HLP003 (previously CYB003) - (APPROACH)

June 24, 2026: Helus Pharma (NASDAQ: HELP; Cboe CA: HELP) reported that enrollment in the APPROACH Phase 3 trial of HLP003 as an adjunctive treatment for major depressive disorder (MDD) has surpassed 86% and is progressing as planned. HLP003, the company’s lead novel serotonergic agonist, previously received FDA Breakthrough Therapy Designation.

The APPROACH study is part of the Phase 3 PARADIGM program for HLP003, which also includes the EMBRACE study and the EXTEND long-term extension study. The company said it remains on track to report topline data in Q4 2026.

The release also reiterated previously reported Phase 2 HLP003 results: approximately a 23-point reduction in MADRS score versus baseline at 12 months after two 16 mg doses given three weeks apart; response and remission rates were 75% at week 18, improving by 12 months to 100% response and 71% remission.