Actuate Therapeutics, Inc.

Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Fort Worth, Texas, in the United States. The company is focused on the development of novel therapies for hard-to-treat cancers, with a particular emphasis on glycogen synthase kinase-3 beta (GSK-3β) as a therapeutic target. Its lead drug candidate, elraglusib (formerly known as 9-ING-41), is a small-molecule GSK-3 inhibitor that targets multiple molecular pathways involved in tumor growth and resistance to conventional cancer drugs such as chemotherapy. According to the company, elraglusib is also emerging as a mediator of anti-tumor immunity through the inhibition of multiple immune checkpoints and the regulation of immune cell function. Actuate Therapeutics is pursuing clinical development of elraglusib across a range of cancer indications, both as a monotherapy and in combination with other cancer therapies, including chemotherapy and immune modulators such as checkpoint inhibitors. The company's pipeline activities have included studies in metastatic pancreatic ductal adenocarcinoma, pediatric neuroblastoma, Ewing sarcoma, and other refractory pediatric cancers. In 2026, the company announced FDA clearance of an Investigational New Drug (IND) application for an oral formulation of elraglusib, along with strategic initiatives to advance the elraglusib development program, including a Phase 1/2 clinical program for an elraglusib tablet in refractory cancers. Actuate Therapeutics is led by President and Chief Executive Officer Daniel M. Schmitt, with Andrew P. Mazar, Ph.D., serving as Chief Operating Officer and Paul Lytle as Chief Financial Officer. The company's board of directors is chaired by Aaron G.L. Fletcher, Ph.D. Actuate also maintains a scientific advisory board that includes academic and clinical experts in oncology. The company states that it is open to new partnerships with academic and scientific organizations as it continues to develop novel therapies to improve outcomes for patients. As a clinical-stage company, Actuate Therapeutics does not currently market approved pharmaceutical products; its activities center on research, clinical trials, and regulatory interactions. The company's strategy emphasizes the potential of elraglusib to slow, stop, or shrink tumors with minimal adverse effects, and to improve clinical outcomes for patients with advanced, hard-to-treat cancers.

Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Fort Worth, Texas, United States. The company was founded to develop novel therapeutics for hard-to-treat cancers, with a scientific focus on glycogen synthase kinase-3 beta (GSK-3β). Its lead drug candidate, elraglusib (formerly known as 9-ING-41), is a small-molecule GSK-3 inhibitor that targets multiple molecular pathways involved in tumor growth and resistance to conventional cancer drugs such as chemotherapy. According to the company, elraglusib is also emerging as a mediator of anti-tumor immunity through the inhibition of multiple immune checkpoints and the regulation of immune cell function. Actuate Therapeutics has pursued clinical development of elraglusib across a range of cancer indications, both as a monotherapy and in combination with other cancer therapies, including chemotherapy and immune modulators such as checkpoint inhibitors. The company's timeline highlights a series of clinical and regulatory milestones. In 2025, Actuate reported positive Phase 1 trial results in difficult-to-treat pediatric sarcomas, including complete and partial responses, and advanced its clinical program in Ewing sarcoma. The company also highlighted a significant and sustained survival benefit in a key metastatic pancreatic cancer patient population. In 2026, Actuate announced FDA clearance of an Investigational New Drug (IND) application for an oral formulation of elraglusib, along with strategic initiatives to advance the elraglusib development program. This included plans to expand the clinical pipeline by advancing an elraglusib tablet into a Phase 1/2 clinical program in refractory cancers. The company also launched a strategic research initiative to combine elraglusib with RAS inhibitors, and its elraglusib was selected for evaluation in the BEACON2 trial for high-risk pediatric neuroblastoma. Actuate Therapeutics is led by President and Chief Executive Officer Daniel M. Schmitt, with Andrew P. Mazar, Ph.D., serving as Chief Operating Officer and Paul Lytle as Chief Financial Officer. The company's board of directors is chaired by Aaron G.L. Fletcher, Ph.D., and includes directors Todd Thomson, Dan Zabrowski, Ph.D., Roger Sawhney, Amy Ronneberg, Jason Keyes, and Martin H. Huber, MD. Actuate also maintains a scientific advisory board that includes Dr. Roger Cohen, Dr. Lee Ellis, Dr. John Marshall, Dr. Daniel Billadeau, and Dr. Patricia LoRusso. The company states that it is open to new partnerships with academic and scientific organizations as it continues to develop novel therapies to improve outcomes for patients. As a clinical-stage company, Actuate Therapeutics does not currently market approved pharmaceutical products; its activities center on research, clinical trials, and regulatory interactions. The company's strategy emphasizes the potential of elraglusib to slow, stop, or shrink tumors with minimal adverse effects, and to improve clinical outcomes for patients with advanced, hard-to-treat cancers.

• Actuate Therapeutics highlights significant and sustained survival benefit in key metastatic pancreatic cancer patient population.

• Actuate Therapeutics advances clinical program in Ewing sarcoma after positive Phase 1 trial demonstrates complete and partial responses in difficult-to-treat pediatric sarcomas.

• Actuate Therapeutics announces positive patient outcomes from Phase 1 trial in difficult-to-treat refractory pediatric cancers.

• Actuate Therapeutics announces plans to expand clinical pipeline, advancing elraglusib tablet into a Phase 1/2 clinical program in refractory cancers.

• Actuate Therapeutics launches strategic research initiative to combine elraglusib with RAS inhibitors.

• Actuate Therapeutics announces FDA clearance of IND for oral elraglusib and strategic initiatives to advance the elraglusib development program.

• Actuate Therapeutics’ elraglusib selected for evaluation in BEACON2 trial for high-risk pediatric neuroblastoma.

Clinical-stage biopharmaceutical company developing novel GSK-3 inhibitors for hard-to-treat cancers.

• Elraglusib (9-ING-41)

  A novel GSK-3 inhibitor targeting multiple molecular pathways in cancer involved in tumor growth and resistance to conventional cancer drugs such as chemotherapy. Also emerging as a mediator of anti-tumor immunity through inhibition of multiple immune checkpoints and regulation of immune cell function.

• Oral elraglusib tablet

  An oral formulation of elraglusib in development, with FDA clearance of an IND announced in 2026 and plans for a Phase 1/2 clinical program in refractory cancers.

• 2019-11-12

  Actuate Therapeutics completes $6.5 million Series B-3 financing[6]Actuate Therapeutics完成650万美元B-3轮融资prweb.com

  Reported: 2019-11-12

  Actuate Therapeutics announced it had raised an additional $6.5 million in a Series B-3 financing round led by Bios Partners, with Kairos Ventures, DEFTA Partners, and other existing investors participating. The company said it would use the proceeds to initiate a Phase 2 trial in myelofibrosis and expand its ongoing 1801 clinical trial.

1. 1Targeting Hard-to-Treat Cancers | Actuate Therapeuticsactuatetherapeutics.com
2. 2Improving Clinical Outcomes in Cancer Treatment | Actuate Therapeuticsactuatetherapeutics.com
3. 3TIMELINE | Actuate Therapeutics, Inc.actuatetherapeutics.com
4. 4Corporate Governance | Actuate Therapeutics Investorsactuatetherapeutics.com
5. 5Actuate Therapeutics, Inc. (United States) - Wikidatawikidata.org
6. 6Actuate Therapeutics完成650万美元B-3轮融资prweb.com