Jan. 29 at 6:55 PM
OS Therapies (NYSE-A:
$OSTX) has expanded its immuno-oncology pipeline with the acquisition of all Listeria monocytogenes-based immunotherapy programs from Ayala Pharmaceuticals (OTC:
$ADXS), adding a Phase 2-ready non-small cell lung cancer (NSCLC) and Phase 1-ready prostate cancer program to its portfolio. OS Therapies is a B2i Digital Featured Company. See their profile and learn more about OS Therapies at https://b2idigital.com/os-therapies-1.
OS Therapies anticipates requesting Biologics Licensing Authorization (BLA) for OST-HER2 in osteosarcoma in Q2 2025, with the potential to receive FDA approval and a Priority Review Voucher (PRV) by year-end. The company intends to sell the PRV upon issuance.
Highlights from the announcement include:
- Consolidates ownership of Listeria monocytogenes-based immunotherapy IP.
- Eliminates milestone payments and reduces future royalty obligations relating to OST-HER2 for osteosarcoma and other HER2-related indications.
- Capital allocation focus remains on regulatory approval, priority review voucher (PRV) issuance, and commercialization of OST-HER2 in osteosarcoma.
- Previously disclosed
$7.1M funding for OS therapies priced at
$4.00/share provides cash runway into 2026 and precludes raises below
$12.00 for 6 months.
- Karim Galzahr was appointed to OS Therapies Board of Directors.
Reflecting on the significance of the acquisition, CEO Paul Romness stated: “The assets being acquired from Ayala complete OS Therapies’ ownership of the key intellectual property underlying our Listeria monocytogenes immunotherapy platform while also bolstering our development pipeline with clinical-stage lung cancer and prostate cancer immunotherapy assets. Importantly, this agreement eliminates certain near-term milestone payment obligations related to OST-HER2 in osteosarcoma, projected sales milestone payments, and significantly reduces our effective royalty rate. Taken together, this agreement fortifies our financial and partnership prospects.”
See the full announcement at https://ir.ostherapies.com/news-events/press-releases/detail/42/os-therapies-agrees-to-acquire-all-listeria.
OS Therapies is committed to developing innovative immunotherapies and advanced drug technologies to address hard-to-treat cancers. The company is advancing its “Tunable ADC” technology platform, which aims to transform cancer care by precisely targeting tumors with customizable therapies. Led by CEO Paul Romness and a highly experienced executive team, including Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers.
For investor-related questions, please visit OS Therapies’ Investor Relations page or email
[email protected].