Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — Investor Presentation (July 2021)
37 slides from Ensysce Biosciences's investor presentation, Jul 21, 2021
Slide 1: Corporate Overview: Improving Prescription Drug Safety Through Chemistry
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 ‘Statements contained in this presentation that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other ‘federal securities laws. Without li
Slide 4: Ensysce Overview
Slide 5: 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 2024") Note: 1) Apor
Slide 6: Pain. Pain Killers. Pain Killers That Kill.
PAIN. ; chronic pain Opioid prescriptions constitute more than half of the total prescription pain market with more than 153m opioid prescriptions every year PAIN KILLERS. ® opioid prescriptions Chronic pain, which is caused by rising incidences of cancer, arthritis, post- surgical pain and low back
Slide 7: Not Just a USA Problem
NOT JUSTA USA PROBLEM Latest Prevalence Source: Data collected from National Authorities through Annual Reports Questionnaire (ARQ) ENSYSCE BIOSCIENCES 7
Slide 8: Chronic Pain Sufferers with Out of Control Pain Control
CHRONIC PAIN SUFFERERS WITH UT OF CONTROL PAIN CONTROL Opioid abuse stems from the desire to increase the onset of euphoria, its intensity, and its duration. This canbe done by: aamuammmmmam pecaensctd Breaking down the pill Taking more and more (physically or chemically) for quick medication by swa
Slide 9: The Next Generation of Opioids is Here
The Next Generation of Opioids is Here GEN 1 Tinctures and potions GEN 2 Pharmaceuticals Immediate release opioids GEN 3 Abuse Deterrent Formulations Physical formulation approach ER release to reduce abuse Next GEN 4 TAAP and MPAR™ Chemical modification with 2 step activation
Slide 10: Solving for Opioid Abuse and Overdose: Ensysce Has Created Platforms
SOLVING FOR OPIOID ENSYSCE HAS C B G PLATFORMS, Ensysce biosciences NTEG D PRODRUG TECHNOLOGY PLATFORM ERASE Combining anti-abuse and anti-overdose technology to create new classes of prescription drugs that are expected to be powerful and safe for everyone PROTECTIVE JSE AND PREVENT OV + OVERDOSE N
Slide 11: Innovation Drives Our Strategy
Slide 12: TAAP: Tamper-Proof Opioids
TAAP opioids are designed with a 2-step verification mechanism that cannot be “cracked” like abuse deterrent formulations, thus delivering a TAM p ER PRO OF highly effective solution to combat drug abuse TAAP is only activated by trypsin, a digestive enzyme that exists only in the gut; therefore cru
Slide 13: TAAP Mechanism of Action: Two-Step Release Process
TAAP opioid + linker : amino acid MECHANISM OF ACTION | st=1 | ACTIVATION ists i TWO-STEP RELEASE PROCESS + trypsin edits gut only * The drug is activated by the enzyme trypsin only when it reaches the gut, preventing abuse outside the lesaty STEP 2 RELEASE * The inactive drug releases active oxycod
Slide 14: PF614 Matches OxyContin Extended Release Profile
PF614 MATCHES OXYCONTIN EXTENDED RELEASE PI PF614 TAAP: PRECLINICAL DATA 200 4 cs + PF614 chemically releases oxycodone with the same extended release (ER) profile as Untampered OxyContin dog 20 mg OxyContin 100 * The same release profile demonstrates that 50 PF614 can achieve similar pain relief as
Slide 15: Dose Does Not Change with Manipulation
dose not change with manipulation Blood Concentration of Opioid Vs. Time * Unlike OxyContin, Ensysce’s opioid PF614, even when crushed, releases oxycodone only slowly in the blood, thereby preventing euphoria (pleasure) and abuse CRUSHED Oxycodone 20mg UNTAMPERED * In pre-clinical studies, PF614 ach
Slide 16: PF614 vs. Oxycodone Comparison
nal oxycodone Oxycodone y © Opioid Receptor Binding jyiGy 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 Penetration HIGH CNS PENETRATION ther
Slide 17: MPAR Anti-Overdose Platform
MULTI- PILL ABUSE MPAR™ is a smart anti-overdose platform that is RESISTANT i i ; i designed to protect patients from overdosing when it is combined with TAAP opioids. At its essence, MPAR is a combination product of PF614 and Nafamostat. ANTI = OVE RD 0 GS FE MPAR™ inhibits trypsin when too much TA
Slide 18: MPAR Mechanism of Action
MPAR™ Mechanism of Action COMBINATION PRODUCT WITH DOSE-TRIGGERED TRYPSIN INHIBITION PRESCRIBED DOSE No Interference when normal dose of Ensysce’s opioid PF614 is taken; Low dose of trypsin inhibitor does not affect release of the opioid Trypsin activation releases Free and active drug product SUB-T
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 Discovery Preclinical IND Phase I Phase 2 Phase 3 I Pain PAR es Addiction =e EEE ADHD AF : —— eee Our pipeline of pain, addiction, and ADHD candidates developed TAP and MPAR™ platforms with 505(by(2) regulatory development p
Slide 21: FDA Fast Track and NIH Grant Support
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: Milestones
al a\ Vi I wal J Milestones @@@O0 IND ; ecco PIPELINE PIPELINE PIPELINE PIPELINE eee0e eee ee ee yN + CMC preparation for HAL and + PF614 bioequivalence (Phase 2) + PF614 Phase 3 Trial: chronic pain. bioequivalence. Trial initialed 07 21 (505(b)(2) approval). + Develop MPAR™ overdose + MPAR™ and OUD
Slide 23: Management Team
Fl D. Lynn Kirkpatrick, PhD Chief Executive Officer + 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 SK oncoTHYREON Yale Uni
Slide 24: Board of Directors
Dr. Lynn Kirkpatrick Dr. Bob Gower Andrew Benton Wil liam Chang Dr. Adam Levin Steve Martin Dr. Curtis Rosebraugh Career focused on novel drug discovery and development Former Professor of Chemistry and Biochemistry, U of Regina, Canada Founder of Prolx Pharmaceuticals, Former, Chief Scientific Offi
Slide 25: Scientific Advisors
Dr. Lynn Webster Dr. Webster has dedicated more than three decades to becoming an expert in the field of pain management + Former Vice President of Scientific Affairs of PRA Health Sciences, Past President of the American Academy of Pain Medicine Leading voice in trying to help physicians safely tre
Slide 26: 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 27: Contact Us
CONTACT US ENSYSCE BIOSCIENCES 7946 IVANHOE AVENUE, LA JOLLA, CA, 92037 UNITED STATES (858) 263-4196 INFO@ENSYSCE.COM
Slide 28: Appendix
APPENDIX
Slide 29: Extensive Patent Protection
EXTENSIVE Ensysce has over 100 patents already issued in 25 countries, ensuring barriers to entry for new companies globally 1] 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 o
Slide 30: Proof of Concept
Proof of Concept PF614 F329 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 31: Evolutionary TAAP Technology
EVOLUTIONARY ANT OPIOIL f without causing abuse and addiction is that it believes * 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 u
Slide 32: TAAP + MPAR Preclinical Data
Oxycodone mean concentration (ng/mL) WITHOUT MPAR™ (PF614 without TI nafamostat) 25 ba 10 dose units 6 dose units 3 dose units 1 dose units 18 10 Time (hr) TAAP + MPAR™: PRECLINICAL DATA Oxycodone mean concentration (ng/mL) 25 20 15 10 WITH MPAR™ (PF614 with TI nafamostat) Time (hr) 16 20 24 in rats
Slide 33: Properties
Properties Abuse deterrence Susceptible to abuse. chewing Susceptible to abuse. extraction/injection Simple coating/reformulation PF614 Half-life 12 hrs. for twice a day product Extended release oxycodone Two-step oral activation Overdose solution: MPAR™ 3
Slide 34: Phase 1 Design and Results
Phase 1 Design and Results + Single ascending dose (SAD) study in up to 48 healthy subjects; 15 to 200 mg fasted/ 200 mg fed. * Cohorts 1 to 6: 15 to 200 mg PF614 matched to 10 to 80 mg OxyContin. + Randomized: PF674(n=6 per cohort) or OxyContin comparator arm (n=2). + Safety and pharmacokinetic end
Slide 35: TAAP Clinical Data: Abuse Prevention
‘Oxycodone mean concentration (ng/mL) TAAP: CLINICAL DATA ABUSE PREVENTION 100 * As shown in the graph on the left, the onset of Ensysce’s Donen Meterensoe’ meet PF614 in blood is slow even at higher doses, demonstrating ° He ay SES the ability to prevent opioid pleasure (euphoria) and abuse 25 mg/6
Slide 36: TAAP Clinical Data: Oxycodone Half-Life
40 30 20 10 Oxycodone half life TAAP: CLINICAL DATA Dose (PF614 / OxyContin) © 15 mg/ 10 mg © 25 mg / 10 mg © 50 mg / 20 mg © 100 mg / 50 mg © 200 mg / 80 mg © 200 mg /— True Twice-a-Day Product * Ensysce’s opioid PF614’s half-life is 12.7 hours, versus OxyContin’s 7.6 hours * Asaresult, Ensysce’s P
Slide 37: PF614 Bioactivation and Metabolites
PF614 PFROGO82 PFROG112 “Bioactivation” Via waibinestivelEnzvine Enzyme on _ 0 “Clock” Arg-Gly-Mal NO . H N SE, ae nk By ott Ce ca nan an) ‘OH R SO es eo an nay Intramolecular Cyclization-Release Reaction Cyclic Urea oH Pet 4 WS Oxycodone PFRO6110 All metabolites are followed in clinical trial. One
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