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 -
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.
Amid growing clinical need and increasing regulatory support, our late-stage programs are poised to potentially transform the mental health treatment landscape. This is an exciting time at Helus Pharma as we execute toward key clinical, regulatory and strategic milestones.
Helus Pharma Reports Third Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights
- Cash position of US$195 million as of December 31, 2025, before adjustment for post quarter events - - Topline data readout from the Phase 2 study evaluating HLP004 in generalized anxiety disorder (“GAD”) expected in Q1 2026 -
“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.”
Cybin Reports Second Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights
- Closed registered direct offering for aggregate gross proceeds of US$175 million (the “Registered Direct Offering”) led by a syndicate of prominent biopharmaceutical institutional investors -
- On track to report topline data from Phase 2 study evaluating CYB004 for the treatment of Generalized Anxiety Disorder (“GAD”) in Q1 20261 -
- Continues to advance Phase 3 studies of CYB003 for the adjunctive treatment of major depressive disorder (“MDD”) -
Cybin Reports Important Progress on Key Milestones and First Quarter Fiscal Year 2026 Financial Results
Cybin continues to make significant progress on its journey to bring breakthrough therapies to patients by delivering on the following key milestones
- Received European and United Kingdom Medical and Healthcare Products Regulatory Agency (“MHRA”) approval for EMBRACE, the Company’s second pivotal study evaluating CYB003 for the adjunctive treatment of Major Depressive Disorder (“MDD”) on schedule -
- EMBRACE study to enroll 330 participants at approximately 60 clinical sites across the United States, United Kingdom, Europe, and Australia1 -
