Stonegate Capital Partners Initiates Coverage on OS Therapies Inc. (OSTX)

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

News Market Reaction

-2.23%

2 alerts

-2.23% News Effect

-$2M Valuation Impact

$74M Market Cap

0.2x Rel. Volume

On the day this news was published, OSTX declined 2.23%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $74M at that time.

Data tracked by StockTitan Argus on the day of publication.

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.

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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
(214) 987-4121
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?

The Phase 2b trial showed statistically significant improvements with 35% vs. 20% in 12-month Event Free Survival and 66.6% vs. 40% in interim 2-year Overall Survival, along with an excellent safety profile.

When is OS Therapies (OSTX) planning to launch OST-HER2 in the U.S. market?

OS Therapies is preparing for a potential U.S. launch in the first half of 2026, following their commercial partnership with Eversana.

What regulatory designations has OS Therapies (OSTX) received for OST-HER2?

The FDA has confirmed OST-HER2 qualifies as a Regenerative Medicine Advanced Therapy (RMAT) and issued a Biologics License Application (BLA) number for Accelerated Approval submission.

How much funding did OS Therapies (OSTX) secure in Q3 2025?

OS Therapies completed warrant exchange financings raising approximately $7.9M in Q3, extending their cash runway into 2027.

When will OS Therapies (OSTX) submit their BLA for OST-HER2?

Following a successful FDA End of Phase 2 meeting, OSTX is scheduled to begin their rolling BLA submission in September 2025.