ACTU

- BEACON2 is a landmark European multi-arm, multi-stage Phase 1/2 platform trial conducted and sponsored by the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham  - Elraglusib will be assessed in combination with dinutuximab beta plus chemotherapy in patients with relapsed and refractory neuroblastoma - Complete response in neuroblastoma patient achieved in Phase 1 study of elraglusib in refractory pediatric cancers

- Patients with KRAS wild-type (WT) genomics achieved significant improvement in median overall survival (mOS) when treated with elraglusib plus gemcitabine/Abraxane (GnP) versus GnP alone - Patients with P53WT genomics receiving elraglusib plus GnP showed a near doubling of mOS versus GnP alone - Patients receiving elraglusib plus FOLFIRINOX demonstrated deep and sustained clinical responses and increased mOS versus FOLFIRINOX alone or in combination with losartan - Elraglusib treatment was well tolerated when used in combination with either GnP or FOLFIRINOX CHICAGO and FORT WORTH, Texas, June 01, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, today announced that two presentations were given at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentations featured post-hoc efficacy and biomarker analyses from the randomized Phase 2 study (NCT03678883), along with clinical data from a Phase 2 study conducted at Mass General Brigham Cancer Institute of elraglusib in combination with FOLFIRINOX (FFX) and the TGF-β inhibitor losartan in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Elraglusib oral tablet formulation to drive next-phase clinical development and broader clinical use FDA cleared IND for Phase 1/2 study of oral elraglusib in advanced cancer patients, with focus on metastatic melanoma, NSCLC, colorectal, and pancreatic cancers with initiation planned for 2H 2026 Elraglusib plus RAS inhibitor preclinical results expected in mid-2026 Industry veteran Martin Huber, MD, joins Board of Directors CHICAGO and FORT WORTH, Texas, May 11, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, today announced key initiatives to advance and expand the potential of the elraglusib development program. Actuate is prioritizing the development of the elraglusib oral tablet formulation, which is intended to enhance patient convenience, broaden potential clinical utility, and improve the pharmacokinetic exposure of elraglusib across multiple oncology indications.

Martin Huber, MD brings deep expertise in oncology drug development, regulatory strategy, and commercialization of novel therapies Martin Huber, MD brings deep expertise in oncology drug development, regulatory strategy, and commercialization of novel therapies

CHICAGO and FORT WORTH, Texas, April 14, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the publication of new data in  Nature Medicine from a randomized phase 2 clinical trial (NCT03678883) evaluating elraglusib in combination with the gemcitabine-Nab-paclitaxel (GnP) chemotherapy compared to GnP alone in patients with previously untreated metastatic pancreatic cancer. The peer-reviewed paper (DOI: 10.1038/s41591-026-04327-4), entitled “Elraglusib and Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma: A Randomized Controlled Phase 2 Trial” is available here.