Helus Pharma Appoints Michael Halstead as CEO as Phase 3 Trials Advance

Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has appointed Michael Halstead as chief executive officer, effective immediately, a strategic move 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, 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. Enrollment is complete in the Phase 3 APPROACH trial for HLP003, with topline data expected in Q4 2026. The company is also continuing enrollment in the EMBRACE pivotal study, while advancing HLP004 for generalized anxiety disorder. This leadership transition signals a shift from clinical development toward commercialization readiness, a move that could reshape the mental health treatment landscape.

Halstead's experience is particularly relevant given HLP003's Breakthrough Therapy Designation from the U.S. Food and Drug Administration. His track record with CAPLYTA, a treatment for bipolar depression, demonstrates his ability to navigate regulatory pathways and successfully launch products in the psychiatric space. The strategic appointment suggests Helus Pharma is positioning itself to capitalize on the growing demand for novel treatments for major depressive disorder, a condition affecting millions worldwide.

The implications of this announcement are significant. With a seasoned commercial leader at the helm, Helus Pharma aims to improve the treatment landscape through the introduction of novel serotonergic agonists (NSAs) that promote neuroplasticity and provide durable improvements in mental health. The company's proprietary NSAs are designed to activate serotonin pathways, offering a new approach to treating depression and anxiety, which have large unmet needs.

Analysts view this as a positive signal for investors, as it reduces execution risk during the critical Phase 3 readouts and potential regulatory filings. The company's focus on adjunctive treatment for major depressive disorder, a significant market, could offer a new option for patients who do not respond adequately to existing therapies.

Helus Pharma, the commercial operating name of Cybin Inc., operates in Canada, the United States, the United Kingdom, and Ireland. The company continues to build on its extensive research portfolio of investigational NSAs. For more information, visit Helus Pharma or follow the team on social media. The latest news and updates relating to HELP are available in the company's newsroom at https://nnw.fm/HELP.