Financial Performance - The net loss before noncontrolling interest was $163.3 million for 2024, compared to $135.4 million in 2023[10]. - Revenue for 2024 was $76,000, compared to $0 in 2023 and 2022[21]. - Net loss attributable to Class A ordinary shareholders was $61,186, compared to a loss of $35,468 in 2023[21]. - Basic and diluted net loss per share attributable to Class A ordinary shares was $(0.62), compared to $(0.57) in 2023[21]. Funding and Cash Position - ProKidney secured $140 million in equity funding to extend its cash runway into mid-2027, ending Q4 2024 with $358 million in cash and cash equivalents[5][7]. - Cash and cash equivalents at the end of the period were $99,120, up from $60,649 in 2023[23]. - Proceeds from sales of Class A ordinary shares were $144,322, with no proceeds in 2023[23]. - Net cash flows used in operating activities were $126,351, an increase from $90,069 in 2023[23]. - Net cash flows provided by investing activities were $20,414, a recovery from a net cash outflow of $329,983 in 2023[23]. Expenses - Research and development expenses increased to $127.7 million in 2024, up from $106.7 million in 2023, primarily due to higher personnel costs and clinical trial expenses[8]. - General and administrative expenses rose to $56.1 million in 2024, compared to $44.8 million in 2023, driven by increased cash-based compensation and an impairment charge of $5.3 million[9]. - Total operating expenses increased to $183,752, up 21.3% from $151,522 in 2023[21]. Clinical Development - The FDA confirmed an accelerated approval pathway for rilparencel, contingent on an acceptable surrogate endpoint, with additional details expected in mid-2025[6]. - Full data from Group 1 of the Phase 2 REGEN-007 study is anticipated in Q2 2025, with interim results showing kidney function stabilization for 18 months in patients with advanced CKD and diabetes[5][6]. - The company discontinued the Phase 3 REGEN-016 study to focus on the REGEN-006 (PROACT 1) trial, which could support a potential Biologics License Application submission[6]. - The company plans to expedite rilparencel's path to market in the U.S. to provide a new therapeutic option for patients with advanced CKD and diabetes[3]. - ProKidney's lead product candidate, rilparencel, has received Regenerative Medicine Advanced Therapy designation from the FDA[14]. Assets - Total assets increased to $441.1 million as of December 31, 2024, compared to $420.6 million at the end of 2023[19].

Core Insights - ProKidney Corp. experienced significant advancements in 2024, focusing on chronic kidney disease (CKD) and preparing for the market introduction of its lead product, rilparencel [2][4][6] Financial Highlights - As of December 31, 2024, ProKidney had cash, cash equivalents, and marketable securities totaling $358.3 million, a slight decrease from $363.0 million in 2023, which is expected to fund operations into mid-2027 [4] - Research and development expenses rose to $127.7 million in 2024 from $106.7 million in 2023, primarily due to increased personnel costs and clinical trial expenses [5] - General and administrative expenses increased to $56.1 million in 2024 from $44.8 million in 2023, driven by higher cash-based compensation and an impairment charge [6][8] - The net loss before noncontrolling interest was $163.3 million in 2024, compared to $135.4 million in 2023 [8][17] Clinical and Regulatory Developments - The Phase 3 REGEN-006 (PROACT 1) trial was refined to target advanced CKD patients, with the FDA confirming an accelerated approval pathway for rilparencel if an acceptable surrogate endpoint is used [2][7] - Full data from Group 1 of the Phase 2 REGEN-007 study is expected in Q2 2025, with interim results showing kidney function stabilization for 18 months in patients with advanced CKD and diabetes [7][12] - The company discontinued the Phase 3 REGEN-016 (PROACT 2) study to focus on the more promising REGEN-006 trial [7] Funding and Equity - ProKidney secured $140 million in equity funding in 2024, which will extend its cash runway into mid-2027 [2][6] - The total number of shares outstanding as of December 31, 2024, was 291,748,124 [9]

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of ProKidney Corp. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation by Kuehn Law focuses on whether certain officers and directors of ProKidney Corp. have engaged in self-dealing that could harm shareholder interests [1]. - Shareholders of ProKidney Corp. are encouraged to contact Kuehn Law for a free consultation regarding their rights and potential claims [2]. - The firm emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets [3].

Group 1 - ProKidney (NASDAQ: PROK) is a biotech company focused on autologous cellular therapy for organ preservation, with its leading candidate being Rilparencel (React) for chronic kidney disease (CKD) [1] - Rilparencel utilizes patients' kidney cells to stabilize or slow down the progression of CKD [1]

Company Overview - ProKidney Corp. is a late clinical-stage biotech company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD) [1][3] - The company was founded in 2015 after a decade of research and is pioneering treatments for CKD through innovations in cellular therapy [3] Product Information - ProKidney's lead product candidate, rilparencel (also known as REACT), is an autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies [3] - Rilparencel aims to preserve kidney function in diabetic patients at high risk of kidney failure and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [3] Upcoming Events - ProKidney's CEO, Bruce Culleton, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025, at 7:30 am PST [1][2] - The management team will also host one-on-one meetings throughout the event, and a live webcast of the presentation will be available on the company's website [2]

Company Overview - ProKidney Corp. is a late clinical-stage biotech company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD) [1][2] - The company was founded in 2015 and has a decade of research behind its innovations in cellular therapy [2] Product Information - ProKidney's lead product candidate, rilparencel (also known as REACT®), is an autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies [2] - Rilparencel aims to preserve kidney function in diabetic patients at high risk of kidney failure and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [2] Upcoming Events - ProKidney's management team will participate in two healthcare conferences in December 2024: - Evercore HealthCONx Conference on December 3, 2024, at 8:45 am ET in a fireside chat format [1] - Citi Global Healthcare Conference on December 4, 2024, featuring one-on-one meetings [1] - The live webcast for the Evercore fireside chat will be available on ProKidney's website [1]

Revenue Generation - The company has not generated any revenue since inception and does not expect to do so in the near future[82]. - The company has not recognized any revenue since inception and does not expect to generate revenue from product sales for several years[99]. Research and Development Expenses - Research and development expenses for Q3 2024 were $31.25 million, a decrease of approximately $0.95 million from $32.20 million in Q3 2023[91]. - Research and development expenses increased by approximately $3.7 million to $87.9 million for the nine months ended September 30, 2024, compared to $84.2 million in the same period of 2023[95]. - Research and development expenses are expected to increase significantly as rilparencel moves into later stages of clinical development[85]. - The increase in cash-based compensation costs in R&D was approximately $9.8 million due to hiring additional personnel for clinical development and manufacturing[96]. General and Administrative Expenses - General and administrative expenses increased by approximately $3.3 million to $17.72 million in Q3 2024, primarily due to a $5.3 million impairment charge related to the Greensboro facility[93]. - General and administrative expenses rose by approximately $1.1 million to $44.2 million, driven by a $5.3 million impairment charge related to the Greensboro facility[97]. - The company anticipates increased general and administrative expenses as it expands operations and hires additional personnel[89]. - The company has begun incurring additional costs associated with operating as a public company, including legal, audit, and regulatory expenses[99]. Net Loss - The net loss attributable to Class A ordinary shareholders for Q3 2024 was $17.91 million, compared to a net loss of $10.98 million in Q3 2023, reflecting an increase of $6.93 million[91]. - Net loss attributable to Class A ordinary shareholders increased to $39.9 million for the nine months ended September 30, 2024, compared to a loss of $29.8 million in the prior year, reflecting a change of $10.1 million[95]. Cash Flow and Financing - Net cash used in operating activities was approximately $102.2 million for the nine months ended September 30, 2024, compared to $64.7 million in the same period of 2023, an increase of $37.4 million[102]. - The company raised approximately $144.3 million from financing activities through the sale of Class A ordinary shares during the nine months ended September 30, 2024[104]. - The company expects existing cash and marketable securities will fund operations into mid-2026, but substantial additional funding will be needed to support ongoing research and development[99]. - Cash flows from investing activities provided approximately $5.3 million in 2024, a significant improvement compared to $(234.1 million) in 2023[103]. Clinical Development - The company is conducting a global Phase 3 development program for its lead product candidate, rilparencel, targeting chronic kidney disease[78]. - The ongoing Phase 3 REGEN-006 (PROACT 1) trial has resumed patient enrollment under an amended protocol focusing on Stage 4 CKD patients[79]. - The FDA confirmed that the ongoing Phase 3 trial could support a potential Biologics License Application (BLA) submission for rilparencel[80]. Tax Expense - The change in income tax (benefit) expense is due to new IRS guidance allowing certain research and development expenses to be expensed rather than capitalized[94].

Financial Position - ProKidney ended Q3 2024 with $406.8 million in cash, cash equivalents, and marketable securities, up from $363.0 million at the end of 2023, providing a runway to fund operations into 2027[4] - The total liabilities as of September 30, 2024, were $31.3 million, compared to $29.2 million at the end of 2023[14] - The company's accumulated deficit increased to $(1,179.6) million as of September 30, 2024, from $(1,139.7) million at the end of 2023[16] - Cash and cash equivalents at the end of the period were $108,088,000, down from $191,389,000 in 2023, a decrease of 43.5%[19] Operating Expenses - Research and development expenses for Q3 2024 were $31.3 million, a decrease of $0.9 million compared to $32.2 million in Q3 2023, primarily due to reduced clinical operation costs[5] - General and administrative expenses increased to $17.7 million in Q3 2024 from $14.4 million in Q3 2023, driven by a non-cash impairment charge of $5.3 million and increased cash compensation costs[6] - Total operating expenses for 2024 were $48,973,000, an increase of 5.1% from $46,617,000 in 2023[17] - Research and development expenses decreased to $31,250,000 in 2024 from $32,198,000 in 2023, reflecting a reduction of 2.9%[17] - Equity-based compensation for 2024 was $22,424,000, down from $37,216,000 in 2023, a decrease of 39.8%[19] Net Loss - The net loss before noncontrolling interest was $41.1 million for Q3 2024, slightly improved from a loss of $42.0 million in Q3 2023[7] - Net loss before noncontrolling interest for 2024 was $114,852,000, compared to $113,723,000 in 2023, indicating a slight increase of 1.0%[19] Cash Flow - Net cash flows used in operating activities for 2024 were $102,180,000, up from $64,685,000 in 2023, representing a significant increase of 57.9%[19] - The company reported a net cash flow provided by investing activities of $5,334,000 in 2024, a recovery from a net cash flow used of $234,139,000 in 2023[19] FDA and Clinical Trials - The FDA confirmed that the Phase 3 PROACT 1 study could support a potential Biologics License Application (BLA) submission for rilparencel, validating the company's focus on expediting this study[2] - The FDA also indicated that an accelerated approval pathway is available for rilparencel, potentially using eGFR slope as a surrogate endpoint[3] - The ongoing Phase 3 REGEN-006 (PROACT 1) trial aims to enroll approximately 685 subjects with type 2 diabetes and advanced chronic kidney disease[8] - ProKidney presented five posters at the ASN Kidney Week, including a late-breaking clinical trial poster on rilparencel's product characterization and mechanism of action[3] Shareholder Information - Proceeds from sales of Class A ordinary shares in 2024 amounted to $144,325,000, with no proceeds reported in 2023[19] - Interest income for 2024 was $5,580,000, slightly up from $5,541,000 in 2023, an increase of 0.7%[17] - The weighted average Class A ordinary shares outstanding increased to 126,173,463 in 2024 from 61,592,876 in 2023, a growth of 104.5%[18]

Company Overview - ProKidney Corp. is a late clinical-stage biotech company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD) [1] - The company was founded in 2015 and has a decade of research behind it [6] - ProKidney's lead product candidate, rilparencel (REACT®), is an autologous cellular therapy being evaluated in Phase 2 and Phase 3 studies for preserving kidney function in diabetic patients at high risk of kidney failure [6] - Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA [6] Upcoming Events - ProKidney management will participate in two healthcare conferences in November 2024 [1] - The first event is the Guggenheim Inaugural Healthcare Innovation Conference in Boston on November 13, 2024, at 10:30 am ET [3] - The second event is the Jefferies London Healthcare Conference on November 20, 2024, at 10:00 am GMT [4] - Live webcasts of these events will be accessible through the "Events" section of ProKidney's website, with replays available for 90 days post-event [4] Investor Engagement - ProKidney management will host one-on-one meetings during the conferences [5] - Interested investors are encouraged to contact their Guggenheim and Jefferies representatives to schedule meetings [5]

WINSTON-SALEM, N.C., Oct. 14, 2024 (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 the Company will present five posters, including one late-breaking clinical trial, at the upcoming American Society of Nephrology's (ASN) Kidney Week being held on October 23-27, 2024, in San Diego, CA. The titles for the accepted abstracts are provided below and accessib ...