Actuate Therapeutics, Inc. Common stock

What they do

Actuate Therapeutics develops elraglusib, an ATP-competitive small molecule designed to block glycogen synthase kinase-3 beta (GSK-3 beta), a regulator of signaling cascades involved in tumor survival, growth, migration and invasion. Elraglusib was exclusively licensed from the University of Illinois-Chicago and Northwestern University and has been tested in Phase 1 and Phase 2 studies. The company is advancing both an intravenous injection and an oral tablet formulation across multiple cancer indications.

Revenue drivers

• Elraglusib Injection in mPDAC — Most advanced program; Actuate-1801 Part 3B, a randomized Phase 2 trial in first-line metastatic pancreatic ductal adenocarcinoma, enrolled 286 patients and met its primary endpoint. The company has not generated revenue from product sales.
• Elraglusib Injection in pediatric cancers — The Actuate-1902 Phase 1/2 study evaluated elraglusib alone and with irinotecan or cyclophosphamide/topotecan; objective responses in combination arms led the company to identify Ewing sarcoma and neuroblastoma for further development.
• Elraglusib Oral Tablet — Oral dosage forms are intended to expand targetable indications and offer more convenient daily dosing; an IND for a Phase 1/2 study in advanced refractory cancers was filed in April 2026 and cleared by the FDA.

Recent performance

Actuate has no product revenue and has reported net losses each year, including $24.7M in 2023, $27.3M in 2024 and $22.2M in 2025. Operating cash flow was negative $21.6M, $21.8M and $19.2M in 2023, 2024 and 2025, respectively. At June 30, 2026, total assets were $5.2M, total liabilities $4.2M, shareholder equity $989,152 and cash and equivalents $4.4M. The accumulated deficit was approximately $154.6 million at December 31, 2025.

Strategy

The company plans to meet with the FDA and EMA in the first half of 2026 to discuss a Phase 3 global registration study of elraglusib in mPDAC. It received FDA clearance for a Phase 1/2 study of the Elraglusib Oral Tablet to identify the maximum tolerated dose and Recommended Phase 2 Dose in advanced refractory cancers. After determining a Recommended Phase 2 Dose, the company has identified possible Phase 2 or registrational studies in first-line mPDAC, refractory metastatic melanoma, refractory metastatic colorectal cancer and non-small cell lung cancer, subject to additional funding.

Risks

• Going-concern and funding risk — With $4.4M of cash at June 30, 2026 and an accumulated deficit of about $154.6M at December 31, 2025, the company states it may need to raise additional capital.
• No revenue or profitability — Actuate has not generated revenue from product sales, has incurred significant operating losses since inception and expects continued losses for the foreseeable future.
• Clinical and regulatory uncertainty — The lead program is a Phase 2 trial, and the planned Phase 3 registration study in mPDAC and the oral tablet study remain subject to FDA and EMA discussions and additional funding.
• Listing and market risk — The company disclosed a delisting notice or listing-rule failure on July 17, 2026, which could affect the trading of its common stock.

Outlook

Management expects to discuss a Phase 3 global registration study of elraglusib in mPDAC with the FDA and EMA in the first half of 2026. The FDA has cleared the Phase 1/2 study of the Elraglusib Oral Tablet, and the company plans to identify a Recommended Phase 2 Dose before pursuing further studies. Additional development, including in first-line mPDAC, refractory metastatic melanoma, refractory metastatic colorectal cancer and non-small cell lung cancer, is subject to additional funding.