Ensysce Biosciences (ENSC) investor relations material

Strategic focus and pipeline overview

• Developing next-generation opioids and CNS therapies using trypsin-controlled chemistry and serotonergic modulation.

• Lead products target pain management, opioid use disorder, ADHD, and rare pain syndromes, with several candidates holding FDA Fast Track, Breakthrough Therapy, and Orphan Drug designations.

• Proprietary TAAP and MPAR platforms enable abuse and overdose protection, with MPAR designed to block opioid release in overdose scenarios.

• CY200 targets chronic pain via 5-HT2A serotonin receptor modulation, aiming to reset maladaptive neural circuitry.

• Strong global patent estate and experienced management team support rapid development and commercialization.

Clinical and preclinical progress

• PF614 and PF614-MPAR are in advanced clinical trials, demonstrating safety, efficacy, and overdose protection.

• CY200 has shown promising results in CRPS, with observed effects lasting over 2.5 months and good tolerability.

• Preclinical data confirm MPAR blocks opioid release in overdose, while maintaining efficacy at prescribed doses.

• CY200 and CY201 are advancing through Phase 2 and 3 trials, with regulatory consultations ongoing in the US, Europe, and Australia.

• NCE pipeline includes novel molecules with differentiated serotonin receptor profiles for pain and neuropsychiatric conditions.

Market opportunity and unmet needs

• CRPS affects 200,000 Americans, with 30% unable to work and no approved therapies; current treatments are costly.

• TAAP and MPAR platforms offer lifecycle management, new patent opportunities, and potential for repurposing approved drugs.

• Lead products address significant unmet needs in pain management and opioid safety, supported by government funding and regulatory designations.

• CY200 holds FDA Orphan Drug status, accelerating regulatory pathways for rare pain indications.

• Platform technologies may extend to other drug classes, broadening commercial potential.