Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2024 Financial Results
Cogent Biosciences (NASDAQ: COGT) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical trials for bezuclastinib. The company expects top-line results from three pivotal trials in 2025: SUMMIT trial (NonAdvSM) in July, APEX trial (AdvSM) in 2H, and PEAK trial (GIST) by year-end.
Clinical highlights include impressive data from the SUMMIT trial showing 56% mean improvement in Total Symptom Score and 89% of patients with >50% decrease in serum tryptase levels. The APEX trial demonstrated 52% overall response rate per mIWG criteria, rising to 83% for patients receiving 100mg BID.
Cogent's pipeline expansion includes a selective KRAS inhibitor (CGT6737) and PI3Kα inhibitor (CGT6297). The company plans to submit IND applications in 2025 for CGT4255 (ErbB2 inhibitor) and CGT6297.
Financially, Cogent reported $287.1 million in cash and equivalents as of December 31, 2024, plus $25 million from an ATM offering in February 2025. This funding is expected to sustain operations into late 2026, well past planned clinical readouts. R&D expenses increased to $232.7 million for 2024, up from $173.8 million in 2023, while net loss widened to $255.9 million from $192.4 million.
Cogent Biosciences (NASDAQ: COGT) ha riportato i risultati finanziari del Q4 e dell'intero anno 2024, evidenziando progressi significativi nei suoi studi clinici per il bezuclastinib. L'azienda si aspetta risultati preliminari da tre studi pivotal nel 2025: lo studio SUMMIT (NonAdvSM) a luglio, lo studio APEX (AdvSM) nel secondo semestre e lo studio PEAK (GIST) entro la fine dell'anno.
Tra i punti salienti clinici ci sono dati impressionanti dallo studio SUMMIT che mostrano un miglioramento medio del 56% nel punteggio totale dei sintomi e l'89% dei pazienti con una diminuzione >50% dei livelli di triptasi sierica. Lo studio APEX ha dimostrato un tasso di risposta globale del 52% secondo i criteri mIWG, che sale all'83% per i pazienti che ricevono 100mg BID.
L'espansione del pipeline di Cogent include un inibitore selettivo di KRAS (CGT6737) e un inibitore di PI3Kα (CGT6297). L'azienda prevede di presentare domande IND nel 2025 per CGT4255 (inibitore di ErbB2) e CGT6297.
Dal punto di vista finanziario, Cogent ha riportato $287.1 milioni in contante e equivalenti al 31 dicembre 2024, più $25 milioni da un'offerta ATM a febbraio 2025. Questo finanziamento dovrebbe sostenere le operazioni fino alla fine del 2026, ben oltre i risultati clinici pianificati. Le spese per R&D sono aumentate a $232.7 milioni per il 2024, rispetto ai $173.8 milioni del 2023, mentre la perdita netta è aumentata a $255.9 milioni dai $192.4 milioni.
Cogent Biosciences (NASDAQ: COGT) ha reportado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en sus ensayos clínicos para el bezuclastinib. La compañía espera resultados preliminares de tres ensayos clave en 2025: el ensayo SUMMIT (NonAdvSM) en julio, el ensayo APEX (AdvSM) en la segunda mitad del año y el ensayo PEAK (GIST) para fin de año.
Entre los aspectos destacados clínicos se incluyen datos impresionantes del ensayo SUMMIT que muestran una mejora media del 56% en el puntaje total de síntomas y el 89% de los pacientes con una disminución >50% en los niveles de triptasa sérica. El ensayo APEX demostró una tasa de respuesta global del 52% según los criterios mIWG, que aumenta al 83% para los pacientes que reciben 100mg BID.
La expansión del pipeline de Cogent incluye un inhibidor selectivo de KRAS (CGT6737) y un inhibidor de PI3Kα (CGT6297). La compañía planea presentar solicitudes IND en 2025 para CGT4255 (inhibidor de ErbB2) y CGT6297.
Financieramente, Cogent reportó $287.1 millones en efectivo y equivalentes al 31 de diciembre de 2024, más $25 millones de una oferta ATM en febrero de 2025. Se espera que este financiamiento sostenga las operaciones hasta finales de 2026, bien más allá de las lecturas clínicas planificadas. Los gastos de I+D aumentaron a $232.7 millones para 2024, en comparación con $173.8 millones en 2023, mientras que la pérdida neta se amplió a $255.9 millones desde $192.4 millones.
코겐트 바이오사이언스(COGT, NASDAQ)는 2024년 4분기 및 전체 연도 재무 결과를 발표하며 베주클라스티닙 임상 시험에서의 중요한 진전을 강조했습니다. 이 회사는 2025년 세 가지 주요 시험의 초기 결과를 기대하고 있습니다: SUMMIT 시험(NonAdvSM)은 7월, APEX 시험(AdvSM)은 하반기, PEAK 시험(GIST)은 연말까지 진행됩니다.
임상 하이라이트로는 SUMMIT 시험에서 총 증상 점수가 평균 56% 개선되었고, 89%의 환자가 혈청 트립타제 수치가 50% 이상 감소한 인상적인 데이터가 포함됩니다. APEX 시험은 mIWG 기준에 따라 전체 응답률이 52%로 나타났으며, 100mg BID를 받는 환자에서는 83%로 증가했습니다.
코겐트의 파이프라인 확장에는 선택적 KRAS 억제제(CG6737)와 PI3Kα 억제제(CG6297)가 포함됩니다. 이 회사는 2025년에 CGT4255(ErbB2 억제제)와 CGT6297에 대한 IND 신청서를 제출할 계획입니다.
재무적으로 코겐트는 2024년 12월 31일 기준으로 2억 8,710만 달러의 현금 및 현금성 자산을 보고했으며, 2025년 2월에는 ATM 제공으로 2천 5백만 달러를 추가로 확보했습니다. 이 자금은 계획된 임상 결과 발표를 훨씬 넘겨 2026년 말까지 운영을 지속할 것으로 예상됩니다. R&D 비용은 2024년 2억 3,270만 달러로 증가했으며, 이는 2023년 1억 7,380만 달러에서 증가한 수치입니다. 순손실은 1억 9,240만 달러에서 2억 5,590만 달러로 확대되었습니다.
Cogent Biosciences (NASDAQ: COGT) a publié ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en avant des progrès significatifs dans ses essais cliniques pour le bezuclastinib. La société s'attend à des résultats préliminaires de trois essais pivots en 2025: l'essai SUMMIT (NonAdvSM) en juillet, l'essai APEX (AdvSM) au second semestre, et l'essai PEAK (GIST) d'ici la fin de l'année.
Les points saillants cliniques incluent des données impressionnantes de l'essai SUMMIT montrant une amélioration moyenne de 56% du score total des symptômes et 89% des patients avec une diminution >50% des niveaux de tryptase sérique. L'essai APEX a démontré un taux de réponse global de 52% selon les critères mIWG, atteignant 83% pour les patients recevant 100mg BID.
L'expansion du pipeline de Cogent comprend un inhibiteur sélectif de KRAS (CGT6737) et un inhibiteur de PI3Kα (CGT6297). La société prévoit de soumettre des demandes IND en 2025 pour CGT4255 (inhibiteur d'ErbB2) et CGT6297.
Sur le plan financier, Cogent a rapporté 287,1 millions de dollars en liquidités et équivalents au 31 décembre 2024, plus 25 millions de dollars d'une offre ATM en février 2025. Ce financement devrait soutenir les opérations jusqu'à la fin de 2026, bien au-delà des résultats cliniques prévus. Les dépenses de R&D ont augmenté à 232,7 millions de dollars pour 2024, contre 173,8 millions de dollars en 2023, tandis que la perte nette s'est élargie à 255,9 millions de dollars contre 192,4 millions de dollars.
Cogent Biosciences (NASDAQ: COGT) hat seine Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei erhebliche Fortschritte in seinen klinischen Studien zu Bezuclastinib hervorgehoben. Das Unternehmen erwartet Ergebnisse aus drei entscheidenden Studien im Jahr 2025: die SUMMIT-Studie (NonAdvSM) im Juli, die APEX-Studie (AdvSM) in der zweiten Jahreshälfte und die PEAK-Studie (GIST) bis zum Jahresende.
Zu den klinischen Höhepunkten gehören beeindruckende Daten aus der SUMMIT-Studie, die eine durchschnittliche Verbesserung von 56% im Gesamtsymptomwert zeigen und 89% der Patienten mit einer >50%igen Reduktion der Serumtrypasewerte. Die APEX-Studie zeigte eine Gesamtansprechrate von 52% gemäß mIWG-Kriterien, die auf 83% für Patienten ansteigt, die 100mg BID erhalten.
Die Pipeline-Erweiterung von Cogent umfasst einen selektiven KRAS-Inhibitor (CGT6737) und einen PI3Kα-Inhibitor (CGT6297). Das Unternehmen plant, im Jahr 2025 IND-Anträge für CGT4255 (ErbB2-Inhibitor) und CGT6297 einzureichen.
Finanziell berichtete Cogent 287,1 Millionen Dollar in bar und Äquivalenten zum 31. Dezember 2024, zusätzlich zu 25 Millionen Dollar aus einem ATM-Angebot im Februar 2025. Diese Finanzierung soll die Betriebe bis Ende 2026 aufrechterhalten, weit über die geplanten klinischen Ergebnisse hinaus. Die F&E-Ausgaben stiegen auf 232,7 Millionen Dollar für 2024, verglichen mit 173,8 Millionen Dollar im Jahr 2023, während der Nettoverlust auf 255,9 Millionen Dollar von 192,4 Millionen Dollar ausgeweitet wurde.
- Strong cash position of $312M expected to fund operations into late 2026
- SUMMIT trial showed 56% mean improvement in Total Symptom Score with 76% of patients achieving >50% reduction
- APEX trial demonstrated 52% ORR per mIWG criteria, including 83% ORR for patients on 100mg BID
- Expanded pipeline with KRAS inhibitor and PI3Kα inhibitor showing promising preclinical results
- Plans to submit first NDA for bezuclastinib by end of 2025
- Net loss increased to $255.9M in 2024 from $192.4M in 2023
- R&D expenses rose to $232.7M in 2024 from $173.8M in 2023
- G&A expenses increased to $43.3M in 2024 from $34.4M in 2023
• Top-line results from SUMMIT trial in NonAdvSM patients expected July 2025
• APEX trial enrollment in AdvSM patients complete; top-line results expected in 2H 2025
• Top-line results from PEAK trial in 2nd-line GIST patients expected by end of 2025
•
WALTHAM, Mass. and BOULDER, Colo., Feb. 25, 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 reported financial results for the fourth quarter and full year of 2024.
“Cogent is preparing to report data from three bezuclastinib pivotal clinical trials this year,” said Andrew Robbins, the company’s President and Chief Executive Officer. “Given our strong cash balance, and emerging pipeline of potential best-in-class targeted therapies, we are poised for a transformational year culminating with the planned submission of Cogent’s first NDA for bezuclastinib by the end of 2025.”
Q4 2024 and Recent Business Highlights
- In December 2024, announced updated clinical results from SUMMIT, showcasing dramatic symptomatic improvement in nonadvanced systemic mastocytosis (NonAdvSM) patients and positive updated data from the APEX trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the American Society of Hematology (ASH) annual meeting. In both trials, bezuclastinib continued to demonstrate an encouraging safety and tolerability profile. Highlights include:
- In SUMMIT, a registration-directed, global, randomized, placebo-controlled trial in patients with NonAdvSM, treatment with 100 mg bezuclastinib demonstrated:
56% mean improvement in Total Symptom Score (TSS) at 24 weeks with76% of patients achieving at least a >50% reduction from baseline in TSS89% of patients had >50% decrease in serum tryptase levels by four weeks of treatment
- In APEX, a registration-directed, global, open-label trial in patients with AdvSM, treatment with various doses of bezuclastinib demonstrated:
52% ORR per mIWG criteria, including83% ORR for patients receiving 100 mg BID88% ORR per PPR criteria, including100% ORR for patients receiving 100 mg BID- 2.2 months median time-to-response with median duration-of-response and median PFS not yet reached with at least 20 months follow-up
- In SUMMIT, a registration-directed, global, randomized, placebo-controlled trial in patients with NonAdvSM, treatment with 100 mg bezuclastinib demonstrated:
- In October 2024, announced the addition of a potent and selective KRAS inhibitor to Cogent’s pipeline at the 2024 EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics.
- Cogent’s internally-developed pan-KRAS(ON) inhibitor demonstrated picomolar (pM) activity across KRAS mutations with selectivity over H/NRAS leading to potential advantages versus other molecules in the class. Following oral administration, CGT6737 demonstrated robust PK/PD and tumor growth inhibition with
90% PD inhibition in mouse xenograft models. Lead optimization of the program is ongoing.
- Cogent’s internally-developed pan-KRAS(ON) inhibitor demonstrated picomolar (pM) activity across KRAS mutations with selectivity over H/NRAS leading to potential advantages versus other molecules in the class. Following oral administration, CGT6737 demonstrated robust PK/PD and tumor growth inhibition with
- In October 2024, shared progress on Cogent’s clinical candidate CGT6297, a potent allosteric inhibitor of PI3Kα, with 25-fold selectivity over PI3Kα WT. In a poster at the 2024 EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics, CGT6297 showed high oral bioavailability and low clearance across species, providing robust inhibition of downstream signaling and efficacy in animal models. Importantly, when compared to a clinically relevant dose of a currently approved therapy in a mouse tumor model, CGT6297 demonstrated superior efficacy with no increase in insulin.
Projected Near-Term Milestones
Bezuclastinib – Systemic Mastocytosis (SM)
- Poster presentation focused on symptomatic performance of patients from SUMMIT Part 1 who have received 100 mg bezuclastinib for at least 48 weeks at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI).
- Report top-line results in July 2025 from the SUMMIT trial.
- Report top-line results during the second half of 2025 from the APEX trial.
- Submit the first bezuclastinib New Drug Application (NDA) by the end of 2025.
Bezuclastinib – Gastrointestinal Stromal Tumors (GIST)
- Report top-line results by the end of 2025 from the pivotal Phase 3 PEAK trial. PEAK is a global, blinded, randomized clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST).
Bezuclastinib - Expanded Access Program
- In Q1, initiate Expanded Access Programs (EAP) in the U.S. for SM and GIST patients to receive investigational bezuclastinib after meeting certain eligibility criteria.
CGT4859 (FGFR2 inhibitor)
- Enroll patients in the ongoing Phase 1 trial with CGT4859, a reversible, selective FGFR2 inhibitor in patients with documented FGFR mutations, including advanced cholangiocarcinoma. The trial is designed to explore the safety, tolerability and clinical activity of escalating doses of CGT4859 with a goal of selecting an active and well-tolerated dose for further clinical investigation.
Preclinical Pipeline
- Submit an IND application in 2025 for CGT4255, a potent, selective ErbB2 inhibitor, highlighted by potential best-in-class brain-penetrant properties.
- Submit an IND application in 2025 for CGT6297, a potent allosteric inhibitor of PI3Kα, with 25-fold selectivity over PI3Kα WT.
Upcoming Investor Conference
- Leerink Healthcare Conference on Wednesday, March 12 at 10:00 a.m. ET.
- A live webcast can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.
Fourth Quarter and Full Year 2024 Financial Results
Cash and Cash Equivalents: As of December 31, 2024, 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 February 12, 2025 and February 24, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to five new employees under the company’s 2020 Inducement Plan with grant dates of February 12, 2025, February 19, 2025 and February 24, 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 78,500 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 4-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 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; the planned submission of Cogent’s first NDA for bezuclastinib by the end of 2025; the potential best-in-class attributes of the company’s pipeline programs; plans to initiate Expanded Access Programs in the first quarter of 2025 in the United States for SM and GIST patients to receive investigational bezuclastinib after meeting certain eligibility criteria; and plans to submit INDs in 2025 for the company’s ErbB2 and PI3Kα programs. 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 Quarterly Report on Form 10-Q filed 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 the date hereof.
| COGENT BIOSCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands) (unaudited) | ||||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 62,045 | $ | 48,719 | $ | 232,658 | $ | 173,755 | ||||||||
| General and administrative | 11,689 | 9,509 | 43,281 | 34,375 | ||||||||||||
| Total operating expenses | 73,734 | 58,228 | 275,939 | 208,130 | ||||||||||||
| Loss from operations | (73,734 | ) | (58,228 | ) | (275,939 | ) | (208,130 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 3,859 | 3,870 | 18,088 | 13,077 | ||||||||||||
| Other income, net | 1,948 | (7 | ) | 1,992 | 943 | |||||||||||
| Change in fair value of CVR liability | -- | -- | -- | 1,700 | ||||||||||||
| Total other income, net | 5,807 | 3,863 | 20,080 | 15,720 | ||||||||||||
| Net loss | $ | (67,927 | ) | $ | (54,365 | ) | $ | (255,859 | ) | $ | (192,410 | ) | ||||
| COGENT BIOSCIENCES, INC. SELECTED CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 287,077 | $ | 273,170 | ||||
| Working capital | $ | 240,762 | $ | 232,603 | ||||
| Total assets | $ | 327,898 | $ | 313,437 | ||||
| Total liabilities | $ | 71,612 | $ | 55,635 | ||||
| Total stockholders’ equity | $ | 256,286 | $ | 257,802 | ||||
Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653
FAQ
When will Cogent Biosciences (COGT) report top-line results from the SUMMIT trial for NonAdvSM?
What were the response rates for bezuclastinib in the APEX trial for advanced systemic mastocytosis?
How much cash does COGT have and how long will it last?
When does Cogent Biosciences plan to submit its first NDA for bezuclastinib?
What clinical improvement did bezuclastinib show in NonAdvSM patients in the SUMMIT trial?
What new drug candidates is COGT developing besides bezuclastinib?
How did COGT's R&D and net loss figures change in 2024 compared to 2023?
