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PROK: 1Q26 Earnings In Line; Pivotal PROACT 1 Study Remains On Track for Primary eGFR Slope Data Analysis in 2Q 2027; Reiterate Buy Rating

发布日期: 2026-05-18研究机构: Guggenheim Securities LLC报告页数: 5原文语言: 英语证据页码: 1

研报英文原文证据摘录

PROK: 1Q26 Earnings In Line; Pivotal PROACT 1 Study Remains On Track for Primary eGFR Slope Data Analysis in 2Q 2027; Reiterate Buy Rating

May 18, 2026

Vamil Divan, M.D. vamil.divan@guggenheimpartners.com PROK: 1Q26 Earnings In Line; Pivotal PROACT 1

212 823 6543 Study Remains On Track for Primary eGFR Slope

Edouard Mullarky, Ph.D.

edouard.mullarky@guggenheimpartners.com Data Analysis in 2Q 2027; Reiterate Buy Rating

212 518 9579

Arseniy Shabashvili Key Message: PROK reported 1Q 2026 results and provided a corporate update late arseniy.shabashvili@guggenheimpartners.com last week. 1Q 2026 results included an EPS loss of ($0.14) versus our estimate of an 212 699 1971

EPS loss of ($0.16). Most importantly, Phase 3 enrollment for the pivotal rilparencel study

Daniel Krizay, Ph.D. remains on track, with PROK still anticipating enrollment for the eGFR slope analysis set

daniel.krizay@guggenheimpartners.com of patients to be completed by mid-2026, paving the way for topline eGFR slope results

212 823 6561 in 2Q 2027. We caught up with the management team following the earnings release,

and they explained that an increase in the number of discontinuations in the trial (mainly

in patients following study randomization but before they received either rilparencel or

the sham kidney biopsy) will lower the number of patients in the accelerated eGFR slope

analysis to 320 (from 360 before). However, the study retains 80% power to detect anPROK BUY effect size of 1.5 mL/min/1.73m² in annualized eGFR slope, and 90% power to detect an ProKidney Corp.

Sector: Biotechnology effect size of 1.75 mL/min/1.73m² in annualized eGFR slope. The company also noted

that under rilparencel’s regenerative medicine advanced therapy (RMAT) designation,

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