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Lake Street initiated coverage of OS Therapies with a rating of Buy and set a new price target of $19.00

U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 MeetingFDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcomaStatistically significant 12-month Event Free Survival and interim 2-year Overall Survival and strong safety data in Phase 2b trial drives global accelerated/conditional approval pathwaysCommercial partnership with Eversana positions OST-HER2 for possible U.S. launch in first half of 2026$4.2 million capital

New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025.About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initia

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046)FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 MeetingCompany responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval ProgramCompany's NYSE American listing included in the Russell Microcap, Russell M

MHRA seeks to harmonize UK & US regulatory review via Project OrbisEMA Rapporteur Scientific Advice Meeting scheduled for October 2025New York, New York--(Newsfile Corp. - August 7, 2025) - OS Therapies (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it held a successful Scientific Advice Meeting with the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) in July and has submitted an invited Innovative Licensing and Access Pathway (ILAP) application to begin the regulatory process towards approval of OST-HER2 in the prevention or delay of recurrent, fu

Cash runway extended through 2026, beyond September 30, 2026 sunset date for rare pediatric priority review voucher (PRV) program Additional funding allows Company to advance strategic alternatives for OS Animal Health, close out OST-504 (previously ADXS-504) prostate cancer study and initiate AI-driven next-gen tADC product candidate modelingNew York, New York--(Newsfile Corp. - July 14, 2025) - OS Therapies (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has closed its previously announced warrant exercise inducement and exchange offer. The Company raised a total of $4.2 milli

USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 26, 2025 /PRNewswire/ -- USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns 

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 million of which has already been received by the Company, thereby extending cash runway into second half of 2026 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical com

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 lung metastatic osteosarcoma. OST-HER2, a Listeria monocytogenes-based immunotherapy, is the first potential new treatment in over 40 years for pediatric os

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 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. RMAT designations are granted to sponsors with regenerative

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 recurrent, fully resected, lung metastatic pediatric osteosarcoma OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial res

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USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 26, 2025 /PRNewswire/ -- USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns 

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 $4.00/share provides cash runway into 2026 & precludes raises below $12.00 for 6 months Karim Galzahr appointed to OS Therapies Board of Directors OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted d

Concurrently, the Company accepted the resignations of Dr. Colin Goddard and Mr. Joacim Borg 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 Directors. Collectively, Ms. McKean Dieser and Mr. Jarry bring over 50 years of biopharmaceutical executive decision-making experience to the Company, with a specific focus in commercializing biologic products. "OS Therapies is thrilled to welcome Ms. McKean Dieser and Mr. Jarry to our Board of Directors," sa

OS Therapies (NYSE: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 tunable ADC platform leveraging its proprietary pH-sensitive SiLinker™ silicone linker technology. Dr. Shor has 20 years of experience in leading oncology discovery programs and external R&D partnerships at large pharma (Pfizer, Wyeth) and biotech companies, with specific focus on preclinical discovery and development of sma

SC 13G - OS Therapies Inc (0001795091) (Subject)

New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025.About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initia

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 recurrent, fully resected, lung metastatic pediatric osteosarcoma OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial res

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 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 completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals. The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of

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 f

ORLANDO, FL / ACCESSWIRE / August 9, 2024 / RedChip Companies will air interviews with OS Therapies Inc. (NYSE:OSTX) and Can-Fite BioPharma Ltd. (NYSE:CANF) on the RedChip Small Stocks, Big Money™ show, a sponsored program on Bloomberg TV, this Saturday, August 10, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:OS Therapies: https://www.redchip.com/assets/access/ostx_accessCan-Fite: https://www.redchip.com/assets/access/canf_accessIn an exclusive interview, Paul Romness, Chairman and CEO of OS Therapies, appears on the RedChip Small Stocks Big Money™ show on Bloomberg TV to provide a corporate