Actuate Therapeutics Reports $27.3 Million Net Loss for 2024, IPO Raises $22 Million

Actuate Therapeutics, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $27.3 million for the year ended December 31, 2024, compared to a net loss of $24.7 million in 2023. This increase in net loss is primarily attributable to a $2.5 million increase in operating expenses, partially offset by a decrease in other expenses. Total operating expenses increased by $187,000 to $25.2 million in 2024, driven by a rise in general and administrative expenses, which increased by $3.2 million, while research and development expenses decreased by $3 million.

The decrease in research and development expenses was primarily due to lower preclinical and biomarker study costs, reduced external clinical trial expenses related to the Actuate-1801 Part 3B trial, lower CMC costs, and a decrease in personnel and consulting expenses resulting from consultants transitioning to full-time employment. The increase in general and administrative expenses stemmed from higher personnel-related expenses (including stock-based compensation), increased professional and consulting fees (related to board expansion and valuation services), and higher other expenses (including director and officer insurance).

Significant developments during the year included the completion of the company's initial public offering (IPO) on August 14, 2024, raising net proceeds of approximately $22 million. A 1-for-1.8 reverse stock split was also effected on June 7, 2024. Key operational developments involved the Actuate-1801 Part 3B Phase 2 trial in metastatic pancreatic ductal adenocarcinoma (mPDAC), which completed enrollment in January 2024. A preliminary analysis of interim data as of November 15, 2024, showed statistically significant increases in one-year survival rate and median overall survival compared to the control arm. The company also advanced a Phase 1/2 clinical trial (Actuate-1902) in refractory pediatric malignancies, identifying Ewing sarcoma as a potential indication.

Actuate Therapeutics is planning a Type D meeting with the FDA in 2025 to discuss Phase 3 design for mPDAC and an End of Phase 2 meeting to discuss future development plans. The company is also planning a Phase 1 study (Actuate-2401) for Elraglusib Oral Tablet, subject to future funding, with potential Phase 2 studies in metastatic melanoma and metastatic colorectal cancer. As of December 31, 2024, the company had 10 full-time employees and numerous contract workers. The company's financial condition raises substantial doubt about its ability to continue as a going concern, and it will require substantial additional capital to finance its operations. The company's outlook is contingent upon securing additional funding and achieving successful clinical trial results and regulatory approvals.