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 Phase III Pivotal Study for PF614 was initiated mid-year, with subject enrollment starting in December [13][14] - The clinical development of PF614 MPAR has progressed, with parts one and two of a three-part trial completed [14][15] 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] - The company is working with the FDA to position PF614 MPAR as the first opioid with overdose protection approved for severe pain treatment [15] Company Strategy and Development Direction - Ensysce aims to continue executing the Phase III trial for PF614 and prepare for an NDA submission in early 2026 [16] - The company is expanding its patent portfolios to include novel treatments for opioid use disorder and ADHD [15] 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 [17] - The financial support from the National Institutes of Health and public markets has positioned the company to enter the last phase of development for its novel opioid analgesic [16] Other Important Information - The company held its 2025 Annual Meeting of Stockholders virtually to ensure safety and accessibility for all stockholders [2] - The preliminary voting results indicated approval for several proposals, including the issuance of shares and the amendment of the Omnibus Plan [19] Q&A Session Summary - No specific questions and answers were documented during the meeting, as the company indicated that any questions submitted by registered stockholders would be answered electronically after the meeting adjourned [21][22]

Financial Data and Key Metrics Changes - Ensysce Biosciences has had an exceptional year with significant progress in the development of its next-generation analgesics, PF614 and PF614 MPAR, which have received Fast Track and Breakthrough Therapy designations from the FDA respectively [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 is currently evaluating its analgesic and safety properties in subjects undergoing abdominoplasty, with enrollment initiated in December [14] - Clinical development of PF614 MPAR has progressed with the completion of parts one and two of a three-part trial [14][15] 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] - The company is working with the FDA to position PF614 MPAR as the first opioid with overdose protection approved for treating severe pain [15] Company Strategy and Development Direction - Ensysce aims to continue executing the phase 3 trial for PF614 and plans to move towards an NDA submission in early 2026 [16] - The company is expanding its patent portfolios to include novel treatments for opioid use disorder and ADHD [15] 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 [16] - The company is positioned to enter the last phase of development for its novel opioid analgesic, indicating a strong outlook for future market entry [16] 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 [19] - The election of two nominees to the board and the ratification of the independent registered public accounting firm for fiscal year 2025 were also approved [19] Summary of Q&A Session - There were no specific questions or answers documented in the provided content regarding the Q&A session during the meeting.

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]