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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