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PROKIDNEY CORP.

For the period ended Sep 30, 2025. Filed Nov 10, 2025.

View on SEC.gov

About 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.

Sep 30, 2025 · Filed Nov 10, 2025

PROK$1.14+7.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-12.

0000950170-25-107352

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

Current 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 Operations

The 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 137 previous paragraphs and 141 current paragraphs.

90 unchanged; 41 reworded; 8 added; 4 removed; 2 previous and 2 current paragraphs rearranged.

Tables are not compared: 4 previous and 3 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 (8)

Current 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.

Current report

decrease in manufacturing improvement costs of approximately $1.5 million; and

Current report

increase in material costs of $1.2 million driven by increased manufacturing to support our PROACT 1 clinical trial; and

Current report

decrease in impairment charges of $5.0 million related to our Greensboro facility as the original charge was recognized in the 2024 period;

Current report

decrease in cash-based compensation of approximately $1.0 million driven by lower severance and benefit costs; offset by

Current 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

Current 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.
Removed paragraphs (4)

Previous report

Full results from REGEN-007 will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial.

Previous report

decreases in equity-based compensation of approximately $0.5 million driven by forfeitures of awards and lower fair value of recent awards; offset by

Previous report

increases in cash-based compensation of approximately $2.0 million related to the hiring of new employees; and
Reworded paragraphs (41)

Previous wording

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) trial to demonstrate the therapy’s potential to preserve kidney function in patients with type 2 diabetes and advanced CKD. Rilparencel received Regenerative Medicine Advanced Therapy (“RMAT”) designation from the United States Food & Drug Administration (“FDA”).

Current wording

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 wording

PROACT 1 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with type 2 diabetes and advanced CKD. 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

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.

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/1.73m2/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 nearly 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

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.

Previous wording

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. 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 in the urine albumin to creatinine ratio (“UACR”) from baseline of ≥ 30% and ≥ 30 mg/g.

Current wording

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 wording

The prespecified primary endpoint for REGEN-007 is 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.

Current wording

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 wording

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/1.73m 2. Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g).

Current wording

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 wording

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/1.73m 2 in the pre-injection period to -1.3 mL/min/1.73m 2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m 2 per year difference was statistically significant (p<0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. The Phase 3 PROACT 1 protocol was amended in the first half of 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis (n=23) of high-UACR, Stage 4 CKD patients with type 2 diabetes.

Current wording

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 wording

In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m 2 in the pre-injection period versus -1.7 mL/min/1.73m 2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m 2 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.

Current wording

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 wording

No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy.

Current wording

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 wording

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 (“ProKidney Holdings”) (other than its limited liability company interests in ProKidney Holdings), (ii) PKLP commenced winding-up and made a liquidating distribution of its limited liability company interests in ProKidney 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 ProKidney Holdings received in such liquidating distribution to us (collectively, the “Substitution”). Immediately following the Domestication, ProKidney, then a wholly owned subsidiary of ProKidney 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 ProKidney Holdings, and ProKidney Holdings owns all of the subsidiaries that conduct our business, including ProKidney IPCo.

Current wording

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 wording

In connection with the Domestication and the other Restructuring transactions, we amended and restated certain of its 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 ProKidney Holdings to provide for the governance of ProKidney Holdings and reflect the changes to our capital structure resulting from the Restructuring.

Current wording

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 wording

For presentation purposes, unless otherwise noted, “ordinary shares” before the domestication and “common stock” subsequent to the domestication are referred to herein as common stock.

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 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.

Previous wording

The decrease in research and development expenses of approximately $3.5 million was primarily due to the following:

Current wording

The decrease in research and development expenses of approximately $4.4 million was primarily due to the following:

Previous wording

decreases in clinical study costs of approximately $7.4 million from our clinical trials that have been completed or terminated;

Current wording

decrease in clinical study costs of approximately $4.2 million from our clinical trials that have been completed or terminated;

Previous wording

decreases in professional fees of $1.9 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period; offset by

Current wording

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 wording

increases in cash-based compensation costs of approximately $2.6 million due to the hiring of additional personnel.

Current wording

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 wording

The increase in general and administrative expenses of approximately $0.4 million was primarily driven by the following:

Current wording

The decrease in general and administrative expenses of approximately $5.8 million was primarily driven by the following:

Previous wording

decreases in equity-based compensation of approximately $0.7 million due to forfeitures of awards and lower fair value of recent awards.

Current wording

decrease in equity-based compensation of approximately $0.9 million due to forfeitures of awards and lower fair value of recent awards; and

Previous wording

increases in professional fees of approximately $1.2 million driven by current quarter activities; offset by

Current wording

increase in professional fees of approximately $0.8 million driven by current quarter activities.

Previous wording

The decrease in interest income of approximately $0.9 million was driven primarily by lower investment balances and interest rates for the 2025 period.

Current 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.

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.

Current 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.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The decrease in research and development expenses of $3.5 million was primarily due to the following:

Current wording

The decrease in research and development expenses of $7.9 million was primarily due to the following:

Previous wording

decreases in clinical study costs of approximately $9.3 million from our clinical trials that have been completed or termination; and

Current wording

decrease in clinical study costs of approximately $13.3 million from our clinical trials that have been completed or terminated; and

Previous wording

decreases in professional fees of $1.1 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period; and

Current wording

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 wording

increases in costs for our ongoing Phase 3 trial (PROACT 1) of $4.3 million driven by continued enrollment and increased activities for the trial; and

Current 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

Previous wording

increases in cash-based compensation costs of approximately $1.5 million due to the hiring of additional personnel.

Current wording

increase in cash-based compensation costs of approximately $3.4 million due to the hiring of additional personnel.

Previous wording

The increase in general and administrative expenses of approximately $1.9 million was primarily driven by the following:

Current wording

The decrease in general and administrative expenses of approximately $3.9 million was primarily driven by the following:

Previous wording

decreases in equity-based compensation of approximately $1.5 million due to forfeitures of awards and lower fair value of recent awards.

Current wording

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 wording

increases in other operational expenses of approximately $0.4 million driven by current quarter activities; offset by

Current wording

increase in professional fees and other operating expenses of approximately $2.5 million driven by current quarter activities; and

Previous wording

increases in cash-based compensation of approximately $0.8 million related to the hiring of new employees; and

Current wording

increase in cash-based compensation of approximately $1.0 million related to the hiring of new employees.

Previous wording

The decrease in interest income of approximately $1.8 million was driven primarily by lower investment balances and interest rates for the 2025 period.

Current wording

The decrease in interest income of approximately $4.1 million was driven primarily by lower investment balances and interest rates for the 2025 period.

Previous wording

In July 2025, we terminated the 2024 Sales Agreement and entered into a new Open Market Sale Agreement SM 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.

Current wording

In January 2024, we entered into an Open Market Sale Agreement SM (“2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which we could offer and sell, from time to time, through Jefferies, shares of our Class A common stock 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 of 1933, as amended (the “Securities Act”). The shares were offered and sold pursuant to our shelf registration statement on Form S-3.

Previous wording

In January 2024, we entered into an Open Market Sale Agreement SM (“2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which we could offer and sell, from time to time, through Jefferies, shares of our Class A common stock 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 of 1933, as amended (the “Securities Act”). The shares were offered and sold pursuant to our shelf registration statement on Form S-3. As of June 30, 2025, we had sold $7.9 million worth of Class A common stock under the 2024 Sales Agreement for net proceeds of $7.7 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 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.

Previous wording

Cash Flows for the Six Months Ended June 30, 2025 and 2024

Current wording

Cash Flows for the Nine Months Ended September 30, 2025 and 2024

Previous wording

The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

Net cash used in operating activities was approximately $61.0 million for the six months ended June 30, 2025, reflecting a net loss of approximately $74.9 million along with cash used by changes in working capital of approximately $0.8 million. Such uses were partially offset by non-cash charges and gains on investments of $14.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $13.0 million, depreciation and amortization expense of $3.1 million and gains on marketable securities of $1.9 million. The changes in working capital primarily relate to the timing of payments made to our vendors for services performed and the recognition of receivable amounts related to interest on our marketable security investments.

Current 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.

Previous wording

Net cash used in operating activities was approximately $72.9 million for the six months ended June 30, 2024, reflecting net loss of $73.8 million, and uses driven by changes in working capital of approximately $13.3 million and non-cash charges and gains on investments of $14.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $15.5 million, depreciation and amortization expense of $2.4 million and gains on marketable securities of $3.8 million.

Current 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.

Previous wording

The approximately $11.8 million decrease in cash used in operating activities for the six months ended June 30, 2025 compared to the six months ended June 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 $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.

Previous wording

Net cash provided by investing activities was approximately $46.9 million and $87.0 million for the six months ended June 30, 2025 and 2024, respectively. The cash provided by investing activities during the three months ended June 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 $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.

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Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

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.

Current report — wording carried from elsewhere

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.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

increases in costs for our ongoing Phase 3 trial (PROACT 1) of $5.3 million driven by continued enrollment and increased activities for the trial; and

Previous report — wording carried elsewhere

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.