PresentationGreetings. Welcome to the 2025 Annual Meeting of Stockholders of Ensysce Biosciences, Inc. [Operator Instructions] Please note that this conference is being recorded. [Operator Instructions] I will now turn the conference over to your host, Dr. Bob Gower, Chairman of the Board. Please go ahead.Robert Gower Good morning, ladies and gentlemen, and thank you for joining the Ensysce Biosciences 2025 Virtual Annual Meeting of stockholders that was adjourned from December 23, 2025, to today. I am Bob ...

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]

Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future [108]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product [106]. - Net loss attributable to common stockholders was $3.7 million for the three months ended September 30, 2025, compared to a net income of $0.7 million in the same period of 2024, representing a change of $4.4 million [147]. - Net loss for the nine months ended September 30, 2025, was $7.4 million, compared to a net loss of $4.4 million in the same period of 2024, reflecting an increase of $3.0 million [152]. - The company anticipates continued significant operating losses and has raised substantial doubt about its ability to continue as a going concern without additional capital [161]. Research and Development - Ensysce's lead product candidate, PF614, is in Phase 3 clinical development, while PF614-MPAR is in Phase 1b, and nafamostat has completed Phase 1 clinical development [107]. - Research and development expenses increased by $1.3 million to $3.0 million for the three months ended September 30, 2025, primarily due to increased clinical and pre-clinical activity for PF614 and PF614-MPAR [149]. - For the nine months ended September 30, 2025, research and development expenses totaled $6.8 million, an increase of $3.3 million from $3.4 million in the same period of 2024 [152]. - The company expects future research and development expenses to increase once it begins the Phase 3 clinical trial for PF614, contingent on raising sufficient capital [149]. - Research and development expenses increased to $6.8 million for the nine months ended September 30, 2025, from $3.4 million in 2024, representing an increase of approximately 97% [154]. Funding and Capital Requirements - The company requires substantial additional funding to support ongoing operations and growth strategy, with current cash expected to last until late Q4 2025 [113]. - Ensysce has entered into various financing agreements, including a registered direct offering in March 2025 that raised approximately $1.1 million before fees [119]. - The company has issued unregistered warrants to purchase up to 1,863,706 shares of common stock as part of a concurrent private placement [124]. - The remaining funding under the MPAR federal research grant was $8.7 million as of September 30, 2025, expected to be utilized by May 31, 2027 [160]. - The company expects to incur elevated expenses related to ongoing research and development activities, including preclinical and clinical trials [166]. Grants and Federal Funding - Ensysce has received federal grants from the NIH, including a research and development MPAR Grant awarded in September 2018 and August 2024 [130]. - Federal grants decreased by $2.9 million to $0.5 million for the three months ended September 30, 2025, compared to $3.4 million in the same period of 2024 [148]. - Federal grant funding for the nine months ended September 30, 2025, totaled $3.2 million, a decrease of approximately $0.7 million from $3.9 million in 2024 [153]. Operating Expenses - Total operating expenses increased by $1.5 million to $4.2 million for the three months ended September 30, 2025, compared to $2.8 million in 2024 [147]. - Total operating expenses for the nine months ended September 30, 2025, were $10.6 million, up by $3.6 million from $7.1 million in 2024 [152]. - General and administrative expenses were $1.3 million for the three months ended September 30, 2025, compared to $1.1 million in the same period of 2024 [150]. - General and administrative expenses were $3.9 million for the nine months ended September 30, 2025, compared to $3.6 million in 2024, with expectations to maintain current levels [155]. Cash Flow - As of September 30, 2025, the company had $1.7 million in cash and cash equivalents and completed a convertible preferred stock offering with gross proceeds of $4 million in November 2025 [158]. - Net cash used in operating activities was $6.3 million for the nine months ended September 30, 2025, a slight decrease from $6.7 million in 2024 [163]. - Net cash provided by financing activities was $4.6 million for the nine months ended September 30, 2025, down from $9.8 million in 2024 [164]. Commitments and Obligations - Commitments as of September 30, 2025, included an estimated $7.3 million related to open purchase orders and contractual obligations [167].

Financial Performance - Ensysce reported a net loss attributable to common stockholders of $3.7 million for Q3 2025, compared to a gain of $0.7 million in Q3 2024, reflecting a significant decline in profitability [13]. - Cash and cash equivalents decreased to $1.7 million as of September 30, 2025, down from $3.5 million at the end of 2024 [9]. - Total operating expenses for Q3 2025 were $4.2 million, compared to $2.8 million in Q3 2024, reflecting increased investment in R&D [20]. - Ensysce's total assets decreased to $3.2 million as of September 30, 2025, down from $5.6 million at the end of 2024 [24]. Research and Development - Research and development expenses increased to $3.0 million in Q3 2025, up from $1.7 million in the same period of 2024, driven by heightened clinical and pre-clinical activities [11]. - The initiation of the pivotal Phase 3 PF614-301 trial in July 2025 marks a major milestone in Ensysce's development of PF614, aimed at providing effective pain relief while minimizing abuse risk [5]. - The FDA granted Breakthrough Therapy designation for the PF614-MPAR program, which combines overdose protection with pain management capabilities [7]. - The company is advancing its opioid use disorder (OUD) program, with PF9001 selected as the lead candidate, supported by a multi-year HEAL grant [8]. Funding and Capital - Federal grants funding totaled $0.5 million in Q3 2025, a decrease of $2.9 million compared to $3.4 million in Q3 2024, primarily due to the timing of research activities [10]. - Ensysce completed a convertible preferred stock offering in November 2025, raising gross proceeds of $4 million, with an additional $16 million potentially available through future tranches [9].

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]