2023, with about **70%** of the space being subleased[675](index=675&type=chunk) [Item 3. Legal Proceedings](index=53&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may face ordinary course claims - The company is not currently a party to any material legal proceedings[268](index=268&type=chunk)[683](index=683&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=55&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Cogent's common stock trades on Nasdaq under "COGT"; the company has never paid dividends and retains earnings for operations - The company's common stock trades on the Nasdaq Global Select Market under the symbol "**COGT**"[405](index=405&type=chunk) - Cogent has never paid cash dividends and does not anticipate paying any in the foreseeable future, intending to retain all available funds for business operations[406](index=406&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net loss increased to $140.2 million in 2022 due to higher R&D and G&A expenses, with $259.3 million in cash expected to fund operations into 2025 [Results of Operations](index=60&type=section&id=Results%20of%20Operations) Net loss increased to $140.2 million in 2022, driven by a $72.3 million rise in operating expenses, primarily R&D and G&A Results of Operations (2022 vs 2021) (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Change | |---|---|---|---| | Research and development | $121,627 | $55,913 | $65,714 | | General and administrative | $26,212 | $19,638 | $6,574 | | **Total operating expenses** | **$147,839** | **$75,551** | **$72,288** | | Loss from operations | $(147,839) | $(75,551) | $(72,288) | | Total other income, net | $7,598 | $3,278 | $4,320 | | **Net loss** | **$(140,241)** | **$(72,273)** | **$(67,968)** | - R&D expenses increased by **$65.7 million** in 2022, driven by higher external costs for the manufacturing and development of bezuclastinib for the APEX, SUMMIT, and PEAK trials, as well as increased personnel costs and lab supplies for the research team[601](index=601&type=chunk) - G&A expenses increased by **$6.6 million** in 2022, primarily due to higher personnel costs from increased headcount, including a **$2.6 million** increase in stock-based compensation[602](index=602&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) Cogent held $259.3 million in cash as of Dec 2022, sufficient into 2025, after raising $161.9 million from an offering, but requires more funding - The company had **$259.3 million** in cash, cash equivalents, and marketable securities as of December 31, 2022, which is expected to fund operations into **2025**[448](index=448&type=chunk)[438](index=438&type=chunk) - In June 2022, the company completed an underwritten public offering, raising net proceeds of approximately **$161.9 million**[578](index=578&type=chunk)[569](index=569&type=chunk) Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---| | Net cash used in operating activities | $(118,638) | $(58,763) | | Net cash used in investing activities | $(124,718) | $(1,719) | | Net cash provided by financing activities | $163,558 | $37,976 | [Item 8. Financial Statements and Supplementary Data](index=67&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the independent auditor's report and consolidated financial statements for 2022 and 2021, including balance sheets, income statements, equity, cash flows, and notes [Consolidated Financial Statements](index=69&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show total assets of $300.8 million, liabilities of $45.1 million, and a net loss of $140.2 million in 2022 Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | |---|---|---| | Cash, cash equivalents & marketable securities | $259,276 | $219,684 | | Total Assets | $300,810 | $232,092 | | Total Liabilities | $45,075 | $17,908 | | Total Stockholders' Equity | $255,735 | $214,184 | Consolidated Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---| | Total operating expenses | $147,839 | $75,551 | | Net loss | $(140,241) | $(72,273) | | Net loss per share | $(2.39) | $(1.87) | [Notes to Consolidated Financial Statements](index=74&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail accounting policies, including expensing R&D, valuation allowance for deferred tax assets, NOL carryforwards, and operating lease commitments - Research and development costs, including upfront and milestone payments for licensed technology, are expensed as incurred[504](index=504&type=chunk)[505](index=505&type=chunk) - The company has federal and state net operating loss (NOL) carryforwards of **$151.9 million** and **$65.1 million**, respectively, as of Dec 31, 2022. However, a full valuation allowance has been established against deferred tax assets due to uncertainty of realization[608](index=608&type=chunk)[610](index=610&type=chunk) - Under its license agreement with Plexxikon, 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. A **$2.5 million** clinical milestone was paid in June 2022[617](index=617&type=chunk) [Item 9A. Controls and Procedures](index=91&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with no material changes - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[622](index=622&type=chunk) - Management assessed internal control over financial reporting based on the COSO framework and concluded it was effective as of December 31, 2022[624](index=624&type=chunk) - The company is an emerging growth company and is therefore exempt from the auditor attestation requirement regarding internal control over financial reporting[728](index=728&type=chunk) Part III [Items 10-14](index=93&type=section&id=Items%2010-14) Information for Items 10-14, covering governance, compensation, and ownership, is incorporated by reference from the 2023 proxy statement - The information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[365](index=365&type=chunk)[645](index=645&type=chunk) Part IV [Item 15. Exhibits, Financial Statement Schedules](index=94&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits, including key agreements and certifications, filed as part of the Form 10-K - This item contains the index of financial statements and a list of all exhibits filed with the annual report[632](index=632&type=chunk) - Key exhibits include the License Agreement with Plexxikon Inc. (10.8), the Underwriting Agreement from the June 2022 offering (10.11), and various employment and compensation plan documents[660](index=660&type=chunk)[661](index=661&type=chunk)