Helus Reports $42.7M Q3 Loss, Holds $195.1M Cash, Eyes 2026 Trial Readouts
Helus reported a $42.7 million net loss and $36.7 million in operating expenses in Q3 FY2026, with $195.1 million cash at December 31, 2025. The company expects HLP004 Phase 2 generalized anxiety disorder topline data in Q1 2026 and HLP003 Phase 3 major depressive disorder results in Q4 2026.
1. Third-Quarter Financial Performance
Helus recorded a $42.7 million net loss for the quarter ended December 31, 2025, compared to a $7.5 million loss in the prior year period. Cash-based operating expenses rose to $36.7 million versus $20.0 million year-over-year, while ending cash stood at $195.1 million before post-quarter adjustments.
2. Pipeline Program Progress
The company advanced HLP003 through its Phase 3 program for adjunctive major depressive disorder, including ongoing APPROACH™ and EMBRACE™ pivotal studies and the EXTEND long-term extension study. HLP004 remained in Phase 2 for generalized anxiety disorder with trial activities supporting an expected Q1 2026 topline readout.
3. Leadership and Strategic Focus
Michael Cola assumed the role of CEO to guide the transition toward a potential first commercial product launch and led the rebranding to Helus Pharma. The company also expanded its intellectual property portfolio, protecting lead programs HLP003 and HLP004 until at least 2041 to reinforce strategic flexibility.
4. Upcoming Catalysts
Topline data from the HLP004 Phase 2 GAD trial is scheduled for Q1 2026, while HLP003 Phase 3 major depressive disorder topline results are expected in Q4 2026. Continued patient enrollment in EMBRACE™ and the EXTEND safety study supports long-term data collection ahead of regulatory submissions.