Helus Pharma Surpasses 86% Enrollment in Phase 3 APPROACH Trial for Major Depressive Disorder

Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced that enrollment in its Phase 3 APPROACH clinical trial evaluating HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% and remains on track. The study is one of the company’s Phase 3 trials supporting development of HLP003, its lead proprietary novel serotonergic agonist, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The milestone brings the company closer to reporting topline data in the fourth quarter of 2026.

The APPROACH study is part of Helus Pharma’s broader Phase 3 PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. The company said the enrollment milestone supports its goal of advancing HLP003 toward potential commercialization for patients with major depressive disorder. According to the press release, the company aims to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions through its proprietary NSAs – novel serotonergic agonists designed to activate serotonin pathways believed to promote neuroplasticity.

Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company committed to developing synthetic molecules that aim to provide durable improvements in mental health. In addition to HLP003 in Phase 3 for major depressive disorder, the company is developing HLP004, a proprietary NSA in Phase 2 for generalized anxiety disorder, and has an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom, and Ireland.

For more details on the announcement, the full press release is available at https://ibn.fm/Qpikw. For company updates and to learn more about Helus Pharma, visit www.helus.com.