ProKidney Announces Closing of Purchase of Manufacturing Facility in Greensboro, NC
18 Julho 2023 - 7:05AM
ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the
“Company”), a leading late clinical-stage cellular therapeutics
company focused on preserving kidney function in patients suffering
from chronic kidney disease (CKD), today announced it has closed on
its purchase of a 210,000 square foot facility and approximately 22
acres of land in Greensboro, N.C. ProKidney paid approximately
$25.5 million in cash for the facility and property. The Company
plans to make investments in the facility through 2028 to prepare
for potential commercial-scale manufacturing of REACT®, its
proprietary
REnal
Autologous
Cell
Therapy, currently in Phase
3 development for the treatment of diabetic CKD.
In connection with the purchase, the city of
Greensboro, N.C., Guilford County, N.C. and the North Carolina
State Economic Investment Committee have approved incentive
packages under which ProKidney is eligible to receive, in
aggregate, up to approximately $33.7 million in tax credits, as
well as up to $1.9 million in energy credits from Duke Energy.
Receipt of these incentives is based upon the achievement of
certain milestones, including the creation of at least 330 new jobs
on or before December 31, 2028, and project investment of
approximately $458 million made, or caused to be made, by the
company in real and personal property by December 31, 2027.
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 and expected cash runway, 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 the Company’s product candidates, the
advancement and funding of the Company’s developmental programs
generally, the realization of incentives under the purchase
agreement, and expectations with respect to the Company’s future
manufacturing capabilities. Most of these factors are outside of
the Company’s control and are difficult to predict. Factors that
may cause actual results to differ from the Company’s expectations
include, but are not limited to: market conditions; 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 clearances or approvals for its
products, and any related restrictions and limitations of any
cleared or approved products; 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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