ProKidney(US:PROK)2024-11-12 21:02Revenue 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].