Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported its fiscal 2026 financial results and provided an update on its clinical pipeline, emphasizing the progress of its lead candidate HLP003 for major depressive disorder. The company announced that the 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, while the design for the next clinical study of HLP004 for generalized anxiety disorder is expected to be finalized 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 company, operating under the commercial name Helus Pharma, is a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder. HLP004 is in Phase 2 for generalized anxiety disorder, and the company also has an extensive research portfolio of investigational NSAs.
The company’s progress is significant given the large unmet need for treatments for depression, anxiety, and other mental health conditions. With its proprietary NSAs, Helus aims to provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit the company’s website at www.helus.com.
The full press release is available at https://nnw.fm/WKk5e. For the latest news and updates relating to HELP, visit the company’s newsroom at https://nnw.fm/HELP.
