OS Therapies Q2 net loss $4.5M; FDA confirms RMAT, issues BLA number for OST-HER2, Phase 2b data positive

OS Therapies Inc

2025-Q2 EPS reported -$0.35

FDA confirmed OST-HER2 meets biological criteria for RMAT; issued BLA number for Accelerated Approval submission.
Phase 2b trial: 12-month EFS 35% vs 20% (p=0.0197), interim 2-year OS 66.6% vs 40% (p=0.0046).
Q2 2025 net loss $4.537M vs $1.557M YoY; EPS loss $0.19 on 25.1M shares vs $0.26 on 5.99M shares.
End of Phase 2 FDA meeting scheduled Aug 27, 2025; projected rolling BLA submission late Q3 2025.
$4.2M capital raise closed July 11; entered ATM offering up to $18M; commercial partner Eversana for possible 1H 2026 launch.

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