On May 9, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and provides financial results for the first quarter ended March 31, 2023 (Press release, Cogent Biosciences, MAY 9, 2023, View Source [SID1234631235]).
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"Cogent continued to make important progress in the first quarter," said Andrew Robbins, the Company’s President and Chief Executive Officer. "With three active clinical programs, 2023 will be a year rich in data and milestones that build upon our scientific achievements. We look forward to sharing lead-in data of bezuclastinib plus sunitinib from our PEAK trial in GIST patients at ASCO (Free ASCO Whitepaper). We are pleased with the progress in our SUMMIT trial in NonAdvSM patients and remain on track to report initial clinical data in the second half of 2023. Additionally, we are planning a robust clinical update from approximately 30 patients with AdvSM from our APEX Part 1 study, also in the second half of the year. With these catalysts, a preclinical pipeline with best-in-class potential and a cash runway into 2025, we believe we are well positioned to build on our momentum to bring important therapies to patients fighting rare, genetically driven diseases."
Recent Business Highlights
Initiated Part 2 of the ongoing Phase 2 APEX trial evaluating bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) following completion of enrollment in Part 1.
Part 2 will enroll approximately 65 patients treated at a once-daily 150 mg optimized dose and if successful, is designed to support regulatory submission. Enrollment is expected to be complete by the end of 2024.
Presented preclinical data from the company’s ErbB2 and FGFR2 research programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Preclinical data described a novel EGFR-sparing, brain-penetrant ErbB2 inhibitor with potency across key oncogenic ErbB2 mutations.
In vivo characterization showed a novel, selective, reversible FGFR2 inhibitor that has potency against molecular brake and gatekeeper mutations, with potential advantages over covalent approaches.
Received approvals from European regulatory authorities to initiate the Phase 2 SUMMIT trial in patients with nonadvanced systemic mastocytosis (NonAdvSM) and rapidly activating clinical trial sites across major countries in the European Union.
FDA granted Orphan Drug Designation for bezuclastinib for the treatment of mastocytosis, including systemic mastocytosis (SM) with an estimated 30,000 SM cases diagnosed annually in the United States.
Upcoming Milestones
Present a poster highlighting updated safety and tolerability data from Part 1 of PEAK, the Company’s ongoing Phase 3 trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST), at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023, in Chicago, IL.
Title: Safety, Pharmacokinetics (PK), and Clinical Activity of Bezuclastinib + Sunitinib in Previously-Treated Gastrointestinal Stromal Tumor (GIST): Results from Part 1 of the Phase 3 Peak Study
Presenter: Dr. William Tap
Abstract number: 11537
Date and time: 6/3/2023, 1:15-4:15pm CT
Session: Sarcoma
Data will include measures of safety and tolerability, along with clinical activity, including duration of therapy and objective response rate. Cogent will host an investor webcast to discuss these results. Details will be provided closer to the event.
Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM in the second half of 2023. Data will include safety/tolerability, pharmacokinetics and measures of clinical activity.
Present clinical data from approximately 30 patients in Part 1 of APEX in patients with AdvSM at a scientific meeting in the second half of 2023.
First Quarter 2023 Financial Results
Cash and Cash Equivalents: As of March 31, 2023, cash, cash equivalents and marketable securities were $220.3 million as compared to $259.3 million as of December 31, 2022. Total cash spent was $39.0 million, including a one-time payment of $5.1 million related to performance-based bonus compensation. Based on its current plans, the company expects its existing 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 $36.0 million for the first quarter of 2023 compared to $25.5 million for the first 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 $3.0 million for the first quarter of 2023 as compared to $1.9 million for the first quarter of 2022.
G&A Expenses: General and administrative expenses were $7.2 million for the first quarter of 2023 compared to $5.9 million for the first quarter of 2022. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $2.9 million for the first quarter of 2023 as compared to $2.3 million for the first quarter of 2022.
Net Loss: Net loss was $38.6 million for the first quarter of 2023 compared to a net loss of $30.6 million for the first quarter of 2022.