Retifanlimab

Elraglusib represents a potential back bone therapy in pancreatic cancer with three ongoing trials in combination with current standards of care and novel immunotherapies Recent financing provides extended runway through key anticipated regulatory inflection points Additional nonclinical studies are ongoing combining elraglusib with RAS inhibitors based on potential synergies and complimentary mechanisms of action CHICAGO and FORT WORTH, Texas, Sept. 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 a corporate update on the regulatory path for elraglusib in pancreatic cancer and anticipated milestones enabled by the recent $17.25 million public offering. Actuate has amended its investigational new drug (IND) application with updated clinical data from its international randomized Phase 2 trial in first-line treatment of metastatic pancreatic cancer (Actuate-1801 Part 3B), which showed a statistically significant improvement in median overall survival with the combination arm of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone. These data are intended to support planned regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) beginning later this year and continuing into early 2026. The 1801-3β Phase 2 study is currently ongoing, with 22 patients in the elraglusib plus GnP arm either in active treatment or survival follow-up, ranging from 20 to 42 months in time on study, while only 3 patients remain in survival follow-up in the GnP arm, with time on study ranging from 21 to 23 months. These compelling results of elraglusib in combination with GnP, combined with early data demonstrating significant and durable long term responses in patients with highly metastatic disease treated with the combination of elraglusib/FOLFIRINOX/losartan in the ongoing clinical trial in patients with mPDAC led by Havard/MGH, plus the new clinical collaboration with Incyte and UPMC Hillman Cancer Center in patients with advanced pancreatic cancer using the combination of modified FOLFIRINOX and Incyte’s anti-PD-1 retifanlimab, further strengthen the case for elraglusib as a back-bone therapy that can be combined with different regimens used to treat this highly aggressive and deadly disease. “We are confident that our recently completed financing provides sufficient capital to support our corporate initiatives into the second half of 2026, and well through our upcoming anticipated interactions with the FDA and EMA. We have already updated the clinical data package on file with the FDA, and during the remainder of this year and into the first quarter of 2026, we expect to gain clarity on elraglusib’s regulatory path forward for the first-line treatment of metastatic PDAC,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The survival benefit we’ve observed with elraglusib to date is compelling, and both its mechanism of action and safety profile support combination with chemotherapy, immunotherapy and potentially RAS inhibitors, increasing elraglusib’s potential as a backbone therapy, specifically in pancreatic cancers, where clinicians have limited options to extend and improve the lives of patients.” About Actuate-1801 Part 3β Study The Actuate-1801 Part 3β study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in first-line metastatic pancreatic adenocarcinoma (mPDAC). The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. In the Phase 2 study, elraglusib in combination with GnP met its primary endpoint, showing a significant increase in median overall survival, a 37% reduction in the risk of death, and a doubling of the 12-month survival rate. In addition, increased CD8-positive and granzyme B-positive T cells, increased NK cells, and decreased myeloid-derived suppressor cells were observed in tumor biopsies only from elraglusib-treated patients, demonstrating elraglusib’s proposed immune modulating mechanism of action in patients with mPDAC. Inhibition of GSK-3β may inhibit pancreatic tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, regulation of anti-tumor immunity, and regulation of tumor gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT). About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com or follow us on LinkedIn, X and Facebook. Forward-Looking Statements This press release contains forward-looking statements about us, including our and other parties’ clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies, early clinical trials and sub-group studies are not necessarily predictive of future results and may not correlate with improved responses, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond the second quarter of fiscal year 2026, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, and our Quarterly Reports on Form 10-Q, and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. Investor Contact Mike MoyerManaging DirectorLifeSci Advisors, LLCmmoyer@lifesciadvisors.com Media Contact Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.comDavid.schull@russopartnersllc.com(858) 717-2310 or (646) 942-5604

SAN DIEGO, Sept. 16, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network (PanCAN). "The GOBLET trial is designed to rigorously evaluate pelareorep's potential across gastrointestinal cancers," said Dr. Dirk Arnold, Director of Asklepios Tumorzentrum Hamburg and Primary Investigator of the GOBLET study. "The strong early efficacy signals give us confidence that pelareorep may become a foundational immunotherapy for these difficult-to-treat tumors, and expanding enrollment into the U.S. will broaden the scope and impact of these data." Cohort 4 (Second-Line or later Squamous Cell Carcinoma of the Anal Canal, "SCAC") Pelareorep is being studied in combination with atezolizumab in the rare but deadly relapsed, unresectable SCAC indication. In January, the Company released efficacy data showing a 33% overall response rate (ORR) in 12 patients. This nearly triples the ORR achieved by retifanlimab in second-line or later SCAC patients. Enrollment is currently at 20 evaluable patients and is expected to be completed by the end of 2025. The Company expects to provide an efficacy update regarding ORR in Cohort 4 in the fourth quarter of 2025. Cohort 5 (First-Line Metastatic Pancreatic Ductal Adenocarcinoma, "mPDAC") In a randomized two-arm cohort, pelareorep is being evaluated in combination with modified FOLFIRINOX with or without atezolizumab to gain greater clarity regarding the contribution of the checkpoint inhibitor to the efficacy achieved in GOBLET Cohort 1. In that cohort, pelareorep combined with gemcitabine/nab-paclitaxel and atezolizumab achieved a 62% ORR in 13 evaluable patients. Enrollment into Cohort 5 is approximately 40% complete and is expected to be fully enrolled by the end of 2026. The Company anticipates providing a Cohort 5 interim efficacy update, including overall survival, in the first quarter of 2026. GOBLET Expansion to U.S. Sites The Company recently submitted a protocol amendment to allow the GOBLET study to open U.S. clinical sites within the next few months. Upon approval, Northwestern University and other academic institutions are expected to serve as U.S. sites for GOBLET. "We are pleased to bring this important study to U.S. patients with pancreatic cancer, a population urgently in need of novel immunotherapy strategies," said Dr. Devalingam Mahalingham, who is expected to lead the Cohort 5 study at Northwestern University. "The combination of pelareorep and a checkpoint inhibitor with chemotherapy has shown early signs of durability, and I am excited to be part of advancing this program toward registration." "We expect to build on this clinical momentum to lay the foundation for our regulatory strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "It's imperative that we leverage our clinical data to obtain regulatory clarity and position pelareorep as a platform immunotherapy in these gastrointestinal tumors where patients desperately need treatment options." About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics' plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; its expectations regarding the efficacy, enrollment, and results of pelareorep in future studies and partnerships for future studies; and its belief in the clinical promise of pelareorep in metastatic colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Owen Blaschak LifeSci Communications [email protected] Logo: SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED