Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — Leisure Acquisition — SPAC Merger (May 2021)
35 slides from Ensysce Biosciences's SPAC merger presentation, May 18, 2021
Slide 1: Corporate Overview: Improving Prescription Drug Safety Through Chemistry
May 2021 CORPORATE OVERVIEW IMPROVING PRESCRIPTION DRUG SAFETY THROUGH CHEMISTRY
Slide 2: Disclaimer
Disclaimer Ensysce’s PF614 and nafamostat are currently in clinical and pre-clinical trials, involving both the TAAP platform and MPAR platform. Accordingly, PF614 and nafamostat have the risks and uncertainties inherent in any drug in trial-phase, which include, but are not limited to, a failure to
Slide 3: Forward Looking Statements
Forward Looking Statements Certain statements included in this presentation that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accom
Slide 4: Experienced Leadership
a — EXPERIENCED. TODAY'S PA D. Lynn Kirkpatrick, PhD CEO of Ensysce + Co-founded 2 start up companies + Developed three targeted small molecule oncology drugs from discovery to clinic + Experience in private and public company raising funds from private, public and government sources BIOMIRA JK onco
Slide 5: Transaction Overview
TRANSACTION OVERVIEW Summary of Ensysce and LACQ proposed business combination Transaction Summary Key Economic Terms Required Approvals Management and Independent Board Leisure Acquisition Corp. ("LACQ") and Ensysce Biosciences, Inc. (“Ensysce”) have entered into a definitive merger agreement Exist
Slide 6: Transaction Overview (cont'd)
TRANSACTION OVERVIEW (cont'd Illustrative Sources and Uses“) Illustrative Pro Forma Capitalization” (say (SMM, except share price) Sources of Funds Equity Consideration to Existing Ensysce Shareholders $1734 SPAC Trust Proceeds $12.7 (=) Issue Price of LACQ Shares $10.00 Equity Consideration to Exis
Slide 7: Ensysce Overview
Slide 8: Overview
OVERVIEW * Two new platforms that aim to eliminate opioid abuse (TAAP) and prevent drug overdose (MPAR) * Covistat, an Ensysce subsidiary, is repositioning a protease inhibitor program for an COVID-19 Therapeutic and Cystic Fibrosis. lead drug product PF614 major funding through 20241) Note: 1) Apor
Slide 9: Unmet Need to Address Societal Crisis
UNMET NEED T0 ADDRESS SOCIETAL CRISIS MORE PAIN KILLERS THAT KILL. MORE PAIN KILLERS. 222 0. MORE PAIN. Fema 191M 50M —— ee ai ahi [~] $560B in costs chronic pain Pune nae ah HEM IEES sufferers Chronic pain, which is caused by rising incidences of cancer, arthritis, post- But drugs have turned deadl
Slide 10: Chronic Pain Sufferers with Out of Control Pain
CHRONIC PAIN SUFFERERS WITH OUT OF CONTROL PAIN CONTROL Opioid abuse stems from the desire to increase the onset of euphoria, its intensity, and its duration. This can be done bi a! a Breaking down the pill Taking more and more (physically or chemically) for quick medication by swallowing, digestion
Slide 11: Solving for Opioid Abuse and Overdose
SOLVING FOR OPIOID + OVERDOSE ENSYSCE ED TWO NEW DRL NED TO COMBAT ABUSE Ensysce PLATFORM biosciences MPAR™ designed to prevent drug overdose by inhibiting the release of a drug when excessive amounts are taken INTEGRATED PRODRUG TECHNOLOGY PLATFORM FFECTI\ . “ . 1. EFFECTIVE: Combining anti-abuse a
Slide 12: Innovation Drives Our Strategy
Slide 13: Tamper-Proof
TAMPER-PROOF nse P64 and nafrostt are carrer in nical and pene wa, wong both the TAA pater and MPAR patra TAAP™ opioids are designed with a 2-step verification mechanism that cannot be “cracked” like abuse deterrent formulations, thus delivering a highly effective solution to combat drug abuse ) " T
Slide 14: TAAP Mechanism of Action
TAAP™ MECHANISM OF ACTION =| ster1 ACTIVATION TWO-STEP RELEASE PROCESS * The drug is activated by the enzyme trypsin only when it reaches the ae preventing abuse outside the step 2 ody RELEASE * The inactive drug releases active oxycodone gradually in the blood, preventing immediate onset and abuse
Slide 15: PF614 Matches OxyContin
PF614 MATCHES OXYCONTIN Oxycodone mean concentration (ng/mL) 200 150 100 50 TAAP™: PRECLINICAL DATA * PF614 chemically releases oxycodone with the same extended release (ER) profile as OxyContin * The same release profile demonstrates that PF614 can achieve similar pain relief as OxyContin
Slide 16: Longer Pain Relief and Lower Risk
le longer pain relief and a lower risk Oxycodone Y 0 /PFBI4. ; Opioid Receptor Binding HIGH AFFINITY: increasing the strength of binding to LOW AFFINITY: without Gl activation, reducing the ‘receptors and hence, promoting pleasure (euphoria) binding to receptors and hence, minimal side effect CNS Pe
Slide 17: MPAR Anti-Overdose Platform
MULTI- ABUSE RESISTANT MPAR™ is a smart anti-overdose platform that is designed to protect patients from overdosing when it is combined with TAAP™ opioids ANTI = OVERD 0 SE MPAR™ inhibits trypsin when too much TAAP™ opioid is swallowed, inhibiting full activation and opioid release, and p LAT FO R M
Slide 18: MPAR Mechanism of Action
MPAR™ Mechanism of Action Leen DOSE-TRIGGERED TRYPSIN INHIBITION TAAP™~enabled opioid MPAR™ trypsin inhibitor ABOVE THRESHOLD trypsin inhibitor PRESCRIBED DOSE No Interference when normal dose of Ensysce’s opioid PF614 is taken; MPAR™ (trypsin inhibitor) does not affect the opioid ATTEMPTED / ACCIDE
Slide 19: Leveraging Our Platform to Drive Long-Term Value
Slide 20: TAAP & MPAR Portfolio
TAAP™ & MPAR™ PORTFOLIO DIVERSIFIED PIPELINE TO ADDRESS AREAS OF UNMET NEEDS Pain Addiction ADHD ENSYSCE BIDSCIENCES Discovery Preclinical Phase 3 TAAP™ and MPAR™ platforms with 505(b\2) regulatory development path Our pipeline of pain, addiction, and ADHD candidates developed using TAAP™ & MPAR™ sh
Slide 21: FDA Fast Track and NIH Grants
FOA fast track 2018 FDA granted Fast Track designation for TAAP PF614. Fast Track may expedite review of drugs to treat serious conditions that address an unmet medical need NIH support 2018 NIDA awarded Ensysce up to $12M grant to progress MPAR™ Four year award to undertake the pre- clinical and cl
Slide 22: Clinical Pipeline Milestones
ate CLINICAL @@@O IND PIPELINE CMC preparation for HAL and bioequivalence. MPAR™ and OUD preclinical program initated. Nafamostat Phase 1 trial. MPAR™ IND submission. CLINICAL eee0e PIPELINE eee + PF614 Human Abuse Liability (HAL) clinical trial: nasal and oral. + PF614 bioequivalence (Phase 2) data
Slide 23: Board of Directors
Andrew Benton William Chang Dr. Adam Levin Steve Martin Dr. Curtis Rosebraugh Career focusedon | Seasoned Executive | President Emeritus of Entrepreneur, Academic and clinical | Experienced Senior | Extensive FDA drug novel drug discovery and Entrepreneur Pepperdine Realty Company orthopedic surgeon
Slide 24: Investment Highlights
Ensysce’ biosciences Unmet Need — With individuals suffering from severe pain and need for safer options Ensysce has focused on using its TAAP and MPAR technology to help address the need. Revolutionary Abuse-Resistant Opioids — Ensysce believes it has developed a breakthrough technology to deliver
Slide 25: Contact Us
CONTACT US ENSYSCE BIOSCIENCES 7946 IVANHOE AVENUE, LA JOLLA UNITED STATES (858) 263-4196 INFO@ENSYSCE.COM ENSYSCE BIOSCIENCES
Slide 26: Appendix
APPENDIX
Slide 27: Extensive Patent Protection
XTENSIVE Ensysce has over 100 patents already issued in 25 countries, ensuring barriers to entry for new companies globally @ Color coded regions on the map indicate countries where patents have been issued * Ensysce’s technology is well-protected by a suite of 111 patents issued in the U.S. and ove
Slide 28: Proof of Concept
Proof of Concept PFBI4 PF329 TAAP Oxycodone TAAP Hydromorphone prodrug evaluated in prodrug evaluated in Phase 1 Phase 1 clinical trial. clinical trial alone and in combination with trypsin inhibitor, Nafamostat.
Slide 29: TAAP Breakthrough Technology
+ TAAP™ breakthrough technology is a chemical modulation of opioids. * It has a revolutionary 2-step release process that seeks to achieve the intended goal of effective pain-relief while eliminating the potential for user abuse. * TAAP™ PF614 is chemically modified oxycodone — is inactive and can o
Slide 30: PF614 Matches OxyContin
PF614 MATCHES OXYCONTIN Oxycodone mean concentration (ng/mL) 200 150 100 50 TAAP™: PRECLINICAL DATA * PF614 chemically releases oxycodone with the same extended release (ER) profile as OxyContin * The same release profile demonstrates that PF614 can achieve similar pain relief as OxyContin
Slide 31: PF614 Abuse-Resistant Further Development
PF614 to be abuse- further development * Unlike OxyContin, Ensysce’s opioid PF614, even when crushed, releases oxycodone only slowly in the blood, thereby preventing euphoria (pleasure) and abuse * In pre-clinical studies, PF614 achieved similar concentrations and duration of action in the blood as
Slide 32: TAAP Clinical Data
100 80 20 ‘Oxycodone mean concentration (ng/mL) TAAP™: CLINICAL DATA ese/ Naltrexone / meal 15mg/21/no/ fasted 15 mg/22/ yes / fasted 25 mg/6/ yes / fasted 50 mg/6/ yes / fasted 100 mg/6/ yes / fasted 200 mg//6/ yes / fasted 200 mg/8/ yes / high-fat 2 18 28 30 36 Time (hr) ABUSE PREVENTION * As show
Slide 33: PF614 ER Oxycodone
: ER Oxycodone Chemical approach to abuse deter PF614 Extended release oxycodone Properties Abuse deterrence Susceptible to abuse. chewing Susceptible to abuse. extraction/injection Simple coating/reformulation Half-life 12 hrs. for twice a day product Two-step oral activation Overdose solution: MPA
Slide 34: Preclinical Data Without and With MPAR
WITHOUT MPAR™ (PF614 without TI nafamostat) 10 dose units 6 dose units 3 dose units 15 wont 1 dose units 10 Oxycodone mean concentration (ng/mL) o 4 8 2 16 Oh Time (hr) TAAP™ + MPAR™: PRECLINICAL DATA Oxycodone mean concentration (ng/mL) 15 10 WITH MPAR™ (PF614 with TI nafamostat) Time (hr) 16 2 inr
Slide 35: Not Just a USA Problem
NOT JUST A USA PROBLEM i NNUAL Prevalence Source: Data collected from National Authorities through Annual Reports Questionnaire (ARQ) ENSYSCE BIDSCIENCES 3b: