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. The financial results underscore the capital-intensive nature of late-stage clinical development, but the cash position provides runway for key milestones.
The progress of HLP003 is particularly significant given the large unmet need in major depressive disorder. Helus Pharma's proprietary novel serotonergic agonists (NSAs) are designed to promote neuroplasticity, offering a potential new treatment paradigm. The company's lead candidate has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, which may expedite its development and review. If successful, HLP003 could become a first-in-class adjunctive treatment for depression.
Helus Pharma is also advancing HLP004 for generalized anxiety disorder and has 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 full press release.
