ProKidney(PROK) - 2025 Q3 - Quarterly Report

Financial Performance - Revenue for the three months ended September 30, 2025, was $217,000, compared to $0 in the same period of 2024, representing a change of $217,000 [160]. - Revenue for the nine months ended September 30, 2025, was $668,000, compared to $0 in the same period of 2024, representing a change of $668,000 [164]. - Interest income for the three months ended September 30, 2025, was $3.3 million, down from $5.6 million in Q3 2024, a decrease of $2.3 million [160]. - Net loss available to Class A common stockholders for the three months ended September 30, 2025, was $16.5 million, an improvement of $1.4 million compared to a net loss of $17.9 million in Q3 2024 [160]. - The net loss for the nine months ended September 30, 2025, was approximately $110.8 million, compared to a net loss of $114.9 million for the same period in 2024 [179][180]. - Total operating expenses for the three months ended September 30, 2025, were $38.8 million, down from $49.0 million in the same period of 2024, a decrease of $10.2 million [160]. - Total operating expenses for the nine months ended September 30, 2025, were $120.3 million, down from $132.1 million in the same period of 2024, a decrease of $11.8 million [164]. - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $87.6 million, a decrease from $102.2 million in the same period of 2024 [179][180]. - The decrease in cash used in operating activities for the nine months ended September 30, 2025, was primarily driven by improved timing of payments to vendors and receipt of interest due [182]. - Non-cash charges in operating activities for the nine months ended September 30, 2025, included equity-based compensation expense of $19.6 million and depreciation and amortization expense of $4.7 million [179]. Research and Development - ProKidney has not generated any revenue since its inception and does not expect to do so in the near future unless development efforts for rilparencel are successful [146]. - The ongoing Phase 3 PROACT 1 study aims to enroll approximately 685 subjects with advanced CKD and type 2 diabetes, focusing on patients with Stage 4 CKD and late Stage 3b CKD [131]. - The FDA confirmed that an effect size of at least 1.5 mL/min/1.73m²/year improvement in eGFR slope would demonstrate efficacy for rilparencel under the accelerated approval pathway [132]. - ProKidney's lead product candidate, rilparencel, is a first-in-class autologous cell therapy with RMAT designation from the FDA [129]. - Research and development expenses are expected to increase significantly as rilparencel progresses into later stages of clinical development [152]. - In the REGEN-007 trial, Group 1 showed a statistically significant improvement of 4.6 mL/min/1.73m² per year in eGFR slope after rilparencel treatment, representing a 78% reduction in annual decline [138]. - Group 2 in the REGEN-007 trial demonstrated a 50% improvement in eGFR slope, with an annual change of -1.7 mL/min/1.73m² post-treatment [139]. - The median UACR was significantly higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g) at baseline [137]. Operational Changes - ProKidney completed a domestication process changing its jurisdiction from the Cayman Islands to Delaware effective July 1, 2025 [141]. - Following the domestication, ProKidney underwent a series of transactions to streamline its operating subsidiaries for tax purposes, finalized on September 1, 2025 [144]. Funding and Financial Strategy - The company anticipates needing substantial additional funding to support ongoing operations and growth strategy, potentially through equity sales, grants, or debt financing [177]. - The ability to raise additional funds may be adversely impacted by worsening global economic conditions and market volatility [177]. - As of September 30, 2025, approximately $192.7 million remained available to be sold under the 2025 Sales Agreement [172]. - The company expects existing cash, cash equivalents, and marketable securities will fund operations into mid-2027, subject to assumptions that may prove incorrect [174]. - Net cash provided by investing activities increased significantly to approximately $75.9 million for the nine months ended September 30, 2025, from $5.3 million in 2024 [183]. - Net cash provided by financing activities was $7.9 million for the nine months ended September 30, 2025, a substantial decrease from $144.3 million in 2024 [184]. - The company plans to seek regulatory and marketing approvals for additional product candidates and invest in internal manufacturing capabilities [181]. - The company may have to relinquish valuable rights or grant unfavorable licenses if it raises funds through strategic collaborations [177].