What changed in PROKIDNEY CORP.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of PROKIDNEY CORP.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+56 added−61 removedSource: 10-K (2026-03-18) vs 10-K (2024-12-31)
Top changes in PROKIDNEY CORP.'s 2025 10-K
56 paragraphs added · 61 removed · 49 edited across 1 sections
- Item 1C. Cybersecurity+56 / −61 · 49 edited
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
49 edited+7 added−12 removed57 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
49 edited+7 added−12 removed57 unchanged
2024 filing
2025 filing
Biggest changeComparison of Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023 (in thousands): Years Ended December 31, 2024 2023 Change Revenue $ 76 $ – $ 76 Operating expenses: Research and development 127,668 106,707 20,961 General and administrative 56,084 44,815 11,269 Total operating expense 183,752 151,522 32,230 Loss from operations (183,676 ) (151,522 ) (32,154 ) Interest income 19,752 22,083 (2,331 ) Interest expense (9 ) (12 ) 3 Net loss before taxes (163,933 ) (129,451 ) (34,482 ) Income tax (benefit) expense (598 ) 5,996 (6,594 ) Net loss before noncontrolling interest (163,335 ) (135,447 ) (27,888 ) Net loss attributable to noncontrolling interest (102,149 ) (99,979 ) (2,170 ) Net loss available to Class A ordinary shareholders $ (61,186 ) $ (35,468 ) $ (25,718 ) Research and development expenses The increase in research and development expenses of approximately $21.0 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily driven by the following: • increases in cash-based compensation and recruitment costs of approximately $12.2 million related to the hiring of additional employees in 2024; • increases in cost of clinical study conduct and clinical product manufacturing materials of $7.7 million related primarily to the progress of our Phase 3 study as we resumed enrollment in PROACT 1; • increases in operational costs of $4.5 million as we continue to expand operations to support our Phase 3 clinical reflecting costs related to the remediation of quality management systems and processes in the first half of 2024; partially offset by • decreases in equity-based compensation costs of approximately $3.4 million driven by awards forfeited by terminated employees as well as lower valuations for awards granted in 2024.
Biggest changeSecurities and Exchange Commission on March 17, 2025. 89 Comparison of Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024 (in thousands): Years Ended December 31, 2025 2024 Change Revenue $ 893 $ 76 $ 817 Operating expenses: Research and development 114,123 127,668 (13,545 ) General and administrative 51,777 56,084 (4,307 ) Total operating expense 165,900 183,752 (17,852 ) Loss from operations (165,007 ) (183,676 ) 18,669 Interest income 13,813 19,752 (5,939 ) Interest expense (4 ) (9 ) 5 Net loss before taxes (151,198 ) (163,933 ) 12,735 Income tax expense (benefit) 414 (598 ) 1,012 Net loss before noncontrolling interest (151,612 ) (163,335 ) 11,723 Net loss attributable to noncontrolling interest (82,626 ) (102,149 ) 19,523 Net loss available to Class A common stockholders $ (68,986 ) $ (61,186 ) $ (7,800 ) Revenue The increase in revenue of approximately $0.8 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily driven by the inclusion of a full year of leasing activities for the year ended December 31, 2025.
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 nonclinical and clinical development activities; • the number and scope of nonclinical 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.
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 nonclinical and clinical development activities; • the number and scope of nonclinical 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; 88 • 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.
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.
Liquidity and Capital Resources Sources of liquidity Since our inception, we 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.
We expect that our general and administrative expenses will increase for the foreseeable future as our business expands and we hire additional personnel to support our operations. 90 Other Income (Expense) Other income consists primarily of interest income earned on cash, cash equivalents and marketable securities.
We expect that our general and administrative expenses will increase for the foreseeable future as our business expands and we hire additional personnel to support our operations. Other Income (Expense) Other income consists primarily of interest income earned on cash, cash equivalents and marketable securities.
We have not experienced any material cybersecurity incidents and the expenses we have incurred from cybersecurity incidents were immaterial. Cybersecurity Governance Cybersecurity is an important part of our overall risk management processes and an area of focus for our Board and management.
We have not experienced any material cybersecurity incidents and the expenses we have incurred from cybersecurity incidents were immaterial. 85 Cybersecurity Governance Cybersecurity is an important part of our overall risk management processes and an area of focus for our Board and management.
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 nonclinical 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.
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 nonclinical studies and clinical trials of our product candidate and, if approved, its commercialization; • seek to identify and develop additional product candidates; • make investments in developing internal manufacturing capabilities; and • seek regulatory and marketing approvals for our product candidates.
During the quarter ended December 31, 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).
During the quarter ended December 31, 2025 , 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).
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 92 we may obtain marketing approval.
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 91 we may obtain marketing approval.
We expect that our existing cash, cash equivalents and marketable securities held at December 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027. 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 that our existing cash, cash equivalents and marketable securities held at December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and procedures were effective in causing material information relating to us (including our consolidated subsidiaries) to be recorded, processed, summarized and reported by management on a timely basis and to ensure the quality and timeliness of our public disclosures with SEC disclosure obligations.
Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2025, our disclosure controls and procedures were effective in causing 93 material information relating to us (including our consolidated subsidiaries) to be recorded, processed, summarized and reported by management on a timely basis and to ensure the quality and timeliness of our public disclosures with SEC disclosure obligations.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. Management based this assessment on criteria described in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. Management based this assessment on criteria described in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In January 2024, the Company entered into an Open Market Sale Agreement SM (“Sales Agreement”) with Jefferies LLC 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, par value $0.0001 per share, 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 “ATM Offering”).
In January 2024, the Company entered into an Open Market Sale Agreement SM (the “2024 Sales Agreement”) with Jefferies LLC as the sales agent, pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of its Class A common stock, par value $0.0001 per share, 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 “ATM Offering”).
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 94 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2024.
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 of December 31, 2025.
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 7A . Quantitative and Qualitative Disclosures About Market Risk.
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 common stock less attractive to investors. Item 7A . Quantitative and Qualitative Disclosures About Market Risk.
In November 2024, we purchased two buildings in Winston-Salem, North Carolina, portions of which buildings we previously occupied pursuant to real estate leases. The two buildings represent total usable space of approximately 180,000 square feet. The portion of the buildings we currently occupy are used for office, manufacturing and research space.
We own two buildings in Winston-Salem, North Carolina, portions of which buildings we previously occupied pursuant to real estate leases. The two buildings represent total usable space of approximately 180,000 square feet. The portion of the buildings we currently occupy are used for office, manufacturing and research space.
Based on this assessment, management determined that as of December 31, 2024, we maintained effective internal control over financial reporting.
Based on this assessment, management determined that as of December 31, 2025, we maintained effective internal control over financial reporting.
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.
Additionally, in June 2024, the Company sold 11,030,574 of its Class A common stock to certain investment entities at a price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements.
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.
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, establishing and protecting our intellectual property portfolio, developing and progressing rilparencel, raising capital, sponsoring clinical trials, establishing arrangements with third parties for the manufacture of component materials, and providing general and administrative support for these operations.
For a discussion of the year ended December 31, 2023 compared to December 31, 2022, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 22, 2024.
For a discussion of the year ended December 31, 2024 compared to December 31, 2023, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form 10-K filed with the U.S.
From our inception through December 31, 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 public equity offerings.
From our inception through December 31, 2025, we funded our operations primarily through capital contributions from the holders of PK Holdings, the proceeds obtained through the Business Combination and related private placement financing and public equity offerings.
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 CKD, shifting the emphasis away from management of kidney failure to the preservation of kidney function.
Overview We are a clinical-stage biotechnology company with a proprietary cell therapy platform that has the potential to treat CKD using a patient’s own cells. Our approach seeks to redefine the treatment of CKD, shifting the emphasis away from management of kidney failure to the preservation of kidney function.
Additionally, we engage external auditors and consultants to assess our internal cybersecurity program and our compliance with applicable practices and standards. Security events and data incidents are evaluated, ranked by severity and prioritized for response and remediation. Incidents are evaluated to determine materiality as well as operational and business impact and reviewed for privacy impact.
Security events and data incidents are evaluated, ranked by severity and prioritized for response and remediation. Incidents are evaluated to determine materiality as well as operational and business impact and reviewed for privacy impact. As part of the above processes, we engage external auditors and consultants to assess our internal cybersecurity programs and compliance with applicable practices and standards .
Because a large portion of our Class A ordinary shares are held by brokers, nominees and other institutions on behalf of shareholders, we are unable to estimate the total number of shareholders represented by these record holders. There is no public market for our Class B ordinary shares. Unregistered Sales of Securities Not applicable.
Because a large portion of our Class A common stock are held by brokers, nominees and other institutions on behalf of shareholders, we are unable to estimate the total number of shareholders represented by these record holders. There is no public market for our Class B common stock.
The cash provided by investment activities during the year ended December 31, 2024 was primarily related to net investment activity of $49.9 million partially offset by the purchase of two facilities in Winston-Salem, North 93 Carolina that we occupied subject to real estate leases for $22.5 million.
The cash provided by investing activities during the year ended December 31, 2024 was primarily related to net investment activity of $49.9 million partially offset by the purchase of two facilities in Winston-Salem, North Carolina for $22.5 million.
Investing Activities Net cash provided by (used in) investing activities were approximately $20.4 million and $(330.0 million) for the years ended December 31, 2024 and 2023, respectively.
Investing Activities Net cash provided by investing activities were approximately $104.0 million and $20.4 million for the years ended December 31, 2025 and 2024, respectively.
Beginning in the year ended December 31, 2024, we recognized revenue related to leasing activities associated with existing lease agreements assumed through the acquisition of two buildings in Winston-Salem, North Carolina where we also conduct our manufacturing operations.
Beginning in the year ended December 31, 2024, we recognized revenue related to leasing activities associated with existing lease agreements assumed through the acquisition of two buildings in Winston-Salem, North Carolina where we also conduct our manufacturing operations. 87 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.
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 no alternative future use for the research and development.
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 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.
Issuer Purchases of Equity Securities There were no repurchases of the Company’s Class A ordinary shares during the quarter ended December 31, 2024. Item 6 . RESERVED. Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Unregistered Sales of Securities Not applicable. 86 Issuer Purchases of Equity Securities There were no repurchases of the Company’s Class A common stock during the quarter ended December 31, 2025. Item 6 . RESERVED. Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The approximate $36.3 million increase in cash used in operating activities for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily driven by an increase in net loss before noncontrolling interest after adjusting for the non-cash charges and gains on investments of approximately $24.3 million coupled with the impact of changes in working capital driven by the timing of payments to our vendors.
The approximate $6.2 million decrease in cash used in operating activities for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily driven by a decrease in net loss before noncontrolling interest after adjusting for the non-cash charges and gains on investments of approximately $8.9 million offset by the impact of changes in working capital driven by the timing of payments to our vendors.
The changes in working capital primarily relate to the timing of payments made to our vendors for services performed. Net cash used in operating activities was approximately $90.1 million for the year ended December 31, 2023, reflecting a net loss before noncontrolling interest of approximately $135.4 million.
Gains on investments in marketable securities were $3.4 million. The changes in working capital primarily relate to the timing of payments made to our vendors for services performed. Net cash used in operating activities was approximately $126.4 million for the year ended December 31, 2024, reflecting a net loss before noncontrolling interest of approximately $163.3 million.
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 consolidated financial statements included in this Annual Report.
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 consolidated financial statements included in this Annual Report. JOBS Act Accounting Election We are an emerging growth company, as defined in the JOBS Act.
Cash Flows Cash Flows for the Years Ended December 31, 2024 and 2023 The following table provides information regarding our cash flows for the years ended December 31, 2024 and 2023 (in thousands): Years Ended December 31, 2024 2023 Net cash flows used in operating activities $ (126,351 ) $ (90,069 ) Net cash flows provided by (used in) investing activities 20,414 (329,983 ) Net cash flows provided by (used in) financing activities 144,408 (9,551 ) Net change in cash and cash equivalents $ 38,471 $ (429,603 ) Operating Activities Net cash used in operating activities was approximately $126.4 million for the year ended December 31, 2024, reflecting a net loss before noncontrolling interest of approximately $163.3 million.
Cash Flows Cash Flows for the Years Ended December 31, 2025 and 2024 The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024 (in thousands): Years Ended December 31, 2025 2024 Net cash flows used in operating activities $ (120,117 ) $ (126,351 ) Net cash flows provided by investing activities 103,965 20,414 Net cash flows provided by financing activities 25,569 144,408 Net change in cash and cash equivalents $ 9,417 $ 38,471 Operating Activities Net cash used in operating activities was approximately $120.1 million for the year ended December 31, 2025, reflecting a net loss before noncontrolling interest of approximately $151.6 million.
Income tax expense The increase in income tax expense of approximately $6.6 million for the year ended December 31, 2024 as compared to the year ended December 31, 2023, was driven primarily by the increase in the valuation allowance which was impacted by the timing of deductions for qualified research and development costs.
Income tax expense The increase in income tax expense of approximately $1.0 million for the year ended December 31, 2025 as compared to the year ended December 31, 2024, was driven primarily by tax benefits recognized in the year ended December 31, 2024 due to the effects of the change in timing of deductions for qualified research and development costs.
Such uses were offset by changes in working capital of approximately $16.7 million and non-cash charges and gains on investments of $28.7 million. The non-cash charges primarily consisted of equity-based compensation expense of $30.8 million, depreciation and amortization expense of $3.9 million and gains on investments in marketable securities of $6.0 million.
Such uses were offset by changes in working capital of approximately $1.3 million and non-cash charges and gains on investments totaling $30.2 million. The non-cash charges primarily consisted of equity-based compensation expense of $25.3 million, depreciation and amortization expense of $6.6 million, loss on disposal of equipment of $1.4 million and an impairment charge of $0.3 million.
Not applicable. PART II Item 5 . Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 87 Market Information Our Class A ordinary shares are listed on the Nasdaq Capital Market under the symbol “PROK”. Dividend Policy No cash dividends have ever been declared or paid on the common equity to date by the Company.
Market Information Our Class A common stock are listed on the Nasdaq Capital Market under the symbol “PROK”. Dividend Policy No cash dividends have ever been declared or paid on the common equity to date by the Company.
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.
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.
The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3. As of December 31, 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.
The shares were offered and sold pursuant to the Company’s shelf registration statement on Form S-3. During the year ended December 31, 2024, we sold 4,170,791 shares of our Class A common stock under the 2024 Sales Agreement for net proceeds of approximately $7.7 million.
We have also leased approximately 14,700 square feet of office and warehouse space in Winston-Salem under leases that expire in 2027. Additionally, we have leased a total of approximately 12,400 square feet of office and laboratory space in the Research Triangle Park area of North Carolina under leases expiring in July 2027 and March 2028, respectively.
Additionally, we have leased a total of approximately 16,300 square feet of office and laboratory space in the Research Triangle Park area of North Carolina under leases expiring in July 2027 and July 2031, respectively. Finally, we have leased approximately 7,400 square feet of office space in Boston, Massachusetts under a lease that expires in January 2029. Item 3 .
General and administrative expenses The increase in general and administrative expenses of approximately $11.3 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily driven by the following: • increases in cash-based compensation and recruitment costs of approximately $5.4 million due to the hiring of additional personnel and severance costs incurred for terminated employees; 91 • the recognition of an impairment charge of $5.3 million related to our Greensboro facility; • increases in equity-based compensation costs of $1.9 million related to additional awards granted to employees during 2024; partially offset by • decreases in operating costs of $2.1 million related to decreased legal costs, professional fees and other operating costs.
General and administrative expenses The decrease in general and administrative expenses of approximately $4.3 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily driven by the following: • decrease in impairment charges of $5.0 million related to our Greensboro facility as the original charge was recognized in the 2024 period; and • decrease in equity-based compensation of approximately $3.4 million due to forfeitures of awards and lower fair value of recent awards; offset by • increase in professional fees and other operating expenses of approximately $3.8 million driven by ongoing initiatives in 2025 including the domestication; and • increases in cash-based compensation and recruitment costs of approximately $0.5 million due to the hiring of additional personnel. 90 Interest income The decrease in interest income of approximately $5.9 million for the year ended December 31, 2025 as compared to the year ended December 31, 2024, was driven by lower investment balances and interest rates for the 2025 period.
The capitalized amounts are recorded as prepaid clinical and are expensed as the related goods are delivered or the services are performed. 89 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 we continue to develop rilparencel and prepare for potential commercialization.
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 we continue to develop rilparencel and prepare for potential commercialization. The successful development of rilparencel and any product candidates we may develop in the future is highly uncertain.
We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4 . Mine Safety Disclosures.
Legal Proceedings. From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.
Income Tax (Expense) Benefit 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 In this section we discuss the results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Income Tax (Expense) Benefit Prior to the Domestication and other Restructuring transactions, 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. The Domestication and other Restructuring transactions resulted in the Company becoming subject to corporate level income taxes in the U.S.
Financing Activities Net cash provided by (used in) financing activities was $144.4 million and $(9.6 million) for the years ended December 31, 2024 and 2023, respectively.
Financing Activities Net cash provided by financing activities was $25.6 million and $144.4 million for the years ended December 31, 2025 and 2024, respectively. The cash provided by financing activities for the years ended December 31, 2025 and 2024 was related to the sale of our Class A common stock and exercise of employee stock options.
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.
As of December 31, 2025, there was approximately $175.0 million remaining available to be sold under the 2025 Sales Agreement. In June 2024, the Company sold 46,886,452 of its Class A common stock in an underwritten public offering at a price of $2.42 per share.
This includes 1) defined roles and incident response initiation processes, 2) incident detection and analysis, 3) containment, eradication and recovery, and 4) post-incident analysis.
This includes 1) defined roles and incident response initiation processes, 2) incident detection and analysis, 3) containment, eradication and recovery, and 4) post-incident analysis. Such incident responses and related matters of cybersecurity are overseen by leaders from our Information Technology, Manufacturing, Clinical Operations, Regulatory and Legal teams.
Holders As of March 17, 2025, we had approximately 129,536,121 Class A ordinary shares issued and outstanding held by 41 holders of record and approximately 163,161,528 Class B ordinary shares issued and outstanding held by three holders of record.
Holders As of March 17, 2026, we had approximately 141,942,905 Class A common stock issued and outstanding held by 30 holders of record and approximately 159,973,180 Class B common stock issued and outstanding held by three holders of record.
Such incident responses and related matters of cybersecurity are overseen by leaders from our Information Technology, Manufacturing, Clinical Operations, Regulatory and Legal teams. 86 We employ a range of tools and services, including regular network and endpoint monitoring, audits, vulnerability assessments and penetration testing to inform our risk identification and assessment.
We employ a range of tools and services, including regular network and endpoint monitoring, audits, vulnerability assessments and penetration testing to inform our risk identification and assessment. Additionally, we engage external auditors and consultants to assess our internal cybersecurity program and our compliance with applicable practices and standards.
The remaining portion of these buildings are leased by us to third parties under lease agreements that expire between 2026 and 2029. As of December 31, 2024, we also owned a 210,000 square foot facility and approximately 22 acres of land in Greensboro, North Carolina. This property is being actively marketed for sale.
The remaining portion of these buildings are leased by us to third parties under lease agreements that expire between 2026 and 2029. We have also leased approximately 14,700 square feet of office and warehouse space in Winston-Salem under leases that expire in 2027.
The cash used in investing activities during the year ended December 31, 2023 was primarily related to the investment of a portion of the proceeds raised through the Business Combination in marketable securities coupled with the purchase of land and a building in Greensboro, North Carolina for $25.5 million.
The cash provided by investment activities during the year ended December 31, 2025 was primarily related to net investment activity of $100.9 million and the sale of our facility in Greensboro, North Carolina, which 92 provided net proceeds of $18.2 million. These were partially offset by capital spending for facility expansion of $15.2 million.
Removed
As part of the above processes, we engage external auditors and consultants to assess our internal cybersecurity programs and compliance with applicable practices and standards .
Added
Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4 . Mine Safety Disclosures. Not applicable. PART II Item 5 . Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
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Finally, we have leased approximately 7,400 square feet of office space in Boston, Massachusetts under a lease that expires in January 2029. Item 3 . Legal Proceedings. From time to time, we may become involved in litigation or other legal proceedings.
Added
ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cell therapy being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. Rilparencel received RMAT designation from the FDA.
Removed
Our lead product candidate, rilparencel, is designed to preserve kidney function in a CKD patient’s diseased kidneys. Rilparencel is a product that includes autologous SRC prepared from a patient’s own 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.
Added
Further, the Post-Domestication Reorganization, which was effective on September 1, 2025, resulted in certain of the Company’s subsidiaries becoming part of a consolidated group and ProKidney-US becoming disregarded as separate from its owner, “PK Holdings” for U.S. federal income tax purposes Results of Operations In this section we discuss the results of our operations for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Removed
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.
Added
For the year ended December 31, 2024, revenue reflected approximately one month of leasing activities.
Removed
We are currently conducting a Phase 3 development program and an ongoing Phase 2 clinical trial for rilparencel in subjects with moderate to severe CKD and diabetes. Rilparencel has received RMAT designation from the FDA.
Added
Research and development expenses The decrease in research and development expenses of approximately $13.5 million for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily driven by the following: • decreases in clinical study costs of $18.1 million from our clinical trials that have been completed or terminated; • decreases in professional fees of $3.3 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period; and • decreases in equity-based compensation of $0.6 million driven by forfeitures of awards and lower fair value of new awards granted; partially offset by • increases in cash-based compensation and recruitment costs of approximately $6.1 million related to the hiring of additional employees; and • increase in clinical study costs and cost of manufacturing materials for our ongoing Phase 3 trial (PROACT 1) of $2.4 million driven by continued enrollment and increased activities for the trial.
Removed
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 88 the last subject visit occurred in January 2023 and the clinical study report was submitted to the FDA in December 2023.
Added
In July 2025, we terminated the 2024 Sales Agreement and entered into a new Open Market Sale Agreement SM (“2025 Sales Agreement”) with Jefferies, as the sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our Class A common stock having an aggregate offering price of up to $200.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act.
Removed
Rilparencel has, to date, been generally well tolerated by subjects with moderate to severe CKD in Phase 1 and 2 clinical testing.
Added
The shares are offered and sold pursuant to our shelf registration statement on Form S-3. During the year ended December 31, 2025, we sold 7,452,342 shares of our Class A common stock under the 2025 Sales Agreement for net proceeds of approximately $24.2 million.
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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.
Removed
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.
Removed
Interest income The decrease in interest income of approximately $2.3 million for the year ended December 31, 2024 as compared to the year ended December 31, 2023, was driven by interest received on lower average cash and investments in marketable debt securities balances as a result of ongoing research and development and general and administrative expenses, offset by $136.6 million of proceeds from a public offering in June 2024.
Removed
The cash provided by financing activities for the year ended December 31, 2024 was related to the sale of our Class A ordinary shares while cash used in financing activities for the year ended December 31, 2023 was primarily related to the repurchase of our Class A ordinary shares.
Removed
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”).