Financial Performance - For the year ended December 31, 2023, the company reported a loss from operations of $16.8 million, a 27% decrease from a loss of $23.1 million in 2022[368]. - The net loss applicable to common shareholders for 2023 was $10.0 million, compared to $17.7 million in 2022[385]. - The company has not generated any revenue to date and expects to continue incurring substantial operating losses[388]. - The company reported a net decrease in cash of $9.4 million for the year ended December 31, 2023, compared to an increase of $3.9 million in 2022[403]. Research and Development - Total research and development expenses decreased by approximately $4.1 million, or 43%, to $5.45 million in 2023 from $9.56 million in 2022[370]. - The HSCT-TMA clinical development expenses increased by 62% to $1.80 million in 2023, primarily due to the prioritization of the HSCT program[371]. - Research and development expenses are estimated based on discussions with internal personnel and service providers, with adjustments made as necessary to reflect the progress of clinical trials[416]. Cash and Financing - The company had $3.8 million in cash and an accumulated deficit of $227.5 million as of December 31, 2023[387]. - The company expects existing cash, including gross proceeds of approximately $2.0 million from the March 2024 Private Placement, to fund operations through April 2024[397]. - The company raised a total of $7.0 million in net proceeds from various equity offerings in 2023, compared to $25.3 million in 2022[409]. - In December 2023, the company completed a private placement, selling 947,868 ADSs at $2.11 per ADS for gross proceeds of approximately $2.0 million[390]. - In September 2023, the company completed a private placement, selling 551,816 ADSs at $3.30 per ADS, raising approximately $2.0 million in gross proceeds, with net proceeds of about $1.7 million after expenses[391]. - The March 2023 Registered Direct Offering generated approximately $4.0 million in gross proceeds from the sale of 1,333,333 ADSs at $3.00 per ADS, resulting in net proceeds of around $3.5 million[393]. - The company anticipates needing to raise additional capital to continue operations and service obligations in the future, as it currently has no products approved for sale and does not generate revenue[397]. - The company may face significant challenges in obtaining financing, which could adversely affect its ability to continue operations and pursue product development[398]. Expenses - General and administrative expenses decreased by approximately $2.2 million, or 16%, to $11.36 million in 2023 from $13.53 million in 2022[379]. - For the year ended December 31, 2023, the company reported net cash used in operating activities of $16.4 million, a decrease from $21.5 million in 2022, primarily due to a $6.3 million reduction in operating expenses[403]. - As of the filing date, the company has non-cancellable manufacturing-related obligations expected to result in payments of approximately $3.5 million in the third quarter of 2024[406]. Currency and Interest Rate Risks - The company is exposed to currency transactional risk, with operating results translated into U.S. dollars, impacting profitability and asset values due to fluctuations in the British Pound, Euro, and Swiss Franc[419]. - The functional currency is the U.S. dollar, with limited operational exposure to currency fluctuations, and no hedging agreements currently in place[420]. - A hypothetical ten percent adverse movement in interest rates would result in immaterial potential losses in future earnings and cash flows[422]. Valuation and Tax - The estimated fair value of the October 2023 Placement Agent Warrants issued was approximately $0.1 million[392]. - A valuation allowance is recorded to reduce deferred tax assets to realizable amounts, requiring significant judgment based on projected future taxable income and tax planning strategies[417]. - The fair value of the September 2022 Warrants is determined using a Black-Scholes model, with significant fluctuations expected during each remeasurement period due to the subjective nature of the inputs used[414][415].
Akari Therapeutics(AKTX) - 2023 Q4 - Annual Report