Summary of ProKidney Conference Call Company Overview - ProKidney is focused on addressing chronic kidney disease (CKD) in patients, particularly those at risk of requiring dialysis. The company is based in North Carolina and Boston, employing approximately 250 individuals aligned with its mission to keep patients off dialysis [2][3]. Product and Clinical Trials - ProKidney's primary product, rilparencel, is an autologous cell therapy currently in a Phase 3 clinical trial aimed at preserving kidney function in patients with advanced CKD [2][4]. - The company has made significant progress in its clinical studies, overcoming initial manufacturing challenges and achieving Good Manufacturing Practice (GMP) compliance [4][5]. - An accelerated approval pathway has been established with the FDA, allowing for a readout based on eGFR slope, with top-line data expected in Q2 2027 [5][14]. Clinical Study Details - The Phase 3 study is a double-blind, sham-controlled trial conducted at over 60 sites in the U.S., Taiwan, and Mexico, with a primary endpoint of a composite time-to-event measure [13][14]. - The study aims to demonstrate a 1.5 mL per minute per year difference in eGFR progression between treated and sham groups, with a 90% power to detect this difference [14][15]. - Enrollment is progressing well, with over 50% of participants already enrolled [5][17]. Efficacy and Safety Data - In a Phase 2 study (007), rilparencel demonstrated a 78% improvement in kidney function decline in one treatment group, while another group showed a 50% benefit, suggesting a dose-response relationship [5][9]. - Safety measures include strict eligibility criteria to minimize risks associated with kidney biopsies, and the company reports no serious events related to rilparencel [25][26]. Market Opportunity - The addressable market includes 1 to 1.5 million stage 3B and 4 CKD patients with diabetes in the U.S. A 1% market penetration could result in 10,000 to 15,000 patients treated annually [31]. - Rilparencel could potentially save the healthcare system up to $150,000 annually per patient by delaying the need for dialysis [31][32]. - The Medicare budget allocates 7% to manage end-stage kidney disease, indicating a significant financial burden that rilparencel aims to alleviate [36][38]. Financial Position and Future Catalysts - As of September 30, ProKidney has $272 million in cash, sufficient to fund operations through mid-2027 [40]. - Key upcoming catalysts include the Phase 3 data readout in Q2 2027 and additional data on the mechanism of action in the following year [40][41]. Conclusion - ProKidney is positioned in a promising market with a unique product aimed at a significant health issue. The company is on track with its clinical trials and has a solid financial foundation to support its upcoming milestones [41].

Financial Performance - ProKidney reported a net loss before noncontrolling interest of $35.8 million for Q3 2025, an improvement from a loss of $41.1 million in Q3 2024[11]. - Total revenue for the nine months ended September 30, 2025, was $668,000, compared to $0 for the same period in 2024[24]. - Net loss attributable to Class A common stockholders for the nine months ended September 30, 2025, was $49,755, compared to a loss of $39,908 in 2024, representing a 24% increase in losses[24]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $271.7 million as of September 30, 2025, down from $358.3 million at the end of 2024, expected to support operations into mid-2027[8]. - Cash and cash equivalents decreased to $95,323 as of September 30, 2025, from $99,120 at the end of 2024, a decline of 3%[25]. - Total assets decreased to $351,608 as of September 30, 2025, from $441,073 at the end of 2024, a reduction of 20%[22]. - Total liabilities decreased to $33,270 as of September 30, 2025, from $39,436 at the end of 2024, a decline of 16%[22]. Operating Expenses - Operating expenses for the nine months ended September 30, 2025, were $120,304, a decrease of 9% from $132,105 in 2024[24]. - Research and development expenses decreased to $26.8 million in Q3 2025 from $31.3 million in Q3 2024, primarily due to reduced clinical operation costs[9]. - General and administrative expenses were $11.9 million for Q3 2025, down from $17.7 million in Q3 2024, mainly due to lower non-cash impairment charges[10]. - Research and development expenses for the nine months ended September 30, 2025, were $79,966, down 9% from $87,887 in 2024[24]. Cash Flows - Net cash flows used in operating activities for the nine months ended September 30, 2025, were $87,604, compared to $102,180 in 2024, a reduction of 14%[26]. - Cash flows from investing activities provided $75,872 for the nine months ended September 30, 2025, compared to $5,334 in 2024, indicating a significant increase in cash inflow from investments[26]. Clinical Development - In the Phase 2 REGEN-007 study, rilparencel showed a 4.6 mL/min/1.73m² improvement in eGFR slope, representing a 78% improvement (p<0.001)[6]. - Among Group 1 patients in the Phase 2 study, 63% met the key PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² improvement in eGFR slope observed in this subgroup, an 85% improvement (p=0.005)[6]. - More than half of the required 360 patients for the Phase 3 PROACT 1 study have been enrolled, with topline results anticipated in Q2 2027[7]. - ProKidney's ongoing dialogue with the FDA under the RMAT designation supports the potential for accelerated approval of rilparencel[7]. - The FDA confirmed that eGFR slope can serve as a surrogate endpoint for the Biologics License Application submission for rilparencel[5]. - ProKidney is focused on addressing the significant unmet need for therapies that stabilize kidney function in patients with advanced CKD and diabetes[3].

Financial Performance - Revenue for the three months ended September 30, 2025, was $217,000, compared to $0 in the same period of 2024, representing a change of $217,000 [160]. - Revenue for the nine months ended September 30, 2025, was $668,000, compared to $0 in the same period of 2024, representing a change of $668,000 [164]. - Interest income for the three months ended September 30, 2025, was $3.3 million, down from $5.6 million in Q3 2024, a decrease of $2.3 million [160]. - Net loss available to Class A common stockholders for the three months ended September 30, 2025, was $16.5 million, an improvement of $1.4 million compared to a net loss of $17.9 million in Q3 2024 [160]. - The net loss for the nine months ended September 30, 2025, was approximately $110.8 million, compared to a net loss of $114.9 million for the same period in 2024 [179][180]. - Total operating expenses for the three months ended September 30, 2025, were $38.8 million, down from $49.0 million in the same period of 2024, a decrease of $10.2 million [160]. - Total operating expenses for the nine months ended September 30, 2025, were $120.3 million, down from $132.1 million in the same period of 2024, a decrease of $11.8 million [164]. - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $87.6 million, a decrease from $102.2 million in the same period of 2024 [179][180]. - The decrease in cash used in operating activities for the nine months ended September 30, 2025, was primarily driven by improved timing of payments to vendors and receipt of interest due [182]. - Non-cash charges in operating activities for the nine months ended September 30, 2025, included equity-based compensation expense of $19.6 million and depreciation and amortization expense of $4.7 million [179]. Research and Development - ProKidney has not generated any revenue since its inception and does not expect to do so in the near future unless development efforts for rilparencel are successful [146]. - The ongoing Phase 3 PROACT 1 study aims to enroll approximately 685 subjects with advanced CKD and type 2 diabetes, focusing on patients with Stage 4 CKD and late Stage 3b CKD [131]. - The FDA confirmed that an effect size of at least 1.5 mL/min/1.73m²/year improvement in eGFR slope would demonstrate efficacy for rilparencel under the accelerated approval pathway [132]. - ProKidney's lead product candidate, rilparencel, is a first-in-class autologous cell therapy with RMAT designation from the FDA [129]. - Research and development expenses are expected to increase significantly as rilparencel progresses into later stages of clinical development [152]. - In the REGEN-007 trial, Group 1 showed a statistically significant improvement of 4.6 mL/min/1.73m² per year in eGFR slope after rilparencel treatment, representing a 78% reduction in annual decline [138]. - Group 2 in the REGEN-007 trial demonstrated a 50% improvement in eGFR slope, with an annual change of -1.7 mL/min/1.73m² post-treatment [139]. - The median UACR was significantly higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g) at baseline [137]. Operational Changes - ProKidney completed a domestication process changing its jurisdiction from the Cayman Islands to Delaware effective July 1, 2025 [141]. - Following the domestication, ProKidney underwent a series of transactions to streamline its operating subsidiaries for tax purposes, finalized on September 1, 2025 [144]. Funding and Financial Strategy - The company anticipates needing substantial additional funding to support ongoing operations and growth strategy, potentially through equity sales, grants, or debt financing [177]. - The ability to raise additional funds may be adversely impacted by worsening global economic conditions and market volatility [177]. - As of September 30, 2025, approximately $192.7 million remained available to be sold under the 2025 Sales Agreement [172]. - The company expects existing cash, cash equivalents, and marketable securities will fund operations into mid-2027, subject to assumptions that may prove incorrect [174]. - Net cash provided by investing activities increased significantly to approximately $75.9 million for the nine months ended September 30, 2025, from $5.3 million in 2024 [183]. - Net cash provided by financing activities was $7.9 million for the nine months ended September 30, 2025, a substantial decrease from $144.3 million in 2024 [184]. - The company plans to seek regulatory and marketing approvals for additional product candidates and invest in internal manufacturing capabilities [181]. - The company may have to relinquish valuable rights or grant unfavorable licenses if it raises funds through strategic collaborations [177].

Core Viewpoint - ProKidney Corp. reported promising results from its Phase 2 REGEN-007 study, indicating that rilparencel may effectively stabilize kidney function in patients with advanced chronic kidney disease (CKD) and diabetes, supporting the ongoing Phase 3 PROACT 1 study [2][3][4]. Financial Highlights - As of September 30, 2025, ProKidney had cash, cash equivalents, and marketable securities totaling $271.7 million, down from $358.3 million at the end of 2024, which is expected to fund operations into mid-2027 [5][6]. - Research and development expenses for Q3 2025 were $26.8 million, a decrease from $31.3 million in Q3 2024, primarily due to reduced clinical operation costs [8]. - General and administrative expenses decreased to $11.9 million in Q3 2025 from $17.7 million in Q3 2024, mainly due to lower non-cash impairment charges [9]. - The net loss before noncontrolling interest was $35.8 million for Q3 2025, compared to $41.1 million for the same period in 2024 [10]. Clinical Updates - The Phase 2 REGEN-007 study showed a 4.6 mL/min/1.73m improvement in the annual decline in eGFR slope for Group 1, representing a 78% improvement, which was statistically significant (p<0.001) [7]. - Among Group 1 patients, 63% met the key PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m improvement in eGFR slope observed in this subgroup, indicating an 85% improvement (p=0.005) [7]. - The FDA has confirmed that the eGFR slope can serve as a surrogate endpoint for the accelerated approval pathway for rilparencel, with topline data readout expected in Q2 2027 [4][6]. Company Overview - ProKidney is focused on developing rilparencel, a first-in-class autologous cell therapy for patients with Stage 3b/4 CKD and diabetes, addressing a significant unmet need in the treatment of CKD [11][15].

Core Insights - ProKidney Corp. presented full results from the Phase 2 REGEN-007 trial, demonstrating the potential of rilparencel to preserve kidney function in patients with advanced chronic kidney disease (CKD) and diabetes [1][2][3] Phase 2 REGEN-007 Overview - The REGEN-007 trial was a multi-center, open-label, randomized study involving two treatment groups, focusing on different dosing regimens of rilparencel [4] - Group 1 followed the dosing schedule of the ongoing Phase 3 PROACT 1 study, while Group 2 tested an exploratory regimen based on disease progression triggers [4] - A total of 87 rilparencel injections were administered to 49 participants, with follow-ups extending up to 18 months post-injection [4] Efficacy and Safety Findings - Rilparencel treatment resulted in a statistically significant 4.6 mL/min/1.73m² (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 [6][7] - Among Group 1 patients, 63% met key Phase 3 PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² (85%) improvement observed in this subgroup [7] - Group 2 showed a 1.7 mL/min/1.73m² (50%) improvement in eGFR slope, although this was not statistically significant [8] - No serious adverse events related to rilparencel were reported, and the safety profile was consistent with previous studies [6][14] Phase 3 PROACT 1 Program Update - The Phase 3 PROACT 1 trial aims to further assess rilparencel's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes [9] - The FDA confirmed that eGFR slope is an acceptable surrogate endpoint for the study, supporting both accelerated and confirmatory approval pathways for rilparencel [9] - More than half of the required 360 patients for the accelerated approval analysis had been enrolled as of August 2025, with topline results expected in Q2 2027 [9] About Chronic Kidney Disease - CKD is a progressive condition affecting approximately 37 million adults in the U.S., with diabetes being the leading cause [11] - ProKidney is targeting patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S. [11] - There is a significant unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in advanced CKD patients [11] About ProKidney Corp. - ProKidney is a pioneer in cell therapy for CKD, with rilparencel being a first-in-class autologous cellular therapy currently in Phase 3 trials [12] - The company was founded in 2015 and has a decade of research backing its innovative treatment approach [12]

Core Insights - ProKidney Corp. is a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD) [1][2] - The company will participate in two upcoming healthcare conferences in November 2025, including the Guggenheim Healthcare Innovation Conference and the Jefferies Global Healthcare Conference [1] Company Overview - ProKidney was founded in 2015 after a decade of research and is a pioneer in the treatment of CKD through innovations in cellular therapy [2] - The lead product candidate, rilparencel (REACT), is a first-in-class, patented, proprietary autologous cellular therapy with regenerative medicine advanced therapy designation [2] - Rilparencel is currently 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 [2]

Core Insights - ProKidney Corp. will present two posters at the American Society of Nephrology's Kidney Week from November 6-9, 2025, including a late-breaking poster on the Phase 2 REGEN-007 study results [1][2] Group 1: Presentation Details - The late-breaking poster is titled "Renal Autologous Cell Therapy in Diabetes and CKD (Phase 2 REGEN-007 Study Results)" and will be presented on November 6, 2025, from 10:00 AM to 12:00 PM CST [2] - The other poster presentation is focused on "Cell-Specific Inflammatory Profile Characterization of the Cell Therapy Candidate Rilparencel," also scheduled for November 6, 2025, during the same time frame [2] Group 2: Company Background - ProKidney Corp. specializes in cellular therapeutics for chronic kidney disease (CKD) and was founded in 2015 after a decade of research [3] - The company's lead product candidate, rilparencel (REACT), is a patented autologous cellular therapy currently in the Phase 3 REGEN-006 (PROACT 1) study, aimed at preserving kidney function in patients with advanced CKD and type 2 diabetes [3]

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]

Group 1 - The article discusses the significant stock movement of ProKidney (NASDAQ: PROK), which saw its share price increase from $0.6 to over $4.5 overnight, indicating strong market interest and potential catalysts driving this valuation change [1] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including product sales forecasts, integrated financial statements, and market analysis for major pharmaceutical companies [1] - Edmund Ingham, a biotech consultant with over five years of experience, leads the Haggerston BioHealth investing group and has compiled detailed reports on more than 1,000 companies in the biotech, healthcare, and pharma sectors [1]

Group 1 - The conference is hosted by Morgan Stanley, focusing on global healthcare research, with Judah Frommer as the equity analyst leading the session [1] - ProKidney is introduced as a key participant in the conference, highlighting its focus on addressing unmet needs in chronic kidney disease [2]