On August 16, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2021 and provided corporate updates (Press release, Cogent Biosciences, AUG 16, 2021, View Source [SID1234586605]).

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"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
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.
Announced long-term lease on ~40,000 sq. ft. facility which will serve as laboratory and office space headquarters for Cogent Research Team.
Formed the Cogent Scientific Advisory Board
Comprised of world-class experts involved in the discovery and development of novel therapeutics for patients with genetically-driven diseases, this group has been brought together to provide external perspective for the Cogent Research Team as it develops a robust portfolio of novel, small molecule discovery programs designed to address significant patient unmet needs.
Dr. Ryan Corcoran, MD, PhD – Director of the Gastrointestinal Cancer Center Program and Scientific Director, Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School
Dr. Michael Vasconcelles, MD – Chief Medical Officer of Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving patient care
Dr. Srdan Verstovsek, MD, PhD – United Energy Resources, Inc. Professor of Medicine and a hematologist-oncologist at the MD Anderson Cancer Center, Houston, Texas, USA
Dr. Kwok-Kin Wong, MD, PhD – Director, Division of Hematology and Medical Oncology, Anne Murnick Cogan and David H. Cogan Professor of Oncology, Department of Medicine, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health
Second Quarter 2021 Summarized Financial Results

R&D Expenses: Research and development expenses were $12.4 million for the second quarter of 2021 as compared to $5.1 million for the second quarter of 2020. R&D expenses include non-cash stock compensation expense of $1.0 million for the second quarter of 2021 compared to $0.5 million for the second quarter of 2020.
G&A Expenses: General and administrative expenses were $4.9 million for the second quarter of 2021 as compared to $2.8 million for the second quarter of 2020. G&A expenses include non-cash stock compensation expense of $1.6 million for the second quarter of 2021 compared to $0.4 million for the second quarter of 2020.
Net Loss: Net loss was $16.5 million for the second quarter of 2021 as compared to a net loss of $7.4 million for the second quarter of 2020. During the second quarter of 2021, the company spent $12.6 million of its cash and cash equivalents.
Cash and Cash Equivalents: As of June 30, 2021, Cogent had cash and cash equivalents of $218.1 million. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.