New Research on OS Therapies Inc. (NYSE American: OSTX)

A new Executive Informational Overview is now available on OS Therapies Inc. (NYSE American: OSTX), a clinical-stage cancer immunotherapy company developing treatments for osteosarcoma and other solid tumors. Its lead program, OST-HER2, targets HER2-expressing cancers and has shown positive Phase 2b results in lung-metastatic osteosarcoma, alongside a broader pipeline built on two proprietary platforms. This 62-page report explores OS Therapies' business model, growth strategy, market opportunity, competitive landscape, and key risks. Download the full report below.

Snapshot

OS Therapies Inc. (“OS Therapies” or “the Company”) is a clinical-stage cancer immunotherapy company focused on discovering, developing, and commercializing treatments for osteosarcoma and other solid tumors. The Company has built a diversified pipeline around two novel technology platforms: OST-Lm, a bioengineered form of Listeria monocytogenes designed to drive robust immune responses against HER2-expressing cancer cells; and OST-tADC, a next-generation tunable antibody-drug conjugate platform. The lead OST-Lm program, OST-HER2, is in clinical development for osteosarcoma and breast cancer and holds conditional approval for canine osteosarcoma. A Phase 2b clinical trial in resected lung-metastatic osteosarcoma has completed its treatment phase and has demonstrated statistically significant improvements in 12-month Event-Free Survival (EFS) (primary endpoint) and overall survival (OS) (secondary endpoint), with a favorable safety profile. OS Therapies’ pipeline also includes multiple mid- and early-stage assets—OST-AXAL (HPV-related cancers), OST-503 (NSCLC and glioblastoma), and OST-504/PSA (prostate cancer)—along with additional preclinical programs targeting more than 30 solid tumor types. OS Therapies is also advancing its proprietary OST-tADC platform, currently in pre-clinical development. The Company is initially assessing the use of this platform on ovarian and breast cancer. The Company established a subsidiary, OS Drug Conjugates, to develop the OST-tADC platform internally and pursue licensing and partnership opportunities.

Key Points of OS Therapies Inc.  

• OST-HER2 received the FDA’s rare pediatric disease designation (RPDD), together with orphan drug and fast track designations from the FDA and the EMA for its osteosarcoma program. Its RPDD makes it eligible for a Priority Review Voucher (PRV), which the Company plans to sell. 
  
  
• OST-HER2’s Phase 2b osteosarcoma trial met its primary endpoint, achieving a 35% 12-month EFS rate versus roughly 20% in historical controls. Interim two-year assessments of the secondary endpoint (three-year OS) were also positive, with 75% of patients still alive versus about 40% in historical controls.
  
  
• OS Therapies intends to submit a Biologics License Application (BLA) for OST-HER2 in osteosarcoma by the end of January 2026, aiming for FDA Accelerated Approval in Q3 2026. The Company intends to submit for conditional Marketing Authorization Application (MAA) to the UK’s MHRA (end of January 2026) and the EMA (end of February 2026).
  
  
• OS Therapies formed OS Animal Health, Inc., focused on OST-HER2 for canine osteosarcoma. The Company aims to file documentation for a ‘go-public’ transaction in January 2026.
  
  
• On August 7, 2025, the Company announced that its NYSE listing was included in the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes. 
  
  
• As of September 30, 2025, OS Therapies held $1.876 million in cash, and received an additional $1.5 million after quarter-end, primarily from the previously announced warrant exercise inducement and exchange offer.

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