Articles from OS Therapies, Inc.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah. Key data will be presented from the Company’s Phase 2b clinical trial of OST-HER2 in the prevention of recurrent, fully resected, lung metastatic osteosarcoma. This data will be compared with a newly created regulatorily compliant synthetic control group comprised of case matched controls that will be used for the Company’s US Food & Drug Administration (FDA) OST-HER2 Biologics License Application (BLA) submission. Equivalent submissions with international regulatory authorities will be made in order to gain commercial marketing authorization. MIB Agents FACTOR is the most important annual osteosarcoma conference bringing together the leading osteosarcoma researchers, clinicians, patient families, osteosarcoma survivors, patients, and bereaved parents to “Make It Better” (MIB) for those battling this deadly cancer.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has scheduled a Scientific Advice Meeting (SAM) in the third quarter of 2025 to discuss the Innovative Licensing and Access Pathway (ILAP) with the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for OST-HER2, its immunotherapy candidate for the prevention of recurrence of metastases in osteosarcoma. The Company released positive Phase 2b data in January 2025 that demonstrates statistically significant results in the primary endpoint of the study, 12-month event free survival (EFS). The meeting with MHRA has been scheduled to position the Company to bring OST-HER2 to market in the UK in 2025.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, announced the formation of subsidiary OS Drug Conjugates (OSDC). The formation of OSDC coincides with formal strategic options initiatives to create value from the Company’s leading-edge, patented silicone dioxide-based, pH sensitive tunable antibody drug conjugates (tADC) & other tunable drug conjugates (tDC) platforms. The Company has initiated discussions with clinical-stage ADC therapeutics companies in the U.S., China and other jurisdictions to form joint ventures (JVs) pairing those companies’ clinical-stage assets with certain assets from the tADC and/or tDC platforms and spinning the JVs into standalone public companies. If successful, OS Therapies intends to provide stock dividends of the public JVs to shareholders.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it received a Notice of Allowance from the United States Patent & Trademark Office (USPTO) that a patent will be issued covering the manufacturing methods required for the OST-HER2 commercial product. The USPTO granted a Patent Term Adjustment of 572 days, providing market exclusivity for the OST-HER2 commercial drug product into 2040. OS Therapies is preparing to initiate discussions with the United States Food & Drug Administration (FDA) following the successful treatment phase of its Phase 2b clinical trial in the prevention of recurrent, resected, lung metastatic osteosarcoma with a view towards submitting a Biologics Licensing Application (BLA) and gaining conditional or accelerated FDA approval in 2025. The Company recently completed a $7.1 million financing in January 2025 and has sufficient capital into mid-2026.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has entered into agreements for the commercial manufacture of OST-HER2. The Company is currently organizing additional data in relation to the recently-completed treatment phase of its Phase 2b trial of OST-HER2 in the prevention of recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C meeting with the US Food & Drug Administration (“FDA”). Following the FDA meeting, the Company anticipates that it will be submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today provided a corporate update to the marketplace to contextualize recent positive clinical data, corporate and financial developments.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced positive data from a Phase 2b clinical trial (NCT04974008) of OST-HER2 (OST31-164) - the Company’s HER2-targeted immunotherapy candidate in the rare pediatric-designated indication of prevention of recurrent, fully resected, lung metastatic osteosarcoma. The data demonstrate statistically significant results in the primary endpoint of the study, 12-month event free survival (‘EFS’), where an event is defined as the recurrence of metastatic osteosarcoma, in OST-HER2-treated patients when compared with the leading published historical comparable control group. Further as of the most recent follow up, the data show a strong trend in favor of OST-HER2-treated patients in overall survival (‘OS’, remaining alive) at the 1-year and 2-year interim timepoints of the ongoing 3-year overall survival secondary endpoint. Notably, all patients who achieved the primary 12-month EFS endpoint remain alive.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that its Chair & CEO Paul Romness has accepted an invitation to attend the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA taking place on January 13-16, 2025 in San Francisco, CA. This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or the “Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced the closing of a private placement financing, raising approximately $6 million in gross proceeds for the Company, before deducting offering-related expenses. The Company intends to use the proceeds from the private placement for working capital, primarily focused on the clinical and regulatory milestones to support commercialization of the Company’s lead therapeutic candidate OST-HER2 in the recurrent, resected metastatic osteosarcoma in the United States in 2025, and for general corporate purposes. The US FDA has granted OST-HER2 rare pediatric disease, fast track and orphan drug designations for osteosarcoma.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, has partnered with B2i Digital to enhance investor outreach. B2i Digital will implement data-driven strategies to raise awareness about OS Therapies' pioneering research and upcoming milestones, including its potentially pivotal Phase 2b clinical trial for OST-HER2 in the rare pediatric orphan disease recurrent, resected metastatic osteosarcoma.

OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has entered into securities purchase agreements with investors to sell 1.5 million units at a price of $4.00 per unit, with each unit consisting of one share of Series A Senior Convertible Preferred Stock (“the Preferred Stock”) initially convertible into one share of common stock and one warrant to purchase one share of common stock, expected to yield gross proceeds to the Company of $6 million, before deducting offering-related expenses. The conversion price of the Preferred Stock into shares of common stock is $4.00 and the exercise price of the warrants is $4.40 per share. The private placement is expected to close on or about December 27, 2024, subject to the satisfaction of customary closing conditions.

OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported financial results for the third quarter of 2024 ended September 30, 2024 and provided a business update.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, today announced positive data from a Phase 1 clinical trial of OST-HER2 in patients with HER2-expressing solid tumors in breast cancer and other cancers. Additionally, the Company announced positive preclinical efficacy data for OST-HER2 in multiple models of breast cancer.

OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, today announced a positive clinical update for AOST-2121 (NCT04974008), its ongoing Phase 2b clinical trial of its immunotherapy OST-HER2 (OST31-154) in patients with resected, recurrent osteosarcoma.