Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 14, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | ProKidney Corp | |
Entity Central Index Key | 0001850270 | |
Securities Act File Number | 001-40560 | |
Entity Tax Identification Number | 98-1586514 | |
Entity Incorporation, State or Country Code | E9 | |
Entity Address, Address Line One | 2000 Frontis Plaza Blvd. | |
Entity Address, Address Line Two | Suite 250 | |
Entity Address, City or Town | Winston-Salem | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27103 | |
City Area Code | 336 | |
Local Phone Number | 999-7028 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Title of 12(b) Security | Class A ordinary shares, $0.0001 par value per share | |
Trading Symbol | PROK | |
Security Exchange Name | NASDAQ | |
Common Class A [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 67,136,714 | |
Common Class B [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 168,297,916 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 191,389 | $ 490,252 |
Marketable securities | 204,945 | 0 |
Interest receivable | 714 | 0 |
Prepaid assets | 4,169 | 2,624 |
Prepaid clinical | 5,203 | 10,459 |
Other current assets | 3 | 1,384 |
Total current assets | 406,423 | 504,719 |
Fixed assets, net | 42,614 | 10,708 |
Right of use assets, net | 2,717 | 2,356 |
Intangible assets, net | 52 | 213 |
Total assets | 451,806 | 517,996 |
Current liabilities | ||
Accounts payable | 4,476 | 3,044 |
Lease liabilities | 676 | 493 |
Accrued expenses and other | 15,464 | 7,336 |
Income taxes payable | 371 | 0 |
Total current liabilities | 20,987 | 10,873 |
Income tax payable, net of current portion | 522 | 278 |
Lease liabilities, net of current portion | 2,109 | 1,906 |
Total liabilities | 23,618 | 13,057 |
Commitments and contingencies | ||
Redeemable noncontrolling interest | 1,520,825 | 1,601,555 |
Shareholders' deficit / members' equity: | ||
Additional paid-in capital | 41,365 | 7,476 |
Accumulated other comprehensive loss | (64) | 0 |
Accumulated deficit | (1,133,962) | (1,104,116) |
Total shareholders' deficit / members equity | (1,092,637) | (1,096,616) |
Total liabilities and shareholders' deficit/members' equity | 451,806 | 517,996 |
Common Class A [Member] | ||
Shareholders' deficit / members' equity: | ||
Common stock value | 6 | 6 |
Common Class B [Member] | ||
Shareholders' deficit / members' equity: | ||
Common stock value | $ 18 | $ 18 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Common Class A [Member] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 61,595,300 | 61,540,231 |
Common stock shares outstanding | 61,595,300 | 61,540,231 |
Common Class B [Member] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 173,839,330 | 171,578,320 |
Common stock shares outstanding | 173,839,330 | 171,578,320 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - Unaudited - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | ||
Operating expenses | |||||
Research and development | $ 32,198 | $ 21,132 | $ 84,179 | $ 61,180 | |
General and administrative | 14,419 | 14,440 | 43,133 | 61,592 | |
Total operating expenses | 46,617 | 35,572 | 127,312 | 122,772 | |
Operating loss | (46,617) | (35,572) | (127,312) | (122,772) | |
Interest income | 5,541 | 1,581 | 16,803 | 1,581 | |
Interest expense | (2) | (29) | (9) | (213) | |
Net loss before income taxes | (41,078) | (34,020) | (110,518) | (121,404) | |
Income tax expense (benefit) | 913 | (75) | 3,205 | 2,158 | |
Net loss before noncontrolling interest | (41,991) | (33,945) | (113,723) | (123,562) | |
Net loss attributable to noncontrolling interest | (31,007) | (22,017) | (83,956) | (22,017) | |
Net loss available to Class A ordinary shareholders | (10,984) | (29,767) | |||
Common Class A [Member] | |||||
Operating expenses | |||||
Net loss available to Class A ordinary shareholders | $ (10,984) | $ (11,928) | $ (29,767) | $ (101,545) | |
Weighted Average Number of Shares Outstanding, Basic | [1] | 61,592,876 | 61,540,231 | 61,565,298 | 61,540,231 |
Weighted Average Number Of Shares Outstanding, Diluted | [1] | 61,592,876 | 61,540,231 | 61,565,298 | 61,540,231 |
Net loss per share attributable to Class A ordinary shares, Basic | [1] | $ (0.18) | $ (0.13) | $ (0.48) | $ (0.13) |
Net loss per share attributable to Class A ordinary shares, Diluted | [1] | $ (0.18) | $ (0.13) | $ (0.48) | $ (0.13) |
[1] (1) The Company analyzed the calculation of net loss per share for periods prior to the Business Combination, as defined in Note 1, 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. The basic and diluted net loss per share attributable to Class A ordinary shareholders for the three and nine months ended September 30, 2022, represents only the period after the Business Combination to September 30, 2022. For more information refer to Note 8. |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - Unaudited - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss including noncontrolling interest | $ (41,991) | $ (33,945) | $ (113,723) | $ (123,562) |
Other comprehensive (loss) income: | ||||
Unrealized gain (loss) on marketable securities | 241 | 0 | (244) | 0 |
Other comprehensive loss | 241 | 0 | (244) | 0 |
Total comprehensive loss including noncontrolling interest | (41,750) | (33,945) | (113,967) | (123,562) |
Less: Total comprehensive loss attributable to noncontrolling interest | (30,829) | (22,017) | (84,136) | (22,017) |
Total comprehensive loss attributable to Class A ordinary shareholders | $ (10,921) | $ (11,928) | $ (29,831) | $ (101,545) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders' Deficit / Members' Equity - Unaudited - USD ($) $ in Thousands | Total | Redeemable Noncontrolling Interest [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Common Class A [Member] | Common Class A [Member] Common Stock [Member] | Common Class B [Member] | Common Class B [Member] Common Stock [Member] | Class A Ordinary Shares [Member] Common Stock [Member] | Class B Ordinary Shares [Member] Common Stock [Member] | Class B Ordinary Shares [Member] Common Stock [Member] Restricted Stock Rights [Member] |
Beginning balance at Dec. 31, 2021 | $ 26,917 | $ 0 | $ (161,510) | $ 186,500 | $ 1,927 | $ 0 | $ 0 | |||||
Beginning balance, shares at Dec. 31, 2021 | 186,500,000 | 0 | 0 | |||||||||
Capital contribution | 6,050 | 6,050 | ||||||||||
Equity-based compensation / payments prior to Business Combination | 63,667 | 63,667 | ||||||||||
Net loss prior to the Business Combination | (93,632) | (93,632) | ||||||||||
Effect of the Business Combination, including net proceeds of shares sold through the PIPE transaction | (1,092,694) | 1,635,829 | (834,574) | $ (186,500) | (71,644) | $ 6 | $ 18 | |||||
Effect of the Business Combination, including net proceeds of shares sold through the PIPE transaction, shares | (18,650,000) | 61,540,231 | 170,723,961 | |||||||||
Equity based compensation after the Business Combination1 | 1,456 | 2,908 | $ 1,456 | |||||||||
Vesting of Class B restricted stock rights, shares | 486,099 | |||||||||||
Exchange of Class B ordinary shares for Class A ordinary shares | 0 | |||||||||||
Net loss after the Business Combination | (7,913) | (22,017) | (7,913) | |||||||||
Net loss attributable to noncontrolling interest | (22,017) | |||||||||||
Net Loss | $ (101,545) | |||||||||||
Impact of equity transactions on redeemable noncontrolling interest | (176) | (176) | (176) | |||||||||
Change in redemption value of noncontrolling interest | 0 | |||||||||||
Net loss including noncontrolling interest | (123,562) | |||||||||||
Ending balance at Sep. 30, 2022 | (1,096,325) | 1,616,896 | 1,456 | (1,097,805) | $ 0 | 0 | $ 6 | $ 18 | ||||
Ending balance, shares at Sep. 30, 2022 | 0 | 171,210,060 | 61,540,231 | 171,210,060 | ||||||||
Beginning balance at Jun. 30, 2022 | 6,537 | 0 | 0 | (251,127) | $ 186,500 | 71,164 | $ 0 | $ 0 | ||||
Beginning balance, shares at Jun. 30, 2022 | 186,500,000 | 0 | 0 | |||||||||
Equity-based compensation / payments prior to Business Combination | 480 | 480 | ||||||||||
Net loss prior to the Business Combination | (4,015) | (4,015) | ||||||||||
Effect of the Business Combination, including net proceeds of shares sold through the PIPE transaction | (1,092,694) | 1,635,829 | (834,574) | $ (186,500) | (71,644) | $ 6 | $ 18 | |||||
Effect of the Business Combination, including net proceeds of shares sold through the PIPE transaction, shares | (186,500,000) | 61,540,231 | 170,723,961 | |||||||||
Equity based compensation after the Business Combination1 | 1,456 | 2,908 | 1,456 | |||||||||
Vesting of Class B restricted stock rights, shares | 486,099 | |||||||||||
Net loss after the Business Combination | (7,913) | (22,017) | (7,913) | |||||||||
Net loss attributable to noncontrolling interest | (22,017) | |||||||||||
Net Loss | (11,928) | |||||||||||
Impact of equity transactions on redeemable noncontrolling interest | (176) | (176) | (176) | |||||||||
Net loss including noncontrolling interest | (33,945) | |||||||||||
Ending balance at Sep. 30, 2022 | (1,096,325) | 1,616,896 | 1,456 | (1,097,805) | $ 0 | $ 0 | $ 6 | $ 18 | ||||
Ending balance, shares at Sep. 30, 2022 | 0 | 171,210,060 | 61,540,231 | 171,210,060 | ||||||||
Beginning balance at Dec. 31, 2022 | (1,096,616) | 1,601,555 | 7,476 | $ 0 | (1,104,116) | $ 6 | $ 18 | |||||
Beginning balance, shares at Dec. 31, 2022 | 61,540,231 | 171,578,320 | ||||||||||
Equity-based compensation | 29,368 | 7,848 | 29,368 | |||||||||
Issuance of Class A ordinary shares, shares | 50,000 | |||||||||||
Vesting of Class B restricted stock rights, shares | 2,266,079 | |||||||||||
Exchange of Class B ordinary shares for Class A ordinary shares | 64 | (64) | 64 | |||||||||
Exchange of Class B ordinary shares for Class A ordinary shares, shares | 5,069 | (5,069) | ||||||||||
Net loss attributable to noncontrolling interest | (83,956) | (83,956) | ||||||||||
Net Loss | (29,767) | (29,767) | (29,767) | |||||||||
Impact of equity transactions on redeemable noncontrolling interest | (4,457) | 4,457 | (4,457) | |||||||||
Change in redemption value of noncontrolling interest | (79) | 79 | (79) | |||||||||
Unrealized loss on marketable securities | (64) | (180) | (64) | |||||||||
Net loss including noncontrolling interest | (113,723) | |||||||||||
Ending balance at Sep. 30, 2023 | (1,092,637) | 1,520,825 | 41,365 | (64) | (1,133,962) | $ 6 | $ 18 | |||||
Ending balance, shares at Sep. 30, 2023 | 173,839,330 | 61,595,300 | 173,839,330 | |||||||||
Beginning balance at Jun. 30, 2023 | (1,322,254) | 1,779,198 | 30,957 | (127) | (1,353,108) | $ 6 | $ 18 | |||||
Beginning balance, shares at Jun. 30, 2023 | 61,590,231 | 173,663,427 | ||||||||||
Equity-based compensation | 10,365 | 2,629 | 10,365 | |||||||||
Vesting of Class B restricted stock rights, shares | 180,972 | |||||||||||
Exchange of Class B ordinary shares for Class A ordinary shares | 64 | (64) | 64 | |||||||||
Exchange of Class B ordinary shares for Class A ordinary shares, shares | 5,069 | (5,069) | ||||||||||
Net loss attributable to noncontrolling interest | (31,007) | (31,007) | ||||||||||
Net Loss | (10,984) | (10,984) | $ (10,984) | |||||||||
Impact of equity transactions on redeemable noncontrolling interest | (21) | (21) | (21) | |||||||||
Change in redemption value of noncontrolling interest | 230,130 | (230,130) | 230,130 | |||||||||
Unrealized loss on marketable securities | 63 | 178 | 63 | |||||||||
Net loss including noncontrolling interest | (41,991) | |||||||||||
Ending balance at Sep. 30, 2023 | $ (1,092,637) | $ 1,520,825 | $ 41,365 | $ (64) | $ (1,133,962) | $ 6 | $ 18 | |||||
Ending balance, shares at Sep. 30, 2023 | 173,839,330 | 61,595,300 | 173,839,330 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss including noncontrolling interest | $ (113,723) | $ (123,562) |
Adjustments to Reconcile Net Income (Loss) to Cash Provided by (Used in) Operating Activities [Abstract] | ||
Depreciation and amortization | 2,707 | 2,245 |
Equity-based compensation | 37,216 | 65,529 |
(Gain) On Marketable Securities, Net | (3,675) | 0 |
Loss on disposal of equipment | 21 | 0 |
Changes in operating assets and liabilities: | ||
Interest Receivable | (714) | 0 |
Prepaid and other assets | 5,094 | (5,810) |
Accounts payable and accrued expenses | 7,774 | (39) |
Income taxes payable | 615 | 309 |
Net cash flows used in operating activities | (64,685) | (61,328) |
Cash flows used in investing activities | ||
Net cash from SCS | 0 | 108 |
Purchases Of Marketable Securities | (301,701) | 0 |
Sales of marketable securities | 100,187 | 0 |
Purchase of equipment and facility expansion | (32,625) | (1,540) |
Net cash flows used in investing activities | (234,139) | (1,432) |
Cash flows from financing activities | ||
Payments on finance leases | (39) | (24) |
Proceeds from Business Combination, including PIPE financing, net of associated costs of $37,856 | 0 | 542,503 |
Borrowings under related party notes payable | 0 | 35,000 |
Repayment of related party notes payable | 0 | (35,000) |
Net cash contribution | 0 | 6,050 |
Net cash flows provided by financing activities | (39) | 548,529 |
Net change in cash and cash equivalents | (298,863) | 485,769 |
Cash, beginning of period | 490,252 | 20,558 |
Cash, end of period | 191,389 | 506,327 |
Supplemental disclosure of non-cash investing activities: | ||
Right of use assets obtained in exchange for lease obligations | 714 | 1,124 |
Exchange of Class B ordinary shares | 64 | 0 |
Impact of equity transactions and compensation on redeemable noncontrolling interest | 3,207 | 3,084 |
Change in redemption value of noncontrolling interest | 79 | 0 |
Equipment and facility expansion included in accounts payable and accrued expenses | $ 1,386 | $ 380 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Proceeds from Business Combination, including PIPE financing, net of associated costs of $37,856 | $ 37,856 | $ 37,856 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | Note 1: Description of Business and Basis of Presentation Description of Business ProKidney Corp. (the “Company” or “ProKidney”) was originally incorporated as Social Capital Suvretta Holdings Corp. III (“SCS”). SCS was a blank check company incorporated as a Cayman Islands exempted company on February 25, 2021 . SCS was incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. On January 18, 2022, SCS executed a definitive business combination agreement (the “Business Combination Agreement”), with ProKidney LP (“PKLP”), a limited partnership under the laws and regulations of Ireland. Pursuant to the terms of the Business Combination Agreement, PKLP became a subsidiary of SCS and was organized in an umbrella partnership corporation (“Up-C”) structure, which would provide potential future tax benefits for SCS when the equity holders ultimately exchanged their pass-through interests for Class A ordinary shares. The transaction closed (the “Closing”) on July 11, 2022 (the “Closing Date”). Upon consummation of the transaction, SCS changed its name to ProKidney Corp. The business combination between SCS and PKLP (the “Business Combination”) resulted in gross proceeds of approximately $ 596,537,000 . This amount reflected a contribution of $ 21,737,000 of cash held in SCS’ trust account, net of redemptions, and a $ 574,800,000 concurrent private placement of Class A ordinary shares of the combined company, priced at $ 10.00 per share (the “PIPE Placement”). Upon close, these proceeds were used to repay the outstanding balance of $ 35,000,000 under PKLP’s two promissory note agreements with certain holders of its Class A Units (the “Promissory Notes”) and related accrued interest. Additionally, the proceeds were used to pay those expenses previously incurred by SCS related to the Business Combination of approximately $ 21,029,000 as well as advisory and placement fees of approximately $ 29,389,000 incurred in connection with the PIPE Placement. The Business Combination was accounted for as a reverse recapitalization transaction between entities under common control, through which PKLP was considered the accounting acquiror and predecessor entity. The Business Combination was reflected as the equivalent of PKLP issuing stock for the net assets of SCS accompanied by a recapitalization with no goodwill or intangible assets recognized. ProKidney Corp., through its operating subsidiaries, ProKidney, which is incorporated under the Cayman Islands Companies Act (as amended) as an exempted company (“ProKidney-KY”) and ProKidney LLC, a limited liability company under the laws of Delaware (“ProKidney-US”) is focused on the development of its Renal Autologous Cell Therapy, which has the potential to preserve kidney function in patients with chronic kidney disease or delay or eliminate the need for dialysis and organ transplantation. Principles of Consolidation ProKidney is a holding company, and its principal asset is a controlling equity interest in PKLP and its wholly-owned operating subsidiaries ProKidney-KY and ProKidney-US. The Company has determined that PKLP is a variable-interest entity for accounting purposes and that ProKidney is the primary beneficiary of PKLP because (through its managing member interest in PKLP and the fact that the senior management of ProKidney is also the senior management of PKLP) it has the power and benefits to direct all of the activities of PKLP, which include those that most significantly impact PKLP’s economic performance. The Company has therefore consolidated PKLP’s results pursuant to Accounting Standards Codification Topic 810, “Consolidation” in its Condensed Consolidated Financial Statements. As of September 30, 2023, various holders own non-voting interests in PKLP, representing a 73.8 % economic interest in PKLP, effectively restricting ProKidney’s interest to 26.2 % of PKLP’s economic results, subject to increase in the future, should ProKidney purchase additional non-voting common units (“PKLP Units”) of PKLP, or should the holders of PKLP Units decide to exchange such units (together with shares of Class B ordinary shares) for Class A ordinary shares (or cash) pursuant to the Exchange Agreement (as defined in Note 6). The Company will not be required to provide financial or other support for PKLP. However, ProKidney will control its business and other activities through its managing member interest in PKLP, and its management is the management of PKLP. Nevertheless, because ProKidney will have no material assets other than its interests in PKLP and its subsidiaries, any financial difficulties at PKLP could result in ProKidney recognizing a loss. All intercompany transactions and balances have been eliminated. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2: Significant Accounting Policies Unaudited Interim Financial Statements The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying Condensed Consolidated Balance Sheet as of September 30, 2023, Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2023 and 2022, Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2023 and 2022, Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity for the three and nine months ended September 30, 2023 and 2022 and Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2023, the results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2022 Condensed Consolidated Balance Sheet included herein was derived from the audited financial statements but does not include all disclosures or notes required by GAAP for complete financial statements. These financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, 2022, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2023, as amended on April 27, 2023. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited consolidated financial statements are presented in U.S. Dollars. Interim results are not necessarily indicative of results for an entire year. Use of Estimates The preparation of unaudited condensed consolidated financial statements, in accordance with GAAP, requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the condensed consolidated financial statements, and the amounts of expenses during the reported periods. Certain estimates in these condensed consolidated financial statements have been made in connection with the calculation of research and development expenses, equity-based compensation expense and the provision for or benefit from income taxes. The Company bases its estimates on historical experience and various other assumptions, including in certain circumstances future projections, which management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known. Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with an original maturity of 90 days or less on the date of purchase to be cash equivalents. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. The Company’s investments in marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as short-term due to its availability for use in its current operations. The cost of securities sold is determined using the specific identification method. The Company considers all available evidence to evaluate if a credit loss exists, and if so, recognizes an allowance for credit loss. Concentrations of Credit Risk Cash and equivalents are the primary financial instruments held by the Company that are potentially subject to concentrations of credit risk. The Company’s cash and equivalents are deposited in accounts at large financial institutions, and such amounts may exceed federally insured limits. Accrued Expenses Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, 2023 December 31, 2022 Compensation $ 3,952 $ 3,355 Clinical study related costs 2,353 1,636 Facility expansion costs 1,860 – Accrued legal costs 1,089 436 Manufacturing improvement costs 4,280 678 Accrued consulting and professional fees 1,006 1,210 Other accrued expenses 924 21 Total accrued expenses and other $ 15,464 $ 7,336 Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, benefits, third party license fees, and external costs of outside vendors engaged to conduct manufacturing and preclinical development activities and clinical trials. The Company records accruals based on estimates of services received, efforts expended, and amounts owed pursuant to contracts with numerous contract research organizations. In the normal course of business, the Company contracts with third parties to perform various clinical study activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variation from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events and the completion of portions of the clinical study or similar conditions. The objective of the Company’s accrual policy is to match the recording of expenses in its financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical studies are recognized based on the company’s estimate of the degree of completion of the event or events specified in the specific clinical study. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss as the Company receives the related goods or services Costs incurred in obtaining technology licenses are charged to research and development expense as purchased in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Generally, expenditures for maintenance and repairs are charged to expense and major improvements or replacements are capitalized. The Company computes depreciation and amortization using the straight-line method over the estimated useful life of the asset. Leasehold improvements are amortized over the lesser of, the life of the lease or the estimated useful life of the leasehold improvement. The estimated useful lives are as follows: Buildings 25 - 30 years Computer equipment and software 3 - 5 years Furniture and equipment 5 - 7 years Leasehold improvements remainder of lease term Fixed assets consisted of the following (in thousands): September 30, 2023 December 31, 2022 Land $ 3,067 $ – Buildings 22,490 – Leasehold improvements 10,867 10,537 Furniture and equipment 3,624 2,376 Computer equipment and software 848 889 Construction in progress 8,487 1,614 Less: accumulated depreciation ( 6,769 ) ( 4,708 ) Total fixed assets, net $ 42,614 $ 10,708 Depreciation expense for the three and nine months ended September 30, 2023 was $ 807,000 and $ 2,084,000 , respectively. Depreciation expense for the three and nine months ended September 30, 2022 was $ 627,000 and $ 1,825,000 , respectively. Intangible Assets Intangible assets are comprised of acquired assembled workforce, which are accounted for in accordance with ASC 350 - Intangibles - Goodwill and Other. The acquired assembled workforce is amortized on a straight-line basis over the useful life of five years. The following table summarizes information related to the Company’s assembled workforce intangible asset (in thousands): September 30, 2023 December 31, 2022 Gross carrying amount $ 1,073 $ 1,073 Accumulated amortization 1,021 860 Net carrying amount $ 52 $ 213 Estimated amortization expense as of September 30, 2023 for the remaining three months of 2023 was $ 47,000 and $ 5,000 for the year ended December 31, 2024. Amortization expense relating to the assembled workforce intangible asset was $ 54,000 and $ 161,000 for each of the three and nine months ended September 30, 2023 and 2022, respectively . Impairment of Long-Lived Assets Long-lived assets such as fixed assets and intangible assets subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. No impairment charges have been recorded for the three and nine months ended September 30, 2023 and 2022 . Income Taxes The Company uses the liability method in accounting for income taxes as required by ASC Topic 740 — Income Taxes, under which deferred tax assets and liabilities are recorded for the future tax consequences attributable to the differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is recorded to reduce the carrying amounts of deferred tax assets unless it is more likely than not that such assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, available taxes in the carryback periods, projected future taxable income and tax planning strategies in making this assessment. Accordingly, the Company has provided a full valuation allowance to offset the net deferred tax assets at September 30, 2023 and December 31, 2022. Interest and penalties related to income taxes are included in the benefit (expense) for income taxes in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company has not incurred any significant interest or penalties related to income taxes in any of the periods presented. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. A three‑level fair value hierarchy that prioritizes the inputs used to measure fair value is described below. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities • Level 2 – Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable through correlation with market data • Level 3 – Unobservable inputs that are supported by little or no market data, which require the reporting entity to develop its own assumptions The carrying values of cash equivalents, accounts payable, and accrued liabilities approximate fair value due to the short‑term nature of these instruments. Leases The Company determines if an arrangement is a lease at inception. Balances recognized related to the Company’s operating and finance leases are included in right-of-use assets, net and lease liabilities in the Condensed Consolidated Balance Sheets. Right of use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Lease terms may include options to extend or terminate the lease if it is reasonably certain that the Company will exercise the option. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The right of use asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has elected a practical expedient to not separate its lease and non-lease components and instead account for them as a single lease component. Leases with a term of 12 months or less are not recorded on the balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Lease payments for short-term leases are recorded to operating expense on a straight-line basis and variable lease payments are recorded in the period in which the obligation for those payments is incurred. Contingent Liabilities The Company records reserves for contingent liabilities when it is probable that an asset has been impaired or a liability has been incurred at the date of the financial statements, and the amount of the loss can be reasonably estimated. Equity-Based Compensation Compensation expense for share-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for those awards earned over the service period on a straight-line basis. The Company records forfeitures of share-based compensation awards as they occur. The grant date fair value of stock option awards is estimated using the Black-Scholes option pricing formula. Due to the lack of sufficient historical trading information with respect to its own shares, the Company estimates expected volatility based on a portfolio of selected stocks of companies believed to have market and economic characteristics similar to its own. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. Due to a lack of historical exercise data, the Company estimates the expected life of its outstanding stock options using the simplified method specified under Staff Accounting Bulletin Topic 14.D.2. Segments The Company operates in only one segment. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 4: Income Taxes ProKidney is considered to be an exempted Cayman Islands company and is presently not subject to income taxes or income tax filing requirements in the Cayman Islands or the United States. The Company’s subsidiary, PKLP, is organized as a limited partnership and is classified as a partnership for U.S. income tax purposes, and as such, only records a provision for federal and state income taxes on its subsidiaries organized as C corporations or which have elected to be treated as corporations for U.S. federal income tax purposes. The Company’s subsidiary, ProKidney-US, is treated as a C corporation, and therefore a provision for federal and state taxes has been recorded. The difference between the Company’s effective tax rates and the U.S. statutory rate of 21 % is primarily attributable to PKLP and ProKidney-KY being treated as partnerships for income tax purposes . The Company’s subsidiary, ProKidney-KY, has been granted, by the Government in Council of the Cayman Islands, tax concessions under an undertaking certificate exempting it from any tax levied on profits, income, gains or appreciations in relation to its operations or in the nature of estate duty or inheritance tax for a period of twenty years from January 20, 2016. ProKidney-KY elected to be treated as an entity disregarded from its owner for U.S. tax purposes, and as a result, it has not recorded an income tax provision. As discussed in Note 6, the Company is party to a tax receivable agreement with a related party which provides for the payment by the Company to holders of PKLP prior to the Closing (“Closing ProKidney Unitholders”) of 85 % of the amount of cash savings, if any, in U.S. federal, state and local income tax or franchise tax that the Company actually realizes (or, in some circumstances, the Company is deemed to realize) as a result of certain transactions. As no transactions have occurred which would trigger a liability under this agreement, the Company has not recognized any liability related to this agreement as of September 30, 2023. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, available taxes in the carryback periods, projected future taxable income and tax planning strategies in making this assessment. There were no net unrecognized tax benefits as of September 30, 2023 which, if recognized, would affect our effective tax rate. We expect none of the gross unrecognized tax benefits will decrease within the next year. There were no significant changes in the Company’s uncertain tax positions during the nine months ended September 30, 2023 . |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 5: Leases The Company has operating leases for real estate (primarily its operating facilities) and certain equipment with various expiration dates. The Company also has one finance lease for certain equipment. Rent expense was $ 276,000 and $ 150,000 , for the three months ended September 30, 2023 and 2022, respectively. For the nine months ended September 30, 2023 and 2022, the Company’s rent expense was $ 736,000 and $ 379,000 , respectively. Cash paid for operating leases during the nine months ended September 30, 2023 , was $ 578,00 0. The following table summarizes the classification of operating and finance lease assets and obligations in the Company's Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 Operating leases: Right of use assets $ 2,558 $ 2,285 Operating lease liabilities, current $ 625 $ 458 Operating lease liabilities, noncurrent 1,991 1,858 Total operating lease liabilities $ 2,616 $ 2,316 Finance leases: Right of use assets $ 159 $ 71 Finance lease liabilities, current $ 51 $ 35 Finance lease liabilities, noncurrent 118 48 Total finance lease liabilities $ 169 $ 83 Maturities of lease liabilities for the Company’s operating and finance leases are as follows as of September 30, 2023 (in thousands): Operating Leases Finance Leases Total 2023 $ 207 $ 16 $ 223 2024 839 62 901 2025 849 32 881 2026 772 22 794 2027 438 22 460 Thereafter 29 40 69 Total lease payments 3,134 194 3,328 Less: imputed interest ( 518 ) ( 25 ) ( 543 ) Present value of lease liabilities $ 2,616 $ 169 $ 2,785 The weighted average remaining lease term for operating leases is 3.7 years, and 4.7 years for finance leases. The weighted average discount rate for operating leases is 9.5 % and 6.6 % for finance leases. |
Investments
Investments | 9 Months Ended |
Sep. 30, 2023 | |
Investments [Abstract] | |
Investments | Note 3: Investments Cash equivalents and marketable securities are measured at fair value and within Level 2 in the fair value hierarchy, because we use quoted market prices to the extent available or alternative pricing sources and models utilizing market observable inputs to determine fair value. The following tables summarize our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2023 (in thousands): Fair Value Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Money market funds Level 2 $ 1,037 $ – $ – $ 1,037 $ 1,037 $ – Time deposits Level 2 30,506 9 ( 17 ) 30,498 – 30,498 Commercial paper Level 2 132,166 35 ( 224 ) 131,977 – 131,977 Government bonds Level 2 12,500 – ( 24 ) 12,476 – 12,476 Corporate debt securities Level 2 30,017 4 ( 27 ) 29,994 – 29,994 Total $ 206,226 $ 48 $ ( 292 ) $ 205,982 $ 1,037 $ 204,945 The following table shows the fair value of the Company’s cash equivalents and marketable securities, by contractual maturity, as of September 30, 2023 (in thousands): September 30, 2023 Due in 1 year or less $ 205,982 Due in 1 year through 5 years – Total $ 205,982 The following table shows fair values and gross unrealized losses recorded to accumulated other comprehensive income, aggregated by category and the length of time that individual securities have been in a continuous loss position as of September 30, 2023 (in thousands): Less than 12 months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Time deposits $ 12,990 $ ( 17 ) $ – $ – $ 12,990 $ ( 17 ) Commercial paper 91,160 ( 224 ) – – 91,160 ( 224 ) Government bonds 12,476 ( 24 ) – – 12,476 ( 24 ) Corporate debt securities 14,989 ( 27 ) – – 14,989 ( 27 ) Total $ 131,615 $ ( 292 ) $ – $ – $ 131,615 $ ( 292 ) The Company holds debt securities of companies with high credit quality and has determined that there was no material change in the credit risk of its debt securities during the nine months ended September 30, 2023. As such, t he Company has no t recognized an allowance for credit losses related to our marketable debt securities during the nine months ended September 30, 2023 and 2022 . |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 6: Related Party Transactions Exchange Agreement On the Closing Date, the Company entered into an exchange agreement with PKLP and certain Closing ProKidney Unitholders (the “Exchange Agreement”) pursuant to which, subject to the procedures and restrictions therein, from and after the waiver or expiration of any contractual lock-up period (including pursuant to the Lock-Up Agreement (as defined below)) the holders of Post-Combination ProKidney Common Units as defined in the Exchange Agreement (or certain permitted transferees thereof) will have the right from time to time at and after 180 days following the Closing to exchange their Post-Combination ProKidney Common Units and an equal number of Class B ordinary shares of the Company on a one-for-one basis for Class A ordinary shares of the Company (the “Exchange”); provided, that, subject to certain exceptions, the Company, at its sole election, subject to certain restrictions, may, other than in the case of certain secondary offerings, instead settle all or a portion of the Exchange in cash based on a volume weighted average price (“VWAP”) of a Class A ordinary share. The Exchange Agreement provides that, as a general matter, a holder of Post-Combination ProKidney Common Units will not have the right to exchange Post-Combination ProKidney Common Units if the Company determines that such exchange would be prohibited by law or regulation or would violate other agreements with the Company and its subsidiaries to which the holder of Post-Combination ProKidney Common Units may be subject, including the Second Amended and Restated ProKidney Limited Partnership Agreement and the Exchange Agreement. Lock-Up Agreement On the Closing Date, the Company, SCS Sponsor III LLC and certain Closing ProKidney Unitholders entered into a lock-up agreement (the “Lock-Up Agreement”). The Lock-Up Agreement contains certain restrictions on transfer with respect to the SCS Sponsor III LLC and the Closing ProKidney Unitholders party thereto. Such restrictions begin at the Closing and end on the earlier of (i) the date that is 180 days after the Closing and (ii)(a) for 33% of the Lock-Up Shares (other than the Earnout Shares and the PIPE Shares), the date on which the last reported sale price of a Class A ordinary share of the Company equals or exceeds $12.50 per share for any 20 trading days within any 30-trading day period commencing at least 30 days after the Closing and (b) for an additional 50% of the Lock-Up Shares (other than the Earnout Shares and the Private Placement Shares (as each such term is defined in the Lock-Up Agreement)), the date on which the last reported sale price of a Class A ordinary share of the Company equals or exceeds $15.00 per share for any 20 trading days within any 30-trading day period commencing at least 30 days after the Closing. Notwithstanding the above, (i) the lock-up period for any Earnout Shares will expire not earlier than 180 days after such Earnout Shares are issued ; (ii) 50% of the Lock-Up Shares held by certain Closing ProKidney Unitholders and their affiliates will remain locked up until the earlier of four years following the Closing and the date that PKLP receives notice of any regulatory market authorization, including full or conditional authorization, to market its lead product candidate, Renal Autologous Cell Therapy (but, in any event, not earlier than 180 days following the Closing or (in the case of Earnout Shares) the date of issuance); and (iii) the lock-up period for the Private Placement Shares expired 30 days after the Closing. The restrictions on transfer set forth in the Lockup Agreement are subject to customary exceptions. During January 2023, the lock-up period for 50 % of the shares held by the Closing ProKidney Unitholders (other than the Earnout Shares) expired. Tax Receivable Agreement On the Closing Date, the Company entered into a tax receivable agreement (the “Tax Receivable Agreement”) with the Closing ProKidney Unitholders. Pursuant to the Tax Receivable Agreement, among other things, the Company will be required to pay the Closing ProKidney Unitholders party thereto 85 % of certain tax savings recognized by the Company, if any, as a result of the increases in tax basis attributable to exchanges by the Closing ProKidney Unitholders of Post-Combination ProKidney Common Units for Class A ordinary shares of the Company or, subject to certain restrictions, cash, pursuant to the Exchange Agreement and certain other tax attributes of PKLP and tax benefits related to entering into the Tax Receivable Agreement. Earnout Rights At the Closing, certain shareholders were issued an aggregate of 17,500,000 Earnout Restricted Common Units and 17,500,000 Earnout Restricted Stock Rights (collectively, the “Earnout Rights”). The Earnout Rights vest in three equal tranches if, during the five-year period after Closing, the VWAP of a Class A ordinary share reaches $ 15.00 per share, $ 20.00 per share and $ 25.00 per share. Likewise, the Earnout Rights will vest upon a change of control with a per share price exceeding those same VWAP thresholds within a five-year period immediately following the Closing. Upon vesting, the Earnout Rights will automatically convert into Post Combination ProKidney Common Units and Class B ordinary shares. Related Party Debt On January 18, 2022, in connection with the execution of the Business Combination Agreement, the Company entered into the Promissory Notes. Through the Promissory Notes, the holders could fund up to $ 100,000,000 to support the operational financing needs of the Company prior to the Closing. These notes bore interest at a rate of 3 % per annum and were due upon the earliest of either (i) the date on which the Business Combination closed or (ii) January 17, 2023. During the nine months ended September 30, 2022, the Company borrowed $ 35,000,000 under the Promissory Notes . During the three and nine months ended September 30, 2022, the Company recognized interest expense of $ 27,000 and $ 207,000 , respectively related to the Promissory Notes. The amounts due under the Promissory Notes were paid, and the Promissory Notes were effectively terminated, upon Closing as described in Note 1. Consulting Services Agreement between ProKidney-KY and Nefro Health On January 1, 2020, ProKidney-KY (formerly known as inRegen) entered into a consulting services agreement with Nefro Health (“Nefro”), an Irish partnership controlled and majority-owned by Mr. Pablo Legorreta, a director of the Company, ProKidney GP Limited, a private limited company incorporated under the laws of Ireland (“ Legacy GP”) and a holder of over 5% of Class A Units in PKLP, pursuant to which Nefro provides consulting services for the research and development of the Company’s product candidates, including the conduct of clinical trials in North America and the European Union, the design and manufacturing of ProKidney’s product candidates as well as pre-commercialization activities, which are primarily performed by Mr. Legorreta. Under the agreement, Nefro receives $ 25,000 per quarter and is reimbursed for any out-of-pocket expenses incurred in connection with activities Nefro conducted under the agreement. ProKidney-KY has paid Nefro an aggregate of $ 25,000 and $ 75,000 for the each of the three and nine month periods ended September 30, 2023 and 2022, respectively. The initial term of the consulting services agreement continued through December 31, 2020 and was renewed pursuant to the provision allowing for automatic renewals for additional periods of one year each unless terminated by either party by providing written notice to the other party at least ninety (90) days prior to the scheduled termination date. Either party may terminate this agreement upon the occurrence of a material breach by the other party in the performance of its obligations under the agreement or in respect of any provision, representation, warranty or covenant if such breach has not been cured within thirty (30) days after receiving written notice from the non-breaching party. Additionally, either of the parties may terminate the consulting services agreement for any reason upon giving thirty (30) days’ advance notice of such termination to the other party. In the event of such termination, ProKidney-KY will be obligated to pay Nefro any earned but unpaid consulting fee as of the termination date. Consulting Services Agreement between ProKidney-US and Nefro Health On January 1, 2020, ProKidney-US (formerly known as Twin City Bio, LLC) entered into a consulting services agreement with Nefro, pursuant to which Nefro provides consulting services for the research and development of the Company’s product candidates, including the conduct of clinical trials in North America and the European Union, the design and manufacturing of the Company’s product candidates as well as pre-commercialization activities, which are primarily performed by Mr. Legorreta. Under the agreement, Nefro receives $ 25,000 per quarter and is reimbursed for any out-of-pocket expenses incurred in connection with activities Nefro conducted under the agreement. ProKidney-US has paid Nefro an aggregate of $ 25,000 and $ 75,000 for each of the three and nine month periods ended September 30, 2023 and 2022, respectively. The initial term of the consulting services agreement continued through December 31, 2020 and was renewed pursuant to the provision allowing for automatic renewals for additional periods of one year each unless terminated by either party by providing written notice to the other party at least ninety (90) days prior to the scheduled termination date. Either party may terminate this agreement upon the occurrence of a material breach by the other party in the performance of its obligations under the agreement or in respect of any provision, representation, warranty or covenant if such breach has not been cured within thirty (30) days after receiving written notice from the non-breaching party. Additionally, either of the parties may terminate the consulting services agreement for any reason upon giving thirty (30) days’ advance notice of such termination to the other party. In the event of such termination, ProKidney-US will be obligated to pay Nefro any earned but unpaid consulting fee as of the termination date. |
Redeemable Noncontrolling Inter
Redeemable Noncontrolling Interest | 9 Months Ended |
Sep. 30, 2023 | |
Noncontrolling Interest [Abstract] | |
Redeemable Noncontrolling Interest | Note 7: Redeemable Noncontrolling Interest The Company is subject to the Exchange Agreement with respect to the Post-Combination ProKidney Common Units representing the outstanding 73.8 % noncontrolling interest in PKLP (see Note 1). The Exchange Agreement requires the surrender of an equal number of Post-Combination ProKidney Common Units and Class B ordinary shares for (i) Class A ordinary shares on a one-for-one basis or (ii) cash (based on the fair market value of the Class A ordinary shares as determined pursuant to the Exchange Agreement), at the Company’s option (as the managing member of PKLP), subject to customary conversion rate adjustments for share splits, share dividends and reclassifications. The exchange value is determined based on a five-day VWAP of the Class A ordinary shares as defined in the Exchange Agreement, subject to customary conversion rate adjustments for share splits, share dividends and reclassifications. The redeemable noncontrolling interest is recognized at the higher of (1) its initial fair value plus accumulated earnings/losses associated with the noncontrolling interest or (2) the redemption value as of the balance sheet date. At September 30, 2023, the redeemable noncontrolling interest was recorded based on its initial fair value plus accumulated losses associated with the noncontrolling interest which was higher than the redemption value as of the balance sheet date. Changes in the Company’s ownership interest in PKLP while the Company retains its controlling interest in PKLP are accounted for as equity transactions, and the Company is required to adjust noncontrolling interest and equity for such changes. The following is a summary of net income attributable to the Company and transfers to noncontrolling interest (in thousands): For the Three Months Ended September 30, 2023 For the Nine Months For the Period from July 11, 2022 through September 30, 2022 Net loss available to Class A ordinary shareholders $ ( 10,984 ) $ ( 29,767 ) $ ( 7,913 ) (Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of 2,629 7,848 2,908 (Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange ( 64 ) ( 64 ) – (Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of 21 ( 4,457 ) 176 Change from net loss available to Class A ordinary shareholders and change $ ( 8,398 ) $ ( 26,440 ) $ ( 4,829 ) |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Note 8: Net Loss per Share Basic net loss per share is calculated by dividing net loss attributable to Class A ordinary shareholders by the weighted-average shares of Class A ordinary shares outstanding without the consideration for potential dilutive securities. Diluted net loss per share represents basic net loss per share adjusted to include the effects of all potentially dilutive shares. Diluted net loss per share is the same as basic loss per share for all periods as the inclusion of potentially issuable shares would be antidilutive. The Company analyzed the calculation of net loss per share for periods prior to 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. The basic and diluted net loss per share attributable to Class A ordinary shareholders for the three and nine months ended September 30, 2022, as presented on the unaudited consolidated statements of operations, represents only the period after the Business Combination to September 30, 2022. The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2023 and the period from July 11, 2022 through September 30, 2022 (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, Period from July 11, 2022 through September 30, 2023 2023 2022 Numerator Net loss $ ( 41,991 ) $ ( 113,723 ) $ ( 29,930 ) Less: Net loss attributable to noncontrolling interests ( 31,007 ) ( 83,956 ) ( 22,017 ) Net loss available to Class A ordinary shareholders of ProKidney Corp., $ ( 10,984 ) $ ( 29,767 ) $ ( 7,913 ) Denominator Weighted average Class A ordinary shares or ProKidney Corp. outstanding, 61,592,876 61,565,298 61,540,231 Net loss per Class A Unit Net loss per Class A ordinary share of ProKidney Corp., basic and diluted $ ( 0.18 ) $ ( 0.48 ) $ ( 0.13 ) Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: As of September 30, Period from July 11, 2022 through September 30, 2023 2022 Antidilutive securities ProKidney Corp. Class B ordinary shares 173,839,330 171,210,060 Unvested Restricted Stock Rights 5,644,596 8,766,071 Earnout Rights 17,500,000 17,500,000 Legacy SCS Restricted Share Units – 50,000 Stock options granted under the 2022 Equity Incentive Plan 17,356,148 129,370 |
Equity Based Compensation
Equity Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Based Compensation | Note 9: Equity Based Compensation 2022 Incentive Equity Plan On July 11, 2022, the shareholders of the Company approved the ProKidney Corp. 2022 Incentive Equity Plan (the “2022 Plan”) which provides for the issuance of equity based awards to the Company’s employees, non-employee directors, individual consultants, advisors and other service providers. As of September 30, 2023 , there were 35,809,951 Class A ordinary shares reserved for issuance. The 2022 Plan provides for the issuance of equity awards in the form of incentive stock options, which are intended to satisfy the requirements of Section 422 of the Internal Revenue Code of 1986, as amended, or nonqualified stock options, which are not intended to meet those requirements, stock appreciation rights, restricted stock, restricted stock units, performance awards or other cash or stock-based awards as determined appropriate by the plan administrator. In settlement of its obligations under this plan, the Company will issue new Class A ordinary shares. The Company has issued incentive and non-qualified stock option awards under the 2022 Plan to certain employees and non-employee directors of the Company. Given that the Company has established a full valuation allowance against its deferred tax assets, the Company has recognized no tax benefit related to these awards. Time-Vested Awards The Company uses the Black-Scholes option pricing model to calculate the fair value of time-vested stock options granted. These awards generally vest ratably over a three or four-year period and the option awards expire after a term of ten years from the date of grant. The fair value of stock options granted was estimated using the following assumptions during the nine months ended September 30, 2023: For the Nine Months Ended September 30, 2023 Expected volatility 81.3 % - 84.0 % Expected life of options, in years 5.2 - 6.1 Risk-free interest rate 3.5 % - 4.3 % Expected dividend yield 0.0 % The following table summarizes the activity related to the Company’s time-vested stock option awards granted under the 2022 Plan for the nine months ended September 30, 2023: Number of Shares Weighted Average Exercise Price Time-vested options outstanding at January 1, 2023 5,865,108 $ 10.30 Granted 8,234,543 9.82 Forfeited ( 383,110 ) 9.32 Time-vested options outstanding at September 30, 2023 13,716,541 $ 10.04 Time-vested options exercisable at September 30, 2023 1,919,253 $ 9.79 Weighted average remaining contractual life 8.9 years Time-vested options vested and expected to vest at September 30, 2023 13,716,541 $ 10.04 Weighted average remaining contractual life 8.9 years For the three and nine months ended September 30, 2023 , the Company recognized $ 6,608,000 and $ 15,276,000 of compensation expense related to time-vested awards under the 2022 Plan, respectively. These amounts are exclusive of the expense related to the modification of awards as discussed below. As of September 30, 2023 , the Company had total unrecognized stock-based compensation expense of approximately $ 77,305,000 related to the time-vested grants under the 2022 Plan, which is expected to be recognized on a straight-line basis over a weighted average period of 3.2 years. The weighted average grant date fair value for the option grants during the three and nine months ended September 30, 2023 was $ 8.61 and $ 7.11 , respectively. The aggregate intrinsic value of the in-the-money time-vested awards outstanding as well as those exercisable as of September 30, 2023 was $ 0 . Market-Vested Awards The Company also has outstanding 3,639,607 market-vested options with an exercise price of $ 10.33 as of September 30, 2023 . These awards contain both time and market based vesting conditions. The market conditions become satisfied in equal one-third tranches upon the Company's Class A ordinary shares exceeding a volume weighted average price hurdle of $ 15.00 , $ 20.00 and $ 25.00 , respectively, for 20 trading days within any 30 consecutive trading day period occurring prior to July 11, 2027. Once the market condition for a tranche is satisfied, such tranche will continue to be subject to time-vesting conditions and will vest ratably on each of the first, second and third anniversaries of the date that such tranche satisfied the performance vesting condition described above. Due to the market condition included in this grant, the Company used the Geometric Brownian Motion/Monte Carlo model to value these awards. For the three and nine months ended September 30, 2023 , the Company recognized $ 2,825,000 and $ 8,383,000 of compensation expense related to market-vested awards under the 2022 Plan, respectively. As of September 30, 2023 , the Company had total unrecognized stock-based compensation expense of approximately $ 17,604,000 related to the market-vested awards outstanding under the 2022 Plan. There were no market-vested awards granted during the three and nine months ended September 30, 2023 and 2022. The aggregate intrinsic value of the in-the-money market based awards outstanding as of September 30, 2023 was $ 0 . There were no market based awards vested at September 30, 2023. Legacy Profits Interests The Deed for the Establishment of a Limited Partnership of PKLP, dated as of August 5, 2021 (the “Limited Partnership Agreement”) which replaced the Amended and Restated Limited Liability Company Agreement of ProKidney LLC as the governing document of the parent entity in the Company, allowed for the issuance of Profits Interests (as defined in the Limited Partnership Agreement) to employees, directors, other service providers of the Company and others denominated in the form of one or more Class B Units of PKLP (as defined in the Limited Partnership Agreement). Under the Limited Partnership Agreement, Legacy GP determined the terms and conditions of the Profits Interests issued. The threshold value assigned to each grant was not to be less than the fair market value of PKLP on the date of grant. Profits Interests awarded would vest at a rate of 25% on the latter of the first anniversary of employment and the first anniversary of the Acquisition Date with the remaining 75% to vest in increments of 25% on each anniversary following the first anniversary date, ratably over a three or four-year period from the date of grant, in annual installments of 33.3% over the three-year period from the date of grant, in increments of 6.25% each calendar quarter following the first anniversary date, or were fully vested upon issuance. On January 17, 2022, PKLP amended and restated its Limited Partnership Agreement (the “Amended and Restated Limited Partnership Agreement”) which provided that certain qualified distribution events would result in holders of Profits Interests receiving disproportionate distributions from PKLP until each such holder’s valuation threshold had been reduced to zero in order to “catch up” such holder’s distributions to its pro rata share of aggregate cumulative distributions, and once sufficient distributions to a holder of Profits Interests had been made in accordance with the foregoing, the associated Class B Units of PKLP would automatically be converted into Class A Units of PKLP (as defined in the Limited Partnership Agreement). The following table summarizes the activity related to the Profits Interest awards for the nine months ended September 30, 2023 : Number of Shares Weighted Average Grant Date Fair Value Unvested awards outstanding at January 1, 2023 8,369,795 $ 7.08 Vested ( 2,266,101 ) 6.47 Forfeited ( 459,098 ) 7.71 Awards outstanding at September 30, 2023 5,644,596 $ 7.27 As of September 30, 2023 , the unrecognized compensation expense related to these awards was $ 31,603,000 . The current weighted average remaining period over which the unrecognized compensation expense is expected to be recognized is 2.2 years. The weighted average grant date fair value of the Profits Interests awarded during the nine months ended September 30, 2022, was $ 7.43 per Class B-1 unit of PKLP (as defined in the Limited Partnership Agreement), as adjusted for the effects of the recapitalization. There were no Profits Interests awarded during the three and nine months ended September 30, 2023 or the three months ended September 30, 2022. Modification to Equity Based Compensation Awards On January 17, 2022, the Limited Partnership Agreement was amended and restated to provide that certain qualified distribution events would result in the holders of Profits Interests receiving disproportionate distributions from PKLP until each such holder’s threshold value was reduced to zero in order to “catch up” such holder’s distributions to its pro rata share of aggregate cumulative distributions, and once sufficient distributions to a holder of Profits Interests had been made in accordance with the foregoing, the associated Class B Units would automatically be converted into Class A Units. This amendment constituted a modification to the Class B-1 Units in PKLP outstanding as of the date of the modification under the provisions of ASC Topic 718. In connection with the modification of its outstanding share-based compensation awards, the Company will recognize total additional compensation expense of $ 5,437,000 related to awards granted to its employees. The portion of this additional compensation expense attributable to vested awards of $ 3,715,000 was recognized immediately upon modification during the six months ended June 30, 2022. During the nine months ended September 30, 2023 , the Company also modified the vesting terms of outstanding time-based stock options issued to certain personnel upon their separation. This amendment constituted a modification of the awards under the provisions of ASC Topic 718 and resulted in the recognition of an additional $ 3,011,000 of compensation expense during the nine months ended September 30, 2023. Issuance of Profits Interests to Service Provider During the nine months ended September 30, 2022, the Company issued 2,253,033 fully vested Class B-1 Units in PKLP to a third-party service provider as payment for research and development services provided in prior periods. The Company had previously recognized expense of $ 2,502,000 for these services based on the liability related to the services incurred. As the fair value of shares issued to satisfy that obligation was higher than the amount previously expensed, the Company recognized additional research and development expense of $ 14,080,000 during the nine months ended September 30, 2022 . Purchase of Class B-1 Units in PKLP Certain of the Company’s employees, board members and service providers purchased 6,648,353 of Class B-1 Units in PKLP, as adjusted for the recapitalization, for total cash proceeds of $ 6,050,000 during the nine months ended September 30, 2022, respectively. Since these Class B-1 Units in PKLP were fully vested upon purchase and contained no service requirements, the Company immediately recognized the difference between the purchase price and the estimated fair value for these Class B-1 Units in PKLP of $ 34,254,000 as equity-based compensation expense during the nine months ended September 30, 2022, respectively. No such sales occurred during the three and nine months ended September 30, 2023 or the three months ended September 30, 2022. Fair Value Estimate for Profits Interest Prior to the Business Combination, PKLP was privately held with no active public market for its equity instruments. Therefore, for financial reporting purposes, management determined the estimated per share fair value of PKLP’s equity shares (including Profits Interests) using contemporaneous valuations. These contemporaneous valuations were done using methodologies consistent with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation , also known as the Practice Aid. For the Profits Interest Awards awarded during the six months ended June 30, 2022, the valuation approach utilized a hybrid method which consists of a combination of an Option Pricing Method (“OPM”) and a Probability Weighted Expected Return Method (”PWERM”) approach. Weighting allocations were assigned to the OPM and PWERM methods based upon the expected likelihood of possible future liquidity events, including the Business Combination. Under the OPM approach, the fair value of the total equity of PKLP within each scenario was first estimated using a back-solve method wherein the equity value is derived from a recent transaction in PKLP’s own securities, and then the total equity value is allocated to the various components of the capital structure, including the Profits Interests, using an OPM or a waterfall approach based on the specific rights of each of the equity classes. The OPM used the fair value of the total equity of PKLP within a scenario as a starting point and incorporates assumptions made regarding the expected returns and volatilities that are consistent with the expectations of market participants, and distribution of equity values is produced which cover the range of events that an informed market participant might expect. This process creates a range of equity values both between and within scenarios. The fair value measurement is sensitive to changes in the unobservable inputs. Changes in those inputs might result in a higher or lower fair value measurement. The PWERM approach is a scenario-based analysis that estimates the value per share of ordinary shares based on the probability-weighted present value of expected future equity values for the ordinary shares, under various possible future liquidity event scenarios, including the proposed Business Combination, in light of the rights and preferences of each class and series of stock, including the Profits Interests, discounted for a lack of marketability. In performing these valuations, management considered all objective and subjective factors that they believed to be relevant, including management’s best estimate of PKLP’s business condition, prospects, and operating performance at each valuation date. Within the valuations performed, a range of factors, assumptions, and methodologies were used. The significant factors included trends within the industry, the prices at which PKLP sold its Class A Units, the rights and preferences of the Class A Units relative to the Class B Units at the time of each measurement date, the results of operations, financial position, status of research and development efforts, stage of development and business strategy, the lack of an active public market for the units, and the likelihood of achieving an exit event in light of prevailing market conditions. The following reflects the key assumptions used in each of the valuation scenarios for the awards granted during the nine months ended September 30, 2022: OPM PWERM Total equity value (in thousands) $ 234,551 - $ 280,400 $ 1,750,000 Expected volatility of total equity 95 % 60 % - 90 % Discount for lack of market 30 % 7 % - 15 % Expected time to exit event 3.4 years - 3.7 years 0.1 years - 0.5 years Compensation Expense Compensation expense related to share-based awards is included in research and development and general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 4,881 $ 1,682 $ 13,324 $ 20,385 General and administrative 8,112 3,162 23,891 45,144 Total equity-based compensation expense $ 12,993 $ 4,844 $ 37,215 $ 65,529 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 10: Subsequent Events On October 30, 2023, the Company issued 5,541,414 Class A ordinary shares in exchange for 5,541,414 Class B ordinary shares and an equal number of Post-Combination ProKidney Common Units. On November 10, 2023, the Company’s board of directors terminated, without cause, Tim Bertram, Ph.D., Chief Executive Officer of the Company, effective November 15, 2023 (the “Effective Date”), following which Dr. Bertram is expected to continue to serve as a consultant of the Company. On the Effective Date, and pursuant to the terms of Dr. Bertram’s employment agreement, Dr. Bertram will also resign from the Board of Directors of the Company. The Company expects to enter into a separation and consulting agreement with Dr. Bertram. In addition, on November 10, 2023, the Company’s board of directors appointed Bruce Culleton, MD, as Chief Executive Officer and director of the Company, as of the Effective Date. The Company expects to enter into a new Employment Agreement with Dr. Culleton, to serve as the Chief Executive Officer of the Company that will become effective and replace Dr. Culleton’s previous employment agreement as of the Effective Date. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Unaudited Interim Financial Statements The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying Condensed Consolidated Balance Sheet as of September 30, 2023, Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2023 and 2022, Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2023 and 2022, Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity for the three and nine months ended September 30, 2023 and 2022 and Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2023, the results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2022 Condensed Consolidated Balance Sheet included herein was derived from the audited financial statements but does not include all disclosures or notes required by GAAP for complete financial statements. These financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, 2022, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2023, as amended on April 27, 2023. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited consolidated financial statements are presented in U.S. Dollars. Interim results are not necessarily indicative of results for an entire year. |
Fixed Assets | Fixed Assets Fixed assets are stated at cost, less accumulated depreciation. Generally, expenditures for maintenance and repairs are charged to expense and major improvements or replacements are capitalized. The Company computes depreciation and amortization using the straight-line method over the estimated useful life of the asset. Leasehold improvements are amortized over the lesser of, the life of the lease or the estimated useful life of the leasehold improvement. The estimated useful lives are as follows: Buildings 25 - 30 years Computer equipment and software 3 - 5 years Furniture and equipment 5 - 7 years Leasehold improvements remainder of lease term Fixed assets consisted of the following (in thousands): September 30, 2023 December 31, 2022 Land $ 3,067 $ – Buildings 22,490 – Leasehold improvements 10,867 10,537 Furniture and equipment 3,624 2,376 Computer equipment and software 848 889 Construction in progress 8,487 1,614 Less: accumulated depreciation ( 6,769 ) ( 4,708 ) Total fixed assets, net $ 42,614 $ 10,708 Depreciation expense for the three and nine months ended September 30, 2023 was $ 807,000 and $ 2,084,000 , respectively. Depreciation expense for the three and nine months ended September 30, 2022 was $ 627,000 and $ 1,825,000 , respectively. |
Equity-Based Compensation | Equity-Based Compensation Compensation expense for share-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for those awards earned over the service period on a straight-line basis. The Company records forfeitures of share-based compensation awards as they occur. The grant date fair value of stock option awards is estimated using the Black-Scholes option pricing formula. Due to the lack of sufficient historical trading information with respect to its own shares, the Company estimates expected volatility based on a portfolio of selected stocks of companies believed to have market and economic characteristics similar to its own. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. Due to a lack of historical exercise data, the Company estimates the expected life of its outstanding stock options using the simplified method specified under Staff Accounting Bulletin Topic 14.D.2. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets such as fixed assets and intangible assets subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. No impairment charges have been recorded for the three and nine months ended September 30, 2023 and 2022 . |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. A three‑level fair value hierarchy that prioritizes the inputs used to measure fair value is described below. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities • Level 2 – Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable through correlation with market data • Level 3 – Unobservable inputs that are supported by little or no market data, which require the reporting entity to develop its own assumptions The carrying values of cash equivalents, accounts payable, and accrued liabilities approximate fair value due to the short‑term nature of these instruments. |
Intangible Assets | Intangible Assets Intangible assets are comprised of acquired assembled workforce, which are accounted for in accordance with ASC 350 - Intangibles - Goodwill and Other. The acquired assembled workforce is amortized on a straight-line basis over the useful life of five years. The following table summarizes information related to the Company’s assembled workforce intangible asset (in thousands): September 30, 2023 December 31, 2022 Gross carrying amount $ 1,073 $ 1,073 Accumulated amortization 1,021 860 Net carrying amount $ 52 $ 213 Estimated amortization expense as of September 30, 2023 for the remaining three months of 2023 was $ 47,000 and $ 5,000 for the year ended December 31, 2024. Amortization expense relating to the assembled workforce intangible asset was $ 54,000 and $ 161,000 for each of the three and nine months ended September 30, 2023 and 2022, respectively . |
Segments | Segments The Company operates in only one segment. |
Contingent Liabilities | Contingent Liabilities The Company records reserves for contingent liabilities when it is probable that an asset has been impaired or a liability has been incurred at the date of the financial statements, and the amount of the loss can be reasonably estimated. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Balances recognized related to the Company’s operating and finance leases are included in right-of-use assets, net and lease liabilities in the Condensed Consolidated Balance Sheets. Right of use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Lease terms may include options to extend or terminate the lease if it is reasonably certain that the Company will exercise the option. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The right of use asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has elected a practical expedient to not separate its lease and non-lease components and instead account for them as a single lease component. Leases with a term of 12 months or less are not recorded on the balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Lease payments for short-term leases are recorded to operating expense on a straight-line basis and variable lease payments are recorded in the period in which the obligation for those payments is incurred. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, benefits, third party license fees, and external costs of outside vendors engaged to conduct manufacturing and preclinical development activities and clinical trials. The Company records accruals based on estimates of services received, efforts expended, and amounts owed pursuant to contracts with numerous contract research organizations. In the normal course of business, the Company contracts with third parties to perform various clinical study activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variation from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events and the completion of portions of the clinical study or similar conditions. The objective of the Company’s accrual policy is to match the recording of expenses in its financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical studies are recognized based on the company’s estimate of the degree of completion of the event or events specified in the specific clinical study. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss as the Company receives the related goods or services Costs incurred in obtaining technology licenses are charged to research and development expense as purchased in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use. |
Use of Estimates | Use of Estimates The preparation of unaudited condensed consolidated financial statements, in accordance with GAAP, requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the condensed consolidated financial statements, and the amounts of expenses during the reported periods. Certain estimates in these condensed consolidated financial statements have been made in connection with the calculation of research and development expenses, equity-based compensation expense and the provision for or benefit from income taxes. The Company bases its estimates on historical experience and various other assumptions, including in certain circumstances future projections, which management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known. |
Cash and Cash Equivalents | Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with an original maturity of 90 days or less on the date of purchase to be cash equivalents. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. The Company’s investments in marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as short-term due to its availability for use in its current operations. The cost of securities sold is determined using the specific identification method. The Company considers all available evidence to evaluate if a credit loss exists, and if so, recognizes an allowance for credit loss. |
Accrued Expenses | Accrued Expenses Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, 2023 December 31, 2022 Compensation $ 3,952 $ 3,355 Clinical study related costs 2,353 1,636 Facility expansion costs 1,860 – Accrued legal costs 1,089 436 Manufacturing improvement costs 4,280 678 Accrued consulting and professional fees 1,006 1,210 Other accrued expenses 924 21 Total accrued expenses and other $ 15,464 $ 7,336 |
Concentration of Credit Risk | Concentrations of Credit Risk Cash and equivalents are the primary financial instruments held by the Company that are potentially subject to concentrations of credit risk. The Company’s cash and equivalents are deposited in accounts at large financial institutions, and such amounts may exceed federally insured limits. |
Income Taxes | Income Taxes The Company uses the liability method in accounting for income taxes as required by ASC Topic 740 — Income Taxes, under which deferred tax assets and liabilities are recorded for the future tax consequences attributable to the differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is recorded to reduce the carrying amounts of deferred tax assets unless it is more likely than not that such assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, available taxes in the carryback periods, projected future taxable income and tax planning strategies in making this assessment. Accordingly, the Company has provided a full valuation allowance to offset the net deferred tax assets at September 30, 2023 and December 31, 2022. Interest and penalties related to income taxes are included in the benefit (expense) for income taxes in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company has not incurred any significant interest or penalties related to income taxes in any of the periods presented. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule Of Estimated Useful Lives | The estimated useful lives are as follows: Buildings 25 - 30 years Computer equipment and software 3 - 5 years Furniture and equipment 5 - 7 years Leasehold improvements remainder of lease term |
Schedule of Fixed Assets | Fixed assets consisted of the following (in thousands): September 30, 2023 December 31, 2022 Land $ 3,067 $ – Buildings 22,490 – Leasehold improvements 10,867 10,537 Furniture and equipment 3,624 2,376 Computer equipment and software 848 889 Construction in progress 8,487 1,614 Less: accumulated depreciation ( 6,769 ) ( 4,708 ) Total fixed assets, net $ 42,614 $ 10,708 |
Condensed Consolidated Balance Sheets of Accrued expense | Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, 2023 December 31, 2022 Compensation $ 3,952 $ 3,355 Clinical study related costs 2,353 1,636 Facility expansion costs 1,860 – Accrued legal costs 1,089 436 Manufacturing improvement costs 4,280 678 Accrued consulting and professional fees 1,006 1,210 Other accrued expenses 924 21 Total accrued expenses and other $ 15,464 $ 7,336 |
Schedule Of Intangible Asset | The following table summarizes information related to the Company’s assembled workforce intangible asset (in thousands): September 30, 2023 December 31, 2022 Gross carrying amount $ 1,073 $ 1,073 Accumulated amortization 1,021 860 Net carrying amount $ 52 $ 213 |
Redeemable Noncontrolling Int_2
Redeemable Noncontrolling Interest (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Noncontrolling Interest [Abstract] | |
Summary of Company and transfers to noncontrolling interest: | The following is a summary of net income attributable to the Company and transfers to noncontrolling interest (in thousands): For the Three Months Ended September 30, 2023 For the Nine Months For the Period from July 11, 2022 through September 30, 2022 Net loss available to Class A ordinary shareholders $ ( 10,984 ) $ ( 29,767 ) $ ( 7,913 ) (Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of 2,629 7,848 2,908 (Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange ( 64 ) ( 64 ) – (Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of 21 ( 4,457 ) 176 Change from net loss available to Class A ordinary shareholders and change $ ( 8,398 ) $ ( 26,440 ) $ ( 4,829 ) |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of computation of basic and diluted net loss per share | The following table sets forth the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2023 and the period from July 11, 2022 through September 30, 2022 (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, Period from July 11, 2022 through September 30, 2023 2023 2022 Numerator Net loss $ ( 41,991 ) $ ( 113,723 ) $ ( 29,930 ) Less: Net loss attributable to noncontrolling interests ( 31,007 ) ( 83,956 ) ( 22,017 ) Net loss available to Class A ordinary shareholders of ProKidney Corp., $ ( 10,984 ) $ ( 29,767 ) $ ( 7,913 ) Denominator Weighted average Class A ordinary shares or ProKidney Corp. outstanding, 61,592,876 61,565,298 61,540,231 Net loss per Class A Unit Net loss per Class A ordinary share of ProKidney Corp., basic and diluted $ ( 0.18 ) $ ( 0.48 ) $ ( 0.13 ) Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following: As of September 30, Period from July 11, 2022 through September 30, 2023 2022 Antidilutive securities ProKidney Corp. Class B ordinary shares 173,839,330 171,210,060 Unvested Restricted Stock Rights 5,644,596 8,766,071 Earnout Rights 17,500,000 17,500,000 Legacy SCS Restricted Share Units – 50,000 Stock options granted under the 2022 Equity Incentive Plan 17,356,148 129,370 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of the classification of operating and finance lease assets and obligations in the Company's Consolidated Balance Sheets | The following table summarizes the classification of operating and finance lease assets and obligations in the Company's Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 Operating leases: Right of use assets $ 2,558 $ 2,285 Operating lease liabilities, current $ 625 $ 458 Operating lease liabilities, noncurrent 1,991 1,858 Total operating lease liabilities $ 2,616 $ 2,316 Finance leases: Right of use assets $ 159 $ 71 Finance lease liabilities, current $ 51 $ 35 Finance lease liabilities, noncurrent 118 48 Total finance lease liabilities $ 169 $ 83 |
Schedule of maturities of lease liabilities | Maturities of lease liabilities for the Company’s operating and finance leases are as follows as of September 30, 2023 (in thousands): Operating Leases Finance Leases Total 2023 $ 207 $ 16 $ 223 2024 839 62 901 2025 849 32 881 2026 772 22 794 2027 438 22 460 Thereafter 29 40 69 Total lease payments 3,134 194 3,328 Less: imputed interest ( 518 ) ( 25 ) ( 543 ) Present value of lease liabilities $ 2,616 $ 169 $ 2,785 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments [Abstract] | |
Schedule of Cash, Cash Equivalents and Marketable Securities | The following tables summarize our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2023 (in thousands): Fair Value Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash Equivalents Marketable Securities Money market funds Level 2 $ 1,037 $ – $ – $ 1,037 $ 1,037 $ – Time deposits Level 2 30,506 9 ( 17 ) 30,498 – 30,498 Commercial paper Level 2 132,166 35 ( 224 ) 131,977 – 131,977 Government bonds Level 2 12,500 – ( 24 ) 12,476 – 12,476 Corporate debt securities Level 2 30,017 4 ( 27 ) 29,994 – 29,994 Total $ 206,226 $ 48 $ ( 292 ) $ 205,982 $ 1,037 $ 204,945 |
Summary of Scheduled Maturity for Marketable Securities | The following table shows the fair value of the Company’s cash equivalents and marketable securities, by contractual maturity, as of September 30, 2023 (in thousands): September 30, 2023 Due in 1 year or less $ 205,982 Due in 1 year through 5 years – Total $ 205,982 |
Schedule of Investments Fair Values and Gross Unrealized Losses | The following table shows fair values and gross unrealized losses recorded to accumulated other comprehensive income, aggregated by category and the length of time that individual securities have been in a continuous loss position as of September 30, 2023 (in thousands): Less than 12 months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Time deposits $ 12,990 $ ( 17 ) $ – $ – $ 12,990 $ ( 17 ) Commercial paper 91,160 ( 224 ) – – 91,160 ( 224 ) Government bonds 12,476 ( 24 ) – – 12,476 ( 24 ) Corporate debt securities 14,989 ( 27 ) – – 14,989 ( 27 ) Total $ 131,615 $ ( 292 ) $ – $ – $ 131,615 $ ( 292 ) |
Equity Based Compensation (Tabl
Equity Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of stock option awards granted, Activity | The following table summarizes the activity related to the Company’s time-vested stock option awards granted under the 2022 Plan for the nine months ended September 30, 2023: Number of Shares Weighted Average Exercise Price Time-vested options outstanding at January 1, 2023 5,865,108 $ 10.30 Granted 8,234,543 9.82 Forfeited ( 383,110 ) 9.32 Time-vested options outstanding at September 30, 2023 13,716,541 $ 10.04 Time-vested options exercisable at September 30, 2023 1,919,253 $ 9.79 Weighted average remaining contractual life 8.9 years Time-vested options vested and expected to vest at September 30, 2023 13,716,541 $ 10.04 Weighted average remaining contractual life 8.9 years |
Summary of Profits Interest awards, Activity | nine months ended September 30, 2023 : Number of Shares Weighted Average Grant Date Fair Value Unvested awards outstanding at January 1, 2023 8,369,795 $ 7.08 Vested ( 2,266,101 ) 6.47 Forfeited ( 459,098 ) 7.71 Awards outstanding at September 30, 2023 5,644,596 $ 7.27 |
Summary of assumptions of the valuation in stock option activity | The fair value of stock options granted was estimated using the following assumptions during the nine months ended September 30, 2023: For the Nine Months Ended September 30, 2023 Expected volatility 81.3 % - 84.0 % Expected life of options, in years 5.2 - 6.1 Risk-free interest rate 3.5 % - 4.3 % Expected dividend yield 0.0 % |
Summary of assumptions of the valuation scenarios | The following reflects the key assumptions used in each of the valuation scenarios for the awards granted during the nine months ended September 30, 2022: OPM PWERM Total equity value (in thousands) $ 234,551 - $ 280,400 $ 1,750,000 Expected volatility of total equity 95 % 60 % - 90 % Discount for lack of market 30 % 7 % - 15 % Expected time to exit event 3.4 years - 3.7 years 0.1 years - 0.5 years |
Schedule of Compensation expense related to share-based awards | Compensation expense related to share-based awards is included in research and development and general and administrative expense as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 4,881 $ 1,682 $ 13,324 $ 20,385 General and administrative 8,112 3,162 23,891 45,144 Total equity-based compensation expense $ 12,993 $ 4,844 $ 37,215 $ 65,529 |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Description of Organization and Business Operations [Line Items] | ||
Incorporation date of entity | Feb. 25, 2021 | |
Repayments of related party debt | $ 0 | $ 35,000,000 |
Proceeds from business combination gross | 596,537,000 | |
Advisory and placement fees | 29,389,000 | |
Costs paid with proceeds for SPAC | $ 21,029,000 | |
PKLP [Member] | ||
Description of Organization and Business Operations [Line Items] | ||
Percentage of non-voting economic interest | 73.80% | |
Percentage of non-voting economic interest by parent | 26.20% | |
Repayments of related party debt | $ 35,000,000 | |
Proceeds from unredeemed shares | $ 21,737,000 | |
Private Placement [Member] | ||
Description of Organization and Business Operations [Line Items] | ||
Sale of stock price per share | $ 10 | |
Common Class A [Member] | ||
Description of Organization and Business Operations [Line Items] | ||
Proceeds from private placement issue | $ 574,800,000 |
Significant Accounting Policies
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Segment | Sep. 30, 2022 USD ($) | |
Accounting Policies [Abstract] | ||||
Amortization expense | $ 54,000 | $ 161,000 | $ 54,000 | $ 161,000 |
Depreciation expense | 807,000 | $ 627,000 | $ 2,084,000 | $ 1,825,000 |
Number of Reportable Segments | Segment | 1 | |||
Finite Lived Intangible Asset Reminder Of Fical Year | 47,000 | $ 47,000 | ||
Finite lived intangible asset one year | $ 5,000 | $ 5,000 |
Significant Accounting Polici_2
Significant Accounting Policies - Summary of Accrued expense (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Compensation | $ 3,952 | $ 3,355 |
Clinical study related costs | 2,353 | 1,636 |
Facility Expansion Costs | 1,860 | 0 |
Accrued legal costs | 1,089 | 436 |
Manufacturing improvement costs | 4,280 | 678 |
Accrued consulting and professional fees | 1,006 | 1,210 |
Other accrued expenses | 924 | 21 |
Total accrued expenses and other | $ 15,464 | $ 7,336 |
Significant Accounting Polici_3
Significant Accounting Policies - Summary of Fixed Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Less: accumulated depreciation | $ (6,769) | $ (4,708) |
Total fixed assets, net | 42,614 | 10,708 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Fixed Assets Gross | 3,067 | 0 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Fixed Assets Gross | $ 22,490 | 0 |
Buildings | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 30 years | |
Buildings | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 25 years | |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Fixed Assets Gross | $ 848 | 889 |
Computer equipment and software | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Computer equipment and software | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 3 years | |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Fixed Assets Gross | $ 3,624 | 2,376 |
Furniture and equipment | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 7 years | |
Furniture and equipment | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property Plant And Equipment Estimated Useful Lives | remainder of lease term | |
Fixed Assets Gross | $ 10,867 | 10,537 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Construction in progress | $ 8,487 | $ 1,614 |
Significant Accounting Polici_4
Significant Accounting Policies - Summarizes intangible asset (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Gross carrying amount | $ 1,073 | $ 1,073 |
Accumulated amortization | 1,021 | 860 |
Finite-Lived Intangible Assets, Net, Total | $ 52 | $ 213 |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Income Tax Disclosure [Abstract] | |
Cash Saving Percentage | 85% |
Effective Income Tax Rate | 21% |
Unrecognized tax benefits | $ 0 |
Uncertain tax positions | $ 0 |
Leases (Additional Information)
Leases (Additional Information) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Operating Lease Expense | $ 276,000 | $ 150,000 | $ 736,000 | $ 379,000 |
Cash paid for operating leases | $ 57,800 | |||
Finance Lease, Weighted Average Remaining Lease Term | 4 years 8 months 12 days | 4 years 8 months 12 days | ||
Operating Lease, Weighted Average Remaining Lease Term | 3 years 8 months 12 days | 3 years 8 months 12 days | ||
Operating lease, weighted average discount rate | 9.50% | 9.50% | ||
Finance lease, weighted average discount rate | 6.60% | 6.60% |
Leases - Schedule of the Classi
Leases - Schedule of the Classification of Operating and Finance Lease Assets and Obligations in the Company's Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Operating leases: | ||
Right of use assets | $ 2,558 | $ 2,285 |
Operating lease liabilities, current | 625 | 458 |
Operating lease liabilities, noncurrent | 1,991 | 1,858 |
Total operating lease liabilities | 2,616 | 2,316 |
Finance leases: | ||
Right of use assets | 159 | 71 |
Finance lease liabilities, current | 51 | 35 |
Finance lease liabilities, noncurrent | 118 | 48 |
Total finance lease liabilities | $ 169 | $ 83 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities for the Company's Operating and Finance Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 | $ 207 | |
2024 | 839 | |
2025 | 849 | |
2026 | 772 | |
2027 | 438 | |
Thereafter | 29 | |
Total lease payments | 3,134 | |
Less: imputed interest | (518) | |
Present value of lease liabilities | 2,616 | $ 2,316 |
2023 | 16 | |
2024 | 62 | |
2025 | 32 | |
2026 | 22 | |
2027 | 22 | |
Thereafter | 40 | |
Total lease payments | 194 | |
Less: imputed interest | (25) | |
Present value of lease liabilities | 169 | $ 83 |
2023 | 223 | |
2024 | 901 | |
2025 | 881 | |
2026 | 794 | |
2027 | 460 | |
Thereafter | 69 | |
Total lease payments | 3,328 | |
Less: imputed interest | (543) | |
Present value of lease liabilities | $ 2,785 |
Investments - Schedule of Marke
Investments - Schedule of Marketable Securities Measured At Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash Equivalents | $ 191,389 | $ 490,252 |
Marketable Securities | 204,945 | $ 0 |
Fair Value Measurements Recurring [Member] | ||
Amortized Cost | 206,226 | |
Unrealized Gains | 48 | |
Unrealized Losses | (292) | |
Fair Value | 205,982 | |
Cash Equivalents | 1,037 | |
Marketable Securities | 204,945 | |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Money Market Funds [Member] | ||
Amortized Cost | 1,037 | |
Unrealized Gains | 0 | |
Unrealized Losses | 0 | |
Fair Value | 1,037 | |
Cash Equivalents | 1,037 | |
Marketable Securities | 0 | |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Time Deposit [Member] | ||
Amortized Cost | 30,506 | |
Unrealized Gains | 9 | |
Unrealized Losses | (17) | |
Fair Value | 30,498 | |
Cash Equivalents | 0 | |
Marketable Securities | 30,498 | |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Commercial Paper [Member] | ||
Amortized Cost | 132,166 | |
Unrealized Gains | 35 | |
Unrealized Losses | (224) | |
Fair Value | 131,977 | |
Cash Equivalents | 0 | |
Marketable Securities | 131,977 | |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Government Bonds [Member] | ||
Amortized Cost | 12,500 | |
Unrealized Gains | 0 | |
Unrealized Losses | (24) | |
Fair Value | 12,476 | |
Cash Equivalents | 0 | |
Marketable Securities | 12,476 | |
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Corporate Debt Securities [Member] | ||
Amortized Cost | 30,017 | |
Unrealized Gains | 4 | |
Unrealized Losses | (27) | |
Fair Value | 29,994 | |
Cash Equivalents | 0 | |
Marketable Securities | $ 29,994 |
Investments - Schedule of Matur
Investments - Schedule of Maturity for Marketable Securities (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Investments [Abstract] | |
Due in 1 year or less | $ 205,982 |
Due in 1 year through 5 years | 0 |
Total | $ 205,982 |
Investments - Schedule of Inves
Investments - Schedule of Investments Fair Values and Gross Unrealized Losses (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Less than 12 months, fair value | $ 131,615 |
Less than 12 months, unrealized loss | (292) |
12 months or greater, fair value | 0 |
12 months or greater, unrealized loss | 0 |
Total, fair value | 131,615 |
Total, unrealized loss | (292) |
Time Deposits [Member] | |
Less than 12 months, fair value | 12,990 |
Less than 12 months, unrealized loss | (17) |
12 months or greater, fair value | 0 |
12 months or greater, unrealized loss | 0 |
Total, fair value | 12,990 |
Total, unrealized loss | (17) |
Commercial Paper [Member] | |
Less than 12 months, fair value | 91,160 |
Less than 12 months, unrealized loss | (224) |
12 months or greater, fair value | 0 |
12 months or greater, unrealized loss | 0 |
Total, fair value | 91,160 |
Total, unrealized loss | (224) |
Government Bonds [Member] | |
Less than 12 months, fair value | 12,476 |
Less than 12 months, unrealized loss | (24) |
12 months or greater, fair value | 0 |
12 months or greater, unrealized loss | 0 |
Total, fair value | 12,476 |
Total, unrealized loss | (24) |
Corporate Debt Securities [Member] | |
Less than 12 months, fair value | 14,989 |
Less than 12 months, unrealized loss | (27) |
12 months or greater, fair value | 0 |
12 months or greater, unrealized loss | 0 |
Total, fair value | 14,989 |
Total, unrealized loss | $ (27) |
Investments (Additional Informa
Investments (Additional Information) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 30, 2022 |
Marketable Debt Securities [Member] | ||
Allowance for credit losses for investments | $ 0 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jan. 31, 2023 | Jan. 18, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||||
Borrowings under related party notes payable | $ 0 | $ 35,000,000 | ||||
Shares Unlocked Percentage | 50% | |||||
Lock Up Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Description Of Terms Earnout Shares | A ordinary share of the Company equals or exceeds $12.50 per share for any 20 trading days within any 30-trading day period commencing at least 30 days after the Closing and (b) for an additional 50% of the Lock-Up Shares (other than the Earnout Shares and the Private Placement Shares (as each such term is defined in the Lock-Up Agreement)), the date on which the last reported sale price of a Class A ordinary share of the Company equals or exceeds $15.00 per share for any 20 trading days within any 30-trading day period commencing at least 30 days after the Closing. Notwithstanding the above, (i) the lock-up period for any Earnout Shares will expire not earlier than 180 days after such Earnout Shares are issued | |||||
Tax Receivable Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Percentage of tax saving recognized | 85% | |||||
ProKidney KY and Nefro Health [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Borrowings under related party notes payable | 35,000,000 | |||||
Quarterly Related Party Fee | $ 25,000 | |||||
Costs And Expenses Related Party | $ 25,000 | $ 75,000 | 25,000 | 75,000 | ||
ProKidney US and Nefro Health [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Quarterly Related Party Fee | 25,000 | |||||
Nefro consulting service | $ 25,000 | 75,000 | $ 25,000 | 75,000 | ||
Commercial Paper [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Interest Expense Debt | $ 27,000 | $ 207,000 | ||||
Related Party Note Maximum Amount | $ 100,000,000 | |||||
Interest rate on notes | 3% | |||||
RCU [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Earnout Restricted Common Units Issued | 17,500,000 | |||||
RSR [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Earnout restricted stock right shares | 17,500,000 | |||||
Earnout Rights [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Vesting Period of Earnout Rights | 5 years | |||||
Earnout Rights [Member] | Vesting [Member] | Tranche one [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Earnout Rights Stock Price Trigger | $ 15 | $ 15 | ||||
Earnout Rights [Member] | Vesting [Member] | Tranche two [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Earnout Rights Stock Price Trigger | 20 | 20 | ||||
Earnout Rights [Member] | Vesting [Member] | Tranche three [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Earnout Rights Stock Price Trigger | $ 25 | $ 25 |
Redeemable Noncontrolling Int_3
Redeemable Noncontrolling Interest - Summary of company non controlling interest (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||||
Net loss available to Class A ordinary shareholders | $ (41,991) | $ (29,930) | $ (33,945) | $ (113,723) | $ (123,562) |
(Increase)/Decrease In ProKidney Corp. additional paid-in capital for vesting of Restricted Common Units in ProKidney LP | 21 | 176 | (4,457) | ||
Change from net loss available to Class A ordinary shareholders and change in ownership interest in ProKidney LP | (8,398) | (4,829) | (26,440) | ||
Subsidiaries [Member] | Noncontrolling Interest [Member] | |||||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||||
(Increase)/Decrease In ProKidney Corp. Accumulated Deficit For Impact Of Subsidiary Equity-Based Compensation | 2,629 | 2,908 | 7,848 | ||
Common Class A [Member] | |||||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||||
(Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange of Common Units in ProKidney LP for Class A ordinary shares | (64) | 0 | (64) | ||
Common Class A [Member] | Noncontrolling Interest [Member] | |||||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||||
Net loss available to Class A ordinary shareholders | $ (10,984) | $ (7,913) | $ (29,767) |
Redeemable Noncontrolling Int_4
Redeemable Noncontrolling Interest (Additional Information) (Details) | Sep. 30, 2023 |
Exchange Agreement [Member] | PKLP [Member] | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |
Non controlling interest percentge | 73.80% |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of computation of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |||||
Numerator | |||||||||
Net loss | $ (41,991) | $ (29,930) | $ (33,945) | $ (113,723) | $ (123,562) | ||||
Less: Net loss attributable to noncontrolling interest | $ (31,007) | $ (22,017) | $ (83,956) | ||||||
Antidilutive securities | |||||||||
Earnout shares | 17,500,000 | 17,500,000 | |||||||
Stock options granted under the 2022 Equity Incentive Plan | 17,356,148 | 129,370 | 129,370 | 17,356,148 | 129,370 | ||||
Restricted Stock Rights [Member] | |||||||||
Antidilutive securities | |||||||||
Restricted Stock Share units | 8,766,071 | 5,644,596 | |||||||
Legacy SCS [Member] | |||||||||
Antidilutive securities | |||||||||
Restricted Stock Share units | 50,000 | 0 | |||||||
Common Class A [Member] | |||||||||
Numerator | |||||||||
Net loss Available To Class A ordinary Shareholders of ProKidney Corp., Basic | $ (10,984) | $ (7,913) | $ (29,767) | ||||||
Net loss Available To Class A ordinary Shareholders of ProKidney Corp., Diluted | $ (10,984) | $ (7,913) | $ (29,767) | ||||||
Denominator | |||||||||
Weighted Average Shares Outstanding, Basic | 61,592,876 | [1] | 61,540,231 | 61,540,231 | [1] | 61,565,298 | [1] | 61,540,231 | [1] |
Weighted Average Shares Outstanding, Diluted | 61,592,876 | [1] | 61,540,231 | 61,540,231 | [1] | 61,565,298 | [1] | 61,540,231 | [1] |
Net loss per share attributable to Class A ordinary shares, Basic | $ (0.18) | [1] | $ (0.13) | $ (0.13) | [1] | $ (0.48) | [1] | $ (0.13) | [1] |
Net loss per share attributable to Class A ordinary shares, Diluted | $ (0.18) | [1] | $ (0.13) | $ (0.13) | [1] | $ (0.48) | [1] | $ (0.13) | [1] |
Common Class B [Member] | |||||||||
Antidilutive securities | |||||||||
ProKidney Corp. Ordinary Shares | 173,839,330 | 171,210,060 | 171,210,060 | 173,839,330 | 171,210,060 | ||||
[1] (1) The Company analyzed the calculation of net loss per share for periods prior to the Business Combination, as defined in Note 1, 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. The basic and diluted net loss per share attributable to Class A ordinary shareholders for the three and nine months ended September 30, 2022, represents only the period after the Business Combination to September 30, 2022. For more information refer to Note 8. |
Equity Based Compensation - Sum
Equity Based Compensation - Summary of assumptions of the valuation in stock option activity (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of assumptions of the valuation scenarios [Line Items] | |
Expected volatility, Minimum | 81.30% |
Expected volatility, Maximum | 84% |
Risk-free interest rate, Minimum | 3.50% |
Risk-free interest rate, Maximum | 4.30% |
Expected dividend yield | 0% |
Maximum [Member] | |
Summary of assumptions of the valuation scenarios [Line Items] | |
Expected life of options, in years | 6 years 1 month 6 days |
Minimum [Member] | |
Summary of assumptions of the valuation scenarios [Line Items] | |
Expected life of options, in years | 5 years 2 months 12 days |
Equity Based Compensation - S_2
Equity Based Compensation - Summary of stock option awards granted, activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Time-vested options outstanding at September 30, 2023 | shares | 17,356,148 |
Stock option awards granted [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Time-vested options outstanding at January 1, 2023 | shares | 5,865,108 |
Number of shares, Granted | shares | 8,234,543 |
Forfeited/ shares | shares | (383,110) |
Time-vested options outstanding at September 30, 2023 | shares | 13,716,541 |
Time-vested options exercisable at September 30, 2023 | shares | 1,919,253 |
Weighted average remaining contractual life | 8 years 10 months 24 days |
Time-vested options vested and expected to vest at September 30, 2023 | $ | $ 13,716,541 |
Weighted average remaining contractual life | 8 years 10 months 24 days |
Weighted Average Exercise Price, Time-vested Options Outstanding, Beginnig Balance | $ / shares | $ / shares | $ 10.3 |
Weighted Average Exercise Price, Granted | $ / shares | 9.82 |
Weighted Average Exercise Price, Forfeited | $ / shares | $ / shares | 9.32 |
Weighted Average Exercise Price, Time-vested Options Outstanding, Ending Balance | $ / shares | $ / shares | 10.04 |
Weighted Average Exercise Price Time-vested options exercisable at September 30, 2023 | $ / shares | 9.79 |
Weighted Average Exercise Price Time-vested options vested and expected to vest at September 30, 2023 | $ / shares | $ 10.04 |
Equity Based Compensation - Sch
Equity Based Compensation - Schedule of Profits Interest awards (Details) - Profits Interest awards [Member] | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Unvested awards outstanding at January 1, 2023 | shares | 8,369,795 |
Number of Shares, Vested | shares | (2,266,101) |
Number of Shares, Forfeited | shares | (459,098) |
Number of Shares, awards outstanding at September 30, 2023 | shares | 5,644,596 |
Weighted Average Grant Date Fair Value, Unvested awards outstanding at January 1, 2023 | $ / shares | $ 7.08 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 6.47 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 7.71 |
Weighted Average Grant Date Fair Value,awards outstanding at September 30, 2023 | $ / shares | $ 7.27 |
Equity Based Compensation - S_3
Equity Based Compensation - Summary of assumptions of the valuation scenarios (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
OPM [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility of total equity | 95% |
Discount for lack of market | 30% |
OPM [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total equity value | $ 280,400 |
Expected time to exit event | 3 years 8 months 12 days |
OPM [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total equity value | $ 234,551 |
Expected time to exit event | 3 years 4 months 24 days |
PWERM [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total equity value | $ 1,750,000 |
PWERM [Member] | Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility of total equity | 90% |
Discount for lack of market | 15% |
Expected time to exit event | 6 months |
PWERM [Member] | Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility of total equity | 60% |
Discount for lack of market | 7% |
Expected time to exit event | 1 month 6 days |
Equity Based Compensation - Com
Equity Based Compensation - Compensation expense related to share-based awards (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total equity-based compensation expense | $ 12,993 | $ 4,844 | $ 37,215 | $ 65,529 |
Research and development | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total equity-based compensation expense | 4,881 | 1,682 | 13,324 | 20,385 |
General and administrative | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total equity-based compensation expense | $ 8,112 | $ 3,162 | $ 23,891 | $ 45,144 |
Equity Based Compensation (Addi
Equity Based Compensation (Additional Information) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Unrecognized compensation expense remaining period | 2 years 2 months 12 days | ||||||
Additional compensation expense | $ 3,011,000 | ||||||
Profits interests granted | 0 | ||||||
Share-Based Payment Arrangement, Expense | $ 12,993,000 | $ 4,844,000 | 37,215,000 | $ 65,529,000 | |||
Employee Benefits and Share-Based Compensation | 10,365,000 | $ 29,368,000 | |||||
Share-Based Payment Arrangement, Tranche One [Member] | |||||||
Weighted Average Vesting Price | $ 15 | ||||||
Share-Based Payment Arrangement, Tranche Two [Member] | |||||||
Weighted Average Vesting Price | 20 | ||||||
Share-Based Payment Arrangement, Tranche Three [Member] | |||||||
Weighted Average Vesting Price | $ 25 | ||||||
Limited Partnership Agreement | |||||||
Profits Interest vesting description | Profits Interests awarded would vest at a rate of 25% on the latter of the first anniversary of employment and the first anniversary of the Acquisition Date with the remaining 75% to vest in increments of 25% on each anniversary following the first anniversary date, ratably over a three or four-year period from the date of grant, in annual installments of 33.3% over the three-year period from the date of grant, in increments of 6.25% each calendar quarter following the first anniversary date, or were fully vested upon issuance. | ||||||
R&D service provider [Member] | |||||||
Share-Based Payment Arrangement, Expense | $ 14,080,000 | ||||||
Profits Interest awards [Member] | |||||||
Profits Interests Issued To Service Provider | $ 7.43 | ||||||
Unrecognized compensation expense | 31,603,000 | $ 31,603,000 | |||||
Time Vested Awards [Member] | |||||||
Unrecognized stock-based compensation expense | 77,305,000 | 77,305,000 | |||||
Employee Benefits and Share-Based Compensation | $ 6,608,000 | $ 15,276,000 | |||||
Weighted Average Period | 3 years 2 months 12 days | 3 years 2 months 12 days | |||||
weighted average grant date fair value | $ 8.61 | $ 7.11 | |||||
Aggregate intrinsic value | $ 0 | $ 0 | |||||
Market-Vested Awards [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Number of Shares | 0 | ||||||
Unrecognized stock-based compensation expense | 17,604,000 | $ 17,604,000 | |||||
Employee Benefits and Share-Based Compensation | $ 2,825,000 | $ 8,383,000 | |||||
weighted average grant date fair value | $ 0 | $ 0 | $ 0 | $ 0 | |||
Aggregate intrinsic value | $ 0 | $ 0 | |||||
Market-Vested Awards [Member] | Chief Executive Officer [Member] | |||||||
Number of shares, Granted | 3,639,607 | ||||||
Market-Vested Awards [Member] | Stock Option Awards Under Twenty Twenty Two Plan | |||||||
Weighted Average Exercise Price, Granted | $ 10.33 | ||||||
Class A [Member] | |||||||
Ordinary shares reserved for issuance | 35,809,951 | 35,809,951 | |||||
Common Class B [Member] | |||||||
Additional compensation expense | $ 5,437,000 | ||||||
Recognized compensation expense modification | $ 3,715,000 | ||||||
Previously Recognized Expense Settled Via Equity Award | $ 2,502,000 | ||||||
Share-Based Payment Arrangement, Expense | 34,254,000 | ||||||
Stock Issued During Period, Value, New Issues | $ 6,050,000 | ||||||
Common Class B [Member] | Limited Partnership Agreement | |||||||
Stock issued during period new shares issued | 6,648,353 | ||||||
Common Class B [Member] | R&D service provider [Member] | |||||||
Issuance of Class B ordinary shares to Sponsor (in shares) | 2,253,033 |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) - shares | 1 Months Ended | ||
Oct. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Common Class A [Member] | |||
Subsequent Event [Line Items] | |||
Common Stock, Shares, Issued | 61,595,300 | 61,540,231 | |
Ordinary shares reserved for issuance | 35,809,951 | ||
Common Class B [Member] | |||
Subsequent Event [Line Items] | |||
Common Stock, Shares, Issued | 173,839,330 | 171,578,320 | |
Subsequent Event [Member] | Common Class A [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares issued for exchange on units | 5,541,414 | ||
Subsequent Event [Member] | Common Class B [Member] | |||
Subsequent Event [Line Items] | |||
Number of shares issued for exchange on units | 5,541,414 |