HELUS Pharma Reports Third Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights

Executive Summary

• Helus Pharma reported Q3 2025 unaudited results showing cash of US$195.1 M, net loss of US$42.7 M, and operating cash outflow of US$31.9 M.
• The company highlighted upcoming clinical catalysts: topline data from the HLP004 Phase 2 GAD study expected in Q1 2026 and HLP003 Phase 3 MDD studies (APPROACH & EMBRACE) with topline readout anticipated in Q4 2026.
• Leadership transition completed with Michael Cola appointed CEO, and the firm announced a rebranding to “Helus Pharma” while emphasizing its expanded IP portfolio protecting lead programs through 2041.

Key Details

• Cash Position: US$195.1 M as of Dec 31 2025 (pre‑post‑quarter adjustments).
• Net Loss: US$42.7 M for Q3 2025 vs. US$7.5 M loss in the same quarter FY 2024.
• Cash‑Based Operating Expenses: US$36.7 M (Q3 2025) vs. US$20 M (FY 2024).
• Operating Cash Flow Used: US$31.9 M (Q3 2025) vs. US$18.6 M (FY 2024).

Clinical Pipeline Highlights

• HLP004 (Phase 2 – Generalized Anxiety Disorder): Topline data readout expected Q1 2026.
• HLP003 (Phase 3 – Major Depressive Disorder):
• APPROACH pivotal study – topline data anticipated Q4 2026.
• EMBRACE complementary Phase 3 study – patient enrollment began in prior quarter, supporting efficacy package.
• EXTEND long‑term extension study – ongoing for safety and durability data collection.

Corporate Updates

• Leadership: Michael Cola appointed Chief Executive Officer, completing the transition to a potential commercial‑stage organization.
• Rebranding: Company now operates under the name “Helus Pharma.”
• Intellectual Property: Expanded IP portfolio protecting HLP003 and HLP004 through at least 2041, enhancing strategic flexibility and blocking position.

Notable Quotes

“The third quarter reflects continued disciplined execution across Helus Pharma’s clinical and operational priorities,” said Michael Cola, CEO. “We are advancing a differentiated, multi‑asset neuroscience portfolio… with a strong balance sheet, continued progress across our HLP003 Phase 3 and HLP004 Phase 2 programs…”

Prepared based on the disclosed unaudited Q3 2025 results and business highlights.