Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs), has announced two key appointments aimed at strengthening its leadership as it advances its pipeline toward commercialization. The company named Regina Donohue as Chief People Officer and appointed Suresh Durgam, M.D., to its Scientific Advisory Board (SAB).
Donohue brings extensive experience in human resources and organizational development, having most recently served as Chief Human Resources Officer at Intra-Cellular Therapies. During her tenure, she built the company's people strategy and infrastructure, managing its growth to over 1,000 employees as it transitioned into a commercial-stage organization. Notably, Intra-Cellular was acquired by Johnson & Johnson in April 2025, underscoring the value of her contributions to scaling a biopharmaceutical company.
Durgam, a seasoned expert in central nervous system (CNS) drug development, joins the SAB with more than two decades of experience across clinical development, medical affairs, regulatory strategy, and pharmacovigilance. He previously served as Executive Vice President and Chief Medical Officer at Intra-Cellular, where he played a pivotal role in securing FDA approvals for CAPLYTA across multiple indications. His deep regulatory and clinical expertise is expected to provide critical guidance to Helus Pharma's ongoing research and development efforts.
Michael Halstead, CEO of Helus Pharma, commented on the appointments, stating that they strengthen the company's organizational capabilities and scientific leadership as it progresses its pipeline. The strategic additions come at a pivotal time for Helus Pharma, which is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder (MDD). HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential to address a significant unmet medical need. Additionally, the company is advancing HLP004, another proprietary NSA, in Phase 2 trials for generalized anxiety disorder (GAD).
Helus Pharma, formerly known as Cybin Inc., operates under the commercial name Helus Pharma and is dedicated to helping minds heal through the development of synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company's focus on NSAs aims to provide durable improvements in mental health conditions, potentially transforming the treatment landscape for depression, anxiety, and other mental health disorders.
These leadership appointments signal Helus Pharma's commitment to building a robust organizational foundation and enhancing its scientific advisory capabilities. By bringing on individuals with proven track records in scaling biopharmaceutical companies and navigating regulatory approval processes, Helus Pharma is positioning itself for success as it moves closer to potential commercialization. The company's pipeline, if successful, could offer new therapeutic options for patients suffering from major depressive disorder and generalized anxiety disorder, addressing areas where current treatments often fall short.
For more information on Helus Pharma and its pipeline, visit https://ibn.fm/Z7rgQ or access the company's newsroom at https://ibn.fm/HELP.
