Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported fiscal 2026 financial results and provided an update on its clinical pipeline, highlighting continued progress of its lead candidate HLP003 for major depressive disorder. The company said its Phase 3 APPROACH trial has surpassed 88% enrollment and remains on track to deliver topline data in the fourth quarter of 2026, while enrollment continues in the second pivotal Phase 3 EMBRACE study. Helus also said it expects to finalize the design of the next clinical study for HLP004 in generalized anxiety disorder by the end of the third quarter of 2026.
Helus ended the fiscal year with $157.3 million in cash and completed a $50 million underwritten offering on June 25 to support continued development of its pipeline. The company reported a fiscal 2026 net loss of $148.0 million, compared with $81.6 million in the prior year, reflecting increased spending on its Phase 3 HLP003 program and advancement of HLP004 and HLP005.
For business leaders, the implications of Helus's progress are significant. If HLP003 receives approval, it could address a large unmet need for patients with major depressive disorder who do not respond adequately to existing treatments. The Breakthrough Therapy Designation from the U.S. Food and Drug Administration underscores the potential of HLP003 to offer durable improvements in mental health. Success in Phase 3 could reshape the treatment landscape for depression, a condition affecting millions worldwide.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways that promote neuroplasticity. The company's pipeline includes HLP003 for major depressive disorder and HLP004 for generalized anxiety disorder, along with an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland. For more information, visit the company's newsroom at https://nnw.fm/HELP.
