Actuate Therapeutics Inc Stock Price, News & Analysis

Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on cancer therapies through GSK-3β inhibition, has announced the pricing of its public offering of 2,142,858 shares at $7.00 per share.

The offering, expected to close on September 11, 2025, aims to raise $15.0 million in gross proceeds. The company has granted underwriters a 30-day option to purchase up to 321,428 additional shares. Lucid Capital Markets is serving as the sole book-running manager, with Titan Partners Group acting as financial advisor.

The proceeds will be used for working capital and general corporate purposes. The offering is being made pursuant to an effective shelf registration statement on Form S-3.

Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company developing cancer therapies through GSK-3β inhibition, has announced a proposed public offering of common stock. The company plans to grant underwriters a 30-day option to purchase an additional 15% of shares at the public offering price, less underwriting discounts.

The offering, managed by Lucid Capital Markets as sole book-running manager, will be conducted under an effective S-3 shelf registration. Proceeds will be used for working capital and general corporate purposes. The completion and terms of the offering are subject to market conditions.

Actuate Therapeutics (NASDAQ: ACTU) has announced the initiation of a Phase 1b trial studying the combination of its drug elraglusib with Incyte's PD-1 inhibitor retifanlimab and mFOLFIRINOX as a frontline therapy for advanced pancreatic cancer. The trial, named RiLEY (NCT06896188), will be conducted at UPMC Hillman Cancer Center.

The study will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma, with potential for expansion based on interim results. In a recent Phase 2 study, elraglusib combined with gemcitabine/nab-paclitaxel showed promising results, including a 37% reduction in death risk and doubled 12-month survival rate in metastatic pancreatic cancer patients.

The collaboration between Actuate, UPMC Hillman Cancer Center, and Incyte aims to explore synergistic opportunities in treatment-naïve patients, building on elraglusib's demonstrated immune-modulating properties.

Actuate Therapeutics (NASDAQ:ACTU) has announced positive results from its Phase 1 trial evaluating elraglusib in pediatric patients with refractory malignancies. The study demonstrated remarkable outcomes in Ewing Sarcoma (EWS), with 2 out of 10 patients achieving complete responses and two additional patients showing stable disease.

The trial also reported a partial response in a patient with desmoplastic small-round-cell tumor (DSRCT). Based on these encouraging results, Actuate plans to advance to a Phase 2 trial in children, adolescents, and adults with relapsed/refractory EWS, expected to initiate in 2026, subject to funding.

Elraglusib, which targets glycogen synthase kinase-3 beta (GSK-3β), could potentially become a first-in-class therapy for EWS, where no approved targeted therapies currently exist.

Actuate Therapeutics (NASDAQ: ACTU) reported significant results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for metastatic pancreatic cancer treatment. Patients receiving at least one cycle showed improved median overall survival of 12.5 months vs 8.5 months in the control group, with a 43% reduction in death risk.

The trial demonstrated enhanced outcomes with elraglusib/GnP combination, including disease control rate of 53.4% vs 44.8% and overall response rate of 37.9% vs 29.3%. Notably, patients with liver metastases experienced a 2.5-fold increase in 1-year overall survival and 38% reduced death risk compared to control, with 13.6% survival probability at 18 months versus 0% in the control group.

Actuate Therapeutics (NASDAQ: ACTU) presented positive biomarker data from their Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for first-line metastatic pancreatic cancer treatment at ASCO. The study used machine learning to analyze 40 pre-treatment plasma biomarkers, identifying 7 significant predictors of favorable survival in elraglusib-treated patients. Notably, CXCL2 emerged as a key biomarker, showing reversed survival trends compared to the control arm. High levels of CXCL2 and TRAIL, along with low levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3, were associated with improved overall survival. The findings suggest elraglusib's potential to enhance immune response mechanisms and its immunomodulatory effects on various immune system components.

Actuate Therapeutics (NASDAQ: ACTU) announced its inclusion in the Russell 3000® and Russell 2000® Indexes, effective June 27, 2025, following its IPO last year. The Russell 3000® Index tracks the top 3,000 U.S. public companies, while the Russell 2000® focuses on small-cap stocks. The inclusion comes after positive Phase 2 trial results for their lead candidate elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC), which showed significant improvement in median overall survival (10.1 months vs 7.2 months, p=0.01) with a 37% reduction in death risk. Approximately $10.6 trillion in assets are benchmarked against Russell U.S. Indexes as of May 2025, making this inclusion a significant milestone for Actuate's visibility in the investment community.

Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in treating metastatic pancreatic cancer. The trial met its primary endpoint with significant survival improvements: median overall survival increased to 10.1 months vs 7.2 months (p=0.01), and 12-month survival rate doubled to 44.1% vs 22.3%. The drug showed continued benefits at 18 and 24 months, with survival rates of 19.7% vs 4.4% and 13.8% vs 0% respectively. The treatment demonstrated a favorable safety profile, with mostly Grade 1-2 adverse events, primarily including reversible visual impairments. The study also showed improved response rates (29.0% vs 21.8%) and progression-free survival (5.6 vs 5.1 months). Key opinion leaders emphasized the significance of these results, highlighting elraglusib's potential to reshape metastatic pancreatic cancer treatment through its unique immune-modulating mechanism.

Actuate Therapeutics (NASDAQ: ACTU) announced positive Phase 2 trial results for elraglusib in treating metastatic pancreatic cancer, presented at ASCO 2025. The trial met its primary endpoint, showing significant improvement in median overall survival (10.1 months vs 7.2 months) when elraglusib was combined with standard chemotherapy (GnP). The treatment reduced death risk by 37% and doubled the 1-year survival rate to 44.1% compared to 22.3% with GnP alone. The drug demonstrated a manageable safety profile with mostly Grade 1-2 adverse events. Biomarker analysis confirmed the drug's immune-modulating mechanism. Based on these promising results, Actuate plans to engage with FDA and EMA in H2 2025 to discuss registration pathway.