ProKidney 2025 Q3 Earnings Net Loss Narrows as Cash Reserves Extend to Mid-2027

ProKidney reported mixed results in Q3 2025, with stable revenue and a narrower net loss compared to the prior year. The company’s cash runway now extends to mid-2027, aligning with its Phase 3 trial timeline. Analysts highlighted the positive Phase 2 REGEN-007 data and FDA alignment on eGFR slope as key catalysts for long-term potential, though near-term financial pressures remain.

Revenue

ProKidney’s total revenue remained stable at $217,000 in Q3 2025, unchanged from the same period. The company reported no material shifts in revenue streams, with operations continuing to focus on clinical development rather than commercial sales.

Earnings/Net Income

The company posted a net loss of $35.84 million in Q3 2025, representing a 13.5% improvement from the $41.1 million loss in Q3 2024. While the EPS of $-0.12 remained stable year-over-year, the reduction in losses signals improved cost management. However, the company emphasized that profitability remains distant as it prioritizes advancing rilparencel through clinical trials.

Price Action

Following the earnings release, ProKidney’s stock edged up 0.72% in intraday trading but declined 7.28% month-to-date. The mixed price performance reflects investor optimism about clinical progress tempered by concerns over cash burn and regulatory risks.

Post-Earnings Price Action Review

The stock’s post-earnings trajectory has been volatile, with a 0.72% intraday gain contrasting a 7.28% monthly decline. Short-term momentum appears driven by the FDA’s endorsement of eGFR slope as a surrogate endpoint, which could accelerate regulatory timelines. However, the broader market remains cautious, with the stock underperforming peers in the biotech sector. Investors are advised to monitor enrollment progress in the Phase 3 PROACT 1 trial and cash reserves, which are projected to last until mid-2027.

CEO Commentary

Bruce Culleton, CEO, emphasized the significance of the REGEN-007 trial results, noting that 63% of Group 1 patients met PROACT 1 inclusion criteria. He reiterated the company’s focus on completing PROACT 1 enrollment and leveraging the RMAT designation to expedite FDA review. The tone remained cautiously optimistic, with Culleton highlighting the potential for rilparencel to address unmet needs in advanced CKD.

Guidance

ProKidney expects its cash, cash equivalents, and marketable securities of $271.7 million as of Q3 2025 to fund operations through mid-2027. The company anticipates topline results from PROACT 1 in Q2 2027, which could support an accelerated approval application. R&D expenses decreased to $26.8 million in Q3 2025 from $31.3 million in Q3 2024, driven by cost efficiencies in clinical operations and manufacturing.

Additional News

1. Phase 2 REGEN-007 Trial Success: ProKidney presented full results from the REGEN-007 study at ASN Kidney Week 2025, showing a 78% improvement in kidney function stabilization (p<0.001) in Group 1 patients. This subgroup, mirroring PROACT 1 criteria, saw an 85% improvement (p=0.005), reinforcing the therapy’s potential.2. **FDA Alignment on eGFR Slope**: In July 2025, the FDA confirmed eGFR slope as a surrogate endpoint for accelerated approval, streamlining the regulatory pathway. Over half of the 360 patients required for the accelerated analysis were enrolled by August 2025.3. **CEO Commentary on Strategic Priorities**: Culleton reiterated the company’s commitment to PROACT 1 enrollment and leveraging RMAT designation to expedite review, underscoring rilparencel’s role in addressing advanced CKD.