ProKidney (PROK) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Technology overview and clinical rationale

• REACT is an autologous cell therapy derived from kidney biopsies, primarily using tubular epithelial cells, aimed at treating advanced kidney disease.

• Manufacturing involves cell digestion, expansion, selection of active cell layers, and cryopreservation, with multiple doses possible per patient.

• Administration involves injection into the kidney cortex, with doses typically spaced three months apart between kidneys.

• Selection of cell type was based on preclinical data showing reduced inflammation and fibrosis in animal models.

Disease landscape and unmet need

• Diabetic kidney disease remains a significant problem despite advances with RAS inhibitors, SGLT2 inhibitors, MRAs, and GLP-1s.

• Current therapies benefit mostly stage 2 and 3a patients, with limited data for advanced stages.

• Approximately 140,000 patients start dialysis annually in the U.S., half with diabetes, highlighting ongoing unmet need.

Phase II clinical data and insights

• REGEN-007 interim data showed stabilization of kidney function in group one, with a -1 mL/min decline over 18 months, compared to -6 mL/min in matched external controls.

• Group two, which received delayed treatment, did not show benefit, leading to focus on early intervention.

• RMCL-002 study found that patients treated after a delay showed flattening of eGFR decline, while those with high albuminuria saw little benefit.

• Subgroup analysis led to protocol amendments for phase III, focusing on high-risk stage 4 CKD patients with specific albuminuria levels.