ProKidney — Q3 2026 Earnings Summary

Financial Performance:

• Cash position is $142 million (as of September 30, 2026), comprising cash, cash equivalents, and marketable securities.
• Current cash runway is expected to support operating plans into mid-2027.
• Shares outstanding are 302,381,712 (Class A and Class B as of November 6, 2026).
• The company reports a clean balance sheet with no specific revenue, earnings, or debt figures disclosed in the presentation.

Guidance and Future Outlook:

• Full enrollment for the Phase 3 PROACT 1 study is anticipated in Q1 2027, with enrollment expected to exceed 500 patients (up from 470) driven by accelerated recruitment in mid-2026.
• Topline readout for the Phase 3 PROACT 1 surrogate endpoint (eGFR slope) for accelerated approval is expected in Q2 2027, with an efficacy analysis set of approximately 320 patients.
• A Biologics License Application (BLA) submission for accelerated approval is targeted for Q1 2028.
• BLA accelerated approval and commercial launch of rilparencel are projected for the first half of 2029.
• Topline readout for the Phase 3 PROACT 1 confirmatory endpoint (composite time-to-event) to support full approval is expected in the second half of 2029.
• First phase of existing North Carolina facility expansion was substantially completed in the second half of 2026; the second phase of construction is planned for 2027.

Business Segments and Product Lines:

• Rilparencel: A novel, first-in-class autologous cell therapy made from a patient's own kidney cells designed to preserve kidney function in patients with advanced Chronic Kidney Disease (CKD) and Type 2 diabetes.
• Clinical Programs:
  • REGEN-006 (PROACT 1): Ongoing Phase 3 pivotal trial in patients with Stage 3b/4 CKD and Type 2 diabetes (eGFR 20-35 mL/min/1.73m2, n>500).
  • REGEN-007: Completed Phase 2 trial showing durable and statistically significant stabilization of kidney function (~18 months) in Group 1 (n=24).
    • Group 1 (Phase 3 dosing regimen) showed an 85% improvement in annual eGFR slope decline (from -6.46 to -0.95 mL/min/1.73m2 per year; p=0.005) in patients meeting key Phase 3 PROACT 1 inclusion criteria.
    • Group 2 (exploratory dosing) showed a 57% improvement in annual eGFR slope decline (from -7.70 to -3.29 mL/min/1.73m2 per year; p=0.025) in patients meeting key Phase 3 PROACT 1 inclusion criteria.
  • Supportive Trials: Completed trials include REGEN-003, RMCL-002, REGEN-007, and REGEN-004.
• Manufacturing: In-house manufacturing is conducted at an existing North Carolina facility used to supply the Phase 3 study. The process involves a standard kidney biopsy, cell isolation, expansion, and freezing, with no viral vectors or genetic modification required.
• Commercialization: A phased rollout strategy is planned starting with 10-20 treatment centers in high-density CKD markets, expanding to additional geographies and outpatient settings (ASCs, OBLs) as manufacturing capacity and payer coverage expand.

Market and Competitive Landscape:

• The target market includes over 1 million U.S. patients with Stage 3b/4 CKD and Type 2 diabetes at high risk of progressing to kidney failure.
• Rilparencel holds Regenerative Medicine Advanced Therapy (RMAT) designation.
• Current standard of care includes four pillars: RAAS inhibitors, SGLT2 inhibitors, nonsteroidal MRAs, and GLP-1 RAs, which primarily focus on moderate CKD and leave a residual risk of progression in advanced stages.
• Landmark trials for existing therapies (Canagliflozin, Dapagliflozin, Empagliflozin, Finerenone, Semaglutide) showed varying reductions in risk (0% to 34%), but progression continues in patients with advanced CKD.
• Market research indicates nephrologists view rilparencel as a transformative option once standard therapies are exhausted, with a potential 2-3 year delay in dialysis considered a "game-changer."
• Patient interviews (N=25) showed high interest (average 6.0/7) in rilparencel and high likelihood (6.2/7) of discussing it with a nephrologist.
• Illustrative revenue scenarios suggest that sub-1% market penetration could support significant U.S. revenue: 0.25% penetration (2-3k patients) could yield $1bn+, 0.5% penetration (5k+ patients) could yield $2bn+, and 1% penetration (10k+ patients) could yield $4bn+.

Risks and Challenges:

• Risks include the inability to maintain the listing of Class A common stock on Nasdaq or inclusion in various indices.
• Potential negative impact on trading price if excluded from indices.
• Risks associated with the recent domestication to the United States.
• Clinical trial results may not support approval, or the FDA may require additional studies.
• Need for additional financing and the inability to raise capital in the future.
• Competition from other companies in the biologics market and kidney disease treatment space.
• Uncertainties inherent in cell therapy research and development, including timing of clinical studies and regulatory decisions.
• Impact of geo-political conflict on the business.
• Risk that interim results from clinical programs may not be indicative of future results.

Management Commentary and Tone:

• Management emphasizes a "clean balance sheet and clear path to value creation."
• The presentation highlights the company's ability to "redefine what's possible in the treatment of chronic kidney disease" by preserving kidney function.
• Management expresses confidence in the Phase 3 PROACT 1 trial being sufficient to support a potential BLA submission and full regulatory approval.
• The company anticipates eGFR slope can be used as a surrogate endpoint on an accelerated approval pathway for rilparencel.
• Management notes that the Phase 3 PROACT 1 trial is designed to support both accelerated and confirmatory approval.

Analyst Questions and Answers:

• No analyst questions and answers section is included in the provided press release.

Other Key Points:

• The company has 450+ patents and pending applications across 23 patent families covering North and South America, Australia, Asia, and the Middle East.
• Patent coverage extends into 2045.
• The company is covered by 7 analyst firms.
• Rilparencel is an outpatient, minimally invasive procedure requiring no preconditioning or immunosuppression.
• No rilparencel-related serious adverse events (SAEs) were observed in the REGEN-007 trial; the safety profile was consistent with a kidney biopsy.
• The company is conducting a nonclinical human decedent study to further elucidate the mechanism of action.
• The presentation includes forward-looking statements regarding the timing of data readouts, regulatory approvals, and financial results, which are subject to risks and uncertainties.