Helus Pharma (NASDAQ: HELP) reported its fiscal 2026 financial results and provided an update on its clinical pipeline, emphasizing progress on its lead candidate HLP003 for major depressive disorder. The company's 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. 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 financial results underscore the company's commitment to bringing novel treatments to market for mental health conditions.
The progress of HLP003 is particularly significant because it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. If successful, HLP003 could become a new adjunctive treatment option for the millions of patients with major depressive disorder who do not respond adequately to existing therapies. The Phase 3 data readout in Q4 2026 will be a critical milestone for the company and the field.
Helus Pharma is a clinical stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways that promote neuroplasticity. The company's pipeline addresses large unmet needs in depression, anxiety, and other mental health conditions. With class-leading data, Helus aims to improve the treatment landscape through NSAs that provide durable improvements in mental health.
For more details on the company's progress and financials, visit the full press release at https://nnw.fm/WKk5e. Additional information about Helus Pharma is available at www.helus.com.
