Page 1

cogent BIOSCIENCES Cogent Biosciences Provides Corporate Updates and Reports Second Quarter 2021 Financial Results August 16 , 2021 Initiated Phase 2 open - label clinical study ( APEX ) for bezuclastinib ( CGT9486 ) in patients with Advanced Systemic Mastocytosis ( AdvSM ) SUMMIT study for patients with Non - Advanced Systemic Mastocytosis ( NonAdvSM ) on track to start 2H 2021 following recent positive interactions with FDA Formed Cogent Scientific Advisory Board , including several world - class experts in targeted therapy Ended Q2 2021 with $ 218.1 million in cash , sufficient to fund operations into 2024 CAMBRIDGE , Mass . and BOULDER , Colo . , Aug. 16 , 2021 / PRNewswire / -- Cogent Biosciences , Inc. ( Nasdaq : COGT ) , a biotechnology company focused on developing precision therapies for genetically defined diseases , today announced financial results for the second quarter ended June 30 , 2021 and provided corporate updates . cogent BIOSCIENCES " People fighting advanced systemic mastocytosis live every day in need of additional treatment options . We initiated the Phase 2 APEX clinical study for our lead program bezuclastinib , designed to specifically target the underlying genetic cause of advanced systemic mastocytosis with the goal of providing new therapeutic options for patients , " said Andrew Robbins , President and CEO of Cogent Biosciences . " In addition , we look forward to advancing bezuclastinib into two new clinical studies by the end of 2021 , including the SUMMIT study for patients with non - advanced systemic mastocytosis , while actively progressing novel discovery programs with the recently formed Cogent Research Team . " Recent Program and Corporate Highlights • APEX Study in AdvSM Patients Initiated • Cogent initiated APEX , a Phase 2 clinical study of bezuclastinib in patients with AdvSM . APEX is an open - label , global , multicenter study that will evaluate the safety , efficacy , pharmacokinetic , and pharmacodynamic profiles of bezuclastinib . Learn more about the APEX study at www.cogentclinicaltrials.com o Cogent expects to report preliminary clinical data from the APEX study in the first half of 2022 , including levels of serum tryptase , a validated biomarker of mast cell activity . • SUMMIT Study of bezuclastinib in NonAdvSM Patients on track to start 2H 2021 • Following recent positive interactions with FDA , Cogent is on track to initiate SUMMIT , a randomized , double - blind placebo - controlled Phase 2 clinical study of bezuclastinib in patients with NonAdvSM . • FDA Granted Orphan Drug Designation for bezuclastinib in GIST ( Gastrointestinal Stromal Tumors ) • FDA granted orphan drug designation for bezuclastinib for the treatment of GIST with an estimated 4,000 to 6,000 GIST cases diagnosed annually in the United States . • Cogent remains on track to initiate a new study of bezuclastinib and sunitinib in GIST patients during 2H 2021 . • Cogent Research Team continues to evolve efforts in pioneering best - in - class , small molecule therapeutics • Based in Boulder , Colorado , the Cogent Research Team continues to focus on developing best - in - class , small molecule therapeutics to expand Cogent's pipeline and deliver novel precision therapies for patients living with unmet medical needs . o Announced long - term lease on ~ 40,000 sq . ft . facility which will serve as laboratory and office space headquarters for