Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as its new chief executive officer, effective immediately. This leadership change comes at a critical juncture as the clinical-stage company 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(R), supported pipeline expansion, and helped lead the company's $14.6 billion acquisition by Johnson & Johnson in 2025.
The appointment of Halstead is particularly significant given the progress of Helus Pharma's pipeline. The company has completed enrollment in the Phase 3 APPROACH trial for HLP003, with topline data expected in Q4 2026. Additionally, enrollment is continuing 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 large unmet needs in mental health treatment.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company's lead candidate, HLP003, 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 is in Phase 2 development for generalized anxiety disorder. The company operates in Canada, the United States, the United Kingdom, and Ireland.
Halstead's appointment is expected to bring seasoned leadership to guide Helus Pharma through the next phases of clinical development and commercialization. His track record with Intra-Cellular Therapies, particularly the successful launch of CAPLYTA(R) and the strategic acquisition by Johnson & Johnson, positions him well to lead Helus Pharma as it approaches potential market entry. The company's focus on innovative treatments for depression and anxiety aligns with a growing demand for new therapeutic options in mental health.
The news of Halstead's appointment, combined with the progress of HLP003 and HLP004, highlights Helus Pharma's strategic direction and its potential to impact the mental health treatment landscape. As the company moves forward, investors and stakeholders will be watching closely for the release of Phase 3 data and subsequent regulatory milestones. The leadership transition signals a new chapter for Helus Pharma as it aims to bring its proprietary NSAs to patients in need.
