ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT) for Diabetic CKD and Provides Corporate Updates - Seite 2

Pablo Legorreta, Chairman of ProKidney’s Board of Directors, said “We are excited to report more mature interim data for ProKidney’s RMCL-002 Phase 2 study which suggests that REACT was able to preserve kidney function for up to 30 months in a meaningful proportion of the patients treated in the study. When I got involved with ProKidney, I hoped that if REACT could slow the decline of kidney function in a meaningful proportion of patients, it could become an important and differentiated therapy. It is exciting to see that REACT appears to have exceeded my expectations of preservation of kidney function in this population that faces significant unmet medical needs.”

Focusing ongoing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy. Based on these emerging results, the Company plans to update its ongoing proact 1 Phase 3 clinical study (REGEN-006) protocol to focus on patients with higher risk of kidney failure. In the proact 1 Phase 3 clinical study we will modify the eGFR enrollment range from the current range of ≥20 to ≤ 50 ml/min/1.73m² to a new range of ≥20 to ≤ 35 ml/min/1.73m², to focus on the most severe patients, to better align with RMCL-002 results and clinical feedback. The Company does not intend to modify the eGFR enrollment range for its second Phase 3 trial, proact 2 (REGEN-016), which is currently ≥20 to ≤ 44 ml/min/1.73m². Maintaining the eGFR enrollment range of proact 2, which includes the CKD Stage 3B population, will enable the Company to seek a broader commercial label. The modification to the eGFR enrollment range to our proact 1 Phase 3 clinical study will cause a delay in enrollment of this study, and we expect to resume enrollment during the first half of 2024.

ProKidney to temporarily pause manufacturing to address Qualified Person Audit - No safety events are responsible for this pause. A recent audit performed by the Company’s contracted qualified person (QP) to evaluate its readiness for release and distribution of REACT to the EU, while still in process, identified certain deficiencies in the documentation of the quality management systems to be addressed prior to release and distribution of product for EU clinical sites. Many of these improvements to GMP systems and control activities were ongoing but had not yet been completed at the time of the audit.