Mr. Eric So reports
HELUS PHARMA APPOINTS MICHAEL HALSTEAD AS CHIEF EXECUTIVE OFFICER
Helus Pharma, the commercial operating name of Cybin Inc., has appointed Michael Halstead as chief executive officer, effective immediately.
Mr. Halstead's appointment comes as Helus Pharma advances HLP003 through late-stage clinical development and prepares for potential commercialization. Enrolment is complete in Approach, with top-line data expected in fourth quarter 2026, while enrolment continues in Embrace, the second pivotal study in the phase 3 Paradigm program. Participant rollover is continuing into Extend, the long-term extension study.
Mr. Halstead brings 25 years of industry experience, most recently serving as president of Intra-Cellular Therapies Inc. During his tenure at Intra-Cellular, he played a pivotal role in transforming the company from an early-stage clinical development organization into a fully integrated commercial biopharmaceutical enterprise. He was instrumental in the successful development, launch and commercialization of Caplyta (lumateperone), which has received approvals across multiple indications, including schizophrenia, bipolar depression and the adjunctive treatment of major depressive disorder. Mr. Halstead also supported the advancement of the company's pipeline programs in generalized anxiety disorder and neuropsychiatric symptoms associated with Alzheimer's disease. In addition, he managed multiple equity offerings and led the company's $14.6-billion (U.S.) sale to Johnson & Johnson in 2025.
"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.
"I'm honoured to join the Helus Pharma team at this crucial stage in the company's evolution," said Mr. Halstead. "HLP003, a potential differentiated new option in the adjunctive treatment landscape for MDD, and HLP004, a compelling short-acting compound in development for generalized anxiety disorder, position Helus Pharma to pursue a unique approach focused on the outcomes that matter most to patients."
"The clinical results in the HLP003 program to date suggest the potential to transform the treatment paradigm for MDD. I am impressed with the program's rigour and focus on providing the optimal solution for patients, providers and payers. The company's intellectual property portfolio of more than 350 patent applications and more than 100 granted patents worldwide provide a solid foundation for continued growth," concluded Mr. Halstead.
Prior to his time at Intra-Cellular, Mr. Halstead held senior leadership roles at Warner Chilcott PLC, where he oversaw major strategic initiatives, including the $3-billion (U.S.) acquisition of Procter & Gamble's pharmaceutical business in 2009 and the integration of its approximately 2,000 employees across multinational operations and Warner Chilcott's $8.5-billion (U.S.) sale to Actavis in 2013.
Mr. Halstead holds a JD from Villanova University Charles Widger school of law and a BA in international relations from Boston University.
About Helus Pharma
Helus Pharma is a clinical-stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company's proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety and other mental health conditions.
With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in phase 3 clinical development for the adjunctive treatment of MDD that has received breakthrough therapy designation from the U.S. Food and Drug Administration, and HLP004, also a proprietary NSA in phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland.
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