PROKIDNEY CORP.

Previous wording

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

Current wording

We are a clinical-stage biotechnology company with a transformative proprietary cell therapy platform that has the potential to treat multiple chronic kidney diseases using a patient’s own cells isolated from the patient intended for treatment. Our approach seeks to redefine the treatment of chronic kidney disease (“CKD”), shifting the emphasis away from management of kidney failure to the preservation of kidney function. 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 Selected Renal Cells (“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. 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.

Previous wording

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

Current wording

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 regenerative medicine advanced therapy (“RMAT”) designation from the United States Food and Drug Administration (“FDA”). We also completed a Phase 1 clinical trial for rilparencel in subjects with CKD due to congenital anomalies of the kidney and urinary tract (“CAKUT”) for which the last subject visit occurred in January 2023 and the clinical study report was submitted to the FDA in December 2023. Rilparencel has, to date, been generally well tolerated by subjects with moderate to severe CKD in Phase 1 and 2 clinical testing.

Previous wording

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

Current wording

In 2024, we completed a comprehensive internal and external review to determine the optimal path to bring rilparencel to patients in the U.S. with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need. An important conclusion of this review was that under the provisions of the RMAT designation, we believe rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial, and that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, we discontinued REGEN-016 (PROACT 2), which was focused on enrollment outside the U.S. Subsequently, we had a Type B meeting with the FDA to discuss updates to rilparencel’s registrational trial strategy. The FDA confirmed that PROACT 1 could be sufficient to support a potential Biologics License Application (“BLA”) submission. Additionally, the FDA confirmed that the accelerated approval pathway is available to rilparencel if an acceptable endpoint, which may include eGFR slope is used. We will continue to engage with the FDA, under our RMAT designation, to further define the details supporting this accelerated pathway. We will continue to advance the U.S. clinical development program with the benefit of enhanced clarity as to the FDA’s expectations and requirements for a registrational program, including the design of the trials needed for approval, manufacturing assays, and comparability studies, as set forth below.

Previous wording

the timing and progress of non-clinical and clinical development activities;

Current wording

the timing and progress of nonclinical and clinical development activities;

Previous wording

the number and scope of non-clinical and clinical programs we decide to pursue;

Current wording

the number and scope of nonclinical and clinical programs we decide to pursue;

Previous wording

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

Current wording

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.

Previous wording

increases in cash-based compensation costs of approximately $9.8 million due to the hiring of additional personnel particularly in the areas of clinical development, manufacturing and quality as we move forward with our clinical programs,

Current wording

increases in cash-based compensation costs of approximately $1.1 million due to the hiring of additional personnel; and

Previous wording

increases in professional fees of $4.4 million related to the remediation of quality and manufacturing compliance deficiencies;

Current wording

decreases in professional fees of $0.8 million related to the remediation of quality and manufacturing compliance deficiencies during the 2024 period.

Previous wording

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

Current wording

The increase in general and administrative expenses of approximately $1.5 million was primarily driven by the following:

Previous wording

increases in cash-based compensation of approximately $6.0 million related to the hiring of new employees; offset by;

Current wording

increases in cash-based compensation of approximately $1.2 million related to the hiring of new employees; and

Previous wording

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

Current wording

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. From our inception through March 31, 2025, 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.

Previous wording

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

Current wording

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

Previous wording

incur third-party manufacturing costs to support our non-clinical studies and clinical trials of our product candidate and, if approved, its commercialization;

Current wording

incur third-party manufacturing costs to support our nonclinical studies and clinical trials of our product candidate and, if approved, its commercialization;

Previous wording

make investment in developing internal manufacturing capabilities; and

Current wording

make investments in developing internal manufacturing capabilities; and

Previous wording

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

Current wording

Cash Flows for the Three Months Ended March 31, 2025 and 2024

Previous wording

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

Current wording

The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):

Previous wording

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

Current wording

Net cash used in operating activities was approximately $29.6 million for the three months ended March 31, 2025, reflecting a net loss of approximately $38.0 million offset by cash provided by changes in working capital of approximately $1.1 million. Such uses were partially offset by 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. 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 $64.7 million for the nine months ended September 30, 2023, reflecting net loss of $113.7 million, partially offset cash provided by changes in working capital of approximately $12.8 million and non-cash charges and gains on investments of $36.2 million. The non-cash charges primarily consisted of equity-based compensation expense of $37.2 million and depreciation and amortization expense of $2.7 million.

Current wording

Net cash used in operating activities was approximately $34.6 million for the three months ended March 31, 2024, reflecting net loss of $35.3 million, and uses driven by changes in working capital of approximately $5.8 million and non-cash charges and gains on investments of $2.3 million. The non-cash charges primarily consisted of equity-based compensation expense of $7.7 million and depreciation and amortization expense of $1.1 million.

Previous wording

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

Current wording

The approximately $5.1 million decrease in cash used in operating activities for the three months ended March 31, 2025 compared to the three months ended March 31, 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, partially offset by an increase in net loss after adjusting for the non-cash charges and gains on investments of approximately $2.1 million.

Previous wording

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

Current wording

Net cash provided by investing activities was approximately $28.3 million and $58.4 million for the three months ended March 31, 2025 and 2024, respectively. The cash provided by investing activities during the three months ended March 31, 2025 and 2024 was primarily related to the conversion of these investments to cash and cash equivalents or use to fund our operations.