ProKidney Announces Q2 2024 Financial Results and Business Updates

ProKidney Corp., a prominent company in the advanced stages of cellular therapeutics for chronic kidney disease (CKD), has recently provided updates on its business and financial performance for the second quarter ending June 30, 2024. The company has reported significant milestones in both clinical and corporate domains.

In June, ProKidney presented interim data from its Phase 2 REGEN-007 study, which demonstrated that rilparencel helped stabilize kidney function over 18 months in patients with diabetes and advanced CKD. The safety profile of rilparencel was consistent with previous studies and comparable to a kidney biopsy. This positive outcome underscores the potential of rilparencel to preserve kidney function in this patient group.

Additionally, manufacturing activities resumed in June, and ProKidney received the QP Declaration of Equivalence to EU GMPs in July, enabling the shipment of rilparencel to clinical study sites in Europe. The company also announced the resumption of its Phase 3 PROACT 1 and PROACT 2 trials, with patient enrollment already underway for PROACT 1 under an amended protocol that focuses on more advanced CKD patients.

Financially, ProKidney successfully closed an upsized $140 million public offering and concurrent registered direct offering in June. This significant capital infusion extends the company's cash runway into mid-2026, supporting the projected full enrollment of the Phase 3 studies.

In a strategic move to strengthen its executive team, ProKidney appointed Carla Poulson as Chief People Officer in May. Ms. Poulson brings approximately 25 years of experience in human resources, talent acquisition, and management development, having previously held senior HR positions at several biotech companies.

From a financial perspective, ProKidney reported substantial liquidity, with cash, cash equivalents, and marketable securities totaling $431.5 million as of June 30, 2024. This is a notable increase from $363.0 million at the end of December 2023. The company expects that its existing cash resources will be sufficient to fund operating expenses and capital expenditure requirements into mid-2026.

Research and development (R&D) expenses for the three months ended June 30, 2024, were $29.4 million, compared to $26.4 million for the same period in 2023. This increase was mainly driven by higher cash compensation costs as the company hired additional personnel to support ongoing clinical trials. There were also increases in professional fees related to quality and manufacturing compliance, as well as higher costs for clinical operations and materials. These increases were partially offset by decreased spending on manufacturing improvements and equity-based compensation.

General and administrative expenses were $13.7 million for the three months ended June 30, 2024, slightly higher than the $13.5 million reported for the same period in 2023. The increase was primarily due to higher cash compensation costs, although this was partially offset by lower equity-based compensation expenses.

ProKidney reported a net loss before noncontrolling interest of $38.5 million for the second quarter of 2024, compared to $34.8 million for the same period in 2023. The company's Class A and Class B ordinary shares outstanding as of June 30, 2024, totaled 289,674,830.

Founded in 2015, ProKidney is a pioneer in treating chronic kidney disease through innovations in cellular therapy. Its lead product candidate, rilparencel (also known as REACT®), is an autologous cellular therapy aimed at preserving kidney function in patients with diabetes and advanced CKD. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as guidance from the FDA and EMA, supporting its ongoing Phase 3 clinical program.