Helus Pharma (HELP) investor relations material

Pipeline and strategic position

• Two clinical programs target major depressive disorder (MDD) and generalized anxiety disorder (GAD), with positive Phase 2 safety and efficacy results.

• HLP003 is in Phase 3 for adjunctive MDD treatment and has FDA Breakthrough Therapy Designation; HLP004 is an intramuscular GAD program with Phase 2 signal-finding results.

• Potential expansion into additional mental health indications addresses an estimated U.S. population of more than 200M people.

HLP003 in MDD

• Phase 2 results after two 16 mg doses showed a mean 23-point MADRS reduction from baseline at 12 months; 100% were responders and 71% were in remission at 12 months.

• In a post-hoc analysis of patients receiving two 16 mg doses, MADRS reduction was 22.7 points at Day 364; 100% were responders and 71% were in remission at 12 months.

• Phase 3 PARADIGM includes APPROACH, EMBRACE and the EXTEND long-term extension; APPROACH topline data were expected in Q4 2026.

• The Phase 3 program spans more than 100 sites across the U.S., Europe and Australia, with clinical supplies manufactured and ready.

HLP004 in GAD

• Phase 2 showed a 10-point within-subject HAM-A improvement from baseline at 6 weeks for both 2 mg and 20 mg doses (p<0.0001); the study was not powered to compare doses.

• Improvements were reported through at least 6 months; pooled-dose results showed 67% responders and 39% in remission at 6 months.

• Reported adverse events were mild to moderate and transient, with no drug-related serious adverse events or suicidality signal.

• Intramuscular administration produced acute effects lasting 90 minutes, with discharge readiness within about 3 hours in the Phase 1 dose-ranging study.