Helus Pharma Completes Enrollment In Its APPROACH Phase 3 Study Of HLP003 In Patients Living With Major Depressive Disorder; Topline Data Readout On Track For Q4 2026

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program

Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data

HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")

HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a MADRS benchmark of ≤10, with remission rising to 100% using more recent peer-study benchmarks of ≤123,4