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Sep 30, 2024
ProKidney Q3 2024 Earnings Report
ProKidney reported financial results and provided regulatory and clinical development updates following a successful FDA Type B meeting.
Key Takeaways
ProKidney reported its Q3 2024 financial results, highlighting a successful FDA Type B meeting where the FDA confirmed the PROACT 1 Phase 3 study could support a full U.S. regulatory approval of rilparencel and that the accelerated approval pathway is available. The company ended the quarter with $406.8 million in cash and cash equivalents, supporting operations into 2027.
FDA confirmed PROACT 1 Phase 3 study could be sufficient for full U.S. regulatory approval of rilparencel.
FDA confirmed the availability of an accelerated approval pathway for rilparencel using a surrogate endpoint like eGFR slope.
ProKidney presented five posters at the ASN Kidney Week, including clinical trial and product characterization data.
ProKidney ended Q3 with $406.8 million in cash and cash equivalents, supporting operations into 2027.
ProKidney
ProKidney
Forward Guidance
The company expects that its existing cash, cash equivalents and marketable securities held on September 30, 2024, will enable it to fund its operating expenses and capital expenditure requirements into 2027.
Positive Outlook
- Existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements into 2027.
- FDA agrees that the Phase 3 PROACT 1 study could be sufficient to support a potential BLA submission and full regulatory approval
- FDA confirmed that ProKidney could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel.
- Company will continue to engage with the FDA, under its regenerative medicine advanced therapy (RMAT) designation, to further define the details supporting this accelerated pathway.
- Advancement of the Company’s development programs into and through the clinic and the expected timing for reporting data
Challenges Ahead
- Inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq
- Risk that results of the Company’s clinical trials may not support approval
- Risk that the FDA could require additional studies before approving the Company’s drug candidates
- The Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing
- Uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities