Ensysce Biosciences (ENSC) investor relations material

Company overview and strategy

• Focuses on next-generation opioid analgesics using trypsin-controlled chemistry for pain management and overdose protection.

• Lead products PF614 and PF614-MPAR target acute and chronic pain with anti-abuse and overdose protection features.

• Pursues blockbuster potential therapies with FDA Fast Track and Breakthrough Therapy designations.

• Utilizes a 505(b)(2) regulatory pathway to shorten development timelines and reduce clinical risk.

• Maintains a strong global patent estate and an experienced management team.

Product pipeline and technology

• PF614 delivers extended pain relief with reduced abuse potential and is in Phase 3 trials for severe pain.

• PF614-MPAR combines analgesia with overdose protection, using a trypsin inhibitor to block opioid release in overdose scenarios.

• TAAP platform enables anti-abuse chemistry, while MPAR provides multi-pill abuse resistance and overdose protection.

• Pipeline includes products for pain, ADHD, opioid use disorder, and infectious diseases.

• TAAP technology allows for new chemical entities, lifecycle management, and repurposing of approved drugs.

Clinical development and regulatory progress

• PF614 has demonstrated strong efficacy, longer duration, and increased safety in clinical studies.

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

• PF614-MPAR has shown preclinical and Phase 1 evidence of overdose protection, with further clinical studies planned.

• Both PF614 and PF614-MPAR have received FDA Fast Track and Breakthrough Therapy designations.

• Clinical advisory board includes experts in pain, addiction, and toxicology.