Akari Therapeutics(US:AKTX)2025-11-13 22:01Financial Performance - The company reported a loss from operations of $7.4 million for the three months ended September 30, 2025, a 153% increase compared to a loss of $2.9 million for the same period in 2024[169]. - The company reported a 14% decrease in loss from operations for the nine months ended September 30, 2025, totaling $14.0 million compared to $16.4 million for the same period in 2024[169]. - The net loss applicable to common shareholders for the three months ended September 30, 2025, was $6.4 million, compared to a net loss of $2.9 million for the same period in 2024[201]. - As of September 30, 2025, the company had $2.5 million in cash and an accumulated deficit of $259.3 million, with no revenue generated to date[202]. - The Company reported a net change in cash of $(115,000) for the nine months ended September 30, 2025, compared to $(1,599,000) for the same period in 2024[228]. - As of September 30, 2025, the Company had net cash used in operating activities of $(7,527,000), an improvement from $(10,428,000) in the same period of 2024[228]. - The Company may face substantial doubt regarding its ability to continue as a going concern within one year due to recurring losses and the need for additional capital[226]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $7.4 million, which includes a $5.18 million non-cash impairment loss on other intangible assets[169]. - Research and development expenses for the three months ended September 30, 2025, were $249,000, an increase of $106,000 compared to $143,000 for the same period in 2024[172]. - HSCT-TMA clinical development expenses decreased by $0.5 million and $1.5 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024, due to the suspension of the AK901 clinical program[173]. - CMC expenses decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2025, respectively, primarily due to the suspension of the pre-clinical PAS-nomacopan program[175]. - General and administrative costs increased by approximately $0.3 million and $0.5 million for the three and nine months ended September 30, 2025, respectively, mainly due to an increase in non-cash stock-based compensation[180][181]. Funding and Capital Structure - The company completed a registered direct offering on October 16, 2025, raising gross proceeds of $2.5 million by issuing 3,125,000 ADSs at a price of $0.80 each[164]. - The company entered into an Ordinary Share Purchase Agreement with White Lion Capital, allowing for the potential purchase of up to $25 million in newly issued Ordinary Shares[165]. - The Company entered into a placement agency agreement, paying $262,500 in cash for the 2025 Registered Direct Offering and granting warrants for 125,000 ADSs at an exercise price of $1.00 per ADS[208]. - Under the ELOC Purchase Agreement, the Company can require White Lion to purchase up to $25,000,000 in newly issued Ordinary Shares, subject to certain conditions[209]. - The Company has the right to control the timing and amount of sales of Ordinary Shares to White Lion, with a commitment period ending on August 29, 2028[210]. - The maximum number of Ordinary Shares that can be issued under the ELOC Purchase Agreement is capped at 13,039,369,358, representing 19.99% of the Company's outstanding shares[211]. - The Company issued August 2025 Notes with an aggregate purchase price of $3,011,000 and a principal amount of $3,763,750, with maturity dates ranging from August 15, 2026, to September 26, 2026[218]. - The Company has outstanding convertible notes and notes payable expected to result in principal payments of approximately $4.6 million as of September 30, 2025[231]. - The Company is seeking additional funding through equity and/or debt securities to continue operations, as it currently has no products approved for sale and does not generate revenue[222]. Management and Corporate Actions - The company has suspended internal development of legacy programs nomacopan and PAS-nomacopan to focus on the ADC platform[156]. - The company appointed Mr. Kameel Farag as Interim Chief Financial Officer, effective October 22, 2025, with a monthly cash fee of $18,000[162]. - The company recognized a gain on settlement of current liabilities of $0.8 million during the three months ended September 30, 2025[189]. - The company recognized an impairment loss related to in-process R&D of PHP 303 due to reprioritization of resources[182]. Research and Development - The company aims to establish AKTX-101 as a best-in-class Trop2-targeting ADC for treating various solid tumors[155]. - The company presented immune mechanism-of-action data for its novel ADC payload at the 2025 Society for Immunotherapy of Cancer Annual Meeting, indicating potential new treatment paradigms[161]. Accounting and Reporting - Management's discussion and analysis is based on unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP[234]. - No material changes to critical accounting policies and estimates have occurred since December 31, 2024[235]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[236].