OS Therapies Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
5analysts covering
FY EPS (est.)
-$0.78next fiscal year
Monitoring Framework
Key Performance Indicators
OST-HER2 Phase 2b Overall Survival (OS) Rate Annually75.0%Target: 47 (Historical Control)%
OST-HER2 Phase 2b Event-Free Survival (EFS) Rate at 12 Months Annually33.0%Target: 20 (Historical Control)%
Watch Items
- FDA Biologics License Application (BLA) Submission and Accelerated ApprovalTrigger: FDA decision on Accelerated Approval and potential Priority Review Voucher (PRV) eligibilityAction: Monitor regulatory feedback, Type D meeting outcomes, and clinical module submission timelines.
- Confirmatory Phase 3 Clinical Trial InitiationTrigger: Trial commencement in Australia (expected late Q3 2026)Action: Track patient enrollment, site activation, and alignment with global regulatory agencies (FDA, EMA, MHRA, TGA).
- Cash Runway and Going Concern StatusTrigger: Cash reserves falling below operational requirements for the next 12 monthsAction: Evaluate capital-raising activities, including registered direct offerings, warrant exercises, and non-dilutive VAT/R&D tax refunds.
Research as of 19 Jun 2026