Mr. Hoppenot, a seasoned biotech leader who has driven transformative therapies to market, joins Maze to fuel its evolution into a leading clinical-stage biotechSOUTH SAN FRANCISCO, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced the appointment of Hervé Hoppenot as Chairman of its Board of Directors, succeeding Charles Ho ...

MZE782 Phase 1 Trial Results - MZE782 demonstrated an excellent safety profile with no serious adverse events observed[18] - MZE782 exhibited linear pharmacokinetics (PK) across single doses ranging from 30 mg to 960 mg, with a half-life of approximately 11 hours[18, 32] - The trial showed up to a 42-fold increase in urinary phenylalanine (Phe) excretion and a 68-fold increase in urinary glutamine (Gln) excretion at Day 7[18] - MZE782 induced a dose-dependent initial estimated glomerular filtration rate (eGFR) dip, similar to SGLT2 inhibitors[18] Planned Phase 2 Trials in 2026 - The company plans to initiate Phase 2 trials for both Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) in 2026[18] - The PKU Phase 2 trial aims to demonstrate proof-of-concept (PoC) with plasma Phe reduction as the endpoint[56] - The CKD Phase 2 trial will focus on demonstrating PoC with proteinuria reduction as the primary endpoint[56] MZE782 Therapeutic Potential - MZE782 aims to deliver potential best-in-class plasma phenylalanine (Phe) reduction with a good safety profile for PKU patients[17] - MZE782 could be a new mechanism of action (MoA) to address CKD patients with inadequate response to current therapies, including SGLT2 inhibitors[56] Company Financial Position - The company has a strong cash position with an expected runway into 2028[12]

Core Viewpoint - Maze Therapeutics has successfully entered into an oversubscribed private placement agreement, raising approximately $150 million to advance its clinical programs and research initiatives [1][4]. Group 1: Private Placement Details - The private placement consists of 4,000,002 shares of common stock priced at $16.25 per share, along with 5,231,090 pre-funded warrants priced at $16.249 each [3]. - The transaction is expected to close on September 12, 2025, pending customary closing conditions [4]. - The placement has attracted both new and existing investors, including notable firms such as Frazier Life Sciences and Janus Henderson Investors [2]. Group 2: Use of Proceeds - Proceeds from the private placement will be utilized to further the development of MZE829 for APOL1-mediated kidney disease, initiate Phase 2 trials for MZE782 targeting phenylketonuria and chronic kidney disease, and support ongoing research and development efforts [4]. - Additional funds will be allocated for working capital and general corporate purposes [4]. Group 3: Company Overview - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for kidney and metabolic diseases [8]. - The company's lead candidates include MZE829, an APOL1 inhibitor in Phase 2 development, and MZE782, a SLC6A19 inhibitor also advancing to Phase 2 [8].

Core Insights - Maze Therapeutics has appointed Misbah Tahir as Chief Financial Officer, effective immediately, during a critical phase for the company [1][2] - The company is preparing for significant milestones, including data releases for MZE782 and MZE829 in 2025 and 2026 [2] - Mr. Tahir brings over 20 years of experience in the biopharmaceutical industry, having previously served as CFO at IGM Biosciences and held senior finance roles at other notable companies [2][3] Company Overview - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for kidney and metabolic diseases [4] - The company utilizes its Compass platform to pursue genetically validated targets, integrating variant discovery and functionalization [4] - Maze's pipeline includes MZE829, an oral APOL1 inhibitor in Phase 2 development, and MZE782, an oral SLC6A19 inhibitor in Phase 1, targeting chronic kidney disease and phenylketonuria [4] Financial Position - Maze Therapeutics has a strong balance sheet with an expected cash runway extending into the second half of 2027 [3] - The company aims to create significant value for patients and shareholders through its differentiated precision genetics platform and disciplined development approach [3]

Core Viewpoint - The National Advertising Division (NAD) is referring claims made by Maze Therapeutics regarding their drug MZE829 to regulatory authorities due to Maze's failure to respond substantively to NAD's inquiry [1][3]. Group 1: Company Overview - Vertex Pharmaceuticals and Maze Therapeutics are competitors in the development of clinical-stage treatments for APOL1-Mediated Kidney Disease (AMKD) [2]. - Maze Therapeutics has made express and implied claims about the efficacy of MZE829 compared to Vertex's drug candidate inaxaplin [2]. Group 2: Regulatory Actions - The NAD's inquiry was prompted by Vertex's request to review Maze's claims about MZE829 [2]. - Maze Therapeutics declined to participate in the NAD process, stating that it does not currently sell any product or advertise MZE829 [3]. - Due to Maze's non-participation, NAD will refer the matter to appropriate government agencies for further action [3].

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]

Group 1 - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for patients with renal, metabolic, and cardiovascular diseases [2] - The company will participate in two upcoming investor conferences in July, with live webcasts available on their website [1] - Maze Therapeutics utilizes its Compass platform to link genetic variants with biological pathways in disease, advancing a pipeline that includes two wholly owned programs, MZE829 and MZE782 [2] Group 2 - The H.C. Wainwright 4th Annual Kidney Virtual Conference is scheduled for July 14, 2025, at 2:30 p.m. ET [3] - The BTIG Virtual Biotech Conference will take place on July 30, 2025, at 9:20 a.m. ET [3]

Company Overview - Maze Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for patients with renal, metabolic, and cardiovascular diseases [3] - The company utilizes its Compass platform to gain insights into genetic variants associated with diseases and their biological pathways [3] Pipeline Development - Maze Therapeutics is advancing a pipeline that includes two wholly owned programs, MZE829 and MZE782, which represent novel precision medicine approaches [3] - The company aims to address conditions such as obesity and other related metabolic diseases through its innovative therapies [3] Upcoming Presentation - Jason Coloma, Ph.D., the CEO of Maze Therapeutics, will present a company overview at the Jefferies 2025 Global Healthcare Conference on June 5, 2025, at 2 p.m. ET [1] - A live webcast of the presentation will be available on the company's website and archived for 60 days [2]

Core Insights - Maze Therapeutics is advancing two clinical programs, MZE829 and MZE782, which are expected to drive growth and innovation in the treatment of chronic kidney disease (CKD) and phenylketonuria (PKU) [2][10] Clinical Programs - MZE829 is an oral small molecule APOL1 inhibitor targeting APOL1 kidney disease (AKD), a subset of CKD affecting over one million people in the U.S. The Phase 2 HORIZON trial is actively enrolling patients and initial data is expected in Q1 2026 [3][7] - MZE782 is an oral small molecule targeting the solute transporter SLC6A19, with potential as a first-in-class treatment for approximately five million U.S. patients with CKD who do not adequately respond to existing therapies, and as a best-in-class therapy for PKU. Initial data from the Phase 1 trial is expected in Q3 2025 [4][8] Financial Performance - As of March 31, 2025, Maze Therapeutics reported cash and cash equivalents of $294.4 million, an increase from $196.8 million as of December 31, 2024. This cash position is expected to fund operations into the second half of 2027 [5][14] - Research and development expenses for Q1 2025 were $27.6 million, up from $21.9 million in Q1 2024, primarily due to increased clinical trial costs for MZE829 and MZE782 [6] - General and administrative expenses rose to $7.8 million in Q1 2025 from $6.1 million in Q1 2024, reflecting higher personnel-related costs [9] Company Overview - Maze Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for renal, cardiovascular, and metabolic diseases. The company utilizes its Compass platform to link genetic variants with disease pathways [10]

Company Overview - Maze Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule precision medicines for patients with renal, metabolic, and cardiovascular diseases [3] - The company utilizes its Compass platform to gain insights into genetic variants associated with diseases and their biological pathways [3] Upcoming Event - Jason Coloma, Ph.D., CEO of Maze Therapeutics, will present a company overview and engage in one-on-one meetings at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025 [1][2] - The presentation is scheduled for 11 a.m. ET and will be accessible on the company's website, with a replay available for 60 days [2] Pipeline and Programs - Maze Therapeutics is advancing a pipeline led by two wholly owned programs, MZE829 and MZE782, which represent novel precision medicine approaches for patients [3]