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.
The company 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. Helus 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.
The progress of HLP003 is particularly significant as it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. If successful, HLP003 could offer a new treatment option for the millions of people suffering from major depressive disorder who do not respond adequately to existing therapies. The Phase 3 data, expected later this year, will be a critical milestone for the company and the field of novel serotonergic agonists, which are designed to activate serotonin pathways believed to promote neuroplasticity.
Helus Pharma is a clinical stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) for mental health conditions. 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.
