Actuate Therapeutics presentation repeats going-concern doubt and need for capital

The warning

Actuate Therapeutics, Inc. furnished a corporate overview dated May 31, 2025 to the Securities and Exchange Commission as an 8-K exhibit on June 2, 2025. Its forward-looking statements repeat the risk language: "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 2025." The filing says a failure to raise that capital in the near term, on acceptable terms or at all, could force the company to delay, limit, reduce or terminate its development programs and other operations.

The overview also says Actuate expects significant operating losses for the foreseeable future, has a high risk of never generating revenue or becoming profitable, and has no approved products. The company is based in Fort Worth, Texas, and listed in August 2024. Elraglusib, a GSK-3 beta inhibitor, is its only product candidate. The overview gives no cash balance or runway figure.

The randomized pancreatic trial

The lead program is Actuate-1801 Part 3B, a randomized Phase 2 trial of elraglusib plus gemcitabine and nab-paclitaxel (GnP) in first-line metastatic pancreatic cancer. Enrollment closed in January 2024. The 10-K reported an interim analysis as of November 15, 2024, with a one-year survival rate of 43.6% against 22.5% on GnP alone, median overall survival of 9.3 months against 7.2, and a hazard ratio of 0.63 (p-value of 0.016).

The deck updates those numbers with draft, unaudited data as of March 27, 2025. In the predefined safety population of 155 patients on the combination and 78 on GnP, median overall survival was 10.1 months against 7.2, with a hazard ratio of 0.63 and a log-rank p-value of 0.01. Twelve-month survival was 44.1% against 22.3%. At 18 months it was 19.7% against 4.4%, and at 24 months 13.8% against none. Of the combination patients, 114 (73.5%) had died, and only eight were still on treatment.

The weaker numbers matter as much. Median progression-free survival was 5.6 months against 5.1, a hazard ratio of 0.90 that the deck marks as not significant. The objective response rate was 29.0% against 21.8% and the disease control rate 61.3% against 56.4%. The deck says the data "should not be relied upon as a final analysis," and that final results may change. The 10-K says the study's primary endpoint, median overall survival, will be summarized at the end of the study.

Safety

The deck says the overall rate of treatment-emergent and serious adverse events was similar between arms, and discontinuations because of them were similar. It also says visual impairment and fatigue were major adverse events attributed to elraglusib as a single agent in Part 1 and were mild to moderate in Part 3B. The visual effect is described as transient alterations in color and skin tones under fluorescent light, with no permanent changes to eye structure or vision.

Earlier data and what is next

The earlier Part 3A trial enrolled 42 patients in a single-arm design and reported a median overall survival of 15.3 months in 29 efficacy-evaluable patients, with 2 confirmed complete responses. The company then moved to the randomized trial. The deck also cites one melanoma patient with a durable complete metabolic response on single-agent elraglusib, a single heavily pretreated patient. The 10-K says that over 500 patients have been treated with the IV injection across Phase 1 and Phase 2 studies.

The deck lists an ASCO presentation of topline data in the second quarter of 2025 and a request for an FDA Type B pre-NDA meeting in the second half of 2025. It says a Phase 3 or confirmatory trial, if required, is to be determined and contingent on future discussions with the FDA and future funding. The 10-K says the company plans to meet the FDA to discuss a Phase 3 registration study and whether the Phase 2 data can support registration. Several other follow-on steps, including an oral tablet study, are marked contingent on future funding.

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