Helus Pharma (HELP) investor relations material

Strategic focus and pipeline highlights

• Advancing two proprietary clinical programs, HLP003 and HLP004, targeting major depressive disorder (MDD) and generalized anxiety disorder (GAD), both with positive Phase 2 safety and efficacy results.

• HLP003 has received FDA Breakthrough Therapy Designation and is in Phase 3 for adjunctive MDD treatment; HLP004 is in Phase 2 for GAD.

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

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

• Cash position of $157.3 million as of March 31, 2026, with a $50 million offering completed in June 2026.

HLP003 (MDD) clinical and pharmacological profile

• Demonstrated rapid, robust, and durable antidepressant effects in Phase 2, with 100% response and 71% remission at 12 months after two 16 mg doses.

• Favorable safety profile: all adverse events mild to moderate, no suicidality or serious adverse events at 12 months.

• Deuterated psilocin design offers improved delivery, higher plasma and brain levels, rapid onset (15 min), and consistent effects compared to psilocybin.

• Phase 3 pivotal program (PARADIGM) underway, with topline data expected Q4 2026.

• Strong IP and regulatory exclusivity, with patent protection and NCE exclusivity extending to at least 2041.

HLP004 (GAD) clinical and pharmacological profile

• Positive Phase 2 results in moderate-to-severe GAD: rapid, robust, and durable symptom relief, 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 after a single treatment cycle.

• Favorable safety profile: all adverse events mild or moderate, no drug-related serious adverse events or suicidality.

• Intramuscular administration allows rapid discharge (within 3 hours), supporting scalability in clinical practice.

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