PROKIDNEY CORP.
For the period ended Mar 31, 2026. Filed May 15, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 15, 2026
PROK$1.14+7.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001193125-25-274303
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001193125-26-225841
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 141 previous paragraphs and 111 current paragraphs.
77 unchanged; 23 reworded; 10 added; 36 removed; 5 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
We are a late-clinical-stage biotechnology company pioneering the development of a first-in-class, autologous cell therapy that is intended to preserve kidney function in patients with advanced chronic kidney disease (“CKD”) and diabetes. Our approach seeks to redefine the treatment of CKD, shifting the emphasis away from management of kidney failure to the preservation of kidney function. Our lead product candidate, rilparencel, is the only cell therapy in Phase 3 clinical study for the treatment of advanced CKD and type 2 diabetes. Rilparencel is a product that includes autologous Selected Renal Cells (“SRC”) prepared from a patient’s own (autologous) kidney cells. The SRC are formulated as rilparencel for reinjection into the patient’s kidneys using a minimally invasive outpatient procedure. Because rilparencel is a personalized product 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.
Current report
We are currently conducting a Phase 3 clinical study for rilparencel in subjects with advanced CKD and type 2 diabetes and have completed two Phase 2 clinical studies for rilparencel in subjects with advanced CKD and diabetes. Rilparencel has received regenerative medicine advanced therapy (“RMAT”) designation from the United States Food and Drug Administration (the “FDA”), a status granted to accelerate the development and review of promising regenerative medicine therapies. Rilparencel has, to date, been generally well tolerated by subjects with moderate to severe CKD in Phase 1 and 2 clinical testing.
Current report
Effective July 1, 2025, ProKidney Corp. completed a domestication process through which it changed its jurisdiction of incorporation from the Cayman Islands to the State of Delaware (the “Domestication”). In connection with and subsequent to the Domestication, we also entered into a series of other transactions to both change the jurisdiction of incorporation of our foreign subsidiaries to the State of Delaware and streamline our operating subsidiaries from a tax perspective (collectively, the “Restructuring”).
Current report
The surrogate endpoint to support a potential accelerated approval of rilparencel is annualized eGFR slope. The efficacy analysis set is expected to contain approximately 320 patients and will include all patients with at least six months of follow-up after first injection.
Current report
The Domestication and other Restructuring transactions resulted in the Company becoming subject to corporate level income taxes in the U.S. 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.
Current report
decreases in equity-based compensation of approximately $1.2 million due to the completion of vesting for legacy profit interests awards issued prior to the business combination and forfeitures of awards;
Current report
decreases in professional fees and other operating costs of approximately $1.4 million driven by ongoing initiatives including the Domestication and Restructuring transactions in 2025; and
Current report
decreases in cash-based compensation of approximately $0.5 million related to reductions in severance amounts paid for terminated employees.
Current report
Other Trends and Uncertainties
Current report
We continue to monitor the impacts of ongoing macroeconomic conditions and geopolitical events. An escalation of geopolitical tensions or the implementation of global trade restrictions, including tariff actions, could adversely impact our business, financial condition or results of operations. Global conflicts, tariffs, labor disruptions, and regulatory developments continue to create volatility in global markets and contribute to supply chain shortages and pricing volatility. We continue to actively collaborate with our suppliers to monitor and, where possible, mitigate shortages and reduce supply and price volatility.
Removed paragraphs (36)
Previous report
ProKidney, a pioneer in the treatment of chronic kidney disease (“CKD”) through innovations in cell therapy, was founded in 2015 after a decade of research. 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.
Previous report
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 Regenerative Medicine Advanced Therapy (“RMAT”) designation from the United States Food & Drug Administration (“FDA”).
Previous report
REGEN-007:
Previous report
We recently completed our REGEN-007 trial, a multi-center Phase 2 open-label 1:1 randomized two-arm trial of rilparencel in patients with diabetes, CKD, and an eGFR of 20-50 mL/min/1.73m². Full results were presented as a late-breaking clinical trial at the American Society of Nephrology Kidney Week 2025.
Previous report
At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of our ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of ≥ 20%, and/or an increase of >30% and >30mg/g in the urine albumin to creatinine ratio (“UACR”) from baseline.
Previous report
The prespecified primary endpoint for REGEN-007 was the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2.
Previous report
Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (69%), and the mean age was 60 years. At baseline, 38 of 49 patients (78%) had type 2 diabetes mellitus and 11 (22%) had type 1 diabetes. Thirty-nine (80%) patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), and 18 (37%) were receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i). At baseline, the mean (SD) eGFR was 33±10 mL/min/1.73m². Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g).
Previous report
In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m² in the pre-injection period to -1.3 mL/min/1.73m² in the period following the last rilparencel injection. This 4.6 mL/min/1.73m² per year difference was statistically significant (p<0.001) and clinically meaningful. Among Group 1 patients, 15 of 24 (63%) met key Phase 3 PROACT 1 inclusion criteria. In this subgroup, treatment with rilparencel resulted in a 5.5 mL/min/1.73m² improvement in the annual decline in eGFR slope. This 85% improvement was statistically significant and clinically meaningful.
Previous report
In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m² in the pre-injection period versus -1.7 mL/min/1.73m² in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m² per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response. Out of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months.
Previous report
No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The overall study safety profile was consistent with previously reported study results and comparable to a kidney biopsy.
Previous report
Completion of Domestication
Previous report
Effective July 1, 2025 (the “Domestication Date”), we completed a domestication process through which we changed our jurisdiction of incorporation from the Cayman Islands to the State of Delaware (the “Domestication”). In connection with the Domestication, we also completed certain other restructuring transactions (such transactions, together with the Domestication, the “Restructuring”) on the Domestication Date. Prior to the Restructuring, we conducted our business indirectly through ProKidney LP (“PKLP”), a limited partnership under the laws and regulations of Ireland, and its subsidiaries. As part of the Restructuring, (i) PKLP contributed substantially all of its assets to a newly formed subsidiary, ProKidney Holdings, LLC, a Delaware limited liability company (“PK Holdings”) (other than its limited liability company interests in PK Holdings), (ii) PKLP commenced winding-up and made a liquidating distribution of its limited liability company interests in PK Holdings to its partners, including the Company, in redemption of their interests in PKLP, and (iii) ProKidney Corp. GP Limited, the general partner of PKLP, sold its nominal economic interest in PK Holdings received in such liquidating distribution to us (collectively, the “Substitution”). Immediately following the Domestication, ProKidney, then a wholly owned subsidiary of PK Holdings and a Cayman Islands exempted company, re-registered as a Cayman Islands limited liability company and then deregistered as a limited liability company in the Cayman Islands and registered by way of continuation out for purposes of the Limited Liability Companies Act (as amended) of the Cayman Islands and domesticated and continued for purposes of the Delaware Limited Liability Company Act as a Delaware limited liability company named ProKidney IPCo, LLC (“ProKidney IPCo”). As a result of the consummation of the Domestication and the other transactions involved in the Restructuring, we and the other former limited partners of PKLP are now members of PK Holdings, and PK Holdings owns all of the subsidiaries that conduct our business, including ProKidney IPCo.
Previous report
In connection with the Domestication and the other Restructuring transactions, we amended and restated certain of our material agreements, each originally dated July 11, 2022, on substantially similar terms in order to reflect updates to our corporate structure resulting from the Restructuring including (i) an Amended and Restated Tax Receivable Agreement, (ii) an Amended and Restated Lock-Up Agreement, and (iii) an Amended and Restated Exchange Agreement. In addition, on the Domestication Date, we, together with the other former limited partners of PKLP, also entered into the Second Amended and Restated Limited Liability Company Agreement of PK Holdings to provide for the governance of PK Holdings and reflect the changes to our capital structure resulting from the Restructuring.
Previous report
After completing the Domestication and other Restructuring transactions, the Company also underwent a series of transactions to streamline its operating subsidiaries from a tax perspective (the “Post-Domestication Reorganization”). The Post-Domestication Reorganization was finalized effective as of September 1, 2025. Pursuant to these steps, ProKidney LLC, a limited liability company under the laws of Delaware (“ProKidney-US”), became disregarded entity as separate from its owner, PK Holdings, for U.S. federal income tax purposes.
Previous report
payments made under third-party licensing agreements;
Previous report
decrease in manufacturing improvement costs of approximately $1.5 million; and
Previous report
decrease in professional fees of $0.9 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period; offset by
Previous report
increase in material costs of $1.2 million driven by increased manufacturing to support our PROACT 1 clinical trial; and
Previous report
increase in equity and cash-based compensation costs of approximately $1.4 million due to the hiring of additional personnel and awards made in the 2025 period.
Previous report
decrease in impairment charges of $5.0 million related to our Greensboro facility as the original charge was recognized in the 2024 period;
Previous report
decrease in equity-based compensation of approximately $0.9 million due to forfeitures of awards and lower fair value of recent awards; and
Previous report
decrease in cash-based compensation of approximately $1.0 million driven by lower severance and benefit costs; offset by
Previous report
increase in professional fees of approximately $0.8 million driven by current quarter activities.
Previous report
Comparison of Nine Months Ended September 30, 2025 and 2024
Previous report
Research and development expenses
Previous report
decrease in professional fees of $2.8 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period; offset by
Previous report
General and administrative expenses
Previous report
decrease in impairment charges of $5.0 million related to our Greensboro facility as the original charge was recognized in the 2024 period; and
Previous report
decrease in equity-based compensation of approximately $2.4 million due to forfeitures of awards and lower fair value of recent awards; offset by
Previous report
increase in professional fees and other operating expenses of approximately $2.5 million driven by current quarter activities; and
Previous report
increase in cash-based compensation of approximately $1.0 million related to the hiring of new employees.
Previous report
Interest income
Previous report
Income tax expense
Previous report
The change in income tax expense was driven by the change in the taxable income associated with the U.S. entities that are treated as corporations for U.S. tax purposes. For the nine months ended September 30, 2024, the income tax benefit was driven by a change in the treatment of specified research and development expenses by our U.S. subsidiary due to guidance issued by the Internal Revenue Service in 2024 such that these costs are no longer required to be capitalized and amortized ratably over a five-year period.
Previous report
During the three months ended September 30, 2024, we sold 1,868,891 shares of its Class A common stock under the 2024 Sales Agreement for net proceeds of approximately $4.5 million. During the nine months ended September 30, 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.
Previous report
In June 2024, we sold 46,886,452 shares of our Class A common stock in an underwritten public offering at a price of $2.42 per share. Additionally, in June 2024, the Company sold 11,030,574 shares of its Class A common stock to certain investors at a price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements. The net proceeds to us from the offerings were approximately $136.7 million, after deducting the underwriting discounts and commissions and offering expenses payable by us. The shares were offered and sold pursuant to our shelf registration statement on Form S-3.
Reworded paragraphs (23)
Previous wording
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.
Current wording
As used in this Quarterly Report on Form 10-Q, the “Company”, the “Registrant”, “we” or “us” refer to ProKidney Corp. and its subsidiaries. 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 for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2026, 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.
Previous wording
For presentation purposes, unless otherwise noted, references to common stock refer to “ordinary shares” before the Domestication and “common stock” subsequent to the Domestication. Similarly, unless otherwise noted, references to PK Holdings herein refer to PKLP prior to the Domestication and PK Holdings subsequent to the Domestication and references to ProKidney IPCo. herein refer to ProKidney-KY prior to the Domestication and ProKidney IPCo. subsequent to the Domestication.
Current wording
For presentation purposes, unless otherwise noted, references to common stock refer to “ordinary shares” before the Domestication and “common stock” subsequent to the Domestication. Similarly, unless otherwise noted, references to PK Holdings LLC (“PK Holdings”) herein refer to ProKidney LP (“PKLP”) prior to the Domestication and PK Holdings subsequent to the Domestication and references to ProKidney IPCo, LLC (“ProKidney IPCo.”) herein refer to ProKidney, a Cayman Islands exempted company (“ProKidney-KY”) prior to the Domestication and ProKidney IPCo. subsequent to the Domestication.
Previous wording
PROACT 1 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (estimated glomerular filtration rate (“eGFR”) 20-30 mL/min/1.73m 2) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m 2) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m 2 and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m 2). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or kidney transplant; or kidney or cardiovascular death.
Current wording
REGEN-006 (PROACT 1) is an ongoing Phase 3, randomized, blinded, bi-lateral kidney dosing, sham controlled arm, efficacy and safety study of rilparencel in subjects with advanced CKD and 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/1.73m 2) and late Stage 3b CKD (eGFR between 30 and 35 mL/min/1.73m 2 with accompanying albuminuria UACR between 300 and 5000 mg/g). This study is being conducted in clinical centers in the United States, Mexico, and Taiwan.
Previous wording
In a recent Type B meeting, the FDA confirmed that the slope of eGFR in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (“BLA”) submission of rilparencel under the accelerated approval pathway. The FDA agreed that a rilparencel effect size (versus sham controls) of at least 1.5 mL/min/1.73m 2/year improvement would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. We anticipate topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in the second quarter of 2027. We have enrolled more than half of the patients required for the accelerated approval analysis. The FDA also confirmed that the ongoing Phase 3 PROACT 1 study may serve as the confirmatory study to support full approval of rilparencel based on the primary time-to-event composite endpoint specified in the protocol. Updated guidance on the expected timing of the confirmatory readout will be provided in the first half of 2026.
Current wording
We anticipate topline data readout of the surrogate endpoint (eGFR slope) in the second quarter of 2027 and anticipate topline data readout of the confirmatory endpoint (composite time-to-event) in the second half of 2029.
Previous wording
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.
Current wording
We have not generated any revenue from the sale of products 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.
Previous wording
Beginning in the three months 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.
Current wording
We recognize 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.
Previous wording
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.
Current wording
Research and development activities are central to our business model. We expect that our research and development expenses will increase as we continue to enroll patients in the PROACT 1 study then trend downward as we near completion.
Previous wording
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.
Current wording
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.
Previous wording
The decrease in research and development expenses of $7.9 million was primarily due to the following:
Current wording
The increase in research and development expenses of $6.6 million was primarily due to the following:
Previous wording
increase in costs for our ongoing Phase 3 trial (PROACT 1) of $4.5 million driven by continued enrollment and increased activities for the trial; and
Current wording
increase in clinical study costs and cost of manufacturing materials for our ongoing Phase 3 trial (PROACT 1) of $6.5 million driven by continued enrollment and increased activities for the trial;
Previous wording
increase in cash-based compensation costs of approximately $3.4 million due to the hiring of additional personnel.
Current wording
increase in compensation costs of approximately $1.2 million due to the hiring of additional personnel; offset by
Previous wording
decrease in clinical study costs of approximately $4.2 million from our clinical trials that have been completed or terminated;
Current wording
decrease in clinical study costs of $1.6 million related to clinical trials that have been completed or terminated.
Previous wording
The decrease in general and administrative expenses of approximately $5.8 million was primarily driven by the following:
Current wording
The decrease in general and administrative expenses of approximately $3.0 million was primarily driven by the following:
Previous wording
The decrease in interest income of approximately $2.3 million was driven primarily by lower investment balances and interest rates for the 2025 period.
Current wording
The decrease in interest income of approximately $1.7 million was driven primarily by lower investment balances and interest rates for the 2026 period.
Previous wording
The change in income tax expense was driven by the change in the taxable income associated with the U.S. entities that are treated as corporations for U.S. tax purposes. For the three months ended September 30, 2024, the income tax benefit was driven by a change in the treatment of specified research and development expenses by our U.S. subsidiary due to guidance issued by the Internal Revenue Service in 2024 such that these costs are no longer required to be capitalized and amortized ratably over a five-year period.
Current wording
The change in income tax expense was driven by the Domestication and Restructuring that occurred in 2025.
Previous wording
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. The shares are offered and sold pursuant to our shelf registration statement on Form S-3. During the three and nine months ended September 30, 2025, we sold 1,989,147 shares of our Class A common stock under the 2025 Sales Agreement for net proceeds of approximately $7.1 million. As of September 30, 2025, there was approximately $192.7 million remaining available to be sold under the 2025 Sales Agreement. Subsequent to September 30, 2025, we have sold an additional 5,463,195 shares of its Class A common stock under the 2025 Sales Agreement for net proceeds of $17.1 million.
Current wording
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. The shares are offered and sold pursuant to our shelf registration statement on Form S-3. During the three months ended March 31, 2026, we sold an insignificant number of shares of our Class A common stock under the 2025 Sales Agreement. As of March 31, 2026, there was approximately $175.0 million remaining available to be sold under the 2025 Sales Agreement.
Previous wording
Cash Flows for the Nine Months Ended September 30, 2025 and 2024
Current wording
Cash Flows for the Three Months Ended March 31, 2026 and 2025
Previous wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):
Current wording
The following table provides information regarding our cash flows for the three months ended March 31, 2026 and 2025 (in thousands):
Previous wording
Net cash used in operating activities was approximately $87.6 million for the nine months ended September 30, 2025, reflecting a net loss of approximately $110.8 million. The net loss was partially offset by non-cash charges and gains on investments of approximately $22.1 million and changes in working capital of $0.5 million. The non-cash charges primarily consisted of equity-based compensation expense of $19.6 million, depreciation and amortization expense of $4.7 million and were partially offset by gains on marketable securities of $2.7 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.
Current wording
Net cash used in operating activities was approximately $41.7 million for the three months ended March 31, 2026, reflecting a net loss of approximately $42.6 million. The net loss was partially offset by non-cash charges and gains on investments of approximately $6.2 million. The non-cash charges primarily consisted of equity-based compensation expense of $4.9 million, depreciation and amortization expense of $1.7 million and were partially offset by gains on marketable securities of $0.4 million. Changes in working capital resulted in an additional use of cash of approximately $5.3 million 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.
Previous wording
Net cash used in operating activities was approximately $102.2 million for the nine months ended September 30, 2024, reflecting net loss of $114.9 million, and uses driven by changes in working capital of approximately $13.6 million and 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, impairment charges of $5.3 million and depreciation and amortization expense of $3.9 million, which were partially offset by gains on marketable securities of $5.5 million.
Current wording
Net cash used in operating activities was approximately $29.6 million for the three months ended March 31, 2025, reflecting net loss of $38.0 million, and uses driven by changes in working capital of approximately $1.1 million and non-cash charges and gains on investments of $1.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $6.4 million and depreciation and amortization expense of $1.6 million, which were partially offset by gains on marketable securities of $1.1 million.
Previous wording
The approximately $14.5 million decrease in cash used in operating activities for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily driven by a decrease in the use of cash related to the timing of payments to our vendors and receipt of interest due.
Current wording
The approximately $12.1 million increase in cash used in operating activities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily driven by higher net loss and an increase in the use of cash related to the timing of payments to our vendors and receipt of interest due.
Previous wording
Net cash provided by investing activities was approximately $75.9 million and $5.3 million for the nine months ended September 30, 2025 and 2024, respectively. The cash provided by investing activities during the nine months ended September 30, 2025 and 2024 was primarily related to timing of the conversion of investments to cash and cash equivalents or use to fund our operations.
Current wording
Net cash provided by investing activities was approximately $34.8 million and $28.3 million for the three months ended March 31, 2026 and 2025, respectively. The cash provided by investing activities during the three months ended March 31, 2026 and 2025 was primarily related to timing of the conversion of investments to cash and cash equivalents or use to fund our operations.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025 of $7.9 million was primarily related to the sale of our Class A common stock through the 2025 Sales Agreement and stock option exercises. The cash provided by financing activities during the nine months ended September 30, 2024 of $144.3 million was primarily related to the sale of our Class A common stock through an underwritten public offering and concurrent registered direct offering in June 2024.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2026 of $0.2 million was primarily related to the sale of our Class A common stock through stock option exercises. The cash provided by financing activities during the three months ended March 31, 2025 was insignificant.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The primary objective of this study is to assess the efficacy of up to two rilparencel injections given three months apart and delivered into both kidneys using a minimally invasive percutaneous approach with a targeted enrollment of approximately 470 patients. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy. Subjects in the treatment group will receive two injections of rilparencel of 3x106 cells/g-KWest.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
The decrease in research and development expenses of approximately $4.4 million was primarily due to the following:
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
decrease in clinical study costs of approximately $13.3 million from our clinical trials that have been completed or terminated; and
Previous report — wording carried elsewhere
The decrease in general and administrative expenses of approximately $3.9 million was primarily driven by the following:
Previous report — wording carried elsewhere
The decrease in interest income of approximately $4.1 million was driven primarily by lower investment balances and interest rates for the 2025 period.