ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a
leading late clinical-stage cellular therapeutics company focused
on chronic kidney disease (CKD), today announced financial results
for the first quarter ended March 31, 2023, and provided an update
on recent corporate developments.
“During the first quarter of 2023, we continued to
advance the Phase 3 clinical development of REACT® to assess its
potential to delay, and possibly eliminate, the need for dialysis,
and in parallel we sharpened our plans for manufacturing and
organizational development as we progress toward potential
commercialization,” said Dr. Tim Bertram, Chief Executive Officer
of ProKidney. “Patient enrollment in proact 1
continues according to plan and we target interim data by year end
2024. In addition, we recently completed enrollment in REGEN-007
with a total of 53 subjects randomized into this open-label Phase 2
study evaluating diabetic patients with Stage 3/4 CKD who either
receive bilateral REACT injections three months apart, consistent
with our Phase 3 studies, or receive a single REACT injection with
a second injection upon satisfying certain reinjection criteria.
With enrollment complete, we continue to biopsy, treat, and monitor
patients following administration of REACT, evaluating them as they
progress through the 18-month follow up period. Once 007 data is
sufficiently mature, we plan to conduct an interim analysis and
target a preliminary data report in late 2023.”
James Coulston, Chief Financial Officer at
ProKidney, added, “With approximately $464 million in cash, cash
equivalents and marketable securities as of March 31st of this
year, we remain well capitalized to continue executing on our
clinical, manufacturing, and strategic objectives as we approach
these and other key inflection points. The consistency of the REACT
clinical results achieved to date, coupled with the steady pace at
which the ProKidney team has progressed REACT through development,
gives us confidence in what the future holds both for the platform
and the Company.”
Recent Corporate Highlights, and REACT®
Clinical Development Updates
- Completed enrollment in REGEN-007, an open-label Phase 2 study
evaluating two injections of the cryopreserved REACT product
administered either three months apart or after one or more
re-injection triggers are met, with one injection delivered into
each kidney. The Company anticipates initial data from this study
in late 2023.
- Continued enrolling subjects in proact 1, a
Phase 3 randomized, blinded, sham-controlled study evaluating up to
two doses of REACT given three months apart, with one dose
delivered into each kidney. The study’s target enrollment is 600
patients at high risk for progressing to kidney failure at sites in
the U.S., UK and select other countries, with initial interim data
expected by the end of 2024.
- Preparing for the initiation of patient enrollment into
proact 2, a Phase 3 randomized, blinded,
sham-controlled study to assess the safety and efficacy of up to
two REACT injections, given three months apart, and delivered once
into each kidney, for patients primarily in the EU, Latin America
and Asia Pacific regions. The Company has protocol allowances in
Belgium, France, Singapore, Spain and Austria and expects to
commence enrollment in the second half of 2023.
- Presented three posters supporting the potential of REACT to
preserve kidney function and slow the progression of chronic kidney
disease at the National Kidney Foundation (NKF) Spring Clinical
Meeting 2023 (SCM23).
- Presented two abstracts on patient demographics in the ongoing
REGEN-007 study and the design of the proact 2 study at the World
Congress of Nephrology (WCN).
- Presented data on the safety and feasibility of the Company’s
image-guided injection procedure during an oral abstract session at
the Society of Interventional Radiology (SIR) 2023 Annual
Scientific Meeting.
First Quarter 2023 Financial
Highlights
Liquidity: Cash, cash equivalents
and marketable securities as of March 31, 2023, totaled $463.7
million, compared to $490.3 million on December 31, 2022.
R&D Expenses: Research and
development expenses were $25.6 million for the three months ended
March 31, 2023, compared to $28.5 million for the same period in
2022. The decrease of $2.9 million was driven primarily by
decreases in equity-based payments offset by increases in clinical
trial and cash compensation costs.
G&A Expenses: General and
administrative expenses were $15.3 million for the three months
ended March 31, 2023, compared to $38.0 million for the same period
in 2022. The decrease of $22.7 million was primarily driven by
decreases in equity-based compensation of approximately $26.0
million offset by increases in cash compensation costs as well as
costs related to our operations as a public company.
Net Loss Before Noncontrolling
Interest: Net loss before noncontrolling interest was
$36.9 million and $67.5 million for the three months ended March
31, 2023, and 2022, respectively.
About ProKidneyProKidney, 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, 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.
About CKDCKD is a serious
diagnosis with significant morbidity and mortality. Notably, the
5-year mortality of newly diagnosed Stage 4 CKD is higher than that
of newly diagnosed non-metastatic cancer. 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. CKD is among the largest single expense
incurred by the U.S. health care system.
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 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
RothLroth@burnsmc.com
Media:Burns McClellanSelina Husain / Robert Flamm,
Ph.D.Shusain@burnsmc.com / rflamm@burnsmc.com
ProKidney Corp. and
SubsidiariesConsolidated Balance
Sheets(in thousands, except for share
data)
|
|
|
|
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
271,635 |
|
|
$ |
490,252 |
|
Marketable securities |
|
192,046 |
|
|
|
– |
|
Interest receivable |
|
5,476 |
|
|
|
– |
|
Prepaid assets |
|
4,950 |
|
|
|
2,624 |
|
Prepaid clinical |
|
5,828 |
|
|
|
10,459 |
|
Other current assets |
|
208 |
|
|
|
1,384 |
|
Total current assets |
|
480,143 |
|
|
|
504,719 |
|
|
|
|
|
|
|
Fixed assets, net |
|
11,810 |
|
|
|
10,708 |
|
Right of use assets, net |
|
3,039 |
|
|
|
2,356 |
|
Intangible assets, net |
|
159 |
|
|
|
213 |
|
Total assets |
$ |
495,151 |
|
|
$ |
517,996 |
|
|
|
|
|
|
|
Liabilities and
Shareholders' Deficit/Members' Equity |
|
|
|
|
|
Accounts payable |
$ |
3,801 |
|
|
$ |
3,044 |
|
Lease liabilities |
|
624 |
|
|
|
493 |
|
Accrued expenses and other |
|
6,854 |
|
|
|
7,336 |
|
Total current liabilities |
|
11,279 |
|
|
|
10,873 |
|
|
|
|
|
|
|
Income tax payable, net of
current portion |
|
426 |
|
|
|
278 |
|
Lease liabilities, net of
current portion |
|
2,468 |
|
|
|
1,906 |
|
Total liabilities |
|
14,173 |
|
|
|
13,057 |
|
Commitments and
contingencies |
|
|
|
|
|
Redeemable noncontrolling
interest |
|
2,082,488 |
|
|
|
1,601,555 |
|
|
|
|
|
|
|
Shareholders’ deficit /
members' equity: |
|
|
|
|
|
Class A ordinary shares,
$0.0001 par value; 500,000,000 shares authorized; 61,540,231
issued and outstanding as of March 31, 2023 and December 31,
2022 |
|
6 |
|
|
|
6 |
|
Class B ordinary shares,
$0.0001 par value; 500,000,000 shares authorized;
173,444,861and 171,578,320 issued and outstanding as of March
31, 2023 and December 31, 2022, respectively |
|
18 |
|
|
|
18 |
|
Additional paid-in
capital |
|
21,792 |
|
|
|
7,476 |
|
Accumulated other
comprehensive income |
|
(19 |
) |
|
|
– |
|
Accumulated deficit |
|
(1,623,307 |
) |
|
|
(1,104,116 |
) |
Total shareholders' deficit /
members’ equity |
|
(1,601,510 |
) |
|
|
(1,096,616 |
) |
Total liabilities and shareholders' deficit/members' equity |
$ |
495,151 |
|
|
$ |
517,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ProKidney Corp. and
SubsidiariesConsolidated Statements of Operations
and Comprehensive Loss(in thousands, except for
share and per share data)
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
Research and development |
$ |
25,617 |
|
|
$ |
28,490 |
|
General and administrative |
|
15,259 |
|
|
|
37,972 |
|
Total operating expenses |
|
40,876 |
|
|
|
66,462 |
|
Operating loss |
|
(40,876 |
) |
|
|
(66,462 |
) |
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
Interest income |
|
5,297 |
|
|
|
– |
|
Interest expense |
|
(3 |
) |
|
|
(14 |
) |
Net loss before income taxes |
|
(35,582 |
) |
|
|
(66,476 |
) |
Income tax expense |
|
1,327 |
|
|
|
1,010 |
|
Net loss before noncontrolling interest |
|
(36,909 |
) |
|
|
(67,486 |
) |
Net loss attributable to
noncontrolling interest |
|
(27,244 |
) |
|
|
– |
|
Net loss available to Class A
ordinary shareholders |
$ |
(9,665 |
) |
|
$ |
(67,486 |
) |
|
|
|
|
|
|
Weighted average Class A ordinary
shares outstanding: (1) |
|
|
|
|
|
Basic and diluted |
|
61,540,231 |
|
|
|
|
Net loss per share
attributable to Class A ordinary shares: (1) |
|
|
|
|
|
Basic and diluted |
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
(1) The Company analyzed the calculation of net
loss per share for periods prior to the business combination with
Social Capital Suvretta Holdings Corp. III (the “Business
Combination”), on July 11, 2022 and determined that it resulted in
values that would not be meaningful to the users of the
consolidated financial statements, as the capital structure
completely changed as a result of the Business Combination.
Therefore, net loss per share information has not been presented
for periods prior to the Business Combination.
ProKidney Corp. and
SubsidiariesConsolidated Statements of Cash
Flows(in thousands)
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
2022 |
|
Cash flows from operating
activities |
|
|
|
|
|
Net loss before noncontrolling interest |
$ |
(36,909 |
) |
|
$ |
(67,486 |
) |
Adjustments to reconcile net
loss before noncontrolling interest to net cash flows used in
operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
832 |
|
|
|
710 |
|
Equity-based compensation |
|
13,020 |
|
|
|
52,684 |
|
Gain on marketable securities, net |
|
(492 |
) |
|
|
– |
|
Loss on disposal of equipment |
|
3 |
|
|
|
– |
|
Changes in operating assets and liabilities |
|
|
|
|
|
Interest receivable |
|
(5,476 |
) |
|
|
– |
|
Prepaid and other assets |
|
3,483 |
|
|
|
(3,843 |
) |
Accounts payable and accrued expenses |
|
(601 |
) |
|
|
1,519 |
|
Income taxes payable |
|
148 |
|
|
|
957 |
|
Net cash flows used in operating
activities |
|
(25,992 |
) |
|
|
(15,459 |
) |
|
|
|
|
|
|
Cash flows used in investing
activities |
|
|
|
|
|
Purchases of marketable securities |
|
(198,038 |
) |
|
|
– |
|
Sales of marketable securities |
|
6,412 |
|
|
|
– |
|
Purchase of equipment and facility expansion |
|
(986 |
) |
|
|
(839 |
) |
Net cash flows used in investing
activities |
|
(192,612 |
) |
|
|
(839 |
) |
|
|
|
|
|
|
Cash flows from financing
activities |
|
|
|
|
|
Payments on finance leases |
|
(13 |
) |
|
|
(8 |
) |
Borrowings under related party notes payable |
|
– |
|
|
|
20,000 |
|
Net cash contribution |
|
– |
|
|
|
5,550 |
|
Net cash flows (used in) provided
by financing activities |
|
(13 |
) |
|
|
25,542 |
|
|
|
|
|
|
|
Net change in cash and cash
equivalents |
|
(218,617 |
) |
|
|
9,244 |
|
Cash, beginning of period |
|
490,252 |
|
|
|
20,558 |
|
Cash, end of period |
$ |
271,635 |
|
|
$ |
29,802 |
|
|
|
|
|
|
|
Supplemental disclosure of
non-cash investing activities: |
|
|
|
|
|
Right of use assets obtained in exchange for lease obligations |
$ |
714 |
|
|
$ |
496 |
|
Impact of equity transactions and compensation on redeemable
noncontrolling interest |
$ |
1,352 |
|
|
$ |
– |
|
Change in redemption value of noncontrolling interest |
$ |
509,526 |
|
|
$ |
– |
|
Equipment and facility expansion included in accounts payable
and accrued expenses |
$ |
744 |
|
|
$ |
501 |
|
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