Cybin's Helus Pharma reports FY2026 results, Phase 3 MDD trial past 88% enrollment

Helus Pharma, the commercial operating name of Cybin Inc. (Nasdaq: HELP), reported financial results for the fiscal year ended March 31, 2026 on June 29, 2026. The company is a clinical stage pharmaceutical company developing novel serotonergic agonists and reported audited financial results for its fiscal year ended March 31, 2026, along with recent business highlights.¹

On the lead program, HLP003 for major depressive disorder, the Phase 3 APPROACH study has surpassed 88% enrollment and remains on track for topline data in the fourth quarter of 2026.¹ Earlier Phase 2 data showed that after two 16 mg doses given three weeks apart, patients had a roughly 23-point drop in MADRS score from baseline at 12 months, with response reaching 100% and remission reaching 71% using a MADRS threshold of 10 or below; using a more recent peer benchmark of MADRS 12 or below, both response and remission rates were 100% at 12 months.¹

For HLP004 in generalized anxiety disorder, the Phase 2 signal detection study found a statistically significant (p<0.0001) and, per the company, clinically meaningful within-subject improvement of about 10 points on the Hamilton Anxiety Rating Scale beyond standard of care at six weeks, with durable effects through at least six months, 67% responders and 39% in remission, and no drug-related serious adverse events.¹ The company intends to finalize the design of the next HLP004 study by the end of the third quarter of 2026.¹

Financially, cash totaled $157.3 million as of March 31, 2026, following a $50 million underwritten offering completed on June 25, 2026.¹ The net loss for the full fiscal year widened to $148.0 million, up from $81.6 million a year earlier, with the year-over-year figures comparing $148.0 million for fiscal 2026 to $81.6 million in the prior year.¹ Cash-based research, general and administrative expenses rose to $131.7 million for the year, from $71.8 million previously.¹