Helus Pharma Advances HLP003 Phase 3 Program, Targets Q4 2026 Topline Data

Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), has reported significant progress in its Phase 3 program for HLP003, its lead candidate for major depressive disorder (MDD). The company announced the completion of enrollment in APPROACH, the first pivotal study in the Phase 3 PARADIGM program, with topline data expected in the fourth quarter of 2026. Concurrently, enrollment is underway in EMBRACE, the second pivotal study, and participants are rolling over into the EXTEND long-term extension study. These milestones underscore the company's commitment to advancing a potential new treatment for MDD, a condition affecting millions worldwide.

The financial results for the quarter ended June 30, 2026, reflect increased investment in the clinical program. Helus Pharma reported cash of $166.4 million as of June 30, 2026, and a quarterly net loss of $47.8 million, compared with $24.6 million in the same period last year. Cash-based operating expenses totaled $37.5 million, up from $23.9 million a year earlier, driven by the continued advancement of the APPROACH, EMBRACE and EXTEND trials. The company's strong cash position is expected to support ongoing development activities.

In addition to HLP003, Helus Pharma is advancing HLP004 for generalized anxiety disorder (GAD). Following Phase 2 results that demonstrated a statistically significant and clinically meaningful improvement from baseline, the company is designing the next study, with the design expected to be completed by the end of the third quarter of 2026. The company is also progressing HLP005 toward candidate selection, with a viable development candidate anticipated in the second half of 2027. These efforts highlight the breadth of Helus Pharma's pipeline and its focus on developing novel serotonergic agonists to address unmet needs in mental health.

The Phase 3 PARADIGM program for HLP003 is designed to evaluate the efficacy and safety of HLP003 as an adjunctive treatment for MDD. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, underscoring its potential to offer a significant improvement over existing therapies. The completion of enrollment in APPROACH is a critical step toward potentially bringing this innovative treatment to patients.

Helus Pharma, the commercial operating name of Cybin Inc., is dedicated to helping minds heal by developing proprietary NSAs: synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to provide durable improvements in mental health and operates in Canada, the United States, the United Kingdom and Ireland. For more information, visit www.helus.com.

The company's recent progress and financial updates were detailed in a press release, which can be accessed at https://ibn.fm/yfpOW. Additionally, the latest news and updates relating to HELP are available in the company's newsroom at https://ibn.fm/HELP.