- Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025
- FDA previously confirmed in a Q4 2024 Type B meeting that the accelerated approval pathway is available for rilparencel; additional details on the accelerated pathway are expected in mid-2025 after our planned Type B meeting with the FDA
- Ended the first quarter with $328.5 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported financial results and business highlights for the first quarter ended March 31, 2025.
“The next two quarters are important for ProKidney as we approach two key milestones: the release of full Group 1 data from the Phase 2 REGEN-007 study and a regulatory update on the accelerated approval pathway for rilparencel following a planned Type B meeting with the FDA,” said Bruce Culleton, M.D., CEO of ProKidney. “With cash runway into mid-2027, we are in a strong financial position to continue executing our Phase 3 PROACT 1 study. I appreciate the continued engagement from our investigators, patients, and the ProKidney team as we work to address a significant unmet therapeutic need in patients with advanced CKD and type 2 diabetes.”
Business Highlights
- 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 a Type B meeting held in Q4 2024, 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.
First Quarter 2025 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of March 31, 2025, totaled $328.5 million, compared to $358.3 million as of December 31, 2024. We expect that our existing cash, cash equivalents and marketable securities held at March 31, 2025 will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.
R&D Expenses: Research and development expenses were relatively consistent between periods at $27.3 million for the three months ended March 31, 2025, compared to $27.2 million for the same period in 2024. We saw increases in cash compensation and facility costs of approximately $1.1 million and $1.0 million, respectively, which were due to the hiring of additional personnel and expansion of our facilities. These increases were offset by a decrease of $1.4 million in clinical trial cost as increases for our Phase 3 trial were outpaced by decreases from our other trials due to timing of activities or termination. Additionally, we experienced decreases in professional fees of $0.8 million related to the remediation of quality and manufacturing compliance deficiencies.
G&A Expenses: General and administrative expenses were $14.4 million for the three months ended March 31, 2025, compared to $12.8 million for the same period in 2024. The increase of approximately $1.5 million has been primarily driven by increases in cash compensation and professional fees of approximately $1.2 million and $0.8 million, respectively. These increases have been partially offset by decreases in equity-based compensation of approximately $0.7 million.
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $38.0 million and $35.3 million for the three months ended March 31, 2025 and 2024, respectively.
Shares outstanding: Class A and Class B ordinary shares outstanding as of March 31, 2025 totaled 292,697,802.
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