Actuate Therapeutics (ACTU) Q4 2025 earnings summary

Executive summary

• Focused on developing elraglusib, a GSK-3β inhibitor, for high-impact cancers, especially metastatic pancreatic ductal adenocarcinoma (mPDAC).

• Phase 2 trial in mPDAC met its primary endpoint, showing statistically significant improvement in median overall survival (mOS) with elraglusib plus GnP vs. GnP alone.

• Pipeline includes both IV and oral formulations, with ongoing and planned studies in pediatric cancers and other solid tumors.

• Over 500 patients treated with elraglusib in clinical trials to date.

Financial highlights

• Net loss for 2025 was $22.2 million, an improvement from $27.3 million in 2024.

• Research and development expenses decreased to $10.3 million in 2025 from $18.7 million in 2024, mainly due to lower clinical trial costs as the Phase 2 mPDAC trial wound down.

• General and administrative expenses increased to $12.2 million in 2025 from $6.5 million in 2024, driven by higher stock-based compensation and professional fees.

• Cash and cash equivalents as of December 31, 2025 were $13.2 million; working capital was $7.9 million.

• No revenue generated from product sales since inception.

Outlook and guidance

• Current cash is expected to fund operations only through July 2026; additional capital will be required.

• Plans to meet with FDA and EMA in 1H 2026 to discuss Phase 3 global registration study for elraglusib in mPDAC.

• Advancement of pipeline and new indications contingent on securing further funding.