Core Insights - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026 for major depressive disorder, showing significant reductions in depressive symptoms compared to placebo [2][3][7] Study Results - The study met its primary endpoint with a mean difference in MADRS score of -7.35 at two weeks, indicating a statistically significant reduction in depressive symptoms [3][7] - Participants treated with SPL026 showed reductions in symptoms as early as one week, with effects lasting up to six months in some cases [3][4] - Response rates for SPL026 were 35% compared to 12% for placebo, and remission rates were 29% versus 12% [4][7] Treatment Efficacy - A single 21.5 mg dose of SPL026 was well tolerated, with no serious adverse events reported [3][4] - The treatment effects were comparable to other longer-duration interventions, suggesting potential cost-effectiveness [4][5] Future Developments - Helus Pharma is advancing HLP004, another proprietary serotonergic agonist, with topline data expected from its Phase 2 study in generalized anxiety disorder in Q1 2026 [5][11] - Insights from the SPL026 trial are informing the development of HLP004, which aims to optimize pharmacology and scalability [5][11] Company Overview - Helus Pharma is focused on developing novel serotonergic agonists to address unmet needs in mental health, including depression and anxiety [10][11] - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12]

Core Viewpoint - Helus Pharma is advancing its clinical programs with a strong financial position and is well-positioned for upcoming clinical milestones, particularly in the treatment of mental health disorders [2][3]. Financial Highlights - As of December 31, 2025, the company reported cash totaling US$195.1 million before adjustments for post-quarter events [7]. - The net loss for the quarter ended December 31, 2025, was US$42.7 million, compared to a net loss of US$7.5 million in the same period last year [16]. - Cash-based operating expenses for the quarter were US$36.7 million, up from US$20 million in the same period last year [16]. Business and Pipeline Highlights - The company is focused on a differentiated neuroscience portfolio, with ongoing clinical programs HLP003 in Phase 3 for major depressive disorder and HLP004 in Phase 2 for generalized anxiety disorder [3][8]. - Upcoming topline data readout from the Phase 2 study evaluating HLP004 in generalized anxiety disorder is expected in Q1 2026 [5]. - The HLP003 Phase 3 program continues with pivotal studies APPROACH™ and EMBRACE™, with topline data anticipated in Q4 2026 [9]. Leadership and Strategic Focus - A leadership transition has been completed with the appointment of Michael Cola as CEO, aimed at leading the company towards a potential first commercial product launch [8]. - The company has rebranded to "Helus Pharma" and is focusing on engineered serotonergic agonists designed for controlled pharmacokinetics and potential commercial scalability [8]. Intellectual Property and Market Position - Helus Pharma is expanding and defending its intellectual property portfolio, which supports multiple programs and provides protection for lead programs HLP003 and HLP004 until at least 2041 [8].