Ensysce Biosciences (ENSC) Investor Presentation summary

Company overview and strategy

• Focuses on next-generation opioids using trypsin-controlled chemistry to address pain management and opioid abuse crises.

• Lead products target blockbuster markets and have received FDA Fast Track and Breakthrough Therapy designations.

• Utilizes TAAP for anti-abuse and MPAR for overdose protection, with a strong global patent portfolio.

• Employs a 505(b)(2) regulatory pathway to accelerate development and reduce risk.

• Management team has extensive experience in drug development, commercialization, and financing.

Product pipeline and technology

• Lead product PF614 delivers extended pain relief with reduced abuse potential and is nearing Phase 3 trials.

• PF614-MPAR combines analgesia with overdose protection, blocking opioid release in overdose scenarios.

• Pipeline includes products for pain, ADHD, opioid use disorder, and infectious diseases, leveraging TAAP and MPAR platforms.

• TAAP technology enables new chemical entities, lifecycle management, and improved drug delivery.

• PF614 and PF614-MPAR have demonstrated strong efficacy and safety in clinical and preclinical studies.

Clinical and regulatory progress

• PF614 has shown efficient oxycodone delivery, longer half-life, and reduced nasal abuse potential in trials.

• PF614 is preparing for Phase 3 pivotal studies in post-surgical pain, with NDA submission planned.

• PF614-MPAR has received FDA Breakthrough Therapy designation and is advancing through Phase 1 and planned Phase 3 studies.

• Clinical data support overdose protection, with MPAR blocking opioid release at high doses.

• Regulatory feedback and development plans are in place for both acute and chronic pain indications.