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 ...

Refined the focus of the Phase 3 program to accelerate path to potential U.S. approval and commercial launch in the Company's highest priority market Discontinued the ex-U.S.-based PROACT 2 trial and focused Company resources on PROACT 1 to expedite enrollment and accelerate estimated topline data readout to Q3 2027 WINSTON-SALEM, N.C., Sept. 03, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ("ProKidney" or the "Company"), a late clinical-stage biotech company focused on the development of a first ...

WINSTON-SALEM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ("ProKidney"), a leading late clinical-stage biotech company focused on the development of a first-inclass cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Morgan Stanley 22nd Annual Global Healthcare Conference, being held in New York, NY on September 4-6, 2024. Morgan Stanley 22nd Annual Global Healthcare Conference Date: Thur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40560 ProKidney Corp. (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1586514 ( State or other jurisdicti ...