Business
ProKidney Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights
WINSTON-SALEM, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular
About this update from Prokidney Corp.
[{"type":"text","content":"WINSTON-SALEM, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the third quarter ended September 30, 2022, and provided an update on recent corporate developments. “During the third quarter of 2022, we made significant advancement in our mission to improve the lives and outcomes for people with CKD. In July, ProKidney listed on the Nasdaq exchange and raised capital that optimally positions us to meet our anticipated clinical milestones. This capitalization moves us closer to bringing REACT® to patients in need as we report data from ongoing studies of REACT, advance additional studies, and launch our second global Phase 3 study, proact 2 (formerly REGEN-016). We believe that the steps we are taking today will help set the stage for a successful year ahead,” said Dr. Tim Bertram, Chief Executive Officer of ProKidney. Dr. Libbie McKenzie, Chief Medical Officer at ProKidney, commented, “Throughout 2022, we have continued to execute on our clinical development and regulatory strategy, furthering enrollment in our ongoing REACT studies including our first global Phase 3 study, proact 1 (formerly REGEN-006), highlighting the proactive nature of REACT to potentially stabilize or improve kidney function and reduce the risk of kidney failure. Our Phase 2 clinical trial, REGEN-007, remains on track to report interim data by the third quarter of 2023. We are grateful to our investigators, the patients and their caregivers for their continued support and look forward to sharing data as it becomes available.” Corporate Highlights and REACT® Clinical Development Program Received allowance of the proact 1 Phase 3 study protocol for its investigational candidate REACT by the United Kingdom’s (UK) MHRA. This follows submission of a clinical trial application for the proact 1 Phase 3 study protocol previously allowed by the Food & Drug Administration (FDA) in the United States (U.S.), where recruitment is actively underway, and now allows ProKidney to begin patient recruitment at clinical trial sites in the UK beginning in early 2023. Received favorable scientific advice from the European Medicines Agency (EMA) on the adequacy of its Phase 3 development p...