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Maze Therapeutics (NASDAQ: MAZE) Q1 2026 loss narrows on milestone revenue

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

Rhea-AI Filing Summary

Maze Therapeutics reported first quarter 2026 results alongside important clinical and financing updates. The company generated $20.0 million in license revenue from a milestone tied to its MZE001 partnership, while R&D and G&A expenses rose to $34.1 million and $12.4 million, respectively.

Net loss narrowed to $24.2 million, or $0.45 per share, from $32.8 million, or $1.15 per share, a year earlier. Cash, cash equivalents and marketable securities were $362.9 million as of March 31, 2026, and the company highlighted a strong balance sheet of $528 million including April financing and milestone proceeds, supporting an expected cash runway into 2029.

Clinically, Maze reported positive topline Phase 2 HORIZON data for MZE829 in APOL1-mediated kidney disease, showing meaningful reductions in proteinuria and no serious treatment-related adverse events, and it plans a pivotal trial in moderate AMKD without diabetes. Phase 2 proof-of-concept trials for MZE782 in PKU and CKD are planned to initiate in 2026.

Positive

  • Positive Phase 2 HORIZON data for MZE829: Clinically meaningful reductions in proteinuria in broad AMKD, severe FSGS, and AMKD without diabetes, with no serious treatment-related adverse events, support advancing MZE829 into a pivotal trial in moderate AMKD.
  • Strengthened balance sheet and extended runway: Cash, cash equivalents and marketable securities of $362.9 million as of March 31, 2026, combined with a $150 million registered offering and $20 million milestone payment, support approximately $528 million in liquidity and an expected cash runway into 2029.
  • New revenue from partnering: License revenue of $20.0 million in Q1 2026, versus none a year earlier, reflects a milestone under the Shionogi agreement for MZE001 and diversifies funding beyond equity capital.
  • Narrower quarterly net loss: Net loss improved to $24.2 million, or $0.45 per share, from $32.8 million, or $1.15 per share, in the prior-year quarter while R&D investment increased to support multiple clinical programs.

Negative

  • None.

Insights

Strong Phase 2 data and added cash extend Maze’s clinical runway.

Maze Therapeutics combined encouraging clinical progress with a meaningfully stronger balance sheet in early 2026. Positive Phase 2 HORIZON results for MZE829 in APOL1-mediated kidney disease showed sizable reductions in proteinuria across several subgroups without serious treatment-related adverse events.

The company also outlined 2026 starts for two Phase 2 proof-of-concept trials of MZE782 in PKU and CKD, plus a planned pivotal trial for MZE829 in moderate AMKD in the first half of 2027, subject to regulatory feedback. This deepens the mid-stage pipeline in genetically defined kidney and metabolic diseases.

Financially, $20.0 million in license revenue from the MZE001 milestone and an April registered offering of about $150 million, along with a $20 million milestone payment, support total cash and securities of $528 million and an expected runway into 2029. That runway reduces near-term financing pressure while the company advances multiple Phase 2 and pivotal programs.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
License revenue $20.0 million Quarter ended March 31, 2026; milestone under Shionogi MZE001 agreement
R&D expenses $34.1 million Quarter ended March 31, 2026; up from $27.6 million in 2025
G&A expenses $12.4 million Quarter ended March 31, 2026; up from $7.8 million in 2025
Net loss $24.2 million ($0.45/share) Quarter ended March 31, 2026; improved from $32.8 million ($1.15/share) in 2025
Cash, cash equivalents and marketable securities $362.9 million As of March 31, 2026; compared with $360.0 million at December 31, 2025
Total liquidity including April transactions $528 million Cash, cash equivalents and marketable securities including $150M offering and $20M milestone
Registered offering gross proceeds $150 million April 2026 common stock and pre-funded warrant offering before costs
MZE829 proteinuria reduction in broad AMKD 35.6% mean reduction Phase 2 HORIZON trial, week 12 uACR change in broad AMKD patients
APOL1-mediated kidney disease (AMKD) medical
"MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD"
Apol1-mediated kidney disease (AMKD) is kidney damage driven by inherited changes in the APOL1 gene that substantially increase the risk of chronic kidney disease and faster progression to kidney failure, most often seen in people of West African descent. It matters to investors because these genetic drivers define a clear patient subgroup, shaping demand for targeted tests and therapies, influencing clinical trial design and regulatory strategy, and helping estimate market size—like a faulty blueprint that predicts who will need specific medical solutions.
Phase 2 HORIZON trial medical
"In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD"
proof-of-concept medical
"representing the first-ever clinical proof-of-concept data in this genetically-defined, broad AMKD population"
A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.
phenylketonuria (PKU) medical
"MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a best-in-class therapy for patients with PKU"
A genetic metabolic disorder in which the body cannot break down the amino acid phenylalanine, causing it to build up and potentially damage the brain if untreated; newborn screening and lifelong management are common. Investors care because the condition creates steady demand for diagnostic tests, specialized diets and medical treatments, and because regulatory approvals, reimbursement rules and advances in therapy can materially affect market size and company revenues—think of it like a clogged drain that needs ongoing tools and fixes.
urinary albumin-to-creatinine ratio (uACR) medical
"mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12"
Urinary albumin-to-creatinine ratio (uACR) is a simple urine test that compares the amount of albumin, a common blood protein, to creatinine, a steady waste product, to adjust for urine concentration. It acts like checking how much dye leaks from a pipe relative to the water flow: higher values signal kidney damage or disease. Investors watch uACR because it’s a common clinical endpoint and diagnostic marker that influences drug trial outcomes, regulatory approval, market size, and reimbursement for kidney-related treatments.
cash runway financial
"cash runway expected to extend into 2029"
Cash runway is the amount of time a company can continue operating using its available cash before needing additional funding or generating enough revenue. It’s like a countdown showing how long a business can keep running with its current funds. Knowing the cash runway helps investors assess the company's financial health and whether it has enough resources to reach its goals or needs to find more support soon.
License revenue $20.0 million from $0 in Q1 2025
R&D expenses $34.1 million up from $27.6 million in Q1 2025
General and administrative expenses $12.4 million up from $7.8 million in Q1 2025
Net loss $24.2 million ($0.45/share) improved from $32.8 million ($1.15/share) in Q1 2025
Guidance

Maze expects its cash, cash equivalents and marketable securities as of March 31, 2026, plus April offering and milestone proceeds, will fund operations into 2029.

0001842295false00018422952026-05-122026-05-12

 

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): May 12, 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 May 12, 2026, Maze Therapeutics Inc. (the “Company”) issued a press release reporting its financial results for the first quarter ended March 31, 2026. 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 9.01 Financial Statements and Exhibits.

 

Exhibit

Number

Description

99.1

Press Release announcing financial results, dated May 12, 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:

May 12, 2026

By:

/s/ Courtney Phillips

 

 

 

Courtney Phillips

General Counsel and Corporate Secretary

 


Exhibit 99.1

img92905542_0.jpg

 

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, 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.

img92905542_0.jpg

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.


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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

abachrodt@mazetx.com


img92905542_0.jpg

Media Contact:

Amanda Lazaro, 1AB Media

Amanda@1ABMedia.com


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Maze Therapeutics, Inc.

Select Condensed Financial Information

(in thousands, except share and per share amounts)

(unaudited)

 

Condensed Statements of Operations

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31,

 

 

2026

 

 

2025

 

License revenue

$

20,000

 

 

$

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

   Research and development

 

34,148

 

 

 

27,580

 

   General and administrative

 

12,405

 

 

 

7,821

 

      Total operating expenses

 

46,553

 

 

 

35,401

 

Loss from operations

 

(26,553

)

 

 

(35,401

)

Other income (expense):

 

 

 

 

 

   Interest and other income, net

 

3,211

 

 

 

2,615

 

   Interest expense

 

(866

)

 

 

 

Total other income, net

 

2,345

 

 

 

2,615

 

Net loss

$

(24,208

)

 

$

(32,786

)

Net loss per share, basic and diluted

$

(0.45

)

 

$

(1.15

)

Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted

 

53,897,216

 

 

 

28,628,430

 

 

 

Condensed Balance Sheet Data

 

 

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

2026

 

 

2025

 

Cash, cash equivalents and marketable securities

$

362,938

 

 

$

360,031

 

Total assets

$

419,710

 

 

$

397,127

 

Total liabilities

$

78,009

 

 

$

42,161

 

Total stockholders’ equity

$

341,701

 

 

$

354,966

 

 


FAQ

How did Maze Therapeutics (MAZE) perform financially in Q1 2026?

Maze reported a net loss of $24.2 million, or $0.45 per share, for Q1 2026. This compares with a net loss of $32.8 million, or $1.15 per share, in Q1 2025, reflecting higher expenses but also new license revenue.

What drove Maze Therapeutics’ revenue in the first quarter of 2026?

Maze recorded $20.0 million in license revenue in Q1 2026, up from none a year earlier. This revenue came from achieving a milestone under its exclusive license agreement with Shionogi & Co., Ltd. related to MZE001, an investigational GYS1 inhibitor for Pompe disease.

What is Maze Therapeutics’ cash position and runway after Q1 2026?

Maze held $362.9 million in cash, cash equivalents and marketable securities as of March 31, 2026. Including a $150 million registered offering and a $20 million milestone payment in April, total liquidity is about $528 million, supporting an expected cash runway into 2029.

What were the key clinical results for MZE829 reported by Maze Therapeutics?

In the Phase 2 HORIZON trial, MZE829 produced a 35.6% mean reduction in proteinuria (uACR) in broad AMKD, a 61.8% reduction in severe FSGS, and a 48.6% reduction in AMKD without diabetes, with no serious treatment-related adverse events observed.

What are the upcoming clinical milestones for MZE829 and MZE782 at Maze Therapeutics?

Maze plans a pivotal trial of MZE829 in moderate AMKD without diabetes, including FSGS, in the first half of 2027, subject to regulatory feedback. It also expects to start two Phase 2 proof-of-concept trials of MZE782 in PKU and CKD during 2026, with PKU topline data expected in 2027.

How did Maze Therapeutics’ R&D and G&A expenses change in Q1 2026?

R&D expenses increased to $34.1 million from $27.6 million year over year, mainly from clinical trial and personnel costs. G&A expenses rose to $12.4 million from $7.8 million, driven by higher personnel-related expenses and professional services.

Filing Exhibits & Attachments

2 documents