Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) reported its fiscal 2026 financial results and provided updates on its clinical pipeline, emphasizing the continued 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. 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.
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 developing proprietary 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. The company also has HLP004 in Phase 2 for generalized anxiety disorder and an extensive research portfolio of investigational NSAs.
The implications of this announcement are significant for patients and the mental health treatment landscape. Major depressive disorder affects millions worldwide, and current treatments often have limited efficacy or significant side effects. If HLP003 proves successful in Phase 3 trials, it could offer a new option for patients who do not respond adequately to existing therapies. The Breakthrough Therapy Designation underscores the potential of HLP003 to address a serious unmet medical need. For investors, the progress of the Phase 3 trials and the company's solid cash position provide a clearer picture of the potential timeline and financial runway for bringing a novel treatment to market.
For more details, the full press release can be viewed at https://nnw.fm/WKk5e. Additional information about Helus Pharma is available at www.helus.com.
