- Announces Completion of Phase 1 Study of Elraglusib in Pediatric Patients - Prolonged and Durable Complete Responses (CRs) Observed in Two of Ten Refractory Ewing Sarcoma Patients - Two Additional Patients Had Durable Stable Disease in Notoriously Difficult-to-Treat Cancer - Confirmed Partial Response (PR) in a patient with a desmoplastic small-round-cell tumor (DSRCT) - Company Initiating Planning of Phase 2 Trial of Elraglusib in Children, Adolescents, and Adults with Refractory/Resistant Ewing Sarcoma CHICAGO and FORT WORTH, Texas, July 17, 2025 (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 end of the Phase 1 portion of its clinical study evaluating elraglusib monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies (Actuate-1902). Following encouraging signals of activity, particularly in treatment-refractory Ewing Sarcoma (EWS), a small round cell sarcoma that forms in soft tissue and bone, the Company will seek to advance the clinical development program towards a Phase 2 study in children, adolescents, and adults with relapsed/refractory EWS.

- Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone

Phase 2 highlights robust biomarker identification and survival correlations in first-line metastatic pancreatic cancer (mPDAC) treated with elraglusib Phase 2 highlights robust biomarker identification and survival correlations in first-line metastatic pancreatic cancer (mPDAC) treated with elraglusib

CHICAGO and FORT WORTH, Texas, June 16, 2025 (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), announced today that the Company will be added to the Russell 3000® Index, with automatic inclusion in the Russell 2000® Index, effective after the U.S. market close on June 27, as part of the 2025 Russell indexes annual reconstitution. The inclusion follows the initial announcement on Friday, May 23, and the latest update on Friday, June 13, 2025, in connection with the annual reconstitution of the Russell U.S. Indexes.

CHICAGO and FORT WORTH, Texas, May 31, 2025 (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 presented topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) Annual Meeting.

CHICAGO and FORT WORTH, Texas, May 22, 2025 (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 online publication of the abstract accepted as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 30-June 3, in Chicago, Illinois.