Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs), has announced significant advancements 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 anticipated in the fourth quarter of 2026. Enrollment is also underway in EMBRACE, the second pivotal study, as part of the PARADIGM program, while patients continue to roll over into the long-term EXTEND study.
These developments mark a critical milestone for Helus Pharma as it seeks to bring a new treatment option to patients with MDD who have inadequate response to standard therapies. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, underscoring its potential to address a significant unmet medical need. The company is also advancing HLP004 for generalized anxiety disorder (GAD), following Phase 2 results that demonstrated statistically significant and clinically meaningful improvement from baseline. The next study design for HLP004 is expected to be completed by the end of the third quarter.
Financially, Helus Pharma reported cash of $166.4 million as of June 30, 2026, which the company believes is sufficient to fund its ongoing clinical programs. However, the company recorded a net loss of $47.8 million for the quarter, compared to a net loss of $24.6 million in the same period last year. Cash-based operating expenses increased to $37.5 million from $23.9 million, driven primarily by the continued advancement of the Phase 3 trials. The company also continues to progress HLP005, with a viable development candidate anticipated in the second half of 2027.
The results from the APPROACH study are expected to be a major catalyst for the company and the broader psychiatric drug development landscape. If successful, HLP003 could offer a new mechanism of action for MDD, potentially providing durable improvements in mental health. The company's focus on NSAs aims to activate serotonin pathways believed to promote neuroplasticity, offering a novel approach compared to traditional antidepressants.
Helus Pharma, the commercial operating name of Cybin Inc., is committed to addressing the large unmet need for people suffering from depression, anxiety, and other mental health conditions. With operations in Canada, the United States, the United Kingdom, and Ireland, the company is advancing a robust pipeline of proprietary NSAs. The company's progress in the Phase 3 program represents a pivotal step toward potentially bringing a new treatment option to market, which could have significant implications for patients, healthcare providers, and the pharmaceutical industry.
For more information, visit the full press release at https://ibn.fm/yfpOW.
