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 ...

WINSTON-SALEM, N.C., Oct. 09, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ("ProKidney"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the UBS Virtual Organ Restoration Day, which will be taking place on October 15, 2024. UBS Virtual Organ Restoration Day Date: Tuesday, October 15, 2024 Time: 9:00am ET Format: Fireside ...