ProKidney (PROK) Q1 2026 earnings summary

Executive summary

• Focused on developing rilparencel, an autologous cell therapy for advanced CKD and type 2 diabetes, currently in Phase 3 trials with no product revenue to date.

• Enrollment for the pivotal Phase 3 PROACT 1 trial is on track for completion in mid-2026, with topline data expected in Q2 2027 for the surrogate endpoint and in H2 2029 for the confirmatory endpoint.

• Positive Phase 2 REGEN-007 results were published and presented, supporting confidence in the ongoing Phase 3 program.

• FDA alignment achieved for accelerated and confirmatory approval pathways for rilparencel, with eGFR slope as the surrogate endpoint.

• Completed domestication from Cayman Islands to Delaware in July 2025, streamlining corporate structure and tax status.

Financial highlights

• Revenue for Q1 2026 was $226,000, primarily from leasing activities, compared to $230,000 in Q1 2025.

• Cash, cash equivalents, and marketable securities totaled $224.9 million as of March 31, 2026, down from $270.0 million at December 31, 2025.

• Net loss before noncontrolling interest was $42.6 million in Q1 2026, up from $38.0 million in Q1 2025.

• Research and development expenses increased to $33.8 million from $27.3 million year-over-year, driven by Phase 3 trial and manufacturing costs.

• General and administrative expenses decreased to $11.3 million from $14.4 million, mainly due to lower equity-based compensation and professional fees.

Outlook and guidance

• Current cash, cash equivalents, and marketable securities expected to fund operations into mid-2027.

• Anticipates increased expenses as clinical development progresses, with no product revenue expected for several years.

• Completion of PROACT 1 enrollment in 2026 and pivotal topline results in Q2 2027 remain key milestones.