Jun. 24 at 9:34 PM
OS Therapies (NYSE-A:
$OSTX) announced two developments: positive FDA feedback on its regulatory pathway for OST-HER2 and a warrant exercise offer that could provide up to
$8 million in funding.
OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1.
The clinical-stage oncology company develops immunotherapies and antibody drug conjugates for osteosarcoma and other solid tumors. According to a company press release, the FDA provided feedback on the company’s Type D meeting regarding statistical methods and external control comparators for its Phase 2b trial, which supports its planned BLA submission approach.
“We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2,” said Dr. Robert Petitt, Chief Medical & Scientific Officer of OS Therapies. “Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program.” Additional Phase 2b data will be presented at the MIB Factor conference on June 28, 2025.
The FDA feedback follows OS Therapies’ ongoing regulatory progression for OST-HER2, a Listeria-based immunotherapy targeting HER2-positive cancers in pediatric osteosarcoma patients. The company has requested an End-of-Phase 2 meeting, expected in Q3 2025, and submitted a Breakthrough Therapy Designation request.
Separately, OS Therapies announced a warrant exercise inducement offer with
$1.76 million already received, extending cash runway into the second half of 2026.
Read both releases at: https://ir.ostherapies.com/news-events/press-releases/detail/66/os-therapies-receives-positive-fda-meeting-feedback-on and https://ir.ostherapies.com/news-events/press-releases/detail/65/os-therapies-announces-warrant-exercise-inducement
In addition to the company’s news, D. Boral Capital issued a research report today on OS Therapies with a Buy rating and a
$20.00 price target. Analyst Jason Kolbert highlighted the regulatory validation and potential for accelerated approval pathway. The D. Boral Capital research represents an analyst’s independent opinion and should not be considered investment advice.
Led by CEO Paul Romness and an experienced executive team that includes 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 see OS Therapies’ Investor Relations page or email
[email protected].
DISCLOSURE: As of June 24, 2025, the management of B2i Digital owns unrestricted shares of OSTX stock purchased in the open market. This post is not intended to solicit the sale of OSTX or any security, and it is not intended to offer any opinion on OSTX as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the full disclosure in the Risks and Disclosures section of https://b2idigital.com/os-therapies-1.
