ACTU

Company Overview — What Does ACTUATE THERAPEUTICS, INC. Do?

We are 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 (GSK-3). We are developing elraglusib (formerly 9-ING-41), an ATP competitive small molecule that is designed to enter cancer cells and block the function of the enzyme GSK-3ß, a master regulator of complex biological signaling cascades, including those mediated by oncogenes, that lead to tumor cell survival, growth, migration, and invasion. We believe that the blockade of GSK-3ß signaling ultimately results in the death of the cancer cells and the regulation of anti-tumor immunity. The enzyme GSK-3ß, a serine/threonine protein kinase, is understood to be an essential positive regulator of nuclear factor kappa B (NF-kB) transcriptional activity. Studies have demonstrated that the inhibition of GSK-3ß decreases cancer cell survival via suppression of the transcriptional activity of its downstream effector NF-kB. In light of these findings, we believe that the inhibition of GSK-3ß may overcome and/or reverse NF-kB-mediated cancer cell survival and chemoresistance to conventional chemotherapeutic drugs in a range of human cancers. Research has also demonstrated that aberrant nuclear GSK-3ß accumulation is limited to cancer cells, making GSK-3ß a potential candidate for specific and targeted cancer therapy. Additionally, GSK-3 regulates the expression of immune modulators such as pro-inflammatory cytokines and checkpoint molecules in tumor and immune cells. We believe blocking GSK-3 in these cells leads to improved immune cell function, which can ultimately result in better, longer clinical responses in patients. Our Lead Product Candidate We have exclusively licensed a portfolio of GSK-3 inhibitors developed in a collaboration between the University of Illinois-Chicago (UIC) and Northwestern University (NU). The lead drug in our portfolio is called elraglusib (9-ING-41), which is being evaluated in a randomized Phase 2 trial in patients with metastatic pancreatic cancer, our most advanced clinical indication to date. Elraglusib represents a broad opportunity for us to potentially initiate and advance multiple drug development programs around our lead asset based on data emerging from completed or ongoing Phase 1/2 trials in pediatric and adult patients with advanced, refractory cancers. Many of the pathological processes that drive cancer are controlled by GSK-3ß and thus, by targeting GSK-3ß, we are pursuing the development of products designed to intervene in the progression of multiple cancer types. Animal tumor model data and Phase 1/2 clinical data have identified a number of areas of unmet clinical need in cancer where elraglusib may play an interventional role, including pancreatic, colon, lung, breast, renal, ovarian, leukemias and lymphomas, and melanoma, as well as some pediatric cancers including Ewing sarcoma, neuroblastoma and pediatric leukemias. Our lead program, Elraglusib Injection, is an intravenous solution of elraglusib that we are evaluating for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). Elraglusib Injection has been evaluated in a Phase 1 dose escalation study (Actuate-1801 Part 1) in 238 adult patients with refractory advanced cancers when given as a single agent (n=67) or in combination with chemotherapy (n=171). The objective of this study was to establish the safety profile of elraglusib when used alone or in combination with chemotherapy and to identify either a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) to then inform the design of exploratory efficacy studies in Phase 2. Subjects in this study were diagnosed with a variety of cancer types and most patients had received two or more previous lines of chemotherapy prior to enrollment in the study. Objective responses and durable disease control were observed in both the single agent and combination treatment arms of the study. The most common treatment-emergent adverse events (TEAEs) attributed to elraglusib were transient visual disturbance (patients described lights as brighter and skin tones darker, which resolved spontaneously) and fatigue across both study parts. The majority (>99%) of TEAEs that occurred in ≥20% of patients were reported as Grade 1 or 2 (mild or moderate). In combination with chemotherapy, no new safety signals were observed. Based on the results of the Phase 1 study, which established 15 mg/kg as the RP2D when combined with chemotherapy, we initiated a single arm Phase 2 study (Actuate-1801 Part 2) in patients with previously untreated mPDAC. This study was originally designed as a single arm exploratory Simon two-stage trial (and therefore not designed or powered to demonstrate statistical significance), but after an analysis conducted following the completion of Stage 1, which showed a median overall survival (mOS) of 15.3 months in the efficacy evaluable (n=29) patient population, we amended and expanded the Stage 2 of the study to a randomized, controlled trial now powered for statistical significance (Actuate-1801 Part 3B) that would allow a comparison of the safety and efficacy of the combination of Elraglusib Injection plus gemcitabine/nab-paclitaxel (GnP) as compared to GnP alone. The primary endpoint for Actuate-1801 Phase 2 is overall survival (OS). Elraglusib is currently being evaluated as a weekly intravenous (IV) infusion in combination with the approved dosing regimen for GnP. This study completed enrollment four months faster than predicted and top line results are expected in the first quarter of 2025. In April 2024, we carried out a preliminary analysis of interim data from Actuate-1801 Part 3B in the pre-specified safety population. This preliminary analysis and overall results may change as the study continues through completion. For this preliminary analysis, we used data based on a cut-off date corresponding to the date when >50% of the patients in the GnP control group had progressed. As of this cut-off date, our preliminary analysis indicates that patients in the (i) GnP control group arm exceeded 50% death events (the outcome measure for survival analysis) at 53.8% and (ii) elraglusib/GnP combination therapy arm were below 50% death events at 34.2%. Based on this interim data, the Kaplan-Meier preliminary analysis demonstrates a mOS of 12.2 months in the elraglusib combination therapy arm versus 7.3 months in the GnP control group arm (HR=0.60; log-rank p=0.012). As with all preliminary analyses of interim data, this data should not be relied upon as a final analysis and is subject to change once full data analysis is complete. We were incorporated in Delaware on January 16, 2015, as Apotheca Therapeutics, Inc. and changed our name to Actuate Therapeutics, Inc. on October 1, 2015. Our principal executive offices are located at 1751 River Run, Suite 400, Fort Worth, Texas. ACTUATE THERAPEUTICS, INC. (ACTU) is classified as a micro-cap stock in the Healthcare sector, specifically within the Pharmaceutical Products industry. The company is led by CEO Daniel M. Schmitt, headquartered in FORT WORTH, Texas. With a market capitalization of $59M, ACTU is one of the notable companies in the Healthcare sector.

ACTUATE THERAPEUTICS, INC. (ACTU) Stock Rating — Avoid (April 2026)

As of April 2026, ACTUATE THERAPEUTICS, INC. receives a Avoid rating with a composite score of 23.7/100 and 1 out of 5 stars from the Blank Capital Research quantitative model.ACTU ranks #4,398 out of 4,446 stocks in our coverage universe. Within the Healthcare sector, ACTUATE THERAPEUTICS, INC. ranks #823 of 838 stocks, placing it in the lower half of its Healthcare peers. The rating is generated by a multi-factor model that weighs quality (30%), momentum (25%), value (15%), investment (10%), stability (10%), and short interest (10%).

ACTU Stock Price and 52-Week Range

ACTUATE THERAPEUTICS, INC. (ACTU) currently trades at $1.71. The stock lost $0.18 (9.5%) in the most recent trading session. The 52-week high for ACTU is $11.99, which means the stock is currently trading -85.7% from its annual peak. The 52-week low is $2.33, putting the stock -26.6% above its annual trough. Recent trading volume was 56K shares, suggesting relatively thin trading activity.

Is ACTU Overvalued or Undervalued? — Valuation Analysis

ACTUATE THERAPEUTICS, INC. (ACTU) carries a value factor score of 15/100 in the Blank Capital model, signaling premium valuation that prices in significant future growth. The price-to-book ratio stands at 6.34x, versus the sector average of 2.75x.

At current multiples, ACTUATE THERAPEUTICS, INC. trades at a premium to most Healthcare peers. This elevated valuation may be justified if the company can sustain above-average growth rates and profitability, but it also creates downside risk if earnings disappoint expectations.

ACTUATE THERAPEUTICS, INC. Profitability — ROE, Margins, and Quality Score

ACTUATE THERAPEUTICS, INC. (ACTU) earns a quality factor score of 24/100, signaling below-average profitability metrics relative to the broader market. The return on equity (ROE) is -298.4%, compared to the Healthcare sector average of -43.5%, which is below typical expectations for high-quality companies. Return on assets (ROA) comes in at -168.5% versus the sector average of -33.1%.

Profitability is below benchmark levels, which may reflect industry headwinds, elevated reinvestment, or structural challenges.

ACTU Debt, Balance Sheet, and Financial Health

ACTUATE THERAPEUTICS, INC. has a debt-to-equity ratio of 77.0%, compared to the Healthcare sector average of 32.0%. Leverage is within a manageable range for the industry, though investors should monitor debt trends over time. The current ratio is 2.39x, indicating strong short-term liquidity. Total debt on the balance sheet is $0. Cash and equivalents stand at $17M.

ACTU has a beta of 0.56, meaning it is less volatile than the S&P 500, making it a relatively defensive holding. The stability factor score for ACTUATE THERAPEUTICS, INC. is 29/100, suggesting elevated price swings that may be unsuitable for conservative portfolios.

ACTUATE THERAPEUTICS, INC. Revenue and Earnings History — Quarterly Trend

In TTM 2026, ACTUATE THERAPEUTICS, INC. reported revenue of $0 and earnings per share (EPS) of $-1.06. Net income for the quarter was $-24M. Operating income came in at $-23M.

In FY 2025, ACTUATE THERAPEUTICS, INC. reported revenue of $0 and earnings per share (EPS) of $-1.06. Net income for the quarter was $-22M. Operating income came in at $-22M.

In Q3 2025, ACTUATE THERAPEUTICS, INC. reported revenue of $0 and earnings per share (EPS) of $-0.25. Net income for the quarter was $-5M. Operating income came in at $-5M.

In Q2 2025, ACTUATE THERAPEUTICS, INC. reported revenue of $0 and earnings per share (EPS) of $-0.30. Net income for the quarter was $-6M. Operating income came in at $-6M.

Over the past 8 quarters, ACTUATE THERAPEUTICS, INC. has experienced revenue contraction from $0 to $0. Investors analyzing ACTU stock should weigh these quarterly trends alongside the valuation and quality metrics discussed above.

ACTU Dividend Yield and Income Analysis

ACTUATE THERAPEUTICS, INC. (ACTU) does not currently pay a dividend. This is common among smaller companies in the Pharmaceutical Products industry that prefer to reinvest cash flows into business expansion rather than returning capital to shareholders. Income-focused investors looking for Healthcare dividend stocks may want to explore other Healthcare stocks or use the stock screener to filter by dividend yield.

ACTU Momentum and Technical Analysis Profile

ACTUATE THERAPEUTICS, INC. (ACTU) has a momentum factor score of 12/100, signaling weak relative price performance. Stocks with low momentum scores have historically tended to continue underperforming in the near term. The investment factor score is 25/100, which measures capital allocation efficiency and asset growth patterns. The short interest score of 61/100 reflects moderate short selling activity.

ACTU vs Competitors — Healthcare Sector Ranking and Peer Comparison

Within the Healthcare sector, ACTUATE THERAPEUTICS, INC. (ACTU) ranks #823 out of 838 stocks based on the Blank Capital composite score. This places ACTU in the lower half of all Healthcare stocks in our coverage universe. Key competitors and sector peers include ASTRAZENECA PLC (AZN) with a score of 61.4/100, Sol-Gel Technologies Ltd. (SLGL) with a score of 56.6/100, VIEMED HEALTHCARE, INC. (VMD) with a score of 53.4/100, Innoviva, Inc. (INVA) with a score of 52.7/100, and JOHNSON & JOHNSON (JNJ) with a score of 51.7/100.

Comparing ACTU against the S&P 500 benchmark is also instructive for understanding relative performance. Investors can view the full ACTU vs S&P 500 (SPY) comparison to assess how ACTUATE THERAPEUTICS, INC. stacks up against the broader market across all factor dimensions.

ACTU Next Earnings Date

No upcoming earnings date has been announced for ACTUATE THERAPEUTICS, INC. (ACTU) at this time. Check the earnings calendar for the latest scheduling updates across all stocks in our coverage universe.

Should You Buy ACTU? — Investment Thesis Summary

The quantitative profile for ACTUATE THERAPEUTICS, INC. suggests caution. The quality score of 24/100 flags below-average profitability. The value score of 15/100 indicates premium valuation. Momentum is weak at 12/100, a headwind for near-term performance. High volatility (stability score 29/100) increases portfolio risk.

In summary, ACTUATE THERAPEUTICS, INC. (ACTU) earns a Avoid rating with a composite score of 23.7/100 as of April 2026. The rating is derived from the Blank Capital Research methodology, which combines six factor dimensions into a single quantitative ranking. Investors should consider these quantitative signals alongside their own fundamental research, risk tolerance, and investment time horizon before making buy or sell decisions on ACTU stock.

Related Resources for ACTU Investors

Explore more research and tools: ACTU vs S&P 500 comparison, top Healthcare stocks, stock screener, our methodology, quality factor explained, value factor explained, momentum factor explained. Compare ACTU head-to-head with peers: ACTU vs AZN, ACTU vs SLGL, ACTU vs VMD.