Cogent Biosciences Announces Bezuclastinib Presentations at the 66th Annual American Society of Hematology (ASH) Meeting

Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two presentations featuring bezuclastinib at the 66th Annual Meeting of the American Society of Hematology (ASH) being held December 7-10, 2024 in San Diego, California.

The first presentation will describe long term follow-up from patients in Part 1 of the ongoing APEX trial. APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial evaluating the safety, efficacy, pharmacokinetic and pharmacodynamic profiles of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM).

The second presentation will describe long term follow-up from patients who participated in the Open Label Extension portion of the ongoing SUMMIT trial. SUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter Phase 2 trial evaluating bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM).

Details for the presentations are as follows:

Apex Part 1: Updated Assessment of Bezuclastinib (CGT9486), a Selective KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM) Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Advancing Treatment Paradigms in Myeloproliferative Neoplasms and MastocytosisPresenter: Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical SchoolSession Date and Time: Sunday, December 8, 2024, 4:30 PM - 6:00 PM PT (7:30pm – 9:00pm ET)Presentation time: 5:30pm PT (8:30pm ET)Publication Number: 659Location: Manchester Grand Hyatt, San Diego Grand Hall D

Updated Efficacy and Safety Results of Patients Receiving Selected 100mg Bezuclastinib Dose and Participating in the Open-Label Extension of Summit: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial of Bezuclastinib in Adult Patients with Nonadvanced Systemic MastocytosisPresenter: Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke UniversitySession Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster IIISession Date and Time: Monday, December 9, 2024, 6:00 PM - 8:00 PM PT (9:00pm-11:00pm ET)Publication Number: 4556Location: San Diego Convention Center Halls G-H

Full abstracts are available for online viewing via the ASH Annual Meeting website: https://www.hematology.org/meetings/annual-meeting.

Investor Webcast DetailsCogent will host a webcast on Monday, December 9, 2024 at 8:00am ET (5:00am PT) led by Cogent’s President and CEO, Andrew Robbins which will include a review of the SUMMIT and APEX data presentations by Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. The speakers and additional members of Cogent leadership will be available during the Question and Answer session.

The live webcast will be accessible on the Investors and Media page of Cogent’s website at investors.cogentbio.com/events. After completion of the event, an archived replay will also be available.

About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding clinical development plans and timelines, as well as upcoming data presentations. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Contact:

Christi WaarichSenior Director, Investor [e-mail]617-830-1653