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R HELUS PHARMA Helus Pharma Highlights Clinical Program Advancements at Investor Presentation Held on October 21 , 2026 October 21 , 2026 Topline data readout from APPROACH Phase 3 study of HLP003 in development for the potential adjunctive treatment of major depressive disorder ( " MDD " ) on track for Q4 2026 1,2 HLP004 Program progressing with Phase 2 monotherapy study for the potential treatment of generalized anxiety disorder ( " GAD " ) expected to initiate in Q1 20271,2,3 -- This news release constitutes a “ designated news release " for the purpose of the Company's prospectus supplement dated December 30 , 2025 , to its short form base shelf prospectus dated September 17 , 2025 , as amended on December 19 , 2025 . NEW YORK and TORONTO , Oct. 21 , 2026 ( GLOBE NEWSWIRE ) Helus Pharma Inc. ( Nasdaq : HELP ) ( Cboe CA : HELP ) ( " Helus Pharma " or the " Company " ) , a clinical - stage pharmaceutical company committed to improving the treatment landscape in mental health through the development of novel serotonergic agonists ( " NSAs " ) , today provided highlights on the advancement of its lead programs HLP003 and HLP004 as detailed in the investor presentation held by the Company on October 21 , 2026 ( the " Investor Presentation " ) . The Company reiterated that HLP003 APPROACH Phase 3 topline data readout is on track for Q4 20261,2 and provided an overview of the competitive landscape and commercial opportunity in the adjunctive treatment of MDD . The Company also shared details of the next HLP004 Phase 2 monotherapy study for the potential treatment of GAD , which is expected to initiate in Q1 2027.1,2,3 " The continued advancement of our two lead candidates represents an important period for Helus Pharma , with several key catalysts anticipated in the near term . We remain focused on achieving our key development milestones and advancing these programs towards regulatory approval and potential commercialization , positioning the Company for its next stage of growth , " said Michael Halstead , Chief Executive Officer of Helus Pharma . The Company previously announced completion of enrollment of 223 participants in its APPROACH Phase 3 pivotal study in July 2026. Enrollment is continuing in EMBRACE , the second pivotal study in the Phase 3 HLP003 program . Eligible participants from APPROACH and EMBRACE may also roll into EXTEND , Helus Pharma's long - term extension study , which is designed to further evaluate safety , durability of clinical effect and the potential role of redosing . Adjunctive therapy is a well - established treatment approach for patients who do not achieve an adequate response to first - line anti - depressants . However , available U.S. Food and Drug Administration ( " FDA " ) approved adjunctive treatment options remain limited and are often associated with tolerability and safety challenges that can impact long - term use . The Company believes that HLP003 may offer a differentiated approach that can build upon the benefits of a patient's existing antidepressant regimen with a potentially favorable safety profile . HLP003 has been granted Breakthrough Therapy Designation by the FDA , which makes HLP003 eligible for an expedited review pathway , with the potential to reduce drug development timelines . Helus Pharma expects to file a New Drug Application with the FDA in 2028. 1,2 In GAD , FDA - approved treatment options remain limited , and approximately half of patients do not respond to initial therapy . 4 The Company believes that this significant unmet need supports the evaluation of HLP004 as a potential monotherapy treatment . Accordingly , the Company's upcoming Phase 2 study will assess the efficacy of two 30 mg administrations of HLP004 as monotherapy in adults with GAD . The study will be a multi - center , randomized , double - blind , placebo - controlled study , evaluating the efficacy and safety of HLP004 versus inactive placebo in adult patients with GAD . The study will enroll adult participants using the Diagnostic and Statistical Manual of Mental Disorders fifth edition primary diagnosis of GAD , who have a minimum Hamilton Anxiety Rating Scale ( " HAM - A " ) total score of ≥ 20 at screening and baseline . Approximately 144 participants will be randomized in a 1 : 1 ratio to either 30 mg of HLP004 or inactive placebo . The primary endpoint and key secondary endpoint are change from baseline in HAM - A total score at Week 6 and Week 12 , respectively . During the presentation , Amir Inamdar , Chief Medical Officer of Helus Pharma , highlighted the key evidence that supported the selection of 30 mg as the optimum dose for further development in a monotherapy GAD study . In addition to Helus Pharma executives , the Investor Presentation featured distinguished key opinion leaders , who shared