Financial Performance - Actuate Therapeutics reported a net loss of $27,285,328 for the year ended December 31, 2024, compared to a net loss of $24,744,620 for 2023, indicating an increase in losses [126]. - The company has an accumulated deficit of $150,053,748 as of September 30, 2025, primarily due to research and development costs and general administrative expenses [126]. - The net loss for the three months ended September 30, 2025 was $5,407,470, a decrease of $563,491 compared to a net loss of $5,970,961 in 2024 [127]. - The net loss for the nine months ended September 30, 2025 was $17,673,899, an improvement of $3,165,340 compared to a net loss of $20,839,239 in 2024 [131]. - The company reported a net loss of $17,673,899 for the nine months ended September 30, 2025, compared to a net loss of $20,839,239 for the same period in 2024 [145]. - The company has incurred significant operating losses and negative cash flows from operations since inception, with expectations of continued losses as it advances clinical development of elraglusib and future product candidates [135]. - The company has substantial doubt regarding its ability to continue as a going concern due to ongoing losses and cash flow challenges [141]. Research and Development - The Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) showed a median overall survival (mOS) of 10.1 months for the elraglusib/GnP group compared to 7.2 months for the GnP group, representing a 37% reduction in the risk of death [106]. - The 12-month overall survival rate was 44.1% for the elraglusib/GnP group versus 22.3% for the GnP group, with a p-value of 0.0005 indicating statistical significance [107]. - The overall response rate (ORR) for the elraglusib/GnP group was 29.0%, compared to 21.8% for the GnP group [108]. - Actuate Therapeutics plans to advance elraglusib for the treatment of relapsed/refractory Ewing sarcoma (EWS) in a Phase 2 study in 2026, subject to funding availability [111]. - The company has developed oral dosage forms of elraglusib and plans to conduct a Phase 1 study for the Elraglusib Oral Tablet to identify the maximum tolerated dose [113]. - Actuate Therapeutics has submitted an amended investigational new drug (IND) application to the FDA and is seeking Breakthrough Therapy Designation (BTD) for elraglusib [109]. - The company anticipates significant increases in research and development expenses as it continues clinical trials and seeks regulatory approvals for elraglusib [117]. - The company is committed to ongoing clinical trials for elraglusib, with costs dependent on the size, number, and length of these trials [142]. Operating Expenses - For the three months ended September 30, 2025, total operating expenses were $5,472,378, a slight increase of $79,475 compared to $5,392,903 in 2024 [127]. - Research and development expenses decreased by $1,579,180 to $2,177,922 for the three months ended September 30, 2025, primarily due to lower external clinical trial expenses [128]. - General and administrative expenses increased by $1,658,655 to $3,294,456 for the three months ended September 30, 2025, mainly driven by a rise in personnel-related expenses [129]. - For the nine months ended September 30, 2025, total operating expenses were $17,806,839, a decrease of $794,767 from $18,601,606 in 2024 [131]. - Research and development expenses for the nine months ended September 30, 2025 were $8,163,046, down $6,827,291 from $14,990,337 in 2024 [132]. - General and administrative expenses for the nine months ended September 30, 2025 increased by $6,032,524 to $9,643,793, largely due to higher personnel-related expenses [133]. Cash Flow and Financing - As of September 30, 2025, the company had cash and cash equivalents of $16,924,763 and working capital of $11,071,338, but expects expenses to increase substantially, potentially exhausting cash reserves by the second quarter of fiscal year 2026 without additional capital [139]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $15,470,210, compared to $17,070,233 for the same period in 2024 [144]. - The company raised net proceeds of $15,573,966 from the September 2025 Public Offering and $4,592,462 from the June 2025 Private Placement during the nine months ended September 30, 2025 [147]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was $23,753,351, down from $27,635,023 in the same period of 2024 [144]. - Interest income for the nine months ended September 30, 2025 increased by $43,950 to $148,128 compared to $104,178 in 2024, attributed to a higher average cash balance [134]. - The company recognized a total other income of $132,940 for the nine months ended September 30, 2025, compared to a total other expense of $2,237,633 in 2024, reflecting a significant improvement [134]. - The company plans to finance operations through equity offerings, debt financings, or other capital sources, but may face challenges in raising additional funds on favorable terms [140]. Company Classification - The company is classified as an emerging growth company and a smaller reporting company, allowing it to take advantage of scaled disclosures and an extended transition period for compliance with new accounting standards [150][151].
Actuate Therapeutics,Inc(ACTU) - 2025 Q3 - Quarterly Report