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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

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: 001-40560

 

ProKidney Corp.

(Exact Name of Registrant as Specified in its Charter)

 

 

Cayman Islands

98-1586514

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

2000 Frontis Plaza Blvd., Suite 250

Winston-Salem, NC

27103

(Address of principal executive offices)

(Zip Code)

(336) 999-7019

(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

Class A ordinary shares, $0.0001 par value per share

 

PROK

 

The Nasdaq Stock Market

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. Yes No

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). Yes No

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

 

 

 

 

Non-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

 

Class of Stock

 

Shares Outstanding as of November 11, 2024

Class A ordinary shares, par value $0.0001 per share

 

127,968,243

Class B ordinary shares, par value $0.0001 per share

 

163,693,707

`

 


 

Table of Contents

 

Page

PART I.

Financial Information (Unaudited)

2

Item 1.

Financial Statements

2

Condensed Consolidated Balance Sheets

2

Condensed Consolidated Statements of Operations

3

 

Condensed Consolidated Statements of Comprehensive Loss

4

 

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit

5

Condensed Consolidated Statements of Cash Flows

9

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

Other Information

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

32

Item 3.

Defaults Upon Senior Securities

32

Item 4.

Mine Safety Disclosures

32

Item 5.

Other Information

33

Item 6.

Exhibits

33

Signatures

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, 2024

 

 

December 31, 2023

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

Cash and cash equivalents

$

108,088

 

 

$

60,649

 

Marketable securities

 

298,724

 

 

 

302,301

 

Interest receivable

 

5,102

 

 

 

1,375

 

Prepaid assets

 

6,227

 

 

 

3,399

 

Prepaid clinical

 

11,053

 

 

 

6,413

 

Other current assets

 

1,031

 

 

 

9

 

Total current assets

 

430,225

 

 

 

374,146

 

 

 

 

 

 

 

Fixed assets, net

 

38,519

 

 

 

42,143

 

Right of use assets, net

 

6,049

 

 

 

4,263

 

Total assets

$

474,793

 

 

$

420,552

 

 

 

 

 

 

 

Liabilities and Shareholders' Deficit

 

 

 

 

 

Accounts payable

$

2,850

 

 

$

5,098

 

Lease liabilities

 

1,067

 

 

 

803

 

Accrued expenses and other

 

21,264

 

 

 

17,665

 

Income taxes payable

 

 

 

 

1,472

 

Total current liabilities

 

25,181

 

 

 

25,038

 

 

 

 

 

 

 

Income tax payable, net of current portion

 

772

 

 

 

568

 

Lease liabilities, net of current portion

 

5,372

 

 

 

3,610

 

Total liabilities

 

31,325

 

 

 

29,216

 

Commitments and contingencies

 

 

 

 

 

Redeemable noncontrolling interest

 

1,423,180

 

 

 

1,494,732

 

 

 

 

 

 

 

Shareholders’ deficit

 

 

 

 

 

Class A ordinary shares, $0.0001 par value; 500,000,000 shares
   authorized;
127,920,274 and 59,880,347 issued and outstanding as
   of September 30, 2024 and December 31, 2023, respectively

 

13

 

 

 

6

 

Class B ordinary shares, $0.0001 par value; 500,000,000 shares
   authorized;
163,741,676 and 168,297,916 issued and outstanding as
   of September 30, 2024 and December 31, 2023, respectively

 

16

 

 

 

17

 

Additional paid-in capital

 

199,509

 

 

 

36,114

 

Accumulated other comprehensive (loss) gain

 

321

 

 

 

130

 

Accumulated deficit

 

(1,179,571

)

 

 

(1,139,663

)

Total shareholders' deficit

 

(979,712

)

 

 

(1,103,396

)

Total liabilities and shareholders' deficit

$

474,793

 

 

$

420,552

 

 

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)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

31,250

 

 

$

32,198

 

 

$

87,887

 

 

$

84,179

 

General and administrative

 

 

17,723

 

 

 

14,419

 

 

 

44,218

 

 

 

43,133

 

Total operating expenses

 

 

48,973

 

 

 

46,617

 

 

 

132,105

 

 

 

127,312

 

Operating loss

 

 

(48,973

)

 

 

(46,617

)

 

 

(132,105

)

 

 

(127,312

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,580

 

 

 

5,541

 

 

 

14,960

 

 

 

16,803

 

Interest expense

 

 

(2

)

 

 

(2

)

 

 

(7

)

 

 

(9

)

Net loss before income taxes

 

 

(43,395

)

 

 

(41,078

)

 

 

(117,152

)

 

 

(110,518

)

Income tax (benefit) expense

 

 

(2,342

)

 

 

913

 

 

 

(2,300

)

 

 

3,205

 

Net loss before noncontrolling
   interest

 

 

(41,053

)

 

 

(41,991

)

 

 

(114,852

)

 

 

(113,723

)

Net loss attributable to noncontrolling interest

 

 

(23,143

)

 

 

(31,007

)

 

 

(74,944

)

 

 

(83,956

)

Net loss available to Class A ordinary shareholders

 

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average Class A ordinary shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

126,173,463

 

 

 

61,592,876

 

 

 

87,818,229

 

 

 

61,565,298

 

Net loss per share attributable to Class A ordinary shares:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.14

)

 

$

(0.18

)

 

$

(0.45

)

 

$

(0.48

)

 

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)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss including noncontrolling interest

 

$

(41,053

)

 

$

(41,991

)

 

$

(114,852

)

 

$

(113,723

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized income (loss) on marketable securities

 

 

750

 

 

 

241

 

 

 

235

 

 

 

(244

)

Other comprehensive income

 

 

750

 

 

 

241

 

 

 

235

 

 

 

(244

)

Total comprehensive loss including noncontrolling interest

 

 

(40,303

)

 

 

(41,750

)

 

 

(114,617

)

 

 

(113,967

)

Less: Total comprehensive loss attributable to noncontrolling interest

 

 

(22,720

)

 

 

(30,829

)

 

 

(74,900

)

 

 

(84,136

)

Total comprehensive loss attributable to Class A ordinary shareholders

 

$

(17,583

)

 

$

(10,921

)

 

$

(39,717

)

 

$

(29,831

)

 

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 - Unaudited

(in thousands, except for share and per share data)

 

 

 

For the Three Months Ended September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit

 

Balance as of July 1, 2024

 

$

1,444,737

 

 

 

 

125,856,877

 

 

$

13

 

 

 

163,817,953

 

 

$

16

 

 

$

189,267

 

 

$

(6

)

 

$

(1,161,661

)

 

$

(972,371

)

Equity-based compensation

 

 

851

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,084

 

 

 

 

 

 

 

 

 

6,084

 

Issuance of Class A ordinary shares, net of offering costs

 

 

 

 

 

 

1,868,891

 

 

 

 

 

 

 

 

 

 

 

 

4,470

 

 

 

 

 

 

 

 

 

4,470

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

117,842

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange of Class B ordinary shares for Class A ordinary shares

 

 

(454

)

 

 

 

194,119

 

 

 

 

 

 

(194,119

)

 

 

 

 

 

454

 

 

 

 

 

 

 

 

 

454

 

Exercise of stock options

 

 

 

 

 

 

387

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

766

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(766

)

 

 

 

 

 

 

 

 

(766

)

Unrealized income on marketable securities

 

 

423

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

327

 

 

 

 

 

 

327

 

Net loss

 

 

(23,143

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,910

)

 

 

(17,910

)

Balance as of September 30, 2024

 

$

1,423,180

 

 

 

 

127,920,274

 

 

$

13

 

 

 

163,741,676

 

 

$

16

 

 

$

199,509

 

 

$

321

 

 

$

(1,179,571

)

 

$

(979,712

)

 

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 - Unaudited

(in thousands, except for share and per share data)

 

 

 

 

 

 

 

For The Three Months Ended September 30, 2023

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit / Members' Equity

 

Balance as of July 1, 2023

 

$

1,779,198

 

 

 

 

61,590,231

 

 

$

6

 

 

 

173,663,427

 

 

$

18

 

 

$

30,957

 

 

$

(127

)

 

$

(1,353,108

)

 

$

(1,322,254

)

Equity-based compensation

 

 

2,629

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,365

 

 

 

 

 

 

 

 

 

10,365

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

180,972

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange of Class B ordinary shares for Class A ordinary shares

 

 

(64

)

 

 

 

5,069

 

 

 

 

 

 

(5,069

)

 

 

 

 

 

64

 

 

 

 

 

 

 

 

 

64

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

21

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21

)

 

 

 

 

 

 

 

 

(21

)

Unrealized loss on marketable securities

 

 

178

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

Net loss

 

 

(31,007

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,984

)

 

 

(10,984

)

Change in redemption value of noncontrolling interest

 

 

(230,130

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

230,130

 

 

 

230,130

 

Balance as of September 30, 2023

 

$

1,520,825

 

 

 

 

61,595,300

 

 

$

6

 

 

 

173,839,330

 

 

$

18

 

 

$

41,365

 

 

$

(64

)

 

$

(1,133,962

)

 

$

(1,092,637

)

 

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 - Unaudited

(in thousands, except for share and per share data)

 

 

 

For the Nine Months Ended September 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit

 

Balance as of January 1, 2024

 

$

1,494,732

 

 

 

 

59,880,347

 

 

$

6

 

 

 

168,297,916

 

 

$

17

 

 

$

36,114

 

 

$

130

 

 

$

(1,139,663

)

 

$

(1,103,396

)

Equity-based compensation

 

 

3,865

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,559

 

 

 

 

 

 

 

 

 

18,559

 

Issuance of Class A ordinary shares, net of offering costs

 

 

 

 

 

 

62,087,817

 

 

 

6

 

 

 

 

 

 

 

 

 

144,319

 

 

 

 

 

 

 

 

 

144,325

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

1,395,202

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange of Class B ordinary shares for Class A ordinary shares

 

 

(15,356

)

 

 

 

5,951,442

 

 

 

1

 

 

 

(5,951,442

)

 

 

(1

)

 

 

15,356

 

 

 

 

 

 

 

 

 

15,356

 

Exercise of stock options

 

 

 

 

 

 

668

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

14,839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,839

)

 

 

 

 

 

 

 

 

(14,839

)

Unrealized loss on marketable securities

 

 

44

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

191

 

 

 

 

 

 

191

 

Net loss

 

 

(74,944

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(39,908

)

 

 

(39,908

)

Balance as of September 30, 2024

 

$

1,423,180

 

 

 

 

127,920,274

 

 

$

13

 

 

 

163,741,676

 

 

$

16

 

 

$

199,509

 

 

$

321

 

 

$

(1,179,571

)

 

$

(979,712

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

7


 

ProKidney Corp.

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit - Unaudited

(in thousands, except for share and per share data)

 

 

 

For The Nine Months Ended September 30, 2023

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit

 

Balance as of January 1, 2023

 

$

1,601,555

 

 

 

 

61,540,231

 

 

$

6

 

 

 

171,578,320

 

 

$

18

 

 

$

7,476

 

 

$

 

 

$

(1,104,116

)

 

$

(1,096,616

)

Equity-based compensation

 

 

7,848

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29,368

 

 

 

 

 

 

 

 

 

29,368

 

Issuance of Class A ordinary shares

 

 

 

 

 

 

50,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

2,266,079

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange of Class B shares for Class A ordinary shares

 

 

(64

)

 

 

 

5,069

 

 

 

 

 

 

(5,069

)

 

 

 

 

 

64

 

 

 

 

 

 

 

 

 

64

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

(4,457

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,457

 

 

 

 

 

 

 

 

 

4,457

 

Unrealized loss on marketable securities

 

 

(180

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(64

)

 

 

 

 

 

(64

)

Net loss

 

 

(83,956

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,767

)

 

 

(29,767

)

Change in redemption value of noncontrolling interest

 

 

79

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(79

)

 

 

(79

)

Balance as of September 30, 2023

 

$

1,520,825

 

 

 

 

61,595,300

 

 

$

6

 

 

 

173,839,330

 

 

$

18

 

 

$

41,365

 

 

$

(64

)

 

$

(1,133,962

)

 

$

(1,092,637

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

8


 

ProKidney Corp.

Condensed Consolidated Statements of Cash Flows – Unaudited

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss before noncontrolling interest

 

$

(114,852

)

 

$

(113,723

)

Adjustments to reconcile net loss before noncontrolling interest to net cash flows used
   in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

3,858

 

 

 

2,707

 

Equity-based compensation

 

 

22,424

 

 

 

37,216

 

Gain on marketable securities, net

 

 

(5,521

)

 

 

(3,675

)

Impairment charges

 

 

5,324

 

 

 

 

Loss on disposal of equipment

 

 

186

 

 

 

21

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Interest receivable

 

 

(3,728

)

 

 

(714

)

Prepaid and other assets

 

 

(8,489

)

 

 

5,094

 

Accounts payable and accrued expenses

 

 

(114

)

 

 

7,774

 

Income taxes payable

 

 

(1,268

)

 

 

615

 

Net cash flows used in operating activities

 

 

(102,180

)

 

 

(64,685

)

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

Purchases of marketable securities

 

 

(277,291

)

 

 

(301,701

)

Sales and maturities of marketable securities

 

 

286,625

 

 

 

100,187

 

Purchase of equipment and facility expansion

 

 

(4,000

)

 

 

(32,625

)

Net cash flows provided by (used in) investing activities

 

 

5,334

 

 

 

(234,139

)

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from sales of Class A ordinary shares, net of offering costs

 

 

144,325

 

 

 

 

Payments on finance leases

 

 

(40

)

 

 

(39

)

Net cash flows provided by (used in) financing activities

 

 

144,285

 

 

 

(39

)

 

 

 

 

 

 

 

Net change in cash and cash equivalents

 

 

47,439

 

 

 

(298,863

)

Cash, beginning of period

 

 

60,649

 

 

 

490,252

 

Cash, end of period

 

$

108,088

 

 

$

191,389

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

Right of use assets obtained in exchange for lease obligations

 

$

2,621

 

 

$

714

 

Exchange of Class B ordinary shares

 

$

15,357

 

 

$

64

 

Impact of equity transactions and compensation on redeemable noncontrolling interest

 

$

18,748

 

 

$

3,207

 

Change in redemption value of noncontrolling interest

 

$

 

 

$

79

 

Equipment and facility expansion included in accounts payable and
   accrued expenses

 

$

910

 

 

$

1,386

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

9


 

ProKidney Corp.

Notes to Unaudited Condensed Consolidated Financial Statements

 

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 business combination between SCS and PKLP (the “Business Combination”) 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 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 rilparencel, 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, 2024, various holders own non-voting interests in PKLP, representing a 56.1% economic interest in PKLP, effectively restricting ProKidney’s interest to 43.9% 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.


.

 

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, 2024, Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit for the three and nine months ended September 30, 2024 and 2023 and Condensed Consolidated Statements of Cash Flows for the nine months ended September 30,

10


 

2024 and 2023 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, 2024, the results of operations for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2023 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, 2023, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2024.

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.

11


 

Accrued Expenses

Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Compensation

$

7,467

 

 

$

5,237

 

Severance

 

1,278

 

 

 

2,283

 

Clinical study related costs

 

4,271

 

 

 

1,658

 

Facility related costs

 

1,622

 

 

 

693

 

Accrued legal costs

 

633

 

 

 

1,015

 

Investment purchases payable

 

2,943

 

 

 

 

Manufacturing improvement costs

 

 

 

 

4,365

 

Accrued consulting and professional fees

 

425

 

 

 

878

 

Other accrued expenses

 

2,625

 

 

 

1,536

 

Total accrued expenses and other

$

21,264

 

 

$

17,665

 

 

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

 

12


 

Fixed assets consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Land

$

3,067

 

 

$

3,067

 

Buildings

 

17,166

 

 

 

22,490

 

Leasehold improvements

 

18,924

 

 

 

10,950

 

Furniture and equipment

 

5,511

 

 

 

3,690

 

Computer equipment and software

 

862

 

 

 

847

 

Construction in progress

 

3,560

 

 

 

8,741

 

Less: accumulated depreciation

 

(10,571

)

 

 

(7,642

)

Total fixed assets, net

$

38,519

 

 

$

42,143

 

 

Depreciation expense for the three months ended September 30, 2024 and 2023 was $1,199,000 and $807,000, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was $2,996,000 and $2,084,000, 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.

Due to a change in the planned use for the Company’s Greensboro facility, the Company performed an impairment analysis to compare the building’s carrying value with its estimated fair value. The fair value was determined through review of prices for similar assets and expected ranges of prices that the Company may be expected to receive upon sale of the property which are considered Level 3 inputs under the fair value hierarchy. This analysis resulted in the recognition of a non-cash impairment charge of $5.3 million during the three and nine months ended September 30, 2024.

No impairment charges were recorded for the three and nine months ended September 30, 2023.

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, 2024 and December 31, 2023.

Interest and penalties related to income taxes are included in the 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. 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

13


 

Level 3 – Unobservable inputs that are supported by little or no market data, which require the reporting entity to develop its own assumptions

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

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 equity-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for time-vested awards earned over the service period on a straight-line basis. The Company recognizes equity-based compensation for options containing performance-based vesting conditions over the requisite service period if it is probable that the performance conditions will be satisfied. The Company records forfeitures of equity-based compensation awards as they occur.

The grant date fair value of time and performance-based 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.

Recently Issued Accounting Pronouncements

In March 2024, the Financial Accounting Standards Board (“FASB”) issued a new standard that provides additional guidance for determining whether profits interests and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock

14


 

Compensation, of the Accounting Standards Codification. The standard will be effective for the Company beginning with our annual reporting for fiscal year 2025 and interim periods in that year, with early adoption permitted. We do not believe that the adoption of this standard will have an impact on the classification of the profits interests that were granted to participants prior to the Business Combination.

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, 2024 (in thousands):

 

 

Fair Value Hierarchy

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

 

Cash Equivalents

 

 

Marketable Securities

 

Money market funds

Level 2

 

$

21,566

 

 

$

 

 

$

 

 

$

21,566

 

 

$

21,566

 

 

$

 

Time deposits

Level 2

 

 

7,176

 

 

 

27

 

 

 

 

 

 

7,203

 

 

 

 

 

 

7,203

 

Commercial paper

Level 2

 

 

37,185

 

 

 

100

 

 

 

 

 

 

37,285

 

 

 

 

 

 

37,285

 

Asset backed securities

Level 2

 

 

7,672

 

 

 

48

 

 

 

 

 

 

7,720

 

 

 

 

 

 

7,720

 

Government bonds

Level 2

 

 

78,434

 

 

 

124

 

 

 

 

 

 

78,558

 

 

 

31,000

 

 

 

47,558

 

Corporate debt securities

Level 2

 

 

199,052

 

 

 

458

 

 

 

(24

)

 

 

199,486

 

 

 

528

 

 

 

198,958

 

Total

 

 

$

351,085

 

 

$

757

 

 

$

(24

)

 

$

351,818

 

 

$

53,094

 

 

$

298,724

 

The following table shows the fair value of the Company’s cash equivalents and marketable securities, by contractual maturity, as of September 30, 2024 (in thousands):

 

 

September 30, 2024

 

Due in 1 year or less

$

324,702

 

Due in 1 year through 5 years

 

27,116

 

Total

$

351,818

 

 

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, 2024 (in thousands):

 

 

Less than 12 months

 

 

12 Months or Greater

 

 

Total

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

Corporate debt securities

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

Total

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

 

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 three and nine months ended September 30, 2024 and 2023. As such, the Company has not recognized an allowance for credit losses related to our marketable debt securities during the three and nine months ended September 30, 2024 and 2023.

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.

15


 

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, 2024.

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, 2024 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 three and nine months ended September 30, 2024 and 2023.

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 $479,000 and $276,000, for the three months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024 and 2023, the Company’s rent expense was $1,413,000 and $736,000, respectively. Cash paid for operating leases during the nine months ended September 30, 2024, was $968,000.

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, 2024 and December 31, 2023 (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Operating leases:

 

 

 

 

 

 

Right of use assets

 

$

5,939

 

 

$

4,116

 

 

 

 

 

 

 

 

Operating lease liabilities, current

 

$

1,032

 

 

$

751

 

Operating lease liabilities, noncurrent

 

 

5,290

 

 

 

3,506

 

Total operating lease liabilities

 

$

6,322

 

 

$

4,257

 

 

 

 

 

 

 

 

Finance leases:

 

 

 

 

 

 

Right of use assets

 

$

110

 

 

$

147

 

 

 

 

 

 

 

 

Finance lease liabilities, current

 

$

35

 

 

$

52

 

Finance lease liabilities, noncurrent

 

 

82

 

 

 

104

 

Total finance lease liabilities

 

$

117

 

 

$

156

 

 

16


 

 

Maturities of lease liabilities for the Company’s operating and finance leases are as follows as of September 30, 2024 (in thousands):

 

 

Operating Leases

 

 

Finance Leases

 

 

Total

 

 2024 (remaining three months)

 

$

496

 

 

$

26

 

 

$

522

 

 2025

 

 

1,681

 

 

 

22

 

 

 

1,703

 

 2026

 

 

1,841

 

 

 

22

 

 

 

1,863

 

 2027

 

 

1,725

 

 

 

22

 

 

 

1,747

 

 2028

 

 

1,361

 

 

 

22

 

 

 

1,383

 

Thereafter

 

 

1,279

 

 

 

22

 

 

 

1,301

 

Total lease payments

 

 

8,383

 

 

 

136

 

 

 

8,519

 

Less: imputed interest

 

 

(2,061

)

 

 

(19

)

 

 

(2,080

)

Present value of lease liabilities

 

$

6,322

 

 

$

117

 

 

$

6,439

 

 

The weighted average remaining lease term for operating leases is 4.6 years, and 4.5 years for finance leases. The weighted average discount rate for operating leases is 10.9% and 6.1% for finance leases.

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) 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 began 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, rilparencel (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.

17


 

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.

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 months ended September 30, 2024 and 2023, 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 months ended September 30, 2024 and 2023, 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.

18


 

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 56.1% 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, 2024, 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,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss available to Class A ordinary shareholders

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

(Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of
   subsidiary equity-based compensation

 

851

 

 

 

2,629

 

 

 

3,865

 

 

 

7,848

 

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange
   of Common Units in ProKidney LP for Class A ordinary shares

 

(454

)

 

 

(64

)

 

 

(15,356

)

 

 

(64

)

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of
   Restricted Common Units in ProKidney LP

 

766

 

 

 

21

 

 

 

14,839

 

 

 

(4,457

)

Change from net loss available to Class A ordinary shareholders and change
   in ownership interest in ProKidney LP

$

(16,747

)

 

$

(8,398

)

 

$

(36,560

)

 

$

(26,440

)

 

Note 8: Shareholders’ Equity

In June 2024, the Company sold 46,886,452 of its Class A ordinary shares in an underwritten public offering at a price of $2.42 per share. Additionally, in June 2024, the Company sold 11,030,574 of its Class A ordinary shares to certain investment entities at price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements. The net proceeds to the Company from the offerings were approximately $136,618,000, after deducting the underwriting discounts and commissions and offering expenses payable by the Company. The shares were offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

In January 2024, the Company entered into an Open Market Sale AgreementSM (“Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of its Class A ordinary shares having an aggregate offering price of up to $100.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

During the three months ended September 30, 2024, the Company sold 1,868,891 of its Class A ordinary shares under the Sales Agreement for net proceeds of $4,470,000. During the nine months ended September 30, 2024, the Company sold 4,170,791 of its Class A ordinary shares under the Sales Agreement for net proceeds of $7,707,000.

Note 9: 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

19


 

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 following table sets forth the computation of basic and diluted net loss per share for the three months ended September 30, 2024 and 2023 (in thousands, except share and per share amounts):

 

 

Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(41,053

)

 

$

(41,991

)

 

$

(114,852

)

 

$

(113,723

)

Less: Net loss attributable to noncontrolling interests

 

(23,143

)

 

 

(31,007

)

 

 

(74,944

)

 

 

(83,956

)

Net loss available to Class A ordinary shareholders of ProKidney Corp.,
   basic and diluted

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

 

 

 

 

 

 

 

 

 

 

 

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

Weighted average Class A ordinary shares or ProKidney Corp. outstanding,
   basic and diluted

 

126,173,463

 

 

 

61,592,876

 

 

 

87,818,229

 

 

 

61,565,298

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share of ProKidney Corp., basic and diluted

$

(0.14

)

 

$

(0.18

)

 

$

(0.45

)

 

$

(0.48

)

 

Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:

 

 

As of September 30,

 

 

2024

 

 

2023

 

Antidilutive securities

 

 

 

 

 

ProKidney Corp. Class B ordinary shares

 

163,741,676

 

 

 

173,839,330

 

Unvested Restricted Stock Rights

 

1,755,686

 

 

 

5,644,596

 

Earnout Rights

 

17,500,000

 

 

 

17,500,000

 

Stock options granted under the 2022 Equity Incentive Plan

 

22,076,832

 

 

 

17,356,148

 

 

Note 10: 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. 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, individual consultants 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, 2024:

 

20


 

 

 

Nine Months Ended September 30,

 

2024

 

2023

Expected volatility

 

82.9% - 85.0%

 

81.3% - 84.0%

Expected life of options, in years

 

5.4 - 6.1

 

5.2 - 6.1

Risk-free interest rate

 

3.7% - 4.6%

 

3.5% - 4.3%

Expected dividend yield

 

0.0%

 

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, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Time-vested options outstanding at January 1, 2024

 

 

14,680,109

 

 

$

7.83

 

Granted

 

 

8,442,907

 

 

 

1.88

 

Exercised

 

 

(668

)

 

 

1.61

 

Forfeited

 

 

(2,716,766

)

 

 

7.23

 

Time-vested options outstanding at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Time-vested options exercisable at September 30, 2024

 

 

4,177,180

 

 

$

9.07

 

Weighted average remaining contractual life

 

8.3 years

 

 

 

 

Time-vested options vested and expected to vest at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Weighted average remaining contractual life

 

8.8 years

 

 

 

 

As of September 30, 2024, the Company had total unrecognized stock-based compensation expense of approximately $47,185,000 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 2.8 years. The weighted average grant date fair value for the option grants during the nine months ended September 30, 2024 and 2023 was $1.37 and $7.11, respectively.

The aggregate intrinsic value of the in-the-money time-vested awards outstanding and those exercisable as of September 30, 2024 was $3,201,000 and $209,000, respectively.

Performance-Based Awards

The Company has issued stock options to certain of its employees which vest based on the achievement of both operational performance metrics and service rendered over a specific time period. The following table summarizes the activity related to the Company’s performance-based stock option awards granted under the 2022 Plan for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Performance-based options outstanding at January 1, 2024

 

 

1,000,000

 

 

$

1.69

 

Granted

 

 

671,250

 

 

 

1.52

 

Performance-based options outstanding at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Performance-based options exercisable at September 30, 2024

 

 

 

 

$

 

Performance-based options vested and expected to vest at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Weighted average remaining contractual life

 

9.3 years

 

 

 

 

 

As of September 30, 2024, the Company had total unrecognized stock-based compensation expense of approximately $458,000 related to the performance-based grants under the 2022 Plan, which is expected to be recognized on a straight-line basis over a weighted average period of 1.0 years.

Market-Vested Awards

In previous periods, the Company had granted market-vested options to its former Chief Executive Officer, these awards were forfeited upon the termination of his employment in November 2023. There were no market-vested awards granted during the three and nine months ended September 30, 2024 and 2023. There were no market based awards outstanding at September 30, 2024.

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

21


 

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).

Upon consummation of the Business Combination discussed in Note 1, PKLP’s existing Class B and B-1 Units were “caught up” and were converted into Class A Units of PKLP. The resulting vested and unvested Class A Units of PKLP were then recapitalized into Post-Combination ProKidney Common Units or Restricted Common Units of the Company, respectively. This recapitalization resulted in a decrease in the number of awards held by each participant. As such, the number of Profits Interests and related per unit values within these financial statements have been adjusted to reflect this recapitalization. Upon recapitalization, the Restricted Common Units maintained the vesting schedules associated with the original Profits Interest awards.

The following table summarizes the activity related to the Profits Interest awards for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

Unvested awards outstanding at January 1, 2024

 

 

3,565,753

 

 

$

7.23

 

Vested

 

 

(1,336,572

)

 

 

6.89

 

Forfeited

 

 

(473,495

)

 

 

7.64

 

Unvested awards outstanding at September 30, 2024

 

 

1,755,686

 

 

$

7.37

 

 

As of September 30, 2024, the unrecognized compensation expense related to these awards was $8,002,000. The current weighted average remaining period over which the unrecognized compensation expense is expected to be recognized is 1.2 years.

Modification to Equity Based Compensation Awards

During the nine months ended September 30, 2023, the Company 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.

Equity Based Compensation Expense

Compensation expense related to equity-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,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

$

2,937

 

 

$

4,881

 

 

$

9,571

 

 

$

13,324

 

General and administrative

 

3,997

 

 

 

8,112

 

 

 

12,853

 

 

 

23,891

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

 

22


 

The following table summarizes our equity based compensation by type of award (in thousands):

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Time-vested stock options

$

5,133

 

 

$

6,609

 

 

$

15,889

 

 

$

18,203

 

Performance-based stock options

 

293

 

 

 

 

 

 

862

 

 

 

 

Market-vested stock options

 

 

 

 

2,825

 

 

 

 

 

 

8,383

 

Legacy profits interests

 

1,508

 

 

 

3,559

 

 

 

5,673

 

 

 

10,629

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

 

23


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

As used in this Quarterly Report on Form 10-Q, the “Company”, the “Registrant”, “we” or “us” refer to ProKidney Corp. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear elsewhere in this report. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, assumptions and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the Risk Factors section of the Annual Report on Form 10-K filed with the Securities and Exchange Commission, and elsewhere in this report under “Part II, Other Information—Item 1A, Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies and operations, financing plans, potential growth opportunities, potential market opportunities, potential results of our drug development efforts or trials, and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s plans, estimates, assumptions and beliefs only as of the date of this report. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Overview

We are a clinical-stage biotechnology company with a transformative proprietary cell therapy platform that has the potential to treat multiple chronic kidney diseases using a patient’s own cells isolated from the patient intended for treatment. Our approach seeks to redefine the treatment of chronic kidney disease (“CKD”), shifting the emphasis away from management of kidney failure to the preservation, if not improvement, of kidney function. Our lead product candidate, rilparencel (which we sometimes refer to as REACT®), is designed to preserve kidney function in a CKD patient’s diseased kidneys. Rilparencel is a product that includes autologous Selected Renal Cells (“SRC”) prepared from a patient’s own (autologous) kidney cells. SRC are formulated into a product for reinjection into the patient’s kidneys using a minimally invasive outpatient procedure that is repeatable, if necessary. Because rilparencel is a personalized treatment composed of cells prepared from a patient’s own kidney, there is no need for treatment with immunosuppressive therapies that are required during a patient’s lifetime when a patient receives a kidney transplant from another, allogeneic donor.

We are currently conducting a global Phase 3 development program and one ongoing Phase 2 clinical trial for rilparencel in subjects with moderate to severe diabetic kidney disease (“DKD”). We also completed a Phase 1 clinical trial for rilparencel in subjects with CKD due to congenital anomalies of the kidney and urinary tract (“CAKUT”) for which the last subject visit occurred in January 2023 and the clinical study report was submitted to the United States Food and Drug Administration (“FDA”) in December 2023. Rilparencel has, to date, been generally well tolerated by subjects with moderate to severe CKD in Phase 1 and 2 clinical testing.

Since our inception, we have devoted substantially all of our resources to organizing and staffing our Company, business and scientific planning, conducting discovery and research activities, acquiring or discovering product candidates, establishing and protecting our intellectual property portfolio, developing and progressing rilparencel, raising capital and preparing for clinical trials, establishing arrangements with third parties for the manufacture of component materials, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue from product sales.

Recent Developments

REGEN-006/PROACT 1 trial:

REGEN-006 (PROACT 1) is an ongoing Phase 3, randomized, blinded, bi-lateral kidney dose, sham control arm, controlled safety and efficacy study of rilparencel in subjects with advanced kidney disease caused by type 2 diabetes. The related study protocol has been amended to focus on a subset of patients with Stage 4 CKD (estimated glomerular filtration rate (“eGFR”)) between 20 and 30 mL/min/1.73m2) and late Stage 3b CKD (eGFR between 30 and 35 mL/min/1.73m2) with accompanying albuminuria (urinary albumin-creatinine ratio (“UACR”) between 300 and 5000 mg/g). PROACT 1 has resumed enrolling patients under the amended protocol.

24


 

REGEN-016/PROACT 2 trial:

REGEN-016 (PROACT 2) was a planned Phase 3, randomized, blinded, sham control arm, bi-lateral kidney dose, controlled safety and efficacy study of rilparencel in subjects with Stages 3b and 4 CKD caused by type 2 diabetes (specifically eGFR between 20 and 44 mL/min/1.73m2 with moderate to severe albuminuria (UACR between 300 and 5,000 mg/g)).

In the third quarter of 2024, we completed a comprehensive internal and external review, including engaging with ex-FDA officials and seasoned regulatory experts, to determine the optimal path to bring rilparencel to patients in the U.S. with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need. An important conclusion of this review was that under the provisions of the Regenerative Medicine Advanced Therapy (“RMAT”) designation, we believe rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial. We believe that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, we have discontinued PROACT 2, which was focused on enrollment outside the U.S.

In October 2024, we had a Type B meeting with the FDA to discuss updates to rilparencel’s registrational trial strategy. The FDA confirmed that PROACT 1 could be sufficient to support a potential Biologics License Application (“BLA”) submission. Additionally,the FDA confirmed that the accelerated approval pathway is available to rilparencel and that the Company could consider eGFR slope as a surrogate endpoint for accelerated approval. We will continue to engage with the FDA, under our RMAT designation, to further define the details supporting this accelerated pathway.

Real Estate Matters:

Due to a change in the planned use for our Greensboro, North Carolina facility, we performed an impairment analysis to compare the building’s carrying value with its estimated fair value. This analysis resulted in the recognition of a non-cash impairment charge of $5.3 million during the three and nine months ended September 30, 2024.

Financial Operations Overview

Revenue

We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for rilparencel or any other product candidates are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.

Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred in connection with our research and development activities, including the development of rilparencel.

Research and development costs include:

external research and development expenses incurred under agreements with CROs and other scientific development services;
costs of other outside consultants, including their fees and related travel expenses;
costs related to compliance with quality and regulatory requirements;
costs of laboratory supplies and acquiring and developing clinical trial materials;
payments made under third-party licensing agreements;
personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation expenses, for individuals involved in research and development activities; and
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, insurance and other internal operating costs.

We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated balance sheets as prepaid clinical or as a component of total accrued expenses and other. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is

25


 

no alternative future use for the research and development. The capitalized amounts are recorded as prepaid clinical and are expensed as the related goods are delivered or the services are performed.

Research and development activities are central to our business model. We expect that our research and development expenses will increase significantly for the foreseeable future as rilparencel moves into later stages of clinical development.

The successful development of rilparencel and any product candidates we may develop in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of rilparencel or potential future product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of:

the timing and progress of non-clinical and clinical development activities;
the number and scope of non-clinical and clinical programs we decide to pursue;
our ability to maintain our current research and development programs and to establish new ones;
establishing an appropriate safety-profile;
the number of sites and patients involved in our clinical trials;
the countries in which the clinical trials are conducted;
per patient trial costs;
successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates;
the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA and comparable foreign regulatory authorities;
the number of trials required for regulatory approval;
the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities;
our ability to establish new licensing or collaboration arrangements;
the performance of our future collaborators, if any;
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
significant and changing government regulation and regulatory guidance;
the impact of any business interruptions to our operations or to those of the third parties with whom we work;
obtaining, maintaining, defending and enforcing patient claims or other intellectual property rights;
the potential benefits of rilparencel over other therapies;
launching commercial sales of rilparencel, if approved, whether alone or in collaboration with others; and
maintaining a continued acceptable safety profile of rilparencel following approval.

Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and equity-based compensation expenses for individuals involved in our executive, finance, corporate and administrative functions, as well as expenses for outside professional services, including legal, audit, accounting and tax-related services and other consulting fees, facility-related expenses, which include depreciation costs and other allocated expenses for rent and maintenance of facilities, insurance costs, recruiting costs, travel expenses and other general administrative expenses.

26


 

We expect that our general and administrative expenses will increase significantly for the foreseeable future as our business expands and we hire additional personnel to support our operations. We also anticipate increased expenses associated with being a public company, including costs for legal, audit, accounting, investor and public relations, tax-related services, director and officer insurance, and regulatory costs related to compliance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) as well as listing standards applicable to companies listed on a national securities exchange.

Other Income (Expense)

Other income consists primarily of interest income earned on cash, cash equivalents and marketable securities.

Income Tax Expense

Income tax expense reflects federal and state taxes on income earned by our subsidiary that is organized as a C corporation for U.S. income tax purposes.

Results of Operations

Comparison of Three Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023 (in thousands):

 

 

Three Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

31,250

 

 

$

32,198

 

 

$

(948

)

General and administrative

 

 

17,723

 

 

 

14,419

 

 

 

3,304

 

Total operating expense

 

 

48,973

 

 

 

46,617

 

 

 

2,356

 

Loss from operations

 

 

(48,973

)

 

 

(46,617

)

 

 

(2,356

)

Interest income

 

 

5,580

 

 

 

5,541

 

 

 

39

 

Interest expense

 

 

(2

)

 

 

(2

)

 

 

 

Net loss before taxes

 

 

(43,395

)

 

 

(41,078

)

 

 

(2,317

)

Income tax (benefit) expense

 

 

(2,342

)

 

 

913

 

 

 

(3,255

)

Net loss before noncontrolling interest

 

 

(41,053

)

 

 

(41,991

)

 

 

938

 

Net loss attributable to noncontrolling interest

 

 

(23,143

)

 

 

(31,007

)

 

 

7,864

 

Net loss available to Class A ordinary shareholders

 

$

(17,910

)

 

$

(10,984

)

 

$

(6,926

)

 

Research and development expenses

The decrease in research and development expenses of approximately $0.9 million was primarily driven by the following:

decreases in costs for clinical operations of approximately $2.5 million, primarily due to wind down of activities related to PROACT 2 as well as decreases in the costs for other trials,
decreases in equity-based compensation costs of approximately $1.9 million driven by awards forfeited by terminated employees as well as lower valuations of awards granted in the current year,
decreases in spending of approximately $1.8 million related to manufacturing process development; offset by;
increases in cash-based compensation costs of approximately $3.5 million due to the hiring of additional personnel particularly in the areas of clinical development, manufacturing and quality as we move forward with our clinical programs; and
increases in operational costs of $1.4 million as we continue to expand operations and purchase materials to support our Phase 3 clinical program.

General and administrative expenses

The increase in general and administrative expenses of approximately $3.3 million was primarily driven by the following:

 

the recognition of an impairment charge of $5.3 million related to our Greensboro facility;
increases in cash-based compensation of approximately $2.0 million related to the hiring of new employees and severance costs for terminated employees; offset by;

27


 

decreases in equity-based compensation of approximately $4.1 million due to lower expenses in the 2024 period driven by the impact of forfeitures of awards made to executives.

Income tax (benefit) expense

The change in income tax (benefit) expense is due to the impact of the change in the treatment of specified research and development expenses by our U.S. subsidiary due to recent guidance issued by the Internal Revenue Service such that these costs are no longer required to be capitalized and amortized ratably over a five-year period.

Comparison of Nine Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

87,887

 

 

$

84,179

 

 

$

3,708

 

General and administrative

 

 

44,218

 

 

 

43,133

 

 

 

1,085

 

Total operating expense

 

 

132,105

 

 

 

127,312

 

 

 

4,793

 

Loss from operations

 

 

(132,105

)

 

 

(127,312

)

 

 

(4,793

)

Interest income

 

 

14,960

 

 

 

16,803

 

 

 

(1,843

)

Interest expense

 

 

(7

)

 

 

(9

)

 

 

2

 

Net loss before taxes

 

 

(117,152

)

 

 

(110,518

)

 

 

(6,634

)

Income tax (benefit) expense

 

 

(2,300

)

 

 

3,205

 

 

 

(5,505

)

Net loss before noncontrolling interest

 

 

(114,852

)

 

 

(113,723

)

 

 

(1,129

)

Net loss attributable to noncontrolling interest

 

 

(74,944

)

 

 

(83,956

)

 

 

9,012

 

Net loss available to Class A ordinary shareholders

 

$

(39,908

)

 

$

(29,767

)

 

$

(10,141

)

 

Research and development expenses

The increase in research and development expenses of approximately $3.7 million was primarily driven by the following:

increases in cash-based compensation costs of approximately $9.8 million due to the hiring of additional personnel particularly in the areas of clinical development, manufacturing and quality as we move forward with our clinical programs,
increases in professional fees of $4.4 million related to the remediation of quality and manufacturing compliance deficiencies;
increases in operational and material costs of $4.1 million as we continue to expand operations and purchase materials to support our Phase 3 clinical trials, offset by;
decreases in spending of approximately $7.1 million related to manufacturing process development;
decreases in equity-based compensation costs of $3.8 million associated with lower valuations of equity-based awards granted in the current period coupled with the impact of forfeitures of awards for terminated employees; and
decreases in clinical study costs of approximately $3.7 million primarily due to the impact of the pause of manufacturing and its impact on our Phase 3 program as well as the levels of activity ongoing with our other clinical trials.

General and administrative expenses

The increase in general and administrative expenses of approximately $1.1 million was primarily driven by the following:

 

the recognition of an impairment charge of $5.3 million related to our Greensboro facility;
increases in cash-based compensation of approximately $6.0 million related to the hiring of new employees; offset by;
decreases in equity-based compensation of approximately $11.0 million due to lower expenses in the 2024 period driven by the impact of forfeitures of awards made to executives.

28


 

Income tax expense

The change in income tax (benefit) expense was driven by a change in the treatment of specified research and development expenses by our U.S. subsidiary due to recent guidance issued by the Internal Revenue Service such that these costs are no longer required to be capitalized and amortized ratably over a five-year period.

Liquidity and Capital Resources

Sources of liquidity

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. From our inception through September 30, 2024, we funded our operations primarily through capital contributions from the holders of PKLP, the proceeds obtained through the Business Combination and related private placement financing, and an underwritten public offering and registered direct offering in June 2024.

As noted above, in June 2024, the Company sold 46,886,452 of its Class A ordinary shares in an underwritten public offering at a price of $2.42 per share. Additionally, in June 2024, the Company sold 11,030,574 of its Class A ordinary shares to certain investment entities at a price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements. The net proceeds to the Company from the offerings were approximately $136.7 million, after deducting the underwriting discounts and commissions and offering expenses payable by the Company. The shares were offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

In January 2024, we entered into an Open Market Sale AgreementSM (“Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, our Class A ordinary shares having an aggregate offering price of up to $100.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3. As of September 30, 2024, we have sold $7.9 million worth of Class A ordinary shares under the Sales Agreement for net proceeds of $7.7 million, leaving $92.1 million available to be sold.

We expect that our existing cash, cash equivalents and marketable securities held at September 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into mid-2026. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.

We expect our expenses to increase substantially if, and as, we:

initiate and continue research and clinical development of our product candidates, including in particular our clinical trials for rilparencel;
incur third-party manufacturing costs to support our non-clinical studies and clinical trials of our product candidate and, if approved, its commercialization;
seek to identify and develop additional product candidates;
make investment in developing internal manufacturing capabilities; and
seek regulatory and marketing approvals for our product candidates.

In addition, since the closing of the Business Combination we have begun incurring additional costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product that we do not expect to be commercially available for at least several years, if ever.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our shareholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or

29


 

any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technology, future- revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our shares. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.

Cash Flows

Cash Flows for the Nine Months Ended September 30, 2024 and 2023

The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Net cash flows used in operating activities

 

$

(102,180

)

 

$

(64,685

)

Net cash flows provided by (used in) investing activities

 

 

5,334

 

 

 

(234,139

)

Net cash flows provided by (used in) financing activities

 

 

144,285

 

 

 

(39

)

Net change in cash and cash equivalents

 

$

47,439

 

 

$

(298,863

)

 

Operating Activities

Net cash used in operating activities was approximately $102.2 million for the nine months ended September 30, 2024, reflecting a net loss of approximately $114.9 million and uses driven by changes in working capital of approximately $13.6 million. Such uses were partially offset by non-cash charges and gains on investments of $26.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $22.4 million, an impairment charge of $5.3 million and depreciation and amortization expense of $3.9 million. The changes in working capital primarily relate to the timing of payments made to our vendors for services performed and the recognition of receivable amounts related to interest on our marketable security investments.

Net cash used in operating activities was approximately $64.7 million for the nine months ended September 30, 2023, reflecting net loss of $113.7 million, partially offset cash provided by changes in working capital of approximately $12.8 million and non-cash charges and gains on investments of $36.2 million. The non-cash charges primarily consisted of equity-based compensation expense of $37.2 million and depreciation and amortization expense of $2.7 million.

The approximately $37.4 million increase in cash used in operating activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily driven by an increase in net loss after adjusting for the non-cash charges and gains on investments of approximately $11.3 million coupled with an increase in the use of cash related to the timing of payments to our vendors and receipt of interest amounts due.

Investing Activities

Net cash provided by (used in) investing activities was approximately $5.3 million and $(234.1 million) for the nine months ended September 30, 2024 and 2023, respectively. The cash provided by investing activities during the nine months ended September 30, 2024 was primarily related to withdrawal of cash from our investments for use in operations. The cash used in investing activities during the nine months ended September 30, 2023, was driven by the investment of a portion of the proceeds raised through the Business Combination in marketable securities as well as the purchase of our facility in Greensboro, North Carolina.

Financing Activities

Net cash from financing activities for the nine months ended September 30, 2024 includes proceeds of $144.3 million related to the sale of our Class A ordinary shares. Net cash used in financing activities for the nine months ended September 30, 2023 was an insignificant amount.

30


 

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements. Our condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Recent Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

JOBS Act Accounting Election

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies, allowing them to delay the adoption of those standards until those standards would otherwise apply to private companies. We have elected to use this extended transition period under the JOBS Act. As a result, our consolidated financial statements may not be comparable to the financial statements of companies that are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make our ordinary shares less attractive to investors.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

The Company’s exposure to changes in interest rates relates primarily to the Company’s investment portfolio. The goals of our investment strategy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we maintain a portfolio of cash equivalents and investments in a variety of securities that management believes to be of high credit quality. All securities in our investment portfolio are not leveraged and are, due to their short-term nature, subject to minimal interest rate risk. Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have a material negative impact on the value of our investment portfolio.

Inflation Risk

We do not believe that inflation has had a material effect on our business, financial condition, or results of operations, other than its impact on the general economy. To the extent our costs are impacted by general inflationary pressures, we may not be able to fully offset such higher costs through price increases or manufacturing efficiencies. Our inability or failure to do so could harm our business, financial condition, and results of operations.

Foreign Currency Risk

We do not have any material foreign currency exposure.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) of the Securities Exchange Act of 1934, as amended) as of September 30, 2024. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective in causing material information relating to us (including our consolidated subsidiaries) to be recorded, processed,

31


 

summarized and reported by management on a timely basis and to ensure the quality and timeliness of our public disclosures pursuant to SEC disclosure obligations.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, with the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error and mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of controls.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or because the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.

Changes to Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Website Availability of Reports and other Corporate Governance Information

The Company maintains a comprehensive corporate governance program, including Corporate Governance Guidelines for its Board of Directors, Board Guidelines for Assessing Director Independence and charters for its Audit Committee, Nominating and Corporate Governance Committee and Talent and Compensation Committee. The Company maintains a corporate investor relations website, https://investors.prokidney.com/, where stockholders and other interested persons may review, without charge, among other things, corporate governance materials and certain SEC filings, which are generally available on the same business day as the filing date with the SEC on the SEC’s website http://www.sec.gov. The contents of our website are not made a part of this Quarterly Report on Form 10-Q.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently a party to any material legal proceedings.

Item 1A. Risk Factors.

Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows, and prospects. These risks are discussed more fully in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 22, 2024 (the “2023 Annual Report”). There have been no material changes to the risk factors described in the 2023 Annual Report.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

There were no sales of unregistered equity securities during the three months ended September 30, 2024.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

32


 

Item 5. Other Information.

During the quarter ended September 30, 2024, none of the Company’s directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408, that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).

Item 6. Exhibits.

 

Exhibit

Number

Description

 

 

 

31.1*

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1*

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.2*

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101*

The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets (unaudited), (ii) Condensed Consolidated Statements of Operations (unaudited), (iii) Condensed Consolidated Statements of Comprehensive Loss (unaudited), (iv) Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit (unaudited), (v) Consolidated Statements of Cash Flows (unaudited) and (vi) Notes to Condensed Consolidated Financial Statements (unaudited), tagged as blocks of text and including detailed tags.

 

 

 

104*

 

The cover page from this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL.

 

 

 

 

† Management contract or compensatory plan or arrangement

* Filed herewith.

 

33


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on

its behalf by the undersigned thereunto duly authorized.

 

Company Name

Date: November 12, 2024

By:

/s/ Bruce Culleton

Name: Bruce Culleton

Title: Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

Date: November 12, 2024

By:

/s/ James Coulston

Name: James Coulston

Title: Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

 

 

34


Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Bruce Culleton, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of ProKidney Corp.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: November 12, 2024

By:

/s/ Bruce Culleton

Bruce Culleton

Chief Executive Officer

 

 

 

(Principal Executive Officer)

 


Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, James Coulston, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of ProKidney Corp.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: November 12, 2024

By:

/s/ James Coulston

James Coulston

Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 


Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of ProKidney Corp. (the “Company”) on Form 10-Q for the period ending September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: November 12, 2024

By:

/s/ Bruce Culleton

Bruce Culleton

Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 


Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of ProKidney Corp. (the “Company”) on Form 10-Q for the period ending September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: November 12, 2024

By:

/s/ James Coulston

James Coulston

Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

 


v3.24.3
Cover Page - shares
9 Months Ended
Sep. 30, 2024
Nov. 12, 2024
Document Information [Line Items]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Sep. 30, 2024  
Document Fiscal Year Focus 2024  
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 999-7019  
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, $0.0001 par value per share  
Trading Symbol PROK  
Security Exchange Name NASDAQ  
Common Class A [Member]    
Document Information [Line Items]    
Entity Common Stock, Shares Outstanding   127,968,243
Common Class B [Member]    
Document Information [Line Items]    
Entity Common Stock, Shares Outstanding   163,693,707
v3.24.3
Condensed Consolidated Balance Sheets - Unaudited - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current assets    
Cash and cash equivalents $ 108,088 $ 60,649
Marketable securities 298,724 302,301
Interest receivable 5,102 1,375
Prepaid assets 6,227 3,399
Prepaid clinical 11,053 6,413
Other current assets 1,031 9
Total current assets 430,225 374,146
Fixed assets, net 38,519 42,143
Right of use assets, net 6,049 4,263
Total assets 474,793 420,552
Current liabilities    
Accounts payable 2,850 5,098
Lease liabilities 1,067 803
Accrued expenses and other 21,264 17,665
Income taxes payable 0 1,472
Total current liabilities 25,181 25,038
Income tax payable, net of current portion 772 568
Lease liabilities, net of current portion 5,372 3,610
Total liabilities 31,325 29,216
Commitments and contingencies
Redeemable noncontrolling interest 1,423,180 1,494,732
Shareholders' deficit    
Additional paid-in capital 199,509 36,114
Accumulated other comprehensive (loss) gain 321 130
Accumulated deficit (1,179,571) (1,139,663)
Total shareholders' deficit (979,712) (1,103,396)
Total liabilities and shareholders' deficit 474,793 420,552
Common Class A [Member]    
Shareholders' deficit    
Common stock value 13 6
Common Class B [Member]    
Shareholders' deficit    
Common stock value $ 16 $ 17
v3.24.3
Condensed Consolidated Balance Sheets (Parenthetical) - Unaudited - $ / shares
Sep. 30, 2024
Dec. 31, 2023
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 127,920,274 59,880,347
Common stock shares outstanding 127,920,274 59,880,347
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 163,741,676 168,297,916
Common stock shares outstanding 163,741,676 168,297,916
v3.24.3
Condensed Consolidated Statements of Operations - Unaudited - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Operating expenses        
Research and development $ 31,250 $ 32,198 $ 87,887 $ 84,179
General and administrative 17,723 14,419 44,218 43,133
Total operating expenses 48,973 46,617 132,105 127,312
Operating loss (48,973) (46,617) (132,105) (127,312)
Interest income 5,580 5,541 14,960 16,803
Interest expense (2) (2) (7) (9)
Net loss before income taxes (43,395) (41,078) (117,152) (110,518)
Income tax (benefit) expense (2,342) 913 (2,300) 3,205
Net loss before noncontrolling interest (41,053) (41,991) (114,852) (113,723)
Net loss attributable to noncontrolling interest (23,143) (31,007) (74,944) (83,956)
Net loss available to Class A ordinary shareholders (17,910) (10,984) (39,908) (29,767)
Common Class A [Member]        
Operating expenses        
Net loss available to Class A ordinary shareholders $ (17,910) $ (10,984) $ (39,908) $ (29,767)
Weighted average Class A ordinary shares outstanding, Basic 126,173,463 61,592,876 87,818,229 61,565,298
Weighted average Class A ordinary shares outstanding, Diluted 126,173,463 61,592,876 87,818,229 61,565,298
Net loss per share attributable to Class A ordinary shares, Basic $ (0.14) $ (0.18) $ (0.45) $ (0.48)
Net loss per share attributable to Class A ordinary shares, Diluted $ (0.14) $ (0.18) $ (0.45) $ (0.48)
v3.24.3
Condensed Consolidated Statements of Comprehensive Loss - Unaudited - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Statement of Comprehensive Income [Abstract]        
Net loss including noncontrolling interest $ (41,053) $ (41,991) $ (114,852) $ (113,723)
Other comprehensive income:        
Unrealized income (loss) on marketable securities 750 241 235 (244)
Other comprehensive income 750 241 235 (244)
Total comprehensive loss including noncontrolling interest (40,303) (41,750) (114,617) (113,967)
Less: Total comprehensive loss attributable to noncontrolling interest (22,720) (30,829) (74,900) (84,136)
Total comprehensive loss attributable to Class A ordinary shareholders $ (17,583) $ (10,921) $ (39,717) $ (29,831)
v3.24.3
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders' Deficit - Unaudited - USD ($)
$ in Thousands
Total
Redeemable Noncontrolling Interest [Member]
Additional Paid-in Capital [Member]
Accumulated Other Comprehensive Loss [Member]
Accumulated Deficit [Member]
Common Class A [Member]
Class A Ordinary Shares [Member]
Common Stock [Member]
Class B Ordinary Shares [Member]
Common Stock [Member]
Beginning balance at Dec. 31, 2022 $ (1,096,616) $ 1,601,555 $ 7,476   $ (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             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              
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)
Impact of equity transactions on redeemable noncontrolling interest 4,457 (4,457) 4,457          
Unrealized income on marketable securities (64) (180)   $ (64)        
Net loss and comprehensive loss attributable to noncontrolling interest 83,956 (83,956)            
Net Income (Loss) (29,767)       (29,767) $ (29,767)    
Change in redemption value of noncontrolling interest (79) 79     (79)      
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             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)
Impact of equity transactions on redeemable noncontrolling interest (21) 21 (21)          
Unrealized income on marketable securities 63 178   63        
Net loss and comprehensive loss attributable to noncontrolling interest 31,007 (31,007)            
Net Income (Loss) (10,984)       (10,984) (10,984)    
Change in redemption value of noncontrolling interest 230,130 (230,130)     230,130      
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             61,595,300 173,839,330
Beginning balance at Dec. 31, 2023 (1,103,396) 1,494,732 36,114 130 (1,139,663)   $ 6 $ 17
Beginning balance, shares at Dec. 31, 2023             59,880,347 168,297,916
Equity-based compensation 18,559 3,865 18,559          
Issuance of Class A ordinary shares             62,087,817  
Issuance of Class A ordinary shares, net of offering costs 144,325   144,319       $ 6  
Vesting of Class B restricted stock rights, shares               1,395,202
Exchange of Class B ordinary shares for Class A ordinary shares 15,357              
Exchange of Class B ordinary shares for Class A ordinary shares 15,356 (15,356) 15,356       $ 1 $ (1)
Exercise of stock options, Shares             668  
Exchange of Class B ordinary shares for Class A ordinary shares, shares             5,951,442 (5,951,442)
Impact of equity transactions on redeemable noncontrolling interest (14,839) 14,839 (14,839)          
Unrealized income on marketable securities 191 44   191        
Net loss and comprehensive loss attributable to noncontrolling interest 74,944 (74,944)            
Net Income (Loss) (39,908)       (39,908) (39,908)    
Change in redemption value of noncontrolling interest 0              
Ending balance at Sep. 30, 2024 (979,712) 1,423,180 199,509 321 (1,179,571)   $ 13 $ 16
Ending balance, shares at Sep. 30, 2024             127,920,274 163,741,676
Beginning balance at Jun. 30, 2024 (972,371) 1,444,737 189,267 (6) (1,161,661)   $ 13 $ 16
Beginning balance, shares at Jun. 30, 2024             125,856,877 163,817,953
Equity-based compensation 6,084 851 6,084          
Issuance of Class A ordinary shares             1,868,891  
Issuance of Class A ordinary shares, net of offering costs 4,470   4,470       $ 0  
Vesting of Class B restricted stock rights, shares               117,842
Exchange of Class B ordinary shares for Class A ordinary shares 454 (454) 454          
Exercise of stock options, Shares             387  
Exchange of Class B ordinary shares for Class A ordinary shares, shares             194,119 (194,119)
Impact of equity transactions on redeemable noncontrolling interest (766) 766 (766)          
Unrealized income on marketable securities 327 423   327        
Net loss and comprehensive loss attributable to noncontrolling interest 23,143 (23,143)            
Net Income (Loss) (17,910)       (17,910) $ (17,910)    
Ending balance at Sep. 30, 2024 $ (979,712) $ 1,423,180 $ 199,509 $ 321 $ (1,179,571)   $ 13 $ 16
Ending balance, shares at Sep. 30, 2024             127,920,274 163,741,676
v3.24.3
Condensed Consolidated Statements of Cash Flows - Unaudited - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Cash flows from operating activities    
Net loss before noncontrolling interest $ (114,852) $ (113,723)
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities:    
Depreciation and amortization 3,858 2,707
Equity-based compensation 22,424 37,216
Gain on marketable securities, net (5,521) (3,675)
Impairment charges 5,324 0
Loss on disposal of equipment 186 21
Changes in operating assets and liabilities:    
Interest receivable (3,728) (714)
Prepaid and other assets (8,489) 5,094
Accounts payable and accrued expenses (114) 7,774
Income taxes payable (1,268) 615
Net cash flows used in operating activities (102,180) (64,685)
Cash flows from investing activities    
Purchases of marketable securities (277,291) (301,701)
Sales and maturities of marketable securities 286,625 100,187
Purchase of equipment and facility expansion (4,000) (32,625)
Net cash flows provided by (used in) investing activities 5,334 (234,139)
Cash flows from financing activities    
Proceeds from sales of Class A ordinary shares, net of offering costs 144,325 0
Payments on finance leases (40) (39)
Net cash flows provided by (used in) financing activities 144,285 (39)
Net change in cash and cash equivalents 47,439 (298,863)
Cash, beginning of period 60,649 490,252
Cash, end of period 108,088 191,389
Supplemental disclosure of non-cash investing and financing activities:    
Right of use assets obtained in exchange for lease obligations 2,621 714
Exchange of Class B ordinary shares 15,357 64
Impact of equity transactions and compensation on redeemable noncontrolling interest 18,748 3,207
Change in redemption value of noncontrolling interest 0 79
Equipment and facility expansion included in accounts payable and accrued expenses $ 910 $ 1,386
v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure        
Net Income (Loss) $ (17,910) $ (10,984) $ (39,908) $ (29,767)
v3.24.3
Insider Trading Arrangements
3 Months Ended
Sep. 30, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
Description of Business and Basis of Presentation
9 Months Ended
Sep. 30, 2024
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 business combination between SCS and PKLP (the “Business Combination”) 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 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 rilparencel, 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, 2024, various holders own non-voting interests in PKLP, representing a 56.1% economic interest in PKLP, effectively restricting ProKidney’s interest to 43.9% 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.

v3.24.3
Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
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, 2024, Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit for the three and nine months ended September 30, 2024 and 2023 and Condensed Consolidated Statements of Cash Flows for the nine months ended September 30,

2024 and 2023 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, 2024, the results of operations for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2023 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, 2023, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2024.

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, 2024 and December 31, 2023 consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Compensation

$

7,467

 

 

$

5,237

 

Severance

 

1,278

 

 

 

2,283

 

Clinical study related costs

 

4,271

 

 

 

1,658

 

Facility related costs

 

1,622

 

 

 

693

 

Accrued legal costs

 

633

 

 

 

1,015

 

Investment purchases payable

 

2,943

 

 

 

 

Manufacturing improvement costs

 

 

 

 

4,365

 

Accrued consulting and professional fees

 

425

 

 

 

878

 

Other accrued expenses

 

2,625

 

 

 

1,536

 

Total accrued expenses and other

$

21,264

 

 

$

17,665

 

 

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, 2024

 

 

December 31, 2023

 

Land

$

3,067

 

 

$

3,067

 

Buildings

 

17,166

 

 

 

22,490

 

Leasehold improvements

 

18,924

 

 

 

10,950

 

Furniture and equipment

 

5,511

 

 

 

3,690

 

Computer equipment and software

 

862

 

 

 

847

 

Construction in progress

 

3,560

 

 

 

8,741

 

Less: accumulated depreciation

 

(10,571

)

 

 

(7,642

)

Total fixed assets, net

$

38,519

 

 

$

42,143

 

 

Depreciation expense for the three months ended September 30, 2024 and 2023 was $1,199,000 and $807,000, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was $2,996,000 and $2,084,000, 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.

Due to a change in the planned use for the Company’s Greensboro facility, the Company performed an impairment analysis to compare the building’s carrying value with its estimated fair value. The fair value was determined through review of prices for similar assets and expected ranges of prices that the Company may be expected to receive upon sale of the property which are considered Level 3 inputs under the fair value hierarchy. This analysis resulted in the recognition of a non-cash impairment charge of $5.3 million during the three and nine months ended September 30, 2024.

No impairment charges were recorded for the three and nine months ended September 30, 2023.

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, 2024 and December 31, 2023.

Interest and penalties related to income taxes are included in the 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. 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

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

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 equity-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for time-vested awards earned over the service period on a straight-line basis. The Company recognizes equity-based compensation for options containing performance-based vesting conditions over the requisite service period if it is probable that the performance conditions will be satisfied. The Company records forfeitures of equity-based compensation awards as they occur.

The grant date fair value of time and performance-based 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.

Recently Issued Accounting Pronouncements

In March 2024, the Financial Accounting Standards Board (“FASB”) issued a new standard that provides additional guidance for determining whether profits interests and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock

Compensation, of the Accounting Standards Codification. The standard will be effective for the Company beginning with our annual reporting for fiscal year 2025 and interim periods in that year, with early adoption permitted. We do not believe that the adoption of this standard will have an impact on the classification of the profits interests that were granted to participants prior to the Business Combination.

v3.24.3
Investments
9 Months Ended
Sep. 30, 2024
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, 2024 (in thousands):

 

 

Fair Value Hierarchy

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

 

Cash Equivalents

 

 

Marketable Securities

 

Money market funds

Level 2

 

$

21,566

 

 

$

 

 

$

 

 

$

21,566

 

 

$

21,566

 

 

$

 

Time deposits

Level 2

 

 

7,176

 

 

 

27

 

 

 

 

 

 

7,203

 

 

 

 

 

 

7,203

 

Commercial paper

Level 2

 

 

37,185

 

 

 

100

 

 

 

 

 

 

37,285

 

 

 

 

 

 

37,285

 

Asset backed securities

Level 2

 

 

7,672

 

 

 

48

 

 

 

 

 

 

7,720

 

 

 

 

 

 

7,720

 

Government bonds

Level 2

 

 

78,434

 

 

 

124

 

 

 

 

 

 

78,558

 

 

 

31,000

 

 

 

47,558

 

Corporate debt securities

Level 2

 

 

199,052

 

 

 

458

 

 

 

(24

)

 

 

199,486

 

 

 

528

 

 

 

198,958

 

Total

 

 

$

351,085

 

 

$

757

 

 

$

(24

)

 

$

351,818

 

 

$

53,094

 

 

$

298,724

 

The following table shows the fair value of the Company’s cash equivalents and marketable securities, by contractual maturity, as of September 30, 2024 (in thousands):

 

 

September 30, 2024

 

Due in 1 year or less

$

324,702

 

Due in 1 year through 5 years

 

27,116

 

Total

$

351,818

 

 

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, 2024 (in thousands):

 

 

Less than 12 months

 

 

12 Months or Greater

 

 

Total

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

Corporate debt securities

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

Total

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

 

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 three and nine months ended September 30, 2024 and 2023. As such, the Company has not recognized an allowance for credit losses related to our marketable debt securities during the three and nine months ended September 30, 2024 and 2023.

v3.24.3
Income Taxes
9 Months Ended
Sep. 30, 2024
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, 2024.

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, 2024 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 three and nine months ended September 30, 2024 and 2023.

v3.24.3
Leases
9 Months Ended
Sep. 30, 2024
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 $479,000 and $276,000, for the three months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024 and 2023, the Company’s rent expense was $1,413,000 and $736,000, respectively. Cash paid for operating leases during the nine months ended September 30, 2024, was $968,000.

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, 2024 and December 31, 2023 (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Operating leases:

 

 

 

 

 

 

Right of use assets

 

$

5,939

 

 

$

4,116

 

 

 

 

 

 

 

 

Operating lease liabilities, current

 

$

1,032

 

 

$

751

 

Operating lease liabilities, noncurrent

 

 

5,290

 

 

 

3,506

 

Total operating lease liabilities

 

$

6,322

 

 

$

4,257

 

 

 

 

 

 

 

 

Finance leases:

 

 

 

 

 

 

Right of use assets

 

$

110

 

 

$

147

 

 

 

 

 

 

 

 

Finance lease liabilities, current

 

$

35

 

 

$

52

 

Finance lease liabilities, noncurrent

 

 

82

 

 

 

104

 

Total finance lease liabilities

 

$

117

 

 

$

156

 

 

 

Maturities of lease liabilities for the Company’s operating and finance leases are as follows as of September 30, 2024 (in thousands):

 

 

Operating Leases

 

 

Finance Leases

 

 

Total

 

 2024 (remaining three months)

 

$

496

 

 

$

26

 

 

$

522

 

 2025

 

 

1,681

 

 

 

22

 

 

 

1,703

 

 2026

 

 

1,841

 

 

 

22

 

 

 

1,863

 

 2027

 

 

1,725

 

 

 

22

 

 

 

1,747

 

 2028

 

 

1,361

 

 

 

22

 

 

 

1,383

 

Thereafter

 

 

1,279

 

 

 

22

 

 

 

1,301

 

Total lease payments

 

 

8,383

 

 

 

136

 

 

 

8,519

 

Less: imputed interest

 

 

(2,061

)

 

 

(19

)

 

 

(2,080

)

Present value of lease liabilities

 

$

6,322

 

 

$

117

 

 

$

6,439

 

 

The weighted average remaining lease term for operating leases is 4.6 years, and 4.5 years for finance leases. The weighted average discount rate for operating leases is 10.9% and 6.1% for finance leases.

v3.24.3
Related Party Transactions
9 Months Ended
Sep. 30, 2024
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) 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 began 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, rilparencel (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.

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 months ended September 30, 2024 and 2023, 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 months ended September 30, 2024 and 2023, 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.

v3.24.3
Redeemable Noncontrolling Interest
9 Months Ended
Sep. 30, 2024
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 56.1% 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, 2024, 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,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss available to Class A ordinary shareholders

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

(Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of
   subsidiary equity-based compensation

 

851

 

 

 

2,629

 

 

 

3,865

 

 

 

7,848

 

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange
   of Common Units in ProKidney LP for Class A ordinary shares

 

(454

)

 

 

(64

)

 

 

(15,356

)

 

 

(64

)

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of
   Restricted Common Units in ProKidney LP

 

766

 

 

 

21

 

 

 

14,839

 

 

 

(4,457

)

Change from net loss available to Class A ordinary shareholders and change
   in ownership interest in ProKidney LP

$

(16,747

)

 

$

(8,398

)

 

$

(36,560

)

 

$

(26,440

)

v3.24.3
Shareholders' Equity
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Shareholders' Equity

Note 8: Shareholders’ Equity

In June 2024, the Company sold 46,886,452 of its Class A ordinary shares in an underwritten public offering at a price of $2.42 per share. Additionally, in June 2024, the Company sold 11,030,574 of its Class A ordinary shares to certain investment entities at price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements. The net proceeds to the Company from the offerings were approximately $136,618,000, after deducting the underwriting discounts and commissions and offering expenses payable by the Company. The shares were offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

In January 2024, the Company entered into an Open Market Sale AgreementSM (“Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of its Class A ordinary shares having an aggregate offering price of up to $100.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3.

During the three months ended September 30, 2024, the Company sold 1,868,891 of its Class A ordinary shares under the Sales Agreement for net proceeds of $4,470,000. During the nine months ended September 30, 2024, the Company sold 4,170,791 of its Class A ordinary shares under the Sales Agreement for net proceeds of $7,707,000.

v3.24.3
Net Loss per Share
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Net Loss per Share

Note 9: 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 following table sets forth the computation of basic and diluted net loss per share for the three months ended September 30, 2024 and 2023 (in thousands, except share and per share amounts):

 

 

Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(41,053

)

 

$

(41,991

)

 

$

(114,852

)

 

$

(113,723

)

Less: Net loss attributable to noncontrolling interests

 

(23,143

)

 

 

(31,007

)

 

 

(74,944

)

 

 

(83,956

)

Net loss available to Class A ordinary shareholders of ProKidney Corp.,
   basic and diluted

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

 

 

 

 

 

 

 

 

 

 

 

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

Weighted average Class A ordinary shares or ProKidney Corp. outstanding,
   basic and diluted

 

126,173,463

 

 

 

61,592,876

 

 

 

87,818,229

 

 

 

61,565,298

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share of ProKidney Corp., basic and diluted

$

(0.14

)

 

$

(0.18

)

 

$

(0.45

)

 

$

(0.48

)

 

Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:

 

 

As of September 30,

 

 

2024

 

 

2023

 

Antidilutive securities

 

 

 

 

 

ProKidney Corp. Class B ordinary shares

 

163,741,676

 

 

 

173,839,330

 

Unvested Restricted Stock Rights

 

1,755,686

 

 

 

5,644,596

 

Earnout Rights

 

17,500,000

 

 

 

17,500,000

 

Stock options granted under the 2022 Equity Incentive Plan

 

22,076,832

 

 

 

17,356,148

 

v3.24.3
Equity Based Compensation
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Equity Based Compensation

Note 10: 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. 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, individual consultants 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, 2024:

 

 

 

Nine Months Ended September 30,

 

2024

 

2023

Expected volatility

 

82.9% - 85.0%

 

81.3% - 84.0%

Expected life of options, in years

 

5.4 - 6.1

 

5.2 - 6.1

Risk-free interest rate

 

3.7% - 4.6%

 

3.5% - 4.3%

Expected dividend yield

 

0.0%

 

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, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Time-vested options outstanding at January 1, 2024

 

 

14,680,109

 

 

$

7.83

 

Granted

 

 

8,442,907

 

 

 

1.88

 

Exercised

 

 

(668

)

 

 

1.61

 

Forfeited

 

 

(2,716,766

)

 

 

7.23

 

Time-vested options outstanding at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Time-vested options exercisable at September 30, 2024

 

 

4,177,180

 

 

$

9.07

 

Weighted average remaining contractual life

 

8.3 years

 

 

 

 

Time-vested options vested and expected to vest at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Weighted average remaining contractual life

 

8.8 years

 

 

 

 

As of September 30, 2024, the Company had total unrecognized stock-based compensation expense of approximately $47,185,000 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 2.8 years. The weighted average grant date fair value for the option grants during the nine months ended September 30, 2024 and 2023 was $1.37 and $7.11, respectively.

The aggregate intrinsic value of the in-the-money time-vested awards outstanding and those exercisable as of September 30, 2024 was $3,201,000 and $209,000, respectively.

Performance-Based Awards

The Company has issued stock options to certain of its employees which vest based on the achievement of both operational performance metrics and service rendered over a specific time period. The following table summarizes the activity related to the Company’s performance-based stock option awards granted under the 2022 Plan for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Performance-based options outstanding at January 1, 2024

 

 

1,000,000

 

 

$

1.69

 

Granted

 

 

671,250

 

 

 

1.52

 

Performance-based options outstanding at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Performance-based options exercisable at September 30, 2024

 

 

 

 

$

 

Performance-based options vested and expected to vest at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Weighted average remaining contractual life

 

9.3 years

 

 

 

 

 

As of September 30, 2024, the Company had total unrecognized stock-based compensation expense of approximately $458,000 related to the performance-based grants under the 2022 Plan, which is expected to be recognized on a straight-line basis over a weighted average period of 1.0 years.

Market-Vested Awards

In previous periods, the Company had granted market-vested options to its former Chief Executive Officer, these awards were forfeited upon the termination of his employment in November 2023. There were no market-vested awards granted during the three and nine months ended September 30, 2024 and 2023. There were no market based awards outstanding at September 30, 2024.

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).

Upon consummation of the Business Combination discussed in Note 1, PKLP’s existing Class B and B-1 Units were “caught up” and were converted into Class A Units of PKLP. The resulting vested and unvested Class A Units of PKLP were then recapitalized into Post-Combination ProKidney Common Units or Restricted Common Units of the Company, respectively. This recapitalization resulted in a decrease in the number of awards held by each participant. As such, the number of Profits Interests and related per unit values within these financial statements have been adjusted to reflect this recapitalization. Upon recapitalization, the Restricted Common Units maintained the vesting schedules associated with the original Profits Interest awards.

The following table summarizes the activity related to the Profits Interest awards for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

Unvested awards outstanding at January 1, 2024

 

 

3,565,753

 

 

$

7.23

 

Vested

 

 

(1,336,572

)

 

 

6.89

 

Forfeited

 

 

(473,495

)

 

 

7.64

 

Unvested awards outstanding at September 30, 2024

 

 

1,755,686

 

 

$

7.37

 

 

As of September 30, 2024, the unrecognized compensation expense related to these awards was $8,002,000. The current weighted average remaining period over which the unrecognized compensation expense is expected to be recognized is 1.2 years.

Modification to Equity Based Compensation Awards

During the nine months ended September 30, 2023, the Company 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.

Equity Based Compensation Expense

Compensation expense related to equity-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,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

$

2,937

 

 

$

4,881

 

 

$

9,571

 

 

$

13,324

 

General and administrative

 

3,997

 

 

 

8,112

 

 

 

12,853

 

 

 

23,891

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

 

The following table summarizes our equity based compensation by type of award (in thousands):

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Time-vested stock options

$

5,133

 

 

$

6,609

 

 

$

15,889

 

 

$

18,203

 

Performance-based stock options

 

293

 

 

 

 

 

 

862

 

 

 

 

Market-vested stock options

 

 

 

 

2,825

 

 

 

 

 

 

8,383

 

Legacy profits interests

 

1,508

 

 

 

3,559

 

 

 

5,673

 

 

 

10,629

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

v3.24.3
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Unaudited Interim Financial Statements

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, 2024, Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023, Condensed Consolidated Statement of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit for the three and nine months ended September 30, 2024 and 2023 and Condensed Consolidated Statements of Cash Flows for the nine months ended September 30,

2024 and 2023 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, 2024, the results of operations for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2023 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, 2023, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2024.

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

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

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.

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.

Accrued Expenses

Accrued Expenses

Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Compensation

$

7,467

 

 

$

5,237

 

Severance

 

1,278

 

 

 

2,283

 

Clinical study related costs

 

4,271

 

 

 

1,658

 

Facility related costs

 

1,622

 

 

 

693

 

Accrued legal costs

 

633

 

 

 

1,015

 

Investment purchases payable

 

2,943

 

 

 

 

Manufacturing improvement costs

 

 

 

 

4,365

 

Accrued consulting and professional fees

 

425

 

 

 

878

 

Other accrued expenses

 

2,625

 

 

 

1,536

 

Total accrued expenses and other

$

21,264

 

 

$

17,665

 

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.

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, 2024

 

 

December 31, 2023

 

Land

$

3,067

 

 

$

3,067

 

Buildings

 

17,166

 

 

 

22,490

 

Leasehold improvements

 

18,924

 

 

 

10,950

 

Furniture and equipment

 

5,511

 

 

 

3,690

 

Computer equipment and software

 

862

 

 

 

847

 

Construction in progress

 

3,560

 

 

 

8,741

 

Less: accumulated depreciation

 

(10,571

)

 

 

(7,642

)

Total fixed assets, net

$

38,519

 

 

$

42,143

 

 

Depreciation expense for the three months ended September 30, 2024 and 2023 was $1,199,000 and $807,000, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was $2,996,000 and $2,084,000, respectively.

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.

Due to a change in the planned use for the Company’s Greensboro facility, the Company performed an impairment analysis to compare the building’s carrying value with its estimated fair value. The fair value was determined through review of prices for similar assets and expected ranges of prices that the Company may be expected to receive upon sale of the property which are considered Level 3 inputs under the fair value hierarchy. This analysis resulted in the recognition of a non-cash impairment charge of $5.3 million during the three and nine months ended September 30, 2024.

No impairment charges were recorded for the three and nine months ended September 30, 2023.

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, 2024 and December 31, 2023.

Interest and penalties related to income taxes are included in the 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 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. 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

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

The carrying values of cash equivalents, accounts payable, and accrued liabilities approximate fair value due to the short‑term nature of these instruments.

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.

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.

Equity-Based Compensation

Equity-Based Compensation

Compensation expense for equity-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for time-vested awards earned over the service period on a straight-line basis. The Company recognizes equity-based compensation for options containing performance-based vesting conditions over the requisite service period if it is probable that the performance conditions will be satisfied. The Company records forfeitures of equity-based compensation awards as they occur.

The grant date fair value of time and performance-based 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

Segments

The Company operates in only one segment
Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

In March 2024, the Financial Accounting Standards Board (“FASB”) issued a new standard that provides additional guidance for determining whether profits interests and similar awards should be accounted for in accordance with Topic 718, Compensation - Stock

Compensation, of the Accounting Standards Codification. The standard will be effective for the Company beginning with our annual reporting for fiscal year 2025 and interim periods in that year, with early adoption permitted. We do not believe that the adoption of this standard will have an impact on the classification of the profits interests that were granted to participants prior to the Business Combination.

v3.24.3
Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2024
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, 2024

 

 

December 31, 2023

 

Land

$

3,067

 

 

$

3,067

 

Buildings

 

17,166

 

 

 

22,490

 

Leasehold improvements

 

18,924

 

 

 

10,950

 

Furniture and equipment

 

5,511

 

 

 

3,690

 

Computer equipment and software

 

862

 

 

 

847

 

Construction in progress

 

3,560

 

 

 

8,741

 

Less: accumulated depreciation

 

(10,571

)

 

 

(7,642

)

Total fixed assets, net

$

38,519

 

 

$

42,143

 

Condensed Consolidated Balance Sheets of Accrued expense

Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Compensation

$

7,467

 

 

$

5,237

 

Severance

 

1,278

 

 

 

2,283

 

Clinical study related costs

 

4,271

 

 

 

1,658

 

Facility related costs

 

1,622

 

 

 

693

 

Accrued legal costs

 

633

 

 

 

1,015

 

Investment purchases payable

 

2,943

 

 

 

 

Manufacturing improvement costs

 

 

 

 

4,365

 

Accrued consulting and professional fees

 

425

 

 

 

878

 

Other accrued expenses

 

2,625

 

 

 

1,536

 

Total accrued expenses and other

$

21,264

 

 

$

17,665

 

v3.24.3
Redeemable Noncontrolling Interest (Tables)
9 Months Ended
Sep. 30, 2024
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,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss available to Class A ordinary shareholders

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

(Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of
   subsidiary equity-based compensation

 

851

 

 

 

2,629

 

 

 

3,865

 

 

 

7,848

 

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange
   of Common Units in ProKidney LP for Class A ordinary shares

 

(454

)

 

 

(64

)

 

 

(15,356

)

 

 

(64

)

(Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of
   Restricted Common Units in ProKidney LP

 

766

 

 

 

21

 

 

 

14,839

 

 

 

(4,457

)

Change from net loss available to Class A ordinary shareholders and change
   in ownership interest in ProKidney LP

$

(16,747

)

 

$

(8,398

)

 

$

(36,560

)

 

$

(26,440

)

v3.24.3
Investments (Tables)
9 Months Ended
Sep. 30, 2024
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, 2024 (in thousands):

 

 

Fair Value Hierarchy

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

 

Cash Equivalents

 

 

Marketable Securities

 

Money market funds

Level 2

 

$

21,566

 

 

$

 

 

$

 

 

$

21,566

 

 

$

21,566

 

 

$

 

Time deposits

Level 2

 

 

7,176

 

 

 

27

 

 

 

 

 

 

7,203

 

 

 

 

 

 

7,203

 

Commercial paper

Level 2

 

 

37,185

 

 

 

100

 

 

 

 

 

 

37,285

 

 

 

 

 

 

37,285

 

Asset backed securities

Level 2

 

 

7,672

 

 

 

48

 

 

 

 

 

 

7,720

 

 

 

 

 

 

7,720

 

Government bonds

Level 2

 

 

78,434

 

 

 

124

 

 

 

 

 

 

78,558

 

 

 

31,000

 

 

 

47,558

 

Corporate debt securities

Level 2

 

 

199,052

 

 

 

458

 

 

 

(24

)

 

 

199,486

 

 

 

528

 

 

 

198,958

 

Total

 

 

$

351,085

 

 

$

757

 

 

$

(24

)

 

$

351,818

 

 

$

53,094

 

 

$

298,724

 

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, 2024 (in thousands):

 

 

September 30, 2024

 

Due in 1 year or less

$

324,702

 

Due in 1 year through 5 years

 

27,116

 

Total

$

351,818

 

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, 2024 (in thousands):

 

 

Less than 12 months

 

 

12 Months or Greater

 

 

Total

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

Corporate debt securities

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

Total

$

18,681

 

 

$

(24

)

 

$

 

 

$

 

 

$

18,681

 

 

$

(24

)

v3.24.3
Leases (Tables)
9 Months Ended
Sep. 30, 2024
Leases [Abstract]  
Schedule of Classification of Operating and Finance Lease Assets and Obligations

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, 2024 and December 31, 2023 (in thousands):

 

 

September 30, 2024

 

 

December 31, 2023

 

Operating leases:

 

 

 

 

 

 

Right of use assets

 

$

5,939

 

 

$

4,116

 

 

 

 

 

 

 

 

Operating lease liabilities, current

 

$

1,032

 

 

$

751

 

Operating lease liabilities, noncurrent

 

 

5,290

 

 

 

3,506

 

Total operating lease liabilities

 

$

6,322

 

 

$

4,257

 

 

 

 

 

 

 

 

Finance leases:

 

 

 

 

 

 

Right of use assets

 

$

110

 

 

$

147

 

 

 

 

 

 

 

 

Finance lease liabilities, current

 

$

35

 

 

$

52

 

Finance lease liabilities, noncurrent

 

 

82

 

 

 

104

 

Total finance lease liabilities

 

$

117

 

 

$

156

 

 

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, 2024 (in thousands):

 

 

Operating Leases

 

 

Finance Leases

 

 

Total

 

 2024 (remaining three months)

 

$

496

 

 

$

26

 

 

$

522

 

 2025

 

 

1,681

 

 

 

22

 

 

 

1,703

 

 2026

 

 

1,841

 

 

 

22

 

 

 

1,863

 

 2027

 

 

1,725

 

 

 

22

 

 

 

1,747

 

 2028

 

 

1,361

 

 

 

22

 

 

 

1,383

 

Thereafter

 

 

1,279

 

 

 

22

 

 

 

1,301

 

Total lease payments

 

 

8,383

 

 

 

136

 

 

 

8,519

 

Less: imputed interest

 

 

(2,061

)

 

 

(19

)

 

 

(2,080

)

Present value of lease liabilities

 

$

6,322

 

 

$

117

 

 

$

6,439

 

v3.24.3
Net Loss per Share (Tables)
9 Months Ended
Sep. 30, 2024
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 months ended September 30, 2024 and 2023 (in thousands, except share and per share amounts):

 

 

Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(41,053

)

 

$

(41,991

)

 

$

(114,852

)

 

$

(113,723

)

Less: Net loss attributable to noncontrolling interests

 

(23,143

)

 

 

(31,007

)

 

 

(74,944

)

 

 

(83,956

)

Net loss available to Class A ordinary shareholders of ProKidney Corp.,
   basic and diluted

$

(17,910

)

 

$

(10,984

)

 

$

(39,908

)

 

$

(29,767

)

 

 

 

 

 

 

 

 

 

 

 

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

Weighted average Class A ordinary shares or ProKidney Corp. outstanding,
   basic and diluted

 

126,173,463

 

 

 

61,592,876

 

 

 

87,818,229

 

 

 

61,565,298

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share

 

 

 

 

 

 

 

 

 

 

 

Net loss per Class A ordinary share of ProKidney Corp., basic and diluted

$

(0.14

)

 

$

(0.18

)

 

$

(0.45

)

 

$

(0.48

)

 

Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:

 

 

As of September 30,

 

 

2024

 

 

2023

 

Antidilutive securities

 

 

 

 

 

ProKidney Corp. Class B ordinary shares

 

163,741,676

 

 

 

173,839,330

 

Unvested Restricted Stock Rights

 

1,755,686

 

 

 

5,644,596

 

Earnout Rights

 

17,500,000

 

 

 

17,500,000

 

Stock options granted under the 2022 Equity Incentive Plan

 

22,076,832

 

 

 

17,356,148

 

v3.24.3
Equity Based Compensation (Tables)
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
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, 2024:

 

 

 

Nine Months Ended September 30,

 

2024

 

2023

Expected volatility

 

82.9% - 85.0%

 

81.3% - 84.0%

Expected life of options, in years

 

5.4 - 6.1

 

5.2 - 6.1

Risk-free interest rate

 

3.7% - 4.6%

 

3.5% - 4.3%

Expected dividend yield

 

0.0%

 

0.0%

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, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Time-vested options outstanding at January 1, 2024

 

 

14,680,109

 

 

$

7.83

 

Granted

 

 

8,442,907

 

 

 

1.88

 

Exercised

 

 

(668

)

 

 

1.61

 

Forfeited

 

 

(2,716,766

)

 

 

7.23

 

Time-vested options outstanding at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Time-vested options exercisable at September 30, 2024

 

 

4,177,180

 

 

$

9.07

 

Weighted average remaining contractual life

 

8.3 years

 

 

 

 

Time-vested options vested and expected to vest at September 30, 2024

 

 

20,405,582

 

 

$

5.45

 

Weighted average remaining contractual life

 

8.8 years

 

 

 

 

Summary of Performance-Based Stock Option Activity The following table summarizes the activity related to the Company’s performance-based stock option awards granted under the 2022 Plan for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Exercise Price

 

Performance-based options outstanding at January 1, 2024

 

 

1,000,000

 

 

$

1.69

 

Granted

 

 

671,250

 

 

 

1.52

 

Performance-based options outstanding at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Performance-based options exercisable at September 30, 2024

 

 

 

 

$

 

Performance-based options vested and expected to vest at September 30, 2024

 

 

1,671,250

 

 

$

1.62

 

Weighted average remaining contractual life

 

9.3 years

 

 

 

 

Summary of Profits Interest awards, Activity

The following table summarizes the activity related to the Profits Interest awards for the nine months ended September 30, 2024:

 

 

Number of Shares

 

 

Weighted Average Grant Date Fair Value

 

Unvested awards outstanding at January 1, 2024

 

 

3,565,753

 

 

$

7.23

 

Vested

 

 

(1,336,572

)

 

 

6.89

 

Forfeited

 

 

(473,495

)

 

 

7.64

 

Unvested awards outstanding at September 30, 2024

 

 

1,755,686

 

 

$

7.37

 

Summary of Compensation Expense Related to Share-Based Awards

Compensation expense related to equity-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,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

$

2,937

 

 

$

4,881

 

 

$

9,571

 

 

$

13,324

 

General and administrative

 

3,997

 

 

 

8,112

 

 

 

12,853

 

 

 

23,891

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

 

The following table summarizes our equity based compensation by type of award (in thousands):

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Time-vested stock options

$

5,133

 

 

$

6,609

 

 

$

15,889

 

 

$

18,203

 

Performance-based stock options

 

293

 

 

 

 

 

 

862

 

 

 

 

Market-vested stock options

 

 

 

 

2,825

 

 

 

 

 

 

8,383

 

Legacy profits interests

 

1,508

 

 

 

3,559

 

 

 

5,673

 

 

 

10,629

 

Total equity-based compensation expense

$

6,934

 

 

$

12,993

 

 

$

22,424

 

 

$

37,215

 

v3.24.3
Description of Business and Basis of Presentation - Additional Information (Detail)
9 Months Ended
Sep. 30, 2024
Description of Organization and Business Operations [Line Items]  
Incorporation date of entity Feb. 25, 2021
PKLP [Member]  
Description of Organization and Business Operations [Line Items]  
Percentage of non-voting economic interest 56.10%
Percentage of non-voting economic interest by parent 43.90%
v3.24.3
Significant Accounting Policies - Additional Information (Detail)
3 Months Ended 9 Months Ended
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2024
USD ($)
Segment
Sep. 30, 2023
USD ($)
Accounting Policies [Abstract]        
Asset Impairment Charges $ 5,300,000 $ 0 $ 5,300,000 $ 0
Depreciation expense $ 1,199,000 $ 807,000 $ 2,996,000 $ 2,084,000
Number of Reportable Segments | Segment     1  
v3.24.3
Significant Accounting Policies - Summary of Accrued expense (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Accounting Policies [Abstract]    
Compensation $ 7,467 $ 5,237
Severance 1,278 2,283
Clinical study related costs 4,271 1,658
Facility related costs 1,622 693
Accrued legal costs 633 1,015
Investment purchases payable 2,943 0
Manufacturing improvement costs 0 4,365
Accrued consulting and professional fees 425 878
Other accrued expenses 2,625 1,536
Total accrued expenses and other $ 21,264 $ 17,665
v3.24.3
Significant Accounting Policies - Summary of Fixed Assets (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Property, Plant and Equipment [Line Items]    
Less: accumulated depreciation $ (10,571) $ (7,642)
Total fixed assets, net 38,519 42,143
Land    
Property, Plant and Equipment [Line Items]    
Fixed Assets Gross 3,067 3,067
Buildings    
Property, Plant and Equipment [Line Items]    
Fixed Assets Gross $ 17,166 22,490
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 $ 862 847
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 $ 5,511 3,690
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 $ 18,924 10,950
Construction in progress    
Property, Plant and Equipment [Line Items]    
Construction in progress $ 3,560 $ 8,741
v3.24.3
Investments - Schedule of Marketable Securities Measured At Fair Value (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Cash Equivalents $ 108,088 $ 60,649
Marketable Securities 298,724 $ 302,301
Fair Value Measurements Recurring [Member]    
Amortized Cost 351,085  
Unrealized Gains 757  
Unrealized Losses (24)  
Fair Value 351,818  
Cash Equivalents 53,094  
Marketable Securities 298,724  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Money Market Funds [Member]    
Amortized Cost 21,566  
Unrealized Gains 0  
Unrealized Losses 0  
Fair Value 21,566  
Cash Equivalents 21,566  
Marketable Securities 0  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Time Deposit [Member]    
Amortized Cost 7,176  
Unrealized Gains 27  
Unrealized Losses 0  
Fair Value 7,203  
Cash Equivalents 0  
Marketable Securities 7,203  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Commercial Paper [Member]    
Amortized Cost 37,185  
Unrealized Gains 100  
Unrealized Losses 0  
Fair Value 37,285  
Cash Equivalents 0  
Marketable Securities 37,285  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Asset Backed Securities [Member]    
Amortized Cost 7,672  
Unrealized Gains 48  
Unrealized Losses 0  
Fair Value 7,720  
Cash Equivalents 0  
Marketable Securities 7,720  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Government Bonds [Member]    
Amortized Cost 78,434  
Unrealized Gains 124  
Unrealized Losses 0  
Fair Value 78,558  
Cash Equivalents 31,000  
Marketable Securities 47,558  
Fair Value Measurements Recurring [Member] | Fair Value Inputs Level 2 [Member] | Corporate Debt Securities [Member]    
Amortized Cost 199,052  
Unrealized Gains 458  
Unrealized Losses (24)  
Fair Value 199,486  
Cash Equivalents 528  
Marketable Securities $ 198,958  
v3.24.3
Investments - Schedule of Maturity for Marketable Securities (Details)
$ in Thousands
Sep. 30, 2024
USD ($)
Investments [Abstract]  
Due in 1 year or less $ 324,702
Due in 1 year through 5 years 27,116
Total $ 351,818
v3.24.3
Investments - Schedule of Investments Fair Values and Gross Unrealized Losses (Details)
$ in Thousands
Sep. 30, 2024
USD ($)
Less than 12 months, fair value $ 18,681
Less than 12 months, unrealized loss (24)
12 months or greater, fair value 0
12 months or greater, unrealized loss 0
Total, fair value 18,681
Total, unrealized loss (24)
Corporate Debt Securities [Member]  
Less than 12 months, fair value 18,681
Less than 12 months, unrealized loss (24)
12 months or greater, fair value 0
12 months or greater, unrealized loss 0
Total, fair value 18,681
Total, unrealized loss $ (24)
v3.24.3
Investments (Additional Information) (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Marketable Debt Securities [Member]        
Allowance for credit losses for investments $ 0 $ 0 $ 0 $ 0
v3.24.3
Income Taxes (Additional Information) (Details)
9 Months Ended
Sep. 30, 2024
USD ($)
Income Tax Disclosure [Abstract]  
Cash Saving Percentage 85.00%
Effective Income Tax Rate 21.00%
Unrecognized tax benefits $ 0
v3.24.3
Leases (Additional Information) (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Leases [Abstract]        
Operating lease expense $ 479,000 $ 276,000 $ 1,413,000 $ 736,000
Cash paid for operating leases     $ 968,000  
Operating lease, weighted average remaining lease term 4 years 7 months 6 days   4 years 7 months 6 days  
Finance lease, weighted average remaining lease term 4 years 6 months   4 years 6 months  
Operating lease, weighted average discount rate 10.90%   10.90%  
Finance lease, weighted average discount rate 6.10%   6.10%  
v3.24.3
Leases - Schedule of Classification of Operating and Finance Lease Assets and Obligations (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Operating leases:    
Right of use assets $ 5,939 $ 4,116
Operating lease liabilities, current 1,032 751
Operating lease liabilities, noncurrent 5,290 3,506
Total operating lease liabilities 6,322 4,257
Finance leases:    
Right of use assets 110 147
Finance lease liabilities, current 35 52
Finance lease liabilities, noncurrent 82 104
Total finance lease liabilities $ 117 $ 156
v3.24.3
Leases - Schedule of Maturities of Lease Liabilities for the Company's Operating and Finance Leases (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Operating Leases    
2024 (remaining six months) $ 496  
2025 1,681  
2026 1,841  
2027 1,725  
2028 1,361  
Thereafter 1,279  
Total lease payments 8,383  
Less: imputed interest (2,061)  
Present value of lease liabilities 6,322 $ 4,257
Finance Leases    
2024 (remaining six months) 26  
2025 22  
2026 22  
2027 22  
2028 22  
Thereafter 22  
Total lease payments 136  
Less: imputed interest (19)  
Present value of lease liabilities 117 $ 156
Total    
2024 (remaining six months) 522  
2025 1,703  
2026 1,863  
2027 1,747  
2028 1,383  
Thereafter 1,301  
Total lease payments 8,519  
Less: imputed interest (2,080)  
Present value of lease liabilities $ 6,439  
v3.24.3
Related Party Transactions - Additional Information (Detail) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Jan. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Related Party Transaction [Line Items]          
Shares Unlocked Percentage 50.00%        
Vesting Period of Earnout Rights       5 years  
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       85.00%  
ProKidney KY and Nefro Health [Member]          
Related Party Transaction [Line Items]          
Quarterly Related Party Fee       $ 25,000  
Costs And Expenses Related Party   $ 25,000 $ 25,000 75,000 $ 75,000
ProKidney US and Nefro Health [Member]          
Related Party Transaction [Line Items]          
Quarterly Related Party Fee       25,000  
Nefro consulting service   $ 25,000 $ 25,000 $ 75,000 $ 75,000
Vesting [Member] | Tranche one [Member]          
Related Party Transaction [Line Items]          
Earnout Rights Stock Price Trigger   $ 15   $ 15  
Vesting [Member] | Tranche two [Member]          
Related Party Transaction [Line Items]          
Earnout Rights Stock Price Trigger   20   20  
Vesting [Member] | Tranche three [Member]          
Related Party Transaction [Line Items]          
Earnout Rights Stock Price Trigger   $ 25   $ 25  
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  
v3.24.3
Redeemable Noncontrolling Interest - Summary of company non controlling interest (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items]        
Net loss before noncontrolling interest $ (41,053) $ (41,991) $ (114,852) $ (113,723)
(Increase)/Decrease In ProKidney Corp. additional paid-in capital for vesting of Restricted Common Units in ProKidney LP 766 21 14,839 (4,457)
Change from net loss available to Class A ordinary shareholders and change in ownership interest in ProKidney LP (16,747) (8,398) (36,560) (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 851 2,629 3,865 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 (454) (64) (15,356) (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 before noncontrolling interest $ (17,910) $ (10,984) $ (39,908) $ (29,767)
v3.24.3
Redeemable Noncontrolling Interest (Additional Information) (Details)
Sep. 30, 2024
Exchange Agreement [Member] | PKLP [Member]  
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items]  
Non controlling interest percentge 56.10%
v3.24.3
Shareholders' Equity (Additional Information) (Details) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Jun. 30, 2024
Jan. 31, 2024
Sep. 30, 2024
Sep. 30, 2024
Dec. 31, 2023
Class of Stock [Line Items]          
Net proceeds from sale of stock $ 136,618,000        
Common Class A [Member]          
Class of Stock [Line Items]          
Common stock, par value     $ 0.0001 $ 0.0001 $ 0.0001
Class A Ordinary Shares [Member]          
Class of Stock [Line Items]          
Number of Shares Sold 46,886,452        
Sale of stock price per share $ 2.42        
Class A Ordinary Shares [Member] | Sales Agreement with Jefferies LLC [Member]          
Class of Stock [Line Items]          
Number of Shares Sold     1,868,891 4,170,791  
Aggregate Offering Price   $ 100,000,000      
Net proceeds from sale of stock     $ 4,470,000 $ 7,707,000  
Class A Ordinary Shares [Member] | Underwritten Public Offering [Member]          
Class of Stock [Line Items]          
Number of Shares Sold 11,030,574        
Sale of stock price per share $ 2.42        
v3.24.3
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, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Numerator          
Net loss $ (41,053) $ (41,991) $ (114,852) $ (113,723)  
Less: Net loss attributable to noncontrolling interest $ (23,143) $ (31,007) $ (74,944) $ (83,956)  
Antidilutive securities          
Earnout Rights     17,500,000 17,500,000  
Stock options granted under the 2022 Equity Incentive Plan 22,076,832 17,356,148 22,076,832 17,356,148  
Restricted Stock Rights [Member]          
Antidilutive securities          
Unvested Restricted Stock Rights     1,755,686 5,644,596  
Common Class A [Member]          
Numerator          
Net loss Available To Class A ordinary Shareholders of ProKidney Corp., Basic $ (17,910) $ (10,984) $ (39,908) $ (29,767)  
Net loss Available To Class A ordinary Shareholders of ProKidney Corp., Diluted $ (17,910) $ (10,984) $ (39,908) $ (29,767)  
Denominator          
Weighted average Class A ordinary shares or ProKidney Corp. outstanding, Basic 126,173,463 61,592,876 87,818,229 61,565,298  
Weighted average Class A ordinary shares or ProKidney Corp. outstanding, Diluted 126,173,463 61,592,876 87,818,229 61,565,298  
Net loss per share attributable to Class A ordinary shares, Basic $ (0.14) $ (0.18) $ (0.45) $ (0.48)  
Net loss per share attributable to Class A ordinary shares, Diluted $ (0.14) $ (0.18) $ (0.45) $ (0.48)  
Antidilutive securities          
ProKidney Corp. ordinary shares 127,920,274   127,920,274   59,880,347
Common Class B [Member]          
Antidilutive securities          
ProKidney Corp. ordinary shares 163,741,676 173,839,330 163,741,676 173,839,330 168,297,916
v3.24.3
Equity Based Compensation - Summary of Assumptions of the Valuation in Stock Option Activity (Details)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Expected volatility, minimum 82.90% 81.30%
Expected volatility, maximum 85.00% 84.00%
Risk-free interest rate, minimum 3.70% 3.50%
Risk-free interest rate, maximum 4.60% 4.30%
Expected dividend yield 0.00% 0.00%
Minimum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Expected life of options, in years 5 years 4 months 24 days 5 years 2 months 12 days
Maximum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Expected life of options, in years 6 years 1 month 6 days 6 years 1 month 6 days
v3.24.3
Equity Based Compensation - Summary of Stock Option Awards Granted, Activity (Details)
3 Months Ended 9 Months Ended
Sep. 30, 2023
shares
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Shares, Options Outstanding, Ending Balance 17,356,148 22,076,832
Time-Vested Awards [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Shares, Options Outstanding, Beginning Balance   14,680,109
Number of Shares, Granted   8,442,907
Number of Shares, Exercised   (668)
Number of Shares, Forfeited   (2,716,766)
Number of Shares, Options Outstanding, Ending Balance   20,405,582
Number of Shares, Options Exercisable   4,177,180
Weighted Average Remaining Contractual Life   8 years 9 months 18 days
Number of Shares, Options Vested and Expected to Vest   20,405,582
Weighted Average Remaining Contractual Life   8 years 3 months 18 days
Weighted Average Exercise Price, Options Outstanding, Beginnig Balance | $ / shares   $ 7.83
Weighted Average Exercise Price, Granted | $ / shares   1.88
Weighted Average Exercise Price, Exercised | $ / shares   1.61
Weighted Average Exercise Price, Forfeited | $ / shares   7.23
Weighted Average Exercise Price, Options Outstanding, Ending Balance | $ / shares   5.45
Weighted Average Exercise Price, Options Exercisable | $ / shares   9.07
Weighted Average Exercise Price, Options Vested and Expected to Vest | $ / shares   $ 5.45
v3.24.3
Equity Based Compensation - Summary of Performance-Based Stock Option Activity (Details)
3 Months Ended 9 Months Ended
Sep. 30, 2023
shares
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Shares, Options Outstanding, Ending Balance 17,356,148 22,076,832
Performance-Based Awards [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Shares, Options Outstanding, Beginning Balance   1,000,000
Number of Shares, Granted   671,250
Number of Shares, Options Outstanding, Ending Balance   1,671,250
Number of Shares, Options Exercisable   0
Number of Shares, Options Vested and Expected to Vest   1,671,250
Weighted Average Remaining Contractual Life   9 years 3 months 18 days
Weighted Average Exercise Price, Options Outstanding, Beginnig Balance | $ / shares   $ 1.69
Weighted Average Exercise Price, Granted | $ / shares   1.52
Weighted Average Exercise Price, Options Outstanding, Ending Balance | $ / shares   1.62
Weighted Average Exercise Price, Options Exercisable | $ / shares   0
Weighted Average Exercise Price, Options Vested and Expected to Vest | $ / shares   $ 1.62
v3.24.3
Equity Based Compensation - Schedule of Profits Interest Awards, Activity (Details) - Profits Interest Awards [Member]
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Number of Shares, Unvested Awards Outstanding, Beginning Balance | shares 3,565,753
Number of Shares, Vested | shares (1,336,572)
Number of Shares, Forfeited | shares (473,495)
Number of Shares, Unvested Awards Outstanding, Ending Balance | shares 1,755,686
Weighted Average Grant Date Fair Value, Unvested Awards Outstanding, Beginning Balance | $ / shares $ 7.23
Weighted Average Grant Date Fair Value, Vested | $ / shares 6.89
Weighted Average Grant Date Fair Value, Forfeited | $ / shares 7.64
Weighted Average Grant Date Fair Value, Unvested Awards Outstanding, Ending Balance | $ / shares $ 7.37
v3.24.3
Equity Based Compensation - Summary of Compensation Expense Related to Share-Based Awards (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense $ 6,934 $ 12,993 $ 22,424 $ 37,215
Time-Vested Stock Options [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense 5,133 6,609 15,889 18,203
Performance-Based Awards [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense 293 0 862 0
Market-Vested Stock Options [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense 0 2,825 0 8,383
Legacy Profits Interests [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense 1,508 3,559 5,673 10,629
Research and Development [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense 2,937 4,881 9,571 13,324
General and Administrative [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total equity-based compensation expense $ 3,997 $ 8,112 $ 12,853 $ 23,891
v3.24.3
Equity Based Compensation (Additional Information) (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Equity-based compensation $ 6,084,000 $ 10,365,000 $ 18,559,000 $ 29,368,000  
Weighted average period     1 year 2 months 12 days    
Number of shares, options outstanding 22,076,832 17,356,148 22,076,832 17,356,148  
Unrecognized compensation expense remaining period     1 year 2 months 12 days    
Additional compensation expense       $ 3,011,000  
Limited Partnership Agreement [Member]          
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.    
Time Vested Awards [Member]          
Unrecognized stock-based compensation expense $ 47,185,000   $ 47,185,000    
Weighted average period     2 years 9 months 18 days    
Weighted average grant date fair value     $ 1.37 $ 7.11  
Aggregate intrinsic value, outstanding $ 3,201,000 $ 209,000 $ 3,201,000 $ 209,000  
Number of shares granted     8,442,907    
Number of shares, options outstanding 20,405,582   20,405,582   14,680,109
Unrecognized compensation expense remaining period     2 years 9 months 18 days    
Performance-Based Awards [Member]          
Unrecognized stock-based compensation expense $ 458,000,000   $ 458,000,000    
Weighted average period     1 year    
Number of shares granted     671,250    
Number of shares, options outstanding 1,671,250   1,671,250   1,000,000
Unrecognized compensation expense remaining period     1 year    
Market-Vested Awards [Member]          
Number of shares granted 0 0 0 0  
Number of shares, options outstanding 0   0    
Profits Interest awards [Member]          
Unrecognized compensation expense $ 8,002,000   $ 8,002,000    
v3.24.3
Subsequent Events (Additional Information) (Details) - shares
Sep. 30, 2024
Dec. 31, 2023
Common Class A [Member]    
Subsequent Event [Line Items]    
Common Stock, Shares, Issued 127,920,274 59,880,347
Common Class B [Member]    
Subsequent Event [Line Items]    
Common Stock, Shares, Issued 163,741,676 168,297,916

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