OSTX: OSTX says regulators aligned on OST-HER2 path; Phase 3 to start late Q3 2026 and FDA Type B meeting expected on 3-year OS use

AI Summary

OS Therapies (OSTX) said EMA, MHRA and TGA are aligned on requirements to support Conditional Marketing Authorisations for OST-HER2 and that a confirmatory Phase 3 will start in late Q3 2026 in Australia using the same drug-product batch as Phase 2b. The company has submitted non-clinical and clinical BLA modules to FDA, is awaiting a Type B Statistical Methods meeting to agree on using 3-year overall survival plus biomarkers for early U.S. approval, and secured a $10M VAT/R&D-backed line of credit that it says supports operations into 2027.

Positives

EMA, MHRA and TGA aligned on CMAA requirements and accept 3-year overall survival plus biomarker data as a basis for early market access (EMA provided a Sept 30, 2026 CMAA submission window).
Confirmatory Phase 3 expected to initiate in late Q3 2026 in Australia; regulators agreed the Phase 3 may use the same OST-HER2 drug-product batch used in Phase 2b/expanded access.
$10 million VAT/R&D-backed line of credit in place and company states it has sufficient cash/resources to continue operations into 2027.

Negatives

Conditional approvals and U.S. accelerated approval remain contingent on completing the confirmatory Phase 3 and obtaining 3-year overall survival data, so approvals are not guaranteed.
Key regulatory items remain outstanding — a Type B Statistical Methods meeting and completion/acceptance of Pediatric Investigation Plans — creating timing uncertainty.
Line of credit draws must be repaid within nine months and the company currently relies on VAT/R&D credits and future accruals, indicating constrained near-term liquidity.