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 announced that 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. Additionally, Helus 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 the full press release, visit https://nnw.fm/WKk5e.
The implications of these results are significant for patients suffering from major depressive disorder, a condition affecting millions worldwide. HLP003, a proprietary novel serotonergic agonist (NSA), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, indicating its potential to offer a meaningful improvement over existing treatments. If successful, HLP003 could provide durable improvements in mental health by promoting neuroplasticity through activation of serotonin pathways, addressing a large unmet need for people who suffer from depression, anxiety, and other mental health conditions.
Helus Pharma is a clinical stage pharmaceutical company committed to developing NSAs – synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company’s pipeline includes HLP003 in Phase 3 for adjunctive treatment of major depressive disorder, HLP004 in Phase 2 for generalized anxiety disorder, and an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom and Ireland. For company updates, visit www.helus.com.
The progress of HLP003 is particularly important given the high prevalence of major depressive disorder and the limitations of current therapies. Many patients do not achieve adequate response with existing antidepressants, highlighting the need for novel mechanisms of action. Helus’s focus on NSAs aims to improve the treatment landscape by offering therapies that may produce faster onset of action and sustained efficacy. The Phase 3 data expected in late 2026 will be a critical milestone for the company and the field.
