Cybin (HELP) Lytham Partners 2025 Investor Healthcare Summit summary

Clinical program highlights

• Phase II depression program shows rapid onset and durable remission, with 75% remission after two doses and 71% at 12 months.

• CYB3 targets major depressive disorder, with Phase III initiated and Breakthrough Therapy designation granted by FDA in February 2024.

• CYB4 targets generalized anxiety disorder, with Phase II top-line results expected end of Q1 this year.

• CYB3 is a deuterated psilocin oral capsule; CYB4 is deuterated DMT with extended duration via intramuscular formulation.

• Large IP portfolio and experienced team support clinical advancement.

Phase III program design and regulatory strategy

• Phase III (Paradigm) includes two short-term placebo-controlled studies and a long-term extension, with primary endpoints at 6 weeks and secondary at 12 weeks.

• First study (Approach) is a two-arm, 220-patient trial; second is a three-arm study to address functional unblinding.

• Most sites are in the U.S.; data readout expected mid-2026.

• No psychotherapy during dosing; pre- and post-dosing care focuses on safety and efficacy follow-up.

• Steps to address functional unblinding include dose-ranging, blinded raters, and AI auditing.

Financial position and outlook

• Cash balance of CAD 154 million ($110 million) as of Q3, with lean operations and headcount.

• Funding expected to cover key milestones: CYB4 Phase II data (Q1) and CYB3 Phase III readout (mid-2026).

• Plans for rolling NDA submission leveraging Breakthrough Therapy designation for accelerated review.