Helus Pharma Reports First Quarter Fiscal 2027 Financial Results and Recent Business Highlights

– Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization –

– Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline data remain on track for Q4 2026 1 , 2 –

– Completed Drug-Drug Interaction (“DDI”) study demonstrated a favorable DDI profile supporting HLP003 as a potential adjunctive treatment for MDD –

– Continued enrollment in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program –

A welcome email is on its way. If you don't see it, please check your junk folder.

– Continued participant rollover into EXTEND to generate long-term safety and durability data –

– Completed USD$50 million underwritten offering in June 2026, strengthening the balance sheet to support continued execution across the Company’s clinical development programs –

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, Aug. 14, 2026 (GLOBE NEWSWIRE) — Helus Pharma™ (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today reported recent business highlights and financial results for its fiscal quarter ended June 30, 2026. Unless otherwise noted, all dollar amounts are expressed in United States dollars.

“Since joining Helus Pharma, I have been impressed by the quality of the Company’s science, the strength of its development programs, and the team’s disciplined execution,” said Michael Halstead, Chief Executive Officer Helus Pharma. “With enrollment in APPROACH completed and topline data expected in Q4 2026 1, 2 , we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients.”

“Michael brings the strategic leadership, operational experience and commercial perspective needed to guide Helus Pharma through its next phase of growth,” said Eric So, Co-founder and Executive Chairman. “He has quickly earned the team’s confidence and is highly focused on successful execution as we advance HLP003 and HLP004 through important clinical, regulatory and commercial milestones.”

Recently, Helus Pharma completed enrollment in APPROACH, its Phase 3 pivotal study evaluating HLP003 in MDD. Previously reported HLP003 Phase 2 data demonstrated a durable and clinically meaningful treatment effect, including an approximately 23-point reduction in MADRS score from baseline at 12 months following two 16 mg doses administered three weeks apart. Using a MADRS remission benchmark of ≤ 10, response and remission rates at 12 months were 100% and 71%, respectively.