Overview

• ProKidney’s PROK shares have surged more than 700% across five trading sessions following the release of positive Phase 2 REGEN-007 topline data on July 8.
• Phase 2 results showed a 78% improvement in annual eGFR decline for patients receiving two injections and a non-significant 50% improvement for those with a single dose, with no serious adverse events reported.
• The company has scheduled a Type B meeting with the FDA this summer to discuss using eGFR slope as a surrogate endpoint for accelerated approval.
• As a clinical-stage, pre-revenue firm, ProKidney holds $358 million in cash against $3.2 million in debt and incurred $185 million in operating expenses over the past year.
• Sustained market volatility underscores the risks of ProKidney’s single-asset pipeline and heavy cash burn as it prepares for Phase 3 trials.