ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a
leading late clinical-stage cellular therapeutics company focused
on dialysis-free living for those with chronic kidney disease
(CKD), today announced financial results for the second quarter
ended June 30, 2023, and provided an update on recent corporate
developments.
“In the second quarter, and throughout the first half of 2023,
we steadily advanced our REACT development programs, including our
initial Phase 3 study, proact 1, that is assessing
the potential for REACT to delay or halt the progression of
moderate to severe diabetic CKD,” said Dr. Tim Bertram, Chief
Executive Officer of ProKidney. “Looking ahead, we expect to reach
several important inflection points in the coming months, including
updated interim data from our Phase 2 RMCL-002 study in the second
half of 2023, potentially furthering an understanding of the
durability of kidney function preservation found with REACT in
patients with advanced stage CKD. Around the end of 2023, we are
also planning to report on the progress of participants in our
open-label Phase 2 REGEN-007 study of REACT. That study is designed
to elicit visibility into the potential kidney outcomes of our
commercial stage REACT formulation when injected into both kidneys.
We expect that these readouts could provide significant insight
into the potential of REACT to preserve kidney health and delay the
need for dialysis in patients with advanced CKD. With regard to our
maturation toward becoming a commercial stage organization, we
recently took an important step with the purchase of the Greensboro
facility that we expect will expand our future manufacturing
capacity for a potential commercial launch of REACT pending
regulatory approval.”
Recent Corporate Highlights, and REACT® Clinical
Development Updates
- Closed on purchase of a 210,000 square
foot facility and approximately 22 acres of land in Greensboro,
N.C., that will support future potential commercial manufacturing
needs for REACT. Received an incentive package totaling 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.
- 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 sites in the U.S., UK
and select other countries at high risk for progressing to kidney
failure, with initial interim data expected by the end of
2024.
- Continued preparation to initiate
patient enrollment in 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 recently
implemented protocol modifications to reflect the evolving
standard-of-care, ongoing regulatory interactions, and facilitation
of potential commercial access. These modifications include a
long-term (60 month) follow-up period and stratification at
randomization based on CKD stage and SGLT2 or sMRA use. Protocol
allowances have been received in Australia, Belgium, Brazil,
Columbia, France, Italy, Malaysia, Portugal, Singapore, and Spain.
ProKidney expects to commence enrollment in the second half of 2023
with initial interim data expected by the end of 2025.
- Presented a poster on REGEN-007 patient
demographics at the 60th European Renal Association (ERA)
Congress.
Second Quarter 2023 Financial Highlights
Liquidity: Cash, cash equivalents and
marketable securities as of June 30, 2023, totaled $446.1 million,
compared to $490.3 million on December 31, 2022.
R&D Expenses: Research and development
expenses were $26.4 million for the three months ended June 30,
2023, compared to $11.6 million for the same period in 2022. The
increase of $14.8 million was driven primarily by increases in cash
and equity compensation costs of approximately $5.9 million as we
continue to hire additional personnel in the areas of clinical
development, quality, manufacturing, and biostatistics to support
our ongoing clinical trials and look to build our commercial
manufacturing capabilities. Additionally, we have seen increases in
clinical trial costs of approximately $6.2 million related
primarily to our Phase 3 program and our REGEN-007 clinical
trial.
G&A Expenses: General and administrative
expenses were $13.5 million for the three months ended June 30,
2023, compared to $9.2 million for the same period in 2022. The
increase of $4.3 million was primarily driven by increases in legal
fees and insurance costs related to our operation as a public
company coupled with professional fees incurred in connection with
our planned commercial scale manufacturing expansion.
Net Loss Before Noncontrolling Interest: Net
loss before noncontrolling interest was $34.8 million and $22.1
million for the three months ended June 30, 2023, and 2022,
respectively.
Shares outstanding: Class A and Class B
ordinary shares outstanding at June 30, 2023 totaled
235,253,658.
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.
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 Roth / Julia
Weilmanlroth@burnsmc.com / jweilman@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) |
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
243,553 |
|
|
$ |
490,252 |
|
Marketable securities |
|
202,575 |
|
|
|
– |
|
Interest receivable |
|
8,090 |
|
|
|
– |
|
Prepaid assets |
|
4,226 |
|
|
|
2,624 |
|
Prepaid clinical |
|
7,385 |
|
|
|
10,459 |
|
Other current assets |
|
603 |
|
|
|
1,384 |
|
Total current assets |
|
466,432 |
|
|
|
504,719 |
|
|
|
|
|
|
|
Fixed assets, net |
|
14,803 |
|
|
|
10,708 |
|
Right of use assets, net |
|
2,880 |
|
|
|
2,356 |
|
Intangible assets, net |
|
106 |
|
|
|
213 |
|
Total assets |
$ |
484,221 |
|
|
$ |
517,996 |
|
|
|
|
|
|
|
Liabilities and
Shareholders' Deficit/Members' Equity |
|
|
|
|
|
Accounts payable |
$ |
2,832 |
|
|
$ |
3,044 |
|
Lease liabilities |
|
654 |
|
|
|
493 |
|
Accrued expenses and other |
|
20,945 |
|
|
|
7,336 |
|
Income taxes payable |
|
66 |
|
|
|
– |
|
Total current liabilities |
|
24,497 |
|
|
|
10,873 |
|
|
|
|
|
|
|
Income tax payable, net of
current portion |
|
494 |
|
|
|
278 |
|
Lease liabilities, net of
current portion |
|
2,286 |
|
|
|
1,906 |
|
Total liabilities |
|
27,277 |
|
|
|
13,057 |
|
Commitments and
contingencies |
|
|
|
|
|
Redeemable noncontrolling
interest |
|
1,779,198 |
|
|
|
1,601,555 |
|
|
|
|
|
|
|
Shareholders’ deficit /
members' equity: |
|
|
|
|
|
Class A ordinary shares, $0.0001 par value; 500,000,000
shares authorized; 61,590,231 and 61,540,231 issued and
outstanding as of June 30, 2023 and December 31, 2022,
respectively |
|
6 |
|
|
|
6 |
|
Class B ordinary shares, $0.0001 par value; 500,000,000
shares authorized; 173,663,427 and 171,578,320 issued and
outstanding as of June 30, 2023 and December 31, 2022,
respectively |
|
18 |
|
|
|
18 |
|
Additional paid-in capital |
|
30,957 |
|
|
|
7,476 |
|
Accumulated other comprehensive loss |
|
(127 |
) |
|
|
– |
|
Accumulated deficit |
|
(1,353,108 |
) |
|
|
(1,104,116 |
) |
Total shareholders' deficit /
members’ equity |
|
(1,322,254 |
) |
|
|
(1,096,616 |
) |
Total liabilities and shareholders' deficit/members' equity |
$ |
484,221 |
|
|
$ |
517,996 |
|
ProKidney Corp. and
SubsidiariesConsolidated Statements of Operations
and Comprehensive Loss(in thousands, except for
share and per share data) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
26,364 |
|
|
$ |
11,558 |
|
|
$ |
51,981 |
|
|
$ |
40,048 |
|
General and administrative |
|
|
13,455 |
|
|
|
9,180 |
|
|
|
28,714 |
|
|
|
47,152 |
|
Total operating expenses |
|
|
39,819 |
|
|
|
20,738 |
|
|
|
80,695 |
|
|
|
87,200 |
|
Operating loss |
|
|
(39,819 |
) |
|
|
(20,738 |
) |
|
|
(80,695 |
) |
|
|
(87,200 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
5,965 |
|
|
|
– |
|
|
|
11,262 |
|
|
|
– |
|
Interest expense |
|
|
(4 |
) |
|
|
(170 |
) |
|
|
(7 |
) |
|
|
(184 |
) |
Net loss before income taxes |
|
|
(33,858 |
) |
|
|
(20,908 |
) |
|
|
(69,440 |
) |
|
|
(87,384 |
) |
Income tax expense |
|
|
965 |
|
|
|
1,223 |
|
|
|
2,292 |
|
|
|
2,233 |
|
Net loss before noncontrolling interest |
|
|
(34,823 |
) |
|
|
(22,131 |
) |
|
|
(71,732 |
) |
|
|
(89,617 |
) |
Net loss attributable to
noncontrolling interest |
|
|
(25,705 |
) |
|
|
– |
|
|
|
(52,949 |
) |
|
|
– |
|
Net loss available to Class A ordinary shareholders |
|
$ |
(9,118 |
) |
|
$ |
(22,131 |
) |
|
$ |
(18,783 |
) |
|
$ |
(89,617 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average Class A
ordinary shares outstanding: (1) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
64,562,209 |
|
|
|
|
|
|
64,551,281 |
|
|
|
|
Net loss per share
attributable to Class A ordinary shares: (1) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.14 |
) |
|
|
|
|
$ |
(0.29 |
) |
|
|
|
(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) |
|
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating
activities |
|
|
|
|
|
|
Net loss before noncontrolling interest |
|
$ |
(71,732 |
) |
|
$ |
(89,617 |
) |
Adjustments to reconcile net
loss before noncontrolling interest to net cash flows used in
operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,702 |
|
|
|
1,462 |
|
Equity-based compensation |
|
|
24,222 |
|
|
|
60,685 |
|
Gain on marketable securities, net |
|
|
(1,981 |
) |
|
|
– |
|
Loss on disposal of equipment |
|
|
3 |
|
|
|
– |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
Interest receivable |
|
|
(8,090 |
) |
|
|
– |
|
Deferred offering costs |
|
|
– |
|
|
|
(6,905 |
) |
Prepaid and other assets |
|
|
2,256 |
|
|
|
(5,320 |
) |
Accounts payable and accrued expenses |
|
|
12,430 |
|
|
|
(520 |
) |
Income taxes payable |
|
|
282 |
|
|
|
1,730 |
|
Net cash flows used in
operating activities |
|
|
(40,908 |
) |
|
|
(38,485 |
) |
|
|
|
|
|
|
|
Cash flows used in investing
activities |
|
|
|
|
|
|
Purchases of marketable securities |
|
|
(261,847 |
) |
|
|
– |
|
Sales of marketable securities |
|
|
60,768 |
|
|
|
– |
|
Purchase of equipment and facility expansion |
|
|
(4,686 |
) |
|
|
(1,225 |
) |
Net cash flows used in
investing activities |
|
|
(205,765 |
) |
|
|
(1,225 |
) |
|
|
|
|
|
|
|
Cash flows from financing
activities |
|
|
|
|
|
|
Payments on finance leases |
|
|
(26 |
) |
|
|
(16 |
) |
Borrowings under related party notes payable |
|
|
– |
|
|
|
35,000 |
|
Net cash contribution |
|
|
– |
|
|
|
6,050 |
|
Net cash flows (used in)
provided by financing activities |
|
|
(26 |
) |
|
|
41,034 |
|
|
|
|
|
|
|
|
Net change in cash and cash
equivalents |
|
|
(246,699 |
) |
|
|
1,324 |
|
Cash, beginning of period |
|
|
490,252 |
|
|
|
20,558 |
|
Cash, end of period |
|
$ |
243,553 |
|
|
$ |
21,882 |
|
|
|
|
|
|
|
|
Supplemental disclosure of
non-cash investing activities: |
|
|
|
|
|
|
Right of use assets obtained in exchange for lease obligations |
|
$ |
714 |
|
|
$ |
878 |
|
Impact of equity transactions and compensation on redeemable
noncontrolling interest |
|
$ |
380 |
|
|
$ |
– |
|
Change in redemption value of noncontrolling interest |
|
$ |
230,209 |
|
|
$ |
– |
|
Equipment and facility expansion included in accounts payable
and accrued expenses |
|
$ |
689 |
|
|
$ |
529 |
|
ProKidney (NASDAQ:PROK)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
ProKidney (NASDAQ:PROK)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024