Ensysce Biosciences, Inc. Q3 FY25 Results

It has been another highly productive quarter as we navigate tumultuous times in drug development. Our team continued meaningful progress throughout the third quarter as we advanced what we consider a new evolution in opioid therapeutics, focused on delivering safer, highly efficacious options for severe pain management using our innovative platforms. The initiation of our pivotal Phase 3 PF614-301 trial in July marks a major milestone in our mission to transform pain management. This study is designed to demonstrate PF614’s ability to provide effective pain relief while supporting safe transitions to non-opioid care. Our alliance with Rho, Inc. ensures rigorous execution as we work to unlock significant long-term value through innovation in opioid safety. We are also buoyed by encouragement from the U.S. Food and Drug Administration (“FDA”) for our PF614-MPAR program, with Breakthrough Therapy designation, including working to align on overdose protection labeling and a regulatory pathway forward. This milestone reinforces our mission and commitment to transform opioid safety through scientific innovation, and we are proud to be working collaboratively with the FDA to ensure the full benefits of our technology reach the patients for which they are intended. Looking ahead, we believe Ensysce is positioned to launch the next-generation opioid analgesia. Our strategy integrates scientific rigor, responsible development, and continued collaboration with National Institute on Drug Abuse (“NIDA”) and FDA to address the dual challenges of pain and abuse. Our current investors have continued to support this development path through a convertible preferred stock financing and we appreciate the opportunity to move forward with our programs buoyed by their commitment to our mission. Each milestone brings us closer to redefining how severe pain can be treated - with efficacy, safety, and accountability at the core.