Actuate Therapeutics (ACTU) presented clinical data and development plans for its small-molecule GSK-3β inhibitor elraglusib at the H.C. Wainwright 28th Annual Global Investment Conference on Monday, Sept. 14, 2026.
The company highlighted results from its BEACON2 trial, sponsored by Cancer Research UK, in which elraglusib combined with gemcitabine and Abraxane produced a median overall survival of 10.1 months in first-line metastatic pancreatic cancer, compared with 7.2 months in the control arm. The hazard ratio for death was 0.62, reflecting a 38% reduction in risk. Among patients who received at least four doses, the hazard ratio improved to 0.58. Those reaching a mean daily concentration of at least 210 nanograms per milliliter — roughly 60% of participants — saw a hazard ratio of 0.48.
Actuate noted the regimen doubled one-year survival and produced a fivefold increase in two-year survival versus control. The company called it the first compound in 12 years to demonstrate a significant overall survival benefit in first-line metastatic pancreatic cancer.
Elraglusib has been tested in more than 500 patients across clinical programs. The firm also presented preclinical data showing synergy or additivity when elraglusib was paired with RAS inhibitors across all 20 human and mouse cell lines tested, including KPC RAS-refractory tumor models.
A central theme of the presentation was the planned transition to an oral formulation. The intravenous version exhibited 95% bioavailability. The oral dose range under evaluation spans 3 to 15 milligrams, against the 9.3-milligram therapeutic dose used in the IV trial. The maximum tolerated dose was set at five times the therapeutic level. A Phase I/II accelerated oral trial is slated to begin in the second half of 2026, with a recommended Phase II dose expected in the second half of 2027.
Actuate also outlined the BEACON2 pediatric program targeting neuroblastoma, the leading cancer killer in children under five, where survival rates remain below 10%. The program's first stage involves a 20-patient dose-confirmation cohort, followed by a randomized registration trial of approximately 75 patients. The BEACON2 trial is projected to start in the first half of 2027.
Chief Executive Dan Schmitt addressed patient adherence challenges with intravenous dosing, noting that a once-weekly versus twice-weekly run-in period for the trial saw significant drop-off because patients were reluctant to make frequent clinic visits. He also said the company does not view upcoming RAS inhibitors as competitors but expects combination strategies, arguing that elraglusib targets escape nodes while RAS inhibitors down-regulate driver mutations.
Schmitt said he was motivated to pursue the pediatric program because of the unmet need in childhood oncology.
On the day of the conference, Actuate shares closed at $1.03, down 3.74%, and traded at $0.98 after hours, down an additional 4.84%. The company's market capitalization stood at $25.7 million, with a current ratio of 1.25. Analyst price targets ranged from $8 to over $15.
Patent protection for Actuate's composition of matter runs through 2037 to 2038, with Patent Term Extension covering through 2043. The company was founded in 2015.
