Actuate Therapeutics Inc (ACTU) News & EventsACTUActuate Therapeutics Inc

Actuate Therapeutics Receives Patent Allowance for Elraglusib

Actuate Therapeutics announced that the United States Patent and Trademark Office, or USPTO, has issued a Notice of Allowance for U.S. Patent Application No. 19/669,218, titled "Oral Dosage Forms of Elraglusib." The allowed claims cover the composition of oral tablet forms of elraglusib, an inhibitor of GSK-3beta, the company's lead clinical investigational candidate, including the optimized Elraglusib Oral Tablet developed for upcoming use in clinical trials.

Actuate Therapeutics Prices Public Offering of 30,985,900 Shares

Actuate Therapeutics announced the pricing of an underwritten public offering of 30,985,900 shares of its common stock and warrants to purchase up to an aggregate of 15,492,950 shares of its common stock. The public offering price for each set of two shares of common stock and one accompanying warrant to purchase one share of common stock is 71c per set of securities. The Warrants are being sold at the rate of one Warrant for every two shares of common stock. The Warrants will have an exercise price of 45c per share, are exercisable immediately upon issuance and will expire five years following the date of issuance. The shares of common stock and Warrants will be issued separately but can only be purchased together in the Offering. The offering is expected to close on October 28, subject to the satisfaction of customary closing conditions. Newbridge Securities Corporation is acting as sole book-running manager for the Offering.

Actuate Therapeutics Receives FDA Approval for Oral Elraglusib Clinical Trial

Actuate Therapeutics announced the FDA has cleared its investigational new drug application to conduct a Phase 1/2 study of oral elraglusib in advanced cancer patients. The study is designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation and will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers. "Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy," said Daniel Schmitt, president and CEO of Actuate. Initiation of the clinical development is planned for the second half of 2026.