Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported its 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. The financial results underscore the company's commitment to advancing its novel serotonergic agonists (NSAs) through late-stage clinical development.
Helus Pharma is a clinical stage pharmaceutical company focused on developing proprietary NSAs designed to activate serotonin pathways and promote neuroplasticity. HLP003, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, is being studied for the adjunctive treatment of major depressive disorder. The company also has HLP004 in Phase 2 for generalized anxiety disorder and an extensive research portfolio of investigational NSAs.
The announcement is significant as it provides investors and the medical community with updated timelines for potentially transformative treatments in mental health. Major depressive disorder affects millions globally, and current treatments often have limited efficacy or significant side effects. Positive results from the Phase 3 trials could position Helus Pharma as a leader in the emerging field of psychedelic-inspired therapies. For more details, the full press release is available at https://nnw.fm/WKk5e.
Helus Pharma operates in Canada, the United States, the United Kingdom and Ireland. Company updates are available at www.helus.com. The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP.
