Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of 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 positions itself for potential commercialization.
Halstead brings over 25 years of biopharmaceutical leadership experience, most recently serving as president of Intra-Cellular Therapies. During his tenure, he oversaw the development and commercialization of CAPLYTA(R), supported pipeline expansion, and helped guide the company's $14.6 billion acquisition by Johnson & Johnson in 2025. His appointment is seen as a strategic step to leverage his expertise in late-stage development and commercial readiness.
The announcement coincides with significant progress in Helus Pharma's clinical programs. Enrollment has been completed in the Phase 3 APPROACH trial, with topline data expected in the fourth quarter of 2026. Additionally, enrollment is continuing in the EMBRACE pivotal study. The company is also advancing HLP004, its candidate for generalized anxiety disorder, which is in Phase 2 development.
The leadership change underscores Helus Pharma's commitment to addressing unmet needs in mental health through its proprietary novel serotonergic agonists (NSAs). These synthetic molecules are designed to activate serotonin pathways believed to promote neuroplasticity, offering potential durable improvements for individuals suffering from depression, anxiety, and other mental health conditions.
HLP003, the company's lead NSA, 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. The Phase 3 program is a critical milestone for the company, and Halstead's experience in bringing CAPLYTA to market is expected to be instrumental in navigating the regulatory and commercial landscape.
The appointment also signals a transition toward a more commercially focused phase for Helus Pharma. With the Phase 3 trial fully enrolled and continued progress in other studies, the company is preparing for potential market entry. Halstead's track record in building commercial infrastructure and driving product adoption will likely be key assets.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. The company continues to expand its research portfolio of investigational NSAs, aiming to improve the treatment landscape for mental health disorders.
For more information about Helus Pharma, visit Helus Pharma or follow the team on social media platforms. The latest news and updates about the company are available in its newsroom.
