Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as chief executive officer, effective immediately. The move comes at a critical juncture for the clinical-stage pharmaceutical company, which is advancing its lead candidate HLP003 through Phase 3 development and gearing up for potential commercialization. Halstead brings over 25 years of biopharmaceutical leadership experience, having most recently served as president of Intra-Cellular Therapies, where he oversaw the development and commercialization of CAPLYTA, supported pipeline expansion, 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 Q4 2026. Additionally, enrollment continues in the EMBRACE pivotal study, and the company is also advancing HLP004 for generalized anxiety disorder. This leadership change underscores the company's focus on navigating the late-stage clinical and regulatory landscape while positioning itself for market entry.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company dedicated to developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address the significant unmet need for individuals suffering from depression, anxiety, and other mental health conditions. With class-leading data, Helus Pharma intends to improve the treatment landscape by introducing NSAs that provide durable improvements in mental health.
HLP003 is currently in Phase 3 clinical development for the adjunctive treatment of major depressive disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, another proprietary NSA, is in Phase 2 for generalized anxiety disorder. The company also has an extensive research portfolio of investigational NSAs.
The appointment of a seasoned executive like Halstead is a strong signal of the company's commitment to executing its clinical development plans and preparing for the commercial phase. His experience in bringing CAPLYTA to market and managing a successful acquisition will be invaluable as Helus Pharma looks to advance its pipeline and potentially bring HLP003 to patients.
For more information about Helus Pharma and its developments, visit www.helus.com. To view the full press release, visit https://nnw.fm/wCjAp.
