Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as chief executive officer, effective immediately. This leadership change comes at a pivotal time for the clinical-stage company, which is advancing its lead candidate HLP003 through Phase 3 development and preparing 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, supported pipeline expansion, and helped lead the company's $14.6 billion acquisition by Johnson & Johnson in 2025.
The appointment is strategically significant as Helus Pharma has completed enrollment in the Phase 3 APPROACH trial, with topline data expected in Q4 2026, and continues enrollment in the EMBRACE pivotal study. Additionally, the company is advancing HLP004 for generalized anxiety disorder. This progress underscores the company's commitment to addressing unmet needs in mental health through its proprietary novel serotonergic agonists (NSAs).
Helus Pharma, the commercial operating name of Cybin Inc., is focused on developing synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company's lead candidate, HLP003, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder. The company operates in Canada, the United States, the United Kingdom, and Ireland.
The appointment of a seasoned executive like Halstead is a clear signal that Helus Pharma is positioning itself for the next phase of growth. His track record in commercializing a successful psychiatric medication and navigating a major acquisition provides the company with the expertise needed to potentially bring HLP003 to market. This move is likely to instill confidence among investors and stakeholders, as the company transitions from a clinical-stage entity to a potential commercial player.
For more information, visit the full press release at https://nnw.fm/wCjAp.
