Cybin (HELP) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Key clinical program updates

• CYB003, a deuterated psilocybin analog, is advancing as an adjunct treatment for major depressive disorder, with strong durability data and a unique positioning compared to competitors.

• Phase III trials for CYB003 will launch at 30 sites across the U.S. and Europe, prioritizing experience in psychedelic trials and DEA licensing for efficiency.

• Patient recruitment is expected to be faster in the U.S., with a balanced site distribution but more patients likely from the U.S.

• CYB004, a deuterated DMT, is in phase II for generalized anxiety disorder, showing rapid onset and short session times, aiming for scalable treatment.

• Top-line phase III data for CYB003 is anticipated in the first half of 2026, with a parallel second study and plans for a rolling NDA submission.

Regulatory and trial design considerations

• Recent regulatory events, such as the Lykos MDMA review, prompted internal review but no major changes to trial design.

• Measures to address functional unblinding include three-arm studies, blinded raters, AI monitoring, and recruiting largely psychedelic-naive patients.

• Long-term safety and efficacy follow-ups are planned for up to a year, with monthly patient reviews and exclusion of those using psychedelics outside the study.

• The adjunct approach in MDD is seen as more practical, allowing patients to remain on antidepressants and targeting a third-line treatment position.

• Durability goal for CYB003 is at least six months, with potential for re-dosing every 8–9 months, impacting pricing and treatment positioning.

Efficacy, safety, and market positioning

• Phase II data for CYB003 showed 75% remission at four months; maintaining 50% at 12 months would surpass current approved treatments.

• No significant safety interactions observed with SSRIs; possible synergistic effects noted in prior studies.

• CYB004 offers a rapid, intense, and short experience, differentiating it from longer-acting psychedelics like LSD.

• Shorter treatment duration is expected to be attractive to treatment centers facing capacity constraints, supporting scalability.

• Big pharma is closely monitoring the space, with broader adoption expected after phase III readouts and regulatory clarity.