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 disclosed that its Phase 3 APPROACH trial has surpassed 88% enrollment and remains on track to deliver topline data in the fourth quarter of 2026. 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. The full press release is available at https://nnw.fm/WKk5e.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. These synthetic molecules aim to address the large unmet need for individuals suffering from depression, anxiety, and other mental health conditions. HLP003, a proprietary NSA, is in Phase 3 clinical development for the adjunctive treatment of MDD and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, also a proprietary NSA, is in Phase 2 for generalized anxiety disorder. The company also 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.
