Maze Starts PKU Trial, Delays Kidney Study
The drug developer’s quarterly net loss widened 33% to $44.7 million.
Maze Therapeutics (MAZE), a clinical-stage drug developer, initiated and began enrolling patients in the Phase 2 CIPheR trial of MZE782 for phenylketonuria during the second quarter.
The trial’s launch moved the PKU program from planning to execution after Maze previously targeted a mid-2026 start. Topline data remain expected in 2027. The company delayed a separate Phase 2 trial of MZE782 in chronic kidney disease to the first half of 2027 from the second half of 2026.
Maze recorded no license revenue for the quarter, down from the $20 million Shionogi milestone recognized in the first quarter. First-half license revenue was $20 million, compared with none a year earlier. The quarterly loss narrowed to $0.76 a share from $0.77 as weighted-average shares increased.
Research-and-development expense rose 24% to $34.9 million, while general and administrative expense increased 57% to $13.1 million. Total operating expenses climbed 32% to $48.0 million, widening the operating loss by the same amount.
Maze also continued enrolling three additional cohorts in the HORIZON trial after reporting initial topline results in the first quarter. The cohorts cover APOL1-mediated kidney disease with and without diabetes and severe focal segmental glomerulosclerosis. Updated data from 10 to 15 patients in each cohort are expected in late 2026 or early 2027.
The company set the planned start of a pivotal trial for MZE829 in APOL1 kidney disease for the first half of 2027, subject to regulatory feedback. Maze previously said only that it intended to advance the drug into a pivotal program.
Cash, cash equivalents and marketable securities totaled $494.9 million at June 30, up about 37% from year-end after an April offering generated approximately $150 million in gross proceeds. The balance was about $33.1 million below the roughly $528 million pro forma figure cited in the prior quarter. Maze continues to expect its cash to fund operations into 2029.