Clinical-stage biotechnology company OS Therapies Inc (NYSE-A:OSTX) announced on Thursday that it has established OS Animal Health Inc, a wholly owned subsidiary focused on commercialising OST-HER2 for the treatment of canine osteosarcoma.

This move targets a market opportunity exceeding USD150m, with the subsidiary operating independently and funded separately from the parent company.

OST-HER2, an off-the-shelf immunotherapy, has shown positive results in both canine and human paediatric osteosarcoma. OS Animal Health is preparing a new USDA conditional approval submission in the second half of 2025, supported by updated commercial manufacturing data and recent clinical outcomes, including amputation prevention and metastatic control.

More than 40,000 dogs in the United States are affected by osteosarcoma each year.

OS Therapies has secured a new patent extending protection of its listeria immunotherapy platform, including OST-HER2, through 2040.

The parent company is separately advancing OST-HER2 in paediatric osteosarcoma with a planned FDA Accelerated Approval submission in Q3 2025. If approved before 30 September 2026, the programme may qualify for a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale, in May 2025, was valued at USD155m.

OS Animal Health is expected to begin generating revenue as early as 2025.