~ Engineered to Deliver Potent Pain Relief with Built-In Abuse Protection ~ SAN DIEGO, CA / ACCESS Newswire / January 28, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced it has enrolled 50% of subjects targeted for interim review in its pivotal Phase 3 clinical trial of PF614, the Company's next-generation opioid candidate engineered to ...

Core Viewpoint - Ensysce Biosciences, Inc. has received a Notice of Allowance from the Brazilian Patent Office for a patent covering additional opioid families, enhancing its intellectual property and expanding global protection for its innovative pain treatment technologies [1] Group 1: Patent and Technology - The newly allowed patent includes both composition of matter and method of use claims, which strengthens the company's intellectual property estate [1] - The patent covers the company's proprietary TAAP™ (Trypsin Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies, aimed at advancing safer pain treatment [1] Group 2: Market Implications - The expansion of patent protection is expected to bolster the company's position in the market for Next Generation analgesics, potentially leading to increased competitiveness and market share [1]

Group 1 - Ensysce Biosciences held its 2025 Annual Meeting of Stockholders virtually, continuing the format to ensure safety and accessibility for all stockholders [2] - Dr. Bob Gower has been the Chairman of the Board since 2008 and presided over the meeting [2] - The Board of Directors includes members with diverse backgrounds and experience, such as Lynn Kirkpatrick, the CEO since 2009, and other members who joined in various years [3]

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].