OS Therapies to acquire listeria programs from Ayala Pharmaceuticals

OS Therapies (OSTX) announced it has entered into an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property assets from Ayala Pharmaceuticals (ADXS). The assets being acquired include a Phase 2 lung cancer and Phase1 prostate cancer program, in addition to the gaining direct ownership of the underlying IP related to OS Therapies’ lead asset OST-HER2 for osteosarcoma and other HER2-related indications. OS Therapies anticipates requesting biologics licensing authorization for OST-HER2 in osteosarcoma in the second quarter of 2025, and hopes to be granted a BLA and related priority review voucher from FDA by the end of 2025. Additionally, the company intends to sell the PRV immediately upon issuance and does not intend to initiate any new clinical development programs until it has completed interactions with FDA around OST-HER2 in osteosarcoma. Under the terms of the agreement, OS Therapies has agreed to pay $500,000 in cash and issue $7.5M worth of OS Therapies’ common shares to Ayala. The transaction is expected to close 60 days from execution of the agreement, subject to customary closing conditions. OS Therapies previously disclosed that it completed a $7.1M financing, priced at $4.00 per share primarily with existing shareholders, that provides the company with sufficient cash runway into 2026 inclusive of payments to Ayala. Under the terms of the financing agreement, OS Therapies is prohibited from issuing shares to raise capital for at least six months and suspended the issuance of shares to raise capital under its equity line of credit so long as the price of the common stock is below $12.00. The company’s burn rate is now approximately $400,000 per month. As part of the financing agreement, OS Therapies agreed to appoint Karim Galzahr to the company’s board of directors. Galzahr is managing partner at OKG Capital, a medtech and life science investor.