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 pivotal time for the clinical-stage pharmaceutical company as it 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, supported pipeline expansion, and helped lead the company's $14.6 billion acquisition by Johnson & Johnson in 2025.
The appointment aligns with significant clinical milestones for Helus Pharma. Enrollment has been completed in the Phase 3 APPROACH trial, 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. These developments underscore the company's commitment to addressing unmet needs in mental health through novel serotonergic agonists (NSAs), which are designed to activate serotonin pathways believed to promote neuroplasticity.
Helus Pharma, the commercial operating name of Cybin Inc., is focused on developing proprietary NSAs for depression, anxiety, and other mental health conditions. HLP003, the company's lead candidate, is being developed as an adjunctive treatment for 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.
Halstead's leadership is expected to be instrumental as Helus Pharma transitions from a development-stage company to a potential commercial entity. His track record in commercializing CAPLYTA and navigating corporate acquisitions provides a strong foundation for guiding Helus Pharma through its next phase of growth. The company operates in Canada, the United States, the United Kingdom, and Ireland, and continues to expand its research and development efforts.
This leadership change signals confidence in the company's pipeline and its ability to bring innovative treatments to market. With topline data from the APPROACH trial on the horizon, the appointment of a seasoned executive like Halstead may enhance investor confidence and position Helus Pharma for success in the competitive mental health landscape.
For more information about Helus Pharma and its pipeline, visit the company's newsroom at https://nnw.fm/HELP or the full press release at https://nnw.fm/wCjAp.
