Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — Investor Presentation (May 2022)
36 slides from Ensysce Biosciences's investor presentation, May 17, 2022
Slide 1: Improving Prescription Drug Safety Through Chemistry
Ensysce" biosciences Improving Prescription Drug Safety Through Chemistry Investor Presentation May 17, 2022
Slide 2: Disclaimer
Ensysce” biosciences 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 lim
Slide 3: Ensysce Overview
Ensysce Overview Who we ore Clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance. 2 Core Technology Platforms MPAR™ Combination Products for SMART Overdose protection Mission To use TAAP/MPAR to launch the Next Generation opioid product
Slide 4: Ensysce Investment Summary
Ensysce Investment Summary ® Clinical stage biotech company using transformative trypsin-controlled chemistry to improve drug safety and performance. = Two highly novel technology platforms that we believe can be applied to a large majority of prescription drugs, driving internal growth and external
Slide 5: TAAP and MPAR
TAAP™ and MPAR" MPAR™ Multi-Pill Abuse Resistance: Combination Products for SMART Overdose Protection Reduce ability to tamper with drug product SMART Active only on overdose. to abuse. . Platform based on trypsin control of UNIQUE activation and release. Trypsin activated release only in small inte
Slide 6: Addressing Opioid Overdose: TAAP/MPAR Platform
Ensysce biosciences Addressing Opioid + )verdose Ensysce" SES M p A R™ PLATFORM Integrated Prodrug Technology Platform Combining anti-abuse and anti-overdose technology to create new classes of prescription drugs that are Overdose designed to be powerful and safe for everyone Designed to Prevent
Slide 7: Improving Pain, Reducing Abuse
Improving Pain reducing Abuse ™ Ensysce biosciences i TODAY 3400 B.C. 1900s 1990s TAAP™ and MPAR™ Originally identified Pharmaceuticals Abuse Deterrent Formulations (ADFs) Trypsin-Activated Chemical lnnmnedinte Yeleaselo lid Physical formulation approach modification Extended release claimed to redu
Slide 8: Market Opportunity
Market Opportunity Global Poin Management Drugs Market Global Opioids Market 2019 2027 2018 2026
Slide 9: Potent Portfolio
Potent Portfolio Ensysce has over 100 patents currently issued in 25 countries, ensuring opportunity to address abuse globally * Technology well-protected by a suite of patents generated from over $100 million of research support * Patents provide protection to the underlying molecules, pharmaceutic
Slide 10: Innovation
Innovation 10
Slide 11: TAAP two-step verification mechanism
Ensysce” biosciences TAAP - 2-step verification mechanism to improve oral delivery, with release of active ingredient only in the small intestine with exposure to trypsin IMPROVED TAAP chemical modification TAAP is only activated by trypsin TAAP not altered by manipulation 11
Slide 12: TAAP Two-Step Release Process
TAAP Two-Step Release Process Step 1: Swallow drug * Following ingestion, the drug is activated only after exposure to trypsin, a digestive enzyme that is active only in the small intestine. Step 2: Timing chemically controlled * Asecond step is required for full release of the active drug. The chem
Slide 13: Release kinetics cannot be altered
Release kinetics cannot be altered 206 ¢ Unlike OxyContin, Ensysce’s opioid PF614, even when crushed, has no altered release kinetics 1sy * In Phase | studies have been able to dose match PF614 to marketed OxyContin dose units. Oxycodone mean concentration (ng/mL) Pre-clinical Blood Concentration of
Slide 14: Release kinetics cannot be altered
Release kinetics cannot be altered 204 * Unlike OxyContin, Ensysce’s opioid PF614, even when crushed, has no altered release kinetics * In Phase | studies have been able to dose match PF614 to marketed OxyContin dose units. Oxycodone mean concentration (ng/mL) Pre-clinical Blood Concentration of Opi
Slide 15: MPAR anti-overdose platform
Ensysce” biosciences TM MULTI- PILL ABUSE ae 7 F AESIEWORTT MPAR™ is a smart anti-overdose platform that is designed to protect patients from overdosing when it is combined with TAAP opioids. ANTI-OVERDOSE PLATFORM @ MPAR™ is only triggered by an overdose @ MPAR™ inhibits trypsin activation step e U
Slide 16: MPAR Mechanism of Action
Ensysce” MPAR™ Mechanism of Action — MPAR™ Combination Product Legend: Combination Product With Dose-Triggered Trypsin Inhibition Ce 2: TAAP-enabled opioid Trypsin Inhibitor SUB-THRESHOLD : ABOVE THRESHOLD trypsin inhibitor : trypsin inhibitor PRESCRIBED DOSE o No Interference when normal dose taken
Slide 17: PF614-MPAR
PF614-MPAR™ Without MPAR™ PF614 without TI nafamostat Oxycodone mean concentration (ng/ml) ° 4 8 2 10 dose units 6 dose units 3 dose units m1 dose units Time (hr) TAAP + MPAR™: PRECLINICAL DATA ‘Oxycodone mean concentration (ng/ml) With MPAR™ PF614 with TI nafamostat Time (hr) in rats n=4 /dose Comb
Slide 18: Safer, More Efficient
PF614-101 Safer, More Efficient Oxycodone Concentration in Blood vs. Time following PF614 administered as oral solution PF614-101 Phase 1 Slow Onset 100 = * PF614 provides slow onset with maximum blood max blood levels reached @ 4-6h across all cohorts concentration reached at 4 to 6 hr after Dose /
Slide 19: Compared OxyContin
COMPARED 10 OXYCONTIN 40 30 20 ° “@ao Oo Oxycodone half life TAAP™: CLINICAL DATA Dose (PF614 / OxyContin) PF614-101Phase 1 . Ensysce’s opioid PF614’s half-life is 12.7 hours, versus OxyContin’s 7.6 hours As a result, Ensysce’s PF614 is more convenient for the patient, since PF614 needs to be taken
Slide 20: PF614 study timelines
PFB14 > Multi-ascending dose/Bioequivalence study in healthy volunteers; MAD Data reported 05/05/22; BE data expected Q2 2022. > Human abuse liability study via intranasal administration. Study initiation Q2 2022. Data expected Q3 2022. > Human abuse liability study via oral administration. Study in
Slide 21: PF614-102 MAD/BE
PF614-102 MAD/BE A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects The primary o
Slide 22: PF614-102 MAD Adverse Events
PF614-102 MAD Table of Adverse Events PF614 OxyContin PF614 OxyContin PF614 OxyContin 50 mg 20 mg 100 mg 40 mg 200 mg 80 mg n=6 n=2 n=6 n=2 n=6 n=2 n(%) n(%) n(%) n(%) n(%) n (%) Total subjects with at least 1 2 (33.3) 1 (50.0) 1 (16.7) 1 (50.0) 6 (100.0) 2 (100.0) TEAE* * Treatment Emergent Adverse
Slide 23: Oxycodone (ng/mL)
Oxycodone (ng/mL) 80 60 40 PF614-102 MAD Oxycodone from 50, 100 and 200 mg PF614 n= 6 first 12 hours PF614 SO mg Solution PF614 100 mg Solution —PF614.200 mg (2x 100mg // capsules) / Hours Oxycodone (ng/mL) Oxycodone from 20, 40 and 80 mg OxyContin n=2 “a first 12 hours 110 100 —— OxyContin 20 mg ——
Slide 24: Oxycodone Cmax
160 140 8 8 3 8 Oxycodone ng/mL PF614-102 MAD or PF614 Day 1 Cmax 20 40 80 Oxycodone mg equivalent dose *-PF614 -e-OxyContin max 160 140 8 8 8 Oxycodone ng/mL Day 5 C,,ax 20 40 80 Oxycodone mg equivalent dose «-PF614-e-OxyContin 24
Slide 25: Oxycodone AUC
ng/mL) Oxycodone (h 2500 y 3 3 3 PF614-102 MAD orPFBI4 AUC, Day 1 AUC,, —————— ae 20 40 80 Oxycodone mg equivalent dose *-PF614-e-OxyContin 2500 Oxycodone (h*ng/mL) Day 5 AUC, 20 40 80 Oxycodone mg equivalent dose *-PF614 -e-OxyContin 25
Slide 26: Day 1 and Day 5 AUC
2000 1000 Oxycodone (h*ng/mL) PF614-102 MAD orPFBI4 AUC,,, Day 1 and Day 5 AUC,, OxyContin —— 20 40 80 Oxycodone mg equivalent dose OxyContin D1 OxyContin D5 Oxycodone (h*ng/mL) 2000 1000 Day 1 and Day 5 AUC,, 20 PF614 40 80 Oxycodone mg equivalent dose PF614 D1 ---PF614 D5 26
Slide 27: PF614-MPAR-101
PF614-MPAR-101 PF614 (25 mg) with and without nofomostat (10 mg) A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 Solution is Co Administered with Nafamostat, as an Immediate Release Solution and/or Extended Release (ER) Capsule Formulations in Healthy Subjects
Slide 28: First Demonstration of Human Overdose Protection
PF614-MPAR-101 PF614 (25 mg) with and without nofamostat (10 mg) First Demonstration of Human Overdose Protection: Average Systemic Oxycodone after Average Systemic PF614 after 25 mg Oral PF614 with/without 10 mg Nafamostat 25 mg Oral PF614 with/without 10 mg Nafamostat 14 R Oxycodone from PF614 » |
Slide 29: Cash Resources
CASH RESOURCES $8.4M NIH Support Cash as of 3/31/22 2018 NIDA awarded Ensysce up to $12M grant to progress MPAR™ S4.1M Grant Funding as of 3/31/22 Four-year award to undertake the pre-clinical and clinical development of the company’s opioid overdose protection platform MPAR™ (Multi Pill §2.8M Abuse
Slide 30: Lead Product
Ensysce” biosciences Lead Product True abuse Not susceptible to Not susceptible to Two-step oral deterrence chewing extraction/injection activation Chemistry modifications, not just a Real 12-hour pain control for a New chemical entity with simple coating or reformulation true twice-a-day product no
Slide 31: PF614 505(b)(2) pathway
PFBI4: * Helps avoid unnecessary duplication of studies already performed ona previously approved drug if bioequivalence can be demonstrated, reducing time and cost for development. ¢ Allowing rolling NDA submission and more access to discussions with agency * Completion of BE Study 06/22; Data H1 2
Slide 32: Diversified Pipeline
Ensysce” biosciences Diversified Pipeline PAIN Program PFG14 PF614-MPAR™ PF329 ADHD Program PF8001/8026 [ Respiratory Program Nafamostst* TAAP and MPAR™ platforms with 50(b)(2) regulatory development path *Nafamostat in develpment for MPAR, infections and respiratory dseases HAL: Human Abuse Liabili
Slide 33: Management team
Management team so &% &@ 6 >. D. Lynn Kirkpatrick, PhD David Humphrey, CPA Geoff Birkett Linda Pestano, PhD Nily Osman, MD Richard Wright, MBA Jeffrey Millard, PhD + Co-founded 2 start up * Extensive experience in + Large pharma leadership + Experienced in the design + Board certified neurologist. *
Slide 34: Clinical Advisory Board
Clinical Advisory Board Dr. Lynn Webster Dr. Richard Dart Dr. Jeffrey Gudin Dr. Dart is the Director of the Rocky Mountain Poison and Drug Center and specializes in emergency medicine and toxicology. Dr. Webster has y dedicated more than three decades to becoming an expert in the field of pain manag
Slide 35: Ensysce Investment Summary
Ensysce Investment Summary ® Clinical stage biotech company using transformative trypsin-controlled chemistry to improve drug safety and performance. = Two highly novel technology platforms that we believe can be applied to a large majority of prescription drugs, driving internal growth and external
Slide 36: Ensysce Biosciences
™. Ensysce biosciences 7946 Ivanhoe Avenue, Ste 201, La Jolla, CA 92037 Investor Relations Shannon Devine MZ North America 203-741-8811
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