Helus Pharma (HELP) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Leadership and company overview

• CEO and CMO both bring over 25 years of industry experience, with backgrounds in CNS and psychiatry, and have led successful drug launches and acquisitions.

• The company focuses on mental health, developing novel serotonergic agonists, with a robust intellectual property portfolio extending to at least 2041 for key programs.

Pipeline and clinical milestones

• CYB-003, a deuterated psilocin, is in phase III for adjunctive major depressive disorder, with top-line data expected in Q4 and an NDA filing targeted for 2028.

• CYB-004, a DMT compound for generalized anxiety disorder, completed a phase II signal-finding study and is preparing for the next clinical trial.

• Early-stage program CYB-005 is expected to advance in 2027, supporting a broad platform approach.

Clinical trial design and strategy

• Phase III PARADIGM program includes APPROACH and EMBRACE studies, focusing on efficacy, dose response, and long-term durability, with a blinded extension (EXTEND) to assess retreatment needs.

• Phase II data showed rapid, durable remission with two doses, informing the phase III design, which closely mirrors phase II to preserve effect size.

• Patient selection criteria were tightened for phase III to ensure quality and maximize effect size.