Helus Pharma (HELP) Corporate presentation summary

Pipeline and clinical programs

• Two proprietary programs, HLP003 and HLP004, target major depressive disorder (MDD) and generalized anxiety disorder (GAD), both showing positive Phase 2 safety and efficacy results.

• HLP003 is in Phase 3 for adjunctive MDD treatment and has FDA Breakthrough Therapy Designation; HLP004 completed a Phase 2 signal-finding study for GAD.

• Pipeline includes potential expansion into additional mental health indications affecting over 200 million people in the U.S.

• Over 350 patents filed, with more than 100 granted, providing protection until at least 2041.

HLP003 (MDD) clinical data and advantages

• Phase 2 results: 100% response and 71% remission at 12 months for 16 mg dose; all adverse events were mild to moderate.

• Demonstrates rapid, durable symptom improvement and favorable safety profile, with no suicidality or serious adverse events.

• Deuterated psilocin formulation offers higher plasma levels, faster onset, and greater brain penetration than psilocybin.

• Pharmacodynamic effects are reproducible with repeated dosing, with acute effects lasting 4–6 hours.

• Phase 3 APPROACH topline data expected in Q4 2026.

HLP004 (GAD) clinical data and advantages

• Phase 2 showed rapid, robust, and durable anxiety symptom improvement, with -10 point HAM-A reduction at 6 weeks and effects sustained for at least 6 months.

• Up to 70% responders and 40% remitters at 6 months; no regression to baseline unlike placebo.

• Favorable safety profile: all adverse events were mild or moderate, transient, and resolved without sequelae.

• Intramuscular administration allows rapid discharge within 3 hours, fitting existing clinical infrastructure.

• Over 90 patents issued, including composition of matter IP through 2041.