Ensysce Biosciences Inc Aktie

Greetings, and welcome to the Ensysce Biosciences, Inc. Corporate Update Call. [Operator Instructions] It is now my pleasure to introduce your host, Dr. Lynn Kirkpatrick, Chief Executive Officer. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining us. We recently issued a press release outlining our acquisition of Cy Biopharma and a concurrent private placement financing. That release, along with an updated corporate presentation, is available at www.ensysce.com under the Investors Section.

Before we begin, I would like to remind everyone that the statements made during this call that are not historical facts, including statements relating to Ensysce's expected future performance, future business prospects and future events or plans and the anticipated benefits of the transaction, may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

All such forward-looking statements are intended to be subject of the safe harbor protection provided by the Reform Act. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual outcomes and results to differ materially from those forecast due to the impact of many factors beyond the control of Ensysce. Ensysce undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Participants are directed to the risk factors set forth in Ensysce's filings and the Securities and Exchange Commission including in its most recent Form 10-K and Form 10-Q and in other filings that it makes with the U.S. Securities and Exchange Commission. During the call today, I will review the details of our acquisition of Cy Biopharma and the concurrent private placement financing. James Morrison, Founder and Chief Executive Officer of Cy Biopharma who has joined Ensysce as President, and Professor Richard Langford, Cy Biopharma's Chief Medical Officer, will then provide an overview of their lead program, CY200, for the treatment of Complex Regional Pain Syndrome or CRPS.

I'd like to start by describing how this transaction developed. Our Board of Directors undertook a thorough evaluation of strategic alternatives with a focus on maximizing value for Ensysce's shareholders. After a robust process, the Board concluded that this acquisition represented the most significant value creation opportunity evaluated, including the synergies between the 2 companies.

The clinical data supporting CY200 and CY Biopharma's approach to treating the devastating condition of CRPS reinforced our conviction to this program. In addition to the acquisition, we also announced financings of up to $77 million that included a private placement of $21.5 million through the sales of Series C nonvoting convertible preferred stock to a group of institutional investors, $17.1 million of CY Biopharma's cash and cash equivalents from a pre-acquisition convertible note financing and up to another $38.6 million upon achievement of a clinical trial milestone. The financing was led by Ally Bridge Group and included participation from Perceptive Advisors, Dellora Investments, Ikarian Capital and Adage Capital Partners LP.

The proceeds from these finances are intended to be used primarily to advance CY200 through key clinical milestones, including top line data from a randomized Phase II trial assessing efficacy, safety and tolerability in participants with CRPS Type 1 and to prepare the program for registrational development. CY200 is a botanical psilocybin extract designed to provide a neuro reset for CRPS. It has already received U.S. FDA orphan drug designation for the treatment of CRPS, which we believe provides important regulatory and commercial advantages as we advance the program. I want to emphasize that the private placement was intentionally sized to support the immediate strategic objectives of executing the Phase II trial of CY200 while maintaining financial discipline. And importantly, this transaction is not expected to come at the expense of our existing pipeline. We will continue to progress PF614 and PF614-MPAR, which we believe represents a fundamentally new approach to opioid safety.

It's now my pleasure to introduce James Morrison, Founder and Chief Executive Officer of CY Biopharma, who joins Ensysce as President and has also joined our Board of Directors. James led CY Biopharma since its founding, building the company's clinical strategy for CY200 from early discovery through orphan drug designation and into Phase II development. James, over to you.

Thank you, Lynn, and good morning, everyone. I would like to echo Lynn's thanks to those joining us this morning and to the investors supporting the recent financings. We at CY Biopharma are excited to join Ensysce with the opportunity to deploy this capital towards developing serotonin receptor agonist therapeutics beyond mood disorders. Starting with a much-needed meaningful treatment for patients suffering from an orphan condition, Complex Regional Pain Syndrome. Professor Richard Langford, our CMO, and I will take a few minutes to walk through why we believe CRPS represents such a significant unmet need and why the neuroplastogenic effect of our lead candidate, CY200, is well positioned to address this. Richard?

Thank you, James, and good morning, everyone. CRPS is widely regarded as one of the most severe chronic pain conditions that exist today. Patients often describe pain that is disproportionate to any known injury, and the condition frequently presents with swelling, changes in skin temperature and color and progressive loss of function in the affected limb.

Because there is no single diagnostic test and no FDA-approved therapies specifically indicated for the condition, patients often cycle through pain management strategies, including opioids, nerve blocks and physical therapy with inconsistent and often short-lived relief, or invasive high-cost measures such as implanted neurostimulation devices. The physical, psychological and socioeconomic burden on these patients is substantial.

CRPS may even develop in adolescence and early adulthood, meaning that they can face decades living with the condition. Our approach with CY200 is different from standard symptom management. Rather than simply blunting pain signaling, CY200 is designed as a neuroplastogenic therapy, meaning it is intended to act on the underlying neurobiology thought to drive and sustain CRPS, with the goal of producing greater and more durable benefits rather than transient or inadequate symptom relief.

With CY200, we are aiming to improve both pain and functioning. We believe that the orphan drug designation CY200 has already received from the FDA reflects both the seriousness of this condition and the potential of our approach. We expect it to provide considerable regulatory and commercial advantages as we move through development including opportunities for closer engagement with the FDA. And if CY200 is ultimately approved, a period of market exclusivity in the United States.

I will now turn it over to James to describe our development strategy.

Thank you, Richard. Our development strategy combines rigorous clinical science with an efficient regulatory pathway intended to accelerate delivery of this therapy to patients. The next milestone for this program is top line data from our randomized Phase II trial evaluating the efficacy, safety and tolerability of CY200 in participants with CRPS Type 1, which the proceeds from the financings are intended to support. This transaction gives our science the capital, the public market platform and the strategic flexibility to help execute on our mission.

We believe we are entering the public markets at the right point where clinical execution, not financing can be our primary near-term focus, and we are looking forward to an exciting second half of the year. I'm honored to join the Ensysce team as President and to join the Board of Directors of the combined company.

With that, I'll turn the call back to Lynn to cover the structure of the transaction.

Thank you, James, and welcome to the team. Now let me walk through a few additional details on the structure of the transaction. The acquisition of CY Biopharma was completed as previously described in our August 6 press release. Concurrent with the closing, we entered into a definitive agreement for the sale of Series C nonvoting convertible preferred stock in a private placement which resulted in gross proceeds to Ensysce of approximately $38.6 million before deducting transaction expenses.

Following completion of the transaction and financing, we expect to have pro forma cash on hand sufficient to fund operations into late 2027, supporting the company through anticipated catalysts, including top line Phase II data for CY200, which may trigger a second investment of up to $38.6 million to carry activities through 2028.

On the advisory side, Troutman Pepper Locke served as legal counsel to Ensysce, and Orrick, Herrington & Sutcliffe served as legal counsel to CY Biopharma. Wedbush Securities served as the exclusive financial adviser to CY Biopharma. Tungsten Advisors and H.C. Wainwright served as financial advisers to Ensysce. Cantor and UBS served as placement agents for the private placement financing. Details on our combined strategy and pipeline are available in an updated corporate presentation now posted to the Investors Section of our website at www.ensysce.com.

We will not be taking any questions for today's call, but we look forward to engaging with our investors and analysts as we move through integration and towards our next clinical milestones. We appreciate your time this morning and your continued interest in Ensysce. We are energized by this transaction and by the opportunity ahead of us with CY200 and the broader pipeline. Thank you, and have a great day.

Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

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.