Ensysce Biosciences (NASDAQ:ENSC) held its 2025 virtual annual meeting of stockholders, which had been adjourned from Dec. 23, 2025, to the meeting date. Chairman of the Board Dr. Bob Gower said the company continued using a virtual format “to help promote safety while providing a consistent experience to all stockholders.”
Gower introduced directors participating virtually and noted that Andrew Benton was not standing for reelection, thanking him for his service to the company. Chief Financial Officer David Humphrey served as corporate secretary and inspector of elections for the meeting.
Meeting and voting matters
Stockholders were asked to vote on five matters, with the fifth—an adjournment proposal—only to be considered if there were insufficient votes to approve another proposal. The board recommended votes in favor of the other proposals.
- Proposal 1: Approval, for purposes of complying with NASDAQ Listing Rule 5635(d), of the full issuance of shares of common stock and exercise of warrants for common stock issued by the company to an investor.
- Proposal 2: Amendment of the company’s amended and restated 2021 Omnibus Incentive Plan to increase the aggregate number of shares issuable under the plan from 121,457 shares to 721,457 shares.
- Proposal 3: Election of two director nominees—William Chang and Lee Rauch—to serve as Class I directors until the company’s 2028 annual meeting.
- Proposal 4: Ratification of the appointment of Baker Tilly US, LLP as independent registered public accounting firm for the fiscal year ending Dec. 31, 2025.
- Proposal 5: A proposal to adjourn the meeting, to be used only if needed to solicit additional votes.
CEO highlights development progress and regulatory designations
Following the close of polls, President and CEO Dr. Lynn Kirkpatrick provided a company update, describing what she called an “exceptional year” advancing two analgesic candidates: PF614 and PF614 MPAR.
Kirkpatrick said PF614 has received FDA Fast Track status. She also stated that PF614 MPAR—described as an overdose-protected product—received Breakthrough Therapy designation from the FDA in 2024. Kirkpatrick said the company believes the FDA’s designations recognize “the uniqueness and potential” of Ensysce’s TAAP and MPAR technologies.
On funding, Kirkpatrick said the National Institute on Drug Abuse continued to support the MPAR program, and that Ensysce received the second $5 million tranche of a multi-year $15 million grant to continue developing PF614 MPAR. She said the funding supports IND-enabling work and early clinical studies.
Clinical and manufacturing updates
Kirkpatrick said PF614’s development “progressed significantly” during the year. She cited the mid-year announcement of the initiation of a Phase III pivotal study and said enrollment began in December. According to Kirkpatrick, the pivotal trial is evaluating analgesic and safety properties of PF614 in subjects undergoing abdominoplasty and is currently being conducted at three U.S. sites.
She also said the company received support from the FDA on its manufacturing approach for PF614, which she said allows the company to move to commercialization scale as it readies plans for a market launch.
For PF614 MPAR, Kirkpatrick said Ensysce completed parts one and two of a three-part trial, PF614 MPAR 102. She said the company met with the FDA to discuss the regulatory path for PF614 MPAR and is working with the agency to understand labeling with the goal of positioning it “as the first opioid with overdose protection” approved to treat severe pain.
Kirkpatrick also said Ensysce has applied its TAAP and MPAR technologies to produce novel treatments for opioid use disorder and ADHD and has expanded its patent portfolios in those areas.
Goals for early 2026 and stockholder vote outcomes
Looking ahead, Kirkpatrick said Ensysce’s goals for early 2026 are to continue executing the Phase III trial for PF614 and to position the program toward an NDA submission. She attributed program progress over the last year to financial support from the National Institutes of Health and the public markets, adding that the company believes it is entering the “last phase of development” toward bringing a novel opioid analgesic to market.
Humphrey then announced preliminary voting results. Stockholders approved Proposal 1 regarding issuance of shares and warrants; approved the amendment to the omnibus plan; elected both director nominees, Chang and Rauch; and ratified Baker Tilly US, LLP as the company’s independent auditor for fiscal 2025. Because sufficient votes were received, the adjournment proposal was not considered. Humphrey said final results would be filed with the SEC on a Form 8-K.
The meeting was adjourned following the announcements, with the company noting it would respond electronically to questions submitted by registered stockholders during the meeting after adjournment.
About Ensysce Biosciences (NASDAQ:ENSC)
Ensysce Biosciences, Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel prodrug therapies aimed at improving pain management and addressing opioid misuse. Leveraging its proprietary prodrug platform, the company designs drug candidates that convert into active pharmaceuticals through specific enzymatic action, providing controlled-release profiles and built-in abuse deterrence features.
The company’s lead product candidate, ENS100, is an investigational oral prodrug of hydrocodone engineered to reduce the potential for misuse and abuse compared to immediate-release opioid formulations.
