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]
OS Therapies Incorporated(OSTX) - 2025 Q1 - Quarterly Report