Clinical and Operational Update
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Effective June 1, 2024, ProKidney resumed manufacturing for U.S. and
non-European clinical study sites |
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Anticipate a potential QP Declaration of Equivalence to EU GMPs to be received by the end of June 2024; this will
allow ProKidney to ship rilparencel to clinical study sites in Europe |
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In its PROACT 1 study, ProKidney has resumed screening patients under an amended protocol that has been enriched
with higher risk patients |
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In its PROACT 2 study, ProKidney recently activated sites in Spain in anticipation of receipt of the QP
Declaration of Equivalence to EU GMPs |
These are critically important operational milestones for ProKidney. Manufacturing has
restarted, and our Phase 3 clinical study program has resumed. Furthermore, the interim results from REGEN-007 are promising and reveal the potential of rilparencel to preserve kidney function in patients with
moderate to severe CKD, said Bruce Culleton, Chief Executive Officer. This is our first clinical study using bilateral kidney dosing and cryopreserved rilparencel replicating our approach in both PROACT 1 and PROACT 2 Phase 3 studies. I
am very excited for the next phase of ProKidneys evolution as we endeavor to demonstrate preservation of kidney function using rilparencel in a patient population with limited therapeutic options.
Webcast Information
Management will host a live
conference call and webcast at 8:00 a.m. ET today, June 10, 2024, to discuss the REGEN-007 data, the restart of manufacturing, and the resumption of the Phase 3 trials. The conference call can be accessed
by dialing 1-877-407-0784 from the United States or 1-201-689-8560 internationally, followed by conference ID: 13747006. The live webcast will be available here and in the Events & Presentation section of ProKidneys website at
www.prokidney.com, with an archived replay available for approximately 90 days following the event.
About ProKidney
ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidneys lead
product candidate, rilparencel (also known as REACT®), is a
first-of-its-kind, patented, proprietary autologous cellular therapy being evaluated to potentially preserve kidney function in
diabetic patients at high risk of kidney failure. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program. For more information, please
visit www.prokidney.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. ProKidneys actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words
such as expect, estimate, project, budget, forecast, anticipate, intend, plan, may, will, could, should,
believes, predicts, potential, continue, and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking
statements include, without limitation, the potential of rilparencel to preserve kidney function in patients with moderate to severe CKD, the potential QP Declaration of Equivalence to EU GMPs, the potential benefits and impact of the Companys
products, if approved, and potential regulatory approvals. Most of these factors are outside of the Companys control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to
maintain the listing of the Companys Class A ordinary shares on the Nasdaq; the inability to implement business