MAZE
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Investor releaseQuarter not tagged2026-08-11Maze Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights
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 Strong balance sheet with $495 million in cash, cash equivalents and marketable securities supports expected runway into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 11, 2026 (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 reported financial results for the second quarter ended June 30, 2026, highlighting recent progress and business updates. “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. We 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.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. In 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…Read full documentShow less
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 Strong balance sheet with $495 million in cash, cash equivalents and marketable securities supports expected runway into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 11, 2026 (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 reported financial results for the second quarter ended June 30, 2026, highlighting recent progress and business updates. “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. We 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.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. In 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). Based on the topline results from HORIZON, Maze plans to initiate a pivotal trial in the first half of 2027, subject to regulatory feedback. MZE782 for Phenylketonuria (PKU) and CKD 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. 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. 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. Second Quarter 2026 Financial Results Cash 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. License 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. The 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. Net 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. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor in Phase 2 development with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow Maze on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the company’s expected cash runway. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact: Argot [email protected] Media Contact:Amanda Lazaro, 1AB [email protected]
Investor releaseQuarter not tagged2026-05-13Maze Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights
Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD provide proof-of-concept and support advancement into pivotal trial; additional HORIZON data expected in late 2026 or early 2027 Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD on track to initiate in 2026 Strong balance sheet with $528 million in cash, cash equivalents and marketable securities; inclusive of net proceeds from the $150 million registered offering and $20 million MZE001 milestone payment in April 2026; cash runway expected to extend into 2029 SOUTH SAN FRANCISCO, Calif., May 12, 2026 (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 reported financial results for the first quarter ended March 31, 2026, highlighting recent progress and business updates. “We continue to execute across our clinical pipeline in 2026, and with positive topline data reported from our Phase 2 HORIZON trial of MZE829 in broad AMKD in the first quarter, we are more confident than ever in our potential to harness the power of genetics to transform the lives of patients,” said Jason Coloma, Ph.D., chief executive officer of Maze. “Looking ahead to the rest of the year, we remain on track to initiate a Phase 2 trial of MZE782 in PKU around the middle of this year with topline data expected in 2027, and an additional Phase 2 study is expected to initiate in CKD in the second half of this year. We also look forward to reporting additional results from the HORIZON study in late 2026 or early 2027, and to advancing MZE829 into a pivotal trial in moderate AMKD patients without diabetes, including those with FSGS. With a strong balance sheet and expected cash runway into 2029, we continue to focus on clinical execution and pivotal study preparation.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD,…Read full documentShow less
Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD provide proof-of-concept and support advancement into pivotal trial; additional HORIZON data expected in late 2026 or early 2027 Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD on track to initiate in 2026 Strong balance sheet with $528 million in cash, cash equivalents and marketable securities; inclusive of net proceeds from the $150 million registered offering and $20 million MZE001 milestone payment in April 2026; cash runway expected to extend into 2029 SOUTH SAN FRANCISCO, Calif., May 12, 2026 (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 reported financial results for the first quarter ended March 31, 2026, highlighting recent progress and business updates. “We continue to execute across our clinical pipeline in 2026, and with positive topline data reported from our Phase 2 HORIZON trial of MZE829 in broad AMKD in the first quarter, we are more confident than ever in our potential to harness the power of genetics to transform the lives of patients,” said Jason Coloma, Ph.D., chief executive officer of Maze. “Looking ahead to the rest of the year, we remain on track to initiate a Phase 2 trial of MZE782 in PKU around the middle of this year with topline data expected in 2027, and an additional Phase 2 study is expected to initiate in CKD in the second half of this year. We also look forward to reporting additional results from the HORIZON study in late 2026 or early 2027, and to advancing MZE829 into a pivotal trial in moderate AMKD patients without diabetes, including those with FSGS. With a strong balance sheet and expected cash runway into 2029, we continue to focus on clinical execution and pivotal study preparation.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. In 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. The results demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12 in broad AMKD patients, with 50% of patients achieving a greater than 30% reduction in uACR. In patients with severe focal segmental glomerulosclerosis (FSGS), treatment with MZE829 led to a mean reduction in uACR of 61.8%. In patients with AMKD without diabetes, treatment with MZE829 resulted in a clinically meaningful mean reduction in uACR of 48.6%. In patients with AMKD with diabetes, five patients were evaluable per protocol for efficacy, with two patients achieving at least a 30% reduction in uACR. No serious adverse events or severe treatment-related adverse events were observed. Based on the topline results from HORIZON, Maze plans to initiate a pivotal trial in patients with moderate AMKD without diabetes, including those with FSGS, in the first half of 2027, subject to regulatory feedback. MZE782 for Phenylketonuria (PKU) and CKD 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. Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU and proteinuria reduction in CKD by mid-2026 and in the second half of 2026, respectively. Topline data from the PKU Phase 2 trial is expected in 2027. 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. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $362.9 million as of March 31, 2026, compared to $360.0 million as of December 31, 2025. Maze expects that its cash, cash equivalents and marketable securities as of March 31, 2026, together with the proceeds from the registered offering completed in April 2026 and a $20 million milestone payment received from Shionogi & Co., Ltd. in April 2026, will fund operations into 2029 based on its current business plan. License Revenue: License revenue was $20.0 million for the quarter ended March 31, 2026. No license revenue was recognized for the quarter ended March 31, 2025. License revenue recognized in the first quarter of 2026 reflects the achievement of a milestone 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 were $34.1 million and $27.6 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher clinical trial expenses for the Phase 2 trial of MZE829 in AMKD and start-up activities for the planned Phase 2 trial of MZE782 in PKU and higher personnel-related costs, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses were $12.4 million and $7.8 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and costs for professional services. Net Loss: Net loss was $24.2 million, or $0.45 per share, and $32.8 million, or $1.15 per share, for the quarter ended March 31, 2026 and 2025, respectively. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow Maze on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Amanda Lazaro, 1AB Media [email protected]
Investor releaseQuarter not tagged2026-05-07Maze Therapeutics CSBO Sells 7,500 Shares for $190,000 After Strong Trial Results and Q4 Financials
Motley Fool
Maze Therapeutics CSBO Sells 7,500 Shares for $190,000 After Strong Trial Results and Q4 Financials
Atul Dandekar, Chief Strategy and Business Officer of Maze Therapeutics (NASDAQ:MAZE), reported the exercise and immediate sale of 7,500 shares of common stock for a transaction value of approximately $190,000 on April 29, 2026, as disclosed in this SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average purchase price ($25.37); post-transaction value based on April 29, 2026, market close ($25.68). How does this transaction affect Dandekar's ongoing exposure to Maze Therapeutics? Dandekar's direct common stock holdings were reduced by 41.66%, but he maintains 44,143 stock options that can be exercised for future equity exposure or liquidity events. What was the nature of the shares disposed in this filing? All 7,500 shares were acquired via option exercise and immediately sold in the open market, reflecting a derivative-driven liquidity event rather than a discretionary open-market sale. Does this sale represent a change in Dandekar's trading cadence? The 7,500-share event is consistent with prior administrative transactions in 2026, with declining trade sizes explained by the reduced available share count after prior exercises and sales. What are the implications for future insider activity? While direct holdings are now modest, the sizable remaining option position provides capacity for additional similar transactions, supporting ongoing liquidity scheduling under the existing Rule 10b5-1 plan. 1-year price change calculated using April 29, 2026, as the reference date. Develops small molecule precision medicines targeting renal, cardiovascular, metabolic diseases, and obesity, with lead programs MZE829 (APOL1 inhibitor, phase 2) and MZE782 (SLC6A19 inhibitor, phase 1). Operates a clinical-stage biopharmaceutical model focused on advancing proprietary drug candidates through early- and mid-stage clinical trials. Develops small-molecule precision medicines for renal and metabolic diseases in the United States. Maze Therapeutics, Inc. is a clinical-stage biotechnology company leveraging genetic insights to develop targeted therapies for complex renal and metabolic diseases. The company’s strategy centers on advancing a focused pipeline of oral small-molecule drugs with the potential to address significant unmet medical needs. With a lean workforce and a strong emphasis on precision medicine, Maze Therapeutics seeks to differentiate itself th…Read full documentShow less
Atul Dandekar, Chief Strategy and Business Officer of Maze Therapeutics (NASDAQ:MAZE), reported the exercise and immediate sale of 7,500 shares of common stock for a transaction value of approximately $190,000 on April 29, 2026, as disclosed in this SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average purchase price ($25.37); post-transaction value based on April 29, 2026, market close ($25.68). How does this transaction affect Dandekar's ongoing exposure to Maze Therapeutics? Dandekar's direct common stock holdings were reduced by 41.66%, but he maintains 44,143 stock options that can be exercised for future equity exposure or liquidity events. What was the nature of the shares disposed in this filing? All 7,500 shares were acquired via option exercise and immediately sold in the open market, reflecting a derivative-driven liquidity event rather than a discretionary open-market sale. Does this sale represent a change in Dandekar's trading cadence? The 7,500-share event is consistent with prior administrative transactions in 2026, with declining trade sizes explained by the reduced available share count after prior exercises and sales. What are the implications for future insider activity? While direct holdings are now modest, the sizable remaining option position provides capacity for additional similar transactions, supporting ongoing liquidity scheduling under the existing Rule 10b5-1 plan. 1-year price change calculated using April 29, 2026, as the reference date. Develops small molecule precision medicines targeting renal, cardiovascular, metabolic diseases, and obesity, with lead programs MZE829 (APOL1 inhibitor, phase 2) and MZE782 (SLC6A19 inhibitor, phase 1). Operates a clinical-stage biopharmaceutical model focused on advancing proprietary drug candidates through early- and mid-stage clinical trials. Develops small-molecule precision medicines for renal and metabolic diseases in the United States. Maze Therapeutics, Inc. is a clinical-stage biotechnology company leveraging genetic insights to develop targeted therapies for complex renal and metabolic diseases. The company’s strategy centers on advancing a focused pipeline of oral small-molecule drugs with the potential to address significant unmet medical needs. With a lean workforce and a strong emphasis on precision medicine, Maze Therapeutics seeks to differentiate itself through innovation and a data-driven approach to drug development. Following insider transactions can be a useful way to gauge what’s going on with a company, but there are limitations to that approach. Dandekar netted nearly $200,000 from his April 29 share sale, but the transaction was an exercise-and-sell maneuver that was pursuant to a Rule 10b5-1 trading plan. That’s a trading tool available for company insiders that allows them to buy or sell shares on a predetermined schedule, so as to avoid the appearance of insider trading. While the move was lucrative, with Maze stock up nearly 200% year over year at the time of the transaction, it shouldn’t signal anything specific to investors about Dandekar’s conviction in the company’s prospects. March was a big month for the clinical-stage biotech. It reported fourth-quarter and full-year 2025 earnings results on March 25, highlighting positive top-line data from its phase 2 Horizon trial of MZE829 and $360 million in cash, cash equivalents, and marketable securities on the balance sheet, which management projects should give the company a cash runway into 2028. It expects to initiate two phase 2 proof-of-concept clinical trials for MZA782 later this year. Shares of small-cap clinical-stage healthcare companies like Maze can swing dramatically on good or bad clinical trial results, highlighting both the opportunity and the risk inherent in investing in the space. The stock received two price target raises in March, according to Insider Monkey. On March 25, H.C. Wainwright raised its price target to $110 from $60 and maintained a buy rating, highlighting MZE829’s Horizon trial data and “best-in-class” profile. On March 31, J.P. Morgan raised its price target to $58 from $52. Before you buy stock in Maze Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Maze Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $473,985!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,204,650!* Now, it’s worth noting Stock Advisor’s total average return is 950% — a market-crushing outperformance compared to 203% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 7, 2026. Sarah Sidlow has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Maze Therapeutics CSBO Sells 7,500 Shares for $190,000 After Strong Trial Results and Q4 Financials was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-03-25Maze Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Highlights
Positive topline data from Phase 2 HORIZON trial of MZE829 demonstrating first clinical proof-of-concept in patients with broad AMKD to support advancement into pivotal program; Maze to host conference call today at 8:00 am EDT Two Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD expected to initiate in 2026 Industry leader Neil Kumar, Ph.D., Founder and CEO of BridgeBio, appointed to Maze Board of Directors Strong balance sheet with $360.0 million in cash, cash equivalents and marketable securities; expected cash runway into 2028 SOUTH SAN FRANCISCO, Calif., March 25, 2026 (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 reported financial results for the fourth quarter and year ended December 31, 2025, highlighting recent progress and business updates. “We are proud of the progress that Maze achieved in 2025 and have already carried our strong record of execution into the new year, as evidenced by today’s positive topline data from our Phase 2 HORIZON trial of MZE829 in broad AMKD,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to advancing MZE829 into a pivotal program and to initiating our two Phase 2 trials of MZE782 in PKU and CKD. As we continue on our mission to deliver potential first- or best-in-class precision medicines to patients with kidney and metabolic diseases, we are grateful to have the support of both the patient and investor communities behind us.” Dr. Coloma continued, “We are also thrilled to announce the addition of Neil Kumar to our Board of Directors. Neil’s experience building BridgeBio into the fully-integrated, commercial-stage, patient-centric organization it is today will be invaluable to the team at Maze as we work to grow our company and transform the lives of patients.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. Today, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broa…Read full documentShow less
Positive topline data from Phase 2 HORIZON trial of MZE829 demonstrating first clinical proof-of-concept in patients with broad AMKD to support advancement into pivotal program; Maze to host conference call today at 8:00 am EDT Two Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD expected to initiate in 2026 Industry leader Neil Kumar, Ph.D., Founder and CEO of BridgeBio, appointed to Maze Board of Directors Strong balance sheet with $360.0 million in cash, cash equivalents and marketable securities; expected cash runway into 2028 SOUTH SAN FRANCISCO, Calif., March 25, 2026 (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 reported financial results for the fourth quarter and year ended December 31, 2025, highlighting recent progress and business updates. “We are proud of the progress that Maze achieved in 2025 and have already carried our strong record of execution into the new year, as evidenced by today’s positive topline data from our Phase 2 HORIZON trial of MZE829 in broad AMKD,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to advancing MZE829 into a pivotal program and to initiating our two Phase 2 trials of MZE782 in PKU and CKD. As we continue on our mission to deliver potential first- or best-in-class precision medicines to patients with kidney and metabolic diseases, we are grateful to have the support of both the patient and investor communities behind us.” Dr. Coloma continued, “We are also thrilled to announce the addition of Neil Kumar to our Board of Directors. Neil’s experience building BridgeBio into the fully-integrated, commercial-stage, patient-centric organization it is today will be invaluable to the team at Maze as we work to grow our company and transform the lives of patients.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. Today, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD. The results, representing the first-ever clinical proof-of-concept data in this genetically-defined, broad AMKD population, demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12 in broad AMKD patients, with 50% of patients achieving a greater than 30% reduction in uACR. In patients with severe focal segmental glomerulosclerosis (FSGS), treatment with MZE829 led to a mean reduction in uACR of 61.8%. In patients with AMKD without diabetes, treatment with MZE829 resulted in a clinically meaningful mean reduction in uACR of 48.6%. In patients with AMKD with diabetes, five patients were evaluable per protocol for efficacy, with two patients achieving at least a 30% reduction in uACR. No serious adverse events or severe treatment-related adverse events were observed. Based on these results, the Company plans to advance MZE829 to a pivotal program, while continuing to enroll in HORIZON. MZE782 in phenylketonuria (PKU) and CKD 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. Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU and proteinuria reduction in CKD by mid-2026 and in the second half of 2026, respectively. MZE001 in Pompe disease MZE001 (S606001) is an investigational small molecule and oral glycogen synthase 1 (GYS1) specific inhibitor to address Pompe disease by limiting disease-causing glycogen accumulation. Results from the Phase 1 study of MZE001 suggest that it has the potential to be the first oral treatment for Pompe disease. Discovery of MZE001 was enabled by Maze’s Compass™ platform. In March 2026, Maze achieved a $20 million milestone under its collaboration agreement with Shionogi & Co., Ltd. in connection with the dosing of the first patient in ESPRIT, a global Phase 2 clinical trial evaluating MZE001 in addition to standard of care enzyme replacement therapy in patients with late-onset Pompe disease. Under the terms of the agreement, Maze is eligible for additional milestone payments of up to $255.0 million in the aggregate upon the completion of certain clinical and regulatory milestones and up to $330.0 million in the aggregate if certain sales milestones are achieved. Maze is also eligible for tiered royalties ranging from percentages in the low double-digits to twenty on net sales. Recent Corporate Highlights Today, Maze announced that Neil Kumar, Ph.D., Founder and Chief Executive Officer of BridgeBio Pharma, Inc., has been appointed to its Board of Directors. In addition to BridgeBio, Dr. Kumar has also served as the Chief Executive Officer of BridgeBio’s subsidiary, Eidos Therapeutics, Inc., and as a member of Eidos Therapeutics’ Board of Directors since March 2016. Before founding BridgeBio in 2015, Dr. Kumar was a Principal at Third Rock Ventures. Dr. Kumar holds BS and MS degrees in Chemical Engineering from Stanford University, and received his Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology (MIT). Conference Call and Webcast Maze will host a conference call and webcast with members of the executive team today at 8:00 am EDT to discuss the HORIZON Phase 2 topline data and next steps. To access the call, please dial 1-888-243-4451 (United States or Canada) or 1-412-542-4135 (international) and request to be joined into the Maze Therapeutics, Inc. call. To access the live webcast and subsequent archived recording of this event and other company presentations, please visit the Investors section of Maze’s website. The archived webcast will remain available for replay and on Maze’s website for 90 days. Fourth Quarter and Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $360.0 million as of December 31, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash, cash equivalents and marketable securities will fund operations into 2028 based on its current business plan. License Revenue: No license revenue was recognized for the quarter and year-ended December 31, 2025. License revenue was none and $167.5 million for the quarter and year-ended December 31, 2024, respectively. License revenue recognized in 2024 primarily reflects the receipt of an upfront payment of $150.0 million pursuant to the exclusive license agreement with Shionogi & Co., Ltd. for the rights to MZE001. Research & Development (R&D) Expenses: R&D expenses for the quarter and year-ended December 31, 2025 were $27.6 million and $108.4 million, respectively, and $22.2 million and $83.5 million for the same periods in 2024. The increase primarily reflects higher clinical trial and manufacturing expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses for the quarter and year-ended December 31, 2025 were $10.5 million and $34.5 million, respectively, and $7.5 million and $26.4 million for the same periods in 2024. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense. Net (Loss) Income: Net loss for the quarter and year-ended December 31, 2025 was $34.6 million and $131.1 million, respectively, compared to a net loss of $29.6 million and net income of $52.2 million for the same periods in 2024. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow the company on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Amanda Lazaro, 1AB Media [email protected]
Investor releaseQuarter not tagged2025-11-07Maze Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
First-in-human data from Phase 1 trial of MZE782 support best- and first-in-class potential; two Phase 2 proof-of-concept trials in phenylketonuria (PKU) and chronic kidney disease (CKD) expected to initiate in 2026 Enrollment ongoing in Phase 2 HORIZON trial of MZE829 in broad APOL1-mediated kidney disease (AMKD); topline data for initial patients expected by the end of Q1 2026 Strong balance sheet with $383.9 million in cash, cash equivalents and marketable securities following oversubscribed private placement; cash runway into 2028 SOUTH SAN FRANCISCO, Calif., Nov. 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 reported financial results for the third quarter ended September 30, 2025, highlighting recent progress and business updates. “We are proud to have delivered another strong quarter marked by continued execution across our pipeline and business. We are particularly thrilled with the positive first-in-human results from our Phase 1 trial of MZE782, which support the continued advancement of MZE782 in two Phase 2 trials in both PKU and CKD, and we look forward to initiating those planned trials in 2026,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We continue to actively enroll patients in our Phase 2 HORIZON trial of MZE829 and anticipate reporting topline proof-of-concept data on initial patients by the end of Q1 2026. These data, from a broad AMKD population, are expected to inform potential advancement into Phase 2b/3 planning. With a strong balance sheet, bolstered by our recently announced oversubscribed private placement, we are well-positioned for multiple milestones ahead.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes patients with broad AMKD, including diabetic and non-diabetic patients and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to report top…Read full documentShow less
First-in-human data from Phase 1 trial of MZE782 support best- and first-in-class potential; two Phase 2 proof-of-concept trials in phenylketonuria (PKU) and chronic kidney disease (CKD) expected to initiate in 2026 Enrollment ongoing in Phase 2 HORIZON trial of MZE829 in broad APOL1-mediated kidney disease (AMKD); topline data for initial patients expected by the end of Q1 2026 Strong balance sheet with $383.9 million in cash, cash equivalents and marketable securities following oversubscribed private placement; cash runway into 2028 SOUTH SAN FRANCISCO, Calif., Nov. 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 reported financial results for the third quarter ended September 30, 2025, highlighting recent progress and business updates. “We are proud to have delivered another strong quarter marked by continued execution across our pipeline and business. We are particularly thrilled with the positive first-in-human results from our Phase 1 trial of MZE782, which support the continued advancement of MZE782 in two Phase 2 trials in both PKU and CKD, and we look forward to initiating those planned trials in 2026,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We continue to actively enroll patients in our Phase 2 HORIZON trial of MZE829 and anticipate reporting topline proof-of-concept data on initial patients by the end of Q1 2026. These data, from a broad AMKD population, are expected to inform potential advancement into Phase 2b/3 planning. With a strong balance sheet, bolstered by our recently announced oversubscribed private placement, we are well-positioned for multiple milestones ahead.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) 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. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes patients with broad AMKD, including diabetic and non-diabetic patients and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to report topline proof-of-concept data from the Phase 2 HORIZON trial by the end of the first quarter of 2026. MZE782 in PKU and CKD 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 approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies. In September 2025, Maze announced positive first-in-human results from the Phase 1 clinical trial evaluating MZE782 in healthy volunteers. MZE782 was well-tolerated across all doses and produced dose-dependent increases in 24-hour urinary excretion of phenylalanine (Phe) and glutamine across both single and multiple ascending dose cohorts, confirming target engagement and SLC6A19 inhibition. A dose-dependent initial eGFR dip similar to SGLT2 inhibitors, MRAs and RAAS inhibitors was also observed, supporting a potential kidney protective effect in CKD. Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782, evaluating plasma Phe reduction in PKU and proteinuria reduction in CKD, in 2026. Recent Corporate Highlights In October 2025, Maze announced the appointment of Hervé Hoppenot as chairman of its board of directors, succeeding Charles Homcy, M.D., who continues to serve on the board. Mr. Hoppenot has over 30 years of experience in therapeutic development and commercial leadership, most recently as chief executive officer of Incyte Corporation. In September 2025, Maze announced an oversubscribed private placement for gross proceeds of approximately $150.0 million, before deducting placement agent fees and other expenses. In September 2025, Maze announced the appointment of Misbah Tahir as chief financial officer. Mr. Tahir brings over 20 years of financial and strategic experience in the biopharmaceutical industry to his position at Maze, most recently as CFO of IGM Biosciences, Inc. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $383.9 million as of September 30, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash, cash equivalents and marketable securities will fund operations into 2028. License Revenue: No license revenue was recognized during the three and nine months ended September 30, 2025. License revenue was $2.5 million and $167.5 million for the three and nine months ended September 30, 2024, respectively. License revenue recognized in 2024 primarily reflects the receipt of an upfront payment of $150.0 million 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 nine months ended September 30, 2025 were $25.2 million and $80.9 million, respectively, and $19.9 million and $61.3 million for the same periods in 2024. The increase primarily reflects higher clinical trial and manufacturing expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025 were $7.8 million and $24.0 million, respectively, and $6.9 million and $18.9 million for the same periods in 2024. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense. Net (Loss) Income: Net loss for the three and nine months ended September 30, 2025 was $30.1 million and $96.6 million, respectively, compared to a net loss of $24.8 million and net income of $81.8 million for the same periods in 2024. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases, including obesity. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow the company on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. For further information, please contact: IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Amanda Lazaro, 1AB Media [email protected]
Investor releaseQuarter not tagged2025-09-12Why Maze Therapeutics, Up 55%, Was Shocked By Its Own Test Results
Investor's Business Daily
Why Maze Therapeutics, Up 55%, Was Shocked By Its Own Test Results
Maze Therapeutics catapulted Thursday after its experimental treatment for a rare, genetic disease blew past the company's own expectations.
Investor releaseQuarter not tagged2025-09-12Maze reports positive results from Phase I trial of PKU and CKD treatment
Clinical Trials Arena
Maze reports positive results from Phase I trial of PKU and CKD treatment
Maze Therapeutics has shared positive outcomes from the randomised Phase I study of the oral SLC6A19 inhibitor, MZE782, for treating phenylketonuria (PKU) and chronic kidney disease (CKD). The placebo-controlled, double-blind trial, which involved 112 healthy adult volunteers, is aimed at assessing single ascending doses (SAD) and multiple ascending doses (MAD) of the therapy. It included 56, 40, and 16 subjects in the SAD, MAD, and the food effect cohorts, respectively. Each SAD and MAD cohort included eight subjects who were randomised in a 6:2 ratio. The single doses ranged from 30mg to 960mg while multiple doses were administered once or twice a day over a week, ranging from 120mg to 720mg. In addition, the impact of a high-fat meal and a low-fat meal on the therapy’s absorption was evaluated. The primary goals of the trial focused on the safety and tolerability of SAD and MAD doses of the therapy while the secondary and exploratory objectives included assessing the impact of food, pharmacokinetic (PK) analysis, and pharmacodynamic (PD) evaluations of the therapy’s target interaction. This included the measurement of urinary excretion levels of phenylalanine (Phe) and glutamine (Gln), which serve as indicative biomarkers for the inhibition of SLC6A19 and the management of the disease. In addition, the study measured the estimated glomerular filtration rate (eGFR) to estimate kidney function. Results were positive, with MZE782 showing good tolerance across all dosage levels. It exhibited a consistent absorption pattern, reaching a maximum concentration in six hours and having a half-life of 11 hours. In terms of PD, MZE782 increased the urinary excretion of phenylalanine (Phe) and glutamine (Gln) across the MAD and SAD cohorts. The study also observed an initial decrease in the estimated glomerular filtration rate (eGFR), a measure of kidney function. The eGFR reduction was reversed after the dosing period ended at day 11. Maze Therapeutics chief medical officer and research and development president Harold Bernstein said: “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” In February 2025, Maze dosed the first subject in the Phase II H…Read full documentShow less
Maze Therapeutics has shared positive outcomes from the randomised Phase I study of the oral SLC6A19 inhibitor, MZE782, for treating phenylketonuria (PKU) and chronic kidney disease (CKD). The placebo-controlled, double-blind trial, which involved 112 healthy adult volunteers, is aimed at assessing single ascending doses (SAD) and multiple ascending doses (MAD) of the therapy. It included 56, 40, and 16 subjects in the SAD, MAD, and the food effect cohorts, respectively. Each SAD and MAD cohort included eight subjects who were randomised in a 6:2 ratio. The single doses ranged from 30mg to 960mg while multiple doses were administered once or twice a day over a week, ranging from 120mg to 720mg. In addition, the impact of a high-fat meal and a low-fat meal on the therapy’s absorption was evaluated. The primary goals of the trial focused on the safety and tolerability of SAD and MAD doses of the therapy while the secondary and exploratory objectives included assessing the impact of food, pharmacokinetic (PK) analysis, and pharmacodynamic (PD) evaluations of the therapy’s target interaction. This included the measurement of urinary excretion levels of phenylalanine (Phe) and glutamine (Gln), which serve as indicative biomarkers for the inhibition of SLC6A19 and the management of the disease. In addition, the study measured the estimated glomerular filtration rate (eGFR) to estimate kidney function. Results were positive, with MZE782 showing good tolerance across all dosage levels. It exhibited a consistent absorption pattern, reaching a maximum concentration in six hours and having a half-life of 11 hours. In terms of PD, MZE782 increased the urinary excretion of phenylalanine (Phe) and glutamine (Gln) across the MAD and SAD cohorts. The study also observed an initial decrease in the estimated glomerular filtration rate (eGFR), a measure of kidney function. The eGFR reduction was reversed after the dosing period ended at day 11. Maze Therapeutics chief medical officer and research and development president Harold Bernstein said: “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” In February 2025, Maze dosed the first subject in the Phase II HORIZON study to evaluate MZE829 in treating subjects with APOL1 kidney disease (AKD). "Maze reports positive results from Phase I trial of PKU and CKD treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Investor releaseQuarter not tagged2025-09-11Maze Therapeutics Announces Positive First-in-Human Results from Phase 1 Trial of MZE782, Establishing Proof of Mechanism for a Potent, Oral SLC6A19 Inhibitor with Potential to Treat Phenylketonuria (PKU) and Chronic Kidney Disease (CKD)
GlobeNewswire
Maze Therapeutics Announces Positive First-in-Human Results from Phase 1 Trial of MZE782, Establishing Proof of Mechanism for a Potent, Oral SLC6A19 Inhibitor with Potential to Treat Phenylketonuria (PKU) and Chronic Kidney Disease (CKD)
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2 inhibitors observed, supporting a potential kidney protective effect in CKD Well tolerated across all doses with an excellent safety profile and no serious adverse events observed Phase 2 trials in both PKU and CKD expected to initiate in 2026 Maze to host investor conference call and webcast today at 8:30 am EDT SOUTH SAN FRANCISCO, Calif., Sept. 11, 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 positive clinical results from the Phase 1 healthy volunteer study of MZE782, an oral small molecule targeting the solute transporter, SLC6A19. MZE782 has potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class therapy for patients with CKD. “These first-in-human results for MZE782 mark an important milestone, demonstrating an excellent safety profile, robust target engagement and compelling pharmacodynamic effects, consistent with our therapeutic hypothesis,” said Harold Bernstein, M.D., Ph.D., president of R&D and chief medical officer of Maze. “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” “We also observed dose-dependent changes in eGFR in healthy individuals with MZE782, similar to those seen with SGLT2 inhibitors, suggesting a potential beneficial effect on kidney physiology in CKD patients. We look forward to advancing MZE782 into Phase 2 studies in both PKU and CKD in 2026,” Dr. Bernstein continued. “These findings also serve as important clinical validation of our Compass platform. MZE782 is the third clinical program to come out of our Compass platform, further demonstratin…Read full documentShow less
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2 inhibitors observed, supporting a potential kidney protective effect in CKD Well tolerated across all doses with an excellent safety profile and no serious adverse events observed Phase 2 trials in both PKU and CKD expected to initiate in 2026 Maze to host investor conference call and webcast today at 8:30 am EDT SOUTH SAN FRANCISCO, Calif., Sept. 11, 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 positive clinical results from the Phase 1 healthy volunteer study of MZE782, an oral small molecule targeting the solute transporter, SLC6A19. MZE782 has potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class therapy for patients with CKD. “These first-in-human results for MZE782 mark an important milestone, demonstrating an excellent safety profile, robust target engagement and compelling pharmacodynamic effects, consistent with our therapeutic hypothesis,” said Harold Bernstein, M.D., Ph.D., president of R&D and chief medical officer of Maze. “The rapid and profound increase in urinary phenylalanine excretion confirms SLC6A19 inhibition in healthy individuals that we anticipate will translate to meaningful reductions in plasma phenylalanine levels in patients with PKU, based on the biology of this transporter.” “We also observed dose-dependent changes in eGFR in healthy individuals with MZE782, similar to those seen with SGLT2 inhibitors, suggesting a potential beneficial effect on kidney physiology in CKD patients. We look forward to advancing MZE782 into Phase 2 studies in both PKU and CKD in 2026,” Dr. Bernstein continued. “These findings also serve as important clinical validation of our Compass platform. MZE782 is the third clinical program to come out of our Compass platform, further demonstrating our ability to harness the power of human genetics to develop small molecule precision medicines designed to transform the lives of patients with kidney and metabolic diseases.” Study Design The Phase 1 trial of MZE782 was a randomized, double-blind, placebo-controlled study evaluating single ascending doses (SAD) and multiple ascending doses (MAD) of orally administered MZE782 in 112 healthy adult volunteers. The study included 56 participants in the SAD, 40 participants in the MAD and 16 participants in the food effect cohorts. Each SAD and MAD cohort included eight participants randomized 6:2 (MZE782: placebo). The SAD doses ranged from 30 to 960 mg. The MAD doses, with dosing once or twice daily for seven days, ranged from 120 to 240 mg twice daily and 120 to 720 mg once daily. One food effect cohort included eight participants administered 480 mg MZE782 or placebo (6:2) with a high-fat meal. The second food effect cohort included eight participants administered 480 mg MZE782 fasted or with a low-fat meal in a crossover design. The primary objective was to evaluate the safety and tolerability of single and multiple ascending oral doses of MZE782 in healthy volunteers. Secondary and exploratory endpoints included pharmacokinetics, food effect, pharmacodynamic measures of target engagement, specifically urinary excretion of phenylalanine (Phe) and glutamine (Gln) as predictive biomarkers of SLC6A19 inhibition and disease control, and estimated glomerular filtration rate (eGFR). Safety and Tolerability Profile MZE782 was well tolerated across all doses in all cohorts. There were no serious adverse events (SAEs), no severe adverse events and no treatment-related adverse events (TRAEs) leading to discontinuation. In the SAD portion of the study (n=56), there were a total of three TRAEs reported that were all mild in severity and not seen at the higher doses. Headache was reported in two patients (4%) and diarrhea was reported in one patient (2%). There were no TRAEs reported in the MAD portion of the study. No clinically relevant changes in vital signs, laboratory tests or ECGs were observed. Pharmacokinetics (PK) MZE782 demonstrated a favorable plasma PK profile after single and multiple oral doses. Oral administration was associated with consistent absorption, with a tmax of six hours and a half-life of 11 hours. Exposure increased proportionally with dose, and steady-state was achieved by Day 3. This is supportive of a once- or twice-daily dosing regimen to be evaluated in Phase 2. Pharmacodynamics (PD) Neutral Amino Acid Excretion MZE782 produced dose-dependent increases in 24-hour urinary excretion of the neutral amino acids Phe and Gln across both SAD and MAD cohorts, confirming target engagement and SLC6A19 inhibition. A 39-fold increase in urinary Phe excretion over 24 hours was observed with a single dose of 960 mg of MZE782. A 42-fold increase in urinary Phe excretion over 24 hours on Day 7 was observed in the 240 mg twice-daily dose cohort. A 55-fold increase in urinary Gln excretion over 24 hours was observed with a single dose of 960 mg of MZE782. A 68-fold increase in urinary Gln excretion over 24 hours on Day 7 was observed in the 240 mg twice-daily dose cohort. Estimated Glomerular Filtration Rate (eGFR) All participants in the MAD cohorts of the Phase 1 study were assessed for changes in eGFR. MZE782 demonstrated a dose-dependent initial eGFR dip over seven days of dosing that was similar in magnitude to what has been observed in patients initiating SGLT2 and RAAS inhibitors. With other renoprotective therapies, this initial dip is correlated to a slower rate of eGFR decline and better preservation of kidney function over longer periods of time in CKD patients. The combined 240 mg BID cohorts (n=12) demonstrated a change of -11.5 mL/min/1.73m2 after seven days of dosing, compared to a change of -2.5 mL/min/1.73m2 in the matched placebo cohort (n=4). This initial eGFR dip rapidly reversed following the end of dosing as assessed at Day 11, strongly suggestive of a drug-related effect on eGFR. Next Steps Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782, evaluating plasma Phe reduction in PKU and proteinuria reduction in CKD in 2026. Conference Call and Webcast Maze will host a conference call and webcast with members of the executive team today at 8:30 am EDT to discuss the data. To access the call, please dial (877) 407-3982 (domestic) or (201) 493-6780 (international) and provide the Conference ID 13755793 to the operator. To access the live webcast and subsequent archived recording of this and other company presentations, please visit the Investors section of Maze’s website. The archived webcast will remain available for replay on Maze’s website for 90 days. About MZE782 MZE782 is an investigational, potent, selective, oral inhibitor of SLC6A19, a sodium-dependent neutral amino acid transporter expressed in the small intestine and kidney proximal tubule that plays a key role in the absorption and reabsorption of neutral amino acids, including Phe. MZE782 is being advanced in two indications: PKU and CKD. In PKU, SLC6A19 enables Phe uptake from the gut and reabsorption in the kidney – two key contributors to elevated plasma Phe levels in patients with deficient PAH activity. Inhibiting SLC6A19 with MZE782 offers a genotype- and PAH-agnostic, oral approach to lowering plasma Phe by limiting its entry into circulation. In CKD, SLC6A19-mediated reabsorption has the potential to contribute to metabolic overload in the proximal tubule of the kidney. Blocking this transporter may therefore reduce the burden of amino acids and toxins, potentially slowing disease progression. The potential mechanism is complementary to, as well as distinct from, SGLT2 inhibition. Loss-of-function mutations in SLC6A19, as seen in Hartnup disease, a generally benign condition, support the potential safety of SLC6A19 inhibition and reinforce the therapeutic rationale for MZE782. In the Phase 1 clinical study in healthy volunteers, MZE782 demonstrated an excellent safety profile, sustained urinary neutral amino acid excretion as well as potential to improve kidney filtration. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow the company on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. For further information, please contact: IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Amanda Lazaro, 1AB Media [email protected]
Investor releaseQuarter not tagged2025-08-13Maze Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights
MZE782 Phase 1 Trial in Healthy Volunteers to Provide Proof of Mechanism Data for Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) Expected in Q3 2025 MZE829 Phase 2 HORIZON Trial Actively Enrolling Patients with APOL1-Mediated Kidney Disease; Initial Data Expected in Q1 2026 Strong Balance Sheet with $264.5 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., Aug. 12, 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 reported financial results for the second quarter ended June 30, 2025, highlighting recent progress and business updates. “With two clinical-stage programs advancing, Maze continues to execute with focus and discipline,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We remain on track to report key mechanistic biomarker data from our Phase 1 study of MZE782 in Q3, a significant milestone toward initiating Phase 2 trials in PKU and CKD. In addition, we continue to enroll our Phase 2 HORIZON trial of MZE829 in APOL1-mediated kidney disease, keeping us on track for an initial proof-of-concept readout in Q1 2026. With a strong balance sheet and cash runway into the second half of 2027, we’re well-positioned to deliver meaningful impact for patients and value for shareholders.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of CKD estimated to affect over one million people in the United States alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AMKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently ava…Read full documentShow less
MZE782 Phase 1 Trial in Healthy Volunteers to Provide Proof of Mechanism Data for Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) Expected in Q3 2025 MZE829 Phase 2 HORIZON Trial Actively Enrolling Patients with APOL1-Mediated Kidney Disease; Initial Data Expected in Q1 2026 Strong Balance Sheet with $264.5 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., Aug. 12, 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 reported financial results for the second quarter ended June 30, 2025, highlighting recent progress and business updates. “With two clinical-stage programs advancing, Maze continues to execute with focus and discipline,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We remain on track to report key mechanistic biomarker data from our Phase 1 study of MZE782 in Q3, a significant milestone toward initiating Phase 2 trials in PKU and CKD. In addition, we continue to enroll our Phase 2 HORIZON trial of MZE829 in APOL1-mediated kidney disease, keeping us on track for an initial proof-of-concept readout in Q1 2026. With a strong balance sheet and cash runway into the second half of 2027, we’re well-positioned to deliver meaningful impact for patients and value for shareholders.” Program Progress and Anticipated Milestones MZE829 for APOL1-Mediated Kidney Disease (AMKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of CKD estimated to affect over one million people in the United States alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AMKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies, as well as potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder. MZE782 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers. Maze expects to report initial data, including biomarker and proof-of-mechanism results relevant for both indications, in the third quarter of 2025. Based on Phase 1 results, Maze plans to initiate two separate Phase 2 clinical trials of MZE782 in CKD and PKU in 2026. Second Quarter 2025 Financial Results Cash Position: Cash and cash equivalents were $264.5 million as of June 30, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash and cash equivalents will fund operations into the second half of 2027. License Revenue: No license revenue was recognized during the three and six months ended June 30, 2025. License revenue was $165.0 million for the three and six months ended June 30, 2024. License revenue recognized in 2024 primarily reflects the receipt of an upfront payment of $150.0 million pursuant to the exclusive license agreement with Shionogi & Co., Ltd. (Shionogi) 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. License revenue in 2024 also included the receipt of an upfront payment of $15.0 million pursuant to an exclusive license agreement with Trace Neuroscience, Inc. (Trace) for the rights to a discovery research program targeting UNC13A for the treatment of amyotrophic lateral sclerosis. Research & Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2025, were $28.1 million and $55.7 million, respectively, and $19.5 million and $41.4 million for the same periods in 2024. The increase primarily reflects higher clinical trial and manufacturing expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2025, were $8.4 million and $16.2 million, respectively, and $5.9 million and $12.0 million for the same periods in 2024. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and fees for professional services. Net (Loss) Income: Net loss for the three and six months ended June 30, 2025, was $33.7 million and $66.5 million, respectively, compared to net income of $139.1 million and $106.6 million for the same periods in 2024. Net income for the three and six months ended June 30, 2024 includes $165.0 million in license revenue recognized in connection with the license agreements with Shionogi and Trace. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance oral small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, an oral APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease, and MZE782, an oral SLC6A19 inhibitor advancing through Phase 1 with the potential to treat both chronic kidney disease (CKD) and phenylketonuria (PKU). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow the company on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Amanda Lazaro, 1AB [email protected]
Investor releaseQuarter not tagged2025-05-15Maze Therapeutics Reports First Quarter 2025 Financial Results and Reiterates Upcoming Milestones
GlobeNewswire
Maze Therapeutics Reports First Quarter 2025 Financial Results and Reiterates Upcoming Milestones
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones. “With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.” Key Anticipated Milestones MZE829 for APOL1 Kidney Disease (AKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently availa…Read full documentShow less
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones. “With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.” Key Anticipated Milestones MZE829 for APOL1 Kidney Disease (AKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS). Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies, as well as potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder. MZE782 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers. Maze expects to report initial data, including proof-of-mechanism biomarker results, in the third quarter of 2025. Based on Phase 1 results, Maze plans to initiate two separate Phase 2 clinical trials of MZE782 in CKD and PKU. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents were $294.4 million as of March 31, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash and cash equivalents will fund operations into the second half of 2027. Research & Development (R&D) Expenses: R&D expenses were $27.6 million and $21.9 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher clinical trial expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses were $7.8 million and $6.1 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and professional services fees. Net Loss: Net loss was $32.8 million and $32.5 million for the first quarter of 2025 and 2024, respectively. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact: Amy Bachrodt, Maze Therapeutics [email protected] Media Contact: Dan Budwick, 1AB [email protected]
Investor releaseQuarter not tagged2025-03-31Maze Therapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Highlights
GlobeNewswire
Maze Therapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Highlights
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease (AKD); Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in H2 2025 Raised $140 Million in Gross Proceeds in Upsized IPO in February 2025, Providing Expected Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, cardiovascular and metabolic diseases, today reported financial results for the fourth quarter and year ended December 31, 2024, highlighted recent progress and reiterated upcoming milestones. “Maze has reached a pivotal moment in our journey. On the heels of a successful IPO and with two ongoing clinical-stage programs - MZE829 for AKD and MZE782 for both chronic kidney disease (CKD) and phenylketonuria (PKU) - we are making meaningful progress towards advancing genetic-based medicines with the potential to transform patient care,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to reporting initial Phase 1 data for MZE782 in healthy volunteers in the second half of 2025, which will enable us to prepare to initiate Phase 2 trials in CKD and PKU. We also expect to report initial data from the Phase 2 HORIZON trial of MZE829 in patients with AKD in the first quarter of next year. With a strong financial foundation, highly accomplished team and clear mission, we are well-positioned to execute our milestones and deliver breakthrough medicines to patients.” Pipeline Accomplishments and Upcoming Milestones MZE829 for AKD MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of CKD estimated to affect over one million people in the United States alone. In February 2025, Maze dosed the first patient in the Phase 2 HORIZON Study of MZE829 in patients with AKD. The trial is enrolling a broad population of AKD patients, including those with more severe disease who have nephrotic range proteinuria, focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy and patients with proteinuria and diabetic kidney disease. Maze expects to announce topline data from the Phase 2 trial in the first quarter…Read full documentShow less
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease (AKD); Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in H2 2025 Raised $140 Million in Gross Proceeds in Upsized IPO in February 2025, Providing Expected Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, cardiovascular and metabolic diseases, today reported financial results for the fourth quarter and year ended December 31, 2024, highlighted recent progress and reiterated upcoming milestones. “Maze has reached a pivotal moment in our journey. On the heels of a successful IPO and with two ongoing clinical-stage programs - MZE829 for AKD and MZE782 for both chronic kidney disease (CKD) and phenylketonuria (PKU) - we are making meaningful progress towards advancing genetic-based medicines with the potential to transform patient care,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to reporting initial Phase 1 data for MZE782 in healthy volunteers in the second half of 2025, which will enable us to prepare to initiate Phase 2 trials in CKD and PKU. We also expect to report initial data from the Phase 2 HORIZON trial of MZE829 in patients with AKD in the first quarter of next year. With a strong financial foundation, highly accomplished team and clear mission, we are well-positioned to execute our milestones and deliver breakthrough medicines to patients.” Pipeline Accomplishments and Upcoming Milestones MZE829 for AKD MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of CKD estimated to affect over one million people in the United States alone. In February 2025, Maze dosed the first patient in the Phase 2 HORIZON Study of MZE829 in patients with AKD. The trial is enrolling a broad population of AKD patients, including those with more severe disease who have nephrotic range proteinuria, focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy and patients with proteinuria and diabetic kidney disease. Maze expects to announce topline data from the Phase 2 trial in the first quarter of 2026. In October 2024, Maze reported positive Phase 1 results for MZE829 in healthy volunteers, which demonstrated that MZE829 was well tolerated at single doses up to 480 mg and multiple doses up to 350 mg daily over seven days, with dose-proportional pharmacokinetics and low variability. The observed half-life of approximately 15 hours supports once-daily dosing of MZE829. MZE782 in CKD and PKU MZE782 is an oral small molecule targeting the solute transporter SLC6A19, with potential to be a first-in-class treatment for approximately five million U.S. patients with CKD who have inadequate responses to currently available CKD therapies, as well as those with PKU, an inherited metabolic disorder. In September 2024, Maze initiated a Phase 1 clinical trial of MZE782 in healthy volunteers. Maze expects to report initial data, including proof-of-mechanism biomarkers, in the second half of 2025. Based on Phase 1 results, Maze plans to initiate two parallel Phase 2 clinical trials of MZE782 in CKD and PKU. Corporate Highlights In February 2025, Maze completed an upsized IPO, raising approximately $140 million in gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, through the sale of 8,750,000 shares at $16.00 per share. In November 2024, Maze closed an oversubscribed $115 million Series D financing co-led by Frazier Life Sciences and Deep Track Capital, with participation from Janus Henderson Investors and Logos Capital. Approximately $40 million of the $115 million represented the conversion of previously issued convertible notes held by existing investors. Combined gross proceeds of approximately $255 million from the two financings are expected to provide runway into the second half of 2027, supporting completion of Phase 2 clinical trials for MZE829 in AKD and MZE782 in CKD and PKU, as well as continued advancement of additional preclinical programs. Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash and cash equivalents were $196.8 million as of December 31, 2024, compared to $29.2 million as of December 31, 2023. Maze expects its current cash and cash equivalents, which includes proceeds from its February 2025 IPO, will fund operations into the second half of 2027. License Revenue: License revenue was $167.5 million for the year ended December 31, 2024, compared to none for the year ended December 31, 2023. The increase was primarily due to the receipt of a one-time upfront payment of $150.0 million in May 2024 under the license agreement with Shionogi & Co., Ltd. (Shionogi) for the development of MZE001 in Pompe disease. No license revenue was recognized for the fourth quarter of 2024 and 2023. Research & Development (R&D) Expenses: R&D expenses were $22.2 million for the fourth quarter of 2024 and $83.5 million for the year ended December 31, 2024, compared to $16.0 million for the fourth quarter of 2023 and $73.9 million for the year ended December 31, 2023. This year-over-year increase primarily reflects higher clinical trial expenses for MZE829 and MZE782 as well as for preclinical studies for MZE782. General & Administrative (G&A) Expenses: G&A expenses were $7.5 million for the fourth quarter of 2024 and $26.4 million for the year ended December 31, 2024, compared to $7.0 million for the fourth quarter of 2023 and $24.6 million for the year ended December 31, 2023. This year-over-year increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, partially offset by lower expenses for professional services. Net (Loss) Income: Net loss was $29.6 million for the fourth quarter of 2024 and net income was $52.2 million for the year ended December 31, 2024, compared to net loss of $26.6 million for the fourth quarter of 2023 and net loss of $100.4 million for the year ended December 31, 2023. Net income for the year ended December 31, 2024 includes $167.5 million in license revenue recognized under various license agreements, including the exclusive license agreement with Shionogi. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 31, 2025, and the company’s annual and quarterly reports and other filings filed from time to time with the SEC. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and Maze undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Corporate Contact: Jillian Connell, Maze Therapeutics [email protected] (650) 850-5080 Media Contact: Dan Budwick, 1AB [email protected]

