Stonegate Capital Partners Revises Coverage for OS Therapies Inc. (OSTX) in Q3 2025
Clinical Milestones: OS Therapies Inc. reported a 75% two-year overall survival (OS) rate for its OST-HER2 treatment in a Phase 2b trial, significantly outperforming historical controls at 40%.
Regulatory Progress: The company is on track for U.S. and U.K. regulatory filings, with submissions to the FDA and UK MHRA expected by early 2026, supported by positive trial results.
Spinoff Announcement: OS Therapies plans to spin off its OS Animal Health division into a standalone public company in the first half of 2026, allowing shareholders to receive direct equity in the new entity.
Financial Overview: The company ended the quarter with approximately $1.9 million in cash and a net loss of $6.9 million, but secured $7.8 million in warrant proceeds post-quarter, extending its financial runway into late 2026.
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OS Therapies (OSTX) Reports Positive OST-HER2 Data but Shares Drop 4.52%
- Clinical Trial Progress: OS Therapies' Phase 2b trial of OST-HER2 revealed that immune blood biomarkers in the interferon gamma pathway effectively distinguish long-term from short-term survivors, bolstering their Biologics License Application (BLA) submission.
- Regulatory Approval Path: The company plans to submit its BLA to the FDA by Q2 2026, with regulatory approvals anticipated in the UK, US, and Europe by the end of 2026, indicating strong potential for market entry.
- Poor Stock Performance: Despite positive clinical data, OSTX shares fell 4.52% to $1.48, trading 2.5% below the 20-day and 12.8% below the 50-day simple moving averages, reflecting market caution regarding future performance.
- Mixed Market Signals: The current RSI of 47.78 suggests neutral territory, while the MACD indicates a potential bullish signal, reflecting complex market sentiment towards OSTX, necessitating investor vigilance.

Oncolytics Biotech Appoints New Executives to Accelerate Cancer Treatment Progress
- Market Potential: The global immuno-oncology market is projected to surge from $35 billion to $185.69 billion, reflecting strong demand for coordinated immune system activation, attracting capital influx and driving the precision medicine market to $537.17 billion.
- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy, which will enhance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: Pelareorep achieved a 29% objective response rate in third-line treatment, nearly tripling historical benchmarks, with a median duration of response reaching 17 months, indicating potential for accelerated approval in a setting with no FDA-approved options.
- FDA Design Approval: Oncolytics secured FDA alignment on its Phase 3 study design for first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease, further solidifying its leadership in the oncology immunotherapy space.






