Nov. 17 at 11:33 AM
$OSTX What’s New or Clarified Compared to the 10-Q
Regulatory Timeline Details
Confirms FDA Type C meeting (Dec 11) and UK MHRA pre-MAA meeting (Dec 8).
Adds EMA pre-MAA meeting request granted (not in the earlier summary).
Explicitly states BLA and UK MAA filings expected January 2026, leveraging Project Orbis.
Pipeline Expansion
Mentions OST-504 Phase 1b prostate cancer program and intent to seek FDA Platform Designation—forward-looking beyond OST-HER2.
Financing update
Confirms
$7.8M warrant exercise funded regulatory payments and extends runway into late 2026.
Notes
$1.5M received post-period, clarifying liquidity beyond the
$1.9M reported at quarter-end.
Explains termination of equity line and replacement with ATM program, signaling a shift in financing strategy.
Clinical Data Emphasis
Reiterates 2-year OS benefit (75% vs 40%, p < 0.0001) but adds subgroup analyses (presentation survival rates).
Highlights biomarker data forthcoming for December meetings—critical for regulatory alignment.
