SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025
Ended 1Q 2024 with
“Our team made important progress in the first quarter,” said
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
- Selected the 100 mg once-daily recommended Phase 2 dose (RP2D) based on:
- Presented preclinical data from the company’s ErbB2 candidate at the
American Association of Cancer Research (AACR) 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.
- 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) annual meeting taking placeMay 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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s clinical development plans and timelines, including the expectation to complete enrollment in APEX by the end of 2024 and to report top-line results mid-2025, the expectation to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and to report top-line results by the end of 2025, the expectation to complete enrollment in PEAK by the end of 2024 and to report top-line results by the end of 2025, plans to share updated clinical data from the lead-in portion of PEAK at the ASCO annual meeting in the second quarter of 2024, the Company’s projected cash runway into 2027, the therapeutic potential of bezuclastinib in both systemic mastocytosis and GIST patients, and the potential best-in-class properties of the Company’s preclinical ErbB2 candidate. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(in thousands, except share and per share amounts) | |||||||
(unaudited) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Operating expenses: | |||||||
Research and development | $ | 52,705 | $ | 36,038 | |||
General and administrative | 9,699 | 7,199 | |||||
Total operating expenses | 62,404 | 43,237 | |||||
Loss from operations | (62,404 | ) | (43,237 | ) | |||
Other income: | |||||||
Interest income | 4,057 | 2,268 | |||||
Other income, net | (1 | ) | 682 | ||||
Change in fair value of CVR liability | — | 1,700 | |||||
Total other income, net | 4,056 | 4,650 | |||||
Net loss | $ | (58,348 | ) | $ | (38,587 | ) | |
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.62 | ) | $ | (0.55 | ) | |
Weighted average common shares outstanding, basic and diluted | 94,804,659 | 70,734,950 | |||||
SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
2024 | 2023 | ||||||
Cash, cash equivalents and marketable securities | $ | 435,740 | $ | 273,170 | |||
Working capital | $ | 405,217 | $ | 232,603 | |||
Total assets | $ | 476,111 | $ | 313,437 | |||
Total liabilities | $ | 53,777 | $ | 55,635 | |||
Total stockholders’ equity | $ | 422,334 | $ | 257,802 | |||
Contact:
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
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2024 GlobeNewswire, Inc., source