ProKidney Corp. announced updated positive interim diabetic CKD data from its RMCL-002 Phase 2 study that support the company?s evolution into late-stage development and position the Company to change the treatment paradigm in high-risk diabetic CKD patients with its REACT® (rilparencel) renal autologous cell therapy. Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.

Updated interim REACT RMCL-002 study data support continued investigation of REACT?s potential to benefit patients with moderate and high-risk diabetic CKD. The updated data include information from 83 patients enrolled in the RMCL-002 study. All patients had Stage 3 or 4 CKD caused by type 2 diabetes.

The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints. The dataset revealed a safety profile in line with previous Phase 1 & 2 REACT trials, with REACT showing a safety profile similar to that of a kidney biopsy. Overall, the updated Phase 2 trial data showed preservation of kidney function in several patient groups with advanced CKD caused by type 2 diabetes, with the most notable potential benefit shown in patients who had the highest risk of kidney failure (CKD Stage 4 with severe albuminuria), where there remains a significant unmet clinical need.

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 it 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 it proact 1 Phase 3 clinical study will cause a delay in enrollment of this study, and it expect to resume enrollment during the first half of 2024.

The company 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.

The company is temporarily pausing manufacturing until the first half of 2024, while the company optimizes its capabilities to meet EU and global standards for its Phase 3 program and future commercial manufacturing. The Company will work to implement these manufacturing and documentation improvements concurrently with the 006 pause for protocol changes such that it expects proact 1 will resume, and proact 2 will commence enrollment in the first half of 2024.