Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), has announced significant advancements in its Phase 3 program for HLP003, a potential treatment for major depressive disorder (MDD). The company completed enrollment in APPROACH, its first pivotal Phase 3 study, and anticipates topline data in the fourth quarter of 2026. Enrollment is also underway in EMBRACE, the second pivotal study within the PARADIGM program, with participants continuing to roll over into the EXTEND long-term extension study.
The announcement comes alongside Helus Pharma's financial results for the quarter ended June 30, 2026. The company reported cash reserves of $166.4 million, a quarterly net loss of $47.8 million (up from $24.6 million in the same period last year), and cash-based operating expenses of $37.5 million (up from $23.9 million). The increased spending reflects the ongoing costs of advancing the Phase 3 trials for HLP003.
In addition to HLP003, Helus Pharma is progressing HLP004, another proprietary NSA, for generalized anxiety disorder (GAD). Following Phase 2 results that demonstrated a statistically significant and clinically meaningful improvement from baseline, the company expects to finalize the design for the next study by the end of the third quarter. Furthermore, the company continues to advance HLP005 toward candidate selection, with a viable development candidate anticipated in the second half of 2027.
These developments underscore Helus Pharma's strategic focus on addressing the large unmet need in mental health treatments. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of MDD, highlighting its potential to offer durable improvements. The company's novel serotonergic agonists are synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity, aiming to provide better outcomes for patients suffering from depression, anxiety, and other mental health conditions.
The progress in the Phase 3 program is a critical milestone for Helus Pharma, as successful results could lead to regulatory submissions and eventual commercialization, potentially transforming the treatment landscape for MDD. The company operates in Canada, the United States, the United Kingdom, and Ireland, and continues to build on its research portfolio of investigational NSAs.
For more details on the full press release, visit https://ibn.fm/yfpOW. For the latest news and updates on Helus Pharma, refer to the company's newsroom at https://ibn.fm/HELP. Additional information about the company is available at www.helus.com.
