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Prokidney Corp.
ProKidney Reports Full Year 2024 Financial Results and Business Highlights
Business
Mar 17 2025
5 min read

ProKidney Reports Full Year 2024 Financial Results and Business Highlights

  • Significant progress was made in 2024, including refining the Phase 3 program to accelerate rilparencel’s path to market in the U.S., the release of positive Phase 2 data, restarting manufacturing, and securing $140 million of equity to extend cash runway into mid-2027
  • In Q4 2024, the FDA confirmed in a Type B meeting that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, which may include eGFR slope, is used; additional details expected in mid-2025
  • Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025; interim data from June 2024 showed kidney function stabilization for 18 months in patients with advanced CKD and diabetes
  • Ended the fourth quarter with $358 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., March 17, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results and business highlights for the year ended December 31, 2024.

“2024 was a pivotal year for ProKidney, marked by significant progress across our clinical, regulatory, manufacturing, and financial initiatives,” said Bruce Culleton, M.D., CEO of ProKidney. “We refined our Phase 3 program to focus on advanced CKD patients with the highest unmet need, engaged in discussions with the FDA to accelerate rilparencel’s path to market, improved and restarted our manufacturing process, and secured $140 million in equity funding. Looking ahead, 2025 will be a critical inflection point, with the expected release of full Group 1 data from the Phase 2 REGEN-007 study and an update on the accelerated approval pathway for the Phase 3 PROACT 1 study after our planned Type B meeting with the FDA. Our objective is clear: expedite rilparencel’s path to market in the U.S. to bring a new therapeutic option to patients with advanced CKD and diabetes at high risk of requiring dialysis.”

Business Highlights

  • In a Q4 2024 Type B meeting, the U.S. Food and Drug Administration (FDA) confirmed that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, which may include eGFR slope, is used. Additional details on the potential accelerated approval pathway are expected in mid-2025 after our planned Type B meeting with the FDA. The FDA also confirmed that REGEN-006 (PROACT 1), a single, large, multi-center, well-controlled Phase 3 study, could be sufficient to support a potential Biologics License Application (BLA) submission. Thus, the Company discontinued the Phase 3 REGEN-016 (PROACT 2) study, which was focused on enrollment outside the U.S.
  • Full data from Group 1 of the Phase 2 REGEN-007 study are expected in Q2 2025 and will comprise approximately 20 patients who have received two rilparencel injections, with an average follow-up of approximately 18 months. In June 2024, ProKidney announced interim results from REGEN-007, which showed stabilization of kidney function for 18 months in 13 patients with advanced CKD and diabetes.

Full Year 2024 Financial Highlights

Liquidity: Cash, cash equivalents and marketable securities as of December 31, 2024, totaled $358.3 million, compared to $363.0 million on December 31, 2023. We expect that our existing cash, cash equivalents and marketable securities held at December 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.

R&D Expenses: Research and development expenses were $127.7 million for the year ended December 31, 2024, compared to $106.7 million for the year ended December 31, 2023. The increase of $21.0 million was driven primarily by increases in cash-based compensation costs of approximately $12.2 million as we continue to hire additional personnel in the areas of clinical development, quality, manufacturing, and biostatistics to support our ongoing clinical trials. Clinical trial costs have increased approximately $7.7 million as we have progressed our Phase 3 study. Additionally, operating costs have increased $4.5 million reflecting costs related to remediation of quality management systems and processes in the first half of 2024. These increases were partially offset by a decrease in equity-based compensation costs of approximately $3.4 million.

G&A Expenses: General and administrative expenses were $56.1 million for the year ended December 31, 2024 compared to $44.8 million for the year ended December 31, 2023. The increase of $11.3 million was driven primarily by increases in cash-based compensation of $5.4 million due to the hiring of personnel and severance cost for terminated employees; the recognition of an impairment charge of $5.3 million related to our Greensboro, North Carolina facility and increases in equity-based compensation. These increases were partially offset by decreases in operating costs of $2.1 million related to decreased legal and professional fees and other operating costs.

Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $163.3 million and $135.4 million for the years ended December 31, 2024, and 2023, respectively.

Shares outstanding: Class A and Class B ordinary shares outstanding at December 31, 2024 totaled 291,748,124.

About the Phase 3 REGEN-006 (PROACT 1) Clinical TrialREGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with type 2 diabetes and advanced CKD. The study protocol was amended in 1H 2024 to focus on a subset of patients with stage 4 CKD (eGFR 20-30ml min/1.73m2) and late stage 3b CKD (eGFR 30-35ml min/1.73m2) with accompanying albuminuria (urine albumin-to-creatinine ratio, or UACR less than 5,000 mg/g for patients with eGFR 20-30ml min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35ml min/1.73m2). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. Subjects in the treatment group are to receive the first rilparencel injection within 18 weeks of kidney biopsy. After three months it is intended that a second rilparencel injection be given into the contralateral kidney. Subjects in the control group, who previously underwent the sham biopsy procedure, are to receive two sham injections at similar time points as the treatment group. The primary objective is to assess the efficacy of up to two rilparencel injections using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR