# EDGAR Filing Document

**Accession Number:** 0001842295
**File Stem:** 0001193125-26-122774
**Filing Date:** 2026-3
**Character Count:** 35638
**Document Hash:** fa1e3ab22faa3cd2a7e63e0068c9ba84
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-122774.hdr.sgml**: 20260325

**ACCESSION NUMBER**: 0001193125-26-122774

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260324

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260325

**DATE AS OF CHANGE**: 20260325

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Maze Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001842295
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42490
- **FILM NUMBER:** 26788359

**BUSINESS ADDRESS:**
- **STREET 1:** 171 OYSTER POINT BOULEVARD, SUITE 300
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080
- **BUSINESS PHONE:** 6508505070

**MAIL ADDRESS:**
- **STREET 1:** 171 OYSTER POINT BOULEVARD, SUITE 300
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080

?xml version='1.0' encoding='ASCII'? 8-K

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

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## FORM 8-K

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**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<br>

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Maze Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-42490 | 82-2635018 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 171 Oyster Point Blvd., Suite 300 |  |  |
| South San Francisco**,** California |  | 94080 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 650 850-5070<br>

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

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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:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock - par value $0.001 per share | MAZE | The Nasdaq Stock Market LLC |

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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. ☐

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## 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.

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## Item 9.01 Financial Statements and Exhibits.

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| | |
|:---|:---|
| **Exhibit**<br>**Number** | **Description** |
| 99.1<br>99.2 | [<u>Press Release announcing financial results, dated March 25, 2026.</u>](maze-ex99_1.htm)<br>[<u>Press Release announcing MZE829 data, dated March 25, 2026.</u>](maze-ex99_2.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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**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.

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| | | | |
|:---|:---|:---|:---|
| Date: | March 25, 2026 | By:  | /s/ Courtney Phillips |
|  |  |  | Courtney Phillips<br>General Counsel and Corporate Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

![img92905542_0.jpg](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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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

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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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

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**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 <u>mazetx.com</u>, or follow the company on <u>LinkedIn</u> and <u>X</u>.

**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

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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

<u>abachrodt@mazetx.com</u>

**Media Contact:**

Amanda Lazaro, 1AB Media

<u>Amanda@1ABMedia.com</u>

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**Maze Therapeutics, Inc.**

**Select Condensed Financial Information**

**(in thousands, except share and per share amounts)**

**(unaudited)**

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| | | | | |
|:---|:---|:---|:---|:---|
| **Condensed Statements of Operations** | **Condensed Statements of Operations** | **Condensed Statements of Operations** | **Condensed Statements of Operations** | **Condensed Statements of Operations** |
|  | **Three months ended** | **Three months ended** | **Year ended** | **Year ended** |
|  | **December 31,** | **December 31,** | **December 31,** | **December 31,** |
|  | **2025** | **2024** | **2025** | **2024** |
| License revenue | $— | $— | $— | $167500 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 27570 | 22216 | 108448 | 83496 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 10489 | 7510 | 34451 | 26418 |
| &nbsp;&nbsp;&nbsp;&nbsp; Total operating expenses | 38059 | 29726 | 142899 | 109914 |
| (Loss) income from operations | (38059) | (29726) | (142899) | 57586 |
| Interest and other income, net | 3491 | 1516 | 11779 | 4654 |
| Change in fair value of convertible promissory notes |  | (1644) |  | (8837) |
| (Loss) income before income tax benefit (expense) | $(34568) | $(29854) | $(131120) | $53403 |
| Income tax benefit (expense) |  | 275 |  | (1172) |
| Net (loss) income | $(34568) | $(29579) | $(131120) | $52231 |
| Net (loss) income attributable to common stockholders, basic and diluted | $(34568) | $(44551) | $(131120) | $3405 |
| Net (loss) income per share attributable to common stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | $(0.65) | $(18.32) | $(3.05) | $1.42 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | $(0.65) | $(18.32) | $(3.05) | $1.25 |
| Weighted-average shares used in computing net (loss) income per share attributable to common stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | 53395691 | 2431764 | 42976024 | 2396094 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | 53395691 | 2431764 | 42976024 | 2730299 |

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| | | |
|:---|:---|:---|
| **Condensed Balance Sheet Data** | **Condensed Balance Sheet Data** | **Condensed Balance Sheet Data** |
|  | **December 31,** | **December 31,** |
|  | **2025** | **2024** |
| Cash, cash equivalents and marketable securities | $360031 | $196812 |
| Total assets | $397127 | $240542 |
| Total liabilities | $42161 | $43638 |
| Total redeemable convertible preferred stock | $— | $508087 |
| Total stockholders' equity (deficit) | $354966 | $(311183) |

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## Exhibit 99.2

**Exhibit 99.2**

![img93829063_0.jpg](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."

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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.

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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

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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<br>abachrodt@mazetx.com

**Media Contact:**<br>Amanda Lazaro, 1AB Media<br>Amanda@1ABMedia.com

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