Jason Gerberry

Jonathan Miller

Justin Zelin

- ProKidney's autologous cell therapy, **roperinsel**, demonstrated a **78% improvement** in the decline of kidney function in Group 1 of its Phase II REGEN-seven trial, with top-line results announced in July.  **[1850270_tx_380787_1]**  Full data, including subgroup analyses and safety, will be presented at **ASN Kidney Week in early November**.  **[1850270_tx_380787_2]** **[1850270_tx_380787_8]** 
- The Phase III PROACT one study, targeting patients with eGFR **20 to 35**, is **over 50% enrolled** for accelerated approval, which is expected to read out in **2027**.  **[1850270_tx_380787_4]** 
- The company holds an **RMAT designation** from the FDA, making a single Phase III study sufficient for approval.  **[1850270_tx_380787_5]** 
- ProKidney has a cash runway into **mid-2027**, covering the accelerated approval readout, but will require additional funding for the full approval confirmatory analysis.  **[1850270_tx_380787_9]** 
- The company is expanding its manufacturing capabilities and anticipates that demand for roperinsel could **outstrip supply** in the initial years post-launch if Phase III efficacy mirrors Phase II results.  **[1850270_tx_380787_7]**

PROKIDNEY (PROK)