Pre-Revenue With Sustained Cash BurnPersistent zero revenue and large negative operating and free cash flow create ongoing financing needs. Over the medium term, continued cash burn can dilute shareholders, constrain R&D choices, and force strategic tradeoffs if clinical or regulatory setbacks delay commercialization.
Manufacturing Compliance Issue Caused CRLA third‑party manufacturing compliance problem that triggered a CRL is a structural execution risk: remediation can be time-consuming, costly, and may require supply‑chain changes. Such issues can materially delay approval and compress the commercial window upon launch.
Revenue Dependent On Regulatory Approval Of OLCThe business model is highly binary: long‑term revenue hinges on one lead candidate achieving regulatory approval and market adoption. This single‑asset dependence increases commercial and regulatory risk, leaving the company vulnerable if OLC fails or faces market access challenges.