ADDED
As of February 13, 2026, there were 162,308,820 shares of the registrant s Common Stock, $0.001 par value per share, outstanding.
The commercial success of any future approved drugs, including bezuclastinib, will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community.
If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates or discover new product candidates on our intended timelines, if at all.
We may have difficulty building our sales, marketing and distribution infrastructure.
We may require additional capital to finance our planned operations.
Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under our convertible notes.
All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, anticipated regulatory approval and commercial launch of bezuclastinib, business strategy and plans, and objectives of management for future operations, are forward-looking statements.
Some of the key factors that could cause actual results to differ from our expectations include: the potential impacts of raising additional capital, including dilution to our existing stockholders, restrictions on our operations or requirements that we relinquish rights to our technologies or product candidates; the success, cost, and duration of our product development activities and clinical trials, including the enrollment rates in our clinical trials; the timing of our planned regulatory submissions to the U.S.
We are developing bezuclastinib to treat patients living with Non-Advanced Systemic Mastocytosis ( NonAdvSM ), Advanced Systemic Mastocytosis ( AdvSM ) and GIST, and in 2025 we reported positive top-line results from registrational trials in each of these indications.
We are building an internal commercial organization and expect to launch bezuclastinib commercially in the United State in the second half of 2026, pending regulatory approval.
REMOVED
As of February 21, 2025, there were 113,850,090 shares of the registrant s Common Stock, $0.001 par value per share, outstanding.
If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates or discover new product candidates.
All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy and plans, and objectives of management for future operations, are forward-looking statements.
We are developing bezuclastinib to treat patients living with Non-Advanced Systemic Mastocytosis ( Non-AdvSM ), Advanced Systemic Mastocytosis ( AdvSM ) and GIST.
We also have an ongoing Phase 1 study of our novel internally developed FGFR2 inhibitor, CGT4859.
In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in ErbB2, PI3K and KRAS.
6 Our Pipeline Bezuclastinib Overview Bezuclastinib is designed to target mutations within the KIT receptor tyrosine kinase, including KIT D816V.
The figures below provide a summary of potency and selectivity preclinical data.
Potent Inhibitor of KIT Activation Loop Mutants, Including D816V (Source: AACR 2022) 7 Figure 2.
Bezuclastinib Demonstrates Minimal Brain Penetration (Source: AACR 2022) We licensed the exclusive worldwide rights to develop and commercialize bezuclastinib from Plexxikon Inc., a Daiichi Sankyo subsidiary ( Plexxikon ).