OS Therapies Inc. (OSTX:NYSEAMERICAN) released strong overall survival data for OST-HER2, its immunotherapy for pulmonary metastatic osteosarcoma, reported Jason Kolbert, analyst at D. Boral Capital, in an Oct. 10 research note.
"These results reinforce the therapeutic potential of OST-HER2 in preventing or delaying recurrence in this high-risk setting," Kolbert wrote.
880% Upside Potential
D. Boral reiterated its US$20 per share target price on the Maryland, U.S.-based immunotherapy company.
"We model osteosarcoma as the first indication but assume it's just the beginning," Kolbert noted.
OS Therapies was trading at the time of Kolbert's report at about US$2.04 per share. The difference between the target and share prices implies a potential return for investors of 880%.
The life sciences firm remains a Buy. Its market cap is US$68 million. Its 52-week range is US$1.12–7 per share.
Compelling Survival Rates
The positive survival data OS Therapies announced for OST-HER2 were from the nonrandomized Phase 2b trial in which safety and tolerability were acceptable, Kolbert wrote.
The new data reflect survival at two years of patients with fully resected pulmonary metastatic osteosarcoma.
In the treated cohort, 75% of patients, or 27 out of 36 evaluable patients, achieved two-year survival compared to 40% in historical controls (p < 0.0001). Of the patients who reached 12-month event-free survival, all of them went on to achieve two-year survival. Even among patients not achieving event-free survival, 59% reached two-year survival, subgroup analyses showed.
"The magnitude of overall survival improvement relative to historical control is compelling," Kolbert wrote.
According to OS Therapies, several regulatory agencies, specifically the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have hinted that overall survival may be the basis for conditional approval of OST-HER2, especially when combined with biomarker data.
Events on the Horizon
OS Therapies has two key potential catalysts ahead in the near term, noted Kolbert. Next month, the company plans to present biomarker correlation data that could increase the chances of OST-HER2 getting regulatory approval.
Subsequently, the company will submit a series of applications to various regulatory agencies in Q1/26, "which may unlock conditional marketing authorizations and expedite commercialization," wrote Kolbert. The first will be a conditional marketing authorization application to the MHRA in December 2025. Second will be a biologics license application to the FDA in January 2026. Third will be a marketing authorization application to the EMA later in Q1/26.
Other potential events to support OS Therapies' advancement of OST-HER2 include the pursuit of funding efforts and/or the formation of partnerships.
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Disclosures for D. Boral Capital, OS Therapies Inc., October 10, 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. Company-Specific Disclosures General Disclosures The information contained in Research Reports or other Research products produced by D. Boral Capital LLC is for informational purposes only and does not constitute solicitation of the sale or purchase of securities or other investments. The information in such products is derived from sources that are believed to be reliable. Prices, numbers, and similar data include past results, estimates, and forecasts, all of which may differ from actual data. These prices, numbers, and similar data may also change without prior notification. D. Boral Capital holds the copyright on this research report. Any unauthorized use or transmission of any part of this research report for any reason, whether by digital, mechanical, or any other means, is prohibited. If you have any questions, please contact your sales representative. Additional information is available upon request. Certain company names, product and/or service names that appear in this research report are trademarks or registered trademarks of D. Boral Capital or other companies mentioned in the report. Copyright 2025 D. Boral Capital LLC. D. Boral Capital rating definitions are expressed as the total return relative to the expected performance of S&P 500 over a 12-month period. BUY (B) - Total return expected to exceed S&P 500 by at least 10% HOLD (H) - Total return expected to be in-line with S&P 500 SELL (S) - Total return expected to underperform S&P 500 by at least 10%