A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals with End Stage Kidney Disease on Hemodialysis (PATH-2) With an Open-Label Extension

ESKD participants with history of secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis

Double-Blind Phase The proportion of participants with a ≥30% decrease in mean iPTH during the Efficacy Assessment Period (EAP, Weeks 22 - 27) relative to the mean baseline iPTH (all Active Screening and predose Day 1 iPTH values)., Open-Label Phase • Safety clinical laboratory tests, vital signs, ECG, AEs, and physical exams, Open-Label Phase • Proportion of participants with a cCa <7.5 mg/dL, and the proportion of participants with a cCa <8.3 mg/dL

• The proportion of participants with a ≥50% decrease in mean iPTH during the EAP (Weeks 22 - 27) relative to the mean baseline iPTH (all Active Screening and predose Day 1 iPTH values), • The proportion of participants with a mean iPTH during the EAP (Weeks 22 - 27) ≥150 pg/mL but ≤300 pg/mL., • The percentage change from baseline in iPTH during the course of the study (weekly iPTH values)., • The absolute and percentage changes in serum cCa and serum P levels and their mathematical product, •The proportion of participants who did not have an increase in Active Vitamin D sterol dose during the double blind phase with a ≥30% reduction in mean iPTH during the EAP relative to mean baseline iPTH., • Cmax and AUC as data permit., • Removal rate by dialysis., • Safety clinical laboratory tests, ECGs, vital signs, AEs, AEs leading to modification of dose or frequency of calcium supplements or phosphate binders, and physical exams, • Proportion of participants with a cCa <7.5 mg/dL, and proportion of participants with a cCa <8.3 mg/dL

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