Helus Pharma (HELP) Q3 2026 earnings summary

Executive summary

• Leadership transition completed with Michael Cola appointed as CEO to guide toward first commercial product launch.

• Advanced clinical pipeline with HLP003 in Phase 3 for major depressive disorder and HLP004 in Phase 2 for generalized anxiety disorder.

• Rebranding to "Helus Pharma" and strategic focus on engineered serotonergic agonists for scalable commercial potential.

• Expanded intellectual property portfolio, protecting lead programs until at least 2041.

Financial highlights

• Cash position of $195.1 million as of December 31, 2025.

• Net loss of $42.7 million for the quarter ended December 31, 2025, compared to $7.5 million in the same period last year.

• Cash-based operating expenses were $36.7 million, up from $20 million year-over-year.

• Cash flows used in operating activities totaled $31.9 million, compared to $18.6 million in the prior year quarter.

Outlook and guidance

• Topline data from HLP004 Phase 2 study in GAD expected in Q1 2026.

• HLP003 Phase 3 APPROACH study topline data anticipated in Q4 2026.

• EMBRACE Phase 3 study for HLP003 initiated patient enrollment, supporting efficacy evidence.

• Ongoing EXTEND long-term extension study to collect safety and durability data.