Helus Pharma Reports Fiscal 2026 Results, Phase 3 Trial on Track

Helus Pharma announced fiscal 2026 financial results and provided updates on its clinical pipeline, with its lead candidate HLP003 for major depressive disorder showing strong enrollment progress and a clear path to topline data in Q4 2026.

Bay Area Metrowire Staff
Business
Helus Pharma Reports Fiscal 2026 Results, Phase 3 Trial on Track

Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) released its fiscal 2026 financial results and provided a clinical pipeline update, emphasizing the continued advancement of its lead candidate HLP003 for major depressive disorder. The company reported that its Phase 3 APPROACH trial has surpassed 88% enrollment and remains on schedule to deliver topline data in the fourth quarter of 2026. Enrollment is also ongoing 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 net loss of $148.0 million for fiscal 2026, 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 the full press release, visit 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. These synthetic molecules aim to address the large unmet need for individuals suffering from depression, anxiety, and other mental health conditions. HLP003, a proprietary NSA, is in Phase 3 clinical development for the adjunctive treatment of major depressive disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, also a proprietary NSA, is in Phase 2 for generalized anxiety disorder. The company also has an extensive research portfolio of investigational NSAs.

Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. For company updates and more information, visit www.helus.com or follow the team on X, LinkedIn, YouTube, and Instagram. The latest news and updates relating to HELP are available in the company’s newsroom at https://nnw.fm/HELP.

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