Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — Investor Presentation (January 2023)
38 slides from Ensysce Biosciences's investor presentation, Jan 19, 2023
Slide 1: Improving Prescription Drug Safety Through Chemistry
Ensysce" biosciences Improving Prescription Drug Safety Through Chemistry _,. Investor Presentation January 2023
Slide 2: Disclaimer
Ensysc 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 fai
Slide 3: Ensysce Overview — Platform Technology
Ensysce Overview — Platform Technology Who we ore Clinical-stage biotech company with mission to improve drug safety to reduce abuse and overdose. Using 2 Core Technology Platforms TAAP™ —=MPAR™ Multi-Pill Abuse Resistance: Combination Products for Overdose Protection Immediate Focus - Severe Pain D
Slide 4: TAAP and MPAR
TAAP™ and MPAR" Reduce ability to tamper with drug product to abuse. Trypsin TURNS ON RELEASE only in small intestine. Chemically able to provide immediate or extended-release products. TAAP™ to improve product delivery . MPAR" Multi-Pill Abuse Resistance: Combination Products for Overdose Protectio
Slide 5: Prescription Drug Abuse: a Health Crisis in America
Prescription Orug Abuse: a Health Crises in America Substance Abuse is the Nation’s #1 Health Problem — Department of Justice 107,000 Overdose Deaths in 2021 - National Institute for Health Care Management (NIHCM) *HHS Publication No. PEP20-07-01-001 2020; *https://www.aspenridgerecoverycenters.com/
Slide 6: Dueling Crises: Pain vs Abuse and Overdose
Oueling Crises: Poin vs Abuse and Overdose @e@eee R 35 Million Americans 10 Million Misuse in Severe Pain Opioids 153 million Rx in USA Severe Pain is #1 fear in Cancer Patients https://drugabusestatistics.org/opioid-epidemic/ https://ww
Slide 7: The Ensysce Solution
The Ensysce Solution Rs 2020s 9400 B.C. 1900s 1990s TAAP™ and MPAR™ Immediate and extended-release chemistry to deliver pain relief when needed Originally identified Pharmaceuticals Abuse Deterrent Formulations (ADFs) Immediate release opioids Extended-release formulations claimed to reduce abuse an
Slide 8: The Ensysce Difference
The Ensysce Difference PF614 Bioequivalent to OxyContin’ 1) Clinical support; Potential 505(b)(2) path 2) Retaining Abuse Deterrence 3) Compared to Xtampza Longer Pain Relief - True 12-hour Half-Life Ease of Swallowing - Can Dissolve in Water? Can Be Taken with or without Food? Difficult to Manipula
Slide 9: Diversified Pipeline
Ensysce” biosciences Diversified Pipeline PAIN Platform PFEI4 PF614-MPAR™ PF929 ADHD Platform PF8001 ER a a) | | Respiratory Platform Nofomostat* | TAAP and MPAR™ platforms with 505(b)(2) regulatory development path; *Nafamostat in development for MPAR, infections and respiratory diseases. ER = Exte
Slide 10: PF614 for severe pain - 'TAAP' oxycodone
Slide 11: PF614 for Severe Pain
PF614 for Severe Pain Y TAAP™Pr Y FostTroc odrug > Delivers potent pain relief — equivalent to Oxycontin with reduced abuse potential K granted > Shortened path to registration 11,
Slide 12: Pain Relief Delivery by TAAP
Ensysce” biosciences Pain Relief Delivery by TAAP Two-Step Release Process Cp opioid + linker : amino acid STEP 1 ACTIVATION . “¢: . 1 +trypsin Chemical modification 30. Trypsin exists in the Allowing either immediate or extended release ¢ im Dy eo gut only opioid + linker amino acid Only activated
Slide 13: PF614 Delivery Profile
PF614 Delivery Profile = PF614 chemically releases oxycodone with the same extended release (ER) profile as OxyContin = The same release profile demonstrates that PF614 will achieve similar pain relief as OxyContin Ref: Kirkpatrick DL et al., J Opioid Manag 2017;13(1):39-49 Oxycodone mean concentrat
Slide 14: PF614 Cannot be Manipulated to Change Delivery
PF614 Cannot be Manipulated to Change Delivery 200 CRUSHED OxyContin 20 mg = PF614, even when crushed, releases oxycodone slowly in the blood, thereby reducing the large Cmax which leads to reduced ‘drug liking’. 150 = The study demonstrated the significant difference between the manipulated PF614 v
Slide 15: PF614-101 Clinical Data
PF614-101 Clinical Dota Oxycodone Concentration in Blood vs. Time following PF614 administered as oral solution 10 Cid jon (ng/mL) o oo 2 ‘Oxycodone mean concent ‘TAAP: HUMAN CLINICAL DATA Max blood levels reached @ 4-6h across all cohorts Time (hr) Dose /n / Naltrexone / meal 15 mg/ 21 /no / fasted
Slide 16: PF614 Development Plans
PF614 Development Plans PF614-103 HAP PF614-102 Nasal BE PF614-301 PF614-201 bis 3 nitiation pr614-104 POC ° HAP Initiation Oral if t Proof of concept study exploring onset of PF614 pain relief Phase 3 efficacy studies in soft tissue and bony tissue surgeries PF614-302 PF614 Phase 3b NDA Initiation
Slide 17: PF614-MPAR: TAAP oxycodone with overdose protection
Slide 18: MPAR Mechanism of Action
Ensysce” MPAR™ Mechanism of Action ssi Combination Product With Dose-Triggered Overdose Protection — irae TAAP-enabled opioid Trypsin Inhibitor PRESCRIBED DOSE : EXCESS DOSE ACCIDENTAL OVERDOSE MPAR™ begins to inhibit : trypsin, ‘turning off’ : activation of TAAP and Trypsin Activation blocked limit
Slide 19: PF614-MPAR
PF614-MPAR" Without MPAR™ PF614 without nafamostat 25 20 15 10 | ‘Oxycodone mean concentration (ng/ml) 0 4 8 2 M10 dose units 6 dose units 3 dose units 1 dose units Time (hr) TAAP + MPAR™: PRECLINICAL DATA Oxycodone mean concentration (ng/mt) 25 20 18 10 With MPAR™ PF614 with nafamostat Time (hr) in
Slide 20: PF614-MPAR Development Plans
PF614-MPAR Development Plans PF614-MPAR-101 = PF614-IMPAR-102 PF614-MPAR-301 PF614-MPAR-101 Part 3 Data MAD Efficacy Part 2 Data ? 9 b _ PF614-MPAR-201 PF614-MPAR-101 PF614-MPAR-101 aie aa ae Efficacy Initial data ( Part 3 initiation 8 : Bold text: Current Studies Non-bold text: Planned studies
Slide 21: Milestones 2022-2023
Milestones 2022-2023 STUDY OUTCOME Bioequivalence study Positive bioequivalence data: July 2022 Nasal Human Abuse Potential (HAP) study Positive topline data reported Nov 2022 PF614 nafamostat combination Positive PK data to define drug product Oral Human abuse potential study Study recruitment comp
Slide 22: Opportunities with TAAP
Opportunities with TAAP™ TAAP™ Chemical Modification Attributes: Reaches the gastrointestinal tract/epithelial cells intact Chemistry controlled GI delivery for ‘Immediate’ or ‘Extended-Release’ Improves aqueous solubility Enhances the drug’s permeation through the epithelial lining VV V Vv Opportun
Slide 23: Cash Resources
Ensysce biosciences Cash Resources 45M NIH Support NIDA grant Cash as of 9/30/22* 2018 2019 Ensysce received $11+M to NIDA awarded Ensysce up to progress MPAR™ $15M grant to progress $5.9M TAAP/MPAR™ for OUD Grant Funding Available Final year of four-year award received Five-year award to undertake
Slide 24: Management Team
Management Team 2 =e « er <2) oe, D. Lynn Kirkpatrick, PhD David Humphrey, CPA Geoff Birkett + Co-founded 2 start up + Extensive experience in + Large pharma leadership companies entrepreneurial experience * Developed three targeted environments + Launched 5 major market- small molecule oncology > M
Slide 25: Clinical Advisory Board and Board of Directors
Clinical Advisory Board Dr. Lynn Webster \ Dr. Jeffrey Gudin Dr. Richard Dart Dr. Webster has Dr. Gudin is Faculty Dept of Dr. Dart is the Director dedicated more than Anesthesiology/Pain of the Rocky Mountain three decades to > Management, Univ of is Poison and Drug Center becoming an expert in Mia
Slide 26: Ensysce Investment Highlights
Ensysce Investment Highlights Clinical-stage biotech company - transformative trypsin-controlled chemistry. Two highly novel technology platforms to control delivery of prescription drugs. e a Targeted therapy areas focus on products with blockbuster potential. Shortened development with Fast Track
Slide 27: Ensysce Biosciences contact
TM Ensysce biosciences 7946 Ivanhoe Avenue, Ste 201, La Jolla, CA 92037 Investor Relations Shannon Devine MZ North America 203-741-8811
Slide 28: Appendix
Slide 29: PF614 Data Updates
Slide 30: 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
Slide 31: PF614-102 MAD
PF614-102 MAU Oxycodone from 50, 100 and 200 mg PF614 n=6 120 first 12 hours PF614 50 mg Solution 100 oo SEPPF614 100 mg Solution /~ 80 | emmmePF614 200 mg (2x 100 mg capsules) 70 Oxycodone (ng/mL) Oxycodone (ng/mL) 120 110 100 90 &6éeésea8 Oxycodone from 20, 40 and 80 mg OxyContin n=2 first 12 hour
Slide 32: PF614-102 BE
PF614-102 BE Oxycodone Crax ng/mL T 100 mg PF614 Fasted a e ke of 100 mg PF614 fed 40 mg OxyContin Fasted Treatment >k e COOMIDCIDGD GoanDanD 40 mg OxyContin Fed 32
Slide 33: PF614-102 BE
PF614-102 BE © Oxycodone AUC ing *ng/ML a g eo d= tL BE 100 mg PF614 Fasted 100 mg PF614 fed 40 mg OxyContin Fasted Treatment 40 mg OxyContin Fed 33
Slide 34: PF614-102 Treatment Emergent Adverse Events
PF614-102 Total subjects with at least 1 TEAE* Total subjects with at least 1 TEAE* PF614 50 mg n=6 n (%) 2 (33.3) PF614 fasted 100 mg n=58 n(%) 14 (24.1) OxyContin PF614 OxyContin PF614 20 mg 100 mg 40 mg 200 mg n=2 n(%) n=6 n(%) n=2 n(%) n=6 n (%) 1 (50.0) 1 (16.7) 1 (50.0) 6 (100.0) OxyContin fas
Slide 35: PF614-MPAR Data Updates
Slide 36: PF614-MPAR-101
PF614-MPAR-I01 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 The primary objectives of the study are: To assess
Slide 37: PF614-MPAR-101: First Demonstration of Human Overdose Protection
PF614-MPAR-IO1 Oxycodone (ng/mL) First Demonstration of Human Overdose Protection: Average Systemic Oxycodone after 25 mg Oral PF614 with/without 10 mg Nafamostat | Oxycodone from PF614 | alone -Reduced Oxycodone from PF614 & nafamostat 20 24 «28 «32 36 404 a hours —eWith Nafamostat Without Nafamost
Slide 38: PF614-MPAR-101: Improved Overdose Protection with Formulated Nafamostat
PF614-MPAR-IO1 Improved Overdose Protection with Formulated Nafamostat: Average Systemic Oxycodone after . ” Average Systemic PF614 after 25 mg Oral PF614 with or without Nafamostat 25 mg Oral PF614 with or without Nafamostat 2.5 mg 80:20 Beads / 7.5 mg IR Solution 18 18 2.5 mg 80:20 Beads / 7.5 mg
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