ACTUATE THERAPEUTICS, INC.

Actuate Therapeutics announced that its lead investigational drug, elraglusib, will be evaluated in the BEACON2 clinical trial for children with relapsed and refractory neuroblastoma. This international, multi-arm, multi-stage Phase 1/2 platform study will initially assess elraglusib in combination with dinutuximab beta plus chemotherapy in a dose confirmation cohort. The inclusion in BEACON2 is a significant milestone, supported by compelling preclinical evidence, early clinical evidence including a complete response in a neuroblastoma patient, and FDA Rare Pediatric Disease designation.

Actuate Therapeutics announced positive post-hoc efficacy and biomarker analyses from two Phase 2 studies of elraglusib for metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2026 ASCO Annual Meeting. In one study, elraglusib combined with gemcitabine/Abraxane (GnP) significantly improved median overall survival (mOS) in KRAS wild-type patients (16.9 vs 10.1 months) and P53 wild-type patients (13.4 vs 7.6 months) compared to GnP alone. Another Phase 2 study demonstrated that elraglusib plus FOLFIRINOX (FFX) achieved an mOS of 9.8 months versus 7.7 months for FFX alone, showing deep and durable responses. The company highlighted the consistent survival benefit, response depth, and favorable safety profile of elraglusib across both combination regimens.

Actuate Therapeutics reported a net loss of $(5.63) million for the first quarter of 2026, an improvement from $(6.32) million in the same period last year. Despite the reduced loss, the company's cash and cash equivalents significantly declined to $8.13 million from $13.16 million at the end of 2025. Management expressed substantial doubt about the company's ability to continue as a going concern beyond July 2026 without securing additional capital.

Actuate Therapeutics announced FDA clearance of an Investigational New Drug (IND) application for its oral elraglusib formulation, enabling a Phase 1/2 study in advanced cancer patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers. The company plans to initiate the study in the second half of 2026, aiming to optimize drug exposure and response with the oral tablet. Additionally, Actuate expects preclinical results for elraglusib combined with RAS inhibitors in mid-2026 and appointed Dr. Martin Huber to its Board of Directors. However, the company also noted its financial condition raises substantial doubt about its ability to continue as a going concern beyond July 2026 without additional capital.

Actuate Therapeutics, Inc. announced the appointment of Martin H. Huber, MD, to its Board of Directors, effective May 1, 2026. This appointment expands the Board from seven to eight directors. Dr. Huber, an industry veteran with extensive experience in oncology drug development, will serve as a Class III director and on the Nominating and Corporate Governance Committee. He will receive an initial grant of 30,000 stock options, an annual retainer of $44,000, and a quarterly consulting fee of $3,000.

Actuate Therapeutics, Inc. announced the immediate appointment of Martin Huber, MD, as an Independent Director to its Board. This strategic addition aims to bolster the company's leadership as it progresses its lead investigational drug, elraglusib, through registration studies and towards commercialization for various difficult-to-treat cancers. Dr. Huber brings decades of experience in drug development and oncology, having previously served as CEO of Mersana Therapeutics and held key R&D roles at Xilio Therapeutics and TESARO.

Actuate Therapeutics announced the publication of positive Phase 2 clinical trial data for elraglusib in combination with chemotherapy for previously untreated metastatic pancreatic cancer. The study, published in Nature Medicine, showed a significant increase in median overall survival by over 40% and doubled the one-year survival rate to 44% compared to standard chemotherapy alone. This data reinforces elraglusib's potential as a first-line therapy for a difficult-to-treat cancer, with an acceptable safety profile, and the company plans further research into synergistic combinations.