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Investing.com - H.C. Wainwright reiterated its Buy rating and $20.00 price target on Actuate Therapeutics (NASDAQ:ACTU), currently trading at $5.76, following the company’s completion of the Phase 1 portion of its ongoing Phase 1/2 trial with lead candidate elraglusib. The stock is trading near its 52-week low of $5.50, while analyst targets range from $20 to $35, according to InvestingPro data.
The company, with a market capitalization of $113 million, announced on July 17 that it had completed the Phase 1 portion of the Actuate-1902 trial, which evaluated elraglusib in refractory pediatric malignancies. Based on positive data in Ewing sarcoma (EWS) patients, Actuate plans to initiate a Phase 2 study in 2026. InvestingPro analysis indicates the company’s financial health score is currently rated as WEAK, with a current ratio of 0.46.
In the Phase 1 portion, two of ten pediatric EWS patients treated with elraglusib in combination with cyclophosphamide and topotecan achieved a complete response by CT scan and/or complete metabolic response. The company expects to publish detailed analysis of the EWS patient results in the near future.
Actuate Therapeutics plans to enter discussions with the FDA to design a potential pivotal Phase 2 study evaluating elraglusib in pediatric, adolescent, and adult EWS patients. According to the American Cancer Society, Ewing sarcoma is diagnosed in approximately 200 children and teens in the U.S. annually.
H.C. Wainwright noted that while its current financial estimates do not account for revenues associated with the EWS indication, success in this area could provide upside to their projections. The firm maintained its 12-month price target of $20.00 per share. For deeper insights into Actuate Therapeutics’ financial health and additional analyst coverage, subscribers can access more than 7 exclusive InvestingPro Tips and comprehensive financial metrics.
In other recent news, Actuate Therapeutics announced the completion of the Phase 1 portion of its clinical study evaluating elraglusib in pediatric patients with refractory malignancies, showing notable responses in Ewing sarcoma patients. The trial involved ten patients, with two achieving complete responses and two maintaining stable disease. Actuate plans to advance to a Phase 2 study in 2026, contingent on funding. Additionally, the company identified seven biomarkers that may predict which metastatic pancreatic cancer patients could benefit from elraglusib, with CXCL2 emerging as a reliable indicator for improved survival. In a separate development, elraglusib demonstrated a significant survival benefit in a Phase 2 trial for metastatic pancreatic ductal adenocarcinoma, meeting primary endpoints and showing a statistically significant improvement in overall survival. Craig-Hallum has initiated coverage on Actuate Therapeutics with a Buy rating and a price target of $21.00, expressing optimism about elraglusib’s potential to improve survival outcomes in metastatic pancreatic cancer. The analysts’ confidence is supported by interim data from a Phase II study, suggesting a meaningful difference in median overall survival compared to standard treatment. Actuate Therapeutics plans to engage with U.S. and EU regulators to discuss advancing elraglusib toward a New Drug Application and registration.
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