PROK

• Introduced new CEO Dr. Bruce Culleton, who has over 25 years of experience in kidney disease treatment. • Provided update on REACT-002 Phase II data, showing REACT has a safety profile similar to kidney biopsy and potential to preserve kidney function in higher-risk CKD patients. • Modified Phase III program proact 1 to focus on patients with eGFR 20-35 ml per minute (previously 20-50) to align with Phase II results. • Paused manufacturing to address EU qualified person audit deficiencies in quality management systems documentation. • Outlined clinical trial milestones, including completion of Phase II 002 patient visits by end of 2023 and anticipation of full results in first half of 2024, and updates on Phase II 007 and Phase III proact 1/2 trials.

• Proact 1 enrollment delay expected to resume in first half of 2024. • Manufacturing expected to resume in first half of 2024. • Anticipates completion of proact 1 and proact 2 Phase III trials in 2027. • Phase II 007 interim results expected mid-2024, final results in first half of 2025.

No specific product segment financial performance with revenue contribution % discussed as the transcript does not detail breakdown by product segments.

• Manufacturing pause due to EU qualified person audit identifying deficiencies in quality management systems documentation, which must be addressed prior to product release and distribution to EU clinical sites.

Q: For patients already enrolled in proact 1 above 35 eGFR, what happens?

A: Will continue to follow them and they'll be part of final analysis for FDA.

Q: Why delay in proact 1 enrollment?

A: To enrich with higher-risk patients and pause manufacturing for system improvements.

Q: Durability of REACT treatment effect?

A: Data suggests potential benefit may tail off, but more insights from Phase III program.

Q: Impact of GLP-1 treatments on REACT activity?

A: Unclear yet, need to wait for published data.

Q: Number of enrolled patients not meeting new criteria?

A: Over 80 enrolled in proact 1, ~50 expected to meet new criteria.

Q: Benefit in stage 4 patients?

A: REACT shows impressive preservation of eGFR in stage 4 patients with high UACR, and there's high interest from clinicians and patients due to lack of alternatives.

Q: How many patients needed for proact 1?

A: Targeting 600 new incremental patients meeting new criteria.