On May 07, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and announced financial results for the first quarter ended March 31, 2024 (Press release, Cogent Biosciences, MAY 7, 2024, View Source [SID1234642766]).
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"Our team made important progress in the first quarter," said Andrew Robbins, the Company’s President and Chief Executive Officer. "Based on the emerging clinical results demonstrating the potential of bezuclastinib in both systemic mastocytosis and GIST patients, we have experienced very strong interest in our ongoing clinical trials from patients and investigators. We remain on track to complete enrollment in APEX and PEAK by the end of this year, and to complete enrollment in SUMMIT during 2Q 2025. This should allow us to report topline results from all three registration-directed trials during 2025. Following our successful financing in February, we are well positioned with a cash runway into 2027, allowing us to complete our ongoing studies while continuing to broaden our portfolio with a robust research pipeline of novel compounds."
Recent Business Highlights
Reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting and initiated the registration-directed SUMMIT Part 2.
Selected the 100 mg once-daily recommended Phase 2 dose (RP2D) based on:
51% week 12 mean improvement in Total Symptom Score (TSS), including 70% of patients achieving ≥50% reduction in TSS at week 12
49% week 12 mean improvement in quality-of-life (MC-QoL)
Safety and tolerability profile generally similar to placebo with no grade 3/4 events, and no bleeding, edema or cognitive events, no dose reductions and no discontinuations
Presented preclinical data from the company’s ErbB2 candidate at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
The new preclinical data described CGT4255’s exceptional stability in human whole blood and liver cytosol fractions, high oral bioavailability and low clearance across preclinical species. CGT4255 also demonstrated 80% brain penetrance in mice and was well-tolerated at 10x maximally efficacious concentration, resulting in mouse tumor regression, suggesting potential best-in-class properties.
Completed oversubscribed private placement, resulting in $213.4 million net proceeds, extending the company’s cash runway into 2027.
Upcoming Milestones
Share updated clinical data from the lead-in portion of the PEAK trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place May 31-June 4, 2024. PEAK is the Company’s ongoing Phase 3 trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST). Cogent remains on track to complete enrollment in PEAK by the end of 2024 and report top-line results by the end of 2025.
ASCO Poster details
Title: Peak part 1 summary: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST)
Session Type and Title: Poster Session – Sarcoma
Session Date and Time: June 1, 2024, 1:30 PM-4:30 PM CDT
Complete enrollment in APEX in patients with advanced systemic mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025.
Complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025.
First Quarter 2024 Financial Results
Cash and Cash Equivalents: As of March 31, 2024, cash, cash equivalents and marketable securities were $435.7 million as compared to $273.2 million as of December 31, 2023. Total cash spend in the quarter was $51.2 million, including a non-recurring payment of $8.6 million related to annual performance-based bonus compensation. Based on its current plans, the company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2027 and through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials.
R&D Expenses: Research and development expenses were $52.7 million for the first quarter of 2024 compared to $36.0 million for the first quarter of 2023. The increase was primarily due to costs associated with accelerating enrollment in both SUMMIT and PEAK clinical trials, on-going APEX costs and costs related to development of the research pipeline. R&D expenses include non-cash stock compensation expense of $4.4 million for the first quarter of 2024 as compared to $3.0 million for the first quarter of 2023.
G&A Expenses: General and administrative expenses were $9.7 million for the first quarter of 2024 compared to $7.2 million for the first quarter of 2023. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $5.0 million for the first quarter of 2024 as compared to $2.9 million for the first quarter of 2023.
Net Loss: Net loss was $58.3 million for the first quarter of 2024 compared to a net loss of $38.6 million for the first quarter of 2023.