Ensysce Biosciences, Inc. · NASDAQ:ENSC
Ensysce Biosciences — SPAC Merger (February 2021)
40 slides from Ensysce Biosciences's SPAC merger presentation, Feb 3, 2021
Slide 1: Ensysce Biosciences Investor Presentation February 2021
ENSYSCE BIOSCIENCES INVESTOR PRESENTATION FEBRUARY 2021
Slide 2: Disclaimer
General This presentation (the “ Presentation ”) has been prepared to assist interested parties in making their own evaluation with respect to a potential business combina tio n between Leisure Acquisition Corp. (“ Leisure ”) and Ensysce Biosciences, Inc. (“ Ensysce ”) and the related transactions (
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 th e safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward - looking statements are sometimes
Slide 4: Additional Information and Where to Find It
Additional Information and Where to Find It In connection with the transaction described herein, Leisure intends to file relevant materials with the SEC, including a reg ist ration statement on Form S - 4, which will include a proxy statement/ prospectus. Promptly after the registration statement is
Slide 5: Presenters
https://media - exp1.licdn.com/dms/image/C560BAQFJDJxIA426VQ/company - logo_200_200/0?e=1605744000&v=beta&t=KMNNYcZb2xGhs6jY9 - k1q5970xG4ChaU5Bfxk6kTtGU Presenters D. Lynn Kirkpatrick, PhD CEO of Ensysce • Co - founded 2 start up companies • Developed three targeted small molecule oncology drugs fr
Slide 6: I. Transaction Overview
6 I. Transaction Overview
Slide 7: Transaction Summary
Transaction Summary • Leisure Acquisition Corp. (“ LACQ ”) and Ensysce Biosciences, Inc. (“ Ensysce ”) have entered into a definitive merger agreement • Existing shareholders and convertible note holders of Ensysce will be rolling their entire interest into the combined Company • Ensysce existing sh
Slide 8: Transaction Summary (Cont'd)
Transaction Summary (Cont’d) 8 Illustrative Sources and Uses (1) Illustrative Pro Forma Capitalization (1) Notes: 1) As of 1/31/21. Assumes no redemptions from LACQ’s existing public shareholders. Does not give effect to prospective equity co mmi tment previously provided to Ensysce. 2) Includes con
Slide 9: Anticipated Transaction Timeline
Anticipated Transaction Timeline • Transaction Agreement Executed and Announced 9 January/February 2021 March 2021 Second Quarter 2021 • Set Record Date for Shareholder Vote • Expected Mailing of Final Proxy Materials to Shareholders • Hold Shareholder Vote and Anticipated Close of Transaction • Pre
Slide 10: II. Ensysce Overview
10 II. Ensysce Overview
Slide 11: Ensysce Overview
ENSYSCE OVERVIEW Ensysce is a clinical - stage drug company using its proprietary prodrug technology platform to improve safety of prescription drugs. First focus is to develop an entirely new class of powerful, tamper - proof opioids that prevent both drug abuse and drug overdoses 11 • CLINICAL STA
Slide 12: Massive Opioid Crisis
Massive Opioid Crisis The deaths related to the misuse or abuse of opioids have exponentially increased over the past two decades, and drug manufacturers have not been able to develop a successful solution to this crisis 12 Source: FDA Analysis of Long - Term Trends in Prescription Opioid Analgesic
Slide 13: Ensysce's Solutions for Abuse + Overdose
MPAR TM designed go prevent drug overdose by inhibiting the release of a drug when excessive amounts are taken ENSYSCE’S SOLUTIONS FOR ABUSE + OVERDOSE 13 MPAR TM Combining anti - abuse and anti - overdose technology to create new classes of prescription drugs that are powerful and safe for everyone
Slide 14: Ensysce Solution vs. the Competition
LOW CNS PENETRATION thereby limiting the amount of drug in the brain to bind to receptors and preventing euphoric side effect Opioid Receptor Binding PF614 LOW AFFINITY: without GI activation, reducing the binding to receptors and hence, minimal side effect INACTIVE if inhaled or injected CANNOT BE
Slide 15: COVISTAT Investment Opportunity
COVISTAT INVESTMENT Opportunity • COVISTAT - utilizing Ensysce Bioscience’s knowledge of Nafamostat for a COVID - 19 drug therapy through a perpetual, royalty free license to oral nafamostat. • Drug repurposing business model potentially significantly lowers clinical development risk and increases r
Slide 16: III. Key Investment Highlights
16 III. Key Investment Highlights
Slide 17: Key Investment Highlights
Key Investment Highlights Revolutionary Abuse - Resistant Opioids – Ensysce has developed a breakthrough technology to produce opioids in a manner that can provide effective pain - relief without allowing for abuse. C 17 Successful Phase I Data – Phase I data have demonstrated Ensysce’s opioid PF614
Slide 18: Huge Unmet Need
HUGE UNMET NEED The chronic pain market with opioid indication has a huge unmet need with virtually no effective opioids that can be prescribed without abuse and overdose potential 18 Massive Market • Annual U.S. opioid is an attractive market of approximately $18.4 (1) Billion with opioid prescript
Slide 19: Ensysce's Revolutionary Abuse-Resistant Opioids
ENSYSCE’S REVOLUTIONARY ABUSE - RESISTANT OPIOIDS Ensysce has developed a breakthrough technology to make novel opioids that provide effective pain - relief without causing abuse and addiction 19 Ensysce’s breakthrough opioid is activated by enzyme Trypsin present only in gut • TAAP TM breakthrough
Slide 20: Successful Pre-Clinical & Phase I Data
SUCCESSFUL PRE - CLINICAL & PHASE I DATA Pre - clinical and phase I data has proven Ensysce’s opioid PF614 to be abuse - resistant and safe without compromising on efficacy, de - risking the further development 20 Time (hr) Oxycodone mean concentration (ng/mL) 0 2 4 6 8 10 12 0 50 100 150 200 UNTAMP
Slide 21: De-Risked and Accelerated FDA Milestones
DE - RISKED AND ACCELERATED FDA MILESTONES Ensysce has secured FDA Fast - Track Designation and is using the 505(b)(2) regulatory pathway, substantially reducing the trial/regulatory risk and time to market 21 • 505(b)(2) regulatory pathway status from the FDA and successful Phase I data de - risk t
Slide 22: Coveted, Non-Dilutive NIH/NIDA Grant of $23MM
COVETED, NON - DILUTIVE NIH/NIDA GRANT OF $23MM Ensysce has been awarded coveted $23MM non - dilutive funding by NIH/NIDA, providing recognition to Ensysce’s technologies in combating abuse and reducing equity risk for investors (1) 22 • The NIH/NIDA funding is a testament of credibility and recogni
Slide 23: Extensive Patent Portfolio
Ensysce has over 100 patents already issued in 25 countries, ensuring barriers to entry for new companies globally 23 • Ensysce’s technology is well - protected by a suite of 111 patents i ssued in the U.S. and overseas (the UK, a majority of the EU, Australia, China, and others with a total of 25 c
Slide 24: Well-Rounded Management Team
Ensysce’s leadership has significant experience in all facets of biotech company - building, from drug development to commercialization 24 • Ensysce’s team is led by CEO Lynn Kirkpatrick, who is a serial biotech entrepreneur with over 100 publications in peer - reviewed journals and a featured biote
Slide 25: Experienced Leaders
https://media - exp1.licdn.com/dms/image/C560BAQFJDJxIA426VQ/company - logo_200_200/0?e=1605744000&v=beta&t=KMNNYcZb2xGhs6jY9 - k1q5970xG4ChaU5Bfxk6kTtGU FINANCE, DRUG DEVELOPMENT & DRUG COMMERCIALIZATION EXPERIENCED LEADERS D. Lynn Kirkpatrick, PhD Chief Executive Officer Chief Medical Officer Will
Slide 26: IV. Ensysce Forward Looking Projections
26 IV. Ensysce Forward Looking Projections
Slide 27: Pipeline and Key Milestones
2020 2021 2022 2023 PIPELINE 27 CLINICAL IND NDA • CMC preparation for HAL and bioequivalence. • MPAR TM and OUD preclinical program initated. • Nafamostat Phase 1 trial. • MPAR TM IND submission. • PF614 Human Abuse Liability (HAL) clinical trial: nasal and oral. • PF614 bioequivalence (Phase 2) da
Slide 28: Summary Forward Looking Projections
28 Ensysce intends to fund its ongoing development efforts through a combination of non - dilutive government grants and potential equity issuance including through existing commitments Summary Forward Looking Projections (1) ($MM) 2021P 2022P 2023P 2024P 2025P 2026P 2027P 2028P 2029P 2030P Revenue:
Slide 29: V. Appendices
29 V. Appendices
Slide 30: Ensysce Product Pipeline
30 Ensysce Product Pipeline
Slide 31: Tamper-Proof Anti-Abuse
TAMPER - PROOF ANTI - ABUSE TM TAAP TM is only activated by trypsin , a digestive enzyme that exists only in the gut; therefore crushing, inhaling or injecting it will not cause the opioid to be released faster to produce pleasure/euphoria 31 TAAP TM chemically modifies the opioid, thereby eliminati
Slide 32: Two-Step Release Process
The picture can't be displayed. 32 TWO - STEP RELEASE PROCESS opioid + linker : amino acid opioid + linker + trypsin amino acid opioid cyclic urea chemically designed release timing T = 1 to 6 hours Fast = IR (immediate release) Slow = ER (extended release) Free and active drug absorbed into blood 1
Slide 33: Smart Anti-Overdose
SMART ANTI - OVERDOSE The prescribed activity of trypsin will not be affected by MPAR TM , therefore making it very safe for daily use TM MPAR TM inhibits trypsin when too much TAAP TM opioid is swallowed, inhibiting full activation and opioid release, and therefore, preventing overdose - related de
Slide 34: MPAR Mechanism of Action
MPAR TM Mechanism of Action DOSE - TRIGGERED TRYPSIN INHIBITION ABOVE THRESHOLD trypsin inhibitor ATTEMPTED / ACCIDENTAL OVERDOSE Free and active drug product Dose blocked / overdose averted 34 PRESCRIBED DOSE No Interference when normal dose of Ensysce’s opioid PF614 is taken; MPAR TM (trypsin inhi
Slide 35: TAAP: Preclinical Data
0 2 4 6 8 10 12 0 50 100 150 200 Time (hr) Oxycodone mean concentration (ng/mL) • 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 35 Untampered OxyContin dog P
Slide 36: TAAP: Clinical Data
ABUSE PREVENTION • As show in the graph on the left, the onset of Ensysce’s PF614 in blood is slow even at higher doses, demonstrating the ability to prevent opioid pleasure (euphoria) and abuse SAFE • PF614 has shown to be safe , and no unexpected adverse events were observed in Phase I EFFICIENT C
Slide 37: True Twice-a-Day Product
True Twice - a - Day Product • 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 only twice - a - day , in contrast to OxyContin (which some patients end up taking three t
Slide 38: TAAP + MPAR: Preclinical Data
• Trypsin inhibition using nafamostat prevents opioid overdose by reducing PF614 activation with increasing dose unit administration • Data on the right demonstrate the effectiveness of Ensysce’s MPAR TM overdose protection, as oxycodone concentration does not rise in blood at high - doses due to MP
Slide 39: Market Opportunity: ADHD
39 ADHD abuse has been consistently trending upward and, unless preventive measures are taken, is likely to evolve into the next opioid abuse epidemic in the U.S. MARKET OPPORTUNITY: ADHD The Next Epidemic: ADHD Medication Abuse on the Rise The ADHD Market is Expected to Reach $25Bn by 2025 (4) The
Slide 40: Preventing the ADHD Epidemic
40 • Ensysce’s TAAP TM and MPAR TM platforms can be easily integrated into ADHD prescription drugs by using the same TAAP platform the Company developed for opioids • Ensysce is currently in the development and testing phases for its ADHD drug, TAAP TM PF8026, and is seeing promising results • PF802