Actuate Therapeutics Reports $22.2 Million Net Loss for Fiscal Year 2025

Actuate Therapeutics, Inc. has reported its financial performance for the fiscal year ending December 31, 2025, revealing a net loss of $22.2 million, a decrease from a loss of $27.3 million in the previous year. The company’s total operating expenses for 2025 were approximately $22.5 million, down from $25.2 million in 2024. This reduction was primarily driven by a significant decrease in research and development expenses, which fell to $10.3 million from $18.7 million, largely due to lower patient fees and costs associated with clinical trials as the company winds down its Phase 2 study of elraglusib for metastatic pancreatic ductal adenocarcinoma (mPDAC). General and administrative expenses, however, increased to $12.2 million, reflecting higher personnel-related costs and professional fees.

Actuate Therapeutics has made notable strides in its clinical development, particularly with elraglusib, which is currently in Phase 2 trials. The company has treated over 500 patients with elraglusib, and recent data presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium indicated that the trial met its primary endpoint, showing a statistically significant improvement in median overall survival (mOS) for patients receiving elraglusib in combination with standard chemotherapy compared to those receiving chemotherapy alone. The mOS was reported at 10.1 months for the elraglusib group versus 7.2 months for the control group.

In terms of strategic developments, Actuate has expanded its product pipeline by developing oral dosage forms of elraglusib, which are expected to facilitate the treatment of additional cancer indications. The company is also exploring new indications for elraglusib, including pediatric cancers such as Ewing sarcoma and neuroblastoma, based on promising preliminary data. The company has received Orphan Drug Designation from the FDA for elraglusib in these indications, which may provide additional market exclusivity and incentives for development.

As of December 31, 2025, Actuate reported cash and cash equivalents of approximately $13.2 million, with working capital of about $7.9 million. The company anticipates that its existing cash will not be sufficient to meet operational needs beyond July 2026 without raising additional capital. Actuate has entered into various financing agreements, including a common stock purchase agreement with B. Riley Principal Capital II, which allows the company to raise up to $50 million over a 36-month period. However, the company acknowledges the uncertainty surrounding its ability to secure additional funding, which is critical for continuing its clinical development and operational activities.

Looking ahead, Actuate plans to meet with the FDA and European Medicines Agency in the first half of 2026 to discuss the design of a Phase 3 global registration study for elraglusib. The company remains focused on advancing its clinical trials and expanding its product pipeline, but it faces significant challenges, including the need for substantial additional capital and the inherent uncertainties of drug development and regulatory approval processes.