ACTUATE THERAPEUTICS, INC. Annual Report - How They Did This Year

I’ve put together this guide to help you understand how Actuate Therapeutics performed this year. My goal is to translate complex filing language into plain English to help you decide if they belong in your portfolio.

1. What does this company do?

Actuate Therapeutics is a clinical-stage biotech company. They aren't selling medicine yet. Instead, they are researching and testing one drug candidate called elraglusib (9-ING-41). Their entire business depends on the success of this single treatment. It is designed to treat high-mortality cancers, including pancreatic cancer, Ewing sarcoma, and myelodysplastic syndromes.

2. Financial health: The "Burn"

Because they have no product on the market, the company has zero sales revenue. For the year ending December 31, 2025, they reported a $32.4 million loss, with most of this going toward research and development. As of March 2026, they had 23.7 million shares outstanding. To stay in business, they sell more shares to investors. Every time they issue new shares to raise cash, your ownership percentage shrinks, which is known as dilution.

3. Major wins and challenges

The company’s biggest win this year was completing their IPO and follow-on offerings. This provided enough cash to fund operations through the second half of 2026. However, they are in a race against time. They spend about $2.5 million to $3 million every month. They must prove elraglusib works in clinical trials before their cash runs out. If they cannot raise more money or if their trials fail, they may have to shut down their programs.

4. Key risks: What could go wrong?

This is a high-risk investment. Here is what you should watch:

• The "One-Trick Pony" Risk: The company’s future relies entirely on elraglusib. If it fails to show clear results in trials, they have no other drugs to fall back on.
• Supply Chain Vulnerability: They rely on one manufacturer in China to produce their drug’s active ingredient. Geopolitical tensions or new regulations could disrupt this relationship and halt their clinical trials.
• Dilution: Because they aren't profitable, they will likely need to sell more stock before the end of 2026. This will further reduce your ownership stake and could push the stock price down.

5. Future outlook

The company is at a turning point. They plan to meet with FDA and European regulators in early 2026 to discuss a "Phase 3" study, which is the final, major hurdle before a drug can be sold. They are specifically targeting a trial for patients with advanced pancreatic cancer. If regulators agree to a clear path forward, it is a big step toward success. If regulators demand more testing, the company will face a funding gap and a long delay.

6. The Bottom Line

Actuate is a bet on a single scientific outcome. They are a research project funded by investors, not a business with steady sales. Their cash will only last through the third quarter of 2026. This is not a stable, dividend-paying stock. If you are interested in high-risk biotech, watch their 2026 FDA meetings and look for signs of new funding or partnerships.