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]

Core Viewpoint - Ensysce Biosciences, Inc. has initiated a pivotal Phase 3 clinical trial for its lead product candidate PF614, aimed at providing effective pain relief with built-in abuse protection [1] Group 1: Clinical Trial Details - The first patient has been enrolled in the Phase 3 clinical trial, named PF614-301 [1] - The study is a multicenter, randomized, double-blind, placebo- and active-controlled trial [1] - The trial aims to evaluate the efficacy and safety of PF614 for treating moderate to severe pain following abdominoplasty [1] Group 2: Product Features - PF614 is designed to deliver strong and consistent post-surgical pain relief [1] - The product incorporates an innovative chemical mechanism intended to reduce the risk of abuse and overdose [1]

Core Points - The FDA has provided Written Responses to Ensysce Biosciences regarding its request for guidance on the manufacturing approach for PF614 [1] - Ensysce is focused on developing next-generation pain and central nervous system therapeutics aimed at reducing abuse and overdose risks [1] Company Summary - Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company [1] - The company is listed on NASDAQ under the ticker ENSC [1] - The request to the FDA was aimed at understanding the appropriateness of regulatory starting materials (RSMs) and specifications for the PF614 drug substance [1]

Core Insights - Ensysce Biosciences, Inc. has successfully closed a $4 million convertible preferred stock financing, with the potential for an additional $16 million in future funding over the next 24 months [1] Funding and Development - The funding will accelerate the Phase 3 clinical program for PF614, which is Ensysce's flagship analgesic candidate [1] - The capital raised will also support general corporate initiatives within the company [1]

Core Insights - Ensysce Biosciences has initiated a Phase 3 study of PF614, highlighting its progress towards market readiness and commitment to developing novel opioid solutions [1] - The company reported financial and operational results for the third quarter ended September 30, 2025, indicating a productive quarter despite challenges in drug development [1] Financial Performance - Ensysce's financial results for Q3 2025 were disclosed, reflecting the company's ongoing efforts to advance its programs [1] - The company has secured preferred stock financing to support further program advancement [1] Operational Highlights - The initiation of the Phase 3 study of PF614 is a significant milestone for Ensysce, emphasizing its focus on severe pain therapeutics designed to minimize abuse and overdose risks [1] - Dr. Lynn Kirkpatrick, CEO, noted the productivity of the quarter amidst the complexities of drug development [1]

As filed with the Securities and Exchange Commission on March 26, 2024 Registration No. 333-276537 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-effective Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 82-2755287 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...

As filed with the Securities and Exchange Commission on January 16, 2024 Registration No. 333-****** UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-2755287 (I.R.S. Employer Identification Number) 7946 Iva ...

As filed with the Securities and Exchange Commission on November 17, 2023 Registration No. 333-275456 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-effective Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Delaware 2834 82-2755287 (I.R.S. Employer Identification Number) 79 ...