Intellectual Property and Product Development - The company has acquired HER2 Assets from Ayala, gaining ownership or co-ownership of certain patents for lead product candidates, including OST-HER2 and OST-tADC[70]. - The intellectual property related to OST-HER2 includes two granted U.S. utility patents and is expected to expire between 2029 and 2035, while patents for OST-tADC licensed from BlinkBio are expected to expire between 2036 and 2037[70]. - The company plans to commercialize its product candidates independently or with partners, but currently lacks sales and marketing capabilities, intending to build necessary infrastructure over time[76]. - The manufacturing of OST-HER2 active pharmaceutical ingredients is conducted in accordance with GMPs, with a focus on producing lyophilized therapeutics with consistent release profiles[80]. - The company relies on third-party manufacturers for the production of its product candidates and plans to establish framework agreements for necessary quantities of active pharmaceutical ingredients[81]. - The company has not yet received marketing approval for any product candidates and expects to rely on third-party organizations for regulatory submissions[93]. - The FDA requires extensive preclinical and clinical data for marketing approval, including safety and efficacy information, which the company must provide[94]. - The company anticipates that post-marketing requirements will include ongoing compliance with cGMPs and GCPs, as well as safety reporting[95]. - The company is developing its supply chain and plans to add backup suppliers to mitigate potential supply disruptions for its product candidates[82]. - The commercialization strategy includes developing educational initiatives and establishing relationships with oncologists to support product adoption[76]. Financial Activities and Capital Raising - The company completed a PIPE Financing on December 24, 2024, issuing 1,775,750 shares of Series A Preferred Stock and warrants, generating gross proceeds of approximately $7.1 million[127]. - The acquisition of HER2 Assets from Ayala was completed on April 9, 2025, for a total purchase price of $8 million, which included $400,000 in cash and 4,774,637 shares of common stock[130]. - An at-the-market equity offering program was initiated on August 8, 2025, allowing the company to sell shares of common stock with an aggregate offering price of up to $18 million[131]. - The company sold 282,679 shares of common stock for aggregate gross proceeds of $530,162 under the Sales Agreement as of March 26, 2026[131]. - The company executed a series of warrant exercise inducement and exchange offers, resulting in the exercise of 7,154,338 shares at an exercise price of $1.12 per share[133]. - The Third Inducement Offering allowed holders of New Warrants to purchase 2,499,558 shares at a reduced exercise price of $1.40 per share[134]. - The gross proceeds from the Inducement Offerings were approximately $11.5 million, which will be used for regulatory efforts and general corporate purposes[136]. - The company issued 10.0% original issue discount unsecured convertible promissory notes totaling $2,200,000, along with warrants for 1,666,667 shares, resulting in gross proceeds of $2,000,000 from the Bridge Financing[140]. - The company plans to use net proceeds from the Bridge Financing to fund clinical development activities and advance research and development programs[142]. - The company has agreed to file a registration statement for the resale of shares related to the Bridge Notes and Bridge Warrants by April 3, 2026[144]. - The company is actively seeking additional capital through public or private equity offerings or debt financings to fund its operations and research[435]. Financial Performance and Position - As of December 31, 2025, total assets amounted to $6,839,534, compared to $5,538,797 in 2024, reflecting an increase of approximately 23.5%[419]. - Current liabilities increased significantly to $11,764,460 in 2025 from $4,627,310 in 2024, indicating a rise of approximately 154%[419]. - The accumulated deficit as of December 31, 2025, was $(67,186,219), up from $(38,432,375) in 2024, representing an increase of approximately 74.8%[419]. - For the year ended December 31, 2025, the net loss was $28.75 million, compared to a net loss of $8.88 million for the year ended December 31, 2024, representing an increase of 224%[421]. - Research and development expenses for the year ended December 31, 2025, were $16.36 million, significantly up from $2.84 million in 2024, indicating a growth of 475%[421]. - The total operating expenses for 2025 were $28.71 million, compared to $6.81 million in 2024, reflecting an increase of 321%[421]. - The company had cash and cash equivalents of $269,830 as of December 31, 2025, a decrease from $5.53 million at the end of 2024[426]. - The company used $14.24 million in cash for operating activities in 2025, compared to $7.28 million in 2024, marking an increase of 95%[426]. - The company expects vendor and related costs associated with regulatory approvals to total approximately $25 million, continuing into 2026[434]. - The weighted average number of shares outstanding increased to 29,253,292 in 2025 from 6,950,100 in 2024, representing a growth of 320%[421]. - The basic and diluted loss per common share for 2025 was $(0.98), compared to $(1.28) for 2024, showing an improvement of 23.4%[421]. - The company has a net capital deficiency that raises substantial doubt about its ability to continue as a going concern[413]. Corporate Structure and Operations - The company has four full-time employees and one part-time employee as of March 26, 2026, with no labor unions involved[125]. - The company’s corporate address is located in Grasonville, Maryland, and all operations are currently conducted remotely[126]. - The company formed two wholly-owned subsidiaries in 2025, OS Animal Health Corp and OS Therapies UK LTD, to expand its research and development capabilities[431][432]. - The company is subject to various U.S. and foreign laws regarding trade, anti-corruption, and data protection, which inform its operational policies[119][111]. - The biotechnology and pharmaceutical industries are highly competitive, with the company facing competition from large pharmaceutical firms and research institutions[122]. Asset Management and Liabilities - Amortization expense for acquired intangible assets was $360,305 for the year ended December 31, 2025, compared to $0 for 2024[445]. - The Company has projected future amortization expenses totaling $6,504,132, with annual expenses of $496,972 from 2026 to 2030 and $4,019,272 thereafter[449]. - The Company reported net operating loss carryforwards of $9,900,522 as of December 31, 2025, up from $6,559,791 in 2024[461]. - Total deferred tax assets were $13,214,741 as of December 31, 2025, with a corresponding valuation allowance of the same amount[461]. - The Company recognized no impairment losses on long-lived assets for the years ended December 31, 2025, and 2024[450]. - The carrying value of the warrant liability was $0 as of December 31, 2025, compared to $1,971,975 as of December 31, 2024, indicating a significant reduction in liability[473]. - The company evaluated its financial instruments and determined that the convertible notes should be recorded as liabilities, reflecting their share-settled nature[492]. - The company’s convertible notes had a maturity date extended to October 31, 2024, under the same terms, indicating ongoing financing arrangements[496]. - The Company entered into unsecured Subordinated Convertible Promissory Note Agreements with lenders, accruing interest at a rate of 6% per annum[503]. - The Company will automatically convert the outstanding principal and unpaid accrued interest into equity securities at 50% of the price paid per share in the Next Equity Financing, provided it raises at least $10,000,000[520].
OS Therapies Incorporated(OSTX) - 2025 Q4 - Annual Report