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 Q2 2025 Financial Results and Business Update](index=1&type=section&id=OS%20Therapies%20Q2%202025%20Financial%20Results%20and%20Business%20Update) [Business Update and Strategic Outlook](index=1&type=section&id=Business%20Update%20and%20Strategic%20Outlook) The company reports positive clinical data and regulatory progress for its lead candidate OST-HER2, advancing towards a BLA submission and a potential 2026 launch - Updated interim 2-year overall survival and final 12-month Event Free Survival (EFS) data both show a **statistically significant benefit** for patients treated with OST-HER2[3](index=3&type=chunk) - The company is progressing towards a **Biologics Licensing Application (BLA) submission** to the U.S. FDA for OST-HER2 under the Accelerated Approval Program[3](index=3&type=chunk) - A commercial partnership with Eversana is in place, preparing for a potential **U.S. launch of OST-HER2 in the first half of 2026**[3](index=3&type=chunk) - The company is eligible for a Priority Review Voucher (PRV) upon BLA approval, which it intends to sell; recent PRV sales were valued between **$155 million and $160 million**[3](index=3&type=chunk) - Regulatory processes have been initiated internationally, with an ILAP submission to the U.K's MHRA and a scheduled meeting with the European Medicines Agency (EMA)[3](index=3&type=chunk) [Key Corporate Highlights](index=1&type=section&id=Key%20Corporate%20Highlights) The company highlights positive FDA interactions, strong clinical data, a commercial partnership, a successful capital raise, and inclusion in Russell indexes - The FDA confirmed OST-HER2 meets the biological definition of a **Regenerative Medicine Advanced Therapy (RMAT)** and issued a BLA number in preparation for submission[4](index=4&type=chunk) - **Statistically significant** 12-month Event Free Survival and interim 2-year Overall Survival data are driving global accelerated approval pathways[4](index=4&type=chunk) - A commercial partnership with Eversana positions OST-HER2 for a potential **U.S. launch in the first half of 2026**[4](index=4&type=chunk) - A **$4.2 million capital raise**, closed in July 2025, extends the company's cash runway into mid-2026[4](index=4&type=chunk) - The company's stock (OSTX) was included in the **Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes**[4](index=4&type=chunk) [Detailed Progress and Upcoming Milestones](index=2&type=section&id=Detailed%20Progress%20and%20Upcoming%20Milestones) The company outlines significant clinical, regulatory, and corporate achievements and key milestones for the remainder of 2025 [Progress to Date](index=2&type=section&id=Progress%20to%20Date) The company details positive clinical data, regulatory progress in the US and Europe, and key corporate developments including a capital raise and partnership **OST-HER2 Phase 2b Clinical Trial Data** | Metric | OST-HER2 vs. Control | P-value | | :--- | :--- | :--- | | **Final 12-month EFS** | 35% vs. 20% | p = 0.0197 | | **Interim 2-year Overall Survival** | 66.6% vs. 40% | p = 0.0046 | - OST-HER2 demonstrated a **strong safety profile**, with zero patients experiencing grade 4 or grade 5 treatment-associated adverse events[5](index=5&type=chunk) - Acquired the listeria cancer immunotherapy platform from Ayala Pharmaceuticals, adding **4 clinical-stage and 8 preclinical-stage candidates** to the pipeline[5](index=5&type=chunk) - Closed a warrant exercise inducement and exchange offering, raising **$4.2 million in gross proceeds** and extending the cash runway into mid-2026[5](index=5&type=chunk) [Upcoming 2025 Milestones](index=3&type=section&id=Upcoming%202025%20Milestones) Key upcoming milestones include FDA and EMA meetings and the initiation of a rolling BLA submission for OST-HER2 - An **End of Phase 2 Meeting with the FDA** is scheduled for August 27, 2025, to guide the BLA submission process[9](index=9&type=chunk) - The company projects initiating a **rolling BLA submission** for OST-HER2 in late Q3 2025[9](index=9&type=chunk) - A rapporteur meeting with the EMA is scheduled for October 2025 to advance the **European approval process**[9](index=9&type=chunk) - The company is targeting potential **regulatory approval for OST-HER2 in the U.S. and U.K.** as early as year-end 2025[9](index=9&type=chunk) - An At-The-Market (ATM) offering agreement was established, enabling the company to raise up to **$18 million in gross proceeds**[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reports a higher net operating loss due to increased regulatory expenses, though net loss per share improved with more shares outstanding **Q2 2025 vs. Q2 2024 Financials** | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net Operating Loss** | $4.537 million | $1.557 million | | **Net Loss Per Share** | $0.19 | $0.26 | | **Weighted Avg. Shares** | 25.114 million | 5.991 million | - The increase in net operating loss was largely due to expenses associated with U.S. and international **regulatory activities** for the OST-HER2 Phase 2b osteosarcoma program[6](index=6&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) The company is a clinical-stage oncology firm focused on Osteosarcoma, with a lead immunotherapy candidate, OST-HER2, and a tADC platform - The company's lead asset is **OST-HER2**, an immunotherapy for Osteosarcoma that targets the HER2 protein[7](index=7&type=chunk) - OST-HER2 has received **Rare Pediatric Disease Designation (RPDD), Fast-Track, and Orphan Drug designations** from the U.S. FDA and EMA[7](index=7&type=chunk) - The company is also advancing a next-generation tunable **Antibody Drug Conjugate (tADC) platform** using proprietary Si-Linker and Conditionally Active Payload (CAP) technology[8](index=8&type=chunk)

OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update August 19, 2025 6:00 AM EDT | Source: OS Therapies New York, New York--(Newsfile Corp. - August 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported second quarter 2025 financial results ended June 30, 2025 and provided a business update. End of Phase 2 Meeting with FDA scheduled for A ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements, management's financial analysis, market risk, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited consolidated financial statements, including balance sheets, operations, equity, and cash flows, highlighting increased net loss, asset growth, and liquidity concerns [Balance Sheets](index=3&type=section&id=Balance%20Sheets) The balance sheets show significant asset growth driven by patent acquisition and a shift from stockholders' deficit to positive equity Balance Sheet Summary (unaudited) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,802,013 | $5,533,527 | | Total Current Assets | $3,553,976 | $5,533,527 | | Patents (Net) | $6,752,619 | $0 | | **Total Assets** | **$10,310,475** | **$5,538,797** | | **Liabilities & Equity** | | | | Total Current Liabilities | $3,458,034 | $4,627,310 | | Total Liabilities | $3,558,034 | $4,727,310 | | Total Stockholders' Equity (Deficit) | $4,943,647 | ($3,266,538) | - Total assets increased significantly from **$5.5 million** to **$10.3 million**, primarily driven by the acquisition of patents valued at **$6.8 million**[9](index=9&type=chunk) - The company's financial position improved from a stockholders' deficit of **($3.3 million)** at the end of 2024 to a positive stockholders' equity of **$4.9 million** as of June 30, 2025[9](index=9&type=chunk) [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) The statements of operations reveal a substantial increase in net loss due to higher research and development and general and administrative expenses Statements of Operations Summary (unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2,499,498 | $396,567 | $3,808,653 | $758,376 | | General & Administrative | $2,339,230 | $383,233 | $6,029,561 | $651,656 | | Loss from Operations | ($4,838,728) | ($779,800) | ($9,838,214) | ($1,410,032) | | **Net Loss** | **($4,536,622)** | **($1,557,480)** | **($8,413,481)** | **($3,016,472)** | | Basic & Diluted Loss per Share | ($0.19) | ($0.26) | ($0.35) | ($0.52) | - Net loss for the six months ended June 30, 2025, increased to **$8.4 million** from **$3.0 million** in the same period of 2024, driven by a substantial rise in both Research & Development and General & Administrative expenses[11](index=11&type=chunk) [Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) This section details the increase in common shares outstanding and the drivers of the shift to positive stockholders' equity, including conversions and stock issuances - The number of common shares issued and outstanding increased from **20.9 million** at the end of 2024 to **29.7 million** by June 30, 2025[14](index=14&type=chunk) - The increase in stockholders' equity during the first half of 2025 was driven by several non-cash and financing activities, including the conversion of preferred shares and warrants to common stock, and issuance of common stock for a patent purchase and services[14](index=14&type=chunk) [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) The cash flow statements show a significant increase in cash used in operating activities, partially offset by cash provided from financing activities Cash Flow Summary (unaudited) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,802,138) | ($1,522,920) | | Net cash used in investing activities | ($466,423) | $0 | | Net cash provided by financing activities | $3,537,047 | $1,578,863 | | **Net change in cash** | **($2,731,514)** | **$55,943** | | Cash – end of period | $2,802,013 | $94,925 | - Cash used in operating activities significantly increased to **$5.8 million** in the first six months of 2025, compared to **$1.5 million** in the prior year period, reflecting the higher net loss[17](index=17&type=chunk) - Financing activities provided **$3.5 million** in cash, primarily from the sale of preferred stock and warrant conversions, which partially offset the cash used in operations and investing[17](index=17&type=chunk) [Notes to the Financial Statements](index=7&type=section&id=Notes%20to%20the%20Financial%20Statements) These notes detail critical accounting policies, significant transactions like the HER2 asset acquisition, debt conversions, and the company's going concern assessment - The company's financial statements are prepared on a going concern basis, but its history of net losses and negative operating cash flows raises substantial doubt about its ability to continue as a going concern. As of June 30, 2025, the company had cash of **$2.8 million** and is dependent on raising additional capital[22](index=22&type=chunk)[23](index=23&type=chunk) - On April 9, 2025, the company acquired HER2 Assets from Ayala Pharmaceuticals for a total fair value of **$6,864,438**, consisting of cash and common stock. This is accounted for as an asset acquisition[33](index=33&type=chunk)[34](index=34&type=chunk) - All convertible notes were converted into common stock on August 2, 2024, upon the consummation of the company's IPO, resulting in a zero balance for convertible debt as of June 30, 2025[75](index=75&type=chunk)[80](index=80&type=chunk) - Subsequent to the quarter end, the company issued an aggregate of **1,621,060 shares** of common stock upon the exercise of Series A Warrants and filed a registration statement on Form S-3 for a potential offering of up to **$100 million** in securities[189](index=189&type=chunk)[190](index=190&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's clinical-stage biopharmaceutical focus, recent financing activities, significant increases in operating expenses leading to higher net loss, and ongoing liquidity challenges requiring additional capital - The company is a clinical-stage biopharmaceutical firm focused on treatments for Osteosarcoma (OS), with its lead product candidate being OST-HER2. A clinical study for OST-HER2 achieved full enrollment in October 2023, and the company plans to submit a Biologics License Application (BLA) following an anticipated End of Phase 2 meeting with the FDA in Q3 2025[196](index=196&type=chunk) - Recent financing activities include a PIPE financing in late 2024/early 2025 raising gross proceeds of **~$7.1 million** and a warrant exercise inducement offer completed in July 2025 raising gross proceeds of **~$4.2 million**[198](index=198&type=chunk)[207](index=207&type=chunk)[210](index=210&type=chunk) - On April 9, 2025, the company acquired Lm-based immune-oncology programs and related intellectual property assets (the "HER2 Assets") from Ayala Pharmaceuticals, Inc[203](index=203&type=chunk) Comparison of Operating Results (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development | ~$3.8 million | ~$0.8 million | +$3.0 million | | General & Administrative | ~$6.0 million | ~$0.7 million | +$5.3 million | | **Net Loss** | **~$8.4 million** | **~$3.0 million** | **+$5.4 million** | - As of June 30, 2025, the company had approximately **$2.8 million** in cash. Management believes this, along with proceeds from recent financing, will fund operations and capital requirements for the next 9 to 12 months[241](index=241&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company, as a smaller reporting company, has indicated that this section is not applicable and has not provided any disclosures regarding market risk - This section is marked as 'Not applicable', which is common for smaller reporting companies[279](index=279&type=chunk) [Item 4. Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were ineffective as of June 30, 2025, due to limited personnel and insufficient policies, with no material changes to internal controls during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were not effective[281](index=281&type=chunk) - The identified weakness is a lack of segregation of duties due to limited personnel and insufficient written policies for accounting, IT, and financial reporting[281](index=281&type=chunk) [PART II. OTHER INFORMATION](index=56&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, updated risk factors, unregistered sales of equity securities, and a list of exhibits [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports no pending legal proceedings, though an arbitration claim from a former investment advisor regarding IPO compensation is disclosed in Note 6 - The company is not currently a party to any pending legal proceedings[284](index=284&type=chunk) - Note 6 to the financial statements discloses an arbitration claim brought by a former investment advisor regarding underwriter compensation for the IPO, which the company believes is meritless[159](index=159&type=chunk)[284](index=284&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors.) This section references existing risk factors and introduces a new one concerning the potential adverse impact on common stock price from the issuance and resale of shares related to a recent warrant inducement offering - A new risk factor has been added concerning the potential for the market price of common stock to be adversely affected by the issuance of **3,764,995 shares** in connection with the recent warrant inducement offering and the potential resale of these shares[286](index=286&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) In Q2 2025, the company issued **10,000 shares** of common stock to an advisor for services, relying on a Section 4(a)(2) Securities Act registration exemption - In Q2 2025, the company issued **10,000 shares** of common stock to an advisor for services, exempt from registration under Section 4(a)(2) of the Securities Act[288](index=288&type=chunk) [Item 6. Exhibits](index=57&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Form 10-Q, including warrant and inducement offer forms, and required CEO/CFO certifications - The report includes several exhibits, notably the Form of Warrant and Form of Inducement Offer Letter from the June 2025 financing activities, and CEO/CFO certifications as required by the Sarbanes-Oxley Act[289](index=289&type=chunk)

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 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]