On August 9, 2022 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, 2022 (Press release, Cogent Biosciences, AUG 9, 2022, View Source [SID1234617861]).
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"In the second quarter we achieved a number of important milestones as we continued to advance bezuclastinib and grow the research and development pipeline," said Andrew Robbins, President and CEO of Cogent Biosciences. "Most notably, we reported positive initial clinical data from our APEX trial that strengthened our belief in bezuclastinib’s potential to provide meaningful clinical activity for systemic mastocytosis patients, without the tolerability challenges seen with other available treatment options. We remain on track to provide another clinical update from this trial by the end of 2022. We are equally excited about the opportunity with bezuclastinib in non-advanced systemic mastocytosis and gastrointestinal stromal tumor (GIST) patients and expect to provide clinical data updates on these programs during the first half of 2023. Based on the positive APEX data, we were able to secure additional financing at the end of the quarter, and we are confident this will support our go forward strategy into 2025."
Recent Business Highlights
In June 2022, Cogent reported positive initial data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with advanced systemic mastocytosis (AdvSM).
As of the data cutoff date, May 24, 2022, all 11 patients treated were evaluated for signs of clinical activity. Bezuclastinib demonstrated rapid reductions in serum tryptase, with all patients achieving a ≥50% reduction (10/11 achieved within the first week of treatment) and 6/11 achieving serum tryptase <20ng/mL. All patients remained on treatment with treatment duration ranging from 0.5 – 4.8 months. Bezuclastinib was generally well-tolerated at all doses with no reported periorbital or peripheral edema, cognitive effects or intracranial bleeding events.
In April 2022, the Company presented early data and outlined its strategy to create best-in-class small molecules from the company’s growing pipeline of novel, targeted therapy programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and company sponsored R&D investor event.
Announced plans to advance a potent, selective FGFR2 inhibitor toward candidate selection with a product profile that includes best-in-class selectivity against all known FGFR2 primary driver and secondary resistance mutations.
Announced development of an ErbB2 mutant selective inhibitor for patients with mutations that are not well addressed by therapies currently approved or in clinical development.
Appointed Fang Fang, Ph.D., Vice President, Biometrics in Development Operations.
Dr. Fang joins Cogent with over 20 years of industry experience and leadership in oncology biometrics and biostatistics. Prior to joining, she was Vice President, Biometrics at Kiniksa Pharmaceuticals. Earlier in her career, Dr. Fang held roles of increasing responsibility at Merrimack Pharmaceuticals, Bayer Healthcare, Eisai Medical Research and Astellas Pharma. Dr. Fang received her Ph.D. in Biostatistics from Rutgers University.
Upcoming Milestones
Present additional data from APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) by the end of 2022.
Present initial data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial with bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM) in the first half of 2023.
Present lead-in data from PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with gastrointestinal stromal tumors (GIST), in the first half of 2023.
File first internally developed Investigational New Drug application (IND) from Cogent’s potent, selective FGFR2 inhibitor program in the second half of 2023.
Second Quarter 2022 Financial Results
Cash Position: As of June 30, 2022, cash and cash equivalents were $325.6 million, as compared to $191.0 million as of March 31, 2022. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2025.
R&D Expenses: Research and development expenses were $29.5 million for the second quarter of 2022 as compared to $12.4 million for the second quarter of 2021. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to expanding the Cogent Research Team, which was formed in the second quarter of 2021. R&D expenses include non-cash stock compensation expense of $2.1 million for the second quarter of 2022 compared to $1.0 million for the second quarter of 2021.
G&A Expenses: General and administrative expenses were $6.4 million for the second quarter of 2022 as compared to $4.9 million for the second quarter of 2021. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $2.4 million for the second quarter of 2021 compared to $1.6 million for the second quarter of 2021.
Net Loss: Net loss was $34.9 million for the second quarter of 2022 as compared to a net loss of $16.5 million for the same period of 2021.