Financial Performance - The company reported a loss from operations of $2.9 million for the three months ended September 30, 2024, a 17% increase from a loss of $2.5 million in the same period of 2023[176]. - For the nine months ended September 30, 2024, the loss from operations totaled $16.4 million, a 40% increase compared to a loss of $11.7 million for the same period in 2023[176]. - Net loss applicable to ordinary shareholders for the three months ended September 30, 2024, was $2.9 million, and for the nine months ended September 30, 2024, it was $16.0 million, compared to $5.9 million for the same period in 2023[200]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $2.9 million, up 17% from $2.5 million in the same period of 2023[176]. - Research and development expenses increased by approximately $0.5 million, or 146%, for the three months ended September 30, 2024, compared to the same period in 2023[178]. - Total research and development expenses for the nine months ended September 30, 2024, were $5.7 million, a 95% increase from $2.9 million in the same period of 2023[178]. - Personnel costs decreased by $0.5 million, or 60%, for the three months ended September 30, 2024, and by $1.2 million, or 48%, for the nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to the impact of the RIF announced in May 2024[184]. - General and administrative expenses decreased by approximately $1.1 million, or 39%, for the three months ended September 30, 2024, and by approximately $2.2 million, or 25%, for the nine months ended September 30, 2024, compared to the same periods in 2023[187]. - Merger-related costs for the three and nine months ended September 30, 2024, were $1.0 million and $2.3 million, respectively, with no such costs incurred during the corresponding 2023 periods[188]. - Restructuring and other costs for the three and nine months ended September 30, 2024, were $0.1 million and $1.7 million, respectively, including $0.3 million of non-cash share-based compensation expense for the nine months ended September 30, 2024[190]. Cash Position and Funding - As of September 30, 2024, the company had $2.2 million in cash and an accumulated deficit of $243.5 million, with no revenue generated to date[202]. - The company expects existing cash, plus cash from the November 2024 Private Placement, to fund operations into the first quarter of 2025[211]. - In November 2024, the company agreed to sell and issue 1,713,402 ADSs and warrants for aggregate gross proceeds of $3.2 million[207]. - In May 2024, the company raised approximately $7.6 million from a private placement of 4,029,754 ADSs and warrants[208]. - The company may need to raise additional funds and is exploring various financing options, including equity and debt securities[204]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $10,428 thousand, compared to $12,023 thousand for the same period in 2023[219]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $8,834 thousand, an increase from $3,503 thousand in the same period of 2023[221]. - The company reported a net decrease in cash of $1,599 thousand for the nine months ended September 30, 2024, compared to a decrease of $8,519 thousand in 2023[219]. - The company has substantial doubt regarding its ability to continue as a going concern within one year after the issuance of its unaudited condensed consolidated financial statements[217]. - The company is facing challenges in obtaining funding due to market receptivity and integration of operations following a merger[216]. - The company’s cash position may be adversely impacted by increases in expenses or delays in clinical development[216]. Operational Changes - The company implemented a reduction-in-force of approximately 67% of its total workforce as part of an operational restructuring plan[172]. - The HSCT-TMA program was suspended in May 2024 due to a portfolio prioritization review, impacting clinical trial costs[169][172]. - The merger with Peak Bio was completed on November 14, 2024, expanding the company's pipeline with new assets and technologies[173]. Regulatory and Development Plans - The company plans to file an Investigational New Drug Application (IND) with the FDA in 2025 for PAS-nomacopan, a long-acting form of nomacopan[168]. Accounting Policies - The company has not experienced material changes to its critical accounting policies and estimates since December 31, 2023[226]. - The company is a smaller reporting company and is not required to provide certain market risk disclosures[227].
Akari Therapeutics(AKTX) - 2024 Q3 - Quarterly Report