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]
ProKidney(PROK) - 2024 Q3 - Quarterly Results