Cogent Biosciences, Inc., a biotechnology company, focuses on developing precision therapies for genetically defined diseases. Its lead product candidate includes CGT9486, a selective tyrosine kinase inhibitor designed to inhibit the KIT D816V mutation that drives systemic mastocytosis, as well as other mutations in KIT exon 17, which are found in patients with advanced gastrointestinal stromal tumors. It has a licensing agreement with Plexxikon Inc. for the research, development, and commercialization of bezuclastinib. The company was formerly known as Unum Therapeutics Inc. and changed its name to Cogent Biosciences, Inc. in October 2020. Cogent Biosciences, Inc. was incorporated in 2014 and is headquartered in Cambridge, Massachusetts.
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Here are 1-2 brief analogies to describe Cogent Biosciences:
Vertex Pharmaceuticals for certain rare cancers and genetic diseases. (Like Vertex's targeted approach to cystic fibrosis, Cogent focuses on precision therapies for specific genetically defined rare cancers and disorders.)
Moderna, but instead of mRNA vaccines, they focus on precision small molecule therapies for genetically defined rare cancers and disorders. (Similar to how Moderna specializes in an innovative technology platform, Cogent builds its pipeline around highly specific small molecule inhibitors for niche indications.)
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- Bezopirdine (CGT9486): A selective inhibitor targeting the KIT D816V mutation, currently in clinical development for the treatment of systemic mastocytosis and gastrointestinal stromal tumors.
- CGT5696: A selective inhibitor of FGFR2, currently in early clinical development for the treatment of FGFR2-driven cholangiocarcinoma.
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Cogent Biosciences (COGT) is a clinical-stage biotechnology company focused on developing precision therapies for patients with genetically defined diseases. As of its current stage, the company does not have any approved commercial products on the market, nor does it generate revenue from product sales.
Therefore, Cogent Biosciences does not currently have major commercial customers, either companies or individuals, that purchase its drugs or therapies. Its revenue primarily comes from capital raises (e.g., selling equity to investors) and potential future collaboration or licensing agreements with larger pharmaceutical companies, rather than from direct sales of products to customers or individuals.
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Andrew Robbins, Chief Executive Officer and President
Mr. Robbins is an accomplished executive with over 20 years of commercial, development, and strategic leadership experience in the pharmaceutical industry, particularly in oncology and hematology products. He previously served as Chief Operating Officer at Array BioPharma until its acquisition by Pfizer in 2019, where he was responsible for leading sales, marketing, manufacturing, and corporate strategy teams, culminating in the successful commercialization of Mektovi and Braftovi. Prior to Array, he held management positions at Hospira, Inc. and Pfizer, Inc.'s Oncology business unit. Mr. Robbins also served on the Board of Directors for Harpoon Therapeutics, which was acquired by Merck in March 2024.
John Green, Chief Financial Officer
Mr. Green was appointed Chief Financial Officer in 2020.
Jessica Sachs, MD, Chief Medical Officer
Brad Barnett, Chief Technology Officer
Mr. Barnett is an experienced technical operations executive, with nearly 20 years at Array BioPharma, where he served as Vice President of Supply Chain & Manufacturing. He played a key role in bringing precision oncology medicines Mektovi and Braftovi to market and led their manufacturing integration into Pfizer following Array's acquisition.
John Robinson, PhD, Chief Scientific Officer
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Cogent Biosciences (NASDAQ: COGT) focuses on developing precision therapies, with its lead product candidate, bezuclastinib (CGT9486), targeting genetically defined diseases such as Non-Advanced Systemic Mastocytosis (Non-AdvSM), Advanced Systemic Mastocytosis (AdvSM), and Gastrointestinal Stromal Tumors (GIST).
The addressable markets for bezuclastinib in these key indications are as follows:
- For the aggregate market across Non-Advanced Systemic Mastocytosis, Advanced Systemic Mastocytosis, and Gastrointestinal Stromal Tumors, the total addressable market (TAM) is estimated to be up to $2.5 billion.
- This aggregate market can be broken down further:
- Non-Advanced Systemic Mastocytosis: $1.5 billion
- Advanced Systemic Mastocytosis: $300 million
- Gastrointestinal Stromal Tumors: $700 million
- Another estimate suggests that bezuclastinib could achieve aggregate U.S. annual sales of greater than $3 billion across GIST, Non-AdvSM, and AdvSM.
The market sizes provided are primarily for the U.S. region.
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Cogent Biosciences (COGT) is a clinical-stage biotechnology company with no current revenue, meaning its future revenue growth will be driven by the successful development and commercialization of its pipeline assets. The primary expected drivers of future revenue growth over the next 2-3 years include:
- Commercial Launch of Bezuclastinib for Non-Advanced Systemic Mastocytosis (NonAdvSM): This is the most significant near-term revenue driver. Cogent Biosciences reported positive top-line results from the registration-directed SUMMIT trial for bezuclastinib in NonAdvSM in July 2025. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for bezuclastinib in this indication, which is expected to expedite regulatory review. The company plans to submit its first New Drug Application (NDA) by the end of 2025, with an anticipated commercial launch in 2026. Analysts anticipate a robust market presence and significant growth potential, potentially capturing a substantial share of the non-AdvSM market.
- Potential Approval and Commercialization of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM): Top-line results from the registration-directed APEX trial for bezuclastinib in Advanced Systemic Mastocytosis are expected in the second half of 2025. Positive data and subsequent regulatory approval would open another significant market opportunity for bezuclastinib.
- Potential Approval and Commercialization of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST): The pivotal Phase 3 PEAK trial evaluating bezuclastinib in second-line GIST patients is expected to report top-line results by the end of 2025 (or in November 2025). Successful outcomes and regulatory approval in this indication would further expand bezuclastinib's market potential, which has an aggregate total addressable market of up to $2.5 billion across systemic mastocytosis and GIST.
- Advancement and Potential Commercialization of Early-Stage Pipeline Candidates: Beyond bezuclastinib, Cogent Biosciences is developing other targeted therapies. This includes an ongoing Phase 1 study for its novel FGFR2 inhibitor (CGT4859). The company also plans to file Investigational New Drug (IND) applications for its ErbB2 and PI3Kα programs during 2025. Additionally, preclinical data for a pan-KRAS inhibitor program and a JAK2 V617F mutant-selective inhibitor program suggest future IND filings in 2026, representing longer-term growth potential. A Phase 1 trial for CGT4255, a CNS-penetrant ErbB2 inhibitor, is on track to initiate in November 2025.
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Share Issuance
- In July 2025, Cogent Biosciences successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at $9.00 per share, generating net proceeds of $215.8 million.
- In November 2020, the company announced an underwritten public offering of $60.0 million of common stock, granting underwriters an option to purchase an additional $9.0 million in shares.
- As of November 2025, Cogent Biosciences also raised an additional $39 million through targeted share sales via its at-the-market (ATM) facility.
Inbound Investments
- In June 2025, Cogent Biosciences secured a non-dilutive debt financing facility of up to $400 million with SLR Capital Partners, drawing an initial tranche of $50 million at closing.
- Director Fairmount Funds Management LLC made a significant investment on July 14, 2025, purchasing 2,777,777 shares of the company's stock valued at approximately $25 million.
Outbound Investments
- In 2020, Cogent Biosciences acquired worldwide rights to develop and market its lead candidate, bezuclastinib (previously CGT0206), by purchasing Kiq Bio, assuming potential milestone obligations of $32.5 million, of which $2.5 million has been paid to date.
Capital Expenditures
- Cogent Biosciences anticipates its cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into late 2026 or into 2027.
- The primary focus for capital allocation and expenditures is on advancing its research and development pipeline, particularly for clinical trials such as SUMMIT, PEAK, and APEX, and the progression of early-stage programs.
- Research and development expenses were $69.0 million for the third quarter of 2025, an increase from $63.6 million in the third quarter of 2024, reflecting increased costs for ongoing clinical trials and preclinical programs.