Clinical Trials and Regulatory Approvals - In Q1 2025, OS Therapies' Phase IIb clinical trial for OST-HER2 achieved a primary endpoint with 75% overall survival at two years, compared to 40% in historical controls (p < 0.0001) [207] - The company plans to submit a conditional Marketing Authorization Application to the MHRA in December 2025 and a Biologics License Application to the FDA in January 2026 [208] - The company intends to explore OST-HER2's potential in treating other solid tumors, including breast, esophageal, and lung cancers, following regulatory approval [209] - The company is analyzing patient samples from the Phase IIb trial to assess correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [208] - The OST-Tunable Drug Conjugate platform is being investigated for clinical indications in Osteosarcoma and other solid tumors [210] Financing and Capital Raising - OS Therapies completed a PIPE Financing on January 14, 2025, raising approximately $7.1 million through the issuance of 1,775,750 shares of Series A Preferred Stock and warrants [212] - The company has engaged Brookline Capital Markets as the exclusive placement agent for the PIPE Financing, with a cash fee of 7% on gross proceeds [213] - Gross proceeds from the Offerings were approximately $6,398,358, which will be used for regulatory efforts and general corporate purposes [225] - The company raised total gross proceeds of $41.1 million as of September 30, 2025, from various financing activities including private placements and an initial public offering [255] - The company has entered into a Sales Agreement to offer up to $18,000,000 in common stock, with a commission of up to 3.0% on gross sales price per share [275] Expenses and Financial Performance - Research and development expenses for the nine months ended September 30, 2025, were approximately $7.6 million, a significant increase from approximately $2.0 million for the same period in 2024 [246] - Operating loss for the nine months ended September 30, 2025, was $16,717,809 compared to a loss of $3,847,422 for the same period in 2024 [246] - General and administrative expenses for the nine months ended September 30, 2025, were $9,153,821, up from $1,878,831 in 2024 [246] - The company anticipates substantial increases in research and development expenses as it advances OST-HER2 and OST-tADC into clinical development [236] - For the nine months ended September 30, 2025, the company reported a net loss of approximately $15.3 million, compared to a net loss of $5.9 million for the same period in 2024, resulting in an accumulated deficit of approximately $55 million [254] Cash Flow and Financial Position - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $10.5 million, compared to $4.9 million for the same period in 2024 [256] - The company had cash of approximately $1.9 million as of September 30, 2025, down from $5.5 million as of December 31, 2024 [255] - Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $7.3 million, compared to $6.7 million for the same period in 2024 [261] Stockholder and Shareholder Matters - The issuance of shares related to the acquisition of HER2 assets required stockholder approval, which was obtained on April 9, 2025 [216] - The Series A preferred stock dividend requirement was $375,000 as of September 30, 2025, and has been consistent since December 31, 2024 [241] - The fair value of the Series A Warrants is subject to re-measurement at each balance sheet date until exercised or reclassified [232] Licensing and Agreements - The company has a licensing agreement with Advaxis, requiring a one-time payment of $1,550,000 and milestone payments based on specific achievements, with no payments made for the nine months ended September 30, 2025 [277] - The milestone payment schedule under the Advaxis agreement includes payments of $1,375,000 and $5,000,000 based on funding and regulatory approval milestones [278] - The company has a licensing agreement with BlinkBio, which includes an upfront fee of $300,000 and milestone payments totaling up to $22,375,000 [282] - The company has eliminated $3,500,000 in payments owed to Ayala upon the first filing of a BLA approval for OST-HER2 and reduced royalty consideration from 10% to 1.5% of net sales [279] Other Financial Matters - The company has not recorded income tax benefits for net operating losses due to uncertainty in realizing those benefits [242] - The adjustment of the fair value of the warrant liability was $1.4 million for the nine months ended September 30, 2025, compared to $0.0 million for the same period in 2024 [253] - The company has a contractual obligation of approximately $2,436,928 with George Clinical for clinical research services, with no payments made for the nine months ended September 30, 2025 [286] - The company paid $2,397,131 in consulting fees to Biolacuna Ltd for assistance in registering OST-HER2, with accounts payable of $2,022,496 as of September 30, 2025 [288] - The company has not engaged in any off-balance sheet arrangements during the reported periods [289] - The company remains an emerging growth company until certain revenue or filing thresholds are met, with total annual gross revenues of $1.235 billion or more being one of the criteria [293]
OS Therapies Incorporated(OSTX) - 2025 Q3 - Quarterly Report