Helus Pharma Highlights Clinical Program Advancements at Investor Presentation Held on October 21, 2026

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. asserted

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”). asserted

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. asserted

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. asserted

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. asserted

The Company previously announced completion of enrollment of 223 participants in its APPROACH Phase 3 pivotal study in July 2026. asserted

Enrollment is continuing in EMBRACE, the second pivotal study in the Phase 3 HLP003 program. asserted

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. uncertain

Adjunctive therapy is a well-established treatment approach for patients who do not achieve an adequate response to first-line anti-depressants. asserted

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. asserted

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. uncertain

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. asserted

Helus Pharma expects to file a New Drug Application with the FDA in 2028. asserted

In GAD, FDA-approved treatment options remain limited, and approximately half of patients do not respond to initial therapy.4 asserted

The Company believes that this significant unmet need supports the evaluation of HLP004 as a potential monotherapy treatment. asserted

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. asserted

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. asserted

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. asserted

Approximately 144 participants will be randomized in a 1:1 ratio to either 30 mg of HLP004 or inactive placebo. asserted

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. asserted

In addition to Helus Pharma executives, the Investor Presentation featured distinguished key opinion leaders, who shared perspectives on the current and evolving landscape in depression and anxiety treatment. asserted

Featured key opinion leaders included: - Rakesh Jain, M.D., MPH, Clinical Professor Department of Psychiatry, at Texas Tech University School of Medicine. - Martha B. Koo, M.D., FASAM, FCTMSS, LFAPA, Board-certified psychiatrist, addiction specialist, psychoanalyst, and certified psychedelic-assisted therapist. - Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology at the University of Toronto. Presentation materials and the webcast of the Investor Presentation are available on the Company’s website on the Events & Presentations page. About Helus Pharma Helus Pharma is a clinical stage pharmaceutical company committed to improving the treatment landscape in mental health through the development of NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. asserted

The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions. asserted

Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the potential adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the FDA and HLP004, also a proprietary NSA in Phase 2 for GAD. asserted

Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs. asserted

The Company operates in Canada, the United States, the United Kingdom, and Ireland. asserted

Notes - There is no assurance that this timeline will be met or that the program will advance clinical trials, at all. asserted

Drug development involves long lead times, is very expensive and involves many variables of uncertainty. asserted

Anticipated timelines regarding drug development and recruitment of patients for participation in clinical trials are dependent on various factors and are based on reasonable assumptions informed by current knowledge and information available to the Company. asserted

Such statements are informed by, among other things, eligibility and exclusion criteria for the trial, design of the clinical trial, competition with other companies for clinical sites or patients, perceived risks and benefits of the prescription drug product candidate, the number, availability, location and accessibility of clinical trial sites, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date. asserted

- There is no assurance that timelines will be met. asserted

Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. asserted

- The Company had previously disclosed that the HLP004 Program was being developed as an adjunctive therapy for GAD. asserted

This program is now being developed as a monotherapy. asserted

The decision to pursue a monotherapy development strategy reflects the Company’s assessment of the current GAD treatment landscape, including the limited availability of new treatment options and limitations associated with currently approved monotherapies. asserted

Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks, uncertainties, and other important factors which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. uncertain

These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. uncertain

Forward-looking statements in this news release include statements regarding the Company’s plans to readout topline APPROACH Phase 3 study data in Q4 2026; initiate next Phase 2 HLP004 monotherapy study in Q1 2027; roll eligible participants from APPROACH and EMBRACE into the EXTEND long-term extension study; the Company’s belief that HLP003 may offer a differentiated approach that can build upon the benefits of a patient’s existing antidepressant regimen with a favorable safety profile; file a New Drug Application with the FDA in 2028; leverage FDA Breakthrough Therapy Designation towards expedited review and resulting reduced drug development timelines; obtain regulatory review or approval; enroll approximately 144 eligible participants in the Company’s next Phase 2 GAD monotherapy study; commercialize the Company’s programs following receipt of regulatory approval and the related competitive landscape; the Company’s next stage of growth; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions, and the timing of any of the foregoing. uncertain

Any forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. asserted

Forward-looking statements involve known and unknown risks, uncertainties, and other important factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. uncertain