Actuate to Present Elraglusib Phase 2 Topline Data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Rhea-AI Summary

Actuate Therapeutics (NASDAQ: ACTU) has announced that topline data from its Phase 2 study of elraglusib will be presented at the 2025 ASCO Annual Meeting. The presentation will focus on results from the Actuate-1801 Part 3B trial, which evaluated elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).

The oral presentation, scheduled for May 31, 2025, at 3:00 PM CDT, will be part of the Gastrointestinal Cancer session at the conference taking place in Chicago from May 30 to June 3. The study represents a significant milestone in the company's development of therapies targeting GSK-3β inhibition for difficult-to-treat cancers.

- Oral presentation at ASCO to highlight topline Phase 2 data of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

CHICAGO and FORT WORTH, Texas, April 23, 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 topline clinical data from the randomized Phase 2 study (Actuate-1801 Part 3B) evaluating elraglusib have been selected for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 30- June 3, in Chicago, Illinois.

Details of the oral presentation are as follows:

Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Abstract Number: 4006

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date and Time: Saturday, May 31, 2025, 3:00 PM-6:00 PM CDT

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.

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 clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, 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; preliminary and unpublished data may be subject to change 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; 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 will require substantial additional capital to finance our operations, 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 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 Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com

FAQ

What are the key findings from Actuate's Phase 2 elraglusib trial for pancreatic cancer (NASDAQ: ACTU)?

The topline data findings will be presented at the 2025 ASCO Annual Meeting on May 31, 2025. The specific results have not been disclosed in the announcement.

How does elraglusib work in combination with GnP for metastatic pancreatic cancer treatment?

Elraglusib works through GSK-3β inhibition and is being studied in combination with gemcitabine/nab-paclitaxel (GnP) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma.

When will Actuate Therapeutics present its Phase 2 elraglusib data at ASCO 2025?

Actuate will present the Phase 2 elraglusib data on Saturday, May 31, 2025, between 3:00 PM-6:00 PM CDT during the Gastrointestinal Cancer session.

What type of cancer is Actuate's elraglusib targeting in the Phase 2 trial?

Elraglusib is targeting metastatic pancreatic ductal adenocarcinoma (mPDAC) in previously untreated patients.