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 (MDD). The company stated 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. Helus also 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.
Financially, 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.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company committed to developing proprietary NSAs – novel serotonergic agonists designed to activate serotonin pathways believed to promote neuroplasticity. The company's NSAs aim to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. HLP003, currently in Phase 3 for the adjunctive treatment of MDD, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004 is in Phase 2 for generalized anxiety disorder, and the company maintains an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland. For company updates and more information, visit www.helus.com. The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP.
This news matters because it provides insight into the progress of a potentially transformative treatment for major depressive disorder, a condition affecting millions worldwide. The Phase 3 data readout in Q4 2026 could significantly impact the mental health treatment landscape if HLP003 demonstrates efficacy and safety. Additionally, the company's financial position, with over $150 million in cash, suggests it has the resources to advance its pipeline, which includes candidates for generalized anxiety disorder. Investors and patients alike will be watching closely as Helus Pharma moves toward potential regulatory submissions.
