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 |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
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 |
|
☐ |
|
Accelerated filer |
|
☐ |
|
|
|
|
|||
|
☒ |
|
Smaller reporting company |
|
||
|
|
|
|
|
|
|
Emerging growth company |
|
|
|
|
|
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 ☐ No
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 |
|
Shares Outstanding as of November 14, 2022 |
Class A ordinary shares, par value $0.0001 per share |
|
|
Class B ordinary shares, par value $0.0001 per share |
|
\`
Table of Contents
|
|
Page |
PART I. |
2 |
|
Item 1. |
2 |
|
|
2 |
|
|
3 |
|
|
4 |
|
|
8 |
|
|
Notes to Unaudited Condensed Consolidated Financial Statements |
9 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
Item 3. |
31 |
|
Item 4. |
31 |
|
PART II. |
32 |
|
Item 1. |
32 |
|
Item 1A. |
32 |
|
Item 2. |
32 |
|
Item 3. |
32 |
|
Item 4. |
32 |
|
Item 5. |
32 |
|
Item 6. |
32 |
|
34 |
i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
ProKidney Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
(Unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
|
|
$ |
|
||
Prepaid assets |
|
|
|
|
|
||
Prepaid clinical |
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
||
|
|
|
|
|
|
||
Fixed assets, net |
|
|
|
|
|
||
Right of use assets, net |
|
|
|
|
|
||
Intangible assets, net |
|
|
|
|
|
||
Total assets |
$ |
|
|
$ |
|
||
|
|
|
|
|
|
||
Liabilities and Equity |
|
|
|
|
|
||
Accounts payable |
$ |
|
|
$ |
|
||
Lease liabilities |
|
|
|
|
|
||
Accrued expenses and other |
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
||
|
|
|
|
|
|
||
Income tax payable, net of current portion |
|
|
|
|
|
||
Lease liabilities, net of current portion |
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
||
|
|
|
|
|
|||
Redeemable noncontrolling interest |
|
|
|
|
|
||
|
|
|
|
|
|
||
Shareholders’ deficit / members' equity: |
|
|
|
|
|
||
Class A units ( |
|
|
|
|
|
||
Class B units ( |
|
|
|
|
|
||
Class A ordinary shares, $ |
|
|
|
|
|
||
Class B ordinary shares, $ |
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
||
Accumulated deficit |
|
( |
) |
|
|
( |
) |
Total shareholders' deficit / members’ equity |
|
( |
) |
|
|
|
|
Total liabilities and equity |
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ProKidney Corp.
Condensed Consolidated Statements of Operations and Comprehensive Loss - Unaudited
(in thousands, except for share and per share data)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
Net loss before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Income tax (benefit) expense |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Net and comprehensive loss before noncontrolling |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss and comprehensive loss attributable to |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Net loss and comprehensive loss available to Class A |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average Class A ordinary shares outstanding: (1) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to Class A ordinary shares: (1) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
|
|
|
$ |
( |
) |
|
|
|
(1)
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
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 Three Months Ended September 30, 2022 |
|
||||||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
|
|
|
|
|
Class A |
|
|
Class B |
|
|
Class A Ordinary Shares |
|
|
Class B Ordinary Shares |
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Units |
|
|
Amount |
|
|
Profits Interests |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Deficit |
|
|
Total Shareholders' Deficit / Members' Equity |
|
|||||||||||
Balance as of June 30, 2022 |
|
$ |
– |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
– |
|
|
$ |
– |
|
|
|
– |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
( |
) |
|
$ |
|
||||
Equity-based compensation / payments prior to Business Combination |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Net loss prior to the Business Combination |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Effect of Business Combination |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
|||||
Equity-based compensation after the Business Combination |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
|
|||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Impact of equity transactions on redeemable noncontrolling interest |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
|
Net loss after the Business Combination |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of September 30, 2022 |
|
$ |
|
|
|
|
– |
|
|
$ |
– |
|
|
$ |
– |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
4
|
|
For the Three Months Ended September 30, 2021 |
|
|||||||||||||||||
|
|
Class A |
|
|
Class B |
|
|
Accumulated |
|
|
Total Members' |
|
||||||||
|
|
Units |
|
|
Amount |
|
|
Profits Interests |
|
|
Deficit |
|
|
Equity |
|
|||||
Balance as of June 30, 2021 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Capital contribution |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Equity-based payments |
|
|
– |
|
|
|
– |
|
|
|
|
|
|
|
|
|
|
|||
Net loss |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of September 30, 2021 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
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)
|
|
For the Nine Months Ended September 30, 2022 |
|
||||||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
|
|
|
|
|
Class A Units |
|
|
Class B Units |
|
|
Class A Ordinary Shares |
|
|
Class B Ordinary Shares |
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Units |
|
|
Amount |
|
|
Profits Interests |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Deficit |
|
|
Total Shareholder's Deficit / Members' Equity |
|
|||||||||||
Balance as of December 31, 2021 |
|
$ |
– |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
– |
|
|
$ |
– |
|
|
|
– |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
( |
) |
|
$ |
|
||||
Capital contribution |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Equity-based compensation / payments prior to Business Combination |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Net loss prior to the Business Combination |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Effect of the Business Combination, including net proceeds of shares sold |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
|||||
Equity-based compensation after the Business Combination |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
|
|||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Impact of equity transactions on redeemable noncontrolling interest |
|
|
|
|
|
|
– |
|
|
|
– |
|