Stonegate Capital Partners Initiates Coverage on OS Therapies Inc. (OSTX)
OS Therapies (NYSE American: OSTX) has achieved significant milestones in its development of OST-HER2 for treating recurrent, fully resected, pulmonary metastatic osteosarcoma. The FDA has confirmed OST-HER2's qualification as a Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number for Accelerated Approval submission.
The company's Phase 2b trial demonstrated statistically significant improvements with 35% vs. 20% in 12-month Event Free Survival and 66.6% vs. 40% in interim 2-year Overall Survival. OSTX has secured a U.S. commercial partnership with Eversana and raised $7.9M through warrant exchange financings, extending its cash runway into 2027. The company is preparing for potential U.S. launch in H1 2026.
OS Therapies (NYSE American: OSTX) ha raggiunto traguardi importanti nello sviluppo di OST-HER2 per il trattamento dell'osteosarcoma polmonare metastatico ricorrente completamente asportato. La FDA ha confermato la qualifica di OST-HER2 come Regenerative Medicine Advanced Therapy (RMAT) e ha assegnato un numero BLA per la sottomissione ai fini dell'Accelerated Approval.
Lo studio di Fase 2b dell'azienda ha mostrato miglioramenti statisticamente significativi: 35% vs 20% di sopravvivenza senza eventi a 12 mesi e 66,6% vs 40% di sopravvivenza complessiva a 2 anni in valutazione intermedia. OSTX ha siglato una partnership commerciale negli USA con Eversana e raccolto 7,9 milioni di dollari tramite finanziamenti con scambio di warrant, portando la liquidità prevista fino al 2027. L'azienda si sta preparando per un potenziale lancio negli Stati Uniti nella prima metà del 2026.
OS Therapies (NYSE American: OSTX) ha alcanzado hitos importantes en el desarrollo de OST-HER2 para el tratamiento del osteosarcoma pulmonar metastásico recurrente completamente resecado. La FDA ha confirmado la calificación de OST-HER2 como Regenerative Medicine Advanced Therapy (RMAT) y ha emitido un número BLA para la presentación de Aprobación Acelerada.
El ensayo de Fase 2b de la compañía mostró mejoras estadísticamente significativas: 35% vs 20% de Supervivencia Libre de Eventos a 12 meses y 66,6% vs 40% de Supervivencia Global a 2 años en el análisis intermedio. OSTX aseguró una asociación comercial en EE. UU. con Eversana y recaudó 7,9 millones de dólares mediante financiamientos por intercambio de warrants, extendiendo su runway de caja hasta 2027. La compañía se prepara para un posible lanzamiento en EE. UU. en la primera mitad de 2026.
OS Therapies (NYSE American: OSTX)는 재발한 완전 절제된 폐 전이성 골육종 치료를 위한 OST-HER2 개발에서 중요한 이정표를 달성했습니다. FDA는 OST-HER2를 Regenerative Medicine Advanced Therapy (RMAT)로 인정했으며 Accelerated Approval 제출을 위한 BLA 번호를 부여했습니다.
회사의 2상(Phase 2b) 시험은 통계적으로 유의한 개선을 보였습니다: 12개월 무사건생존(Event Free Survival) 35% 대 20% 및 중간 평가 기준 2년 전체생존(Overall Survival) 66.6% 대 40%. OSTX는 Eversana와 미국 상용화 파트너십을 체결했고, 워런트 교환 방식의 자금 조달로 790만 달러를 확보하여 현금 유통 기한을 2027년까지 연장했습니다. 회사는 2026년 상반기 미국에서의 잠재적 출시를 준비하고 있습니다.
OS Therapies (NYSE American: OSTX) a franchi des étapes importantes dans le développement d'OST-HER2 pour le traitement de l'ostéosarcome pulmonaire métastatique récidivant et complètement réséqué. La FDA a confirmé la qualification d'OST-HER2 en tant que Regenerative Medicine Advanced Therapy (RMAT) et a attribué un numéro BLA pour le dépôt en vue d'une approbation accélérée.
L'essai de phase 2b de la société a montré des améliorations statistiquement significatives : 35% vs 20% de survie sans événement à 12 mois et 66,6% vs 40% de survie globale à 2 ans en analyse intermédiaire. OSTX a sécurisé un partenariat commercial aux États-Unis avec Eversana et levé 7,9 millions de dollars via des financements par échange de bons de souscription, prolongeant sa trésorerie jusqu'en 2027. La société se prépare à un lancement potentiel aux États-Unis au premier semestre 2026.
OS Therapies (NYSE American: OSTX) hat bedeutende Meilensteine bei der Entwicklung von OST-HER2 zur Behandlung rezidivierender, vollständig resezierter pulmonaler Metastasen beim Osteosarkom erreicht. Die FDA hat OST-HER2 als Regenerative Medicine Advanced Therapy (RMAT) qualifiziert und eine BLA-Nummer für die Einreichung zur beschleunigten Zulassung vergeben.
Die Phase-2b-Studie des Unternehmens zeigte statistisch signifikante Verbesserungen: 35% vs. 20% ereignisfreie Überlebensrate nach 12 Monaten und 66,6% vs. 40% Gesamtüberleben nach 2 Jahren (interim). OSTX hat eine US-Vertriebspartnerschaft mit Eversana geschlossen und 7,9 Mio. USD durch Warrant-Exchange-Finanzierungen aufgenommen, wodurch die Liquiditätsreichweite bis 2027 verlängert wurde. Das Unternehmen bereitet sich auf einen möglichen US-Start in der ersten Hälfte 2026 vor.
- Phase 2b trial showed significant improvement in survival rates (35% vs 20% EFS, 66.6% vs 40% OS)
- FDA granted RMAT designation and BLA number for Accelerated Approval pathway
- Secured commercial partnership with Eversana for U.S. launch
- Raised $7.9M, extending cash runway into 2027
- On track for rolling BLA submission in September 2025
- None.
Dallas, Texas--(Newsfile Corp. - September 8, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners initiates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced meaningful clinical, regulatory, and financial milestones in 2Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully resected, pulmonary metastatic osteosarcoma. Importantly, the FDA confirmed that OST-HER2 meets the biological definition of a Regenerative Medicine Advanced Therapy (RMAT) and issued a Biologics License Application (BLA) number in preparation for an Accelerated Approval submission. Final 12-month Event Free Survival (EFS) results from the Phase 2b trial demonstrated statistically significant improvement, supported by interim 2-year Overall Survival (OS) data, further validating the clinical benefit. With a U.S. commercial partnership secured with Eversana, OS Therapies is positioning for a potential U.S. launch in the first half of 2026.
To view the full announcement, including downloadable images, bios, and more, click here.
Key Takeaways:
- Following a successful FDA End of Phase 2 meeting, OSTX is on track to begin rolling BLA submission for OST-HER2 in September 2025.
- Phase 2b trial showed statistically significant improvements in 12-month Event Free Survival (
35% vs.20% ) and interim 2-year Overall Survival (66.6% vs.40% ), with an excellent safety profile. - Completed warrant exchange financings raising ~
$7.9M in Q3, extending cash runway into 2027 and funding commercial launch preparations.
Click image above to view full announcement.
About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.
Contacts:
Stonegate Capital Partners
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info@stonegateinc.com
Source: Stonegate, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/265606
FAQ
What were the key results of OS Therapies' (OSTX) Phase 2b trial for OST-HER2?
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