Commercial And Competitive RiskIntense competition among short‑acting psychedelics, along with reimbursement and pricing pressures and potential future capital needs, could limit market share and pressure valuation even if clinical milestones are met.
Regulatory UncertaintyU.S. IND clearance does not guarantee approval in other jurisdictions, and the proprietary delivery device may face different review standards abroad, creating regulatory uncertainty for global commercialization.
Safety And Durability ConcernsOutstanding toxicology questions tied to animal respiratory histology and severe adverse events reported in the open‑label study raise clinical risks that could require additional safety studies or dosing adjustments.