Clinical Trial RisksRisks include, but are not limited to: failure of KPI-012 in clinical trials, failure to obtain regulatory approval, and potential dilution risk.
Funding RisksManagement expects current capital together with anticipated funding under the CIRM award to fund operations into 4Q25, suggesting potential financial constraints beyond this period.
Regulatory Approval UncertaintyThe Phase 2b CHASE trial of KPI-012 could potentially serve as the first of two pivotal trials required for a Biologics License Application (BLA) submission, indicating uncertainty until further trials are completed.