Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has appointed Michael Halstead as chief executive officer, effective immediately. The move comes as the clinical-stage company advances its lead candidate, HLP003, through Phase 3 development and prepares for potential commercialization. Halstead brings over 25 years of biopharmaceutical leadership experience, most recently serving as president of Intra-Cellular Therapies, where he oversaw the development and commercialization of CAPLYTA, a treatment for bipolar depression, and helped lead the company's $14.6 billion acquisition by Johnson & Johnson in 2025.
The appointment is strategically timed as Helus Pharma has completed enrollment in the Phase 3 APPROACH trial for HLP003, with topline data expected in the fourth quarter of 2026. Enrollment is also continuing in the EMBRACE pivotal study. HLP003 is a proprietary novel serotonergic agonist (NSA) designed to activate serotonin pathways believed to promote neuroplasticity, and it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder. The company is also advancing HLP004, another NSA, in Phase 2 for generalized anxiety disorder.
Halstead's appointment brings deep commercial expertise to Helus Pharma as it navigates the late-stage clinical and regulatory landscape. His track record with CAPLYTA, which achieved significant commercial success, is likely to be instrumental in shaping the company's market entry strategy. The leadership change underscores Helus Pharma's commitment to addressing the large unmet need in mental health treatments, particularly for depression and anxiety.
Helus Pharma, the commercial operating name of Cybin Inc., founded in 2019, focuses on developing proprietary NSAs intended to provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland. With the clinical milestones ahead, the appointment of a seasoned executive like Halstead could be pivotal in transitioning from a clinical-stage entity to a commercial-stage biopharmaceutical company.
Investors and industry observers will be watching closely as Helus Pharma reports topline data from the APPROACH trial next year. The success of HLP003 could position the company to compete in the mental health market, which has seen increasing interest in novel therapies. Halstead's experience in launching and commercializing CNS drugs will be critical in maximizing HLP003's potential if approved.
For more information on Helus Pharma, visit the company's website at https://www.helus.com. The latest news and updates are available in the company's newsroom at https://nnw.fm/HELP.
