Helus Pharma announced its audited financial results for the fiscal year ended March 31, 2026, along with recent business highlights. The company recently closed a $50 million underwritten offering, which reinforces institutional investor conviction and strengthens its balance sheet for the execution of the second Phase 3 HLP003 trial, EMBRACE, with a potential U.S. FDA New Drug Application in 2028.
The Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (MDD) has surpassed 88% enrollment and is on track for a topline data readout in Q4 2026. Additionally, the Phase 2 signal detection study for HLP004 in Generalized Anxiety Disorder (GAD) reported a ~10-point improvement from baseline in HAM-A on top of Standard of Care at 6 weeks. The company intends to complete the design of the next HLP004 study by the end of Q3 2026.
Phase 2 data for HLP003 demonstrated durability at 12 months following two 16mg doses, with 100% response and 71% remission based on a MADRS benchmark of ≤10. Remission rose to 100% based on recent peer benchmarks of ≤12. Helus Pharma has also strengthened its scientific and medical leadership with the addition of globally recognized experts in clinical development, translational science, and medical affairs.