CHICAGO and FORT WORTH, Texas - Actuate Therapeutics, Inc. (NASDAQ: ACTU), a biopharmaceutical company specializing in cancer treatment drugs with a market capitalization of $170 million, announced significant findings from its Phase 2 trial of elraglusib in combination with chemotherapy for metastatic pancreatic cancer. According to InvestingPro data, the company maintains a strong cash position relative to debt, positioning it well for continued clinical development. The trial met its primary endpoints, showing a notable improvement in survival rates and reduction in the risk of death.
The randomized trial, which compared the efficacy of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) to GnP alone, revealed a doubling of the one-year survival rate to 43.6% in the elraglusib-GnP arm, compared to 22.5% with GnP alone. Furthermore, the combination treatment also demonstrated an increased median overall survival (mOS) by two months, with patients on the elraglusib-GnP combination living an average of 9.3 months versus 7.2 months for those on GnP.
Actuate's President & CEO, Daniel Schmitt, expressed optimism about the potential of elraglusib, highlighting its favorable risk-benefit profile and the possibility of improved outcomes for patients with limited treatment alternatives. The company plans to engage with the FDA in the first half of 2025 to discuss the topline data and the prospects of a Phase 3 registration trial.
The study's interim data, cut off on November 15, 2024, also showed a 37% reduction in the risk of death and improvements in disease control and overall response rates. The trial's safety endpoint was met, with treatment-emergent adverse events comparable to the control arm. While the company is not yet profitable, InvestingPro analysis indicates a "GREAT" financial health score, suggesting strong operational fundamentals. Subscribers can access 3 additional ProTips and comprehensive financial metrics.
Elraglusib's mode of action includes inhibiting tumor growth and enhancing chemotherapy activity, as well as activating anti-tumor immunity. Dr. Andrew Mazar, Actuate’s Scientific Co-Founder and COO, noted the consistent evidence of clinical benefit and anti-tumor activity in the elraglusib combination arm across multiple endpoints.
Pancreatic cancer remains one of the most aggressive and lethal cancers, with a less than 5% five-year survival rate in the US. This development could offer a new treatment option for patients with metastatic pancreatic cancer.
Actuate Therapeutics continues to monitor the ongoing trial, with further data expected in the first half of 2025, with the next earnings report scheduled for February 26, 2025. Trading at $8.69, the stock has shown resilience, maintaining a position closer to its 52-week high of $10.16 than its low. This news is based on a press release statement from Actuate Therapeutics. For detailed valuation analysis and exclusive insights, visit InvestingPro.
In other recent news, Actuate Therapeutics, a biopharmaceutical company, has made significant strides in its clinical trials and operations. The U.S. Food and Drug Administration (FDA) granted rare pediatric disease designation to Actuate's drug, elraglusib, for the treatment of Ewing sarcoma, a metastatic form of bone cancer primarily affecting children and adolescents. This designation is a milestone for elraglusib, which is currently under evaluation in a Phase 1/2 trial for safety and efficacy in pediatric patients with relapsed or refractory malignancies.
Additionally, Actuate has reported encouraging results from its Phase 1/2 trial of elraglusib, with two ongoing complete responses and a disease control rate of approximately 62%. The company aims to enroll up to 12 Ewing Sarcoma patients in this trial, further advancing the development path for elraglusib.
In terms of corporate changes, Actuate announced a significant shift in its independent registered public accounting firm. KMJ Corbin & Company LLP has resigned and will be replaced by Crowe LLP effective immediately. The company confirmed that there were no disagreements with KMJ on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure. These recent developments provide a glimpse into Actuate's progress in both its clinical trials and financial operations.
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