Ensysce Biosciences : Corporate Overview
ENSC
Published on 04/20/2026 at 02:17 pm EDT
NASDAQ: ENSC Investor Presentation April 2026
Investor Presentation | Apr 2026
Clinical-stage company - 'Next generation opioids' - disrupting analgesia using transformative trypsin-controlled chemistry.
Targeted therapy areas focus on products with blockbuster potential with FAST TRACK and BREAKTHROUGH THERAPY designations.
Lead Product near term launch with demonstrated safety and efficacy,
reducing clinical risk with shortened development timeline.
Strong global patent estate
Highly experienced management team - broad biopharma background, from drug development to commercialization.
TAAPTM
Anti-abuse chemistry
MPAR®
Overdose protection
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Investor Presentation | Apr 2026
Investor Presentation | Apr 2026
Pain is the Leading Cause of Doctor Visits
Americans in
severe pain Misuse Opioids Opioid Rx in USA
Severe Pain is in Cancer Patients
https://drugabusestatistics.org/opioid-epidemic/ | https://www.cnn.com/2022/12/14/health/drug-overdose-deaths-slowing/index.html
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Investor Presentation | Apr 2026
TAAP & MPAR®: Chemical Safety Switches
TAAPTM
Trypsin-Activated Abuse Protection*
MPAR®
Multi-Pill Abuse Resistance: Combination Product for Overdose Protection *
PROTECTIVE CONTROLLABLE
ANTI-ABUSE PERFORMANCE
Trypsin TURNS ON RELEASE.
Chemically engineered to control release.
Reduces abuse.
Improves product delivery.
TURNS OFF RELEASE only with overdose. Trypsin inhibitor and TAAP prodrug.
Platform based on trypsin control of activation and release.
MPAR® can provide overdose protection to other drug classes.
SMART COMBINATION UNIQUE
MULTI-USE
*For mechanism see appendix
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Investor Presentation | Apr 2026
New class of opioid > Low abuse - Prescriber confidence/reassurance
to patients
Reduced risk of overdose,
first time ever
Originally identified Pharmaceuticals
Immediate release opioids
Abuse Deterrent Formulations (ADFs) Extended-release formulations claimed to reduce abuse and addiction
V
Immediate and extended-release chemistry
to deliver pain relief when needed
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US Pain Management Drugs Market *
LAUNCH STRATEGY
V
V
V
*Ref: IQVIA 2023 Market Data
ACUTE CHRONIC
** PF614 used for post-surgical pain is anticipated to have four key advantages over traditional opioids: (a) pre-dosing at the start of surgery to reduce pain generation from the beginning vs. chasing pain that is already moderate to severe at the end of surgery,
(b) having a longer duration of action to allow patients to stop or transition off opioids before leaving the hospital or clinic and continue using only non-opioid drugs at home, (c) reducing overall opioid use, and (d) potentially reducing overall healthcare costs.
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Investor Presentation | Apr 2026
Investor Presentation | Apr 2026
Neuroscience and Respiratory Diseases
TAAP-Oxycodone
TAAP-MPAR-Oxycodone TAAP-Hydromorphone
TAAP-Dexamphetamine TAAP-Dexamphetamine
TAAP-Methadone
FDA Fast Track FDA Breakthrough Therapy
TAAP and MPAR® platforms with 505(b)(2) regulatory development path; *Nafamostat in development for MPAR®, infections and respiratory diseases. ER = Extended Release, IR = Immediate Release
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Strong Efficacy - Pain Management RE-Invented
Fast Track Designation Grant by FDA January 2018
Investor Presentation | Apr 2026
PF614 Clinical Data
PF614 efficiently delivers oxycodone
Longer oxycodone half-life supports BID dosing
Reduced nasal abuse potential
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RE
Investor Presentation | Apr 2026
PF614 Clinical Studies
Investor Presentation | Apr 2026
Strong Efficacy -longer efficacy and increased safety Phase 3 Launched
2025/2026 DESCRIPTION SIGNIFICANCE
Regulatory
Phase 3 Protocol reviewed FDA feedback on Pivotal study plans received
PF614-301
Phase 3 study Abdominoplasty: Post-surgical pain initiated 2025
Pivotal study leading to NDA*
PF614-302 Open label study Bunionectomy: Post-surgical
pain - to initiate 2026
Study to support safety data base leading to NDA*
*NDA = New Drug Application submitted for approval to the FDA.
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Investor Presentation | Apr 2026
- Development Pathway for Acute and Chronic Pain Indications
Acute Severe Pain
PF614-301
Phase 3 Initiation
2025
2026
PF614-302
V
V
V
Phase 3 Initiation
2027
PF614 NDA
Non-clinical studies for chronic indications
Supporting PF614-MPAR
Clinical studies
2025
2026
2027
Chronic Severe Pain
V
V
V
V
Bold text: Completed
Non-bold text: Planned studies
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Powerful Analgesia + Overdose protection
TAAP Oxycodone combination product
Breakthrough Therapy Designation Grant by FDA January 2024
Investor Presentation | Apr 2026 Investor Presentation | Apr 2026
Blocks Activation of PF614 and Oxycodone Release if Overdosed
PRE-CLINICAL MPAR SUPPORT DATA
V
Combination product of PF614 with an ultrapotent trypsin inhibitor, nafamostat
Oxycodone levels without MPAR®
PF614 without nafamostat
Oxycodone mean concentration (ng/mL)
25
20 10 dose units
6 dose units
3 dose units
15 1 dose units
Oxycodone levels with MPAR®
PF614 with nafamostat
Oxycodone mean concentration (ng/mL)
25
20
15
Taken at prescribed doses there is no change in oxycodone release from PF614
V
V
With increasing dose unit administration, increasing amounts of nafamostat blocks trypsin release of oxycodone and prevents opioid overdose
10 10
5 5
0
0 4 8 12 16
Time (hr)
20 24
0
0 4 8 12 16 20 24
Time (hr)
TAAP + MPARTM: PRECLINICAL DATA
in rats n=4 / dose
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Investor Presentation | Apr 2026
Phase 1 Clinical Study Demonstrating Overdose Protection
PF614 alone no MPAR® overdose protection PF614-MPAR 25 mg with MPAR® overdose protection
PF614-MPAR
with overdose protection
[1] [2] [3] [4] [5]
[6] [7]
[8]
PF614 mg
PF614 (mg) or PF614-MPAR [# dose units]
PF614 alone (SAD-MAD studies) PF614 + nafamostat (PF614-MPAR study)
Goal to deliver two doses up to twice daily Trypsin controlled opioid release
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Investor Presentation | Apr 2026
Clinical Development for Overdose Protection
2025/2026 OUTCOME SIGNIFICANCE
Continue Phase 1b SAD 100 mg dose followed by MAD Confirm overdose protection followed by MAD
study to support Type B FDA meeting
PF614-MPAR Meeting held with FDA to discuss development plans Outline path to commercialization
PF614-MPAR-102
SAD Part A
PF614-MPAR
FDA meeting
PF614-MPAR-301
Efficacy/Safety
V
2024 2025
PF614-MPAR-102
Food Effect Part B
PF614-MPAR-102
Part C
2026
2027
PF614-MPAR NDA
V
V
Bold text: Completed
Non-bold text: Planned studies OD: Overdose
SAD: Single Ascending dose study MAD: Multi-Ascending dose Study
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Expanded Opportunities
Investor Presentation | Apr 2026
Improving Drug Delivery and Lifecycle Management
TAAP MODIFICATION ATTRIBUTES
OPPORTUNITY
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
Our TAAP platform enables new chemical entity (NCE) solutions that allow us to obtain new patents and extend market positions, revitalize approved medications and repurpose approved medications for the benefit of patients and care givers. Specifically, Ensysce has used to develop a highly novel product for OUD.
Possible oral delivery of injectable drugs
Enhance activity of drugs on GI tract
Extend half-life to improve dosing
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Disclaimer
Ensysce Biosciences Inc. published this content on April 20, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 20, 2026 at 18:16 UTC.