UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
Class of Stock |
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Shares Outstanding as of November 14, 2023 |
Class A ordinary shares, par value $0.0001 per share |
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Class B ordinary shares, par value $0.0001 per share |
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\`
Table of Contents
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Page |
PART I. |
2 |
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Item 1. |
2 |
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2 |
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3 |
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4 |
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7 |
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9 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
10 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
25 |
Item 3. |
34 |
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Item 4. |
34 |
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PART II. |
35 |
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Item 1. |
35 |
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Item 1A. |
35 |
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Item 2. |
Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities |
35 |
Item 3. |
35 |
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Item 4. |
35 |
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Item 5. |
35 |
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Item 6. |
35 |
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37 |
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i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
ProKidney Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
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September 30, 2023 |
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December 31, 2022 |
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(Unaudited) |
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Assets |
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Cash and cash equivalents |
$ |
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$ |
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Marketable securities |
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Interest receivable |
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Prepaid assets |
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Prepaid clinical |
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Other current assets |
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Total current assets |
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Fixed assets, net |
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Right of use assets, net |
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Intangible assets, net |
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Total assets |
$ |
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$ |
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Liabilities and Shareholders' Deficit/Members' Equity |
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Accounts payable |
$ |
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$ |
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Lease liabilities |
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Accrued expenses and other |
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Income taxes payable |
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Total current liabilities |
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Income tax payable, net of current portion |
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Lease liabilities, net of current portion |
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Total liabilities |
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Redeemable noncontrolling interest |
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Shareholders’ deficit / members' equity: |
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Class A ordinary shares, $ |
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Class B ordinary shares, $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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Accumulated deficit |
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( |
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( |
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Total shareholders' deficit / members’ equity |
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( |
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( |
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Total liabilities and shareholders' deficit/members' equity |
$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ProKidney Corp.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Operating loss |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
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( |
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( |
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( |
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Net loss before income taxes |
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( |
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( |
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( |
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( |
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Income tax expense (benefit) |
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( |
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Net loss before noncontrolling |
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( |
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( |
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( |
) |
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( |
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Net loss attributable to noncontrolling interest |
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( |
) |
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( |
) |
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( |
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( |
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Net loss available to Class A ordinary shareholders |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted average Class A ordinary shares outstanding: (1) |
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Basic and diluted |
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Net loss per share attributable to Class A ordinary shares: (1) |
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Basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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(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.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ProKidney Corp.
Condensed Consolidated Statements of Comprehensive Loss - Unaudited
(in thousands, except for share and per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Net loss including noncontrolling interest |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive (loss) income: |
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Unrealized gain (loss) on marketable securities |
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( |
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Other comprehensive loss |
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( |
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Total comprehensive loss including noncontrolling interest |
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( |
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( |
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( |
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( |
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Less: Total comprehensive loss attributable to noncontrolling interest |
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( |
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( |
) |
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( |
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( |
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Total comprehensive loss attributable to Class A ordinary shareholders |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity - Unaudited
(in thousands, except for share and per share data)
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For the Three Months Ended September 30, 2023 |
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Class A Ordinary Shares |
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Class B Ordinary Shares |
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Redeemable Noncontrolling Interest |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Other Comprehensive Loss |
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Accumulated Deficit |
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Total Shareholders' Deficit / Members' Equity |
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Balance as of July 1, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Equity-based compensation |
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– |
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– |
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– |
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– |
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– |
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– |
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Issuance of Class A ordinary shares |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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Vesting of Class B restricted stock rights |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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Exchange of Class B ordinary shares for Class A ordinary shares |
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( |
) |
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– |
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( |
) |
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– |
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– |
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– |
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Impact of equity transactions on redeemable noncontrolling interest |
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– |
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– |
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– |
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– |
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( |
) |
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– |
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– |
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( |
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Unrealized loss on marketable securities |
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– |
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– |
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– |
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– |
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– |
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– |
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Net loss |
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( |
) |
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– |
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– |
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– |
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– |
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– |
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– |
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( |
) |
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( |
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Change in redemption value of noncontrolling interest |
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( |
) |
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– |
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– |
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– |
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– |
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– |
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– |
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Balance as of September 30, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity - Unaudited
(in thousands, except for share and per share data)
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For the Three Months Ended September 30, 2022 |
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Class A Units |
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Class B Units |
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Class A Ordinary Shares |
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Class B Ordinary Shares |
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Redeemable Noncontrolling Interest |
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Units |
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Amount |
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Profits Interests |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Deficit |
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Total Shareholders' Deficit / Members' Equity |
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Balance as of July 1, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Equity-based compensation / payments prior to Business Combination |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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Net loss prior to the Business Combination |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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( |
) |
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( |
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Effect of the Business Combination, including net proceeds of shares sold |
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( |
) |
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( |
) |
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( |
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– |
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( |
) |
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( |
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Equity-based compensation after the Business Combination |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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Vesting of Class B restricted stock rights |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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Impact of equity transactions on redeemable noncontrolling interest |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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( |
) |
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( |
) |
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Net loss after the Business Combination |
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( |
) |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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– |
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( |
) |
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( |
) |
Balance as of September 30, 2022 |
|
$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
|||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity - Unaudited
(in thousands, except for share and per share data)
|
|
For the Nine Months Ended September 30, 2023 |
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Class A Ordinary Shares |
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Class B Ordinary Shares |
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Redeemable Noncontrolling Interest |
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Shares |
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Amount |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Other Comprehensive Loss |
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Accumulated Deficit |
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Total Shareholders' Deficit / Members' Equity |
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|||||||||
Balance as of January 1, 2023 |
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( |
) |
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( |
) |
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Equity-based compensation |
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– |
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– |
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– |
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– |
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– |
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– |
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|||
Issuance of Class A ordinary shares |
|
|
– |
|
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
|
|
|
– |
|
|||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Exchange of Class B ordinary shares for Class A ordinary shares |
|
|
( |
) |
|
|
|
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Impact of equity transactions on redeemable noncontrolling interest |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Unrealized loss on marketable securities |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
( |
) |
Net loss |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|||||||||||||||