On August 8, 2023 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, 2023 (Press release, Cogent Biosciences, AUG 8, 2023, View Source [SID1234633961]).
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"Cogent continues to deliver on our mission to bring best-in-class therapies to patients with genetically defined diseases," said Andrew Robbins, the Company’s President and Chief Executive Officer. "During the second quarter we presented positive data from the lead-in portion of our ongoing Phase 3 PEAK study reinforcing our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients. With great support from new and existing investors, we completed a public equity offering that has put us in a very strong financial position, extending our cash runway into 2026. As we turn to the second half of 2023, we look forward to presenting initial results from the SUMMIT trial with bezuclastinib in patients with non-advanced systemic mastocytosis as well as presenting updated APEX data with bezuclastinib in patients with advanced systemic mastocytosis. Finally, we are excited to announce the selection of our FGFR2 clinical candidate, which we believe has a best-in-class potency and selectivity profile. We plan to present additional preclinical data later this year and are on track to initiate clinical trials in 2024."
Recent Business Highlights
Presented positive lead-in data from the ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) at the 2023 ASCO (Free ASCO Whitepaper) annual meeting.
As of the cutoff date of March 29, 2023, data demonstrated a 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients.
The combination of bezuclastinib and sunitinib was generally well-tolerated with an encouraging safety profile.
Selected a potent, selective, reversible FGFR2 kinase inhibitor as the first internally developed clinical candidate from the Cogent Research Team.
In vivo characterization of the candidate shows a novel, selective, reversible FGFR2 inhibitor that has potency against molecular brake and gatekeeper mutations, with potential advantages over current covalent approaches.
Presented preclinical data describing a novel EGFR-sparing, brain-penetrant ErbB2 inhibitor with potency across key oncogenic ErbB2 mutations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Closed an underwritten public offering of 14,375,000 shares of common stock at a public offering price of $12.00 per share, including an additional 1,875,000 shares of common stock related to the underwriters’ option, which was exercised in full. Cogent received estimated net proceeds of approximately $161.8 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Upcoming Milestones
Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) in the second half of 2023. Data will include safety/tolerability and measures of clinical activity.
Present updated clinical data from approximately 30 patients in Part 1 of APEX, a global, multicenter Phase 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at a scientific meeting in the second half of 2023.
Upcoming Investor Conference
Cogent will participate in the Morgan Stanley 21st Annual Global Healthcare Conference on Wednesday, September 13, 2023 at 8:10 a.m. ET.
A live webcast of the event can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.
Second Quarter 2023 Financial Results
Cash Position: As of June 30, 2023, cash, cash equivalents and marketable securities were $350.9 million, as compared to $220.3 million as of March 31, 2023. The company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.
R&D Expenses: Research and development expenses were $38.9 million for the second quarter of 2023 as compared to $29.5 million for the second quarter of 2022. The increase was primarily due to costs associated with the on-going APEX, SUMMIT and PEAK clinical trials and costs related to development of the research pipeline. R&D expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.1 million for the second quarter of 2022.
G&A Expenses: General and administrative expenses were $8.2 million for the second quarter of 2023 as compared to $6.4 million for the second quarter of 2022. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $3.6 million for the second quarter of 2023 compared to $2.4 million for the second quarter of 2022.
Net Loss: Net loss was $44.1 million for the second quarter of 2023 as compared to a net loss of $34.9 million for the same period of 2022.