Northwire Canada EditionTuesday, August 25, 2026
Northwire
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Regulatory Routine −

Helus Pharma Expresses Support for Executive Order Advancing Psychedelic Research and Regulatory Pathways for Serious Mental Health Conditions

Management Instability Clouds Near-Term Catalysts Despite Strong Cash Position

Executive Summary
  • Management Transition: Michael Cola stepped down as CEO effective April 20, 2026, after only two months in the role (appointed Feb 10). Eric So, Co-founder and Executive Chairman, has resumed the Interim CEO position. The Board is searching for a permanent replacement.
  • Regulatory Support: Helus Pharma issued support for a new White House Executive Order accelerating psychedelic research and FDA review pathways for Breakthrough Therapy designations.
  • Pipeline Status: HLP003 (MDD) remains in Phase 3 with data expected Q4 2026. HLP004 (GAD) completed Phase 2 Signal Detection in March 2026 with positive results. SPL026 Phase 2a proof-of-concept was published in Nature Medicine in February 2026.
  • Financials: Q3 FY2026 results showed $195.1M cash, net loss of $42.7M, and operating cash outflow of $31.9M as of Dec 31, 2025.
Material Impact
  • Leadership Churn Risk: The departure of Michael Cola after a brief tenure signals potential internal friction or strategic misalignment at a critical juncture (pre-catalyst). While Eric So's return provides operational continuity, the sudden exit raises questions about execution confidence and investor trust. This is not immediately catastrophic but creates sentiment headwinds.
  • Policy Tailwind: The Executive Order support is positive for the sector but does not alter specific company timelines or cash flow. It is a "nice to have" rather than a value driver compared to clinical data.
  • Financial Runway: With $195M cash and ~$32M quarterly burn, the runway is approximately 6 months from Dec 2025. This necessitates capital raising before Q4 2026 HLP003 readout. Management instability complicates investor relations during a potential financing window.
  • Clinical Progress: The March 2026 HLP004 data was positive, but the stock price had already declined significantly prior to the April news (dropping from $8.53 in early March to $4.32 by month-end). This suggests the market may have priced in concerns about burn or execution before the CEO change occurred.
HELP · Price
Company Overview
  • Company: Helus Pharma (rebranded from Cybin Inc. in Feb 2026).
  • Flagship Project: HLP003, a proprietary serotonergic agonist (NSA) for Major Depressive Disorder (MDD).
    • Status: Phase 3 Clinical Development.
    • Designation: FDA Breakthrough Therapy.
    • Catalysts: APPROACH pivotal study topline data expected Q4 2026.
  • Secondary Project: HLP004 for Generalized Anxiety Disorder (GAD).
    • Status: Phase 2 Signal Detection completed March 2026 with positive results (10.4-point HAM-A reduction).
  • Mechanism: Novel serotonergic agonists designed to activate serotonin pathways for neuroplasticity.
Read the original news release →

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