Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results
Cogent Biosciences (NASDAQ: COGT) reported significant achievements in Q2 2025, highlighted by positive top-line results from the SUMMIT trial evaluating bezuclastinib in NonAdvanced Systemic Mastocytosis. The trial met its primary endpoint with a statistically significant improvement in Total Symptom Score (24.3-point reduction vs. 15.4 points for placebo, p=0.0002).
The company strengthened its financial position through two major transactions: a $400 million debt facility with SLR Capital Partners and an upsized $230 million public offering. With $453 million in pro-forma cash, Cogent is funded through anticipated launch and into 2027. Q2 2025 resulted in a net loss of $73.5 million, with R&D expenses of $62.2 million.
Key upcoming catalysts include pivotal trial results from PEAK (GIST) and APEX (AdvSM) trials in 2H 2025, followed by the company's first NDA submission by year-end.
Cogent Biosciences (NASDAQ: COGT) ha riportato risultati significativi nel secondo trimestre del 2025, evidenziati dai risultati positivi della sperimentazione SUMMIT che valuta bezuclastinib nella Mastocitosi Sistemica Non Avanzata. Lo studio ha raggiunto l'endpoint primario con un miglioramento statisticamente significativo del punteggio totale dei sintomi (riduzione di 24,3 punti contro 15,4 punti per il placebo, p=0,0002).
L'azienda ha rafforzato la propria posizione finanziaria attraverso due operazioni importanti: una linea di credito da 400 milioni di dollari con SLR Capital Partners e un offerta pubblica aumentata a 230 milioni di dollari. Con 453 milioni di dollari in cassa pro-forma, Cogent è finanziata fino al lancio previsto e oltre, fino al 2027. Il secondo trimestre del 2025 si è chiuso con una perdita netta di 73,5 milioni di dollari, con spese di R&S pari a 62,2 milioni di dollari.
I principali eventi attesi includono i risultati degli studi fondamentali PEAK (GIST) e APEX (AdvSM) nella seconda metà del 2025, seguiti dalla prima presentazione NDA dell'azienda entro fine anno.
Cogent Biosciences (NASDAQ: COGT) reportó logros significativos en el segundo trimestre de 2025, destacando resultados positivos principales del ensayo SUMMIT que evalúa bezuclastinib en Mastocitosis Sistémica No Avanzada. El ensayo cumplió su objetivo primario con una mejora estadísticamente significativa en la puntuación total de síntomas (reducción de 24.3 puntos frente a 15.4 puntos para placebo, p=0.0002).
La compañía fortaleció su posición financiera mediante dos transacciones importantes: una línea de deuda de 400 millones de dólares con SLR Capital Partners y una oferta pública ampliada de 230 millones de dólares. Con 453 millones de dólares en efectivo pro forma, Cogent está financiada hasta el lanzamiento previsto y hasta 2027. El segundo trimestre de 2025 resultó en una pérdida neta de 73.5 millones de dólares, con gastos en I+D de 62.2 millones de dólares.
Los principales catalizadores futuros incluyen resultados de ensayos clave de PEAK (GIST) y APEX (AdvSM) en la segunda mitad de 2025, seguidos por la primera presentación de NDA de la compañía antes de fin de año.
Cogent Biosciences (NASDAQ: COGT)� 2025� 2분기� 중요� 성과� 보고했으�, 비진행성 전신 비만세포�(Non-Advanced Systemic Mastocytosis)에서 bezuclastinib� 평가� SUMMIT 임상시험� 긍정적인 주요 결과가 강조되었습니�. � 임상시험은 � 증상 점수(Total Symptom Score)� 통계적으� 유의미한 개선� 주된 목표� 달성하였으며(플라시보 대� 24.3� 감소 vs. 15.4�, p=0.0002) 성공하였습니�.
회사� SLR Capital Partners와� 4� 달러 부� 시설� 2� 3천만 달러 규모� 확대� 공개 모집 � 가지 주요 거래� 통해 재무 상태� 강화했습니다. 프로포르� 기준 4� 5,300� 달러� 현금� 보유� Cogent은 예정� 출시까지 그리� 2027년까지 자금� 확보� 상태입니�. 2025� 2분기� 7,350� 달러� 순손�� 기록했으�, 연구개발 비용은 6,220� 달러였습니�.
앞으로의 주요 촉매제로� 2025� 하반기에 예정� PEAK (GIST) � APEX (AdvSM) 임상시험� 중대� 결과와 연말까지 회사� � NDA 제출� 포함됩니�.
Cogent Biosciences (NASDAQ : COGT) a annoncé des résultats significatifs au deuxième trimestre 2025, notamment des résultats positifs de l'essai SUMMIT évaluant le bezuclastinib dans la mastocytose systémique non avancée. L'essai a atteint son critère principal avec une amélioration statistiquement significative du score total des symptômes (réduction de 24,3 points contre 15,4 points pour le placebo, p=0,0002).
L'entreprise a renforcé sa position financière grâce à deux opérations majeures : une facilité de dette de 400 millions de dollars avec SLR Capital Partners et une offre publique augmentée à 230 millions de dollars. Avec 453 millions de dollars en trésorerie pro forma, Cogent est financée jusqu'au lancement prévu et jusqu'en 2027. Le deuxième trimestre 2025 s'est soldé par une perte nette de 73,5 millions de dollars, avec des dépenses de R&D de 62,2 millions de dollars.
Les catalyseurs clés à venir incluent les résultats des essais pivots PEAK (GIST) et APEX (AdvSM) au second semestre 2025, suivis par la première soumission de NDA de l'entreprise d'ici la fin de l'année.
Cogent Biosciences (NASDAQ: COGT) meldete bedeutende Erfolge im zweiten Quartal 2025, insbesondere positive Ergebnisse der SUMMIT-Studie zur Bewertung von Bezuclastinib bei nicht-weiter fortgeschrittener systemischer Mastozytose. Die Studie erreichte ihren primären Endpunkt mit einer statistisch signifikanten Verbesserung des Gesamtsymptom-Scores (24,3-Punkte-Reduktion gegenüber 15,4 Punkten beim Placebo, p=0,0002).
Das Unternehmen stärkte seine finanzielle Lage durch zwei wesentliche Transaktionen: eine 400-ѾDzԱ-ٴDZ-ٲԲڲä mit SLR Capital Partners und ein erhöhtes öffentliches Angebot von 230 Millionen Dollar. Mit 453 Millionen Dollar an Pro-forma-Barmitteln ist Cogent bis zum erwarteten Markteintritt und bis ins Jahr 2027 finanziert. Das zweite Quartal 2025 schloss mit einem Nettoverlust von 73,5 Millionen Dollar ab, wobei die F&E-Ausgaben 62,2 Millionen Dollar betrugen.
Wichtige bevorstehende Meilensteine sind die entscheidenden Studienergebnisse der PEAK (GIST) und APEX (AdvSM)-Studien in der zweiten Jahreshälfte 2025, gefolgt von der ersten NDA-Einreichung des Unternehmens bis Jahresende.
- SUMMIT trial achieved statistical significance across all primary and secondary endpoints in NonAdvSM
- 87.4% of bezuclastinib-treated patients showed �50% reduction in serum tryptase vs 0% in control arm
- Secured $400M debt facility and raised $230M through public offering, with $453M pro-forma cash runway into 2027
- Favorable safety profile with majority of adverse events being low grade
- On track for first NDA submission by end of 2025 with potential commercial launch in 2026
- Increased net loss to $73.5M in Q2 2025 from $59.0M in Q2 2024
- R&D expenses increased to $62.2M from $54.3M year-over-year
- 5.9% discontinuation rate in SUMMIT trial due to ALT/AST elevations
- Significant dilution from 25.5M share public offering
Insights
Cogent's bezuclastinib shows impressive efficacy in NonAdvSM with strong statistical significance and favorable safety profile, positioning it as potential standard-of-care.
Cogent has delivered exceptionally strong clinical results for bezuclastinib in their SUMMIT trial for NonAdvanced Systemic Mastocytosis (NonAdvSM). The data shows clear statistical significance (p=0.0002) in the primary endpoint of Total Symptom Score reduction, with bezuclastinib-treated patients experiencing a 24.3-point reduction versus 15.4 points for placebo � a meaningful 8.91-point treatment benefit.
What's particularly impressive is the 87.4% of patients achieving �50% reduction in serum tryptase levels compared to 0% in the placebo arm (p<0.0001). This biomarker reduction strongly validates bezuclastinib's mechanism of action in targeting the underlying disease pathology.
The safety profile appears quite manageable, with most adverse events being low-grade. The most common side effects were hair color change (69.5%), taste alterations (23.7%), nausea (22.0%), and liver enzyme elevations (22.0%). The discontinuation rate of 5.9% due to ALT/AST elevations is reasonable, particularly as all cases fully resolved. Importantly, serious adverse events were actually lower in the treatment arm (4.2%) than placebo (5.0%).
With two additional pivotal readouts expected in 2H 2025 (PEAK for GIST and APEX for AdvSM), Cogent is positioned for potential multi-indication approvals. The company appears on track to submit their first NDA by year-end, suggesting a possible 2026 commercial launch timeline for bezuclastinib, which could become the new standard-of-care in NonAdvSM based on these compelling results.
Cogent strengthens financial position with $230M offering and $400M debt facility, securing runway through FDA approval and into 2027.
Cogent has substantially strengthened its balance sheet through two strategic financial transactions. The company raised $215.8 million in net proceeds from an upsized public offering in July 2025, selling 25.5 million shares at $9.00 per share. Additionally, they secured a substantial $400 million debt facility with SLR Capital Partners, with $50 million already drawn and additional tranches available upon achieving clinical and commercial milestones.
These transactions provide Cogent with $453 million in pro-forma cash, which management projects will fund operations into 2027, covering their anticipated bezuclastinib launch. This extended runway reduces near-term financing risk and provides flexibility through a critical commercialization period.
The company's R&D expenses increased to $62.2 million for Q2 2025 from $54.3 million in Q2 2024, reflecting their advancing clinical programs. G&A expenses rose to $13.4 million from $10.1 million year-over-year, indicating organizational growth in preparation for potential commercialization. The net loss expanded to $73.5 million compared to $59.0 million in the prior year period.
With positive SUMMIT trial results and two additional pivotal readouts expected in 2H 2025, Cogent's financial positioning appears well-timed. The capital infusion provides resources to potentially file their first NDA by year-end and prepare for commercial launch in 2026, while maintaining operational flexibility through these critical value-creating milestones.
Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints
On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025
WALTHAM, Mass. and BOULDER, Colo., Aug. 05, 2025 (GLOBE NEWSWIRE) -- (岹: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter endedJune 30, 2025.
“We were thrilled to announce bezuclastinib’s impressive performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all primary and key secondary endpoints,� said Andrew Robbins, the Company’s President and Chief Executive Officer. “These positive data along with the favorable safety profile give us confidence that bezuclastinib has the potential to become the new standard-of-care for NonAdvSM patients. Supported by our recent upsized public offering, Cogent is advancing our mission from a position of strength as we prepare to report top-line results from two additional pivotal trials in GIST and AdvSM in the second half of this year, submit our first New Drug Application by the end of 2025 and make continued progress toward the anticipated commercial launch of bezuclastinib in 2026.�
Recent Business Highlights
- Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients.
- The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which
87.4% of bezuclastinib-treated patients had �50% reduction, compared to no patients in the control arm (87.4% vs.0% ; p<0.0001). - Bezuclastinib demonstrated a favorable safety and tolerability profile in SUMMIT.
- The majority of treatment emergent adverse events (TEAEs) (
98.3% in bezuclastinib arm vs.88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs.5.0% placebo), altered taste (23.7% bezuclastinib vs.0% placebo), nausea (22.0% bezuclastinib vs.13.3% placebo) and ALT/AST elevations (22.0% bezuclastinib vs.6.6% placebo; >Gr 3,5.9% vs.0% ). Serious AEs occurred in4.2% of patients treated with bezuclastinib, compared to5.0% of patients treated with placebo. Discontinuations due to treatment-related AEs occurred in5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic AEs reported in any patient other than transient and manageable lab abnormalities.
- The majority of treatment emergent adverse events (TEAEs) (
- The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which
- Announced two financial transactions, positioning Cogent with access to over
$800 million in capital.- In June, secured a debt financing facility of up to
$400 million with SLR Capital Partners. An initial tranche of$50 million was drawn at closing in June 2025, with additional tranches available upon achieving key clinical and commercial milestones. - In July, successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at
$9.00 per share, including the full exercise of the underwriters� option to purchase an additional 3,333,333 shares. This offering generated net proceeds of$215.8 million .
- In June, secured a debt financing facility of up to
Anticipated Upcoming Milestones
- Announce top-line results from PEAK in the second half 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).
- 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).
- Submit Cogent’s first NDA for bezuclastinib by the end of 2025.
Second Quarter 2025 Financial Results
Cash Position:As ofJune 30, 2025, Cogent had cash, cash equivalents and marketable securities of
R&D Expenses:Research and development expenses were
G&A Expenses:General and administrative expenses were
Net Loss:Net loss was
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on July 30, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement� equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of August 4, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 172,450 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a four-year vesting schedule with
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 FGFR2/3 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. Follow Cogent Biosciences on social media:(formerly known as Twitter)and. Information that may be important to investors will be routinely posted on our website and.
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 expectation to report top-line results from both PEAK and APEX in the second half of 2025; the potential for bezuclastinib to become the new standard of care for NonAdvSM patients; the company’s expectation to submit its first NDA by the end of 2025; the anticipated commercial launch of bezuclastinib in 2026; and the company’s anticipated cash runway into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities. 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 or 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 June 30, | Six Months Ended June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 62,203 | $ | 54,294 | $ | 125,232 | $ | 106,999 | |||||||
General and administrative | 13,378 | 10,093 | 25,283 | 19,792 | |||||||||||
Total operating expenses | 75,581 | 64,387 | 150,515 | 126,791 | |||||||||||
Loss from operations | (75,581 | ) | (64,387 | ) | (150,515 | ) | (126,791 | ) | |||||||
Other income: | |||||||||||||||
Interest income | 2,373 | 5,393 | 5,325 | 9,450 | |||||||||||
Interest expense | (314 | ) | � | (314 | ) | � | |||||||||
Other income (expense), net | (6 | ) | 44 | (11 | ) | 43 | |||||||||
Total other income, net | 2,053 | 5,437 | 5,000 | 9,493 | |||||||||||
Net loss | $ | (73,529 | ) | $ | (58,950 | ) | $ | (145,515 | ) | $ | (117,298 | ) |
COGENT BIOSCIENCES, INC. SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) | ||||||
June 30, | December 31, | |||||
2025 | 2024 | |||||
Cash, cash equivalents and marketable securities | $ | 237,848 | $ | 287,077 | ||
Working capital | $ | 186,586 | $ | 240,762 | ||
Total assets | $ | 274,817 | $ | 327,898 | ||
Total liabilities | $ | 119,781 | $ | 71,612 | ||
Total stockholders� equity | $ | 155,036 | $ | 256,286 |
Contact:
Christi Waarich
Sr. Director, Investor Relations
617-830-1653
