Helus Pharma Prices Underwritten Offering Of 10.3M Shares At $4.85 Per Share; Announces That Enrollment In The APPROACH Phase 3 Clinical Trial Of HLP003 For Adjunctive Treatment Of Major Depressive Disorder Is Progressing As Planned, Surpassing 86...
Cybin, Inc. HELP | 0.00 |
- APPROACH Phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder ("MDD") is progressing as planned and has surpassed 86% enrollment -
- Phase 2 HLP003 data demonstrated long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score compared to baseline at 12 months after two 16 mg doses of HLP003 three weeks apart -
- Previously reported Phase 2 HLP003 results showed response and remission rates of 75% at week 18 and by the 12-month mark, response and remission rates improved to 100% and 71% respectively -
- Previously granted Breakthrough Therapy Designation for HLP003 by the FDA -
- Company remains on track for topline data readout in Q4 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.
– The Offering is expected to close on June 25, 2026 or such other date as may be mutually agreed by the Company and the underwriters. The Offering is subject to customary closing conditions, including approval of Cboe Canada Inc. ("Cboe Canada") and notification of the Offering to the Nasdaq Global Market (the "Nasdaq").
– The Company intends to use the net proceeds from the Offering to progress the Company’s HLP003 for major depressive disorder with Phase 3 APPROACH data expected in the fourth quarter of 2026, HLP004 for generalized anxiety disorder, and HLP005 programs, and for working capital and general corporate purposes.