No Product Revenue And Widening LossesThe company remains unprofitable with no product revenue and rapidly increasing net losses. Persistent, large negative earnings and cash consumption mean the business cannot self-fund operations long-term without successful approval, commercialization or sustained external financing.
Rising Debt And LeverageMaterial increase in debt and higher leverage reduces financial flexibility and raises refinancing, interest and covenant risks. Coupled with ongoing cash burn, rising indebtedness increases dependence on capital markets and the potential for dilutive financing if commercial milestones are delayed.
Manufacturing-related Approvability Uncertainty (Catalent Indiana)Regulatory classification of the Catalent Indiana facility remains unresolved and was the core issue in the prior CRL. Until classified favorably, approvability and European timing remain conditional, posing a sustained execution risk that could delay or constrain launch and revenue realization.