Core Viewpoint - Helus Pharma announced positive results from a Phase 2a clinical trial of SPL026, a novel serotonergic agonist for treating major depressive disorder, demonstrating significant reductions in depressive symptoms compared to placebo [2][3][7]. Study Results - The Phase 2a trial met its primary endpoint, showing a mean difference of -7.35 in MADRS scores at two weeks for SPL026 compared to placebo, with a p-value of 0.023 [3][7]. - Significant reductions in depressive symptoms were observed as early as one week post-dosing, with effects lasting up to six months in some participants [3][4]. - Response rates for SPL026 were 35% at Week 2, compared to 12% for placebo, while remission rates were 29% for SPL026 versus 12% for placebo [4][7]. Treatment Safety and Efficacy - SPL026 was generally well tolerated, with no serious treatment-related adverse events reported [3][4]. - The study involved 34 participants with a mean age of 32.8 years, predominantly white, who had experienced depression for an average of 10.5 years [8]. Future Developments - Helus Pharma plans to advance HLP004, another proprietary NSA, for generalized anxiety disorder, with topline data expected in Q1 2026 [5][11]. - The findings from the SPL026 trial support the potential of short-acting serotonergic agonists in mental health treatments, reinforcing the company's strategy for developing novel serotonergic agonist molecules [5][7]. Company Overview - Helus Pharma is a clinical-stage pharmaceutical company focused on developing proprietary NSAs aimed at addressing mental health conditions such as depression and anxiety [10][11]. - The company operates in multiple regions, including Canada, the United States, the United Kingdom, and Ireland [12].

Randomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint demonstrating a clinically significant reduction in depressive symptoms as measured by MADRS score (mean difference: -7.35) versus placebo at two weeksAntidepressant treatment effects observed within one week and sustained for up to three months Findings reinforce the therapeutic potential of short-acting serotonergic agonists and inform Helus Pharma’s HLP004 development program, with Phase 2 topline data in generalized anxiety ...

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].

Core Viewpoint - Helus Pharma has appointed Michael Cola as CEO at a pivotal moment for the company, as it advances its next-generation mental health therapies and approaches critical clinical milestones [2][3]. Company Developments - Helus Pharma is progressing its clinical pipeline, with HLP004 Phase II data expected to be released this quarter and HLP003 Phase III topline data anticipated in Q4 2026 [2][6]. - The company has submitted over 350 patent applications globally and has received more than 100 patents, indicating a strong intellectual property portfolio [2]. - Helus Pharma is focused on addressing severe mental health disorders through differentiated projects and is transitioning from early clinical development to late-stage execution [2][6]. Leadership Appointment - Michael Cola brings over 30 years of experience in neuroscience, rare diseases, and specialty pharmaceuticals, making him a suitable leader for Helus [3][4]. - Cola's previous achievements include transforming Shire into a leader in the CNS field and significantly increasing its market value from $5 billion to $20 billion [4][5]. - Cola has also held leadership roles in various companies, contributing to successful clinical transitions and product launches [5][6]. Company Background - Helus Pharma, established in 2019, focuses on developing proprietary new serotonin agonists (NSAs) aimed at improving mental health recovery [8]. - The company is currently developing two proprietary NSAs: HLP003, in Phase III for major depressive disorder, and HLP004, in Phase II for generalized anxiety disorder [8]. - Helus Pharma aims to address the significant unmet treatment needs of patients with depression, anxiety, and other mental health disorders [8].

Core Viewpoint - Helus Pharma has appointed Michael Cola as CEO to lead the company through pivotal clinical milestones in its mental health therapy pipeline, focusing on novel serotonergic agonists [2][3][4]. Company Overview - Helus Pharma, a clinical stage pharmaceutical company, is dedicated to developing novel serotonergic agonists aimed at treating mental health disorders such as depression and anxiety [8][9]. - The company has filed over 350 patent applications globally and holds more than 100 granted patents, indicating a strong intellectual property position [3]. Leadership Appointment - Michael Cola's appointment as CEO is seen as crucial for advancing Helus's pipeline, particularly with upcoming Phase 2 data for HLP004 and Phase 3 topline data for HLP003 [3][6]. - Cola has over 30 years of experience in neuroscience and pharmaceuticals, having previously led significant growth initiatives at Shire and other companies [4][5]. Clinical Development - Helus is advancing HLP003, which is in Phase 3 for major depressive disorder and has received Breakthrough Therapy Designation from the FDA, and HLP004, currently in Phase 2 for generalized anxiety disorder [9]. - The company aims to improve treatment outcomes for serious mental health disorders through its differentiated pipeline of NSAs [9]. Market Position and Strategy - The company is focused on global regulatory engagement and long-term commercial planning as it transitions from early clinical development to later-stage execution [3]. - Cola's leadership is expected to enhance the company's ability to translate scientific advancements into effective therapies and shareholder value [4][5].