UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-2755287 | | --- | --- | | (State or othe ...

Exhibit 99.1 Dr. Kirkpatrick continued, "Enrollment in the PF614-301 Phase 3 study has progressed rapidly, while PF614-MPAR remains on an accelerated development path under Breakthrough Therapy designation. In parallel, we have advanced commercial manufacturing readiness for PF614 and have generated additional data supporting overdose-protection labeling for our MPAR platform. Beyond our late-stage programs, we strengthened the long-term value of our technology platforms through expanded patent protection a ...

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Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results Back to the Newsroom Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results TAAPTM (Opioid Abuse Deterrent) Program Update Ensysce's lead drug candidate, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone designed to deliver effective pain relief while incorporating built-in abuse protection. Through proprietary chemical modification of ox ...

Core Viewpoint - Ensysce Biosciences, Inc. is focused on strategic execution plans, regulatory risk mitigation, pipeline prioritization, and the commercial potential of its product PF614 [1] Group 1: Strategic Execution and Community Engagement - The company successfully initiated its live "Ask Me Anything" (AMA) series on March 4, 2024, highlighting its commitment to transparency and open dialogue with the community [1] - A replay of the AMA series is available on the company's website, emphasizing accessibility for stakeholders [1] Group 2: Product Development and Market Potential - Ensysce is pioneering next-generation pain and central nervous system therapeutics aimed at minimizing the risk of abuse and overdose, indicating a strong focus on addressing critical healthcare needs [1]

Ensysce Biosciences (NASDAQ:ENSC) shares are up on Friday as the company has initiated a review of strategic alternatives aimed at enhancing shareholder value.The company on Wednesday announced that its Board of Directors is exploring a range of strategic alternatives, which may include partnerships, licensing arrangements, or asset sales.The strategic review is intended to support the advancement of its proprietary technologies, specifically the TAAP and MPAR platforms.“Our technologies were designed to fu ...

Core Viewpoint - Ensysce Biosciences, Inc. is advancing its pivotal Phase 3 clinical trial for PF614, a next-generation opioid designed to provide effective pain relief while incorporating built-in abuse and overdose protection [1] Enrollment Progress - The company has successfully enrolled 50% of the targeted subjects for an interim review in the Phase 3 clinical trial [1] - Enrollment commenced in late December 2025 and is progressing rapidly across three clinical sites in the U.S. [1] Clinical Sites - The clinical trial is being conducted at three locations: CenExel JBR in Salt Lake City, Utah; CenExel Atlanta in Decatur, Georgia; and ERG-HD Research, LLC in Houston, Texas [1]

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]