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 APPROACH topline data readout on track for Q4 2026 1,2 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 ≤12 3 , 4 This news release constitutes a “designated news release” for the purpose of the Company's prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. NEW YORK and TORONTO, July 21, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”) a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced that it has completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 in patients living with Major Depressive Disorder (“MDD”).
