Maze Therapeutics — Third Quarter 2026 Earnings Summary
Financial Performance:
- Cash, cash equivalents, and marketable securities totaled $477.0 million as of September 30, 2026, an increase from $360.0 million as of December 31, 2025.
- License revenue was $0 for the three months ended September 30, 2026, compared to $0 in the same period in 2025; $20.0 million was recognized for the nine months ended September 30, 2026, compared to $0 in the same period in 2025.
- Research and development expenses were $40.2 million for the three months ended September 30, 2026, up from $25.2 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $109.3 million, up from $80.9 million in the same period in 2025.
- General and administrative expenses were $11.3 million for the three months ended September 30, 2026, up from $7.8 million in the same period in 2025; for the nine months ended September 30, 2026, expenses were $36.8 million, up from $24.0 million in the same period in 2025.
- Net loss was $48.0 million ($0.79 per share) for the three months ended September 30, 2026, compared to $30.1 million ($0.66 per share) in the same period in 2025; for the nine months ended September 30, 2026, net loss was $116.9 million ($2.02 per share), compared to $96.6 million ($2.45 per share) in the same period in 2025.
- Total operating expenses were $51.5 million for the three months ended September 30, 2026, compared to $33.0 million in the same period in 2025; for the nine months ended September 30, 2026, total operating expenses were $146.1 million, compared to $104.8 million in the same period in 2025.
- Interest and other income, net, was $4.5 million for the three months ended September 30, 2026, compared to $2.9 million in the same period in 2025; for the nine months ended September 30, 2026, it was $12.0 million, compared to $8.3 million in the same period in 2025.
- Interest expense was $1.0 million for the three months ended September 30, 2026, compared to $0 in the same period in 2025; for the nine months ended September 30, 2026, it was $2.8 million, compared to $0 in the same period in 2025.
- Total assets were $511.6 million as of September 30, 2026, compared to $397.1 million as of December 31, 2025.
- Total liabilities were $83.0 million as of September 30, 2026, compared to $42.2 million as of December 31, 2025.
- Total stockholders' equity was $428.5 million as of September 30, 2026, compared to $355.0 million as of December 31, 2025.
Guidance and Future Outlook:
- The company expects its current cash position to fund operations into 2029 based on its current business plan.
- Final data from the Phase 2 HORIZON trial for MZE829 is expected to be announced in early 2027.
- A pivotal trial for MZE829 is planned to initiate in the first half of 2027, subject to regulatory feedback.
- Topline data from the Phase 2 CIPheR trial of MZE782 in PKU is expected in 2027.
- A Phase 2 proof-of-concept trial of MZE782 in CKD is planned to initiate in the first half of 2027.
Business Segments and Product Lines:
- MZE829 (APOL1-Mediated Kidney Disease): Enrollment in the Phase 2 HORIZON trial is complete with more than 50 patients across three cohorts, exceeding the target of 10-15 patients per cohort. Interim data showed clinically meaningful uACR reductions at 12 weeks among 12 efficacy-evaluable patients. The trial evaluates MZE829 in three subgroups: AMKD without diabetes, AMKD with diabetes, and AMKD with focal segmental glomerulosclerosis (FSGS).
- MZE782 (PKU and CKD): Enrollment is ongoing in the Phase 2 CIPheR trial evaluating plasma phenylalanine reduction in PKU. Phase 1 results previously demonstrated a 42-fold increase in urinary phenylalanine excretion in healthy volunteers and a dose-dependent eGFR dip suggestive of kidney-protective potential.
- MZE001: License revenue recognized in 2026 reflects the achievement of a milestone in the first quarter of 2026 pursuant to an exclusive license agreement with Shionogi & Co., Ltd. for rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor for Pompe disease.
Market and Competitive Landscape:
- AMKD is estimated to affect over one million people in the United States.
- CKD is estimated to affect five million U.S. patients who inadequately respond to currently available therapies.
- MZE829 is positioned as a potential best-in-class therapy for a broad AMKD population with a differentiated dual mechanism of action.
- MZE782 is positioned as a potential best-in-class therapy for PKU and a first-in-class treatment for CKD.
Risks and Challenges:
- Forward-looking statements highlight risks related to the ability to advance MZE829, MZE782, and other candidates, obtain regulatory approval, and commercialize products.
- Risks include the timing and results of preclinical studies and clinical trials, the ability to fund development activities, and the ability to protect intellectual property.
- Risks also include general business and economic conditions, macroeconomic factors such as inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises.
Management Commentary and Tone:
- CEO Jason Coloma, Ph.D., stated that completing HORIZON enrollment exceeded targets and marks an important milestone, providing a comprehensive view of MZE829's potential.
- Management expressed encouragement regarding previously reported clinically meaningful uACR reductions and plans to use the complete HORIZON dataset to inform the pivotal program.
- Management noted strong progress with MZE782 regarding continued enrollment in the CIPheR trial and advancement of the CKD trial plan.
Other Key Points:
- In August 2026, Paula Johnson, M.D., M.P.H., and Sophie Kornowski, Pharm.D., M.B.A., were appointed to the Board of Directors.
- In October 2026, Maze delivered an oral presentation of HORIZON data at the American Society of Nephrology (ASN) Kidney Week.
- In October 2026, Maze presented two posters at ASN Kidney Week highlighting preclinical research supporting MZE782's mechanism for CKD.
- Weighted-average shares of common stock outstanding used to compute net loss per share were 60.9 million for the three months ended September 30, 2026, compared to 45.8 million in the same period in 2025; for the nine months ended September 30, 2026, shares were 57.9 million, compared to 39.5 million in the same period in 2025.
- Company
- MAZE THERAPEUTICS INC
- Sector
- Healthcare
- Industry
- Biotechnology