Cogent Biosciences Reports First Quarter 2025 Financial Results

Rhea-AI Summary

Cogent Biosciences (NASDAQ: COGT) reported Q1 2025 financial results and provided key business updates. The company is preparing for three major clinical trial readouts in 2025: SUMMIT trial results for nonadvanced systemic mastocytosis in July, APEX trial for advanced systemic mastocytosis in H2, and PEAK trial for GIST by year-end. Recent highlights include positive clinical data from SUMMIT's Open Label Extension, showing 65% mean improvement in Total Symptom Score at 48 weeks. Financially, Cogent ended Q1 with $245.7 million in cash, expected to fund operations into late 2026. The company reported increased R&D expenses of $63.0 million (vs $52.7M in Q1 2024) and a net loss of $72.0 million (vs $58.3M in Q1 2024). The company raised $24.3 million through ATM stock offering during the quarter.

Positive

• Strong cash position of $245.7M, sufficient to fund operations into late 2026
• Positive SUMMIT trial data showing 65% mean improvement in Total Symptom Score, with 88% of patients achieving 50%+ reduction
• Three potential registration-directed trial readouts expected in 2025
• Favorable safety profile for bezuclastinib with primarily low-grade and reversible adverse events

Negative

• Increased net loss to $72.0M in Q1 2025 from $58.3M in Q1 2024
• Higher R&D expenses at $63.0M compared to $52.7M year-over-year
• Additional share dilution through $24.3M ATM stock offering

Insights

Biotechnology Expert

Cogent approaches three pivotal trial readouts in 2025 with promising early efficacy data and favorable safety profile for bezuclastinib.

Cogent Biosciences is navigating a transformative year with three registration-directed trial readouts for their lead candidate bezuclastinib. The first milestone comes this July with the SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM), followed by APEX in advanced systemic mastocytosis and PEAK in gastrointestinal stromal tumors (GIST) later in 2025.

The Open Label Extension portion of SUMMIT has already yielded encouraging signals, showing a 65% mean improvement in Total Symptom Score at 48 weeks, with 88% of patients achieving at least a 50% reduction. These results suggest meaningful symptomatic benefit in NonAdvSM, a rare disease characterized by mast cell accumulation and mediator release.

Bezuclastinib's safety profile appears favorable – a critical factor for chronic conditions like NonAdvSM where treatment tolerability significantly impacts quality of life. Adverse events were primarily low-grade and reversible, with notably no treatment-related bleeding or cognitive impairment – side effects that have complicated other kinase inhibitors. The most common treatment-related adverse events were hair discoloration and transient liver enzyme elevations, all asymptomatic and reversible.

Beyond bezuclastinib, Cogent is advancing early-stage programs targeting KRAS, PI3Kα, FGFR2/3, and ErbB2 – all genetically defined oncology targets with significant unmet needs. These programs demonstrate pipeline diversification beyond their lead asset.

With potential regulatory submissions following positive readouts, Cogent is preparing for a possible commercial launch in 2026, signaling confidence in their clinical programs while acknowledging the binary nature of these upcoming catalysts.

Financial Analyst

Cogent maintains strong $245.7M cash position with runway into late 2026, covering three critical clinical readouts despite accelerating R&D investment.

Cogent Biosciences ended Q1 2025 with $245.7 million in cash, cash equivalents and marketable securities, providing runway into late 2026 according to management guidance. This timeline strategically extends beyond their three registration-directed trial readouts expected throughout 2025, giving the company financial flexibility to navigate potential regulatory submissions and pre-commercial activities.

R&D expenses increased to $63.0 million compared to $52.7 million in Q1 2024 (19.5% increase), reflecting intensified investment in the SUMMIT, APEX, and PEAK clinical trials alongside continued progress in early-stage programs. This accelerated spending is typical for biotech companies approaching pivotal data readouts and potential commercialization.

G&A expenses rose to $11.9 million from $9.7 million year-over-year (22.7% increase), attributed to organizational growth in preparation for potential commercial activities. The combined elevated expense profile resulted in a net loss of $72.0 million for Q1 2025, compared to $58.3 million in Q1 2024.

Notably, Cogent raised $24.3 million during the quarter through its at-the-market (ATM) stock offering facility, partially offsetting the $9.6 million non-recurring payment related to annual performance-based bonus compensation. This controlled capital raise demonstrates disciplined financial management while maintaining flexibility.

The company's burn rate indicates that quarterly cash utilization is approximately $70-75 million, meaning the current cash position provides about 3-3.5 quarters of runway without additional financing. However, positive clinical readouts could significantly change the company's financial trajectory through potential partnerships, licensing deals, or improved capital raising conditions.

Three Registration-Directed Top-line Data Readouts Remain on Track in 2025:

SUMMIT in NonAdvanced SM expected in July, APEX in Advanced SM expected in second half of the-year and PEAK in GIST expected by end of year

Ended 1Q 2025 with $245.7 million in cash, sufficient to fund operations into late 2026

WALTHAM, Mass. and BOULDER, Colo., May 06, 2025 (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, 2025.

“The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR conference.”

Recent Business Highlights

• Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting.
  • Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS.
  • The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible.
    
• Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting.
  

Upcoming Milestones

• Announce top-line results from SUMMIT in July 2025. SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM.
  
• Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM).
  
• Announce top-line results from PEAK by the end of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST).
  

First Quarter 2025 Financial Results

Cash and Cash Equivalents: As of March 31, 2025, cash, cash equivalents and marketable securities were $245.7 million. During the quarter, the Company sold shares under the Company’s at-the-market (ATM) stock offering for net proceeds of $24.3 million and incurred a non-recurring payment of $9.6 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 late 2026, including through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials.

R&D Expenses: Research and development expenses were $63.0 million for the first quarter of 2025 compared to $52.7 million for the first quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.3 million for the first quarter of 2025 as compared to $4.4 million for the first quarter of 2024.

G&A Expenses: General and administrative expenses were $11.9 million for the first quarter of 2025 compared to $9.7 million for the first quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the first quarter of 2025 as compared to $5.0 million for the first quarter of 2024.

Net Loss: Net loss was $72.0 million for the first quarter of 2025 compared to a net loss of $58.3 million for the first quarter of 2024.

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. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. 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 expectation to report SUMMIT top-line results in July 2025; the expectation to report APEX top-line results in the second half of 2025; the expectation to report PEAK top-line results by the end of 2025; the company’s anticipated cash runway into late 2026; and the potential commercial launch of bezuclastinib in 2026. 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) (unaudited)
		Three Months Ended March 31,
		2025				2024
Operating expenses:
Research and development		$	63,029			$	52,705
General and administrative			11,904				9,699
Total operating expenses			74,933				62,404
Loss from operations			(74,933	)			(62,404	)
Other income:
Interest income			2,952				4,057
Other expense, net			(5	)			(1	)
Total other income, net			2,947				4,056
Net loss		$	(71,986	)		$	(58,348	)

COGENT BIOSCIENCES, INC. SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited)
		March 31,				December 31,
		2025				2024
Cash, cash equivalents and marketable securities		$	245,661			$	287,077
Working capital		$	203,556			$	240,762
Total assets		$	283,798			$	327,898
Total liabilities		$	64,803			$	71,612
Total stockholders’ equity		$	218,995			$	256,286

Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653

FAQ

What are the key clinical trial readouts expected for Cogent Biosciences (COGT) in 2025?

Cogent expects three major readouts in 2025: SUMMIT trial results for nonadvanced systemic mastocytosis in July, APEX trial for advanced systemic mastocytosis in H2, and PEAK trial for GIST by year-end.

What were Cogent Biosciences' (COGT) Q1 2025 financial results?

Cogent reported $245.7M in cash, R&D expenses of $63.0M, G&A expenses of $11.9M, and a net loss of $72.0M. The company raised $24.3M through ATM offering.

What were the clinical results from COGT's SUMMIT trial Open Label Extension?

The SUMMIT trial showed 65% mean improvement in Total Symptom Score at 48 weeks, with 88% of patients achieving at least 50% reduction in TSS. Safety profile was favorable with primarily low-grade, reversible adverse events.

How long can Cogent Biosciences (COGT) fund its operations with current cash?

With $245.7M in cash as of March 31, 2025, Cogent expects to fund operations into late 2026, including through clinical readouts from SUMMIT, PEAK, and APEX trials.

What were the main safety findings for bezuclastinib in COGT's clinical trials?

Bezuclastinib showed a favorable safety profile with primarily low-grade and reversible adverse events. Common side effects were hair discoloration and transient liver enzyme elevations, with no treatment-related bleeding or cognitive impairment.