Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), has announced significant progress in its Phase 3 program for HLP003, its lead candidate for major depressive disorder (MDD). The company completed enrollment in APPROACH, the first pivotal Phase 3 study, and topline data are expected in the fourth quarter of 2026. Enrollment is also underway in EMBRACE, the second pivotal study in the PARADIGM program, while participants continue to roll over into the EXTEND long-term extension study. These milestones underscore Helus Pharma's commitment to addressing the large unmet need in mental health treatment.
The company's financial results for the quarter ended June 30, 2026, reflect increased investment in clinical development. Helus Pharma reported cash of $166.4 million and a quarterly net loss of $47.8 million, compared with a net loss of $24.6 million in the same period last year. Cash-based operating expenses rose to $37.5 million from $23.9 million, driven by the 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). Phase 2 results demonstrated a statistically significant and clinically meaningful improvement from baseline, and the company expects to finalize the design for the next study by the end of the third quarter. Helus Pharma is also progressing HLP005 toward candidate selection, with a viable development candidate anticipated in the second half of 2027.
The company's proprietary NSAs are synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity, offering a novel approach to treating depression, anxiety, and other mental health conditions. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD, highlighting its potential to provide durable improvements in mental health.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit the company's website at www.helus.com. The latest news and updates are available in the company's newsroom at https://ibn.fm/HELP. The full press release can be viewed at https://ibn.fm/yfpOW.
