Ensysce Biosciences Inc Aktie

Greetings. 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.

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 Gower and I have served as Chairman of the Board since 2008. We've continued the virtual format for our annual meeting to help promote safety while providing a consistent experience to all stockholders regardless of your location. I am pleased to be presiding over today's meeting.

Also joining us today virtually are the members of our Board of Directors, and it's my pleasure to introduce each of them now. William Chang. William joined the Board in 2016 and serves on our Compensation Committee. Bob Gower. I joined the Board in 2008, and I'm a member of our Nominating Committee and Nominating and Corporate Governance Committee, and I also serve on the Audit Committee and Compensation Committee. Lynn Kirkpatrick. Lynn joined our board in 2009 and has served since that time as our Chief Executive Officer. Adam S. Levin, MD. Adam joined the Board in 2021 and chairs our Compensation Committee. Steve R. Martin. Steve joined the Board in 2020 and Chairs the Audit Committee. He also serves on our Nominating and Corporate Governance Committee. Lee Rusch. Lee joined the Board in 2022 and serves on our Audit Committee and Compensation Committee and as Chairperson of our Nominating and Corporate Governance Committee. Curtis Rosebraugh. Curtis joined the Board in 2021. Curtis serves on our Nominating and Corporate Governance Committee. Andrew Benton is not standing for reelection to the Board of Directors, and we are grateful for his service to the company.

After consideration of the matters to be voted upon, Dr. Lynn Kirkpatrick, our CEO, will give a brief company update. If you are a stockholder entitled to vote and have not yet voted or if you want to change your previously cast vote, you can vote at any time before the voting closes by using the link to the Annual Meeting voting section of the meeting web page. If you already voted, it's not necessary to vote again.

Before I turn the meeting over to David Humphrey, our Chief Financial Officer, Corporate Secretary and Treasurer, I'd like to take a moment to thank our entire inside leadership team led by Lynn Kirkpatrick. And finally, on behalf of the Board and the management, I'd like to thank our stockholders for your continued confidence and investment in Insight. I also want to thank our directors, the directors of our Board for their significant contribution over the past year. Your guidance and your stewardship is greatly valued and appreciated. Now it's my pleasure to call to order our 2025 Annual Meeting of Stockholders.

David Humphrey will act as secretary of the meeting. And at this time, I'll turn the meeting over to him.

Thank you, Dr. Gower. Good morning, and welcome, everyone. I am David Humphrey, the company's Chief Financial Officer, Corporate Secretary and Treasurer. Today's meeting is being recorded and will be made available on our website, ensysce.com as soon as practical after the meeting. Copies of our 2025 proxy statement and 2024 annual report can be found on the meeting web page.

Continental Stock Transfer & Trust Company has confirmed to me that the proxy materials for this meeting were mailed on or about December 5, 2025, to stockholders of record as of October 29, 2025, the record date for this meeting. An additional notice concerning adjournment and a proxy card were mailed on or about December 16, 2025, to stockholders of record as of October 29, 2025. An affidavit to this effect will be filed with the minutes of the meeting.

I, David Humphrey, the company's Chief Financial Officer, Corporate Secretary and Treasurer, and acting as Inspector of Election for this meeting and have taken the oath of office, which will be filed with the minutes of the meeting. All stockholders of record at the close of business on October 29, 2025, are entitled to vote at this meeting. A list of the stockholders as of the record date of October 29, 2025, who are entitled to vote and to receive notice and to vote at this meeting has been available for inspection at our principal offices during regular business hours for more than 10 days.

I have confirmed that a quorum is represented, so this meeting has been duly called and is officially convened. There are 5 matters before stockholders today. Each is identified on the proxy card and more fully described in our proxy statement. The first order of business is to consider the proposal to approve for purposes of complying with NASDAQ Listing Rule 5635(d), the full issuance of shares of common stock and exercise of warrants for common stock issued by the company to an investor known as Proposal 1. The Board of Directors unanimously recommends that stockholders vote in favor of Proposal 1.

The second item of business before this meeting is the amendment of the Ensysce Biosciences, Inc. amended and restated 2021 Omnibus Incentive Plan to increase the aggregate number of shares of the company's common stock that may be issued under the plan from 121,457 shares to 721,457 shares known as Proposal 2. The Board of Directors unanimously recommends that stockholders vote in favor of proposal 2. The third item of business is the election of the following 2 nominees as directors of Ensysce Biosciences, Inc. William Chang and Lee Rusch. Each director nominee has been nominated to serve as a Class I director until our 2028 Annual Meeting.

As Corporate Secretary, I've advised the company that no other nominations have been received. The Board of Directors unanimously recommends that the stockholders vote in favor of the election of each nominee to the Board.

The fourth item of business before the meeting is the ratification of the appointment of Baker Tilly US, LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2025. The Board of Directors unanimously recommends that stockholders ratify the foregoing appointment.

A fifth item of business listed in the proxy statement is consideration of a proposal to adjourn the meeting. However, because this proposal is relevant only if the number of votes for another proposal is insufficient to approve that proposal, this proposal will not be considered unless that occurs.

Dr. Gower, each of the items has been properly brought before this meeting, and it does not appear at this time that the fifth item of business must be considered. Now I turn the meeting back to you.

Thank you, Dave. At this time, voting ends as the polls are now closed. While the votes are being tabulated, I would like to invite Dr. Lynn Kirkpatrick, our President and Chief Executive Officer, to address the meeting. After Lynn's comments, we will announce the preliminary voting results and adjourn the formal portion of the meeting. Now I would like to turn the meeting over to Dr. Lynn Kirkpatrick, our CEO and President.

Thank you, Bob. Good morning, and thank you for joining us. Ensysce has had an exceptional year in the continued development of our 2 next-generation analgesics. PF614, which has been designated with fast track status and PF614-MPAR with overdose protection, which received breakthrough therapy designation from the FDA in 2024. We are honored that the FDA recognizes the uniqueness and potential of our TAAP and MPAR technologies. Additionally, the National Institute on Drug Abuse has continued to support our MPAR program with the receipt of the second $5 million of a multiyear $15 million grant to continue the development of PF614-MPAR, helping us move this highly novel analgesic through IND-enabling and early clinical studies.

The development path for PF614 progressed significantly during the year. We announced the initiation of our Phase III pivotal study midyear and the initiation of enrollment of subjects in this study in December. This pivotal trial is evaluating the analgesic and safety properties of PF614 in subjects undergoing abdominoplasty, currently at 3 sites in the U.S. Importantly, we received support from the FDA on our manufacturing approach for PF614, allowing us to move to commercialization scale as we ready our plans for market launch.

We have also continued the clinical development of our overdose protected PF614-MPAR with completing parts 1 and 2 of a 3-part trial PF614-MPAR-102. We met with the FDA to discuss the regulatory path for PF614-MPAR and are working with the agency to understand labeling to position it as the first opioid with overdose protection to be approved to treat severe pain.

Additionally, we've also applied our TAAP and MPAR technologies to produce novel treatments for opioid use disorder and ADHD and have expanded our patent portfolios in these areas. Our goals for early 2026 are to continue to execute our Phase III trial for PF614 and to position to move it toward an NDA submission. Over the last year, the financial support that Ensysce has achieved from the National Institutes of Health and the public markets has driven the progress of our programs and put us in a position to enter the last phase of development poised to bring a highly novel opioid analgesic to the market and to individuals suffering in severe pain. These accomplishments over the last year were made due to the dedication of my highly experienced team and the drive we all have to provide the public with safer medications for strong pain relief.

Finally, on behalf of the Board and the management team, I want to thank our stockholders for your continued trust and investment in insights. Thank you for joining us today. I'd like to hand the floor back to Bob Gower.

Thank you, Lynn. It is now time for David Humphrey to announce the preliminary voting results.

Thank you, Dr. Gower. As the inspector of elections, I have been furnished with the preliminary voting results. The preliminary results are as follows: Stockholders have approved for purposes of complying with NASDAQ Listing Rule 5635(d), the full issuance of shares of common stock and exercise of warrants for common stock issued by the company to an investor. Stockholders have approved an amendment to the Ensysce Biosciences Omnibus Plan. Each of the 2 nominees for director has been elected to the Board and the selection of Baker Tilly US, LLP as the company's independent registered public accounting firm for fiscal year 2025 has been ratified.

In addition, because the number of votes on these proposals is sufficient to approve the proposals, the proposal to consider an adjournment of the meeting if the number of votes is insufficient does not need to be considered. The final report of the inspector of elections will be filed with the minutes of the meeting, and the results will be filed with the SEC on a Form 8-K.

Now I'd like to turn the meeting back to Dr. Gower.

Thank you, Dave. This completes our 2025 Annual Meeting of Stockholders, and the meeting is adjourned. Thank you all for attending. The final votes will be tabulated and results of voting will be publicly disclosed. The company will reply electronically to any questions submitted by registered stockholders during the meeting.

Thank you for your continued dedication to Ensysce. I'd now like to turn the meeting back over to the host to bring the session to a conclusion.

This concludes today's meeting, and you may disconnect at this time. Thank you for your participation.