Helus Pharma (HELP) H.C. Wainwright 28th Annual Global Investment Conference summary

Company overview and pipeline

• Focuses on neuropsychiatry, developing next-generation psychedelics and neuromodulators for mental health indications.

• Lead candidate HLP003, a deuterated psilocin analog, is in phase III for adjunctive major depressive disorder (MDD), with top-line data expected in Q4 2026.

• HLP004, a deuterated DMT compound, targets generalized anxiety disorder (GAD) and completed a phase II signal-finding study; next trial design to be announced soon.

• Early-stage program HLP005 includes a library of compounds with potential in various mental health indications, with lead candidate advancement expected in 2027.

• Strong intellectual property portfolio, with anticipated patent protection through at least 2041 for key programs.

Clinical development and data

• HLP003 phase II showed rapid brain penetration, higher drug exposure, and significant efficacy with 13–14 point improvements after a single dose and additional benefit after a second dose.

• Durability observed with over 70% remission rates at one year after two doses in phase II.

• Phase III PARADIGM program includes APPROACH and EMBRACE (short-term studies) and EXTEND (long-term extension), with primary endpoint at six weeks and secondary at 12 weeks.

• APPROACH compares two 16 mg doses to placebo; EMBRACE introduces an 8 mg dose to assess dose response.

• EXTEND follows patients for up to a year, assessing durability and retreatment needs.

Market positioning and product profile

• Adjunctive MDD indication targets patients not fully benefiting from standard SSRIs/SNRIs, representing a large market segment.

• Adjunctive approach allows continued use of standard care, avoiding the need for monotherapy washout.

• Product aims for efficacy, durability (potentially four doses per year), and favorable safety/tolerability profile, with mostly mild, transient adverse events.

• Breakthrough Therapy designation and supportive regulatory environment expected to facilitate NDA filing and potential approval in 2028.