Maze Therapeutics (NasdaqGM:MAZE) FY Conference Transcript

Summary of Maze Therapeutics FY Conference Call (December 03, 2025) Company Overview - Company: Maze Therapeutics (NasdaqGM: MAZE) - Focus: Development of therapies for genetically defined diseases, particularly APOL1-mediated kidney disease Key Accomplishments in 2025 - Public Offering: Maze Therapeutics went public early in 2025, enabling significant transformation and capital acquisition for further development [4][5] - Clinical Trials: Initiated study for MZE829 targeting APOL1 kidney disease, with data expected by the end of Q1 2026 [4][5] - Second Program: Additional data on MZE782 was well received, leading to a small PIPE financing [4][5] APOL1 Kidney Disease Insights - Patient Demographics: Affects approximately 6 million individuals in the U.S., with about 1 million having kidney disease; around 250,000 could benefit from therapy [7][8] - Disease Characteristics: Patients are generally younger and progress to dialysis about 10 years earlier than non-APOL1 patients [7][8] - Current Treatment Gap: No approved therapies exist for APOL1 kidney disease, and current standard care is ineffective [8][10] Mechanism of Action for MZE829 - Targeting APOL1: MZE829 aims to block the toxic gain of function caused by APOL1 variants G1 and G2, which lead to kidney toxicity [11][12] - Differentiation from Competitors: MZE829 has a dual mechanism of action, blocking pore formation and disrupting assembly, which differentiates it from Vertex's inaxaplin [12][13] Clinical Trial Design - Horizon Study: Enrolling patients with G1 or G2 genotypes, aiming for a 30% reduction in proteinuria as measured by UACR [16][18] - Inclusion Criteria: Includes both diabetic and non-diabetic patients, with a longer lead-in time of eight weeks to ensure accurate measurement of treatment effects [20][32] Regulatory Considerations - UACR as Endpoint: UACR is a sensitive measure for proteinuria, and a 30% reduction is considered clinically significant, correlating with improved eGFR and reduced risk of end-stage kidney disease [33][34] Future Plans - Next Steps: If successful data is obtained, planning for a phase 2b/3 study will commence, similar to Vertex's Amplitude study [36][41] - 2026 Objectives: Key events include the release of APOL1 kidney disease data and the initiation of two phase 2 studies based on promising data from MZE782 [46] Market Landscape - Competitive Environment: The landscape for APOL1-mediated kidney disease is evolving, with interest from large pharmaceutical companies. Maze Therapeutics aims to establish itself as a leader in this space [40][41] - Potential for Multiple Players: The unmet need in this area suggests opportunities for various companies to develop effective therapies [42][44] Conclusion - Significant Year Ahead: 2026 is poised to be a pivotal year for Maze Therapeutics, with critical data releases and potential advancements in their clinical programs [46]