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Actuate Therapeutics, Inc. has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing therapies for difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 (GSK-3). Actuate's lead product candidate, elraglusib, is in Phase 2 clinical trials for metastatic pancreatic ductal adenocarcinoma (mPDAC).
The company has reported interim data showing statistically significant improvements in 1-year survival rates and median overall survival for patients treated with elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) compared to GnP alone.
Actuate plans to meet with the FDA to discuss the design of a Phase 3 registration study and the potential use of Phase 2 data to support registration. Additionally, elraglusib is being evaluated in pediatric cancer patients, with a focus on refractory Ewing sarcoma.
The company is also developing an oral tablet form of elraglusib, with plans for a Phase 1 study to identify the maximum tolerated dose and recommended Phase 2 dose.
Actuate's market opportunity includes the treatment of mPDAC, with an estimated annual incidence of over 67,000 patients in the U.S. by 2025. The company believes elraglusib may improve outcomes regardless of the chemotherapy backbone used.
The company holds exclusive licenses for elraglusib and related compounds from Northwestern University and the University of Illinois-Chicago. Actuate plans to pursue additional development incentives and strategic partnerships to advance its pipeline.
The filing outlines various risks, including reliance on third-party manufacturers, potential competition, and the need for substantial additional capital to finance operations. Actuate acknowledges its dependence on regulatory approvals and market acceptance of its product candidates.
Actuate's financial condition raises substantial doubt about its ability to continue as a going concern, with expectations of continued operating losses and the need for additional funding to support its development programs.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Actuate Therapeutics Inc. annual 10-K report dated March 13, 2025. To report an error, please email earnings@qz.com.