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Helus Pharma Fiscal 2026 Results and Pipeline Progress FAQ
Helus Pharma (Cybin Inc.) reported fiscal 2026 financial results, highlighting strong cash position and key Phase 3 progress for lead candidate HLP003 in major depressive disorder, with topline data expected in Q4 2026.
Helus Pharma ended fiscal 2026 with $157.3 million in cash and completed a $50 million underwritten offering on June 25. The company reported a net loss of $148.0 million, compared to $81.6 million in the prior year, reflecting increased spending on its Phase 3 HLP003 program and advancement of HLP004 and HLP005.
The Phase 3 APPROACH trial for HLP003 in major depressive disorder has surpassed 88% enrollment and remains on track to deliver topline data in the fourth quarter of 2026.
The EMBRACE study is a second pivotal Phase 3 trial for HLP003 in major depressive disorder. Enrollment is continuing, and it is part of the overall Phase 3 program for HLP003.
Helus Pharma 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 Pharma's lead drug candidate is HLP003, a proprietary novel serotonergic agonist (NSA) in Phase 3 clinical development for the adjunctive treatment of major depressive disorder. It has received Breakthrough Therapy Designation from the U.S. FDA.
Helus Pharma ended fiscal 2026 with $157.3 million in cash and completed a $50 million underwritten offering on June 25 to support continued development of its pipeline.
For more information, visit www.helus.com or follow the team on X, LinkedIn, YouTube, and Instagram. The company also has a newsroom at https://nnw.fm/HELP.
The Breakthrough Therapy Designation from the U.S. FDA indicates that HLP003 may offer a substantial improvement over existing therapies for major depressive disorder, potentially expediting its development and review.