Helus Pharma (HELP) investor relations material

Leadership transition and vision

• New CEO Michael Halstead brings over 25 years of industry experience, including leading a CNS company through growth and acquisition.

• Halstead emphasizes a shared vision and passion for transforming mental health treatment within the organization.

• The leadership team and board alignment were key factors in his decision to join.

• Halstead highlights the importance of a competent, passionate team for successful execution.

Pipeline and clinical development

• Lead candidate HLP003, a deuterated psilocin, is in phase III for adjunctive major depressive disorder, with top-line data expected in Q4.

• HLP004 is in phase II for generalized anxiety disorder, with further trial details forthcoming.

• HLP005 is an early-stage platform with promising compounds for mental health indications.

• The two-dose induction strategy is seen as critical for durability and efficacy.

Clinical results and differentiation

• Phase II results for HLP003 showed 13–14 point MADRS improvement after one dose, with additional gains after a second dose.

• No drug-related serious adverse events; side effects were mild, moderate, and transient.

• Durability of response extended up to 12 months, with high remission and response rates.

• Deuteration enables composition of matter patents and improved pharmacokinetics.