ACTU

Median overall survival increased by >40% in elraglusib arm compared to the control arm, with a 1-year survival rate of 44% in the elraglusib arm versus 22% in the control arm 18-month survival rate >20% in elraglusib arm compared to 4% in control arm Consistent survival benefit observed across the poorest prognosis patient subgroups, including those with liver metastases and high disease burden 7-40X increases in tumor-infiltrating cytotoxic immune cells and biomarker signals in the elraglusib arm reflect immunomodulatory mechanisms of action 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. “These Phase 2 results continue to reinforce elraglusib’s potential as a combination-ready, first-line therapy with the ability to enhance the activity of standard of care chemotherapeutic backbones,” said Daniel Schmitt, Chief Executive Officer of Actuate. “The significant improvement in overall survival with an acceptable safety profile marks an important milestone for patients facing metastatic pancreatic cancer, historically one of the most difficult to treat diseases. The elraglusib containing regimen delivered a 40% improvement in median overall survival, a 38% lower risk of death, and doubled the survival rate at one year compared to the current first-line chemotherapy regimen of GnP alone. By targeting a central signaling node such as GSK-3β, elraglusib may modulate tumor cell survival, reshape tumor microenvironment, and suppress adaptive resistance pathways, enabling a broader biological impact across a broad range of cancers. Importantly, we are also advancing our research focuse...

Topline data shows statistically significant improvement in overall survival in elraglusib plus GnP combination arm versus GnP control arm Elraglusib/GnP combination arm demonstrated substantial improvement in median overall survival since the last data analysis Clinical trial meets primary endpoint for overall survival and confirms significant 1-year survival rate Elraglusib/GnP combination arm demonstrated a favorable risk-benefit profile Topline dataset to be presented in an oral presentation at the upcoming ASCO Annual Meeting Company plans to work with regulators to expeditiously bring elraglusib to commercialization CHICAGO and FORT WORTH, Texas, May 06, 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 that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The topline results, which demonstrate a substantial improvement in median overall survival benefit in the elraglusib/GnP combination arm compared to the results announced in December 2024, will be presented on May 31, 2025, at the Annual Meeting of the American Society of Clinical Oncology (ASCO). “Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “There have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade. Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this Phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in mPDAC. We are incredibly excited to present the topline data at ASCO. Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with...