Welcome to our dedicated page for OS THERAPIES INCORPORATED news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES INCORPORATED stock.
OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage oncology and biopharmaceutical company focused on osteosarcoma and other solid tumors. News about OS Therapies centers on its listeria-based cancer immunotherapy programs, regulatory interactions, capital markets activity, and the planned spin-off of its veterinary oncology subsidiary, OS Animal Health.
A major theme in OSTX news flow is the progress of OST-HER2 (daznelene lisbac), the company’s lead listeria-based immunotherapy targeting the HER2 protein. Press releases highlight positive Phase 2b data in recurrent, fully resected, pulmonary metastatic osteosarcoma, including statistically significant benefit in 12-month event free survival and reported 2-year overall survival outcomes. The company also reports immune biomarker analyses from its human metastatic osteosarcoma trial and related canine osteosarcoma studies, emphasizing the role of Comparative Oncology and interferon gamma pathway biomarkers as potential surrogate markers of clinical efficacy.
Investors following OSTX news will see regular updates on regulatory milestones, such as FDA Type C and other meetings, waiver of the BLA application fee for OST-HER2, EMA Union Marketing Authorisation eligibility, and preparations for Biologics License Application and Marketing Authorisation Application submissions in the United States, United Kingdom, and European Union. Company outlook releases describe anticipated timelines for regulatory submissions, potential conditional approvals, and planned interactions with FDA, MHRA, and EMA.
OS Therapies also issues news on capital raising and corporate transactions, including warrant exercise inducement agreements, gross proceeds from warrant exercises, and the intended use of proceeds to fund OST-HER2 regulatory and commercial preparation activities and the proposed OS Animal Health spin-off. Additional news items cover the veterinary oncology strategy for canine osteosarcoma, recognition of OST-HER2 in documentaries and awards, and the development of the company’s tunable ADC (tADC) platform.
For readers tracking OSTX, this news feed provides a consolidated view of clinical trial updates, biomarker findings, regulatory developments, financing events, and the evolution of both the human and animal health franchises. Regular visits can help investors and observers monitor how OS Therapies advances OST-HER2 and its broader oncology pipeline through key clinical and regulatory inflection points.
OS Therapies (NYSE American: OSTX), a clinical-stage biopharmaceutical company, has been accepted into Johnson & Johnson Innovation – JLABS. The company aims to develop its tunable Antibody Drug Conjugate (ADC) linker-based platform at JLABS. This platform uses pH sensitive linkers & coating technology to reduce off-target effects, potentially improving safety and increasing the diversity of therapeutic payloads delivered.
OS Therapies' goal is to offer improved efficacy compared to other ADCs in the market or in development. The company's unique linker platform allows for the creation of new intellectual property for both novel and off-patent targeting antibodies and drug payloads. This development could potentially lead to more effective and safer ADC-based therapies in the future.
OS Therapies (NYSE American: OSTX) reported Q2 2024 financial results, highlighting a successful IPO on July 31, 2024, raising $6.4 million without issuing warrants. The company converted all outstanding preferred shares and debt into equity, resulting in 20.85 million common shares outstanding post-IPO. Key points include:
1. Cash runway extended into mid-2025
2. $1.557 million net operating loss in Q2 2024, down from $2.505 million in Q2 2023
3. Net loss per share of $0.26 on 5.991 million weighted average shares
4. Fully enrolled Phase 2b clinical trial for OST-HER2 in osteosarcoma, with results expected in Q4 2024
5. Positive safety data from Phase 1 study of OST-HER2 in breast cancer
RedChip Companies will air interviews with OS Therapies Inc. (NYSE American:OSTX) and Can-Fite BioPharma on Bloomberg TV on August 10, 2024, at 7 p.m. ET. Paul Romness, Chairman and CEO of OS Therapies, will provide a corporate update on the company's novel treatments for Osteosarcoma and other solid tumors. OS Therapies' product candidates, OST-HER2 and OST-tADC, aim to address gaps in pediatric and young adult cancer care. The company is approaching significant clinical milestones and potential revenue streams, including out-licensing deals and a priority review voucher valued at $100-110M.
OS Therapies (NYSE American:OSTX) has announced its Scientific and Medical Advisory Board (SMAB) for osteosarcoma, consisting of experts from six US institutions. The SMAB will assist in FDA engagement regarding OST-HER2, the company's lead immunotherapy product candidate. OST-HER2, an innovative HER2-targeted Listeria-based immunotherapy, is designed to combat osteosarcoma by triggering immune responses against HER2-expressing cancer cells.
The company has fully enrolled a Phase IIb clinical trial with 41 patients across 21 US sites, reporting positive interim data in June 2024. Topline data is expected in Q4 2024. OST-HER2 has received multiple FDA designations, including Rare Pediatric Disease, Fast Track, and Orphan Drug. OS Therapies is pursuing Breakthrough Therapy Designation and plans to expand into breast cancer treatment post-FDA approval for osteosarcoma.
OS Therapies (NYSE-A: OSTX) has formed a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program. The PAAB will represent the osteosarcoma community in discussions with the FDA regarding potential Biologics License Authorization for OST-HER2, the company's immunotherapeutic product candidate. The board includes representatives from various osteosarcoma organizations and patients.
OST-HER2 is an innovative immunotherapy using a HER2 bioengineered form of Listeria monocytogenes to trigger an immune response against HER2-expressing cancer cells. A Phase IIb clinical trial for recurred, resected osteosarcoma has been fully enrolled with 41 patients across 21 US sites. Positive interim data was reported in June 2024, with topline data expected in Q4 2024.
OST-HER2 has received Rare Pediatric Disease, Fast Track, and Orphan Drug Designations from the FDA and EMA. OS Therapies is seeking Breakthrough Therapy Designation based on Phase IIb trial data. The company plans to pursue therapeutic development in breast cancer following FDA approval for osteosarcoma.
OS Therapies (NYSE-A: OSTX) has announced the pricing of its initial public offering of 1,600,000 shares at $4.00 per share, raising $6.4 million in gross proceeds. The company plans to use the funds to advance its clinical development of OST-HER2 and OST-tADC, two innovative cancer treatments. OST-HER2, their lead product, is in a Phase IIb trial for osteosarcoma with topline data expected in Q4 2024. It has received Rare Pediatric Disease, Fast Track, and Orphan Drug Designations from the FDA and EMA. OST-tADC is a next-generation Antibody Drug Conjugate platform. Trading under the symbol OSTX on the NYSE American is set to begin on August 1, 2024, with the offering closing on August 2, 2024.
OS Therapies (NYSE-A: OSTX) has announced positive safety data from a Phase 1 clinical trial of OST-HER2 in HER2-expressing solid tumors, primarily breast cancer. The trial involved 12 patients, with 10 having breast cancer. The dose selected for the ongoing Phase 2b trial in Osteosarcoma was well-tolerated in breast cancer patients.
Additionally, preclinical efficacy data showed promising results in breast cancer models, including:
- 78% reduction in tumor size
- 33% prevention of breast cancer
- 20% reduction in tumor size when combined with HER2-targeted antibodies
- 65% reduction in metastatic cells in brain metastasis models
OST-HER2 has received Rare Pediatric Disease, Orphan Drug, and Fast Track Designations from the FDA for Osteosarcoma. The company is currently in discussions with the FDA regarding a Breakthrough Therapy designation application based on interim results from their Phase 2b trial.
OS Therapies (NYSE-A: OSTX) announced a positive update from its Phase 2b clinical trial for the immunotherapy OST-HER2 in resected, recurrent osteosarcoma patients. The trial achieved a 1-year event-free survival (EFS) rate of 32.5%, significantly higher than the 20% EFS rate for an unsuccessful comparator. The 1-year and 18-month overall survival (OS) rates were both 90.4%. Importantly, no grade 3, 4, or 5 treatment-related adverse events were reported among the 41 patients. Full enrollment is complete, with primary 12-month EFS and interim 12-month OS data expected by Q4 2024. OST-HER2 aims to prevent metastasis and recurrence while enhancing overall survival.