Ensysce Biosciences reports Q1 EPS (55c) vs. ($2.08) last year

Lynn Kirkpatrick, CEO, commented, “In the first quarter of 2024, we continued to accelerate the progress of our clinical programs toward regulatory approvals. Early in the quarter, a constructive end of Phase 2 meeting was held with the U.S. Food & Drug Administration for our lead opioid product, PF614, providing solid guidance for a Phase 3 clinical trial expected to initiate in the second half of 2024. The FDA also provided guidelines to reduce the regulatory risks for our commercialization plan. Additionally, in January, the FDA’s grant of Breakthrough Therapy designation for PF614-MPAR affirms belief in our novel approach to providing the ‘Next Generation’ of opioid products. This exclusive designation, granted to fewer than 300 drugs since its introduction in 2012, was based on data generated in our Phase 1 study, PF614-MPAR-101, which demonstrated that the unique combination can add oral overdose protection to our prescription TAAP products. This designation is intended to accelerate product development and provide guidance to aid the design of our PF614-MPAR programs to efficiently move toward a new drug application submission and approval of this innovative opioid. Coupled with the previously granted Fast Track designation for PF614, Breakthrough Therapy designation for PF614-MPAR demonstrates the FDA’s recognition of these transformational pain medications. We look forward to beginning our Phase 3 clinical trials in the second half of 2024. We believe the data we have generated to date from multiple clinical studies de-risk our path to commercialization. These studies have verified PF614 delivers oxycodone in an equivalent manner to commercially available opioids and provides pain relief with reduced abuse potential. We believe our TAAP and MPAR opioids have a proven safety profile that surpasses the current slate of extended-release opioid analgesics, and we look forward to providing additional milestones and updates in the months ahead.”