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ProKidney reports Q4 EPS (11c), consensus (24c)
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ProKidney reports Q4 EPS (11c), consensus (24c)

Cash and cash equivalents as of December 31 were $490.3M, compared to $20.6M on December 31, 2021. "Throughout 2022, we made great progress in our mission to develop and provide a treatment with the potential to preserve kidney function in patients with late-stage CKD who are at high risk for kidney failure," said Dr. Tim Bertram, Chief Executive Officer of ProKidney. "The first of two pivotal Phase 3 trials of REACT(R) is progressing with enrollment, as are several ongoing Phase 2 clinical studies, while the second Phase 3 trial continues to advance toward enrollment. Moreover, our accomplishments over the past year leave us well positioned to deliver on multiple potential value-creating milestones in 2023, including interim data from REGEN-007, our open-label Phase 2 study designed with contralateral kidney injections to provide visibility into potential outcomes of our global Phase 3 program. We remain actively engaged with the FDA, facilitated by REACT’s RMAT designation, to ensure that the steps we are taking today are positioning REACT for future success. We continue to believe that our balance sheet, strengthened by the more than $500 million in net proceeds from our PIPE financing in July 2022, will be sufficient to fund operations through 2024 when we expect to report topline data from proact1 which, if positive, could help support a future BLA submission for potential U.S. regulatory approval." Dr. Joseph Stavas, SVP and Head of Global Clinical Development, Safety and Interventional Procedures, added, "We have meaningfully advanced the execution of our clinical development strategy, including regular interactions with the physician community at key medical congresses, aimed at broadening awareness of REACT among physicians. We look forward to advancing our REACT clinical trials, and to reporting additional data as it becomes available."

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