OS THERAPIES INCORPORATED Stock Price, News & Analysis

OS Therapies (NYSE-A: OSTX) has scheduled a Scientific Advice Meeting with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in Q3 2025 to discuss the Innovative Licensing and Access Pathway for its OST-HER2 immunotherapy. This therapy aims to prevent metastases recurrence in osteosarcoma patients.

The company reported positive Phase 2b data in January 2025, showing statistically significant results in the primary endpoint of 12-month event-free survival. The meeting positions OS Therapies to potentially launch OST-HER2 in the UK market in 2025.

As a UK reference country approval could facilitate approvals in multiple nations including Australia, Canada, and several European countries. The treatment has already received Fast Track and Orphan Drug designations from the European Medicines Agency.

Calidi Biotherapeutics (NYSE:CLDI) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on March 1, 2025, at 7 p.m. ET. During the interview, CFO Andrew Jackson discusses the company's oncolytic virotherapy (OV) platforms for cancer treatment.

The company's technology utilizes stem cells to protect, amplify, and enhance oncolytic viruses for targeting cancer cells. Their pipeline includes CLD-101, currently in Phase 1/1b trials with upcoming Phase 1b/2 study, and CLD-201 targeting Phase 1 initiation in 2025. The company estimates its addressable U.S. market at $13-15 billion.

OS Therapies (OSTX) announces an exclusive live investor webinar scheduled for February 27, 2025, at 4:15 p.m. ET. The event will feature presentations from CEO Paul Romness and CBO Gerald Commissiong, focusing on the company's pipeline developments.

The company's lead candidate, OST-HER2, has shown significant improvements in 12-month event-free survival for recurrent, fully resected metastatic osteosarcoma, positioning it for potential accelerated FDA approval. Their proprietary Tunable Antibody Drug Conjugate (tADC) platform, featuring SiLinker™ technology, has demonstrated preclinical efficacy in ovarian and HER2-positive cancers.

The company highlights potential value drivers including upcoming clinical and regulatory milestones, licensing agreement revenues, and a possible Priority Review Voucher valued at approximately $150 million.

OS Therapies (NYSE-A: OSTX) announced positive results from their Phase 2b clinical trial of OST-HER2, a HER2-targeted immunotherapy for recurrent osteosarcoma with lung metastases. The study demonstrated statistically significant results in the primary endpoint, with 33.3% 12-month Event Free Survival (EFS) compared to 20% historical control (p=0.0158).

The trial included 39 evaluable patients aged 12-39 years across 21 centers, receiving 16 doses over 48 weeks. Interim analysis showed promising overall survival rates, with 91% 1-year survival and 61% 2-year survival compared to historical controls of 80% and 40% respectively. Notably, all patients achieving 12-month EFS remain alive.

Subgroup analyses revealed higher EFS rates in females (47%) versus males (20%), and in patients with multiple lung resections (55%) versus single resection (25%). The company is preparing to engage with FDA for an accelerated approval pathway, as there are currently no approved treatments for this indication.

OS Therapies (NYSE-A: OSTX) has announced the formation of a new subsidiary, OS Drug Conjugates (OSDC), alongside strategic initiatives to leverage its patented silicone dioxide-based, pH-sensitive tunable antibody drug conjugates (tADC) and drug conjugates (tDC) platforms. The company is pursuing discussions with clinical-stage ADC therapeutics companies across the U.S. and China to establish joint ventures, with plans to spin these JVs into standalone public companies.

The company's proprietary technology utilizes SiLinkers™, pH-sensitive silicon-based linkers that connect targeting antibodies with therapeutic agents. This system is designed to release therapeutic agents specifically within tumors and their microenvironment, where pH levels are lower, maximizing treatment effectiveness while reducing harm to healthy cells.

According to BCC Research, the global antibody-drug conjugates market is projected to grow from $10.8 billion in 2023 to $47.0 billion by 2029, representing a CAGR of 28.4%.

OS Therapies (NYSE-A: OSTX) received a USPTO Notice of Allowance for a patent covering OST-HER2 commercial manufacturing methods, with market exclusivity extended into 2040. The company is preparing for FDA discussions following its Phase 2b clinical trial in osteosarcoma, aiming for BLA submission and potential FDA approval in 2025.

The company completed a $7.1 million financing in January 2025, providing capital into mid-2026. OST-HER2 holds rare pediatric disease, fast-track, and orphan drug designations. Phase 1 trials in HER2-expressing cancers showed promising results, including a 78% reduction in tumor size in breast cancer models and 65% reduction in metastatic cells.

The company targets the osteosarcoma market, estimated at $1.2 billion in 2022, with an expected $500 million opportunity for OST-HER2. The breast cancer market, valued at $29.2 billion in 2023, presents an additional $1 billion opportunity.

OS Therapies (NYSE-A: OSTX) has announced steps toward commercial manufacturing of OST-HER2, marking progress in its development of cancer immunotherapies. The company has secured agreements for commercial manufacturing as it prepares for a potential Biologics Licensing Authorization (BLA) submission to the FDA.

The announcement follows the completion of a Phase 2b trial testing OST-HER2 for preventing lung metastatic osteosarcoma recurrence. The company is currently organizing trial data for an upcoming Type B or Type C meeting with the FDA, after which it plans to submit a BLA application for accelerated or conditional approval consideration.

OS Therapies (NYSE-A: OSTX) provided a corporate update highlighting significant developments. The company completed a $7.1M financing round in January 2025, following a $6M IPO in August 2024, securing funding through mid-2026. Their Phase 2b trial of OST-HER2 for osteosarcoma met its primary endpoint with 33% responder rate vs 20% in control group, showing improved survival rates at 12 and 24 months.

The company acquired assets from Ayala, reducing future milestone payments and royalty rates from 10% to 1.5%. This acquisition includes rights to two Listeria-based immunotherapy candidates for lung and prostate cancer. OS Therapies is targeting FDA approval by late 2025, which could qualify for a Priority Review Voucher worth approximately $150M in non-dilutive capital.

OS Therapies (NYSE-A: OSTX) has entered into an asset purchase agreement to acquire listeria monocytogenes-based immuno-oncology programs and IP assets from Ayala Pharmaceuticals. The acquisition includes a Phase 2 lung cancer and Phase 1 prostate cancer program, along with direct ownership of IP related to OST-HER2 for osteosarcoma.

The deal, valued at $0.5 million in cash and $7.5 million in OSTX shares, eliminates milestone payments and reduces royalty obligations for OST-HER2. The company recently secured $7.1 million in financing at $4.00 per share, providing cash runway into 2026. The monthly burn rate is approximately $0.4M.

OS Therapies plans to request BLA for OST-HER2 in osteosarcoma in Q2 2025, with potential approval and Priority Review Voucher by end of 2025. The company is prohibited from issuing shares for 6 months and suspended equity line usage below $12.00 per share.