OS Therapies

OS Therapies held a live investor webinar and Q&A session yesterday, February 27, 2025, at 4:15 p.m. ET. The event, presented by RedChip Companies, featured CEO Paul Romness and Chief Business Officer Gerald Commissiong to discuss the company’s latest developments and plans. You can watch it on demand here: https://lnkd.in/eGZ3RaY6 It included discussions on OS Therapies’ key programs, including OST-HER2 and its drug development pipeline. See the press release here: https://lnkd.in/eqq_eBke Led by?CEO Paul Romness and a highly experienced executive team, including Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. For investor-related questions, please visit OS Therapies’ Investor Relations page or email [email protected]. #OSTherapies #Immunotherapy #CancerResearch

Today we issued a press release announcing that we have formed a new subsidiary, OS Drug Conjugates (OSDC), to advance our tunable ADC (tADC) and tunable drug conjugates (tDC) platforms. We are also exploring strategic options to create value through potential joint ventures that could be spun into standalone public companies, with stock dividends distributed to shareholders if successful. Highlights from the announcement include: · OSDC will focus on the company’s proprietary silicon-based, pH-sensitive SiLinkers?, designed to selectively release therapeutic agents within tumor environments. · We are discussing joint ventures with clinical-stage ADC companies in the U.S., China, and other markets. · The global antibody-drug conjugates market is projected to grow from $10.8 billion in 2023 to $47.0 billion by 2029, reflecting a 28.4% CAGR.OST-HER2, Our lead immunotherapy for lung metastatic osteosarcoma, has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Following positive Phase 2b trial results, the company plans to submit a Biologics Licensing Application (BLA) to the FDA in 2025. OST-HER2 has also shown preclinical efficacy in breast cancer models and is conditionally approved in the U.S. for canine osteosarcoma. See the full announcement at https://lnkd.in/g8hi-B3e. Led by CEO Paul Romness and a highly experienced executive team, including Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies (NYSE-A: $OSTX) is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. Learn more about OS Therapies’ work at https://ostherapies.com. For investor-related questions, please visit OS Therapies’ Investor Relations page or email [email protected]. #OSTherapies #Immunotherapy #CancerResearch

We are proud to announce that we have received positive news from the U.S. Patent & Trademark Office (USPTO), a Notice of Allowance for a patent covering the commercial manufacturing methods of OST-HER2, with market exclusivity extended into 2040. This milestone supports the Company’s ongoing preparation for a Biologics Licensing Application (BLA) submission to the FDA, and gaining conditional or accelerated approval in 2025. Highlights from the announcement include: ·?????The patent provides market exclusivity in the U.S. until 2040 for all therapeutic indications of OST-HER2. ·?????The Company is preparing for FDA discussions following positive Phase 2b trial results in osteosarcoma. ·?????A Priority Review Voucher (PRV), valued at approximately $150 million based on recent transactions, may be available upon FDA approval. OST-HER2 is an immunotherapy designed to prevent recurrence of lung metastatic osteosarcoma. It has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA and has also shown promising results in breast cancer models. We are advancing our tunable Antibody Drug Conjugate (tADC) platform, which features proprietary silicon linker technology for delivering tailored antibody-linker-payload therapies targeting solid tumors. See the full announcement at?https://lnkd.in/grvSmSfJ. Led by?CEO Paul Romness?and a highly experienced executive team, including?Christopher Acevedo (CFO),?Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. For investor-related questions, please visit OS Therapies’ Investor Relations page or email?[email protected]. #OSTherapies #Immunotherapy #CancerResearch

We are proud to announce that we have initiated commercial-ready manufacturing of OST-HER2 in preparation for a Biologics Licensing Application (BLA) submission to the FDA. We are finalizing data from our recently completed Phase 2b trial and expect to hold a Type B or Type C meeting with the FDA ahead of the submission. OST-HER2, an immunotherapy designed to prevent recurrence in lung metastatic osteosarcoma, has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations. If approved, OS Therapies (NYSE-A: OSTX) would be eligible for a Priority Review Voucher (PRV), which has historically held significant market value. This milestone represents continued progress toward potential regulatory approval. Highlights from the announcement include: - Agreements for the commercial manufacture of OST-HER2 are now in place. - Regulatory discussions with the FDA are expected ahead of the planned BLA submission. - Positive Phase 2b trial data supports the pathway to potential accelerated or conditional approval. - Also noted in the news release is the advancement of our next-generation Antibody Drug Conjugate (ADC) platform, known as?tunable ADC?(tADC), which features tunable, tailored antibody-linker-payload candidates and leverages our proprietary silicon linker technology. The tADC technology platform aims to transform cancer care by targeting tumors with customized therapies. See the full announcement at?https://lnkd.in/dZai5x2D. OS Therapies is committed to developing innovative immunotherapies and advanced drug technologies to address hard-to-treat cancers. Led by?CEO Paul Romness?and a highly experienced executive team, including?Christopher Acevedo (CFO),?Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. For investor-related questions, please visit OS Therapies’ Investor Relations page or email?[email protected]. #OSTherapies #Immunotherapy #CancerResearch

Continuing our focus on osteosarcoma and other hard-to-treat cancers, OS Therapies (NYSE-A: OSTX) released a new corporate update detailing its strong cash position, advancing regulatory milestones, and strategic plans for its Listeria-based immunotherapies and tunable ADC platform. In the update, the Company emphasized: - Capital Position: Recent financings total $13.1 million, expected to fully fund regulatory submissions and commercial launch preparations for OST-HER2 in osteosarcoma. - Regulatory Milestones: OST-HER2 met its Phase 2b primary endpoint for preventing recurrent, fully resected lung metastatic osteosarcoma; BLA submission is anticipated in 2025. - Acquisition & Pipeline: New Listeria-based immunotherapy candidates acquired from Ayala, plus a lower royalty burden and accelerated path to potential FDA approval. - ADC Platform: The tunable antibody-drug conjugate technology remains a key strategic focus for future combination therapies. Paul Romness, CEO, noted, “January 2025 was the most significant month in the Company’s history. We started OS Therapies because someone very close to my family developed osteosarcoma and we realized that if first line therapy failed, the metastasis that could follow had very poor long-term prognosis. The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease. We intend to stay laser focused on our mission of bringing this therapy to market so that when the next family that gets the devastating news of an osteosarcoma diagnosis, they’ll know that treatment options might exist in the event that chemotherapy and resection/amputation fail to prevent metastasis, which is the case in approximately 50% of patients.” For the full announcement, read the press release at https://lnkd.in/gY7_9JkU Led by Paul Romness and a highly experienced executive team, including, Christopher Acevedo, Robert Petit John Doll, and Gerald Commissiong, the Company is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers.

We are pleased to share an important news announcement. OS Therapies announced at the?J.P. Morgan Healthcare Conference?that its Phase 2b Clinical Trial of OST-HER2 (OST31-164) achieved the primary endpoint of 12-month Event Free Survival (EFS) with statistical significance (33% vs. 20% in historical controls; p=0.0158). This milestone underscores OST-HER2's potential in preventing the recurrence of fully resected, lung metastatic osteosarcoma, an indication with no currently approved treatments. Our Chair and CEO Paul Romness?commented on the importance of the results: “ The achievement of the primary endpoint in the OST-HER2 phase 2b is a tremendous success that opens the possibility, for the first time, of meaningful therapy for patients suffering from osteosarcoma with lung metastases after resection. This is a leap forward in the development of OST-HER2 and we are pleased that our regulatory strategy is consistent with the FDA’s recent draft guidance update for accelerated approvals. With these positive data in hand, we are preparing to engage with U.S. FDA on an accelerated pathway for approval in this extremely challenging indication. We do not expect to have to treat additional patients as part of this process with FDA.” Robert Petit (Chief Medical and Scientific Officer)?further commented, “We are extremely pleased with these results of our Phase 2b clinical trial because they show that OST-HER2-treated patients achieved the primary endpoint of 12-month EFS in a statistically significantly higher ratio than comparable historical controls, in addition to increasing the likelihood of 1-year and 2-year survival as compared with comparable historical controls. The strong safety profile shown in this study also supports the use of OST-HER2 in this incredibly difficult-to-treat population that has no currently approved therapies.” View the full release at:?https://lnkd.in/eSgDhJ6T Our team is led by?CEO Paul Romness?and a highly experienced executive team, including?Christopher Acevedo (CFO),?Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer). We are committed to developing innovative immunotherapies and advanced drug technologies to address hard-to-treat cancers. Our company is advancing its “tunable ADC” technology platform, which aims to transform cancer care by precisely targeting tumors with customizable therapies. Learn more about OS Therapies’ work at?https://lnkd.in/eetih6v7?and visit B2i Digital for more updates. https://lnkd.in/eWRy5ZYe For investor-related questions, please visit?OS Therapies' Investor Relations page?or email?[email protected]. #OSTherapies #Immunotherapy #Oncology #Biotechnology

The team at B2i Digital is pleased to share a news announcement from our B2i Digital Featured Company,?OS Therapies, Inc. (NYSE-A: OSTX). https://lnkd.in/epFNRZQB The Company announced that its?Chair and CEO, Paul Romness, has accepted an invitation to attend the?43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA, from January 13-16, 2025. This milestone comes as OS Therapies prepares to engage with institutional investors and share pivotal updates on its lead therapeutic immunotherapy candidate. In a statement, Romness said, “After having successfully completed our IPO in 2024 and finished the treatment phase of our potentially pivotal Phase 2b clinical trial of lead therapeutic immunotherapy candidate OST-HER2 in the treatment of the rare pediatric disease recurrent, resected metastatic Osteosarcoma, we are excited to begin to engage with the institutional investor community and raise the profile of OS Therapies in the capital markets. We intend to announce an update of the data from this trial throughout the week of the conference and expect that this will provide a good opportunity for the markets to get a better understanding of our Company’s potential for an approval in 2025 that would not only change the lives of families afflicted by this devastating childhood cancer, but would also make the Company eligible to be granted a Priority Review Voucher (PRV), currently valued at approximately $150 million, that would further capitalize the Company to allow it expand the clinical development of OST-HER2 into other HER2 positive cancers such as Breast cancer and/or Colorectal cancer.” View the full release at:?https://lnkd.in/eErFGixF OS Therapies is dedicated to developing innovative cancer treatments, including immunotherapies that harness the immune system to fight tumors and advanced drug technologies designed to deliver chemotherapy more precisely to cancer cells while reducing side effects. Led by?CEO Paul Romness?and an experienced executive team, including?Christopher Acevedo (CFO),?Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer), OS Therapies is advancing its “tunable ADC” technology platform, which aims to transform cancer care by precisely targeting tumors with customizable therapies. Learn more about their work at?https://lnkd.in/eaAJSfqz?and visit B2i Digital for updates. For investor-related questions, please visit?OS Therapies' Investor Relations page https://lnkd.in/ee-bFrAk?or email?[email protected]. #OSTherapies #Immunotherapy #Biotechnology #Oncology #B2iDigital

The team at B2i Digital is pleased to share news from our B2i Digital Featured Company,?OS Therapies, Inc. (NYSE-A: OSTX). The company recently announced the pricing of a $6 million private placement, with 95% of the investment coming from pre-IPO and/or IPO investors, giving the company sufficient cash runway into 2026. Proceeds will support clinical and regulatory milestones for OST-HER2, OS Therapies’ lead therapeutic candidate, which aims to treat recurrent, resected metastatic osteosarcoma. View the full release at:?https://lnkd.in/euxfVwcC OS Therapies is dedicated to developing innovative cancer treatments, including immunotherapies that harness the immune system to fight tumors and advanced drug technologies designed to deliver chemotherapy more precisely to cancer cells while reducing side effects. Their lead candidate, OST-HER2, has reached noteworthy milestones, including completing a 41-patient Phase 2b trial for recurrent osteosarcoma, with data expected to be announced during the week of the JP Morgan Healthcare Conference in January 2025. Led by?CEO Paul Romness?and an experienced executive team, including?Christopher Acevedo (CFO),??Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer), OS Therapies is advancing its “tunable ADC” technology platform, which aims to transform cancer care by precisely targeting tumors with customizable therapies. Their flexible approach may open the door to treating a wide range of cancers more effectively and with fewer side effects. Learn more about their work at?https://lnkd.in/eaAJSfqz?and visit B2i Digital for updates. For investor-related questions, please visit?OS Therapies' Investor Relations page?or email?[email protected]. #OSTherapies #Immunotherapy #Biotechnology #Oncology #B2iDigital

We are pleased to welcome?OS Therapies, Inc. (NYSE-A: OSTX)?as a B2i Digital Featured Company. OS Therapies is dedicated to developing innovative cancer treatments, including immunotherapies that harness the immune system to fight tumors and advanced drug technologies designed to deliver chemotherapy more precisely to cancer cells while reducing side effects. Their lead candidate, OST-HER2, has reached noteworthy milestones, including completing a 41-patient Phase 2b trial for recurrent osteosarcoma, with data expected later this month. OST-HER2 is a groundbreaking cancer immunotherapy designed to teach the immune system to identify and destroy cancer cells that produce a protein called HER2. This easy-to-administer treatment uses a harmless version of a bacteria called?Listeria monocytogenes?to activate the body’s natural defenses. Notable Achievements Include: - Special designations from U.S. and European regulators recognizing OST-HER2 as a potential breakthrough for rare and challenging cancers, including: Rare Pediatric Disease, Fast Track, and Orphan Drug Designations granted by the FDA and EMA. - Conditional approval by the USDA for treating osteosarcoma in dogs, which shares key genetic similarities with the human form of the disease. - Acceptance into Johnson & Johnson’s JLABS innovation network. - A planned Phase 1 trial in 2025 for using OST-HER2 to treat breast cancer and other HER2-positive tumors. Learn more about their work at?https://lnkd.in/eaAJSfqz?and visit B2i Digital for updates. Led by?CEO Paul Romness?and an experienced executive team, including?Christopher Acevedo (CFO),??Robert Petit (Chief Medical and Scientific Officer),?John Doll (Chief of Staff), and?Gerald Commissiong (Chief Business Officer), OS Therapies is advancing its “tunable ADC” technology platform, which aims to transform cancer care by precisely targeting tumors with customizable therapies. Their flexible approach may open the door to treating a wide range of cancers more effectively and with fewer side effects. For investor-related questions, please visit?OS Therapies' Investor Relations page https://lnkd.in/ee-bFrAk?or email?[email protected]. #OSTherapies #Immunotherapy #Biotechnology #Oncology #B2iDigital

Join us at the upcoming LD Micro event on October 29, where OS Therapies (NYSE: $OSTX) CEO Paul Romness and CBO Gerald Commissiong will present a corporate overview at 11:30 AM PT. Register to watch our presentation here:?https://lnkd.in/g6qPWxzN https://lnkd.in/eTgPzsx9 #OSTherapies #LDMicro #InvestorConference?