Core Insights - ProKidney Corp is highlighted as a promising investment opportunity in the healthcare penny stock sector, particularly due to its focus on the cell therapy Reparencel [1] - The company is currently in Phase 3 of the Proactive One study, with top-line results expected by the second quarter of 2027 [2] - ProKidney is targeting high-risk patients with chronic kidney disease, specifically those with a GFR of 30 or less, and has completed 50% of enrollment for the study [2] Financial Position - As of June, ProKidney holds $295 million in cash, which is deemed sufficient to support the ongoing clinical trial [2] - The company is also enhancing its manufacturing capacity in North Carolina to prepare for anticipated strong demand for its therapy [2] Product Development - ProKidney is developing a first-in-class cell therapy, rilparencel (REACT), aimed at treating Chronic Kidney Disease (CKD) [2] - The therapy utilizes a patient's own kidney cells to potentially preserve kidney function and delay the need for dialysis [2]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?The last time I covered ProKidney (NASDAQ: PROK ), the Winston-Salem, North Carolina based biotech, for Seeking Alpha, it was July, and its share price was skyrocketing, jumping from $0.6, to >$4.5 overnight, after ...

PresentationJudah FrommerEquity Analyst Good morning, everyone. Welcome to the Morgan Stanley Global Healthcare Research Conference. I'm Judah Frommer. I'm one of the smid-cap biotech analysts here at Morgan Stanley. We're just going to start out with a brief disclosure. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. We're excited to kic ...

Summary of ProKidney Conference Call Company Overview - **Company**: ProKidney - **Headquarters**: Winston-Salem and Boston - **Employee Count**: Approximately 250 - **Public Offering**: Went public in 2022 - **Product**: Autologous cell therapy named Reparencel aimed at keeping patients with advanced chronic kidney disease (CKD) off dialysis - **Current Study**: In a phase 3 study called ProAct One [2][3] Phase 3 Study Details - **Study Design**: Randomized, sham-controlled, multicenter study primarily in the U.S., with some sites in Mexico and Taiwan - **Sample Size**: Targeting over 600 patients to achieve 122 events, which is significant for a cell therapy [3][4] - **Regulatory Progress**: Achieved RMAT designation in 2021, allowing for regulatory flexibility; discussions with the FDA have led to alignment on an accelerated approval process based on eGFR slope [4][5] - **Expected Readout**: Top-line results anticipated by Q2 2027 [5][11] Efficacy and Effect Size - **Effect Size**: FDA agreed on a meaningful effect size of at least 1.5 mL/min/year difference between treatment and control groups [7][8] - **Context**: This target is 50% greater than the differences observed in SGLT2 trials, which typically show less than 1 mL/min/year [8][9] - **Phase 2 Results**: In the phase 2 study, a decline of -5.8 mL/min/year was observed pre-treatment, reduced to -1.3 mL/min/year post-treatment, indicating a substantial difference [9][10] Market Opportunity - **Target Population**: Focus on high-risk CKD patients, particularly those with eGFR around 30 or less and high albuminuria [15][16] - **Market Size**: Estimated over 1 million patients in stage 4 CKD and 3B with high UACR, with around 500,000 being diabetics [29] Financials and Cash Runway - **Cash Position**: As of June, ProKidney had $295 million, expected to last until mid-2027, covering the phase 3 data and accelerated approval [33] - **Cost Management**: Strategic changes, including halting another phase 3 study (ProAct Two), saved approximately $150 million [36] Competitive Landscape - **Therapeutic Positioning**: ProKidney's therapy is expected to complement standard care, targeting patients who do not respond adequately to existing treatments like ACE inhibitors, ARBs, SGLT2s, and GLP-1 agonists [28][29] - **Manufacturing Capabilities**: Own manufacturing facility in North Carolina, capable of supporting both phase 3 and commercial launch [29] Regulatory and Strategic Considerations - **FDA Relationship**: Strong relationship with FDA, with RMAT designation providing a favorable regulatory environment [47] - **Tariffs Impact**: Minimal impact from tariffs due to primarily U.S.-sourced operations [48] Future Directions - **Potential for Earlier CKD Populations**: While there is interest in targeting earlier stages of CKD, the current focus remains on the high-risk population due to sufficient demand [31] - **AI Utilization**: ProKidney is cautiously exploring AI for administrative and cybersecurity tasks, with careful consideration in regulatory contexts [44][46] Conclusion ProKidney is positioned to address a significant unmet need in the chronic kidney disease market with its innovative cell therapy, Reparencel. The company is making substantial progress in its phase 3 study and has a solid financial foundation to support its upcoming milestones.

Question-and-Answer SessionSo Bruce, obviously, you've had a very busy summer with some pretty important data that sent the stock up quite a lot, actually. So tell us about the data, tell us about the platform, I guess, maybe to start with and how you got to this point?Bruce CulletonCEO & Director Sure. So first, Yigal, thanks for having us here. We appreciate the opportunity to talk and answer any questions as well. So you're right, we had a busy summer. We announced the results of one of our Phase II tria ...

ProKidney (PROK) Conference Summary Company Overview - ProKidney is an autologous cell therapy company focused on preserving kidney function in patients with type two diabetes and advanced chronic kidney disease (CKD) [6][5] - The company's headquarters are located in North Carolina, with manufacturing in Winston Salem and clinical offices in Raleigh [6] Key Clinical Data - ProKidney announced top-line results from its Phase II trial, REGEN-seven, in July 2025 [7][9] - The trial involved 49 subjects with advanced CKD and type two diabetes, comparing two injection regimens of the therapy, roperinsel [9][10] - Group one (two injections) showed a 78% improvement in the decline of kidney function, with a pre-injection slope of -5.8 mL/min/year changing to -1.3 mL/min/year post-treatment [10][12] - Group two (one injection) showed a 50% improvement in kidney function decline, although this was not statistically significant [12] Regulatory and Future Plans - ProKidney is preparing for a late-breaking trial presentation at the ASN Kidney Week in November 2025, with an abstract submission deadline of September 9, 2025 [19][20] - The Phase III study, PROACT one, has been narrowed to patients with an eGFR of 20 to 35, focusing on those with advanced CKD [34][39] - The primary endpoint for PROACT one is the difference in eGFR slope between treatment and control groups, with an expected enrollment of 600 to 700 patients [39][42] Market Potential and Strategy - The potential total addressable market (TAM) for ProKidney's therapy is estimated to be between 500,000 to 1 million patients [69] - The company is focused on the largest market segment within CKD, specifically targeting patients with diabetes and advanced CKD [70] - ProKidney aims to explore other indications in the future, including rare kidney diseases, but is currently focused on executing the Phase III study [71] Manufacturing and Cost Considerations - Roperinsel is an autologous cell product, requiring a kidney biopsy from the patient for cell extraction, which is then expanded and injected back into the patient [55][57] - ProKidney is expanding its manufacturing capabilities to meet potential demand, which may exceed supply if Phase III results are favorable [79] - The company is confident in its ability to price the product competitively while maintaining a profitable business model [80][82] Intellectual Property and Financials - ProKidney has a solid patent portfolio with multiple patent families [95] - As of June 2025, the company reported sufficient cash runway into mid-2027, covering the timeline for accelerated approval [92][93] Additional Studies - REGEN008 is a long-term safety follow-up study for patients from prior Phase II trials, focusing on safety data collection without further injections [84][85] Conclusion - ProKidney is positioned to make significant advancements in the treatment of advanced CKD with its innovative cell therapy, backed by promising clinical data and a clear regulatory pathway. The upcoming ASN presentation is anticipated to provide further insights into the efficacy and safety of roperinsel.

WINSTON-SALEM, N.C., Aug. 27, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the following two upcoming healthcare conferences in September: Citi Biopharma Back to School Conference (Boston)Date:Wednesday, September 3, 2025Time:10:30am ETFormat:Fireside ChatWebcast:Link Morgan Stanley ...

Executive Summary [Key Highlights of Q2 2025](index=1&type=section&id=Key%20Highlights%20of%20Q2%202025) ProKidney reported significant progress in Q2 2025, including positive topline data from the Phase 2 REGEN-007 study and alignment with the FDA on an accelerated approval pathway for rilparencel using eGFR slope as a surrogate endpoint. The company ended the quarter with strong liquidity, supporting operations into mid-2027 - Achieved FDA alignment on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint, with topline data anticipated in **Q2 2027**[3](index=3&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - Reported positive topline results from the Phase 2 REGEN-007 study on July 8, 2025, showing a **78% improvement in eGFR slope** in Group 1[3](index=3&type=chunk)[5](index=5&type=chunk) - Ended Q2 2025 with **$295 million** in cash, cash equivalents, and marketable securities, projected to fund operations into **mid-2027**[5](index=5&type=chunk) Regulatory and Clinical Updates [FDA Alignment for Accelerated Approval Pathway](index=1&type=section&id=FDA%20Alignment%20for%20Accelerated%20Approval%20Pathway) The FDA confirmed that eGFR slope from the Phase 3 PROACT 1 study can serve as the surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD. The PROACT 1 study can also support full confirmatory approval, with topline data for accelerated approval expected in Q2 2027 - FDA confirmed eGFR slope as an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD[4](index=4&type=chunk)[5](index=5&type=chunk) - An effect size of at least **1.5 mL/min/1.73m² per year improvement** in eGFR slope (versus sham controls) is considered an acceptable demonstration of efficacy[4](index=4&type=chunk) - Topline data readout for eGFR slope to support accelerated approval is anticipated in **Q2 2027**, with more than half of the required patients already enrolled in the Phase 3 PROACT 1 study[5](index=5&type=chunk)[6](index=6&type=chunk) [Phase 2 REGEN-007 Positive Topline Results](index=2&type=section&id=Phase%202%20REGEN-007%20Positive%20Topline%20Results) The Phase 2 REGEN-007 study yielded statistically and clinically significant positive topline results, demonstrating a 78% improvement in eGFR slope in Group 1, which replicated the Phase 3 PROACT 1 dosing schedule. The study also showed a favorable safety profile with no rilparencel-related serious adverse events - In Group 1 (n=24), the annual decline in eGFR slope improved by **78%**, from **-5.8 to -1.3 mL/min/1.73m²** after rilparencel treatment, a statistically significant difference (p<0.001)[7](index=7&type=chunk) - No rilparencel-related serious adverse events were observed across all **49 patients** who received at least one injection, consistent with previous safety profiles[8](index=8&type=chunk) - Full results from REGEN-007 will be submitted as a late-breaking clinical trial at the American Society of Nephrology **2025 Kidney Week**[5](index=5&type=chunk)[8](index=8&type=chunk) Second Quarter 2025 Financial Highlights [Liquidity and Cash Runway](index=2&type=section&id=Liquidity%20and%20Cash%20Runway) ProKidney's cash, cash equivalents, and marketable securities decreased from Q1 2025 but are expected to fund operating expenses and capital expenditures into mid-2027 | Metric | June 30, 2025 (Millions) | March 31, 2025 (Millions) | | :-------------------------------- | :----------------------- | :------------------------ | | Cash, cash equivalents and marketable securities | $294.7 | $328.5 | - Existing cash, cash equivalents, and marketable securities are expected to fund operating expenses and capital expenditures into **mid-2027**[10](index=10&type=chunk) [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses decreased year-over-year, primarily due to the completion or termination of certain clinical trials, partially offset by increased costs for the ongoing Phase 3 trial and additional R&D personnel | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------- | :----------------- | :----------------- | :---------------- | | Research and development expenses | $25.9 | $29.4 | -$3.5 | - Decrease driven by approximately **$7.4 million** reduction in clinical study costs from completed/terminated trials, **$1.1 million** in professional fees, and **$0.5 million** in equity-based compensation[11](index=11&type=chunk) - Offset by increases of approximately **$4.3 million** for the ongoing Phase 3 trial and **$1.5 million** in cash compensation due to additional R&D personnel[11](index=11&type=chunk) [General and Administrative Expenses](index=3&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses saw a slight increase year-over-year, mainly due to higher cash compensation and operational expenses, partially mitigated by a decrease in equity-based compensation | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------- | :----------------- | :----------------- | :---------------- | | General and administrative expenses | $14.0 | $13.7 | +$0.4 | - Increase primarily driven by approximately **$0.8 million** in cash compensation and **$0.4 million** in other operational expenses[13](index=13&type=chunk) - Partially offset by a decrease of approximately **$0.7 million** in equity-based compensation[13](index=13&type=chunk) [Net Loss and Shares Outstanding](index=3&type=section&id=Net%20Loss%20and%20Shares%20Outstanding) The net loss before noncontrolling interest slightly decreased in Q2 2025 compared to the same period in 2024, while the total number of Class A and Class B common stock outstanding increased | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | | :-------------------------------- | :----------------- | :----------------- | | Net loss before noncontrolling interest | $37.0 | $38.5 | - Total Class A and Class B common stock outstanding as of June 30, 2025, was **292,707,888**[14](index=14&type=chunk) Disease and Company Background [About Chronic Kidney Disease](index=3&type=section&id=About%20Chronic%20Kidney%20Disease) Chronic Kidney Disease (CKD) is a progressive condition affecting an estimated 37 million adults in the U.S., with diabetes being its leading cause. ProKidney is developing rilparencel to address the significant unmet need for therapies that can stabilize kidney function in patients with advanced CKD and diabetes - An estimated **37 million adults** in the U.S. have CKD, with diabetes being the leading cause[15](index=15&type=chunk) - ProKidney is developing rilparencel for **1 to 2 million U.S. patients** with Stage 3b/4 CKD and diabetes, a population with high unmet clinical need for therapies that stabilize kidney function[15](index=15&type=chunk) [About ProKidney Corp.](index=4&type=section&id=About%20ProKidney%20Corp.) ProKidney is a late clinical-stage cell therapeutics company founded in 2015, focused on chronic kidney disease. Its lead product candidate, rilparencel (REACT®), is a first-in-class, patented, proprietary autologous cellular therapy with RMAT designation, aimed at preserving kidney function in diabetic patients at high risk of kidney failure - ProKidney was founded in **2015** and is a pioneer in treating chronic kidney disease through cellular therapy innovations[19](index=19&type=chunk) - Rilparencel (REACT®) is the lead product candidate, a first-in-class, patented, proprietary autologous cellular therapy with **RMAT designation**[19](index=19&type=chunk) - Rilparencel is being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure[19](index=19&type=chunk) Detailed Clinical Trial Information [About the Phase 2 REGEN-007 Clinical Trial](index=3&type=section&id=About%20the%20Phase%202%20REGEN-007%20Clinical%20Trial) REGEN-007 was a multi-center, open-label, 1:1 randomized Phase 2 trial designed to assess the safety, efficacy, and durability of up to two rilparencel injections on renal function progression in patients with diabetes and CKD, utilizing two distinct dosing regimens - REGEN-007 was a multi-center Phase 2 open-label **1:1 randomized two-armed trial**[16](index=16&type=chunk) - Patients had diabetes and CKD with an eGFR of **20-50 mL/min/1.73m²**[16](index=16&type=chunk) - The study assessed safety, efficacy, and durability of up to two rilparencel injections on renal function progression, with Group 1 replicating the Phase 3 PROACT 1 dosing schedule and Group 2 testing an exploratory, disease progression-triggered regimen[16](index=16&type=chunk) [About the Phase 3 REGEN-006 (PROACT 1) Clinical Trial](index=4&type=section&id=About%20the%20Phase%203%20REGEN-006%20(PROACT%201)%20Clinical%20Trial) PROACT 1 is an ongoing Phase 3, randomized, blinded, sham-controlled study evaluating the safety and efficacy of rilparencel in subjects with advanced CKD and type 2 diabetes. It targets specific eGFR and albuminuria criteria, with eGFR slope as the surrogate endpoint for accelerated approval and a composite endpoint for full approval - PROACT 1 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel[17](index=17&type=chunk) - The study focuses on 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[17](index=17&type=chunk) - The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint includes at least **40% reduction in eGFR**, eGFR **<15 mL/min/1.73m²**, dialysis, renal transplant, or renal/cardiovascular death[17](index=17&type=chunk)[18](index=18&type=chunk) Forward-Looking Statements [Disclaimer and Risk Factors](index=4&type=section&id=Disclaimer%20and%20Risk%20Factors) This section provides a standard disclaimer regarding forward-looking statements, emphasizing that actual results may differ from expectations due to various risks and uncertainties. It lists numerous factors that could impact future performance, including regulatory approvals, clinical trial outcomes, financial stability, and market conditions - The press release includes forward-looking statements, and actual results may differ from expectations due to various factors[20](index=20&type=chunk) - Factors that may cause differences include disruptions from domestication, inability to maintain Nasdaq listing, competition, clinical trial results, regulatory requirements, financing challenges, intellectual property rights, and uncertainties inherent in cell therapy R&D[20](index=20&type=chunk)[21](index=21&type=chunk) - The Company cautions readers not to place undue reliance on forward-looking statements and does not undertake any obligation to publicly update or revise them[21](index=21&type=chunk) Consolidated Financial Statements [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets present ProKidney's financial position, detailing assets, liabilities, and stockholders' deficit as of June 30, 2025, and December 31, 2024 | Assets (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $84,940 | $99,120 | | Marketable securities | $209,788 | $259,172 | | Total current assets | $324,440 | $395,884 | | Total assets | $372,133 | $441,073 | | Liabilities and Stockholders' Deficit (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Total current liabilities | $28,262 | $36,217 | | Total liabilities | $32,680 | $39,436 | | Redeemable noncontrolling interest | $1,341,953 | $1,396,591 | | Total stockholders' deficit | $(1,002,500) | $(994,954) | | Total liabilities and stockholders' deficit | $372,133 | $441,073 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations provide a summary of ProKidney's financial performance for the three and six months ended June 30, 2025, and 2024, including revenue, operating expenses, and net loss | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $221 | $– | $451 | $– | | Research and development | $25,882 | $29,404 | $53,145 | $56,637 | | General and administrative | $14,048 | $13,652 | $28,403 | $26,495 | | Operating loss | $(39,709) | $(43,056) | $(81,097) | $(83,132) | | Interest income | $3,593 | $4,537 | $7,620 | $9,380 | | Net loss before noncontrolling interest | $(36,965) | $(38,466) | $(74,917) | $(73,799) | | Net loss available to Class A common stockholders | $(16,552) | $(12,506) | $(33,286) | $(21,998) | | Basic and diluted EPS | $(0.13) | $(0.16) | $(0.26) | $(0.32) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows detail the cash generated from or used in operating, investing, and financing activities for the six months ended June 30, 2025, and 2024, showing the overall change in cash and cash equivalents | Cash Flows (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash flows used in operating activities | $(61,008) | $(72,939) | | Net cash flows provided by investing activities | $46,854 | $86,969 | | Net cash flows (used in) provided by financing activities | $(26) | $139,829 | | Net change in cash and cash equivalents | $(14,180) | $153,859 | | Cash, beginning of period | $99,120 | $60,649 | | Cash, end of period | $84,940 | $214,508 |

PART I. Financial Information (Unaudited) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements detail the company's financial position, operational results, and cash flows with explanatory notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $372,133 thousand as of June 30, 2025, primarily due to lower cash and marketable securities balances | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $84,940 | $99,120 | | Marketable securities | $209,788 | $259,172 | | Total current assets | $324,440 | $395,884 | | Total assets | $372,133 | $441,073 | | Total liabilities | $32,680 | $39,436 | | Redeemable noncontrolling interest | $1,341,953 | $1,396,591 | | Total stockholders' deficit | $(1,002,500) | $(994,954) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss available to Class A common stockholders increased to $(16,552) thousand for Q2 2025 despite new revenue generation | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :----------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Revenue | $221 | $– | $451 | $– | | Research and development | $25,882 | $29,404 | $53,145 | $56,637 | | General and administrative | $14,048 | $13,652 | $28,403 | $26,495 | | Operating loss | $(39,709) | $(43,056) | $(81,097) | $(83,132) | | Net loss before income taxes | $(36,117) | $(38,522) | $(73,478) | $(73,757) | | Net loss available to Class A common stockholders | $(16,552) | $(12,506) | $(33,286) | $(21,998) | | Basic and diluted EPS | $(0.13) | $(0.16) | $(0.26) | $(0.32) | [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Total comprehensive loss for Class A common stockholders increased to $(16,597) thousand in Q2 2025 due to net loss and investment losses | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss including noncontrolling interest | $(36,965) | $(38,466) | $(74,917) | $(73,799) | | Unrealized income (loss) on marketable securities | $(100) | $132 | $(224) | $(515) | | Total comprehensive loss attributable to Class A common stockholders | $(16,597) | $(12,468) | $(33,386) | $(22,134) | [Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Noncontrolling%20Interest%20and%20Stockholders'%20Deficit) This statement details changes in redeemable noncontrolling interest and an increasing accumulated deficit for the six months ended June 30, 2025 | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------------- | :----------------------------- | :------------------------------- | | Redeemable noncontrolling interest | $1,341,953 | $1,396,591 | | Additional paid-in capital | $231,576 | $205,736 | | Accumulated deficit | $(1,234,135) | $(1,200,849) | | Total stockholders' deficit | $(1,002,500) | $(994,954) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased while cash from investing activities also decreased significantly for the six months ended June 30, 2025 | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash flows used in operating activities | $(61,008) | $(72,939) | | Net cash flows provided by investing activities | $46,854 | $86,969 | | Net cash flows (used in) provided by financing activities | $(26) | $139,829 | | Net change in cash and cash equivalents | $(14,180) | $153,859 | | Cash, end of period | $84,940 | $214,508 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide crucial context for the financial statements, detailing business operations, accounting policies, and specific financial items [Note 1: Description of Business and Basis of Presentation](index=12&type=section&id=Note%201%3A%20Description%20of%20Business%20and%20Basis%20of%20Presentation) The company is a clinical-stage biotech developing rilparencel for chronic kidney disease and recently domesticated to Delaware - ProKidney Corp is focused on the development of rilparencel to preserve kidney function in patients with chronic kidney disease[34](index=34&type=chunk) - The company operates under an umbrella partnership corporation ("Up-C") structure, with PKLP considered the accounting acquiror and predecessor entity[32](index=32&type=chunk)[33](index=33&type=chunk) - As of June 30, 2025, various holders own a **54.4% economic interest** in PKLP, representing a redeemable noncontrolling interest[36](index=36&type=chunk) - The company completed a domestication process effective July 1, 2025, changing its jurisdiction of incorporation from the Cayman Islands to the State of Delaware[35](index=35&type=chunk) [Note 2: Significant Accounting Policies](index=12&type=section&id=Note%202%3A%20Significant%20Accounting%20Policies) This note details key accounting policies, including the use of estimates, marketable securities classification, and R&D cost treatment - Unaudited interim financial statements are prepared in accordance with GAAP and SEC rules, with estimates made for R&D expenses, equity-based compensation, and income taxes[38](index=38&type=chunk)[39](index=39&type=chunk)[42](index=42&type=chunk) - Marketable debt securities are classified as **available-for-sale and short-term**[44](index=44&type=chunk) - Research and development costs are **expensed as incurred**, including salaries, benefits, third-party fees, and clinical trial expenses[48](index=48&type=chunk) - The company uses the liability method for income taxes and applies a **full valuation allowance** to offset net deferred tax assets[56](index=56&type=chunk) - Leases are recognized on the balance sheet, with short-term leases (12 months or less) excluded[61](index=61&type=chunk) - Equity-based compensation expense is based on the fair value of awards at the grant date and recognized over the service period[64](index=64&type=chunk) - The company operates in a single segment and is evaluating new FASB ASUs on income tax disclosures (ASU 2023-09) and expense disaggregation (ASU 2024-03)[66](index=66&type=chunk)[67](index=67&type=chunk)[70](index=70&type=chunk) [Note 3: Investments](index=20&type=section&id=Note%203%3A%20Investments) The fair value of cash equivalents and marketable securities, measured at Level 2, decreased to $236,788 thousand by June 30, 2025 - All cash equivalents and marketable securities are measured at fair value within **Level 2** of the fair value hierarchy[71](index=71&type=chunk) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :----------------------------- | :------------------------------- | | Money market funds | $2,256 | $5,979 | | Time deposits | $2,082 | $6,737 | | Commercial paper | $14,902 | $34,894 | | Asset backed securities | $5,506 | $6,935 | | Government bonds | $63,740 | $80,571 | | Corporate debt securities | $148,302 | $180,030 | | **Total Fair Value** | **$236,788** | **$315,146** | - As of June 30, 2025, **$228,162 thousand** of investments are due in one year or less[73](index=73&type=chunk) - Total gross unrealized losses on marketable securities were **$(27) thousand** as of June 30, 2025[74](index=74&type=chunk) [Note 4: Income Taxes](index=21&type=section&id=Note%204%3A%20Income%20Taxes) The company is exempt from Cayman Islands taxes but its US subsidiary is subject to US taxes, with a full valuation allowance on deferred tax assets - ProKidney Corp (Cayman Islands) is exempt from income taxes, while its US subsidiary (ProKidney-US) is subject to US federal and state income taxes[75](index=75&type=chunk)[76](index=76&type=chunk) - A **full valuation allowance** is recorded to offset net deferred tax assets due to uncertainty of realization[56](index=56&type=chunk)[79](index=79&type=chunk) - The company is assessing the impact of the 'One Big Beautiful Bill Act,' signed July 4, 2025, on its consolidated financial statements[81](index=81&type=chunk) - The domestication to Delaware, effective July 1, 2025, is **not expected to adversely impact** the company's tax positions[82](index=82&type=chunk) [Note 5: Leases](index=22&type=section&id=Note%205%3A%20Leases) The company holds operating and finance leases, incurring rent expense while also generating leasing revenue from subleased properties | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :---------------- | :---------------------------------------------- | :---------------------------------------------- | | Rent expense | $298 | $513 | | Leasing revenue | $221 | $– | | Lease Type | June 30, 2025 (in thousands) | | :------------------------ | :----------------------------- | | Operating lease liabilities, current | $896 | | Operating lease liabilities, noncurrent | $3,446 | | Finance lease liabilities, current | $7 | | Finance lease liabilities, noncurrent | $69 | - The weighted average remaining lease term for operating leases is **4.3 years**, and for finance leases, it is **4.5 years**[85](index=85&type=chunk) [Note 6: Related Party Transactions](index=23&type=section&id=Note%206%3A%20Related%20Party%20Transactions) The company maintains several agreements with related parties governing stock exchanges, tax savings, and consulting services - The Exchange Agreement allows holders of Post-Combination ProKidney Common Units and Class B common stock to exchange them for Class A common stock or cash[88](index=88&type=chunk) - The Lock-Up Agreement imposes transfer restrictions on certain shares, with 50% of shares held by Closing ProKidney Unitholders (excluding Earnout Shares) having expired in January 2023[89](index=89&type=chunk)[90](index=90&type=chunk) - The Tax Receivable Agreement obligates the company to pay Closing ProKidney Unitholders **85% of certain tax savings** resulting from increases in tax basis due to unit exchanges[91](index=91&type=chunk) - Earnout Rights, totaling **17.5 million units**, vest in three equal tranches if the Class A common stock's VWAP reaches $15.00, $20.00, and $25.00 per share within five years post-closing[92](index=92&type=chunk) - ProKidney-KY and ProKidney-US each pay Nefro Health, an entity controlled by a company director, **$25,000 per quarter** for consulting services related to research and development[93](index=93&type=chunk)[94](index=94&type=chunk) [Note 7: Redeemable Noncontrolling Interest](index=27&type=section&id=Note%207%3A%20Redeemable%20Noncontrolling%20Interest) The redeemable noncontrolling interest, representing a 54.4% economic stake in PKLP, is recognized at the greater of fair value or redemption value - The redeemable noncontrolling interest represents a **54.4% economic interest** in PKLP[95](index=95&type=chunk) - The noncontrolling interest is recognized at the **higher of its initial fair value** plus accumulated earnings/losses or its redemption value[96](index=96&type=chunk) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss attributable to noncontrolling interest | $(20,413) | $(25,960) | $(41,631) | $(51,801) | [Note 8: Stockholders' Equity](index=27&type=section&id=Note%208%3A%20Stockholders'%20Equity) The company established a new $200 million at-the-market offering in July 2025 after raising $136.6 million from offerings in June 2024 - On July 14, 2025, the company entered into a new Open Market Sales Agreement with Jefferies LLC, allowing it to offer and sell up to **$200 million** of Class A common stock[99](index=99&type=chunk) - **No shares were sold** under the 2024 Sales Agreement during the three and six months ended June 30, 2025[101](index=101&type=chunk) - Subsequent to June 30, 2025, the company sold 1,490,748 shares of Class A common stock for net proceeds of **$5,669,000** under the 2025 Sales Agreement[101](index=101&type=chunk) - In June 2024, the company sold 46,886,452 shares in a public offering and 11,030,574 shares in a concurrent registered direct offering, generating approximately **$136,618,000 in net proceeds**[102](index=102&type=chunk) [Note 9: Net Loss per Share](index=29&type=section&id=Note%209%3A%20Net%20Loss%20per%20Share) Basic and diluted net loss per share are identical as potential shares are anti-dilutive, with Q2 2025 EPS improving to $(0.13) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss per share attributable to Class A common stock | $(0.13) | $(0.16) | $(0.26) | $(0.32) | - Outstanding anti-dilutive securities as of June 30, 2025, include **159,288,931 Class B common stock**, 742,684 unvested Restricted Stock Rights, 17,500,000 Earnout Rights, and 30,504,248 stock options[104](index=104&type=chunk) [Note 10: Equity-Based Compensation](index=29&type=section&id=Note%2010%3A%20Equity-Based%20Compensation) Equity-based compensation expense decreased to $6,540 thousand in Q2 2025 under the company's 2022 Incentive Equity Plan - The 2022 Incentive Equity Plan provides for various equity awards to employees, non-employee directors, consultants, and other service providers[105](index=105&type=chunk) - As of June 30, 2025, there were **29,110,498 time-vested stock options** outstanding with a weighted average exercise price of $3.83, and $37,836 thousand in unrecognized compensation expense[108](index=108&type=chunk) - As of June 30, 2025, there were **1,393,750 performance-based stock options** outstanding with a weighted average exercise price of $1.57, with no remaining unrecognized compensation expense[111](index=111&type=chunk) - As of June 30, 2025, there were **742,684 unvested Legacy Profits Interests** outstanding, with $3,042 thousand in unrecognized compensation expense[116](index=116&type=chunk)[117](index=117&type=chunk) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Total equity-based compensation expense | $6,540 | $7,808 | $12,957 | $15,489 | [Note 11: Segment Information](index=34&type=section&id=Note%2011%3A%20Segment%20Information) The company operates as a single business segment and currently generates revenue only from leasing activities, not product sales - The company manages its business as a **single operating segment**[119](index=119&type=chunk) - No revenue has been generated from product sales; revenue is recognized from leasing activities related to facilities[120](index=120&type=chunk) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | Net loss before noncontrolling interest | $(36,965) | $(38,466) | | Rental income | $221 | $– | | Depreciation and amortization | $1,491 | $964 | | Equity-based compensation | $6,540 | $7,808 | | Income tax (benefit) expense | $848 | $(56) | | Interest expense | $(1) | $(3) | | Interest income | $3,593 | $4,537 | [Note 12: Subsequent Events](index=35&type=section&id=Note%2012%3A%20Subsequent%20Events) Effective July 1, 2025, the company completed its domestication to Delaware, restructuring its corporate organization and related agreements - The company completed its domestication from the Cayman Islands to the State of Delaware, effective **July 1, 2025**[123](index=123&type=chunk) - As part of the restructuring, PKLP contributed substantially all its assets to ProKidney Holdings, LLC, and subsequently commenced winding-up[123](index=123&type=chunk) - Key agreements, including the Tax Receivable Agreement, Lock-Up Agreement, and Exchange Agreement, were **amended and restated** to reflect the updated corporate structure[124](index=124&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical trial progress, financial performance, and future capital needs through mid-2027 [Overview](index=36&type=section&id=Overview) ProKidney is a clinical-stage biotech developing rilparencel, an autologous cell therapy for chronic kidney disease, which has RMAT designation - ProKidney is a clinical-stage biotechnology company focused on cell therapy to treat chronic kidney disease (CKD) by preserving kidney function[126](index=126&type=chunk) - Rilparencel (REACT®), the lead product candidate, is a patented autologous cell therapy in an ongoing **Phase 3 REGEN-006 (PROACT 1) trial**[127](index=127&type=chunk) - Rilparencel received **Regenerative Medicine Advanced Therapy ("RMAT") designation** from the United States Food & Drug Administration ("FDA")[127](index=127&type=chunk) - The company has **not generated any revenue from product sales** since its inception[128](index=128&type=chunk) [Recent Developments](index=36&type=section&id=Recent%20Developments) The FDA confirmed eGFR slope as a surrogate endpoint for accelerated approval, with topline data for the PROACT 1 trial expected in Q2 2027 - The FDA confirmed that the **eGFR slope** in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint for a Biologics License Application (BLA) submission under the accelerated approval pathway[130](index=130&type=chunk) - Topline data readout of eGFR slope to support accelerated approval is anticipated in the **second quarter of 2027**[130](index=130&type=chunk) - In the completed Phase 2 REGEN-007 trial, Group 1 (n=24) showed a statistically significant (p<0.001) **78% improvement in annual eGFR slope**, from -5.8 to -1.3 mL/min/1.73m2, after receiving rilparencel[135](index=135&type=chunk) - **No rilparencel-related serious adverse events** were observed across all 49 patients who received at least one injection in the REGEN-007 study, with a safety profile consistent with previous results[137](index=137&type=chunk) - Effective July 1, 2025, the company completed its domestication process, changing its jurisdiction of incorporation from the Cayman Islands to the State of Delaware[138](index=138&type=chunk) [Financial Operations Overview](index=40&type=section&id=Financial%20Operations%20Overview) The company expects to incur increasing R&D and G&A expenses as it advances clinical trials, with revenue currently limited to leasing activities - The company has not generated any revenue from product sales since its inception and does not expect to in the near future[142](index=142&type=chunk) - Revenue is currently recognized from leasing activities associated with acquired buildings in Winston-Salem, North Carolina, where manufacturing operations are also conducted[143](index=143&type=chunk) - Research and development expenses are **expected to increase significantly** as rilparencel moves into later stages of clinical development[148](index=148&type=chunk) - General and administrative expenses are **expected to increase** as the business expands and additional personnel are hired[153](index=153&type=chunk) - Other income primarily consists of interest income earned on cash, cash equivalents, and marketable securities[154](index=154&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) For Q2 2025, R&D expenses decreased by $3.5 million while G&A expenses rose slightly, resulting in a net loss of $(16.5) million | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :----------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------- | | Revenue | $221 | $– | $221 | | Research and development | $25,882 | $29,404 | $(3,522) | | General and administrative | $14,048 | $13,652 | $396 | | Net loss available to Class A common stockholders | $(16,552) | $(12,506) | $(4,046) | | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :----------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Revenue | $451 | $– | $451 | | Research and development | $53,145 | $56,637 | $(3,492) | | General and administrative | $28,403 | $26,495 | $1,908 | | Net loss available to Class A common stockholders | $(33,286) | $(21,998) | $(11,288) | - The decrease in R&D expenses was primarily due to a **$7.4 million decrease in clinical study costs** from completed/terminated trials and a $1.1 million decrease in professional fees, partially offset by a $4.3 million increase in costs for the ongoing Phase 3 PROACT 1 trial and a $1.5 million increase in cash-based compensation[157](index=157&type=chunk) - The increase in G&A expenses was mainly driven by an **$0.8 million increase in cash-based compensation** and a $0.4 million increase in other operational expenses, partially offset by a $0.7 million decrease in equity-based compensation[157](index=157&type=chunk) - Interest income decreased by approximately **$0.9 million** for the three months and **$1.8 million** for the six months, primarily due to lower investment balances and interest rates[158](index=158&type=chunk)[161](index=161&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) Existing cash is expected to fund operations into mid-2027, but substantial additional funding will be required thereafter - The company has funded operations primarily through capital contributions, proceeds from the Business Combination, and public equity offerings[164](index=164&type=chunk) - As of June 30, 2025, the company had sold **$7.9 million** worth of Class A common stock under the 2024 Sales Agreement, generating $7.7 million in net proceeds[165](index=165&type=chunk) - In July 2025, a new Open Market Sale Agreement was entered into, allowing for the sale of up to **$200 million** of Class A common stock[166](index=166&type=chunk) - In June 2024, the company raised approximately **$136.7 million in net proceeds** from public and direct offerings of Class A common stock[167](index=167&type=chunk) - Existing cash, cash equivalents, and marketable securities are expected to fund operating expenses and capital expenditure requirements **into mid-2027**[168](index=168&type=chunk) - **Substantial additional funding will be required**, likely through public or private equity sales, debt financings, or collaborations, which may result in stockholder dilution or restrictive covenants[169](index=169&type=chunk)[171](index=171&type=chunk) [Cash Flows](index=49&type=section&id=Cash%20Flows) For the first half of 2025, cash used in operations decreased by $11.8 million, while cash from investing also decreased significantly | Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash flows used in operating activities | $(61,008) | $(72,939) | | Net cash flows provided by investing activities | $46,854 | $86,969 | | Net cash flows (used in) provided by financing activities | $(26) | $139,829 | | Net change in cash and cash equivalents | $(14,180) | $153,859 | - The **$11.8 million decrease in cash used in operating activities** for the six months ended June 30, 2025, was primarily driven by the timing of payments to vendors and receipt of interest due[175](index=175&type=chunk) - Net cash provided by investing activities decreased from $87.0 million in 2024 to **$46.9 million in 2025**, mainly due to the timing of investment conversions[176](index=176&type=chunk) - Net cash used in financing activities was insignificant in 2025, compared to **$139.8 million provided in 2024** from the sale of Class A common stock[177](index=177&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=49&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statement preparation requires management to make significant estimates, particularly for R&D expenses and equity-based compensation - Management makes estimates and judgments that affect reported amounts of assets, liabilities, costs, and expenses, particularly for **research and development expenses, equity-based compensation, and income taxes**[179](index=179&type=chunk) - The company's significant accounting policies are detailed in Note 2 to the unaudited condensed consolidated financial statements[180](index=180&type=chunk) [JOBS Act Accounting Election](index=51&type=section&id=JOBS%20Act%20Accounting%20Election) As an emerging growth company, ProKidney uses the extended transition period for new accounting standards under the JOBS Act - ProKidney is an emerging growth company and has elected to use the **extended transition period** for complying with new or revised accounting standards[182](index=182&type=chunk) - This election may result in the company's consolidated financial statements **not being comparable** to those of companies that comply with earlier effective dates for new accounting standards[182](index=182&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, ProKidney is not required to provide detailed disclosures about market risk - ProKidney Corp is a smaller reporting company and is therefore **not required to provide** quantitative and qualitative disclosures about market risk[183](index=183&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[184](index=184&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[187](index=187&type=chunk) - Management acknowledges that control systems provide only **reasonable assurance** and can be subject to inherent limitations, including errors, collusion, or management override[185](index=185&type=chunk)[186](index=186&type=chunk) PART II. Other Information [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) ProKidney Corp is not currently involved in any material legal proceedings - The company is **not currently a party** to any material legal proceedings[190](index=190&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's 2024 Form 10-K and Q1 2025 Form 10-Q - **No material changes** to the risk factors described in the 2024 Annual Report on Form 10-K and the 1Q Form 10-Q[191](index=191&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were sold during the three months ended June 30, 2025 - **No sales of unregistered equity securities** occurred during the three months ended June 30, 2025[192](index=192&type=chunk) [Item 3. Defaults Upon Senior Securities](index=52&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is **not applicable**[193](index=193&type=chunk) [Item 4. Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is **not applicable**[194](index=194&type=chunk) [Item 5. Other Information](index=52&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated any Rule 10b5-1 trading arrangements during the second quarter of 2025 - **No Rule 10b5-1 trading arrangements** were adopted or terminated by directors or officers during the quarter ended June 30, 2025[195](index=195&type=chunk) [Item 6. Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance and employment-related documents - Exhibits include corporate documents (e.g., Certificate of Incorporation, Bylaws), amended agreements (e.g., Tax Receivable Agreement, Lock-Up Agreement, Exchange Agreement) reflecting the domestication, employment agreements, and certifications (e.g., Principal Executive Officer and Financial Officer certifications)[196](index=196&type=chunk)[198](index=198&type=chunk) [Signatures](index=55&type=section&id=Signatures) The report was duly signed by the Chief Executive Officer and Chief Financial Officer on August 12, 2025 - The report was signed by Bruce Culleton, Chief Executive Officer, and James Coulston, Chief Financial Officer, on **August 12, 2025**[201](index=201&type=chunk)

Core Insights - ProKidney Corp. has made significant advancements in 2025, particularly with positive topline data from the Phase 2 REGEN-007 study and alignment with the FDA on the accelerated approval pathway for rilparencel [2][3][7] Regulatory and Clinical Updates - The FDA confirmed that the slope of estimated glomerular filtration rate (eGFR) can serve as a surrogate endpoint for the accelerated approval of rilparencel, requiring an effect size of at least 1.5 mL/min/1.73m² per year improvement [3][4][7] - ProKidney anticipates topline data readout to support the accelerated approval application in Q2 2027, with over half of the required 350 patients already enrolled in the Phase 3 PROACT 1 study [4][7] - The Phase 2 REGEN-007 study showed a 78% improvement in annual decline of eGFR slope, from -5.8 to -1.3 mL/min/1.73m², with 63% of patients meeting key Phase 3 inclusion criteria [5][6][7] Financial Highlights - As of June 30, 2025, ProKidney reported cash, cash equivalents, and marketable securities totaling $294.7 million, down from $328.5 million as of March 31, 2025, expected to fund operations into mid-2027 [10][11][12] - Research and development expenses decreased to $25.9 million for Q2 2025 from $29.4 million in Q2 2024, primarily due to reduced clinical study costs [11] - General and administrative expenses increased slightly to $14.0 million in Q2 2025 from $13.7 million in Q2 2024, driven by higher cash compensation and operational expenses [12] Company Overview - ProKidney is focused on developing rilparencel, a first-in-class autologous cellular therapy for chronic kidney disease (CKD) patients, particularly those with diabetes and advanced CKD [18][14] - CKD affects an estimated 37 million adults in the U.S., with diabetes being the leading cause, highlighting the significant unmet clinical need for effective treatments [14]