Helus Pharma (Nasdaq: HELP) announced the appointment of Michael Halstead as Chief Executive Officer, effective immediately, according to a company statement.

Halstead most recently served as President of Intra-Cellular Therapies, Inc., where he was involved in the development and commercialization of CAPLYTA® (lumateperone) across multiple indications, including schizophrenia, bipolar depression, and the adjunctive treatment of major depressive disorder. He also led the company's $14.6 billion sale to Johnson & Johnson in 2025.

Prior to Intra-Cellular, Halstead held senior roles at Warner Chilcott plc, where he oversaw the $3 billion acquisition of Procter & Gamble's pharmaceutical business in 2009 and the company's $8.5 billion sale to Actavis in 2013. He holds a J.D. from Villanova University Charles Widger School of Law and a B.A. in International Relations from Boston University.

The appointment comes as Helus Pharma prepares for topline data from APPROACH, its first pivotal Phase 3 study of HLP003 as an adjunctive treatment for Major Depressive Disorder, expected in the fourth quarter of 2026. Enrollment in APPROACH is complete. A second pivotal Phase 3 study, EMBRACE, continues enrollment, and participant rollover is ongoing into EXTEND, a long-term extension study.

"Mr. Halstead's leadership and operational experience guiding pharmaceutical companies through late-stage development, infrastructure buildout, and commercialization will be invaluable as we execute against our upcoming HLP003 and HLP004 clinical, regulatory, and commercial milestones," said Eric So, Co-Founder and Executive Chairman.

Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage company developing novel serotonergic agonists. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The company also has HLP004 in Phase 2 development for generalized anxiety disorder.