ProKidney Appoints Bruce Culleton, MD, as Executive Vice President, Clinical Development and Commercialization
July 17 2023 - 6:05AM
ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the
“Company”), a leading late clinical-stage cellular therapeutics
company focused on chronic kidney disease (CKD), today announced
the appointment of Bruce Culleton, MD, as Executive Vice President,
Clinical Development and Commercialization. Dr. Culleton, who will
report to Chief Executive Officer Tim Bertram, joins ProKidney
after more than two decades in industry and academia with a primary
focus on kidney health.
Tim Bertram, Chief Executive Officer of
ProKidney, said: “I am thrilled to welcome Bruce to the ProKidney
team. His extensive experience in the identification and management
of CKD and development of novel solutions for CKD patients will be
invaluable as we continue advancing the development of REACT®
toward a potential commercial launch. I look forward to working
closely with Bruce to optimally position each of our ongoing
clinical studies for successful outcomes and preparing for
ProKidney’s anticipated shift to a commercial organization.”
Dr. Culleton joins ProKidney from CVS Kidney
Care, a wholly owned subsidiary of CVS Health, where he was most
recently Vice President and General Manager. Previously, he served
as Vice President and Chief Medical Officer at CVS Kidney Care.
Before joining CVS Health, he was Vice President, Global Clinical
Development and World Wide Vice President, Medical Affairs,
Medication and Procedural Solutions at Becton Dickinson; and
previously Vice President, Renal Therapeutic Area at Baxter
Healthcare. Prior to beginning his industry career in 2007, Dr.
Culleton was a Clinical Associate Professor, Department of Medicine
at the University of Calgary.
Dr. Culleton holds a Bachelor’s degree in
Medical Science and a Doctor of Medicine degree from Memorial
University of Newfoundland; and a Master’s degree in Business
Administration from Northwestern University, Kellogg School of
Management. He completed a specialization in Internal Medicine and
Nephrology through the Royal College of Physicians and Surgeons of
Canada, as well as a fellowship in Clinical Epidemiology at Boston
University, Framingham Heart Study.
Dr. Culleton added, “With Phase 3 clinical
development well underway and initial interim data expected in late
2024, ProKidney is rapidly approaching an important inflection
point. I am excited to work with Tim and the rest of the team as we
continue advancing our mission of improving the lives of patients
with CKD.”
About ProKidneyProKidney, a
pioneer in the treatment of CKD through innovations in cellular
therapy, was founded in 2018 after a decade of research.
ProKidney’s lead product candidate, REACT® (Renal Autologous
Cell Therapy), is a first-of-its-kind, patented, proprietary
autologous cellular therapy with the potential to preserve kidney
function in patients at high risk of kidney failure. Late-stage CKD
patients, Stage 3b - 4, are a key target population 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 that launched in January 2022. For
more information, visit www.prokidney.com.
Forward-Looking StatementsThis
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, the size and potential growth of
current or future markets for the Company’s products, if approved,
the advancement of the Company’s development programs into and
through the clinic and the expected timing for reporting data, the
making of regulatory filings or achieving other milestones related
to related to the Company’s product candidates, and the advancement
and funding of the Company’s developmental programs generally. 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 fact that
interim results from our clinical programs may not be indicative of
future results; the impact of COVID-19 or geo-political conflict
such as the war in Ukraine on the Company’s business; and other
risks and uncertainties included under the heading “Risk Factors”
in the Company’s most recent Annual Report on Form 10-K, subsequent
Quarterly Reports on Form 10-Q and other 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.
Contacts:
Corporate:Glenn Schulman,
PharmD, MPHSVP, Investor Relationsglenn.schulman@prokidney.com
Investors:Burns McClellanLee
Roth / Julia Weilmanlroth@burnsmc.com / jweilman@burnsmc.com
Media:Burns McClellanSelina
Husain / Robert Flamm, Ph.D.shusain@burnsmc.com /
rflamm@burnsmc.com
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