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].

他曾任 Shire PLC (“Shire”) 特殊药品业务部前总裁，拥有超过 30 年涵盖神经科学、罕见疾病及特殊药品领域的丰富经验，并曾在 Astra-Merck 与 AstraZeneca PLC 担任高管职务作为领导者，他在中枢神经系统 (“CNS”) 领域项目中，于晚期临床研发、全球商业化及资本筹集方面拥有公认的成功经验此次任命正值 Helus Pharma 推动研发管线迈向关键临床里程碑，包括预计本季度发布的 HLP004 II 期数据与预计今年晚些时候发布的 HLP003 III 期顶线数据 本新闻稿构成该公司于 2025 年 12 月 30 日发布的补充招股书中所指的“指定新闻稿”；该补充招股书作为公司 2025 年 9 月 17 日发布的简式基础储架招股说明书的补充，已于 2025 年 12 月 19 日完成修订。 波士顿和多伦多, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Helus PharmaTM (“Helus”) (Nasdaq: HELP) (Cboe CA: HELP) 是一家临床阶段制药公司，致力于通过开发新型血清素能激动剂 (“NSAs”) 推动心 ...

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].