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Maze Therapeutics (Nasdaq: MAZE) posts positive Phase 2 MZE829 data and ends 2025 with $360M cash

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Maze Therapeutics reported a pivotal year, combining strong clinical progress with a fortified balance sheet. The company announced positive Phase 2 HORIZON data for MZE829 in APOL1-mediated kidney disease, showing a 35.6% mean proteinuria reduction at week 12 and no serious treatment-related safety issues, and plans to advance the drug into a pivotal program.

Maze is also preparing two Phase 2 proof-of-concept trials for MZE782 in phenylketonuria and chronic kidney disease in 2026, and recorded a $20 million milestone from partner Shionogi tied to the Phase 2 ESPRIT trial of Pompe candidate MZE001. Cash, cash equivalents and marketable securities reached $360.0 million as of December 31, 2025, providing expected runway into 2028.

For 2025, Maze reported a net loss of $131.1 million as it increased R&D spending to $108.4 million and G&A to $34.5 million, compared with prior-year license revenue of $167.5 million that had produced net income. The company also strengthened governance by appointing BridgeBio founder and CEO Neil Kumar to its Board of Directors, with an equity grant vesting over three years.

Positive

  • First clinical proof-of-concept in broad APOL1-mediated kidney disease: Phase 2 HORIZON data for MZE829 showed a 35.6% mean proteinuria reduction at week 12 with no serious treatment-related adverse events, supporting advancement into a pivotal program.
  • Strengthened financial position and runway: Cash, cash equivalents and marketable securities rose to $360.0 million as of December 31, 2025, and the company now expects its current resources to fund operations into 2028 under its stated business plan.

Negative

  • None.

Insights

Phase 2 data de-risks Maze’s lead kidney program and supports pivotal planning.

Maze Therapeutics delivered its first clinical proof-of-concept in broad APOL1-mediated kidney disease with MZE829. In the Phase 2 HORIZON trial, treatment produced a 35.6% mean reduction in proteinuria at week 12 and half of patients reached at least a 30% uACR decline, a clinically meaningful benchmark cited by external experts.

Subgroups showed deeper responses, including a 61.8% mean uACR reduction in severe FSGS and 48.6% in non-diabetic AMKD. Importantly, no serious or severe treatment-related adverse events were observed, with mainly mild headaches and diarrhea. This tolerability profile is encouraging for chronic kidney disease, where long-term therapy is expected.

Maze plans to advance MZE829 into a pivotal program while continuing HORIZON enrollment, indicating confidence in both efficacy and safety. Combined with planned Phase 2 trials for MZE782 in PKU and CKD during 2026, the company now has multiple mid-stage assets that could generate additional data catalysts as outlined in its current development plans.

Cash of $360M and a Shionogi milestone support an expanded R&D push.

Maze ended December 31, 2025 with $360.0 million in cash, cash equivalents and marketable securities, up from $196.8 million a year earlier, and now expects its cash runway to extend into 2028. This reflects prior licensing economics and disciplined treasury management.

Operationally, R&D spending rose to $108.4 million in 2025 and G&A to $34.5 million, driving a net loss of $131.1 million versus prior-year net income that benefited from $167.5 million in license revenue. The newly earned $20 million milestone from Shionogi, and eligibility for up to $585.0 million in future milestones plus tiered royalties, provides a non-dilutive funding avenue tied to MZE001.

The appointment of Neil Kumar as a Class I director, with an option grant for up to 36,000 shares or a $750,000 grant-date fair value vesting monthly over 36 months, adds experienced company-building expertise as Maze scales its pipeline and infrastructure under its current strategy.

0001842295false00018422952026-03-242026-03-24

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 24, 2026

 

 

Maze Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-42490

82-2635018

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

171 Oyster Point Blvd., Suite 300

 

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 650 850-5070

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock - par value $0.001 per share

 

MAZE

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 2.02 Results of Operations and Financial Condition.

On March 25, 2026, Maze Therapeutics Inc. (the “Company”) issued a press release reporting its financial results for the fourth quarter and year ended December 31, 2025. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Section 11 or 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference into any filing by the Company under the Exchange Act or the Securities Act, whether made before or after the date hereof, except as expressly set forth by reference in such filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 24, 2026, the Board of Directors (the “Board”) of the Company appointed Neil Kumar as a Class I director, effective March 27, 2026 (the “Appointment Date”). Dr. Kumar is currently a co-founder and the Chief Executive Officer of BridgeBio Pharma, Inc., where he has worked since April 2015. Dr. Kumar has also served as the Chief Executive Officer of Eidos Therapeutics, Inc., a clinical-stage biopharmaceutical company, and a member of Eidos Therapeutics’ board of directors since March 2016. Dr. Kumar served as Chief Executive Officer and President of BridgeBio Oncology Therapeutics, Inc. from August 2016 to April 2024. Dr. Kumar served as the interim vice president of business development at MyoKardia, Inc. (acquired by Bristol Myers Squibb), a clinical-stage biopharmaceutical company, from 2012 to 2014. Prior to that, Dr. Kumar served as a principal at Third Rock Ventures, a venture capital firm, from 2011 to 2014. Before joining Third Rock Ventures, he served as an associate principal at McKinsey & Company, a worldwide management consulting firm, from 2007 to 2011. Dr. Kumar has served as a member of the board of directors of BridgeBio Pharma, Inc. since April 2015, BridgeBio Oncology Therapeutics, Inc. since August 2016, LianBio since October 2019, and as executive chair of the board of managers of GondolaBio, LLC since August 2024. He received his B.S. and M.S. degrees in chemical engineering from Stanford University and received his Ph.D. in chemical engineering from the Massachusetts Institute of Technology. Dr. Kumar’s qualifications to serve on our Board of Directors include his extensive experience as an executive officer of biotechnology companies.

In connection with Dr. Kumar’s appointment as a non-employee director on the Board, he will receive a pro rata portion of the $40,000 annual retainer for service as a director for the remaining portion of the year, in accordance with the Company’s existing compensation policy for non-employee directors. In addition, the Board granted to Dr. Kumar, effective as of the Appointment Date, an option to purchase the lesser of 36,000 shares of the Company’s common stock (the “Option Award”) or that number of shares of the Company’s common stock resulting in the option having a grant date fair value (as determined pursuant to as computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718) of $750,000 as of the Appointment Date, with 1/36th of the shares underlying the Option Award vesting and becoming exercisable on each monthly anniversary of the Appointment Date, subject to his continued service to the Company.

Except as described above, there are no arrangements or understandings between Dr. Kumar and any other persons, pursuant to which Dr. Kumar was selected as a member of the Board. No family relationships exist among any of the Company’s directors or executive officers and Dr. Kumar. Dr. Kumar does not have any direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

Item 7.01 Regulation FD.

On March 25, 2026, the Company issued a press release announcing topline data from its Phase 2 clinical trial of MZE829 in patients with APOL1-mediated kidney disease. The full text of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section or Section 11 or 12(a)(2) of the Securities Act, nor shall it be deemed incorporated by reference into any filing by the Company under the Exchange Act or the Securities Act, whether made before or after the date hereof, except as expressly set forth by reference in such filing.


Item 9.01 Financial Statements and Exhibits.

 

Exhibit

Number

Description

99.1

99.2

Press Release announcing financial results, dated March 25, 2026.

Press Release announcing MZE829 data, dated March 25, 2026.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

 

 

Date:

March 25, 2026

By:

/s/ Courtney Phillips

 

 

 

Courtney Phillips

General Counsel and Corporate Secretary

 


Exhibit 99.1

img92905542_0.jpg

 

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., Mar. 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

abachrodt@mazetx.com

Media Contact:

Amanda Lazaro, 1AB Media

Amanda@1ABMedia.com


 

Maze Therapeutics, Inc.

Select Condensed Financial Information

(in thousands, except share and per share amounts)

(unaudited)

 

Condensed Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended

 

 

Year ended

 

 

December 31,

 

 

December 31,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

License revenue

$

 

 

$

 

 

$

 

 

$

167,500

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

   Research and development

 

27,570

 

 

 

22,216

 

 

 

108,448

 

 

 

83,496

 

   General and administrative

 

10,489

 

 

 

7,510

 

 

 

34,451

 

 

 

26,418

 

      Total operating expenses

 

38,059

 

 

 

29,726

 

 

 

142,899

 

 

 

109,914

 

(Loss) income from operations

 

(38,059

)

 

 

(29,726

)

 

 

(142,899

)

 

 

57,586

 

Interest and other income, net

 

3,491

 

 

 

1,516

 

 

 

11,779

 

 

 

4,654

 

Change in fair value of convertible promissory notes

 

 

 

 

(1,644

)

 

 

 

 

 

(8,837

)

(Loss) income before income tax benefit (expense)

$

(34,568

)

 

$

(29,854

)

 

$

(131,120

)

 

$

53,403

 

Income tax benefit (expense)

 

 

 

 

275

 

 

 

 

 

 

(1,172

)

Net (loss) income

$

(34,568

)

 

$

(29,579

)

 

$

(131,120

)

 

$

52,231

 

Net (loss) income attributable to common stockholders, basic and diluted

$

(34,568

)

 

$

(44,551

)

 

$

(131,120

)

 

$

3,405

 

Net (loss) income per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

   Basic

$

(0.65

)

 

$

(18.32

)

 

$

(3.05

)

 

$

1.42

 

   Diluted

$

(0.65

)

 

$

(18.32

)

 

$

(3.05

)

 

$

1.25

 

Weighted-average shares used in computing net (loss) income per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

   Basic

 

53,395,691

 

 

 

2,431,764

 

 

 

42,976,024

 

 

 

2,396,094

 

   Diluted

 

53,395,691

 

 

 

2,431,764

 

 

 

42,976,024

 

 

 

2,730,299

 

 

 

Condensed Balance Sheet Data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

December 31,

 

 

 

 

 

 

2025

 

 

2024

 

Cash, cash equivalents and marketable securities

 

 

 

 

$

360,031

 

 

$

196,812

 

Total assets

 

 

 

 

$

397,127

 

 

$

240,542

 

Total liabilities

 

 

 

 

$

42,161

 

 

$

43,638

 

Total redeemable convertible preferred stock

 

 

 

 

$

 

 

$

508,087

 

Total stockholders’ equity (deficit)

 

 

 

 

$

354,966

 

 

$

(311,183

)

 


Exhibit 99.2

img93829063_0.jpg

 

Maze Therapeutics Announces Positive Topline Data from Phase 2 HORIZON Trial of MZE829 Demonstrating the First Clinical Proof-of-Concept in Patients with Broad APOL1-Mediated Kidney Disease

– At week 12, treatment with MZE829 resulted in a 35.6% mean uACR reduction in broad AMKD patients, 50% of the patients achieved a greater than 30% reduction in uACR, and treatment was well-tolerated –

– The subgroup of AMKD patients with FSGS that were treated with MZE829 showed a 61.8% mean reduction in uACR –

– Treatment of non-diabetic AMKD patients with MZE829 led to a clinically meaningful mean reduction in uACR from baseline of 48.6% –

– Results provide first clinical proof-of-concept in genetically defined, broad AMKD population, including patients with moderate proteinuria and diabetes –

– Maze plans to advance MZE829 to a pivotal program –

– Maze to host investor conference call and webcast today at 8:00 am EDT –

SOUTH SAN FRANCISCO, Calif., Mar. 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 announced positive topline data from the Phase 2 HORIZON trial of MZE829, an oral, small molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD). 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. Maze expects to continue enrollment in the HORIZON trial and to advance MZE829 into a pivotal program in patients with AMKD.

“We are pleased to show initial promising proof of concept for MZE829, an oral precision medicine that was designed to treat the underlying cause of AMKD by uniquely inhibiting both pore formation and channel function in the podocyte,” said Harold Bernstein, M.D., Ph.D., president of R&D and chief medical officer of Maze. “Based on the data shown today, as well as genetics data derived through our Compass platform, we believe that MZE829’s dual mechanism approach has the potential to address the unmet need in AMKD patients. We look forward to meeting with regulators and key scientific leaders to align on a pivotal program in patients with AMKD, and anticipate presenting HORIZON data at a future medical conference.”

 


 

 

 

The HORIZON study is a Phase 2, open-label basket design trial that enrolled patients with broad AMKD carrying the APOL1 high risk genotype, including diabetic and non-diabetic patients and non-diabetic patients with severe focal segmental glomerulosclerosis (FSGS). The primary endpoints of the study are safety and tolerability, and the secondary endpoints are pharmacokinetics and reduction of proteinuria, as measured by urinary albumin-to-creatinine ratio. uACR is a sensitive measure of proteinuria across stages of glomerular kidney disease, particularly in hypertension and diabetes, and has been used to assess the risk of cardiovascular disease. Patients had to be on a stable background therapies for chronic kidney disease (CKD) for at least eight weeks prior to initiating MZE829 treatment. Background therapies included SGLT2 inhibitors and GLP-1 receptor agonists.

For this topline analysis, 15 patients were enrolled in the HORIZON study and all were included in a safety and tolerability analysis. Twelve patients were evaluated for efficacy, i.e., uACR reduction, based on meeting the per protocol compliance threshold. Patients were largely sub-nephrotic at baseline, with 10 patients having a baseline uACR of 300 to 1,000 mg/g. Across all enrolled patients, eight were diagnosed with AMKD without diabetes, of whom five patients had biopsy-confirmed FSGS, and seven were diagnosed with AMKD with diabetes.

Across all evaluated patients, a mean reduction in proteinuria from baseline of 35.6% was observed and 50% of patients achieved at least a 30% reduction in uACR. Reduction in proteinuria was seen throughout the course of the 12-week treatment period. In FSGS patients, 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. MZE829 was well-tolerated across all doses evaluated. No serious adverse events (AEs) or severe treatment-related adverse events (TRAEs) were observed. Within the safety-evaluable population (n=15), the most common TRAEs were headache (n=2) and diarrhea (n=2). There was one early treatment discontinuation due to mild nausea that occurred just prior to the week 12 visit.

“AMKD is a subset of chronic kidney disease with a large unmet need, potentially affecting over one million patients in the United States alone and millions more globally,” said Kate Bramham, M.B.B.S., Ph.D., consultant nephrologist at King’s College Hospital, senior clinical lecturer at King’s College London, and HORIZON steering committee member. “APOL1 risk variants are linked to earlier disease onset and accelerated disease progression, with patients initiating dialysis an average of 10 years earlier than non-APOL1 CKD patients and progressing rapidly to end-stage kidney disease, despite treatment with available therapies. A 30% uACR reduction is strongly correlated with a 10-year delay in progression to end-stage kidney disease and is widely recognized as a clinically meaningful threshold. MZE829 has the potential to be a truly differentiated treatment option to deliver meaningful, much-needed benefit to patients who currently have no options for targeted therapies.”

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 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.

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, MZE782 to treat AMKD 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
abachrodt@mazetx.com 

Media Contact:
Amanda Lazaro, 1AB Media
Amanda@1ABMedia.com 

 

 


FAQ

What key clinical results did Maze Therapeutics (MAZE) report for MZE829 in AMKD?

Maze reported positive Phase 2 HORIZON data for MZE829 in APOL1-mediated kidney disease. At week 12, treatment led to a 35.6% mean reduction in urinary albumin-to-creatinine ratio, with 50% of patients achieving at least a 30% reduction, and no serious treatment-related safety events observed.

How strong is Maze Therapeutics’ (MAZE) cash position and runway after 2025 results?

Maze ended 2025 with $360.0 million in cash, cash equivalents and marketable securities. This compares to $196.8 million a year earlier, and the company now expects its current resources to fund operations into 2028, based on its existing business plan and development priorities.

What were Maze Therapeutics’ (MAZE) 2025 R&D, G&A expenses and net results?

In 2025, Maze’s R&D expenses were $108.4 million and G&A expenses were $34.5 million. The company reported a net loss of $131.1 million, versus net income of $52.2 million in 2024, when $167.5 million in license revenue from Shionogi had been recognized.

What is the status of Maze Therapeutics’ (MAZE) MZE782 and MZE001 programs?

Maze plans two Phase 2 proof-of-concept trials of MZE782 in 2026 for PKU and CKD. For MZE001 in Pompe disease, Maze earned a $20 million milestone from Shionogi after first-patient dosing in the global Phase 2 ESPRIT trial and remains eligible for substantial additional milestones and royalties.

Who was appointed to Maze Therapeutics’ (MAZE) Board and what compensation was granted?

Maze appointed Neil Kumar as a Class I director effective March 27, 2026. He will receive a pro rata portion of the $40,000 annual director retainer and an option to purchase up to 36,000 shares or a grant-date fair value of $750,000, vesting monthly over 36 months.

How did Maze Therapeutics’ (MAZE) partnership with Shionogi impact 2025 financials?

In March 2026, Maze achieved a $20 million milestone from Shionogi related to MZE001’s Phase 2 ESPRIT trial. Previously, in 2024, Maze recorded $167.5 million in license revenue, mainly from a $150.0 million upfront payment under the exclusive license agreement for MZE001.

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1.56B
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Biotechnology
Biological Products, (no Diagnostic Substances)
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United States
SOUTH SAN FRANCISCO