Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported fiscal 2026 financial results and highlighted continued progress of its lead candidate HLP003 for major depressive disorder. The company announced 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 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. For more details, view the full press release at https://nnw.fm/WKk5e.
Helus Pharma, the commercial operating name of Cybin Inc., 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 NSAs aim to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. Helus is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder.
The company emphasizes its commitment to improving the treatment landscape with NSAs that provide durable improvements in mental health. The Phase 3 progress for HLP003 is particularly important as major depressive disorder affects millions globally, and current treatments often have limited efficacy or significant side effects. Positive results from the APPROACH and EMBRACE studies could lead to a new treatment option for patients who do not respond adequately to existing therapies.
Helus Pharma operates in Canada, the United States, the United Kingdom and Ireland. For company updates and more information, visit www.helus.com. The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP.
