Cogent Biosciences Reports First Quarter 2024 Financial Results
Cogent Biosciences, Inc. (Nasdaq: COGT) reported on track clinical trial enrollment for three studies with topline results expected in 2025. The company ended the first quarter of 2024 with $435.7 million in cash, sufficient to fund operations until 2027. Recent business highlights include positive clinical data from SUMMIT trial and oversubscribed private placement.
On track clinical trial enrollment with topline results expected in 2025
$435.7 million in cash to fund operations until 2027
Positive Part 1b data from SUMMIT trial
Successful private placement with $213.4 million net proceeds
Net loss of $58.3 million in the first quarter of 2024
Increased research and development expenses compared to the previous year
Insights
The financial health of Cogent Biosciences as indicated by their Q1 2024 report appears robust, particularly focusing on their cash reserves of $435.7 million. This positions the firm with enough liquidity to support their operations and clinical trials through to the expected 2027 timeline. An investor's eye should note, however, that the net loss has increased year-over-year from $38.6 million to $58.3 million - a trend that merits monitoring as it impacts long-term sustainability if not offset by successful product development and subsequent revenue streams.
The increase in R&D expenses, which rose to $52.7 million from $36.0 million, underscores an aggressive investment in the SUMMIT, PEAK and APEX clinical trials. Given that these trials are 'registration-directed,' their success is critical for future FDA approvals and commercialization potential. The non-recurring payment related to performance bonuses, while a one-time expense, also contributed to the overall net loss and should be considered when evaluating operating efficiencies.
From a clinical development perspective, Cogent Biosciences is making significant strides, particularly with their drug candidate bezuclastinib. The reported improvements in Total Symptom Score and quality-of-life metrics are promising indicators for its efficacy in treating systemic mastocytosis and GIST. However, without data from late-phase trials, these results should be considered preliminary.
The selection of the recommended Phase 2 dose based on efficacy and safety profiles is an encouraging sign for the drug's development. Investors should note, though, that the true test will come with the registration-directed trials set to complete enrollment soon and top-line results due in 2025 will be critical to understanding the drug's commercial viability. The strong interest from patients and investigators, as reported, suggests a positive reception from the medical community thus far.
Looking at the broader biotech industry, Cogent Biosciences' strategy to fund operations into 2027 reflects a robust planning, considering the typical long-horizon and capital-intensive nature of biotech ventures. The completion of the oversubscribed private placement speaks to investor confidence and the company's ability to attract capital. Moreover, their preclinical data on ErbB2 candidate CGT4255's potential as a best-in-class property provides a glimpse into their research pipeline strength, which is essential for sustained innovation and growth within biotech.
An investor should also consider the strategic importance of upcoming milestones like the ASCO presentation, which could potentially influence the stock's performance depending on the data disclosed. Staying informed on the development of the company's pipeline and the success of clinical trials is important as it carries substantial weight in the biotech sector's valuation models.
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
WALTHAM, Mass. and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2024.
“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), including70% of patients achieving ≥50% reduction in TSS at week 1249% 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
- 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 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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2, ErbB2 and PI3Kα. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.
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.
| COGENT BIOSCIENCES, INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| (in thousands, except share and per share amounts) | |||||||
| (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 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 | |||||
| COGENT BIOSCIENCES, INC. | |||||||
| SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| March 31, | December 31, | ||||||
| 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:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
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