Ensysce Biosciences responds to recent shareholder inquiries

Ensysce Biosciences provided a response from CEO Lynn Kirkpatrick, regarding recent inquiries from stockholders and other interested parties, which read in part, “It is important to me to directly deliver an update to our supportive shareholders, stakeholders and partners, by addressing some questions we have recently received and providing a concise view of our development progress and timelines. What is the latest update from the Company in terms of Nasdaq listing requirements? As of September 30, 2024, we believe we are in compliance with Nasdaq requirements regarding stockholders’ equity and we are looking forward to the upcoming hearing with Nasdaq to discuss our plans to continue to maintain compliance with both the stockholders’ equity requirement and the $1.00 bid price requirement. How much cash does Ensysce have to continue to make progress on its initiatives? In August, the Company completed a financing transaction which raised $5 million in gross proceeds and received a $14 million multi-year grant award from the NIH. What are the latest plans and timeline of the PF614-301 protocol of the study, “A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty”? We submitted our PF614-301 Phase 3 Protocol to the FDA for our pivotal Phase 3 study, as announced on September 19, 2024. This study is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Results from the study are expected in late 2025. Next Steps: We await feedback on the protocol from the FDA. A Clinical Advisory Board meeting is planned for early November in which we will review the feedback and incorporate any advice into our study plans. Steps are being taken to identify clinical sites, and study management proposals have been solicited and received from interested Contract Research Organizations. Following receipt of grant funding for development of PF614-MPAR, will you provide the progress of the current clinical trial and frame out the remainder of trials to FDA approval? With $14 million of non-dilutive funding through a multi-year grant from the NIH and National Institute on Drug Abuse received for the purpose of continuing our PF614-MPAR studies, we have initiated a number of non-clinical studies required to support our PF614-MPAR NDA. In addition, we have received Investigational Review Board approval of the PF614-MPAR-102 protocol and held a kickoff meeting to prepare for subject enrollment, anticipated to begin later this quarter. What additional components are required in terms of achieving FDA approval and commercialization of PF614? Besides completing the necessary Phase 3 clinical studies to gain FDA approval, outlined above, Ensysce has partnerships in place with both drug substance and drug product contract development and manufacturing organizations to scale our manufacturing needs for production of clinical trial material, registrational material and commercial material for our first drug launch. In addition, we have received proposals from packaging and labeling facilities, and we are finalizing the steps needed to have commercial product in place to be shipped as soon as we receive approval from the FDA. Subject to raising additional funds, which cannot be assured, we are on track to submit our PF614 New Drug Application by 2026 and commercialization to follow by end of that year. Is ENSC evaluating strategic partnerships or indications of interest in terms of funding a safer opioid option and expedite commercialization? Ensysce has been in discussions with several interested partners to expand the commercial success of PF614 and PF614-MPAR. We are committed to leveraging cash and non-cash resources to reach our objectives.”