ProKidney Corp.

PROKIDNEY CORP. is a late-clinical-stage biotechnology company focused on developing a first-in-class, autologous cell therapy to preserve kidney function in patients with advanced chronic kidney disease (CKD) and diabetes. The company aims to shift the treatment of CKD from managing kidney failure to preserving kidney function. Its lead product candidate, rilparencel, is the only cell therapy currently in Phase 3 clinical study for advanced CKD and type 2 diabetes. Rilparencel is a personalized product containing autologous Selected Renal Cells (SRC), which are prepared from a patient's own kidney cells. These SRC are formulated as rilparencel and reinjected into the patient's kidneys through a minimally invasive outpatient procedure. Since rilparencel uses a patient's own cells, it eliminates the need for lifelong immunosuppressive therapies typically required after receiving a kidney transplant from another donor. The company's technology involves expanding and selecting a patient's kidney cells to preserve kidney function that is being lost due to chronic disease. The process starts with a small biopsy of a patient's diseased kidney sent to PROKIDNEY CORP.'s manufacturing facility. There, tissue from the biopsy is processed to isolate SRC, which are then formulated into a personalized product for reinjection into the damaged kidney(s). Clinical studies to date suggest rilparencel can positively impact kidney function by stabilizing the estimated glomerular filtration rate (eGFR) or slowing its decline in patients with CKD and diabetes. CKD is categorized into five stages, from mild (Stage 1) to severe (Stage 5 or kidney failure). Over 37 million people in the United States are estimated to suffer from CKD. PROKIDNEY CORP. is initially developing rilparencel in the United States for patients with moderate to severe CKD and type 2 diabetes, a population exceeding one million people.