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]

Core Insights - OS Therapies has received positive feedback from the UK's MHRA regarding its OST-HER2 application for the prevention or delay of recurrent pulmonary metastatic osteosarcoma [1][2] - The company has initiated the regulatory process in Europe and plans to synchronize its application with the FDA's Accelerated Approval Program through Project Orbis [1][2][4] - OST-HER2 has shown statistically significant benefits in a Phase 2b clinical trial, with a focus on improving 12-month event-free survival rates [5] Regulatory Developments - The company held a successful Scientific Advice Meeting with the MHRA and submitted an Innovative Licensing and Access Pathway (ILAP) application [1][2] - MHRA recommended applying for Project Orbis to align the UK and US regulatory review processes [4] - A European Medicines Agency rapporteur has scheduled a Scientific Advice Meeting for October 2025 [4] Product Information - OST-HER2 is an immunotherapy targeting the HER2 protein, leveraging the immune-stimulatory effects of Listeria bacteria [3] - The product has received Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations from the FDA and EMA [3] - The company anticipates submitting a Biologics Licensing Application (BLA) to the FDA in 2025, which could lead to a Priority Review Voucher [5] Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

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].

Core Insights - OS Therapies is making significant progress in its clinical-stage oncology programs, particularly with the OST-HER2 immunotherapy for recurrent, pulmonary metastatic osteosarcoma, with an End of Phase 2 Meeting scheduled with the FDA on August 27, 2025 [2][7] - The company has confirmed a Scientific Advice Meeting with the European Medicines Agency regarding the OST-HER2 program, which is a critical step for obtaining a centralized marketing authorization in Europe [3][7] - All patients in the Phase 1 clinical study of OST-504 have completed treatment, with updated clinical data expected in the second half of 2025 [4][7] Regulatory Updates - The FDA has granted an End of Phase 2 Meeting to review clinical data for OST-HER2, with the company aiming to align with the FDA for a rolling review Biologics Licensing Application under the Accelerated Approval Program [2][7] - A Scientific Advice Meeting with the EMA is confirmed, which is essential for the Centralized Procedure for marketing authorization across European Member States [3] - The company plans to pursue a Conditional Marketing Authorization in the UK through the MHRA's Innovative Licensing and Access Pathway, contingent on a successful meeting on July 31, 2025 [3] Clinical Development - The OST-HER2 program utilizes a HER2-bioengineered form of Listeria monocytogenes to stimulate an immune response against HER2-expressing cancer cells [5] - The company has completed a Phase 1 clinical study of OST-504, a prostate cancer-specific immunotherapy, with data expected to be reported later in 2025 [4][8] - OST-HER2 has received various designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track designation from the FDA [9] Strategic Focus - The company aims to obtain regulatory approval for OST-HER2 before the expiration of the rare pediatric disease priority review voucher program, which could provide significant non-dilutive funding [5] - OS Therapies intends to focus capital on the OST-HER2 approval while advancing other clinical programs without significant capital deployment [5] - The company is also advancing its next-generation Antibody Drug Conjugate platform, known as tunable ADC, which features tailored antibody-linker-payload candidates [10]

Financial Results - OS Therapies Incorporated reported financial results for Q1 2025, ending March 31, 2025[5] - A press release detailing the financial results was issued on May 16, 2025[5] - The financial results include key metrics that will be detailed in the attached press release (Exhibit 99.1)[6] - The report does not provide specific financial figures or performance metrics in the current document[5] Company Classification and Focus - The company is classified as an emerging growth company under the Securities Act[3] - The company is focused on clinical-stage cancer immunotherapy and ADC biotechnology[5] Company Information - The company is headquartered in Grasonville, Maryland[2] - The trading symbol for OS Therapies Incorporated is OSTX, listed on NYSE American[2] Regulatory Compliance - The report is filed under Section 13 or 15(d) of the Securities Exchange Act of 1934[1] - The document is signed by Paul A. Romness, President and CEO, confirming the report's authenticity[13]

Clinical Development - OS Therapies achieved full enrollment of 41 patients in the clinical study for OST-HER2 by October 2023, with the Phase IIb trial achieving its primary endpoint with statistical significance in Q1 2025[190] - The company plans to request a Type B or Type C FDA meeting in Q2 2025 to discuss the data and the path to a Biologics License Application (BLA) for OST-HER2[190] - The company plans to evaluate OST-HER2's potential use in other solid tumors, including breast, esophageal, and lung cancers, following FDA approval[190] - The HER2 Assets include two investigational new drug filings with the FDA for non-small cell lung cancer and prostate cancer[199] Financial Performance - For the three months ended March 31, 2025, research and development expenses were approximately $1.3 million, a significant increase from approximately $0.4 million for the same period in 2024, primarily due to increased vendor expenses related to the Phase IIb clinical trial[223] - General and administrative expenses for the three months ended March 31, 2025, were approximately $3.7 million, compared to $0.3 million for the same period in 2024, largely attributed to marketing costs and advisory fees associated with PIPE Financing[224] - The net loss for the three months ended March 31, 2025, was approximately $3.9 million, compared to a net loss of approximately $1.5 million for the same period in 2024, reflecting ongoing operational challenges[223] - As of March 31, 2025, the company had cash of approximately $3.0 million, down from $5.5 million as of December 31, 2024, indicating a need for additional funding[228] - The total gross proceeds from private placements and the initial public offering amounted to $34.6 million as of March 31, 2025, which is expected to support operations for the next nine to 12 months[228] - The fair value adjustment of the warrant liability was $1.1 million for the three months ended March 31, 2025, compared to $0 million for the same period in 2024, indicating increased volatility in the company's financial instruments[226] - The company reported cash used in operating activities of approximately $3.4 million for the three months ended March 31, 2025, compared to $0.6 million for the same period in 2024, highlighting increased operational expenditures[229] - The cumulative accrued dividend for Series A preferred stock as of March 31, 2025, was $375,000, unchanged from December 31, 2024, reflecting the conversion of preferred shares into common stock[217] - The company has incurred significant operating losses since inception, with an accumulated deficit of approximately $41 million as of March 31, 2025[227] - For the three months ended March 31, 2025, net cash provided by financing activities was approximately $1.1 million, compared to $0.7 million for the same period in 2024[234] Financing Activities - On December 24, 2024, OS Therapies entered into a PIPE Financing agreement, raising gross proceeds of approximately $7.1 million through the issuance of 1,775,750 shares of Series A Preferred Stock and warrants[192] - The PIPE Purchase Agreement requires stockholder approval for transactions related to the financing, with a special meeting held by April 9, 2025[193] - Ayala has agreed to a 180-day lock-up period for the shares received in the transaction, subject to certain exceptions[203] - The company is committed to filing registration statements for the resale of shares related to the acquisition within 75 days after the closing of the transaction[202] - The company raised total gross proceeds of $19,426,449 from accredited investors through seven separate private financing transactions involving convertible notes from July 2018 to April 2024[235] - The company issued demand promissory notes totaling $250,000 with an interest rate of 8% per annum, which were fully repaid by August 14, 2024[236][237] - The PIPE Financing on December 24, 2024, resulted in gross proceeds of approximately $7,103,000, with the issuance of 1,775,750 shares of Series A Preferred Stock and corresponding Series A Warrants[240] Asset Acquisition - The acquisition of HER2 Assets from Ayala Pharmaceuticals was completed on April 9, 2025, for an aggregate purchase price of $8 million, including $7.5 million in common stock[199][200] - The company acquired HER2 Assets from Ayala on April 9, 2025, which resulted in changes to milestone payments and royalty considerations[250] - The company is required to pay BlinkBio a total of $22,375,000 in milestone payments related to the development of products utilizing BlinkBio's proprietary technology[254] - As of March 31, 2025, the company had paid a total of $2,925,000 to Advaxis, including a $1,550,000 license commencement payment and $1,375,000 for milestone achievements[246] Regulatory and Compliance - The company has no off-balance sheet arrangements during the presented periods[259] - The company has elected to use the extended transition period under the JOBS Act for new or revised financial accounting standards[261] - The company will remain an emerging growth company until total annual gross revenues reach $1.235 billion or more[262]

Core Viewpoint - OS Therapies has announced positive data for its treatment OST-HER2 in dogs with unresected osteosarcoma, indicating potential for use as a frontline therapy in humans, aiming to prevent or delay limb amputation and reduce the need for chemotherapy [2][4][8] Group 1: Treatment Efficacy - OST-HER2 combined with palliative radiation showed clinical and radiographic arrest of primary tumors in dogs, leading to prolonged time to metastasis without surgery or chemotherapy [2][4] - The treatment demonstrated a significant improvement in overall survival, with 5 out of 15 dogs surviving over 500 days [6] - Positive data published in "Molecular Therapy" correlates immune responses to OST-HER2 with prevention of metastasis and long-term survival benefits [3][6] Group 2: Safety and Tolerability - Treatment with OST-HER2 was found to be safe and well tolerated in both studies conducted [4][6] Group 3: Future Plans and Approvals - The company plans to submit data to the USDA for conditional approval of the new manufacturing process for OST-HER2, aiming for sales to begin in 2025 [7] - A pivotal clinical study is planned to gain full approval by 2026 [7] - The company is focused on obtaining Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma by the end of 2025 [8] Group 4: Company Background - OS Therapies is a clinical-stage oncology company specializing in treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [9] - The company has received various designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status [9] - OST-HER2 has shown statistically significant benefits in previous clinical trials for lung metastatic osteosarcoma [9]

Financial Results - OS Therapies Incorporated reported financial results for the quarter and year ended December 31, 2024[5]. - A press release detailing the financial results was issued on March 31, 2025[5]. - The financial results include key metrics that will be elaborated in the attached press release[6]. - Specific revenue figures and growth percentages will be available in the detailed press release[6]. Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[3]. - The company has not opted for the extended transition period for new financial accounting standards[3]. Business Focus - The company is focused on clinical-stage cancer immunotherapy and ADC biotechnology[5]. Leadership and Transparency - The CEO, Paul A. Romness, signed the report, indicating leadership's commitment to transparency[13]. Additional Information - The report includes an interactive data file for enhanced financial analysis[8]. - Further details on user data, market expansion, and new product development are expected in the full press release[5].

Product Development and Manufacturing - The company has entered into a services agreement with George Clinical for a Phase 2 study of OST-HER2 after resection of recurrent osteosarcoma [58]. - The company relies on in-licensed patents for its lead product candidates, OST-HER2 and OST-tADC, with patent expirations expected between 2030 and 2037 [61]. - The company plans to retain significant development and commercial rights to its product candidates and aims to build its own sales and marketing infrastructure over time [65]. - The company does not own any manufacturing facilities and relies on third parties for the manufacture of its product candidates [66]. - The OST-HER2 active pharmaceutical ingredients are manufactured in accordance with Good Manufacturing Practices (GMPs) [69]. - The company is developing its supply chain and intends to establish framework agreements with third-party manufacturers for API and drug products [70]. - The company has not received marketing approval for any product candidates and expects to rely on third-party CROs for regulatory assistance [79]. - The FDA's current good manufacturing practices apply to drug product candidates in Phase II and III clinical trials [78]. - The company is focused on maintaining compliance with FDA regulations and guidelines for its manufacturing processes [83]. Regulatory Compliance - The company is subject to extensive regulatory requirements for post-marketing activities if any product candidates receive approval [82]. - The CVB evaluates the safety, efficacy, and quality of veterinary biologics, granting licenses only to products that meet regulatory requirements [87]. - Conditional licenses allow products to be marketed with specific limitations, requiring manufacturers to collect additional safety and efficacy data [88]. - The CVB conducts inspections of manufacturing facilities to ensure compliance with established manufacturing standards and may revoke licenses for non-compliance [89]. - The licensing process includes pre-license evaluation, licensing decision, labeling approval, and post-licensure surveillance [90]. - Compliance with the GDPR may increase the company's responsibility and liability regarding personal data processing, potentially raising operational costs [103]. - The company is subject to various environmental regulations governing the use and disposal of hazardous materials and waste [105]. - Pricing regulations for new drugs vary by country, potentially delaying commercial launches due to governmental price controls [107]. Market and Financial Considerations - The Affordable Care Act (ACA) significantly impacted the U.S. pharmaceutical industry, introducing competition from lower-cost biosimilars and increasing Medicaid rebates [95]. - The Inflation Reduction Act (IRA) will allow Medicare to negotiate "maximum fair prices" for expensive drugs, with provisions phased in by 2029 [98]. - States are increasingly passing legislation for drug price transparency and may control pharmaceutical pricing, affecting demand for approved products [99]. - The company faces competition from major pharmaceutical and biotechnology companies developing treatments for rare diseases and cancers [112]. - The company is subject to reimbursement challenges from third-party payors, which may impact the demand and pricing of its product candidates [109]. - The company entered into a Securities Purchase Agreement on December 24, 2024, to issue units at a price of $4.00 per unit, aiming for gross proceeds between $6 million and $10 million [115]. - The gross proceeds from the Private Placement were approximately $7,103,000 before deducting transaction fees and expenses [115]. - The company has engaged Brookline Capital Markets as the exclusive placement agent for the Private Placement, with a cash fee structure based on gross proceeds [116]. - The company must seek stockholder approval for transactions related to the Securities Purchase Agreement by April 10, 2025 [115]. - The company is subject to various trade laws that prohibit corrupt payments, which could result in significant penalties if violated [111]. Workforce and Operations - As of March 28, 2025, the company had four full-time employees and one part-time employee, with no labor union representation [113]. - The company is currently conducting all operations remotely and has a corporate address in Grasonville, Maryland [114]. - The company plans to acquire HER2 Assets from Ayala, which include two IND filings with the FDA for ADXS-503 and ADXS-504, expected to close in Q2 2025 [118].

Core Insights - OS Therapies, Inc. has entered into agreements for the commercial manufacture of OST-HER2, an immunotherapy candidate aimed at preventing recurrence of lung metastatic osteosarcoma [1] - The company plans to submit a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval following a recent FDA meeting [2] - The Phase 2b trial data for OST-HER2 shows statistically significant results in the primary endpoint of 12-month event-free survival (EFS) compared to historical controls [3] - There is a strong trend favoring OST-HER2-treated patients in overall survival at the 1-year and 2-year interim time points of the ongoing study [4] - OS Therapies has acquired immuno-oncology programs and related intellectual property from Ayala Pharmaceuticals for $0.5 million in cash and $7.5 million in common shares [4][5] - The company completed a $7.1 million financing, providing sufficient cash runway into 2026, including payments to Ayala [5] - OSTX stock has increased by 28.6%, reaching $2.58 [5]