Conditioning Regimen ChallengesShift to a fludarabine/cyclophosphamide conditioning regimen was prompted by prior incomplete B-cell depletion, indicating earlier protocol limitations that may complicate efficacy interpretation and require further adjustments.
Financial Performance PressureA reported quarterly net loss underscores ongoing operating losses that could heighten funding needs or dilute valuation if additional capital is required.
Safety SignalsReports of deep B-cell aplasias in patients create material safety concerns that could lead to increased monitoring, protocol modifications, or regulatory attention.