competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; 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 geo-political conflict 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.
Investor Contacts:
ProKidney
Ethan Holdaway
Ethan.Holdaway@prokidney.com
LifeSci Advisors, LLC
Daniel Ferry
Daniel@lifesciadvisors.com
ProKidney Corp. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except for share data)
September 30, 2024 December 31, 2023
(Unaudited)
-------------------- -------------------
Assets
Cash and cash
equivalents $ 108,088 $ 60,649
Marketable securities 298,724 302,301
Interest receivable 5,102 1,375
Prepaid assets 6,227 3,399
Prepaid clinical 11,053 6,413
Other current assets 1,031 9
---------------- ---------------
Total current assets 430,225 374,146
Fixed assets, net 38,519 42,143
Right of use assets, net 6,049 4,263
Total assets $ 474,793 $ 420,552
================ ===============
Liabilities and
Shareholders' Deficit
Accounts payable $ 2,850 $ 5,098
Lease liabilities 1,067 803
Accrued expenses and
other 21,264 17,665
Income taxes payable -- 1,472
---------------- ---------------
Total current
liabilities 25,181 25,038
Income tax payable, net of
current portion 772 568
Lease liabilities, net of
current portion 5,372 3,610
---------------- ---------------
Total liabilities 31,325 29,216
Commitments and
contingencies
Redeemable noncontrolling
interest 1,423,180 1,494,732
Shareholders' deficit
Class A ordinary shares,
$0.0001 par value;
500,000,000 shares
authorized; 127,920,274
and 59,880,347 issued
and outstanding as of
September 30, 2024 and
December 31, 2023,
respectively 13 6
Class B ordinary shares,
$0.0001 par value;
500,000,000 shares
authorized; 163,741,676
and 168,297,916 issued
and outstanding as of
September 30, 2024 and
December 31, 2023,
respectively 16 17
Additional paid-in
capital 199,509 36,114
Accumulated other
comprehensive (loss)
gain 321 130
Accumulated deficit (1,179,571) (1,139,663)
---------------- ---------------
Total shareholders' deficit (979,712) (1,103,396)
---------------- ---------------
Total liabilities and
shareholders' deficit $ 474,793 $ 420,552
================ ===============
ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2024 2023 2024 2023
------------ ----------- ----------- -----------
Operating expenses
Research and
development $ 31,250 $ 32,198 $ 87,887 $ 84,179
General and
administrative 17,723 14,419 44,218 43,133
----------- ---------- ---------- ----------
Total operating
expenses 48,973 46,617 132,105 127,312
Operating loss (48,973) (46,617) (132,105) (127,312)
Other income
(expense):
Interest income 5,580 5,541 14,960 16,803
Interest expense (2) (2) (7) (9)
----------- ---------- ---------- ----------
Net loss
before income
taxes (43,395) (41,078) (117,152) (110,518)
Income tax
(benefit) expense (2,342) 913 (2,300) 3,205
----------- ---------- ---------- ----------
Net loss before
noncontrolling
interest (41,053) (41,991) (114,852) (113,723)
----------- ---------- ---------- ----------
Net loss
attributable to
noncontrolling
interest (23,143) (31,007) (74,944) (83,956)
----------- ---------- ---------- ----------
Net loss
available to
Class A ordinary
shareholders $ (17,910) $ (10,984) $ (39,908) $ (29,767)
=========== ========== ========== ==========
Weighted average
Class A ordinary
shares
outstanding:
Basic and
diluted 126,173,463 61,592,876 87,818,229 61,565,298
Net loss per share
attributable to
Class A ordinary
shares:
Basic and
diluted $ (0.14) $ (0.18) $ (0.45) $ (0.48)
=========== ========== ========== ==========
ProKidney Corp. and Subsidiaries
Consolidated Statements of Cash Flows - Unaudited
(in thousands)
Nine Months Ended September 30,
2024 2023
------------------ --------------
Cash flows from operating
activities
Net loss before
noncontrolling interest $ (114,852) $ (113,723)
Adjustments to reconcile net
loss before noncontrolling
interest to net cash flows
used in operating
activities:
Depreciation and
amortization 3,858 2,707
Equity-based compensation 22,424 37,216
Gain on marketable
securities, net (5,521) (3,675)
Impairment charges 5,324 --
Loss on disposal of
equipment 186 21
Changes in operating
assets and liabilities
Interest receivable (3,728) (714)
Prepaid and other assets (8,489) 5,094
Accounts payable and
accrued expenses (114) 7,774
Income taxes payable (1,268) 615
-------------- -------------
Net cash flows used in
operating activities (102,180) (64,685)
Cash flows from investing
activities
Purchases of marketable
securities (277,291) (301,701)
Sales and maturities of
marketable securities 286,625 100,187
Purchase of equipment and
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