Positive Outlook

• Remain on-track to submit an application for conditional marketing authorization for FSGS in Europe later this year.
• Adjusted U.S. timelines for FSGS and look forward to our upcoming Type A meeting with the FDA to further our collaborative discussions on the potential to stay on an accelerated approval pathway.
• Looking forward to the upcoming topline results from our Phase 3 PROTECT Study of sparsentan in IgA nephropathy, which if successful, would contribute to the growing body of evidence for sparsentan in rare kidney disorders, and potentially support submissions for accelerated approval in the U.S. and conditional marketing authorization in Europe.
• The DUPLEX Study is fully enrolled and is scheduled to continue as planned on a blinded basis to assess the confirmatory estimated glomerular filtration rate (eGFR) endpoint after 108 weeks of treatment.
• Completed enrollment in the highest currently planned dosing cohort in the ongoing Phase 1/2 dose escalation study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of pegtibatinase in patients with classical HCU.

Challenges Ahead