Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has appointed Michael Halstead as chief executive officer, effective immediately, as the clinical-stage company advances its lead candidate HLP003 through Phase 3 development and prepares for potential commercialization. Halstead brings 25 years of biopharmaceutical leadership experience, most recently serving 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 comes at a critical juncture for Helus Pharma. The Phase 3 APPROACH trial for HLP003, a proprietary novel serotonergic agonist (NSA) for the adjunctive treatment of major depressive disorder, has completed enrollment, 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.
Halstead's appointment is expected to bring seasoned commercial expertise to Helus Pharma as it transitions from a pure clinical-stage company to one poised for potential market entry. His track record with CAPLYTA, a commercially successful CNS drug, is particularly relevant given HLP003's Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The strategic hire underscores Helus Pharma's commitment to addressing the large unmet need in mental health, with a focus on durable improvements through its proprietary NSAs.
Helus Pharma, the commercial operating name of Cybin Inc., founded in 2019, is dedicated to developing synthetic molecules designed to activate serotonin pathways that promote neuroplasticity. The company's pipeline aims to improve the treatment landscape for depression, anxiety, and other mental health conditions. With the Phase 3 program progressing and a new CEO at the helm, Helus Pharma is positioning itself for a pivotal period as it seeks to bring innovative treatments to patients. For more information, visit https://nnw.fm/wCjAp.
