OS Therapies (OSTX) Corporate presentation summary

Investment highlights and market opportunity

• Over $300M invested in listeria platform, with assets acquired in April 2025.

• Lead program OST-HER2 targets ultra-orphan osteosarcoma, with follow-on applications in breast and other solid tumors.

• Total addressable market for assets and follow-ons is $258B, with $1.2B for human osteosarcoma and $35B for breast cancer.

• Expected US topline revenue for OST-HER2 in osteosarcoma exceeds $500M.

• Market cap is $60M, with cash on hand into mid-2026 and monthly cash burn of $300K.

Clinical pipeline and milestones

• OST-HER2 has positive Phase 2b data in osteosarcoma, targeting accelerated approval in Q2–Q3 2026.

• Orphan, Fast Track, and Rare Pediatric Disease designations granted by FDA and EMA.

• Canine osteosarcoma program achieved USDA conditional approval, with full approval path pending.

• Additional pipeline includes HPV cancers, NSCLC, glioblastoma, prostate, and breast cancer programs.

• Multiple near-term regulatory milestones with FDA, MHRA, and EMA filings planned for late 2025 to early 2026.

Clinical data and efficacy

• OST-HER2 Phase 2b trial in recurrent, resected metastatic osteosarcoma showed 35% 12-month event-free survival vs. 20% in historical controls (p=0.0196).

• Two-year overall survival was 75% vs. 40% in controls (p<0.0001).

• Subgroup analysis showed higher efficacy in females and patients with multiple resections.

• Canine studies demonstrated improved survival and immune response with OST-HER2.

• Breast cancer preclinical and Phase 1 data showed tumor regression and HER2-specific immune responses.