Tricida, Inc. announced an update on the anticipated date for top-line data from the VALOR-CKD trial based on the ongoing events in Ukraine. Approximately 15% of the patients randomized in VALOR-CKD are from Ukraine. Given the uncertainty around future participation of Ukrainian subjects in the trial and the potential challenges to collecting and monitoring data from Ukrainian sites, top-line data from the VALOR-CKD trial is now anticipated early in the fourth quarter of 2022, versus Tricida's previous guidance of the third quarter of 2022.

The revised guidance is based on Tricida's evaluation of the current situation in Ukraine which is dynamic. Its estimates may change as events in Ukraine evolve. Tricida believes it will need this incremental time to deal with anticipated disruptions and/or delays in data collection.

Tricida does not expect the utility of the data already collected from Ukrainian subjects to be affected. Based upon the latest review of its forecast, Tricida believes that its financial resources will extend for approximately six months following the anticipated announcement of top-line results from the VALOR-CKD trial. As of March 1, 2022, the VALOR-CKD trial had accrued 197 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to a 40% decline in estimated glomerular filtration rate (eGFR), with an average treatment duration of approximately 23 months.