Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as chief executive officer, effective immediately. The move comes 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, having previously served 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, while the company advances HLP004 for generalized anxiety disorder. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder.
Halstead's leadership is expected to be pivotal as Helus Pharma transitions from a clinical-stage entity to a commercial-stage one. His track record includes successfully navigating regulatory pathways and driving commercial success, which will be crucial as the company approaches potential market entry. The appointment underscores the company's commitment to addressing the large unmet need in mental health treatment through its proprietary novel serotonergic agonists (NSAs).
Helus Pharma, the commercial operating name of Cybin Inc., founded in 2019, is focused on developing synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company aims to provide durable improvements in mental health conditions such as depression and anxiety. With class-leading data, Helus Pharma is poised to improve the treatment landscape.
The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit Helus Pharma or follow the team on social media. For the latest news and updates relating to HELP, see the company's newsroom at NetworkNewsWire.
This leadership change comes at a critical juncture for Helus Pharma, as the company navigates the complexities of late-stage clinical development and prepares for the commercial launch of its lead product candidate. Halstead's proven expertise in bringing psychiatric treatments to market will be invaluable as the company aims to deliver innovative therapies to patients suffering from mental health conditions.
