Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has named Michael Halstead as its new chief executive officer, effective immediately. The appointment comes as the clinical-stage pharmaceutical company advances its lead candidate, HLP003, through Phase 3 development and prepares for potential commercialization.
Halstead brings 25 years of biopharmaceutical leadership experience to the role, most recently serving as president of Intra-Cellular Therapies. During his tenure there, he oversaw the development and commercialization of CAPLYTA, a treatment for bipolar depression, supported pipeline expansion, and helped lead the company's $14.6 billion acquisition by Johnson & Johnson in 2025. His track record in bringing psychiatric treatments to market is expected to be valuable as Helus Pharma progresses its own mental health portfolio.
The company is currently focused on HLP003, a proprietary novel serotonergic agonist (NSA) being developed as an adjunctive treatment for major depressive disorder. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Enrollment has been completed in the Phase 3 APPROACH trial, with topline data anticipated in the fourth quarter of 2026. Additionally, enrollment is continuing in the EMBRACE pivotal study, which is also part of the Phase 3 program for HLP003.
Beyond HLP003, Helus Pharma is advancing HLP004, another proprietary NSA, in Phase 2 development for generalized anxiety disorder. The company also has an extensive research portfolio of investigational NSAs aimed at addressing unmet needs in depression, anxiety, and other mental health conditions.
Helus Pharma, the commercial operating name of Cybin Inc., was founded in 2019 and is dedicated to developing synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to improve the treatment landscape for mental health conditions through these novel agents, which could offer durable improvements for patients.
The appointment of Halstead signals a strategic move to strengthen leadership as the company approaches critical milestones. His experience in commercializing a psychiatric medication and navigating a major acquisition could provide valuable insights as Helus Pharma prepares for potential market entry of HLP003. This could have significant implications for the mental health treatment landscape, particularly for patients with major depressive disorder who have not responded adequately to existing therapies.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. The company's news and updates are available in its newsroom at https://nnw.fm/HELP.
