Actuate Therapeutics (NASDAQ: ACTU) is a clinical-stage biopharmaceutical company developing small-molecule drug candidates for cancer treatment. The company has no product revenue. It is entirely pre-commercial, funding operations through equity financing, including an IPO completed in August 2024. Its lead program is elraglusib, a GSK-3 inhibitor being evaluated in combination with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The company also supports an investigator-initiated trial combining elraglusib with FOLFIRINOX as a first-line mPDAC treatment. Total operating expenses were $22.5M for the year ended December 31, 2025, down from $25.2M in 2024, driven by a decline in external clinical trial expenses of $8.3M. Research and development expenses were $10.3M in FY2025 versus $18.7M in FY2024. Net loss was $22.2M in FY2025 compared to $27.3M in FY2024. The company relies on third-party contract research organizations and a single supplier for key materials.

Revenue model

Actuate Therapeutics generates no product revenue. Operations are funded through equity capital markets, including proceeds from its August 2024 IPO. Interest income of $287,710 was recorded for the year ended December 31, 2025.

Products and services

Lead asset: elraglusib, a small-molecule GSK-3 inhibitor in clinical development. Primary program: elraglusib combined with gemcitabine and nab-paclitaxel (GnP) for first-line metastatic pancreatic ductal adenocarcinoma. Exploratory program: elraglusib combined with FOLFIRINOX for first-line mPDAC. Additional exploratory combination with NALIRIFOX is under consideration based on clinical data.

Customers and end markets

End market: oncology, specifically metastatic pancreatic ductal adenocarcinoma. Target patient population: first-line mPDAC patients treated with GnP or FOLFIRINOX chemotherapy regimens. No commercial customers as of the 10-K filed March 26, 2026.

Value-chain role

Clinical-stage drug developer. Relies on third-party contract research organizations (CROs) to conduct non-clinical studies and clinical trials, and on a single supplier for key source components used in manufacturing product candidates. Holds a license agreement with the University of Illinois at Chicago (UIC), under which interest on deferred sublicense obligations is owed to UIC.

Geographic exposure

The filing references EU orphan drug regulatory frameworks and EU pharmaceutical legislation, indicating awareness of European regulatory pathways, but no specific geographic revenue or operational footprint is disclosed in the excerpts.

Source: SEC 10-K, filed 2026-03-26

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