ProKidney(PROK) - 2024 Q4 - Annual Results

Financial Performance - The net loss before noncontrolling interest was $163.3 million for 2024, compared to$135.4 million in 2023[10]. - Revenue for 2024 was $76,000, compared to$0 in 2023 and 2022[21]. - Net loss attributable to Class A ordinary shareholders was $61,186, compared to a loss of$35,468 in 2023[21]. - Basic and diluted net loss per share attributable to Class A ordinary shares was $(0.62), compared to$(0.57) in 2023[21]. Funding and Cash Position - ProKidney secured $140 million in equity funding to extend its cash runway into mid-2027, ending Q4 2024 with$358 million in cash and cash equivalents[5][7]. - Cash and cash equivalents at the end of the period were $99,120, up from$60,649 in 2023[23]. - Proceeds from sales of Class A ordinary shares were $144,322, with no proceeds in 2023[23]. - Net cash flows used in operating activities were$126,351, an increase from $90,069 in 2023[23]. - Net cash flows provided by investing activities were$20,414, a recovery from a net cash outflow of $329,983 in 2023[23]. Expenses - Research and development expenses increased to$127.7 million in 2024, up from $106.7 million in 2023, primarily due to higher personnel costs and clinical trial expenses[8]. - General and administrative expenses rose to$56.1 million in 2024, compared to $44.8 million in 2023, driven by increased cash-based compensation and an impairment charge of$5.3 million[9]. - Total operating expenses increased to $183,752, up 21.3$151,522 in 2023[21]. Clinical Development - The FDA confirmed an accelerated approval pathway for rilparencel, contingent on an acceptable surrogate endpoint, with additional details expected in mid-2025[6]. - Full data from Group 1 of the Phase 2 REGEN-007 study is anticipated in Q2 2025, with interim results showing kidney function stabilization for 18 months in patients with advanced CKD and diabetes[5][6]. - The company discontinued the Phase 3 REGEN-016 study to focus on the REGEN-006 (PROACT 1) trial, which could support a potential Biologics License Application submission[6]. - The company plans to expedite rilparencel's path to market in the U.S. to provide a new therapeutic option for patients with advanced CKD and diabetes[3]. - ProKidney's lead product candidate, rilparencel, has received Regenerative Medicine Advanced Therapy designation from the FDA[14]. Assets - Total assets increased to $441.1 million as of December 31, 2024, compared to$420.6 million at the end of 2023[19].