"We are thrilled to welcome Cole to our leadership team, as we begin preparations for commercializing bezuclastinib, a product we believe has clear potential to become a standard of care treatment for patients with systemic mastocytosis and advanced GIST," said Andrew Robbins, the Company's President and Chief Executive Officer. "Cole's broad commercial knowledge and leadership experience will be invaluable in helping Cogent expand from a research and development company to a fully-integrated commercial org ...

"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 ...

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Cogent Biosciences reported an increased net loss for Q1 2023 driven by higher R&D expenses, with a decrease in cash and total assets from year-end 2022 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2023, total assets and liabilities decreased, primarily due to reduced marketable securities and CVR liability settlement | Balance Sheet Items (in thousands) | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $160,698 | $139,886 | | Marketable securities | $59,566 | $119,390 | | Total current assets | $226,270 | $264,966 | | Total assets | $263,198 | $300,810 | | **Liabilities & Equity** | | | | Total current liabilities | $21,120 | $26,849 | | Total liabilities | $39,635 | $45,075 | | Total stockholders' equity | $223,563 | $255,735 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2023, net loss increased to $38.6 million, primarily driven by a significant rise in research and development expenses | Statement of Operations (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $36,038 | $25,470 | | General and administrative | $7,199 | $5,948 | | Total operating expenses | $43,237 | $31,418 | | Loss from operations | ($43,237) | ($31,418) | | Total other income, net | $4,650 | $784 | | **Net loss** | **($38,587)** | **($30,634)** | | **Net loss per share** | **($0.55)** | **($0.68)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased in Q1 2023, offset by significant cash provided by investing activities, resulting in a net increase in cash | Cash Flow Items (in thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($39,517) | ($28,334) | | Net cash (used in) provided by investing activities | $59,884 | ($441) | | Net cash provided by financing activities | $445 | $138 | | **Net (decrease) increase in cash** | **$20,812** | **($28,637)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's lead program bezuclastinib, expected cash runway, CVR liability reduction, and stock-based compensation expenses - The company's most advanced program is **bezuclastinib**, a selective tyrosine kinase inhibitor for genetically defined diseases like Systemic Mastocytosis (SM) and gastrointestinal stromal tumors (GIST)[26](index=26&type=chunk) - The fair value of the CVR liability was reduced by **$1.7 million** to zero during the first quarter of 2023, as the probability of milestone payments occurring before the CVR's expiration is now considered remote[41](index=41&type=chunk)[42](index=42&type=chunk) Stock-Based Compensation (in thousands) | Stock-Based Compensation (in thousands) | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $2,956 | $1,924 | | General and administrative | $2,894 | $2,251 | | **Total** | **$5,850** | **$4,175** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses progress of lead candidate bezuclastinib, pipeline development, increased net loss due to R&D, and the company's liquidity position [Overview and Pipeline](index=17&type=section&id=Overview%20and%20Pipeline) Cogent focuses on bezuclastinib for SM and GIST across three trials, while advancing FGFR2 and ErbB2 inhibitor programs towards 2024 clinical trials - The company's lead program, **bezuclastinib**, is being evaluated in three clinical trials: APEX (Advanced Systemic Mastocytosis), SUMMIT (Non-Advanced Systemic Mastocytosis), and PEAK (Gastrointestinal Stromal Tumors)[71](index=71&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[78](index=78&type=chunk) - Initial clinical data for the SUMMIT trial in patients with Non-AdvSM is expected in the **second half of 2023**[76](index=76&type=chunk) - The research team is developing novel inhibitors for **FGFR2** and **ErbB2** mutations, with plans to initiate clinical trials for both programs in **2024**[83](index=83&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Total operating expenses increased in Q1 2023, driven by a significant rise in research and development costs for clinical trials and pipeline development Operating Results (in thousands) | Operating Results (in thousands) | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $36,038 | $25,470 | $10,568 | | General and administrative | $7,199 | $5,948 | $1,251 | | **Total operating expenses** | **$43,237** | **$31,418** | **$11,819** | | **Net loss** | **($38,587)** | **($30,634)** | **($7,953)** | - The **$10.6 million** increase in R&D expense was driven by manufacturing and development costs for bezuclastinib, costs for the APEX, SUMMIT, and PEAK trials, and development of the research pipeline[106](index=106&type=chunk) - The increase in G&A expenses was primarily due to higher personnel costs from increased headcount, including a **$0.6 million** increase in stock-based compensation[107](index=107&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2023, the company held **$220.3 million** in cash and equivalents, expected to fund operations into 2025, supplemented by prior public offerings - As of March 31, 2023, the company had cash, cash equivalents and marketable securities of **$220.3 million**[92](index=92&type=chunk)[117](index=117&type=chunk) - The current cash position is expected to fund operating expenses and capital expenditure requirements into **2025**[92](index=92&type=chunk)[117](index=117&type=chunk)[125](index=125&type=chunk) - In June 2022, the company completed an underwritten public offering, raising net proceeds of approximately **$161.9 million**[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cogent Biosciences is exempt from providing market risk disclosures - As a smaller reporting company, Cogent Biosciences is not required to provide quantitative and qualitative disclosures about market risk[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[135](index=135&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[136](index=136&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company reports that it is not currently a party to any material legal proceedings[139](index=139&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K - No material changes have occurred to the risk factors described in the company's 2022 Annual Report on Form 10-K[140](index=140&type=chunk) [Other Part II Items](index=28&type=section&id=Other%20Part%20II%20Items) The company reported no recent sales of unregistered securities, no defaults, no mine safety disclosures, and no other material information for Items 2-5 - Item 2: No recent sales of unregistered securities were reported[141](index=141&type=chunk) - Items 3, 4, and 5 were noted as 'Not applicable' or 'None'[142](index=142&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk)