Ensysce Biosciences(ENSC) - 2025 FY - Earnings Call Transcript

Financial Data and Key Metrics Changes - Ensysce Biosciences has achieved significant progress in the development of its next-generation analgesics, PF614 and PF614 MPAR, with the latter receiving Breakthrough Therapy designation from the FDA in 2024 [13][14] - The company received a second $5 million installment of a multi-year $15 million grant from the National Institute on Drug Abuse to support the development of PF614 MPAR [13] Business Line Data and Key Metrics Changes - The pivotal trial for PF614 has been initiated, focusing on its analgesic and safety properties in subjects undergoing abdominoplasty, with enrollment starting in December [14] - Clinical development for PF614 MPAR has progressed, with parts one and two of a three-part trial completed [14] Market Data and Key Metrics Changes - The FDA has provided support for the manufacturing approach of PF614, allowing the company to move towards commercialization scale [14] Company Strategy and Development Direction - Ensysce aims to continue executing the phase 3 trial for PF614 and is preparing for an NDA submission [15] - The company is expanding its patent portfolios to include novel treatments for opioid use disorder and ADHD [14] Management's Comments on Operating Environment and Future Outlook - Management expressed gratitude for the continued support from stockholders and emphasized the dedication of the team in providing safer medications for pain relief [15] - The company is positioned to bring a highly novel opioid analgesic to market, addressing severe pain [15] Other Important Information - The company has successfully approved several proposals during the annual meeting, including the issuance of shares and the amendment of the Omnibus Incentive Plan [18] Q&A Session Summary - There were no specific questions or answers documented during the meeting, as the format was primarily focused on the presentation and voting results [20]