Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported fiscal 2026 financial results and provided a clinical pipeline update, emphasizing the 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. 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. These financial results underscore the company's commitment to advancing its novel serotonergic agonists (NSAs) through late-stage clinical development.
The implications of these announcements are significant for patients suffering from major depressive disorder, a condition affecting millions globally with substantial unmet need. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, indicating the potential for a significant improvement over existing therapies. If successful, HLP003 could offer a new treatment option that provides durable improvements in mental health by promoting neuroplasticity through serotonin pathway activation.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary NSAs designed to address 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.
The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP. This update highlights the importance of Helus Pharma's progress in addressing the large unmet need for individuals with mental health conditions, with the potential to reshape the treatment landscape.
