Helus Pharma Reports Fiscal 2026 Results, Phase 3 Trial for Major Depressive Disorder on Track

Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported its fiscal 2026 financial results on Tuesday, providing an update on its clinical pipeline and emphasizing continued progress for its lead candidate HLP003, a novel serotonergic agonist in development for major depressive disorder (MDD). The company noted 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 said it expects to finalize the design of the next clinical study for HLP004, its candidate for generalized anxiety disorder (GAD), by the end of the third quarter of 2026. HLP004 is currently in Phase 2 development. The company’s pipeline is focused on proprietary NSAs—novel serotonergic agonists designed to activate serotonin pathways believed to promote neuroplasticity, aiming to address unmet needs in mental health conditions such as depression and anxiety.

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 founded in 2019. Its lead candidate HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD. The company also has an extensive research portfolio of investigational NSAs and operates in Canada, the United States, the United Kingdom, and Ireland.

The results underscore the company’s commitment to advancing its pipeline despite a wider net loss, with Phase 3 data for HLP003 expected later this year. For more details, the full press release is available at https://nnw.fm/WKk5e. Additional information about Helus Pharma can be found at www.helus.com.