Rest of 2025 Rich With Catalysts for Immunotherapy Co.
Research Report

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Disclosures for D. Boral Capital, OS Therapies Inc., April 7, 2025:

Analyst Certification: I, Jason Kolbert, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed in this research report.

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OS Therapies Inc. (OSTX:NYSEAMERICAN) has a series of "meaningful milestones" ahead this year, reported D. Boral Capital Analyst Jason Kolbert in an April 7 research note.

"These regulatory and clinical milestones represent critical opportunities to advance the  company's lead immunotherapy candidate toward commercialization and to strengthen its position in rare pediatric oncology," Kolbert wrote.

1,329% Gain Possible

D. Boral has a US$20 per share target price on OS Therapies, now trading at about US$1.40 per share. The difference between these prices implies a potential return for investors of 1,329%.

The immunotherapy company is a Buy.

Its market cap is US$30 million (US$30M). Its 52-week range is US$1.41–7 per share.

Catalysts on the Horizon

Most recently, reported Kolbert, OS Therapies requested a formal meeting with the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research to finalize clinical endpoints and statistical methodology required for OST-HER2 to be granted breakthrough therapy designation and accelerated approval. This investigational immunotherapy is intended to prevent recurrence in fully resected, lung-only metastatic osteosarcoma. The oncology company anticipates that this meeting will happen sometime this quarter.

In June, OS Therapies is scheduled to present comprehensive data from the OST-HER2 Phase 2b osteosarcoma trial at the MIB Factor conference, in conjunction with matched, synthetic control arm data generated through the OST-400 retrospective study.

"This data package is expected to support the company's resubmission for breakthrough therapy designation," noted Kolbert.

The analyst reiterated that, as announced in January, the Phase 2b OST-HER2 trial achieved its primary endpoint. It showed a 12-month, event-free survival rate of 33% in treated patients compared to 20% in historical controls (p=0.0158). Further, interim analysis showed a favorable trend in overall survival at one year and two years.

"These results suggest a meaningful clinical benefit in preventing recurrence of lung metastatic osteosarcoma," commented Kolbert.

Subsequent Milestones

Shortly after the meeting and depending on the feedback received, OS Therapies would start a rolling biologics license application submission, aiming to get accelerated approval of OST-HER2 by 2025E.

"Upon potential approval, the company anticipates being awarded a priority review voucher, which it plans to monetize to fund further development of OST-HER2 and its broader pipeline," Kolbert wrote.

Separately, OS Therapies scheduled a scientific advice meeting with the United Kingdom's Medicines and Healthcare products Regulatory Agency in Q3/25 to discuss advancing OST-HER2 in international markets.

Kolbert pointed out that the immunotherapy firm has sufficient cash, $2M on last report, to operate into mid-2026 and see OST-HER2 through the regulatory process.