Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has released its fiscal 2026 financial results, providing an update on its clinical pipeline and emphasizing the continued advancement of its lead candidate, HLP003, for major depressive disorder. The company reported 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 is also ongoing 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.
HLP003 is a proprietary novel serotonergic agonist (NSA) designed to activate serotonin pathways believed to promote neuroplasticity. It has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder. The company is also developing HLP004, another proprietary NSA, in Phase 2 for generalized anxiety disorder, and maintains an extensive research portfolio of investigational NSAs.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company committed to addressing the large unmet need for people suffering from depression, anxiety, and other mental health conditions. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit www.helus.com or follow the team on X, LinkedIn, YouTube, and Instagram.
To view the full press release, visit https://nnw.fm/WKk5e. For the latest news and updates relating to HELP, visit the company’s newsroom at https://nnw.fm/HELP.
