Outlook
Enrollment in Phase 2 HORIZON trial of MZE829 on track; data from all cohorts expected in late 2026 or early 2027
Phase 2 CIPheR trial of MZE782 in PKU initiated and enrollment ongoing; topline data expected in 2027
Phase 2 trial of MZE782 in CKD on track for H1 2027 initiation
4Strong balance sheet with $495 million in cash, cash equivalents and marketable securities supports expected runway into 2029
Management commentary
6“The second quarter was marked by continued operational excellence by our team, with the Phase 2 CIPheR trial of MZE782 in PKU now underway with initial topline data expected in 2027, and continued strong enrollment in the Phase 2 HORIZON trial of MZE829 across three cohorts with additional data on track for 10-15 patients per cohort in late 2026 or early 2027,” said Jason Coloma, Ph.D., chief executive officer of Maze.
“Looking ahead, we continue to prepare for the pivotal trial of MZE829.
2We are also advancing MZE782 toward a Phase 2 trial in CKD, which we expect to initiate in the first half of next year.
With a strong balance sheet and expected cash runway into 2029, we are well positioned to execute against the clinical milestones in our pipeline.”
Outlook
Program Progress and Anticipated Milestones
MZE829 for APOL1-Mediated Kidney Disease (AMKD)
Corporate events
MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone.
Results
5In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD, representing the first-ever clinical proof-of-concept data in this genetically-defined, broad AMKD population, and demonstrating encouraging early data, including a clinically meaningful reduction in proteinuria in broad AMKD patients.
Maze continues to enroll the HORIZON trial, and expects to announce updated data in late 2026 or early 2027 on three 10-15 patient cohorts: AMKD without diabetes, AMKD with diabetes and AMKD with severe focal segmental glomerulosclerosis (FSGS).
Outlook
Based on the topline results from HORIZON, Maze plans to initiate a pivotal trial in the first half of 2027, subject to regulatory feedback.
Corporate events
MZE782 for Phenylketonuria (PKU) and CKD
Management commentary
MZE782 is an oral, small molecule targeting the solute transporter SLC6A19, with potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class treatment for the estimated five million U.S. patients with CKD who inadequately respond to currently available CKD therapies.
Outlook
In line with previous guidance, Maze initiated the Phase 2 CIPheR proof-of-concept trial of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU and continues to enroll patients.
Topline data from the trial is expected in 2027.
Maze plans to initiate a Phase 2 proof-of-concept trial of MZE782 evaluating proteinuria reduction in CKD in the first half of 2027.
Corporate events
Recent Corporate Highlights
In April 2026, Maze completed a registered offering of its common stock and pre-funded warrants for gross proceeds of approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses payable by Maze.
Results
Second Quarter 2026 Financial Results
Outlook
7Cash Position: Cash, cash equivalents and marketable securities were $494.9 million as of June 30, 2026, compared to $360.0 million as of December 31, 2025.
Maze expects that its current cash, cash equivalents and marketable securities will fund operations into 2029 based on its current business plan.
Results
8License Revenue: No license revenue and $20.0 million in license revenue was recognized for the three and six months ended June 30, 2026, respectively, and no license revenue was recognized for the same periods in 2025.
License revenue recognized in 2026 reflects the achievement of a milestone in the first quarter of 2026 pursuant to the exclusive license agreement with Shionogi & Co., Ltd. for the rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor that aims to address Pompe disease by limiting disease-causing glycogen buildup.
Research & Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2026 were $34.9 million and $69.1 million, respectively, and $28.1 million and $55.7 million for the same periods in 2025.
3The increase primarily reflects higher expenses related to the progression of our clinical development of the MZE829 program and higher personnel-related costs, including non-cash stock-based compensation expense.
General & Administrative (G&A) Expenses : G&A expenses for the three and six months ended June 30, 2026 were $13.1 million and $25.5 million, respectively, and $8.4 million and $16.2 million for the same periods in 2025.
The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and costs for professional services.
1Net Loss: Net loss for the three and six months ended June 30, 2026 was $44.7 million, or $0.76 per share, and $68.9 million, or $1.22 per share, respectively, compared to net loss of $33.7 million, or $0.77 per share, and $66.5 million, or $1.83 per share, for the same periods in 2025.
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