Press Release: ProKidney Reports Third Quarter 2024 Financial Results along with Regulatory and Clinical Development Updates Following Successful FDA Type B Meeting

Dow Jones
2024-11-12

competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Investor Contacts:

ProKidney

Ethan Holdaway

Ethan.Holdaway@prokidney.com

LifeSci Advisors, LLC

Daniel Ferry

Daniel@lifesciadvisors.com

 
 
                     ProKidney Corp. and Subsidiaries 
                        Consolidated Balance Sheets 
                   (in thousands, except for share data) 
 
                              September 30, 2024     December 31, 2023 
                                 (Unaudited) 
                             --------------------   ------------------- 
Assets 
   Cash and cash 
    equivalents               $           108,088    $           60,649 
   Marketable securities                  298,724               302,301 
   Interest receivable                      5,102                 1,375 
   Prepaid assets                           6,227                 3,399 
   Prepaid clinical                        11,053                 6,413 
   Other current assets                     1,031                     9 
                                 ----------------       --------------- 
      Total current assets                430,225               374,146 
 
Fixed assets, net                          38,519                42,143 
Right of use assets, net                    6,049                 4,263 
      Total assets            $           474,793    $          420,552 
                                 ================       =============== 
 
Liabilities and 
Shareholders' Deficit 
   Accounts payable           $             2,850    $            5,098 
   Lease liabilities                        1,067                   803 
   Accrued expenses and 
    other                                  21,264                17,665 
   Income taxes payable                        --                 1,472 
                                 ----------------       --------------- 
      Total current 
       liabilities                         25,181                25,038 
 
Income tax payable, net of 
 current portion                              772                   568 
Lease liabilities, net of 
 current portion                            5,372                 3,610 
                                 ----------------       --------------- 
      Total liabilities                    31,325                29,216 
Commitments and 
contingencies 
Redeemable noncontrolling 
 interest                               1,423,180             1,494,732 
 
Shareholders' deficit 
  Class A ordinary shares, 
   $0.0001 par value; 
   500,000,000 shares 
   authorized; 127,920,274 
   and 59,880,347 issued 
   and outstanding as of 
   September 30, 2024 and 
   December 31, 2023, 
   respectively                                13                     6 
  Class B ordinary shares, 
   $0.0001 par value; 
   500,000,000 shares 
   authorized; 163,741,676 
   and 168,297,916 issued 
   and outstanding as of 
   September 30, 2024 and 
   December 31, 2023, 
   respectively                                16                    17 
  Additional paid-in 
   capital                                199,509                36,114 
  Accumulated other 
   comprehensive (loss) 
   gain                                       321                   130 
  Accumulated deficit                  (1,179,571)           (1,139,663) 
                                 ----------------       --------------- 
Total shareholders' deficit              (979,712)           (1,103,396) 
                                 ----------------       --------------- 
   Total liabilities and 
    shareholders' deficit     $           474,793    $          420,552 
                                 ================       =============== 
 
 
 
 
                       ProKidney Corp. and Subsidiaries 
               Consolidated Statements of Operations - Unaudited 
              (in thousands, except for share and per share data) 
 
                        Three Months Ended            Nine Months Ended 
                           September 30,                September 30, 
                         2024          2023          2024          2023 
                     ------------   -----------   -----------   ----------- 
Operating expenses 
   Research and 
    development      $     31,250   $    32,198   $    87,887   $    84,179 
   General and 
    administrative         17,723        14,419        44,218        43,133 
                      -----------    ----------    ----------    ---------- 
Total operating 
 expenses                  48,973        46,617       132,105       127,312 
Operating loss            (48,973)      (46,617)     (132,105)     (127,312) 
 
Other income 
(expense): 
   Interest income          5,580         5,541        14,960        16,803 
   Interest expense            (2)           (2)           (7)           (9) 
                      -----------    ----------    ----------    ---------- 
     Net loss 
      before income 
      taxes               (43,395)      (41,078)     (117,152)     (110,518) 
Income tax 
 (benefit) expense         (2,342)          913        (2,300)        3,205 
                      -----------    ----------    ----------    ---------- 
   Net loss before 
    noncontrolling 
    interest              (41,053)      (41,991)     (114,852)     (113,723) 
                      -----------    ----------    ----------    ---------- 
Net loss 
 attributable to 
 noncontrolling 
 interest                 (23,143)      (31,007)      (74,944)      (83,956) 
                      -----------    ----------    ----------    ---------- 
  Net loss 
   available to 
   Class A ordinary 
   shareholders      $    (17,910)  $   (10,984)  $   (39,908)  $   (29,767) 
                      ===========    ==========    ==========    ========== 
 
Weighted average 
Class A ordinary 
shares 
outstanding: 
   Basic and 
    diluted           126,173,463    61,592,876    87,818,229    61,565,298 
Net loss per share 
attributable to 
Class A ordinary 
shares: 
   Basic and 
    diluted          $      (0.14)  $     (0.18)  $     (0.45)  $     (0.48) 
                      ===========    ==========    ==========    ========== 
 
 
 
 
                   ProKidney Corp. and Subsidiaries 
           Consolidated Statements of Cash Flows - Unaudited 
                            (in thousands) 
 
                                  Nine Months Ended September 30, 
                                       2024               2023 
                                ------------------   -------------- 
Cash flows from operating 
activities 
   Net loss before 
    noncontrolling interest      $        (114,852)  $     (113,723) 
Adjustments to reconcile net 
loss before noncontrolling 
interest to net cash flows 
used in operating 
activities: 
    Depreciation and 
     amortization                            3,858            2,707 
    Equity-based compensation               22,424           37,216 
    Gain on marketable 
     securities, net                        (5,521)          (3,675) 
    Impairment charges                       5,324               -- 
    Loss on disposal of 
     equipment                                 186               21 
    Changes in operating 
    assets and liabilities 
      Interest receivable                   (3,728)            (714) 
      Prepaid and other assets              (8,489)           5,094 
      Accounts payable and 
       accrued expenses                       (114)           7,774 
      Income taxes payable                  (1,268)             615 
                                    --------------    ------------- 
Net cash flows used in 
 operating activities                     (102,180)         (64,685) 
 
Cash flows from investing 
activities 
   Purchases of marketable 
    securities                            (277,291)        (301,701) 
   Sales and maturities of 
    marketable securities                  286,625          100,187 
   Purchase of equipment and 

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November 12, 2024 07:30 ET (12:30 GMT)

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