AI Earnings Predictions for ProKidney Corp. (PROK)

EX-99.1

2 prok-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

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 slope

• 80% 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 busin

EX-99.1

2 prok-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ProKidney Reports Full Year 2025 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

• In a July 2025 Type B meeting, aligned with FDA on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint

• Presented positive results from the Phase 2 REGEN-007 study of rilparencel as a late-breaking clinical trial at ASN Kidney Week 2025 followed by a peer-reviewed publication in CJASN

• Ended 2025 with $270.0 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., March 18, 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 full year ended December 31, 2025, and provided business highlights.

“2025 was a pivotal year for ProKidney, highlighted by positive Phase 2 REGEN-007 study results, alignment with the FDA on the accelerated approval pathway for rilparencel, and significant enrollment momentum in the Phase 3 PROACT 1 study,” said Bruce Culleton, M.D., CEO of ProKidney. “Looking ahead, we are well positioned to deliver on key upcoming milestones, including completion of enrollment for the Phase 3 PROACT 1 study this year followed by pivotal eGFR slope data in the second quarter of 2027. Our mission remains highly focused on bringing a potential new treatment option to patients with advanced CKD and diabetes at high risk of kidney failure – an area of high unmet medical need.”

Key Accomplishments in 2025

• Generated significant enrollment momentum in the Phase 3 PROACT 1 study, positioning the Company for a pivotal topline readout in Q2 2027 using eGFR slope.

• Confirmed with the U.S. Food and Drug Administration (FDA) in a July 2025 Type B meeting that eGFR slope 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. 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 regenerative medicine advanced therapy (RMAT) designation.

• Presented positive results from the Phase 2 REGEN-007 study of rilparencel in patients with advanced CKD and diabetes as a late-breaking clinical trial at the American Society of Nephrology (ASN) Kidney Week in November 2025, followed by a peer-reviewed publication in the Clinical Journal of the American Society of Nephrology (CJASN).

• Initiated expansion of in-house manufacturing footprint in two adjacent, company-owned facilities totaling 180,000 square feet in Winston-Salem, NC.

Anticipated Upcoming Milestones

• Mid-2026: Complete enrollment of patients to be included in the Phase 3 PROACT 1 accelerated approval efficacy analysis (n=~360)

• 2H 2026: Complete full enrollment for Phase 3 PROACT 1 confirmatory composite time-to-event analysis (n=~470)

• Throughout FY 2026: Present results from ongoing mechanism of action studies of rilparencel at medical and scientific conferences

• Q2 2027: Phase 3 PROACT 1 readout of surrogate endpoint (eGFR slope) for accelerated approval

• Q4 2027: BLA submission of rilparencel

• 2H 2028: BLA approval and commercial launch of rilparencel

• 2H 2029: Phase 3 PROACT 1 topline readout of confirmatory endpoint (composite time-to-event) for full approval

Full Year 2025 Financial Highlights

Liquidity: Cash, cash equivalents and marketable securities as of December 31, 2025, totaled $270.0 million, compared to $358.3 million as of December 31, 2024. We expect that our existing cash, cash equivalents and marketable securities held at December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.

R&D Expenses: Research and development expenses were $114.1 million for the year ended December 31, 2025, compared to $127.7 million for the year ended December 31, 2024. The decrease of $13.5 million was driven primarily by decreases in clinical study costs of $18.1 million from our clinical trials that have been completed or terminated. Additionally, operating costs have decreased $3.3 million related to the recognition of costs related to the remediation of quality management systems and processes in the 2024 period. These decreases have been offset by increases in cash and equity based compensation costs of approximately $5.5 million as we continue to hire additional personnel in the areas of clinical development, quality, manufacturing, and biostatistics to support our ongoing clinical trials. Also, clinical trial costs have increased

8-K

false000185027000018502702025-11-102025-11-10

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 10, 2025

PROKIDNEY CORP.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-40560

98-1586514

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

2000 Frontis Plaza Blvd. Suite 250

Winston-Salem, North Carolina

27103

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 336 999-7019

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A common stock, $0.0001 par value per share

PROK

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On November 10, 2025, ProKidney Corp. (the "Company") issued a press release to announce its financial results for the quarter ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1. The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits

Exhibit No.

Description

99.1

Press Release dated November 10, 2025

104

Cover Page Interactive Data File (embedded within Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

PROKIDNEY CORP.

Date:

November 10, 2025

By:

/s/ James Coulston

James Coulston Chief Financial Officer