Company will be seeking alignment to begin rolling BLA submission NEW YORK / Jul 03, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration (“FDA”) to review the OST-HER2 program in the prevention or... Read More

The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (35%) was statistically significant (p= 0.0194) when compared with peer-reviewed comparable historical control (20%) Company also provides regulatory update on comparator for OST-HER2 Phase 2b Trial in the Prevention or Delay of Recurrence in Fully Resected, Lung Metastatic Osteosarcoma Responses to recent FDA Type D Meeting follow-up... Read More

Company has requested End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) based upon the positive FDA Meeting feedback NEW YORK / Jun 24, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it received positive written feedback from the US Food & Drug Administration... Read More

Current holders of five-year warrants with a current exercise price of $1.12 per share issued in connection with PIPE transaction initially closed on December 31, 2024 (“Old Warrants”) offered opportunity to exercise Old Warrants now to receive new five-year warrants with an exercise price of $3.00 per share (the “New Warrants”) Exercise of all Old Warrants would provide a maximum of ~$8 million in gross proceeds, $1.76... Read More

NEW YORK and CHICAGO , June 10, 2025 /PRNewswire/ -- OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has selected EVERSANA® , a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric... Read More

If awarded, OST-HER2 would become the first listeria investigational medicinal product to be awarded the RMAT designation RMAT designation reduces BLA application review time and permits augmented interactions with FDA to inform market access NEW YORK / Jun 06, 2025 / Business Wire / OS Therapies Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate... Read More

Feedback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy & Breakthrough Therapy designation requests Completed Phase 2b trial data analysis using methods agreed to by FDA to be presented at MIB Factor on June 28, 2025 Company remains on track for Q3 2025 BLA filing for OST-HER2 in the prevention of... Read More

NEW YORK / May 15, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 market opportunity in canine osteosarcoma exceeds $150 million... Read More

Phase 3-stage OST-AXIL for HPV, Phase 2-stage OST-503 for NSCLC & GBM and Phase 1-stage OST-504 for Prostate cancer also covered under patent Eight (8) pre-clinical additional immunotherapy candidates also protect NEW YORK / May 07, 2025 / Business Wire / OS Therapi es (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced... Read More

Official trailer is now live at https://youtu.be/pFaockwrROM LOS ANGELES / May 02, 2025 / Business Wire / The official trailer for “ Shelter Me: The Cancer Pioneers” has just dropped, giving audiences a moving first look at the groundbreaking new documentary that follows the emotional and inspiring journey of dogs helping to pioneer cancer treatments that are saving human lives. The movie will stream through the PBS app and... Read More

Written response-only meeting to align analysis plan of surrogate endpoint to support Breakthrough Therapy Designation & Accelerated Approval of OST-HER2 in the Prevention of Recurrence of Fully Resected, Lung Metastatic Osteosarcoma Analysis to be featured at keynote presentation closing out major osteosarcoma conference MIB Factor on June 28, 2025 at 3:30pm MDT NEW YORK / Apr 22, 2025 / Business Wire / OS Therapies... Read More

Yet to be published data from clinical study combining OST-HER2 with palliative radiation in dogs with unresected, primary osteosarcoma shows clinical and radiographic arrest of the primary tumor, delayed pulmonary metastases and prolonged overall survival of greater than 500 days in 5 out of 15 dogs. Data from new publication in the journal "Molecular Therapy" show OST-HER2 induces strong innate and cytotoxic immune... Read More

Company now listeria-based cancer immunotherapy world leader Expands clinical pipeline with 3 new cancer immunotherapy candidates 8 pre-clinical immunotherapy candidates targeting 30+ cancers added NEW YORK / Apr 09, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has... Read More

OS Therapies applies for meeting per FDA suggestion received on April 2, 2025 Based on prior FDA guidance, greater than 200 suitable matched lung metastatic osteosarcoma patient records identified from leading oncology centers in the US, UK and France for inclusion in OST-400, a Retrospective Longitudinal Study of Recurrent Osteosarcoma after Resection in Children and Young Adults NEW YORK / Apr 07, 2025 / Business Wire / OS... Read More

NEW YORK / Apr 02, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that the Company will be hosting an Analyst Day at the New York Stock Exchange in Lower Manhattan that will start at 10am on Monday, April 7, 2025. The Company intends to focus the Analyst Day discussion on:... Read More

Full data from OST-HER2 Phase 2b osteosarcoma trial, including synthetic control arm data being developed at the request of FDA to support a Breakthrough Therapy Designation request, to be presented at MIB Factor in June 2025 Rolling BLA submission expected to begin thereafter in order to gain regulatory approval by year-end 2025, triggering issuance of a Priority Review Voucher (PRV) NEW YORK / Mar 31, 2025 / Business Wire... Read More

Dialogue open with FDA in preparation for End of Phase 2 Meeting request New canine elite responder biomarkers added to human biomarker strategy NEW YORK / Mar 31, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a regulatory update for its OST-HER2 listeria monocytogenes ( Lm )... Read More

Documentary focusing on canine comparative oncology will premiere at the Los Angeles AMC Century City on April 3 rd NEW YORK / Mar 25, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that OST-HER2 is featured in the upcoming movie Shelter Me: The Cancer Pioneers . The movie offers... Read More

NEW YORK / Mar 21, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that Paul Romness, CEO, and Gerald Commissiong, CBO will be accepting meetings with registered investors at The Jones Healthcare and Technology Innovation Conference. The conference is being held on April 8-9, 2025... Read More

NEW YORK / Mar 13, 2025 / Business Wire / 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... Read More

NEW YORK / Mar 11, 2025 / Business Wire / 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... Read More

NEW YORK / Feb 26, 2025 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, is pleased to invite investors to a webinar on February 27, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature OS Therapies’ Chairman and CEO, Paul Romness, and Chief Business Officer, Gerald... Read More

NEW YORK / Feb 24, 2025 / Business Wire / 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... Read More

Patent Term Adjustment will provide market exclusivity in the United States into 2040 for all therapeutic indications NEW YORK / Feb 20, 2025 / Business Wire / 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... Read More

NEW YORK / Feb 14, 2025 / Business Wire / 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... Read More

Strong cash position relative to monthly burn and cash needs into mid-2026 Significant regulatory milestones upcoming in OST-HER2 osteosarcoma program Pending acquisition paves the way for commercialization and partnerships Evaluating strategic options for tunable Antibody Drug Conjugate platform NEW YORK / Feb 04, 2025 / Business Wire / OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing... Read More

Consolidates ownership of listeria monocytogenes-based immunotherapy IP Eliminates milestone payments and reduces future royalty obligations relating to OST-HER2 for osteosarcoma and other HER2-related indications Capital allocation focus remains on regulatory approval, priority review voucher (PRV) issuance and commercialization of OST-HER2 in osteosarcoma Previously disclosed $7.1M funding for OS therapies priced at... Read More

The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (33.3%) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20%) Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical... Read More

CEO Paul Romness available to meet with institutional investors NEW YORK / Jan 02, 2025 / Business Wire / 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 43 rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA taking place... Read More

Funding expected to provide cash runway into 2026 98% of investment in private placement from Pre-IPO and/or IPO investors Data update from OST-HER2 Phase 2b clinical trial in recurrent, resected metastatic osteosarcoma to be announced during week of JP Morgan Healthcare Conference 2025 Company remains eligible to be awarded Priority Review Voucher (PRV) by US FDA as a result of receiving rare pediatric designation for... Read More

Digital Marketing Campaign to Highlight Clinical-Stage Cancer Innovation OST-HER2 that activates cellular immunity against HER2+ cancer OS Therapies Joins the B2i Digital Featured Companies Program NEW YORK / Dec 26, 2024 / Business Wire / 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... Read More

Funding will provide Company sufficient cash runway into 2026 95% of investment in private placement from Pre-IPO and/or IPO investors Data from OST-HER2 Phase 2b in recurrent, resected metastatic osteosarcoma to be announced during the week of the JP Morgan Healthcare Conference in January 2025 NEW YORK / Dec 24, 2024 / Business Wire / OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage... Read More

Topline Data from Phase 2b clinical trial of OST-HER2 in Osteosarcoma expected to be released in December 2024 NEW YORK / Nov 15, 2024 / Business Wire / 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... Read More

NEW YORK / Nov 04, 2024 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that Paul Romness, Chief Executive Officer, and Gerald Commissiong, Chief Business Officer, will present a corporate overview at The Spartan Capital Investor Conference. The conference is being held on November 4,... Read More

NEW YORK / Oct 30, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, is pleased to invite investors to a webinar on October 30, 2024, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature OS Therapies’ Chairman and CEO Paul Romness, and Chief Business Officer Gerald... Read More

Concurrently, the Company accepted the resignations of Dr. Colin Goddard and Mr. Joacim Borg NEW YORK / Oct 28, 2024 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announced the appointments of Avril McKean Dieser, MA, JD and Olivier R. Jarry, MS, MBA as independent members of the Company’s Board of... Read More

NEW YORK / Oct 24, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that Paul Romness, Chief Executive Officer, and Gerald Commissiong, Chief Business Officer, will present a corporate overview at the LD Micro Main Event XVII. The conference is being held on October 28 – 30, 2024... Read More

NEW YORK / Oct 17, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that Paul Romness, Chief Executive Officer, will be presenting at the 2024 Maxim Healthcare Virtual Summit. The summit is being held virtually on October 15 – 17, 2024. Event: Fireside Chat at 2024 Maxim Healthcare... Read More

Company to ring Closing Bell at NYSE on Thursday, October 3, 2024 Interviews scheduled with Fintech.TV and Schwab Network NEW YORK / Oct 03, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008)... Read More

First therapeutic candidate targets Breast Cancer, Lung Cancer and Gastric Cancer Second therapeutic candidate targets platinum-resistant Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer NEW YORK / Sep 13, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced... Read More

Folate receptor alpha targeting drug conjugate & hexa silanol exatecan (FRA-H) payloads tested in animal models of ovarian cancer Strong efficacy for FRA-H in KB and IGROV-1 mouse models of ovarian cancer Strong safety profile for FRA-H with no loss of bodyweight as compared with control in animal models Success of tADC proof-of-concept study paves way for creating multiple potential therapeutic candidates for preclinical... Read More

NEW YORK / Sep 05, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced its participation in the H.C. Wainright 26 th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. The Company’s President & CEO Paul Romness, MPH, will deliver a... Read More

NEW YORK / Aug 29, 2024 / Business Wire / OS Therapies Incorporated (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial ( NCT04974008 ) of OST-HER2 in recurred, resected Osteosarcoma (OS) - has received its last treatment dose. This last patient is... Read More

NEW YORK / Aug 22, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that it has appointed Borys Shor, PhD to its Antibody Drug Conjugate (ADC) Advisory Board. In his role, Dr. Shor will assist the Company in the selection of antibody and payloads to be developed using the Company’s... Read More

NEW YORK / Aug 22, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today provided a clarification for market participants, specifically brokerage firms, regarding the Committee on Uniform Securities Identification Procedures (CUSIP) identifier of the Company’s common stock. The Company’s common stock... Read More

Focus of work at JLABS on tunable Antibody Drug Conjugate linker-based platform ROCKVILLE, Md. / Aug 19, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that it has been accepted into Johnson & Johnson Innovation – JLABS. Through membership of JLABS, OS Therapies aims to further develop... Read More

Successful IPO that raised $6.4 million on July 31, 2024, without issuing any warrants, occurred after the end of the second quarter and is not reflected in reported financials Conversion of all reported outstanding preferred shares and debt into equity occurred as of the date of the IPO and is not reflected in the reported financials After IPO and preferred shares and debt conversion share issuances, there are 20.85 million... Read More

ROCKVILLE, MD / ACCESSWIRE / August 6, 2024 / OS Therapies (NYSE American:OSTX) ("OS Therapies" or "the Company"), an Antibody Drug Conjugate (ADC) and Immunotherapy research and clinical-stage biopharmaceutical company, highlights its Scientific and Medical Advisory Board (SMAB), comprised of experts in osteosarcoma from six institutions in the United States. The following physicians have agreed to serve on the OS Therapies... Read More

ROCKVILLE, Md. & NEW YORK / Aug 02, 2024 / Business Wire / OS Therapies Incorporated (“OS Therapies” or the “Company”) (NYSE-A: OSTX), a Cancer Immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the formation of a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program. The purpose of the PAAB is to represent voices from the osteosarcoma community regarding the need for new... Read More

ROCKVILLE, Md. & NEW YORK / Jul 31, 2024 / Business Wire / OS Therapies Incorporated (“OS Therapies” or the “Company”) (NYSE-A: OSTX), an Antibody Drug Conjugate (ADC) and Immunotherapy research and clinical stage biopharmaceutical company, today announced the pricing of its initial public offering of 1,600,000 shares of common stock at a public offering price of $4.00 per share, raising gross proceeds of $6.4 million.... Read More

10 of 12 patients treated in HER2 expressing solid tumor Phase 1b trial were breast cancer patients Dose selected for ongoing Phase 2b clinical trial in Osteosarcoma was shown to be well tolerated in breast cancer patients Preclinical breast cancer efficacy models showed positive data to prevent breast cancer metastases to the brain, reduce tumor growth by over 90% in combination with HER2-targeted antibodies, and prevent... Read More