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ProKidney (PROK) reported mixed Q3 2025 results, with earnings per share (EPS) of -$0.12, which exceeded estimates by $0.02, but a net loss of $35.84 million widened from the prior year. The company maintained its cash runway guidance into mid-2027 and highlighted positive Phase 2 trial data for rilparencel.
Revenue
Total revenue remained stable at $217 million in Q3 2025 compared to the same period last year. The company did not provide segment-specific revenue details.
Earnings/Net Income
ProKidney reported an EPS of -$0.12, aligning with the prior year’s figure, while the net loss expanded to $35.84 million. Despite the EPS beat, the net loss reflects ongoing operational challenges, underscoring the need for continued cost management.
Post-Earnings Price Action Review
The strategy of buying
shares on the date of quarterly earnings releases and holding for 30 days resulted in a -44.95% total return over the past three years. This poor performance suggests market skepticism toward the company’s earnings updates, with short-term stock price declines following each release. While the backtest highlights historical underperformance, it is crucial to note that future outcomes may differ. Investors are advised to evaluate broader market conditions and company-specific developments beyond quarterly reports.CEO Commentary
CEO Bruce Culleton emphasized the Phase 2 REGEN-007 trial’s robust results, noting 63% of patients met Phase 3 inclusion criteria. He reiterated confidence in the FDA’s accelerated approval pathway for rilparencel, which could address unmet needs in advanced CKD and diabetes.
Guidance
ProKidney expects current cash reserves of $271.7 million to fund operations into mid-2027. Topline data from the Phase 3 PROACT 1 study is anticipated in Q2 2027, with the FDA validating eGFR slope as a surrogate endpoint for accelerated approval.
Additional News
Phase 2 Trial Results: ProKidney presented full Phase 2 REGEN-007 data at ASN Kidney Week 2025, showing a 78% improvement in kidney function stabilization for patients with advanced CKD and diabetes.
FDA Alignment: The FDA confirmed eGFR slope as a surrogate endpoint for accelerated approval, aligning with the company’s RMAT designation for rilparencel.
Insider Trading: Chief Regulatory Officer Darin J. Weber sold 103,480 shares for $312,509, marking the sole insider sale in the past six months.
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