Highest-materiality recent filing
ProKidney Q1 net loss $42.6M; Phase 3 PROACT 1 enrollment on track for mid-2026
Net loss $42.6M for Q1 2026; cash & equivalents $224.9M supporting operations into mid-2027.
Net loss $151.6M in 2025 vs $163.3M in 2024; no revenue as pre-revenue cell therapy company.
ProKidney updates PROACT 1 enrollment target to ~470; confirmatory readout now H2 2029
Enrollment target increased to ~470 subjects in Phase 3 PROACT 1 (REGEN-006) study.
Q3 net loss before noncontrolling interest $35.8M vs $41.1M YoY; R&D expenses $26.8M.
ProKidney enters agreement to sell Greensboro property for $19.1M cash
Sale of real property in Greensboro, NC to Northpoint Development, LLC for approx. $19.1M cash.
FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel; topline data from PROACT 1 expected Q2 2027.
ProKidney gains FDA alignment on accelerated approval pathway for rilparencel; topline data Q2 2027
FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel in CKD with type 2 diabetes.
eGFR slope improved 78% from -5.8 to -1.3 mL/min/1.73m² per year (p<0.001) in Group 1 (n=24).
ProKidney completes Cayman-to-Delaware domestication effective July 1, 2025
Each Cayman Class A and Class B ordinary share converted 1:1 into Delaware Class A or Class B common stock.
ProKidney posts FY2024 net loss of $163.3M; FDA confirms accelerated approval path for rilparencel
Net loss before noncontrolling interest $163.3M in 2024 vs $135.4M in 2023; R&D expenses rose 20% to $127.7M.
ProKidney sells Greensboro, NC property for ~$20.5M in cash; close expected March 2025
Sale of real property in Greensboro, NC for approximately $20.5 million in cash.
FDA confirms PROACT 1 Phase 3 may support full approval; Q3 cash $406.8M
FDA Type B meeting confirms PROACT 1 Phase 3 could be sufficient for BLA; accelerated approval pathway available using eGFR slope as surrogate endpoint.
ProKidney refocuses Phase 3 program; discontinues PROACT 2, expects topline results Q3 2027
Discontinues ex-U.S. PROACT 2 trial; believes PROACT 1 alone may support FDA approval under RMAT designation.
ProKidney reports Q2 net loss $38.5M, cash $431.5M, restarts Phase 3 trials
Interim Phase 2 REGEN-007 data show kidney function stabilization for 18 months in diabetes/advanced CKD patients.
ProKidney prices upsized $130M offering of 53.7M shares at $2.42 per share
Total offering of 53,719,009 shares at $2.42/share; net proceeds expected ~$136.7M.
ProKidney reports REGEN-007 Phase 2 interim: eGFR stable over 18 months; manufacturing resumed
In Group 1 (n=13), average eGFR change from baseline was -1.3 ml/min/1.73m² at 18 months; subset meeting Phase 3 criteria (n=10) showed -0.6.
ProKidney reports Q1 net loss $35.3M, cash $329M; Phase 2 data to be presented May 25
RMCL-002 Phase 2 final results to be presented at ERA Congress on May 25, 2024; investor call on May 28.
ProKidney appoints EVP Technical Operations and SVP Global Clinical Operations
Ulrich Ernst appointed EVP Technical Operations; base salary $450,000, target bonus 40%.
ProKidney FY2023 net loss $135.4M; cash $363M; positive Phase 2 data; mfg pause
Net loss before noncontrolling interest $135.4M vs $148.1M in 2022; cash $363.0M, funding into Q4 2025.
ProKidney Corp. finalizes separation agreement with former COO Deepak Jain including $495K severance
Severance pay of $495,000 (12 months base salary) plus eligibility for 2023 bonus up to 45% of base salary.
On March 25, 2024, ProKidney Corp. (the “Company”) announced the appointment of Ulrich Ernst, Ph.D. as the Company’s Executive Vice President, Technical Operations effective as of March 25, 2024.
On March 13, 2024 (the “Effective Date”), the Company entered into a Separation Agreement (the “Separation Agreement”) with Dr. Bertram.
On March 13, 2024 (the “Effective Date”), the Company entered into a Separation Agreement (the “Separation Agreement”) with Dr. Jain.
Max materiality 0.85 · Median 0.60 · Most common event other_material