Cybin (HELP) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Clinical development updates

• CYB003, a deuterated psilocin, is entering phase 3 for major depressive disorder (MDD) with rapid, durable effects seen in phase 2, including 75% remission after two doses lasting at least four months.

• CYB004, a deuterated DMT, is in phase 2 for generalized anxiety disorder (GAD), with a data readout expected by end of the year or early next year.

• Phase 3 for CYB003 will start within weeks, with primary endpoints at six weeks and secondary at twelve weeks, followed by a year-long extension allowing redosing.

• The phase 3 program will use largely psychedelic-naive populations to minimize expectancy bias.

• CYB003 is positioned as a third-line treatment for MDD, ahead of esketamine, due to its rapid, durable effects and convenient dosing.

Efficacy and safety data

• Phase 2 data for CYB003 showed a fourteen-point reduction in depression scores, with no serious adverse events; side effects were mild to moderate and resolved spontaneously.

• Two-dose regimen of CYB003 led to increased response and remission rates, with some patients remaining in remission at twelve months.

• CYB004 offers a shorter, 90-minute experience, potentially ideal for anxiety patients and scalable within existing clinical infrastructure.

• No abnormal side effects were observed with subtherapeutic doses in early studies.

• Standard rating scales like MADRS are used, with independent, blinded raters to ensure objectivity.

Regulatory and industry context

• Recent regulatory setbacks for other psychedelic therapies have impacted sector sentiment, but clear FDA alignment exists for CYB003’s phase 3 design.

• The sector is now focused on delivering robust data, with upcoming twelve-month MDD data for CYB003 and phase 2 GAD data for CYB004.

• FDA requires comprehensive recording of all drug effects, including euphoria and likeability, to monitor safety and abuse potential.

• If phase 2 results for CYB004 are positive, a direct move to phase 3 is planned, mirroring the approach taken with CYB003.

• The competitive landscape is shifting, with fewer agents ahead in the pipeline and a focus on demonstrating efficacy and safety.