Actuate Therapeutics Phase 2 Metastatic Pancreatic Cancer Data Selected for Oral and Poster Presentation at ASCO GI 2026
Rhea-AI Summary
Actuate Therapeutics (NASDAQ: ACTU) announced that Phase 2 data for elraglusib in metastatic pancreatic cancer were selected for an oral and a poster presentation at the ASCO GI Cancers Symposium, Jan 8–10, 2026 in San Francisco.
The oral presentation (Abstract 653) reports results from the randomized Phase 2 1801 Part 3B study of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP in previously untreated metastatic pancreatic ductal adenocarcinoma and is scheduled for Jan 9, 2026 at 4:15 PM PST (Rapid Oral Abstract Session B).
The poster (Abstract 761, Board L5) covers mutational analysis and potential biomarkers from the same study and is scheduled for Jan 9, 2026 during Poster Session B; first authors are Devalingam Mahalingam, MD, PhD (oral) and Andrey Ugolkov, MD, PhD (poster).
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News Market Reaction 1 Alert
On the day this news was published, ACTU gained 2.33%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ACTU was down 1.44% pre-news while peers were mixed: CRDF +0.84%, AVTX +1.32%, GLSI +3.27%, but NVCT -1.17% and ONCY -2.88%, indicating stock-specific factors rather than a unified sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 15 | Phase 2 data update | Positive | -8.8% | Published positive Phase II data in recurrent metastatic salivary gland carcinoma. |
| Sep 22 | Regulatory data update | Positive | +6.8% | Updated FDA IND with pancreatic Phase 2 data showing survival improvement. |
| Sep 11 | Equity offering closing | Negative | -4.2% | Closed $17.25M public offering of common stock with net proceeds disclosed. |
| Sep 10 | Equity offering pricing | Negative | -19.1% | Priced $15.0M public offering at $7.00 per share under existing shelf. |
| Sep 09 | Equity offering launch | Negative | -19.1% | Proposed public offering of common stock with 30-day underwriter option. |
ACTU has shown mixed reactions to positive clinical data and consistent declines around equity offerings, with only one clinical update producing a notable positive move.
Over the last six months, ACTU has repeatedly highlighted elraglusib data across several indications. Clinical updates in metastatic pancreatic cancer and salivary gland carcinoma, plus early Ewing sarcoma results, underline a broad oncology program, yet price reactions were often muted or negative, including a -8.78% move on positive salivary gland data and -4.26% on pancreatic survival results. In contrast, September’s planned regulatory interactions update saw a +6.78% move. Equity offerings in September triggered sharper declines, reinforcing sensitivity to financing news.
Regulatory & Risk Context
ACTU has an active Form S-3 shelf filed on 2025-09-02, allowing future offerings of common stock, debt, warrants, or units via prospectus supplements. It has already been used in at least 2 prospectus supplements (424B5 filings on 2025-09-09 and 2025-09-10), indicating a framework for additional capital raises.
Market Pulse Summary
This announcement spotlights elraglusib’s metastatic pancreatic cancer program, with randomized Phase 2 results and biomarker analyses chosen for oral and poster presentation at ASCO GI 2026. It follows earlier updates showing survival benefits and biomarker signals in pancreatic cancer and other tumors. Investors may watch for detailed efficacy, safety, and biomarker correlations, while also considering the company’s use of an active S-3 shelf and past equity offerings as they assess funding needs and potential dilution.
Key Terms
glycogen synthase kinase-3β medical
GSK-3β medical
GSK-3 inhibitor medical
gemcitabine/nab-paclitaxel medical
metastatic pancreatic ductal adenocarcinoma medical
biomarkers medical
AI-generated analysis. Not financial advice.
CHICAGO and FORT WORTH, Texas, Dec. 18, 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-3β (GSK-3β), today announced that data from its Phase 2 study evaluating elraglusib in metastatic pancreatic cancer have been selected for an oral presentation at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI Cancers Symposium), with additional data accepted for poster presentation. ASCO GI Cancers Symposium will be held January 8-10, 2026, in San Francisco, CA. The presentations will highlight results from the Company’s Phase 2 study evaluating elraglusib in combination with gemcitabine/nab-paclitaxel (GnP), a first-line chemotherapy regimen for metastatic pancreatic cancer. Details of the oral and poster presentations are provided below.
Oral Presentation
Title: Results from the randomized Phase 2 study (1801 Part 3B) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
Abstract: 653
Session: Rapid Oral Abstract Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 9, 2026, 4:15 PM-5:00 PM (PST)
First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist and Professor of Medicine at Northwestern University Feinberg School of Medicine
Poster Presentation
Title: Mutational analysis and identification of potential biomarkers in patients with metastatic pancreatic cancer treated with the combination of the GSK-3 inhibitor elraglusib and gemcitabine/nab-paclitaxel in the 1801 Part 3B Phase 2 study.
Abstract: 761
Poster Bd: L5
Session: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 9, 2026, 11:30 AM-1:00 PM; 5:00 PM-6:00 PM (PST)
First Author: Andrey Ugolkov, MD, PhD, Senior Director, Clinical Science at Actuate Therapeutics
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.
Actuate Therapeutics Social Media
Actuate Therapeutics has used, and intends to continue using, its investor relations website (https://actuatetherapeutics.com/investors), in addition to its LinkedIn, X, and Facebook accounts, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.
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 Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
Media Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
FAQ
What Phase 2 elraglusib results will Actuate (ACTU) present at ASCO GI 2026?
When and where is Actuate's oral presentation on ACTU elraglusib at ASCO GI 2026?
What does the Actuate poster (ACTU) at ASCO GI 2026 cover and when is it shown?
Which chemotherapy regimen was elraglusib tested with in Actuate's Phase 2 ACTU study?
Who are the first authors for Actuate's ASCO GI 2026 presentations (ACTU)?
