Core Insights - Maze Therapeutics reported positive topline data from the Phase 2 HORIZON trial of MZE829, demonstrating clinical proof-of-concept in patients with broad APOL1-Mediated Kidney Disease (AMKD) [1][3] - The company plans to advance MZE829 into a pivotal program and initiate two Phase 2 trials for MZE782 in phenylketonuria (PKU) and chronic kidney disease (CKD) by 2026 [2][4] - Neil Kumar, Ph.D., has been appointed to the Board of Directors, bringing valuable experience from BridgeBio [2][6] Program Progress and Anticipated Milestones - MZE829 is an oral, small molecule APOL1 inhibitor targeting AMKD, which affects over one million people in the U.S. [3] - The Phase 2 HORIZON trial showed a mean reduction in proteinuria of 35.6% at week 12, with 50% of patients achieving over a 30% reduction [3] - In patients with severe focal segmental glomerulosclerosis (FSGS), the mean reduction in proteinuria was 61.8% [3] - MZE782 targets the solute transporter SLC6A19, with potential applications in PKU and CKD, with trials expected to start by mid-2026 [4] Financial Highlights - As of December 31, 2025, Maze had $360.0 million in cash, cash equivalents, and marketable securities, up from $196.8 million in 2024, providing a cash runway into 2028 [9][21] - Research and development expenses for 2025 were $108.4 million, an increase from $83.5 million in 2024, primarily due to higher clinical trial costs [11] - General and administrative expenses rose to $34.5 million in 2025 from $26.4 million in 2024, reflecting increased personnel-related costs [12] Recent Corporate Developments - The appointment of Neil Kumar to the Board is expected to enhance the company's strategic direction and growth potential [2][6] - Maze achieved a $20 million milestone in its collaboration with Shionogi & Co., Ltd. for MZE001, with potential additional milestone payments of up to $255.0 million [5]

Core Insights - Maze Therapeutics is advancing two clinical-stage programs, MZE782 and MZE829, targeting chronic kidney disease (CKD) and phenylketonuria (PKU) [2][4] - The company reported a strong cash position of $264.5 million, expected to fund operations into the second half of 2027 [5][16] - Significant milestones are anticipated, including initial data from the Phase 1 trial of MZE782 in Q3 2025 and proof-of-concept data from the Phase 2 HORIZON trial of MZE829 in Q1 2026 [1][7][8] Company Overview - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for kidney and metabolic diseases [13] - The company utilizes its Compass platform to pursue genetically validated targets, aiming for first- or best-in-class therapies [13] Clinical Programs - MZE829 is an oral APOL1 inhibitor for APOL1-mediated kidney disease, which affects over one million people in the U.S. [3] - MZE782 targets the solute transporter SLC6A19 and has potential as a first-in-class treatment for approximately five million U.S. patients with CKD who do not adequately respond to existing therapies [4] Financial Performance - For Q2 2025, Maze reported no license revenue, contrasting with $165 million in license revenue for the same period in 2024, primarily due to an upfront payment from Shionogi [6][12] - Research and development expenses increased to $28.1 million for Q2 2025, up from $19.5 million in Q2 2024, reflecting higher clinical trial and manufacturing costs [10] - General and administrative expenses also rose to $8.4 million in Q2 2025, compared to $5.9 million in Q2 2024 [11] Balance Sheet Highlights - As of June 30, 2025, total assets were $303.5 million, with total liabilities at $41.3 million, indicating a strong financial position [16] - The company’s total stockholders' equity improved to $262.2 million from a deficit of $311.2 million as of December 31, 2024 [16]

Table of Contents As filed with the Securities and Exchange Commission on January 29, 2025 Registration No. 333-284164 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 82-2635018 (I.R.S. Emplo ...

Table of Contents As filed with the Securities and Exchange Commission on January 27, 2025 Registration No. 333-284164 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAZE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 Delaware 2836 82-2635018 (I.R.S. Emplo ...