Helus Pharma (HELP) investor relations material

Company overview and pipeline

• Focuses on novel serotonergic agonists for mental health, modifying compounds for improved brain penetration and treatment durability.

• Lead program targets major depressive disorder (MDD) with a deuterated psilocin molecule, showing remission rates above 71% at 12 months in trials.

• Second program uses deuterated DMT for generalized anxiety disorder, aiming to extend therapeutic duration and improve patient experience.

• Top-line phase III data for MDD program expected in Q4, with NDA submission targeted for 2028.

• Over 350 patent filings, with more than 100 granted, securing IP until at least 2041.

Regulatory and market environment

• Achieved Breakthrough Therapy Designation, benefiting from strong FDA engagement and evolving regulatory support.

• Named in a recent White House press release regarding the Priority Review Voucher program, reflecting increased acceptance and interest.

• Growing interest from large pharmaceutical companies following regulatory changes.

• Voucher program aims to accelerate review for therapies addressing unmet needs with strong safety and efficacy data.

Clinical development and trial design

• Phase III MDD trial involves two doses (16 mg each) at day 1 and day 21, with patients remaining on background medications.

• Phase II showed over 13-point separation from placebo on MADRS at primary endpoint, with up to 23 points at 12 months.

• Enrollment for phase III is on track, with strong recruitment performance in recent months.

• Second phase III includes three arms (placebo, 8 mg, 16 mg) to address FDA's preference for lower dosing options.

• Monitoring during treatment involves two staff (one in-person, one remote), with a four to six-hour observation window.