Financial Performance - The company reported a loss from operations of $17.3 million for the year ended December 31, 2025, a 20% decrease from a loss of $21.6 million in 2024[378]. - Net loss applicable to common shareholders was $17.3 million in 2025, compared to $19.8 million in 2024, reflecting a reduction in losses[406]. - Cash balance at December 31, 2025, was $5.2 million, with an accumulated deficit of $264.5 million[407]. - The company expects existing cash to fund operations into April 2026 but will need to raise additional capital to continue operations[433]. - The Company has substantial doubt regarding its ability to continue as a going concern within one year due to recurring losses and the need for additional capital[438]. Research and Development - Research and development expenses decreased by 60% to $2.8 million in 2025, down from $7.0 million in 2024[378]. - The company aims to establish AKTX-101 as a best-in-class Trop-2-targeting ADC for treating various solid tumors[361]. - The company is focused on advancing its lead program, AKTX-101, through IND-enabling activities, with a projected timeline to enter clinical trials by Q1 2027[367]. - Total research and development expenses decreased by approximately $4.2 million, or 60%, from $6.983 million in 2024 to $2.815 million in 2025[381]. - ADC preclinical development expenses increased by $1.238 million, or 100%, from $47,000 in 2024 to $1.285 million in 2025[381]. - HSCT-TMA clinical development expenses decreased by $1.817 million, or 96%, from $1.896 million in 2024 to $79,000 in 2025 due to the suspension of the AK901 clinical program[383]. - Chemistry, manufacturing and control expenses decreased by $3.281 million, or 94%, from $3.497 million in 2024 to $216,000 in 2025, also due to the suspension of the AK901 program[384]. - The company plans to invest in additional ADC-related discovery and pre-clinical development activities following the strategic prioritization of its ADC technology[382]. Financing Activities - In December 2025, the company completed equity-related transactions totaling approximately $8.7 million in gross cash proceeds[376]. - The Company closed its 2025 Registered Direct Offering on October 16, 2025, issuing 3,125,000 ADSs with gross proceeds of $2.5 million[416]. - The company entered into a securities purchase agreement on December 16, 2025, for the issuance of 10,043,774 ADSs, raising approximately $5 million in gross proceeds[413]. - The Placement Agent received a cash commission of 8.0% and a management fee of 0.5% from the December 2025 Offerings[415]. - The Company issued August 2025 Notes with an aggregate purchase price of $3,011,000 and a principal amount of $3,763,750[428]. - The company recognized $14.2 million in net proceeds from debt and equity securities issuance in 2025, compared to $11.8 million in 2024[446]. Management Changes - The company appointed a new President and CEO, Mr. Abizer Gaslightwala, in April 2025, and an Interim CFO, Mr. Kameel Farag, in October 2025[374][375]. Impairment and Valuation - An impairment charge of $5.18 million was recorded for the PHP 303 IPR&D asset due to resource reprioritization and lack of further development plans[460]. - As of December 31, 2025, the company performed its annual impairment test and concluded that the fair values of the AKTX 101 IPR&D asset and reporting unit exceeded their carrying values[461]. - The estimated fair value of Adjusted Warrants at the acquisition closing date was $1.8 million, calculated using the Black Scholes Option Pricing Model[450]. Currency and Interest Rate Risks - The company's operations are subject to currency transactional risk, particularly with fluctuations in the U.S. dollar against the British Pound, Euro, Swiss Franc, and Korean Won, which may impact profitability and shareholders' equity[466]. - The functional currency is the U.S. dollar, with activities predominantly executed in U.S. dollars, Euros, and British Pounds, and no significant operational exposures to currency fluctuations have been identified[467]. - The company has short-term promissory notes and a short-term insurance premium financing arrangement initiated in January 2026, with no current plans to hedge against interest rate risks[468]. - A hypothetical ten percent adverse movement in interest rates would result in immaterial potential losses in future earnings and cash flows, although actual effects may differ[469].
Akari Therapeutics(AKTX) - 2025 Q4 - Annual Report