Ensysce Biosciences Reports Third Quarter 2024 Financial Results

SAN DIEGO, CA / ACCESSWIRE / November 12, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today reported financial and operational results for the third quarter ended September 30, 2024.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made significant progress in the third quarter, and we have line of sight to meaningful clinical initiatives to close out the year. The highlight of the third quarter was NIH's recognition of the potential value provided by our overdose protection technology MPAR®, by awarding Ensysce with a $14 million multi-year grant to further the clinical development of PF614-MPAR. The support from the NIH allows the completion of a second Phase 1b trial, PF614-MPAR-102. We believe the data from this study will cement PF614-MPAR as the first opioid with oral overdose protection, a game-changer for those suffering with severe pain while mitigating potential abuse and overdose."

Dr. Kirkpatrick continued, "We also built on FDA feedback from our End of Phase 2 meeting in February to complete our Phase 3 protocol and have submitted it to the FDA. We expect FDA feedback by the end of November to allow us to complete plans to execute the study over the coming year. Our August financing transaction that raised $5 million in gross proceeds allows us to advance to clinical site selection for our pivotal Phase 3 trial for PF614, and the $14 million MPAR® grant has allowed us to rapidly initiate our second trial for PF614-MPAR. We anticipate the results from these clinical studies will continue to build on our prior positive safety data to bring our innovative and premium pain products to market. Lastly, we are applying our TAAP and MPAR technology to our opioid use disorder program and look forward to moving the lead agent into clinical development in the coming years."