ProKidney(PROK) - 2025 Q3 - Quarterly Results

Financial Performance - ProKidney reported a net loss before noncontrolling interest of $35.8 million for Q3 2025, an improvement from a loss of $41.1 million in Q3 2024[11]. - Total revenue for the nine months ended September 30, 2025, was $668,000, compared to $0 for the same period in 2024[24]. - Net loss attributable to Class A common stockholders for the nine months ended September 30, 2025, was $49,755, compared to a loss of $39,908 in 2024, representing a 24% increase in losses[24]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $271.7 million as of September 30, 2025, down from $358.3 million at the end of 2024, expected to support operations into mid-2027[8]. - Cash and cash equivalents decreased to $95,323 as of September 30, 2025, from $99,120 at the end of 2024, a decline of 3%[25]. - Total assets decreased to $351,608 as of September 30, 2025, from $441,073 at the end of 2024, a reduction of 20%[22]. - Total liabilities decreased to $33,270 as of September 30, 2025, from $39,436 at the end of 2024, a decline of 16%[22]. Operating Expenses - Operating expenses for the nine months ended September 30, 2025, were $120,304, a decrease of 9% from $132,105 in 2024[24]. - Research and development expenses decreased to $26.8 million in Q3 2025 from $31.3 million in Q3 2024, primarily due to reduced clinical operation costs[9]. - General and administrative expenses were $11.9 million for Q3 2025, down from $17.7 million in Q3 2024, mainly due to lower non-cash impairment charges[10]. - Research and development expenses for the nine months ended September 30, 2025, were $79,966, down 9% from $87,887 in 2024[24]. Cash Flows - Net cash flows used in operating activities for the nine months ended September 30, 2025, were $87,604, compared to $102,180 in 2024, a reduction of 14%[26]. - Cash flows from investing activities provided $75,872 for the nine months ended September 30, 2025, compared to $5,334 in 2024, indicating a significant increase in cash inflow from investments[26]. Clinical Development - In the Phase 2 REGEN-007 study, rilparencel showed a 4.6 mL/min/1.73m² improvement in eGFR slope, representing a 78% improvement (p<0.001)[6]. - Among Group 1 patients in the Phase 2 study, 63% met the key PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² improvement in eGFR slope observed in this subgroup, an 85% improvement (p=0.005)[6]. - More than half of the required 360 patients for the Phase 3 PROACT 1 study have been enrolled, with topline results anticipated in Q2 2027[7]. - ProKidney's ongoing dialogue with the FDA under the RMAT designation supports the potential for accelerated approval of rilparencel[7]. - The FDA confirmed that eGFR slope can serve as a surrogate endpoint for the Biologics License Application submission for rilparencel[5]. - ProKidney is focused on addressing the significant unmet need for therapies that stabilize kidney function in patients with advanced CKD and diabetes[3].