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 $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 $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 $68 million. Its 52-week range is $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 into Q1/26, "which may unlock conditional marketing authorizations and expedite commercialization," wrote Kolbert. The first will be 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 pursuit of funding efforts and/or formation of partnerships.
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