Healthcare
Helus Pharma Reports Recent Business Highlights and Fiscal Year 2026 Financial Results
- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial1,2,3, EMBRACE, for potential U.S. FDA New Drug Application in 20281,2,3 - - Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”) has surpassed 88% enrollment and is on track for topline data readout in Q4 20262,3 - - HLP003 Phase 2 data demonstrated durability at 12 months following two 16mg doses,
About this update from Hongli Group Inc.
- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial1,2,3, EMBRACE, for potential U.S. FDA New Drug Application in 20281,2,3 - - Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder ("MDD") has surpassed 88% enrollment and is on track for topline data readout in Q4 20262,3 - - HLP003 Phase 2 data demonstrated durability at 12 months following two 16mg doses, with 100% response and 71% remission based on a MADRS benchmark of ≤10, with remission rising to 100% based on recent peer benchmarks of ≤124,5 - - Reported topline results in Phase 2 signal detection study for HLP004 in Generalized Anxiety Disorder ("GAD") showing ~10-point improvement from baseline in HAM-A on top of Standard of Care at 6 weeks - - The Company intends to complete design of next HLP004 study by the end of Q3 20262,3 - - Strengthened scientific and medical leadership with addition of globally recognized experts in clinical development, translational science, and medical affairs - 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, June 29, 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 audited financial results for its fiscal year ended March 31, 2026, and recent business highlights. Unless otherwise noted, all dollar amounts are expressed in United States dollars. "Over the past year, Helus Pharma has strengthened its position as a segment-leading, clinical-stage pharmaceutical company, advancing HLP003 toward a critical Phase 3 readout in Q4 2026 and progressing HLP004 to its next study design by the end of Q3 2026," said Eric So, Interim Chief Executive Officer of Helus Pharma. "We are pleased to report that our Phase 3 APPROACH study has surpassed 88% enrollment, with recruited participants at approximately the same level of baseline severity as in Phase 2," continued Mr. So. "With topline data anticipated later this year, Helus Pharma is at an in...