Ensysce Biosciences reports Q4 EPS ($1.13) vs. ($18.30) last year

Reports Q4 grant revenue $515,032 vs. $1.4M last year. Lynn Kirkpatrick, CEO, commented, “We are proud of the significant progress Ensysce has made in 2023 both operationally and clinically for our lead pain therapeutic, PF614, and our overdose protection product, PF614-MPAR. Our advancements were particularly instrumental in providing a foundation for our constructive end of Phase 2 meeting with the U.S. Food & Drug Administration for PF614. We believe the FDA’s guidance positioned Ensysce favorably and solidified the PF614 Phase 3 clinical study designs to initiate enrollment in the second half of 2024, ultimately reducing regulatory risks that could impede our commercialization plan. Especially encouraging was the FDA grant of Breakthrough Therapy designation to PF614-MPAR in January 2024, acknowledging its unique advantage over current opioids. Breakthrough Therapy, an exclusive designation applied to less than 300 drugs historically, offers Ensysce the opportunity to accelerate our clinical programs and go-to market plans. Importantly, the collective empirical data we’ve received from four completed clinical studies verify PF614’s bioequivalence to commercially available opioids but with reduced abuse potential, and reaffirms our belief that Ensysce’s PF614 will provide a “next generation” opioid family with the added value proposition of safer products with overdose protection. We have many reasons to remain optimistic on our path to regulatory approval as we advance through our Phase 3 clinical trials beginning in the second half of 2024. Progress in 2023 and early 2024 has provided further evidence that our innovative analgesics will provide prescribers and patients in severe pain with an alternative, effective option with safety advantages to address the opioid epidemic in the United States.”