ProKidney Reports First Quarter 2026 Financial Results and Business Highlights

• On track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis of rilparencel in mid-2026; anticipate pivotal topline results in Q2 2027
• Peer-reviewed results from the Phase 2 REGEN-007 study were published in the Clinical Journal of the American Society of Nephrology (CJASN) in January 2026
• Ended Q1 2026 with $224.9 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., May 15, 2026 — ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the first quarter ended March 31, 2026, and provided business highlights.

“As we progress through 2026, we continue to build on the momentum established last year through positive Phase 2 REGEN-007 results, alignment with the FDA on the accelerated approval pathway, and meaningful progress on Phase 3 PROACT 1 study enrollment,” said Bruce Culleton, M.D., CEO of ProKidney. “We expect to complete enrollment in PROACT 1 this year, positioning us to deliver pivotal eGFR slope topline results in the second quarter of 2027. Our mission remains highly focused on advancing a potential new treatment option for patients with advanced CKD and diabetes at high risk of kidney failure, an area of significant unmet medical need.”

Business Highlights

Phase 3 REGEN-006 (PROACT 1) — Pivotal Study

• Enrollment: On track to complete enrollment for the surrogate (eGFR slope) endpoint in mid-2026
• Topline readout: Pivotal results expected in Q2 2027
• Study Power 90% power to detect an effect size of 1.75 mL/min/1.73m² in annualized eGFR slope80% power to detect an effect size of 1.5 mL/min/1.73m² in annualized eGFR slope
• FDA Alignment: Under rilparencel’s regenerative medicine advanced therapy (RMAT) designation, the U.S. Food and Drug Administration (FDA) confirmed in a prior Type B meeting that a rilparencel effect size of 1.5 mL/min/1.73m² per year would be an acceptable demonstration of efficacy in patients receiving appropriate standard of care
• Phase 2 REGEN-007 Data: In Group 1, bilateral kidney injections with rilparencel were associated with a 4.6 mL/min/1.73m² improvement in the annual decline in eGFR slope in the pre-injection period versus the period after the last rilparencel injection

Regulatory Position

• July 2025 Type B meeting: FDA confirmed that eGFR slope in patients from the ongoing PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission under the accelerated approval pathway
• FDA also confirmed that PROACT 1 may be used to support both accelerated and confirmatory approval of rilparencel
• ProKidney continues to maintain its ongoing dialogue with the FDA under rilparencel’s RMAT designation

Publications & Presentations

• January 2026: Phase 2 REGEN-007 results published in the Clinical Journal of the American Society of Nephrology (CJASN)
• November 2025: Phase 2 REGEN-007 results presented as a late-breaking clinical trial at ASN Kidney Week

Key Clinical Takeaway

The Company has achieved FDA alignment on the accelerated and confirmatory approval pathways for rilparencel. Completion of PROACT 1 enrollment this year is a key 2026 milestone. The positive Phase 2 REGEN-007 results provide confidence heading into the expected pivotal topline results (eGFR slope) in the second quarter of 2027.

First Quarter 2026 Financial Highlights

Liquidity: Cash, cash equivalents and marketable securities as of March 31, 2026, totaled $224.9 million, compared to $270.0 million as of December 31, 2025. We expect that our existing cash, cash equivalents and marketable securities held at March 31, 2026, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.

R&D Expenses: Research and development expenses were $33.8 million for the three months ended March 31, 2026, compared to $27.3 million for the same period in 2025. The increase of $6.6 million was driven primarily by increases in clinical study and related manufacturing costs of $6.5 million related to our ongoing PROACT 1 study. Additionally, compensation costs increased $1.2 million related to the hiring of additional personnel to support our operations. These increases have been offset by decreases in costs of $1.6 million related to clinical study costs for trials that have been completed or terminated.

G&A Expenses: General and administrative expenses were $11.3 million for the three months ended March 31, 2026 compared to $14.4 million for the same period in 2025. The decrease of $3.1 million was driven primarily by decreases in compensation costs of approximately $1.7 million due to vesting of awards issued prior to the business combination coupled with forfeitures of equity-based awards and reductions in severance costs. Additionally, professional fees and other operating costs have decreased $1.4 million driven by ongoing initiatives, including the domestication and restructuring transactions in 2025.

Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $42.6 million and $38.0 million for the three months ended March 31, 2026, and 2025, respectively.

Shares Outstanding: Class A and Class B common stock outstanding at March 31, 2026, totaled 301,953,977.

About Chronic Kidney Disease

CKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes over 1 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD.

About the Phase 2 REGEN-007 Clinical Trial

REGEN-007 was a multi-center Phase 2 open-label 1:1 randomized two-armed trial in patients with diabetes and CKD who have 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 the 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 ≥ 30 mg/g in the urine albumin to creatinine ratio (UACR) from baseline. The purpose of this study was to assess the safety, efficacy, and durability of up to two rilparencel injections on renal function progression.

About the Phase 3 REGEN-006 (PROACT 1) Clinical Trial

REGEN-006 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 (eGFR 20-30 mL/min/1.73m2) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m2) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m2). The total planned enrollment is approximately 470 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 renal transplant; or renal or cardiovascular death.

About ProKidney Corp.

ProKidney, a pioneer in the treatment of CKD through innovations in cell therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cell therapy with regenerative medicine advanced therapy designation that is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) study for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. For more information, please visit www.prokidney.com.

ProKidney Contact

Ethan Holdaway [email protected]

Media Contact

Audra Friis [email protected]

Investor Relations Contact

Daniel Ferry [email protected]

ProKidney Corp. and Subsidiaries Consolidated Balance Sheets (in thousands, except for share data)

March 31, 2026

December 31, 2025

(Unaudited)

Assets

Cash and cash equivalents

$

101,895

$

108,537

Marketable securities

123,049

161,480

Interest receivable

1,032

1,127

Prepaid assets

3,083

2,808

Prepaid clinical

4,049

3,923

Other current assets

1,794

2,804

Total current assets

234,902

280,679

Fixed assets, net

54,441

51,231

Right of use assets, net

3,441

3,664

Total assets

$

292,784

$

335,574

Liabilities and Stockholders' Deficit

Accounts payable

$

2,592

$

940

Lease liabilities

1,108

1,071

Accrued expenses and other

22,231

28,731

Income taxes payable

–

–

Total current liabilities

25,931

30,742

Income tax payable, net of current portion

1,074

1,074

Lease liabilities, net of current portion

2,675

2,965

Total liabilities

29,680

34,781

Commitments and contingencies

Redeemable noncontrolling interest

1,286,887

1,311,990

Stockholders’ deficit

Class A common stock, $0.0001 par value; 700,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 141,980,643 and 141,807,277 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

14

14

Class B common stock, $0.0001 par value; 500,000,000 shares authorized; 159,973,334 and 159,262,779 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

16

16

Additional paid-in capital

266,112

258,552

Accumulated other comprehensive (loss) gain

(53

)

56

Accumulated deficit

(1,289,872

)

(1,269,835

)

Total stockholders' deficit

(1,023,783

)

(1,011,197

)

Total liabilities and stockholders' deficit

$

292,784

$

335,574

ProKidney Corp. and Subsidiaries Consolidated Statements of Operations - Unaudited (in thousands, except for share and per share data)

Three Months Ended March 31,

2026

2025

Revenue

$

226

$

230

Operating expenses

Research and development

33,842

27,263

General and administrative

11,317

14,355

Total operating expenses

45,159

41,618

Operating loss

(44,933

)

(41,388

)

Other income (expense):

Interest income

2,327

4,027

Interest expense

(15

)

–

Net loss before income taxes

(42,621

)

(37,361

)

Income tax expense

—

591

Net loss before noncontrolling interest

(42,621

)

(37,952

)

Net loss attributable to noncontrolling interest

(22,584

)

(21,218

)

Net loss available to Class A common stockholders

$

(20,037

)

$

(16,734

)

Weighted average shares of Class A common stock outstanding:

Basic and diluted

141,925,099

126,976,366

Net loss per share attributable to Class A common stock:

Basic and diluted

$

(0.14

)

$

(0.13

)

ProKidney Corp. and Subsidiaries Consolidated Statements of Cash Flows – Unaudited (in thousands)

Three Months Ended March 31,

2026

2025

Cash flows from operating activities

Net loss before noncontrolling interest

$

(42,621

)

$

(37,952

)

Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities:

Depreciation and amortization

1,658

1,600

Equity-based compensation

4,945

6,416

Gain on marketable securities, net

(413

)

(1,069

)

Loss on disposal of equipment

–

300

Changes in operating assets and liabilities

Interest receivable

95

695

Prepaid and other assets

609

5,729

Accounts payable and accrued expenses

(5,957

)

(5,902

)

Income taxes payable

–

591

Net cash flows used in operating activities

(41,684

)

(29,592

)

Cash flows from investing activities

Purchases of marketable securities

(44,754

)

(55,449

)

Sales and maturities of marketable securities

83,366

84,873

Purchase of equipment and facility expansion

(3,785

)

(1,135

)

Net cash flows provided by investing activities

34,827

28,289

Cash flows from financing activities

Proceeds from sales of Class A common stock, net of offering costs

7

–

Payments on finance leases

(3

)

(12

)

Exercise of stock options

211

–

Net cash flows provided by (used in) financing activities

215

(12

)

Net change in cash and cash equivalents

(6,642

)

(1,315

)

Cash, beginning of period

108,537

99,120

Cash, end of period

$

101,895

$

97,805

Supplemental disclosure of non-cash investing and financing activities:

Right of use assets obtained in exchange for lease obligations

$

–

$

322

Exchange of Class B common stock

$

26

$

2,418

Impact of equity transactions and compensation on redeemable noncontrolling interest

$

2,366

$

4,426

Equipment and facility expansion included in accounts payable and accrued expenses

$

859

$

1,653