Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), has completed enrollment in its APPROACH Phase 3 pivotal study evaluating HLP003 for major depressive disorder (MDD). The company expects to report topline data in the fourth quarter of 2026, marking a significant milestone in its PARADIGM program.
The company also announced that enrollment is underway in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program, while participants continue to roll over into the EXTEND long-term extension study. These trials are part of a comprehensive development strategy aimed at bringing HLP003, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, to market as an adjunctive treatment for MDD.
In addition to the HLP003 progress, Helus Pharma is advancing HLP004 for generalized anxiety disorder (GAD) following positive Phase 2 results. The company reported that HLP004 demonstrated a statistically significant and clinically meaningful improvement from baseline, and it expects to complete the design of the next study by the end of the third quarter of 2026.
Financially, 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 Phase 3 trials.
The company is also progressing its earlier-stage pipeline, including HLP005, with a viable development candidate anticipated in the second half of 2027. Helus Pharma, which operates in Canada, the United States, the United Kingdom, and Ireland, is focused on developing proprietary NSAs designed to activate serotonin pathways that are believed to promote neuroplasticity, addressing the large unmet need in depression, anxiety, and other mental health conditions.
These developments underscore Helus Pharma’s commitment to advancing its clinical programs and addressing the significant unmet need in mental health. The completion of enrollment in APPROACH is a key step toward potential regulatory submission, and the upcoming topline data will be crucial for the company’s future trajectory. With a strong cash position, Helus Pharma is well-positioned to fund its ongoing trials and operations.
For more details on the full press release, visit https://ibn.fm/yfpOW. For the latest news and updates, see https://ibn.fm/HELP.
