Earnings summaries and quarterly performance for OS Therapies.
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Recent press releases and 8-K filings for OSTX.
OS Therapies Raises Capital Through Warrant Inducement Agreements
OSTX
New Projects/Investments
Guidance Update
- OS Therapies Inc. raised $7.53 million in gross proceeds from pre-existing investors through a warrant exercise inducement and exchange offer.
- These proceeds provide capital runway into 2027 and will fund OST-HER2 regulatory approval submissions, commercial preparation activities, and preparations for the OS Animal Health proposed spinoff transaction.
- The company intends to file a Biologics Licensing Application (BLA) with the U.S. FDA by the end of January 2026, and Marketing Authorisation Application (MAA) submissions to the U.K. MHRA and Europe's EMA by the end of February 2026 and March 2026, respectively.
- Regulatory approval for OST-HER2 is anticipated in the UK in Q2 2026, the US in Q3 2026, and Europe by the end of Q4 2026.
- The existing warrants were exercised at a reduced price of $1.40 per share, and new common stock purchase warrants were issued with the same exercise price and a five-year term.
Jan 12, 2026, 1:35 PM
OS Therapies Provides Update on Lead Program OST-HER2 Regulatory Milestones and Strategic Initiatives
OSTX
New Projects/Investments
Product Launch
- OS Therapies (OSTX) is a clinical-stage drug development company focused on its lead program, OST-HER2, a Listeria-based cancer vaccine targeting pediatric osteosarcoma. The company published Phase II-B data earlier this year, showing event-free survival of 36% at 12 months and overall survival of 75% at two years, significantly higher than historical controls.
- The company is actively pursuing regulatory approvals, having achieved alignment with the EMA on December 2, 2025, and the U.K. MHRA earlier this week. A Type C meeting with the FDA is scheduled for December 11, 2025, with BLA filings expected in the first quarter of 2026 for the U.S. and EMA, and in January 2026 for the U.K. MHRA.
- Upon U.S. approval, OS Therapies expects to be eligible for a Priority Review Voucher (PRV), which it intends to sell, potentially generating upwards of $150 million.
- OS Therapies has spun out a Canine Animal Health Program, which uses the same Listeria technology and was conditionally approved by the USDA. The company plans to take this spinout public, with current OSTX shareholders participating in equity.
- The company is funded through the middle or end of 2026.
Dec 11, 2025, 3:30 PM
OS Therapies Provides Update on OST-HER2 Program and Regulatory Milestones
OSTX
New Projects/Investments
Guidance Update
- OS Therapies (OSTX) is a clinical-stage drug development company focused on its lead program, OST-HER2, a Listeria-based cancer vaccine targeting pediatric osteosarcoma.
- The company reported promising Phase 2b data for OST-HER2, demonstrating 36% event-free survival at 12 months and 75% overall survival at two years, significantly higher than historical controls.
- OS Therapies has achieved regulatory alignment with the EMA (December 2, 2025) and UK MHRA (earlier this week) and is meeting with the FDA today, December 11, 2025, for a Type C meeting.
- The company plans to file for UK MHRA approval in January 2026 and for U.S. BLA and EMA approvals in Q1 2026.
- Upon potential U.S. approval, OS Therapies expects to receive a Priority Review Voucher (PRV), which they intend to sell for upwards of $150 million, and the company is funded through the middle or end of 2026.
Dec 11, 2025, 3:30 PM
OS Therapies Provides Update on Lead Program and Regulatory Milestones
OSTX
New Projects/Investments
Product Launch
- OS Therapies (OSTX) is a clinical-stage drug development company focused on a Listeria-based cancer vaccine (oncology immunotherapy).
- The lead program, OST-HER2, targets pediatric osteosarcoma, showing promising Phase 2b data with 36% event-free survival at 12 months and 75% overall survival at 2 years, significantly higher than historical controls.
- The company is actively pursuing regulatory approvals, having achieved alignment with UK MHRA and EMA earlier this week, and is holding a Type C meeting with the FDA today (December 11, 2025).
- OS Therapies plans to file for approval with UK MHRA in January 2026 and in the U.S. (with an existing BLA number) in Q1 2026, expecting to be eligible for a Priority Review Voucher (PRV), which they intend to sell for potentially upwards of $150 million.
- A spinout company for the K9 Animal Health Program, which uses the same Listeria technology, is planned to go public, with current OSTX shareholders participating in equity.
Dec 11, 2025, 3:30 PM
OS Therapies Inc. Provides Update on OST-HER2 Clinical Program and Annual Meeting Adjournment
OSTX
Product Launch
New Projects/Investments
Proxy Vote Outcomes
- OS Therapies' lead clinical program, OST-HER2, for Osteosarcoma, has demonstrated positive Phase 2b data, reporting a 12-month Event Free Survival of 35% and 2-year Overall Survival of 75% in the treated group. The company aims for FDA Accelerated Approval by Q2/Q3 2026.
- Key regulatory milestones for OST-HER2 in human osteosarcoma include UK MHRA MAA Filing in December 2025, US FDA BLA Filing in January 2026, and EMA MAA Filing in Q1/2026.
- As of October 2025, the company holds approximately $4 million in cash with a monthly cash burn of $300K. The estimated market opportunity for OST-HER2 in human osteosarcoma is $500 million+, with an anticipated $160 million from the sale of a Priority Review Voucher upon FDA Accelerated Approval.
- The 2025 annual meeting of stockholders, initially held on October 14, 2025, was adjourned and will reconvene on October 21, 2025, to allow for additional proxy solicitation.
Oct 17, 2025, 9:06 PM
OS Therapies Completes Warrant Inducement and Exchange Offer
OSTX
New Projects/Investments
Guidance Update
- OS Therapies Inc. completed a warrant inducement and exchange offer on September 2, 2025, generating approximately $3.7 million in gross proceeds.
- The proceeds will primarily fund the acceleration of OST-HER2 commercial launch preparations in the United States, extending the company's funding into 2027.
- The transaction involved issuing new warrants with a $3.00 per share exercise price and a forced exercise provision at $9.00, which could yield over $20 million in additional funding if triggered.
- This strategic move is expected to bring forward the potential commercialization of OST-HER2 in the US into early 2026, pending FDA regulatory approval.
Sep 2, 2025, 8:28 PM
OS Therapies Terminates Equity Line of Credit
OSTX
Guidance Update
- OS Therapies Inc. terminated its Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund, LLC — Series 3, effective August 26, 2025.
- The ELOC previously provided the company with the right to sell up to $15.0 million of its common stock.
- The termination was prompted by a recent warrant exercise inducement and exchange offering that provided OS Therapies with $4.2 million in gross proceeds.
- These proceeds are expected to fund the company's operations into mid-year 2026, extending through the priority review voucher sunset date of September 30, 2026.
- No outstanding borrowings, advance notices, shares to be issued, or termination fees were due by either party in connection with the termination.
Aug 26, 2025, 12:00 AM
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