Leisure Acquisition Corp.(NASDAQ: LACQ, LACQU, LACQW), a special purpose acquisition company formed for the purpose of effecting a merger, acquisition or similar business combination, announced today that it has entered into a definitive agreement to acquire Ensysce Biosciences, Inc. The transaction reflects an enterprise valuation for Ensysce of $207 million, including the Company's existing convertible indebtedness, but excluding transaction expenses as well as the impact of Leisure's sponsor shares and subject to certain closing adjustments.
Consideration paid to Ensysce's shareholders for their interests in the Company will consist of shares of Leisure common stock issued at a price equal to $10.00 per share. Assuming none of Leisure's shares of common stock are redeemed for cash in trust, Ensysce's existing shareholders would own approximately 71% of the combined company's outstanding common stock at closing. Certain liabilities of Ensysce are expected to remain in place at closing, and all of Ensysce's convertible debt will be converted into common stock of the combined company upon closing of the transaction. Ensysce's existing options and warrants will be exchanged for equivalent securities in Leisure on their existing terms (with standard adjustments to exercise price and underlying shares, consistent with the transaction exchange ratio).
Innovator in Deterring Abuse and Overdose Potential from Opioids Ensysce is a clinical-stage drug company that is developing an innovative new class of powerful, tamper-proof prescription medicines that seek to prevent both drug abuse and drug overdoses. The Company has created two revolutionary new drug platforms that have been proven clinically to be safe and effective. 1Ensysce believes Trypsin Activated Abuse Protection (TAAP™) is the only approach that protects against all forms of abuse (snorting, chewing and injecting), accomplished through the Company's proprietary chemical modulation that inactivates the ingredient until it is swallowed. The Company's Multi-Pill Abuse Resistant (MPAR™) overdose-protection is designed to work in unison with TAAP™ in order to eliminate drug overdoses.
The Company's lead program addresses the unmet need for safe, abuse-resistant opioids. With its lead drug candidate PF614, Ensysce has secured FDA "Fast-Track" status and is permitted to use the 505(b)(2) regulatory pathway to accelerate the development timeline. Ensysce believes this will allow for PF614 to be commercialized within three years and to become the drug of choice for responsible severe pain therapy. With several drugs in the pipeline, Ensysce seeks to achieve approximately 20% of the branded opioid market in the United States by 2030.
Ensysce PipelineEnsysce's drug portfolio, consisting of TAAP™, which has been granted "Fast Track" status, and MPAR™, spans an approximate $9 billion and an approximate $13 billion Pain & Addiction and ADHD market, respectively, in the United States. Ensysce believes its pipeline of Pain & Addiction and ADHD candidates using TAAP™ & MPAR™ technologies show advantageous clinical and regulatory positioning because they are safe, effective prodrugs with a decreased development time due to the FDA 505(b)(2) pathway. Further, Ensysce believes certain of its strategic advantages are due to the new drug class designation with potential extended market exclusivity. The Company's leading drug candidate, PF614, is currently positioned to enter the Chronic Pain market in 2024, where market growth has been driven by the rising prevalence of chronic conditions, the surging geriatric population and increasing government support regarding chronic pain management. Other drug candidates in the Company's development pipeline for each of Chronic and Acute Pain Management are expected to follow as the Company progresses its planned clinical roll out of products.
Seasoned Management and BoardEnsysce's management team is comprised of seasoned industry veterans, led by Chief Executive Officer Dr. Lynn Kirkpatrick, who will continue as CEO of the combined company. Dr. Kirkpatrick will continue to be supported by William Schmidt (Chief Medical Officer), Geoff Birkett (Chief Commercial Officer) and Richard Wright (Chief Business Officer) and a highly experienced Advisory Board. Leisure Executive Chairman Lorne Weil and Chief Executive Officer Daniel Silvers are each expected to remain directors of the combined company while each of Leisure's other existing directors will resign in connection with closing of the transaction.
Management CommentaryEnsysce's CEO, Dr. Lynn Kirkpatrick, stated, "Ensysce has achieved significant milestones in its development of the TAAP™ and MPAR™ drug platforms. As we move through our Phase 2 and Phase 3 clinical trials, we expect that our products will satisfy an unmet need in the market: opioid pain therapeutics that limit the potential for abuse or overdose. We are excited to partner with Leisure as we continue to execute our development and commercialization plans. Lorne and Dan's collective experience and extensive relationships, combined with access to public capital markets, are expected to favorably position the Company to achieve its growth targets. The entire Ensysce team looks forward to working with the team at Leisure to create value for shareholders over the long-term."
Leisure Executive Chairman Lorne Weil and Chief Executive Officer Daniel Silvers jointly commented, "We are excited to partner with the Ensysce team, led by Dr. Kirkpatrick, as it seeks to accelerate Ensysce's growth through the many high-return initiatives already in place as well as by pursuing potential future accretive transactions."
Prospective Ensysce MilestonesEnsysce management has established the following operational milestones for 2021 and 2022:
- Complete a multi-ascending dose and bioequivalence clinical study for PF614 in healthy subjects
- Complete two Human Abuse Liability studies for PF614
- Complete a Phase 1 safety study with pharmaceutic development milestones for PF614-MPAR
- Identify a lead drug candidate in its Opioid Use Disorder program
The Company expects to provide updates with respect to these milestones, and other material developments, to the extent material information becomes available.
Key Transaction TermsAt the closing of the Transaction, Ensysce Biosciences, Inc. will merge into a wholly-owned subsidiary of Leisure. In connection with the merger, outstanding shares of Ensysce (including shares resulting from the conversion of Ensyce's convertible debt prior to closing) will be converted in the business combination into the right to receive shares of Leisure at an exchange rate of .06585. In addition, Ensysce's existing options and warrants will be exchanged for equivalent securities in Leisure on their existing terms (with standard adjustments to exercise price and underlying shares, consistent with the foregoing exchange rate).
The combined company's sources of available cash are expected to be comprised of: (i) cash in Leisure's trust account (subject to any redemptions), (ii) any excess cash on the respective balance sheets of Leisure and Ensysce at the closing date and (iii) any proceeds drawn pursuant to a $60 million forward equity purchase facility previously entered into by Ensysce. The combined company's available cash is expected to be used to: (i) pay transaction fees and expenses and (ii) for general corporate purposes of the combined company.
Additional information about the transaction will be provided in a Current Report on Form 8-K that will contain an investor presentation to be filed by Leisure with the Securities and Exchange Commission (SEC) and will be available at www.sec.gov. In addition, Leisure intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/ prospectus, and will file other documents regarding the proposed transaction with the SEC.
Timing and ApprovalsThe proposed transaction has been unanimously approved by the Boards of Directors of both Leisure and Ensysce, and is expected to close in the second quarter of 2021, subject to approval by Leisure's shareholders, required regulatory approvals and other customary closing conditions. Upon closing, Leisure intends to change its name to Ensysce Biosciences, Inc. and remain on the Nasdaq Capital Market, listed under the new ticker symbol ENSC.
Leisure Nasdaq UpdateAs previously disclosed in its SEC filings, Leisure received a notice from Nasdaq regarding non-compliance with certain listing rules and the potential delisting of Leisure's equity securities from the Nasdaq Capital Market. On January 27, 2021, the Nasdaq Hearing Panel granted Leisure's request for the continued listing of its equity securities on the Nasdaq Capital Market pursuant to an extension, subject to certain milestones, through June 1, 2021 so that Leisure may seek to complete an initial business combination and regain compliance with the listing rules. If the Company does not regain compliance by the required date, Nasdaq would delist Leisure's equity securities from the Nasdaq Capital Market. Additional information is available in Leisure's filings with the SEC.
About Ensysce Biosciences, Inc.
Ensysce's TAAP™ chemical modifications overcome abuse, especially for the highly abused opioid and ADHD prescription drugs. As the use of opioids have risen sharply over the last two decades, rates of addiction and overdose deaths have dramatically increased. Drug overdose deaths are now the leading cause of accidental death in the U.S. Abuse Deterrent Formulation (ADF) and modifications of opioids have not stemmed this epidemic. Ensysce's Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR™) products are anticipated to provide safe options to treat pain and provide a promise of halting opioid deaths. Ensysce's TAAP™/MPAR™ platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug prodrug compositions. Additional information can be found at www.ensysce.com.