Financial Performance - For the three months ended September 30, 2024, total operating expenses were $14.0 million, a decrease of 23% from $18.2 million in the same period of 2023[134]. - The net loss for the three months ended September 30, 2024, was $12.7 million, a 24% improvement compared to a net loss of $16.7 million for the same period in 2023[134]. - As of September 30, 2024, the accumulated deficit was $198.3 million, with net losses of $43.8 million and $47.8 million for the nine months ended September 30, 2024, and 2023, respectively[123]. - Net loss for the nine months ended September 30, 2024, was $43.8 million, a reduction of $4.0 million (8%) compared to a net loss of $47.8 million in 2023[146]. - Other income, net for the nine months ended September 30, 2024, was $4.4 million, an increase of $1.4 million (47%) compared to $3.0 million in 2023[145]. Research and Development - Research and development expenses decreased to $8.3 million for the three months ended September 30, 2024, down 43% from $14.4 million in the prior year, primarily due to reduced clinical trial costs and personnel-related expenses[135]. - Research and development expenses for the nine months ended September 30, 2024, were $35.1 million, a decrease of $4.9 million (12%) compared to $40.0 million for the same period in 2023[141]. - The company plans to initiate a Phase 1 trial in Chagas disease and a Phase 2 proof-of-concept trial in melioidosis in 2025, along with advancing earlier-stage programs in oncology and infectious diseases[119]. - The Phase 2 part of the EBO-301 study for epetraborole showed a PRO-based clinical response rate of 39.5% compared to 25.0% for placebo, indicating potential clinical proof of concept[117]. - The company intends to request an End-of-Phase-2 meeting with the FDA in the first half of 2025 to discuss re-initiating a pivotal Phase 3 trial for treatment-refractory MAC lung disease[118]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2024, were $48.2 million, down by $2.6 million (5%) from $50.8 million in the prior year[140]. - General and administrative expenses for the three months ended September 30, 2024, were $3.5 million, down from $3.8 million in the same period of 2023[137]. - A workforce reduction of approximately 50% was announced, resulting in severance and other charges of $2.2 million for the three and nine months ended September 30, 2024[121]. - Restructuring charges for the three months ended September 30, 2024, were $2.2 million, with no charges reported in the same period of 2023[138]. Cash and Investments - Cash, cash equivalents, and investments totaled $93.4 million as of September 30, 2024, expected to fund operations for at least the next twelve months[124]. - The company had cash, cash equivalents, and investments totaling $93.4 million as of September 30, 2024, primarily in money market funds and investment-grade securities[172]. - Net cash used in operating activities was $44.0 million for the nine months ended September 30, 2024, compared to $36.2 million for the same period in 2023, reflecting a net loss primarily due to drug development expenses[156][158]. - Net cash provided by investing activities was $61.5 million for the nine months ended September 30, 2024, primarily from $83.8 million in proceeds from the maturity of investments, while it was a net cash outflow of $43.7 million in 2023[159][160]. - Net cash provided by financing activities was $0.4 million for the nine months ended September 30, 2024, a significant decrease from $85.3 million in 2023, which included proceeds from stock offerings[161][162]. Future Outlook - The company expects to incur substantial additional losses in future periods as it continues its research and development efforts[148]. - Future funding requirements are anticipated to be significant, with the company not expecting to generate meaningful revenue until regulatory approval and commercialization of its product candidates[148]. - The company aims to preserve capital while maximizing income from investments, with a focus on maintaining a portfolio in accordance with its investment policy[173]. Risk Factors - The company does not believe that inflation, interest rate changes, or exchange rate fluctuations had a significant impact on its results of operations for the periods presented[174][176]. - The company was not exposed to material foreign currency risk during the quarter ended September 30, 2024[175].
AN2 Therapeutics(ANTX) - 2024 Q3 - Quarterly Report