Actuate Therapeutics Reports Positive Follow-Up Data from its Randomized Controlled Phase 2 Trial Demonstrating Extended Long-Term Overall Survival Benefit with Elraglusib Plus Chemotherapy for Metastatic Pancreatic Cancer in Oral Presentation at ASCO GI 2026

Rhea-AI Summary

Actuate Therapeutics (NASDAQ: ACTU) reported Phase 2 randomized data showing elraglusib plus gemcitabine/nab-paclitaxel (GnP) met the primary endpoint in previously untreated metastatic pancreatic cancer. The combination reduced risk of death by 38% (HR=0.62) and improved median overall survival to 10.1 months vs 7.2 months for GnP alone (p=0.02). Twelve-month survival rose to 44.4% vs 22.3% and 24-month survival to 12.9% vs 2.6%. Safety was consistent with prior data; no new safety signals at the 9.3 mg/kg dose were identified. Biomarker analyses identified genomic and immune changes associated with benefit. Results were presented at ASCO GI on January 9, 2026.

Positive

• Primary endpoint met: mOS 10.1 vs 7.2 months (p=0.02, HR=0.62)
• 12-month survival doubled to 44.4% versus 22.3% with GnP alone
• 24-month survival increased fivefold to 12.9% versus 2.6% with GnP

Negative

• High rate of serious TEAEs: 56.1% (elraglusib/GnP) and 56.4% (GnP)
• TEAEs resulting in death remain material: 12.3% (elraglusib/GnP) and 16.7% (GnP)
• Phase 2 data only; results require confirmation in larger, randomized Phase 3 studies

News Market Reaction

-6.35%

4 alerts

-6.35% News Effect

-12.5% Trough Tracked

-$10M Valuation Impact

$143M Market Cap

0.7x Rel. Volume

On the day this news was published, ACTU declined 6.35%, reflecting a notable negative market reaction. Argus tracked a trough of -12.5% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $10M from the company's valuation, bringing the market cap to $143M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Median OS elraglusib/GnP: 10.1 months Median OS GnP alone: 7.2 months Hazard ratio for death: HR=0.62 +5 more

8 metrics

Median OS elraglusib/GnP 10.1 months Randomized Phase 2 mPDAC trial (Actuate 1801 Part 3B)

Median OS GnP alone 7.2 months Control arm in Phase 2 mPDAC trial

Hazard ratio for death HR=0.62 Elraglusib/GnP vs GnP alone; p=0.02

12-month survival elraglusib/GnP 44.4% Phase 2 metastatic pancreatic cancer

12-month survival GnP alone 22.3% Control arm in same Phase 2 study

24-month survival elraglusib/GnP 12.9% Phase 2 metastatic pancreatic cancer

24-month survival GnP alone 2.6% Control arm in same Phase 2 study

Trial enrollment 286 patients, 60 sites, 6 countries Randomized controlled Phase 2 1801 Part 3B

Market Reality Check

Price: $5.69 Vol: Volume 70,752 is about 0....

normal vol

$5.69 Last Close

Volume Volume 70,752 is about 0.75x the 20-day average 94,627, indicating subdued pre-news trading. normal

Technical Shares at $6.14 were trading below the 200-day MA of $7.57, and about 48.8% under the 52-week high.

Peers on Argus

ACTU was down 2.23% while peers were mixed: CRDF (-3.45%), AVTX (-1.28%), NVCT (...

ACTU was down 2.23% while peers were mixed: CRDF (-3.45%), AVTX (-1.28%), NVCT (-5.16%), ONCY (-2.95%), but GLSI rose 13.67%. The mixed tape and scanner data point to a stock-specific driver rather than a sector-wide move.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Pediatric Phase 1 data	Positive	+5.0%	Reported pediatric elraglusib responses and FDA Rare Pediatric Disease designations.
Dec 18	ASCO GI selection	Positive	+2.3%	Phase 2 pancreatic data selected for oral and poster sessions at ASCO GI 2026.
Dec 15	Salivary carcinoma data	Positive	-8.8%	Published positive Phase II elraglusib plus platinum chemo data in salivary gland cancer.
Sep 22	Regulatory data update	Positive	+6.8%	Updated FDA with Phase 2 pancreatic data showing improved survival versus GnP alone.
Sep 11	Equity offering	Negative	-4.2%	Closed $17.25M public equity offering of common stock with full over-allotment exercise.

Pattern Detected

Clinical trial news for ACTU has often led to positive price reactions, though there has been at least one notable divergence where favorable data coincided with a selloff.

Recent Company History

Over the past six months, Actuate has repeatedly reported positive data for elraglusib across multiple indications. Pediatric Phase 1 results (news 953556) and salivary gland carcinoma Phase II data (news 947862) highlighted meaningful responses and tolerability. Metastatic pancreatic cancer data have been a recurring theme, with statistically significant survival benefits first flagged in a September 22, 2025 update (news 908118) and later selected for ASCO GI presentations (news 949667). Today’s ASCO GI Phase 2 survival update extends this trajectory of data-rich clinical communication.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-09-02

Actuate has an active Form S-3 shelf filed on 2025-09-02, allowing it to offer common stock, debt, warrants, and units in future transactions, with specific terms defined in accompanying prospectus supplements such as the 424B5 filings dated 2025-09-09 and 2025-09-10.

Market Pulse Summary

The stock moved -6.3% in the session following this news. A negative reaction despite statistically ...

Analysis

The stock moved -6.3% in the session following this news. A negative reaction despite statistically significant survival benefits would fit prior divergence seen when salivary gland data coincided with a selloff of 8.78%. The market may remain focused on financing and going-concern disclosures, given prior offerings under the shelf registration. While clinical signals appear constructive, past behavior shows that strong data have not always translated into sustained price strength.

Key Terms

overall survival, gemcitabine, nab-paclitaxel, gsk-3β, +4 more

8 terms

overall survival medical

"Phase 2 study met its primary endpoint, demonstrating statistically significant improved overall survival"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

gemcitabine medical

"elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone"

Gemcitabine is a chemotherapy drug that works by interfering with cancer cells’ ability to copy their DNA, which slows or stops tumor growth. Investors watch it because clinical trial results, regulatory approvals, patent status, or manufacturing and supply issues for a widely used cancer medicine can materially affect a drugmaker’s sales, partnerships, and stock value—think of it as a key product whose market performance can move a company.

nab-paclitaxel medical

"elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone"

A chemotherapy drug formulation in which the anti-cancer agent paclitaxel is bound to human albumin protein particles to improve delivery into tumors and avoid harsh solvent ingredients used in older versions. Investors pay attention because clinical trial results, regulatory approvals, patent or licensing status, and manufacturing capacity for this specialized formulation can drive sales, pricing power and a company’s future revenue potential — like a better-packaged product that reaches customers more effectively.

gsk-3β medical

"through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced"

GSK-3β is an enzyme inside cells that acts like a molecular switch, helping control processes such as cell growth, survival and response to signals. Investors pay attention because drugs that change this enzyme’s activity are being explored for conditions like neurodegenerative diseases, mood disorders and cancer, so clinical results or regulatory decisions targeting GSK-3β can materially affect a company’s drug pipeline value and risk profile.

kras medical

"Actionable mutations like KRAS or ARID1A could suggest novel drug combinations"

KRAS is a gene that makes a protein acting like a switch to control cell growth; certain changes (mutations) can lock that switch on and drive uncontrolled cell multiplication, which is a common cause of many cancers. Investors care because drugs or tests targeting KRAS mutations can create large markets or avoidable risks depending on trial results and regulatory decisions, much like a key product feature deciding a gadget’s commercial success.

arid1a medical

"Actionable mutations like KRAS or ARID1A could suggest novel drug combinations"

ARID1A is a gene that makes a protein helping cells decide which genes to turn on or off, like a switchboard in the cell’s control room. Mutations or loss of this gene are linked to several cancers and can change how tumors grow and respond to treatments, so it matters to investors because it can be a target for drugs, influence the value of therapies or diagnostics, and affect regulatory and commercial prospects for companies developing cancer medicines.

teae medical

"Serious TEAE were similar between the elraglusib/GnP (56.1%) and the GnP alone arm"

A treatment-emergent adverse event (TEAE) is any new or worsening medical problem that appears after a patient begins a drug or other medical treatment. Investors monitor TEAEs because they reveal safety issues that can influence regulatory approval, product labeling, commercial use and legal risk—like finding unexpected side effects after launch that can shrink the market or require costly warnings or restrictions.

hazard ratio medical

"mOS 10.1 months vs. 7.2 months, p=0.02, HR=0.62"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

AI-generated analysis. Not financial advice.

• Phase 2 study met its primary endpoint, demonstrating statistically significant improved overall survival with elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone
  
  
• Elraglusib combination reduced the risk of death by 38% compared with gemcitabine/nab-paclitaxel alone, with increased durable survival observed beyond 24 months
  

CHICAGO and FORT WORTH, Texas, Jan. 12, 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 that new additional and promising patient survival and biomarker data from treatment with elraglusib for metastatic pancreatic cancer were featured in oral and poster presentations at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) on January 9, 2026. The presentations highlighted new, expanded data from the Company’s Phase 2 clinical program (Actuate 1801-Part 3B) evaluating elraglusib in combination with gemcitabine/nab-paclitaxel (GnP), a first-line chemotherapy regimen for metastatic pancreatic cancer, providing additional evidence that suggests that elraglusib combined with GnP is associated with improved survival when compared with GnP alone.

“Pancreatic cancer continues to have a high unmet medical need, particularly at the metastatic stage,” said Dr. Devalingam Mahalingam, MD, PhD. “The results from this Phase 2 study suggest that adding elraglusib to standard gemcitabine and nab-paclitaxel chemotherapy may improve survival outcomes while maintaining a manageable safety profile. The scope of this trial, which enrolled 286 patients across 60 sites in six countries, underscores the robustness of the dataset. We are grateful to the patients and their families whose participation made this research possible.”

“Metastatic pancreatic cancer remains one of the most difficult cancers to treat, with few effective first-line options,” said Dan Schmitt, Chief Executive Officer of Actuate Therapeutics. “In this randomized Phase 2 study, the addition of elraglusib to gemcitabine and nab-paclitaxel resulted in a meaningful improvement in overall survival compared with chemotherapy alone. As of November 2025, seventeen patients are still alive in the elraglusib/GnP arm, and three of them have remarkably passed the 24-month mark on first-line treatment, while no patients remain on GnP treatment alone. Current patient survival for metastatic pancreatic cancer is less than 12 months, so our findings are especially encouraging. We look forward to building from this data and continuing to advance elraglusib for patients with this devastating disease.”

Key Findings:

Efficacy: The primary efficacy endpoints were met in this study:

• The median overall survival (OS) showed significant benefit in the elraglusib/GnP vs GnP alone arms (mOS 10.1 months vs. 7.2 months, p=0.02, HR=0.62)
• 12-month survival rate doubled to 44.4% (elraglusib/GnP) vs 22.3% (GnP)  
• 24-month survival rate increased fivefold to 12.9% in the elraglusib/GnP arm compared to 2.6% in the GnP arm, emphasizing the potential for long-term clinical benefit.
  

Safety: The safety and tolerability profile of elraglusib was consistent with previously reported data at the 9.3 mg/kg dose, and no new safety signals were identified:

• Serious TEAE were similar between the elraglusib/GnP (56.1%) and the GnP alone arm (56.4%),
• TEAE resulting in death were similar between treatment arms: elraglusib/GnP (12.3%) and GnP alone (16.7%)
• Grade-3 or higher TEAE leading to stoppage of any study drug: elraglusib/GnP (16.8%) and GnP alone (21.8%)
  

Genomic biomarkers: Several mutations commonly associated with pancreatic cancer were identified as potential predictive biomarkers of overall survival in the elraglusib/GnP arm, but not in the GnP-alone arm. Actionable mutations like KRAS or ARID1A could suggest novel drug combinations for future clinical studies.

Immunological biomarkers: The percentage of CD8+ and Granzyme B+ cells, as well as NK cells, was increased in tumors obtained from elraglusib/GnP-treated patients but not in GnP-treated patients, suggesting that combination therapy may potentiate improved anti-tumor immune response.

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 3β 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-1801 Part 3B Study

The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line 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. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.

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 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 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 overall survival benefit did ACTU report for elraglusib plus GnP in Jan 2026?

The trial reported median OS 10.1 months vs 7.2 months for GnP alone, with HR=0.62 (p=0.02), indicating a 38% reduction in risk of death.

How did 12-month and 24-month survival rates compare for ACTU's elraglusib/GnP vs GnP in the Phase 2?

12-month survival was 44.4% vs 22.3%; 24-month survival was 12.9% vs 2.6% for GnP alone.

Were there new safety signals for elraglusib in the ACTU Phase 2 results presented at ASCO GI 2026?

No new safety signals were identified at the 9.3 mg/kg dose; serious TEAEs were similar between arms (~56%).

How many patients were enrolled in the randomized ACTU 1801 Part 3B trial and where was it presented?

The study enrolled 286 patients across 60 sites in six countries and results were presented orally at ASCO GI on January 9, 2026.

Did ACTU report biomarkers tied to response for elraglusib plus GnP in metastatic pancreatic cancer?

Yes; genomic mutations (including KRAS and ARID1A) and increased tumor immune markers (CD8+, Granzyme B+, NK cells) were associated with benefit in the elraglusib/GnP arm.

What is the regulatory or clinical-next-step implication of ACTU's Phase 2 elraglusib data?

The data support advancing elraglusib into larger confirmatory studies, but a Phase 3 trial and regulatory review would be needed to establish clinical benefit.