Helus Pharma names Michael Halstead CEO ahead of HLP003 Phase 3 readout
The former Intra-Cellular Therapies president takes over as topline data from the first pivotal study of HLP003 in major depressive disorder are expected in the fourth quarter of 2026.
Helus Pharma, the commercial name of Cybin Inc. (Nasdaq: HELP; Cboe CA: HELP), announced on August 3, 2026 the appointment of Michael Halstead as Chief Executive Officer, effective immediately.1
The move comes as the company moves its lead compound toward a possible launch. Halstead's appointment arrives as Helus Pharma advances HLP003 through late-stage clinical development and prepares for potential commercialization, with enrollment finished in the APPROACH study and topline results due in the fourth quarter of 2026, while a second pivotal trial called EMBRACE, part of the Phase 3 PARADIGM program, continues to enroll patients.1 Participants are also being rolled over into EXTEND, a long-term extension study.1
Halstead's background centers on his most recent role. He brings 25 years of industry experience, most recently as President of Intra-Cellular Therapies, Inc., where he helped move the company from early-stage clinical development to a fully integrated commercial biopharmaceutical business.1 At Intra-Cellular he contributed to the development, launch and commercialization of CAPLYTA (lumateperone), which holds approvals for schizophrenia, bipolar depression and adjunctive treatment of major depressive disorder.1 He also oversaw multiple equity offerings and led Intra-Cellular's $14.6 billion sale to Johnson & Johnson in 2025.1
Earlier in his career, Halstead held senior leadership positions at Warner Chilcott plc, where he oversaw the $3 billion acquisition of Procter & Gamble's pharmaceutical business in 2009 and later the integration of about 2,000 employees, as well as Warner Chilcott's $8.5 billion sale to Actavis in 2013.1
Helus Pharma describes itself as developing HLP003, a proprietary NSA in Phase 3 for adjunctive treatment of MDD that has received Breakthrough Therapy Designation from the FDA, alongside HLP004, a Phase 2 NSA for generalized anxiety disorder.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.