Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs) for mental health conditions, has announced two key appointments aimed at bolstering its organizational and scientific capabilities. The company named Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board (SAB), according to a press release distributed by InvestorWire.
Donohue brings extensive human resources leadership experience, most recently serving as Chief Human Resources Officer at Intra-Cellular, where she built the company's people strategy and infrastructure, managing its growth to more than 1,000 employees as it transitioned into a commercial-stage organization. Intra-Cellular was acquired by Johnson & Johnson in April 2025, underscoring Donohue's track record in scaling companies for commercial success. In her new role at Helus Pharma, she will be responsible for developing the company's talent and culture as it advances its pipeline toward potential commercialization.
Durgam, a veteran in central nervous system (CNS) drug development, joins the SAB with over two decades of experience in clinical development, medical affairs, regulatory strategy, and pharmacovigilance. He most recently 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 expertise will be instrumental in guiding Helus Pharma's regulatory and clinical strategies as the company progresses its lead candidates.
Helus Pharma CEO Michael Halstead emphasized that the appointments strengthen the company's organizational capabilities and scientific leadership as it advances its pipeline. The company is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder (MDD), which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Additionally, HLP004, another proprietary NSA, is in Phase 2 for generalized anxiety disorder (GAD). The company also has an extensive research portfolio of investigational NSAs.
The appointments come at a critical time for Helus Pharma, which is positioning itself to address the large unmet need in mental health treatment. The company's NSAs are designed to activate serotonin pathways believed to promote neuroplasticity, offering potential durable improvements in conditions like depression and anxiety. With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of these novel therapies.
These strategic hires signal a focus on building the infrastructure needed for commercial readiness. Donohue's experience in scaling organizations from clinical to commercial stages will be vital as Helus Pharma prepares for potential product launches. Meanwhile, Durgam's regulatory and clinical expertise will help navigate the complex approval processes for its pipeline candidates.
Industry observers note that the moves reflect a broader trend in the biotech sector, where companies are investing in leadership to transition from research-focused to commercial-stage entities. For Helus Pharma, these appointments could enhance its ability to bring innovative mental health treatments to market, potentially impacting the competitive landscape in CNS therapeutics.
The company, which operates in Canada, the United States, the United Kingdom, and Ireland, continues to advance its mission of helping minds heal. For more information on Helus Pharma, visit www.helus.com.
