Helus Pharma Reports Fiscal 2026 Results, Phase 3 Depression Trial on Track
Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported fiscal 2026 financial results and provided a clinical pipeline update, underscoring progress for its lead candidate HLP003 in 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 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.
The company 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. Helus 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 highlight the company's investment in late-stage clinical development as it aims to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. HLP003, a proprietary NSA, is in Phase 3 clinical development for the adjunctive treatment of major depressive disorder and 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 has an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland. For Company updates and to learn more about Helus Pharma, visit www.helus.com.
The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP. To view the full press release, visit https://nnw.fm/WKk5e.
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