Update on Third Party Manufacturing Site

On October 10, 2025, Novo Nordisk informed us that, following the FDA Form 483 issued to Catalent Indiana, LLC (owned by Novo Nordisk) on July 14, 2025, FDA has determined that the inspection classification of this facility is “official action indicated” (OAI). We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA. We plan to share more information during our third quarter 2025 business update call in November.