Ensysce Biosciences

~ ~ The Second Study Fully Enrolled for Breakthrough Therapy-Designated, First-in-Class Opioid Designed to Protect Against Oral Overdose ~ ~

~Major symposium to highlight breakthrough innovations in severe pain and Complex Regional Pain Syndrome (CRPS) ~

~Discussions to feature a first-in-class approach to neural reset and novel chemical safety switch technology ~

Acquisition of Cy Biopharma Completed, Adding CY200 for Complex Regional Pain Syndrome
Up to $77 million in new funding with the acquisition of Cy Biopharma
Company to host a Corporate Update Call on Tuesday, August 18, 2026, at 11:00 a.m. ET

Acquisition includes clinical-stage neuroplastogenic therapy with U.S. FDA Orphan Drug Designation for the treatment of Complex Regional Pain Syndrome (CRPS)

Up to $77 million in private financing consisting of $21.5 million in private placement financing at initial close plus $17.1 million of Cy Biopharma's cash and cash equivalents from a pre-acquisition convertible note financing and up to $38.6 million upon achievement of clinical trial milestone

Pro forma cash expected to fund CY200 through Phase 2 proof-of-concept data and into registrational development

Funds Advance FDA-Designated Breakthrough Therapy First-in-Class Opioid with Oral Overdose-Protection

~ ~ Advances First-in-Class, Breakthrough Therapy-Designated Opioid Engineered to Protect Against Oral Overdose ~ ~

~ IRB Approval Secured for PF614-MPAR-102 Part 3 ~

~ Clinical Peer-Reviewed Data Published for First Overdose Protected Opioid PF614-MPAR®; Patent Estate Expanded ~

~ Company Launches Formal Review of Strategic Alternatives ~

~ Patent Extends Jurisdiction and Protection Through 2042 ~

~ Chemical Control, Clinical Confidence: Rethinking Opioids ~

~ Advances First-in-Class Opioid with Oral Overdose-Protection ~

~Continued funding underscores investor confidence and supports advancement of abuse- and overdose-resistant analgesics~

~ Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~

~ Underscores Strategic Execution Plans, Regulatory Risk Mitigation Efforts, Pipeline Prioritization, and the Commercial Potential of PF614 ~

~ Phase 1 Data Published in Journal of Opioid Management Validates First-in-Class Overdose-Limiting Opioid Technology of PF614-MPAR ~

Review Includes Strategic Partnerships, Licensing and Other Corporate Transactions Focused on Advancing TAAP^TM and MPAR^® Platforms 

~ Company leadership to highlight TAAP and MPAR programs, discuss innovation in pain therapeutics and present on commercial excellence ~

~ Engineered to Deliver Potent Pain Relief with Built-In Abuse Protection ~

~ TAAP^™ and MPAR^® technologies extended across opioid products to advance safer pain treatment ~

~ New ADHD pipeline leverages TAAP™ and MPAR® technologies to improve safety for patients ~

• PF614-301 Phase 3 Trial Enrollment Underway, Advancing Toward Market Launch

• FDA Aligned with ENSC Manufacturing Path for PF614, Enabling Commercial Scale Up

• MPAR® Patent Protection Extended Through 2042

• Up to $20 Million in Funding Secured to Advance Late-Stage Programs

~ Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection ~

~ New U.S. Patent Extends Protection Through 2042 ~

~ Patent Allowance Secures Highest Level of Intellectual Property Protection for MPAR^® ~

~ FDA Response Streamlines Path to Commercial Production of PF614~

~Funding supports Phase 3 clinical development of PF614 and continued innovation in abuse- and overdose-resistant analgesics~

~ Third Quarter Highlighted by Initiation of Phase 3 Study of PF614, Underscoring Progress Toward Market Readiness and Commitment to Novel Opioid Solutions ~

~ Further Program Advancement Supported by Preferred Stock Financing ~

~ Pain Management, RE-Invented: Ushering in a New Era for Analgesia ~

~ Experts Spotlight TAAP™ and MPAR® as Next-Generation Solutions for Severe Pain ~

~ The Summit is the Premier Industry Event for Defining How New Product Planning Teams and Related Functions Make Informed, Value-Based, Data-Driven Decisions ~

~ Ensysce Biopharma Leader to Deliver Opening Remarks and Present Case Study on Launching Successful Brands ~

Initiates Critical Milestone, Launching Phase 3 Trial of PF614 to Advance Next-Generation Opioid Therapy Toward Regulatory Approval

Receives $5.3 Million Installment from NIDA To Support Overdose Protection Program

Accelerates PF614-MPAR-102 Study with Full Enrollment of Part 2

~ Productive FDA Meeting Highlights Path Toward Overdose Protection Labeling and 505(b)(2) Regulatory Strategy ~

~ FDA and Ensysce Aligned on Collaborative Approach to Ensure Product's Full Safety Benefits are Recognized ~

~ FDA Protocol Review Completed ~

~ Rho, Inc. Selected as Clinical Research Partner ~

~ Treatment to Evaluate Effect of Food on Overdose Protection of MPAR ~

~ Grant Funds from NIDA Accelerating Clinical Development Program ~

~ Pain Management, RE-Invented: A New Era for Analgesia ~

~ PF614-MPAR Moving to Next Stage of Development, Finalizing Drug Formulation ~

~ Funds Accelerate Path Towards Commercialization ~

Receives U.S. Patent for Groundbreaking Treatment for Opioid Use Disorder

Clinical Trial on Novel Analgesic, PF614-MPAR, Demonstrates Overdose Protection

~ Advanced Preparation for New Drug Application ~

~ Applies TAAP and MPAR Technology to Produce Novel OUD Treatments ~

~ Prioritizes Safety and Tolerability for OUD Patients ~

~ Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study ~

~ Analgesic Experts Consider Pain Indications Versus New Classes of Analgesics ~

~ Panel Discussion Posted to Ensysce's Corporate Website ~

Secures Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR

Groundbreaking Trial on PF614-MPAR Generates Positive Interim Results

~ Positive Enrollment Progress and Safety Data ~

~ FDA Attention Establishes Momentum in the Pain Treatment Space ~

~ Positive Phase 1b Data Confirms Overdose Protection for Highest Dosage Form of PF614-MPAR ~

~ FDA Breakthrough Therapy designation received for PF614-MPAR ~
~ PF614-MPAR second clinical trial initiated ~
~ Lead clinical candidate identified for OUD program ~
~ PF614 Phase 3 trial poised to commence 1H 2025 ~

~ Supply Chain Now Fully Secure for PF614-MPAR ~