This news release constitutes a "designated news release" for the purpose of the Company's prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025.
BOSTON and TORONTO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- HELUS PharmaTM (NASDAQ:HELP) (Cboe CA: HELP), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists ("NSAs"), today reported unaudited financial results for its third quarter ended December 31, 2025, and recent business highlights.
"The third quarter reflects continued disciplined execution across Helus Pharma's clinical and operational priorities," said Michael Cola, Chief Executive Officer of Helus Pharma. "We are advancing a differentiated, multi-asset neuroscience portfolio with programs spanning multiple stages of development and indications. With a strong balance sheet, continued progress across our HLP003 Phase 3 and HLP004 Phase 2 programs, and a focus on scalable, repeatable clinical architectures, Helus Pharma is well positioned as we move toward upcoming clinical catalysts and long-term value creation."
Recent Business and Pipeline Highlights:
Leadership transition completed with the appointment of Michael Cola as Chief Executive Officer to lead the Company's transition to a potential first commercial product launch.
Continued advancement of HLP003, the Company's lead proprietary NSA, through its Phase 3 clinical development program for the adjunctive treatment of major depressive disorder ("MDD"), including ongoing activities across both the APPROACH™ and EMBRACE™ pivotal studies and the EXTEND long-term extension study.
Continued progress in the HLP004 Phase 2 program for GAD, with study activities supporting an upcoming topline data readout in Q1 2026.¹
Executed the rebranding to "Helus Pharma".
Reframed the Company's focus on engineered serotonergic agonists designed for controlled pharmacokinetics and potential future commercial scalability, which management of the Company believes more appropriately reflects the Company's transition from a clinical stage entity to a potential commercial stage pharmaceutical company.
Continued expansion and defense of the Company's intellectual property portfolio supporting multiple programs and indications and providing protection around lead programs HLP003 and HLP004 until at least 2041, reinforcing long-term differentiation, strategic flexibility and potential blocking position within the field.
Upcoming Milestones and Catalysts¹
HLP004 Phase 2 Program in Generalized Anxiety Disorder
Anticipated topline data readout from the Phase 2 study evaluating HLP004 in GAD in Q1 2026.
HLP003 Phase 3 Program in Major Depressive Disorder
Continued execution of the APPROACH™ pivotal Phase 3 study evaluating HLP003 as an adjunctive treatment for MDD with topline data anticipated in Q4 2026.
Continued execution of the EMBRACE™ complementary Phase 3 study, which initiated patient enrollment in the prior quarter, designed to reinforce efficacy findings and support the overall evidence package for HLP003 in MDD.
Ongoing patient participation ...
