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Cogent Biosciences
Cogent Biosciences (COGT) investor relations material
Cogent Biosciences Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary17 Feb, 2026
Executive summary
Three positive pivotal trials for bezuclastinib in 2025 led to significant regulatory momentum entering 2026, with multiple NDA submissions underway for NonAdvSM, AdvSM, and 2L GIST indications.
Strong financial position with $900.8 million in cash and equivalents as of December 31, 2025, expected to fund operations into 2028.
Commercial launch of bezuclastinib anticipated in the second half of 2026, pending FDA approvals.
Financial highlights
Cash, cash equivalents, and marketable securities totaled $900.8 million at year-end 2025, up from $287.1 million at year-end 2024, bolstered by $546.8 million in net proceeds from public offerings.
R&D expenses were $75.6 million for Q4 2025 and $269.8 million for the full year, up from $62.0 million and $232.7 million in 2024, reflecting expanded clinical and preclinical activities.
G&A expenses rose to $23.9 million for Q4 2025 and $63.6 million for the year, compared to $11.7 million and $43.3 million in 2024, driven by organizational growth and commercial preparation.
Net loss was $102.5 million for Q4 2025 and $328.9 million for the year, compared to $67.9 million and $255.9 million in 2024.
Outlook and guidance
NDA for bezuclastinib in AdvSM on track for submission in 1H 2026; PEAK NDA for 2L GIST expected to complete in April 2026.
Anticipated FDA acceptance of NonAdvSM NDA in February 2026; commercial launch of bezuclastinib planned for 2H 2026.
Additional clinical data from PEAK and APEX trials to be presented at major medical meetings in 1H 2026.
IND submissions and clinical data updates expected for pipeline assets including CGT1815, CGT1145, and CGT4859.
Impact of RTOR/BTD on PEAK approval timeline?
What drove Q4 2025 non-recurring cash usage?
What differentiates CGT1145 in the JAK2 space?
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Next Cogent Biosciences earnings date
Leerink Global Healthcare Conference 202611 Mar, 2026
Cogent Biosciences
Next Cogent Biosciences earnings date
Leerink Global Healthcare Conference 202611 Mar, 2026
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Frequently asked questions
Cogent Biosciences Inc. is a biotechnology company focused on the development of precision therapies for genetically defined diseases. The company's lead product, bezuclastinib (CGT9486), is a selective tyrosine kinase inhibitor targeting mutations in the KIT receptor tyrosine kinase. These mutations are critical in conditions such as systemic mastocytosis and advanced gastrointestinal stromal tumors. Cogent Biosciences holds a licensing agreement with Plexxikon Inc. for the research, development, and commercialization of bezuclastinib. The company is headquartered in Waltham, Massachusetts, and its shares are listed on the Nasdaq.
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