Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced the appointment of Michael Halstead as chief executive officer, effective immediately. The move comes as the clinical-stage company prepares to advance its lead candidate, HLP003, through Phase 3 development and toward potential commercialization. Halstead brings 25 years of biopharmaceutical leadership experience, including his most recent role 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. Enrollment is also continuing in the EMBRACE pivotal study. Additionally, the company is advancing HLP004 for generalized anxiety disorder, currently in Phase 2 development. These milestones underscore the company’s progress in building a robust pipeline of novel serotonergic agonists (NSAs) aimed at addressing unmet needs in mental health.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company’s mission is to help minds heal by providing durable improvements in mental health conditions such as depression and anxiety. HLP003, a proprietary NSA in Phase 3 for the adjunctive treatment of major depressive disorder, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, also a proprietary NSA, is in Phase 2 for generalized anxiety disorder.
The appointment of Halstead is expected to bring significant commercial expertise to Helus Pharma as it transitions from a development-stage company to one preparing for market. His track record with Intra-Cellular Therapies, particularly the successful launch of CAPLYTA and the subsequent acquisition by Johnson & Johnson, positions him well to guide Helus Pharma through similar growth phases. The company’s focus on NSAs represents a novel approach to treating mental health conditions, which could offer new options for patients who have not responded to existing therapies.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. The company continues to expand its research portfolio of investigational NSAs while advancing its lead candidates. For more information about Helus Pharma and its pipeline, visit helus.com.
