ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on Chronic Kidney Disease (CKD), announces the appointment of nephrologist Kerry Cooper, M.D. as Senior Vice President of Medical Affairs. Dr. Cooper, who will report to Chief Medical Officer Dr. Libbie McKenzie, joins ProKidney from AstraZeneca, where he was Vice President, U.S. Medical Affairs Renal Division. He led medical teams on nephrology programs, including Lokelma®, and contributed to cross functional teams advancing therapeutics utilized by CKD patients. Dr. Cooper has strong relationships with global kidney advocacy organizations and CKD community leaders.
Dr. Libbie McKenzie, CMO of ProKidney, said: “On behalf of our entire team, I am delighted to welcome Dr. Cooper to ProKidney. His deep experience gained through nearly 40 years in clinical practice and industry will be invaluable as we continue to advance REACT™ through multiple mid- and late-stage clinical studies. He has a wealth of nephrology expertise, both treating patients and leading the development of therapies for CKD, and we look forward to leveraging his extensive capabilities as we enter our next phase of growth and development.”
Prior to joining AstraZeneca in 2018, Dr. Cooper worked at Amgen, where he held positions of increasing responsibility, most recently serving as the Nephrology and Bone Global Medical Affairs Therapeutic Area Lead. During his tenure at Amgen, which began in 2010, Dr. Cooper oversaw multiple clinical trials spanning Amgen’s full portfolio of nephrology assets, and he provided medical leadership for the approval and launch of Parsabiv® for the treatment of hyperparathyroidism in patients with CKD.
Before he began his industry career, Dr. Cooper spent more than 20 years in academia and as a practicing nephrologist. He holds a B.S. from the University of Miami and an M.D. from Yale University School of Medicine. He completed a residency in internal medicine and a fellowship in nephrology at Yale New Haven Hospital. A member of the American Society of Nephrology, International Society of Nephrology, and National Kidney Foundation, Dr. Cooper has authored or co-authored more than 25 peer-reviewed articles.
Dr. Cooper added, “With REACT™, ProKidney has a candidate with the potential to change the landscape of CKD treatment through its potential to reverse the decline in renal function, delay or possibly even prevent kidney failure and the onset of dialysis. I am honored to be joining the talented ProKidney team at such a critical juncture and look forward to contributing to the further advancement of REACT™ as we work toward our collective goal of bringing this novel therapy to the patients who need it.”
About ProKidney
ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT™ (Renal Autologous Cell Therapy), is a first-of-its-kind, patented disease-modifying autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases potentially drive meaningful improvement in kidney function. Late-stage CKD, Stage 3b - 4, is a key target for REACT™ therapy. REACT™ has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program, which launched in January 2022. For more information, visit www.prokidney.com.
About CKD
There are no therapies that effectively reverse late-stage CKD. CKD is a serious diagnosis with significant morbidity and mortality, notable for the 5-year mortality of a new diagnosis of CKD Stage 4 being higher than that of a new non-metastatic cancer diagnosis. CKD most often presents as a progressive decline in kidney function ultimately resulting in the failure of the kidneys and the need for renal replacement therapy, such as hemodialysis, or kidney transplant. One in three Americans is at risk for CKD which currently affects approximately 75 million people in the United States and Europe and over 400 million across Asia.
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. ProKidney’s 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 Company’s expectations with respect to financial results, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, and the size and potential growth of current or future markets for the Company’s products, if approved. Most of these factors are outside of the Company’s 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 Company’s Class A ordinary shares on the Nasdaq; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company’s products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the impact of COVID-19 or geo-political conflict such as the war in Ukraine on the combined company’s business; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
Contact Information
ProKidney:
Investors
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