tunable ADC (tADC)

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OS Therapies to Participate in Upcoming Investor Conferences in September 2025
Newsfile· 2025-09-03 11:40
Core Insights - OS Therapies Inc. is a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, particularly for Osteosarcoma and other solid tumors [1][2] - The company's lead asset, OST-HER2, has shown positive results in a Phase 2b clinical trial for recurrent lung metastatic osteosarcoma, achieving statistically significant benefits in the 12-month event-free survival primary endpoint [1] - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations, and the company plans to submit a Biologics Licensing Application in 2025 [1] - The company is also developing a next-generation Antibody Drug Conjugate platform known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [2] Upcoming Events - OS Therapies will participate in several investor conferences in September 2025, including the Cantor Global Healthcare Conference from September 3-5, H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11 [5]
OS Therapies Completes Exercise Inducement and Exchange Offer for All Remaining Outstanding Warrants Issued in Connection with December 2024 Financing
Newsfile· 2025-09-02 10:00
Core Insights - OS Therapies has completed a warrant inducement and exchange offer, raising approximately $3.7 million in gross proceeds to accelerate preparations for the commercial launch of OST-HER2 [1][4] - The company aims to bring OST-HER2 to market in early 2026, pending FDA regulatory approval [2] - New warrants have been issued with an exercise price of $3.00 per share, which includes a forced exercise provision when the stock trades above $9.00, potentially bringing in over $20 million in additional funding [2][4] Financial Details - The warrant exchange raised approximately $3.7 million, which will primarily be used for commercial preparations related to OST-HER2 [1][4] - The forced exercise provision of the new warrants could lead to over $20 million in additional funding if triggered [2] Product Development - OST-HER2 is the lead asset of OS Therapies, targeting osteosarcoma and has received multiple designations from the FDA, including Rare Pediatric Disease Designation [3][5] - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [5] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) technology, known as tunable ADC (tADC) [6]
OS Therapies Terminates Equity Line of Credit
Newsfile· 2025-08-26 01:51
Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].
OS Therapies to Report Second Quarter 2025 Financial Results and Provide Business Update on Tuesday, August 19th, 2025
Newsfile· 2025-08-14 21:44
Core Insights - OS Therapies Inc. will report its second quarter 2025 financial results and provide a business update on August 19, 2025 [1] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for Osteosarcoma and other solid tumors [2] - The lead asset, OST-HER2, is an immunotherapy that targets the HER2 protein and has received multiple designations from the U.S. FDA and European Medicines Agency [2] - Positive data from a Phase 2b clinical trial of OST-HER2 in lung metastatic osteosarcoma showed statistically significant benefits in the 12-month event-free survival primary endpoint [2] - The company plans to submit a Biologics Licensing Application for OST-HER2 in 2025, which could lead to a Priority Review Voucher if approved [2] - OST-HER2 has also shown preclinical efficacy in breast cancer models and has been conditionally approved for treating canines with osteosarcoma [2] Product Development - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for tailored antibody-linker-payload candidates [3] - The tADC platform allows for the delivery of multiple payloads per linker, enhancing treatment options [3]
OS Therapies Closes $4.2 Million in Warrant Exercise Inducement and Exchange Offer
Newsfile· 2025-07-14 11:40
Core Viewpoint - OS Therapies has successfully closed a warrant exercise inducement and exchange offer, raising $4.2 million to support its regulatory and pre-commercial efforts for its lead product, OST-HER2, aimed at treating osteosarcoma [1][2]. Financial Summary - The company raised a total of $4.2 million in gross proceeds from the offering [1]. - The funds will primarily be used for regulatory efforts and to advance strategic alternatives for its OS Animal Health subsidiary [1][2]. Product Development - OST-HER2 is the lead asset of OS Therapies, designed to treat recurrent, fully resected pulmonary metastatic osteosarcoma, and has received various designations from the FDA [3][4]. - The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025, which could yield a Priority Review Voucher (PRV) if approved [4]. - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), utilizing proprietary technology [5]. Strategic Plans - The company aims to pursue a Biologics Licensing Authorization under the Accelerated Approval Program for OST-HER2 within the next 18 months [2]. - OS Therapies intends to evaluate strategic alternatives for its canine osteosarcoma program and report final data for its OST-504 prostate cancer study [2][3]. - The company is focused on improving the treatment landscape for metastatic osteosarcoma patients while minimizing cash expenditure [2].