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Maze Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights

(Positive)
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Maze Therapeutics (Nasdaq: MAZE) reported Q1 2026 results and clinical progress. Positive Phase 2 HORIZON data for MZE829 in broad AMKD showed a 35.6% mean proteinuria reduction at week 12, supporting advancement to a pivotal trial planned for 1H 2027, subject to regulatory feedback.

Maze plans two Phase 2 trials of MZE782 in PKU and CKD starting in 2026. Q1 2026 included $20 million in license revenue, net loss of $24.2 million ($0.45/share), and R&D and G&A expenses of $34.1 million and $12.4 million, respectively. Pro forma cash is about $528 million, with runway expected into 2029.

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Positive

  • Phase 2 HORIZON: 35.6% mean uACR reduction in broad AMKD at week 12
  • HORIZON severe FSGS subgroup: 61.8% mean uACR reduction
  • AMKD without diabetes: 48.6% mean uACR reduction with MZE829
  • No serious or severe treatment-related adverse events reported in HORIZON
  • Pivotal MZE829 trial in moderate AMKD without diabetes planned for 1H 2027
  • Two Phase 2 MZE782 trials in PKU and CKD planned to initiate in 2026
  • Q1 2026 license revenue of $20 million vs. none in Q1 2025
  • Net loss narrowed to $24.2 million from $32.8 million year over year
  • Pro forma cash of about $528 million, runway expected into 2029
  • April 2026 equity offering raised approximately $150 million gross
  • $20 million milestone payment received for MZE001 license in April 2026

Negative

  • Q1 2026 R&D expenses rose to $34.1 million from $27.6 million
  • Q1 2026 G&A expenses increased to $12.4 million from $7.8 million
  • Company remains loss-making with Q1 2026 net loss of $24.2 million
  • Registered offering of common stock and pre-funded warrants dilutes existing shareholders

News Market Reaction – MAZE

+4.58%
2 alerts
+4.58% Session close to close
$1.42B Market Cap
0.0x Rel. Volume

In the May 13 session, MAZE gained 4.58%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combined Q1 2026 financials with detailed HORIZON Phase 2 results and plans for mu...
Analysis

This announcement combined Q1 2026 financials with detailed HORIZON Phase 2 results and plans for multiple MZE782 trials, supported by pro forma cash of $528 million and runway into 2029. Historically, earnings updates have emphasized expanding trials and strong liquidity but drew mixed market reactions. Investors may focus on uACR reductions of up to 61.8%, rising operating expenses, use of the $200,000,000 ATM capacity, and execution on upcoming Phase 2 initiations.

Key Figures

Cash & securities: $528 million Cash & securities: $362.9 million License revenue: $20.0 million +5 more
8 metrics
Cash & securities $528 million Pro forma cash, cash equivalents and marketable securities including April 2026 offering and milestone
Cash & securities $362.9 million Balance as of March 31, 2026
License revenue $20.0 million Q1 2026 milestone revenue from Shionogi for MZE001
R&D expenses $34.1 million Quarter ended March 31, 2026 (vs. $27.6M in Q1 2025)
G&A expenses $12.4 million Quarter ended March 31, 2026 (vs. $7.8M in Q1 2025)
Net loss $24.2 million ($0.45/share) Quarter ended March 31, 2026 (vs. $32.8M, $1.15/share in Q1 2025)
Mean uACR reduction 35.6% Week 12 mean reduction in uACR in broad AMKD patients (HORIZON Phase 2)
FSGS uACR reduction 61.8% Mean uACR reduction in severe FSGS subgroup (HORIZON Phase 2)

Previous Earnings Reports

5 past events · Latest: Mar 25 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 25 Earnings & pipeline Positive -35.2% Q4 2025 results plus strong MZE829 Phase 2 HORIZON topline data.
Nov 06 Earnings & pipeline Positive -3.5% Q3 2025 results with solid cash, MZE782 Phase 1 data, and trial plans.
Aug 12 Quarterly results Neutral -1.0% Q2 2025 financials showing higher R&D spend and net loss vs prior year.
May 14 Quarterly results Positive +2.1% Q1 2025 results with ample cash and advancing MZE829 and MZE782 trials.
Mar 31 Full-year results Positive -3.6% FY 2024 results, IPO and financing proceeds, and strong license revenue.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases have often been followed by negative price reactions, even when updates emphasized cash runway and clinical progress.

Recent Company History

Over the past year, MAZE earnings updates have consistently paired pipeline progress with sizeable cash balances. Prior reports highlighted advancing MZE829 in the Phase 2 HORIZON trial and planning Phase 2 studies for MZE782 in PKU and CKD, with cash runways extending into 2027–2028. Price reactions to these earnings events were frequently negative, including a -35.24% move on Mar 25, 2026. Today’s Q1 2026 release continues that pattern of strong liquidity and advancing trials, now extending projected runway into 2029.

Key Terms

apol1, uacr, fsgs, phenylketonuria, +4 more
8 terms
apol1 medical
"MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing..."
APOL1 is a human gene that makes a protein involved in blood particle handling; certain inherited changes (variants) in APOL1 substantially increase the risk of chronic kidney disease and kidney failure in affected people. Investors follow APOL1 because diagnostic tests, drugs, and transplant policies that target these variants can create new markets or change patient care decisions—similar to how discovering a common defect in a car part can reshape demand for repairs, warranties and replacement parts.
uacr medical
"mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6%..."
UACR is a lab measure that compares the amount of albumin (a blood protein) found in urine to the amount of creatinine, and it indicates how much protein is leaking from the kidneys. Investors watch UACR because rising or falling values act like a car’s warning light for kidney damage — changes can show whether a therapy is working or a disease is progressing, which influences clinical trial outcomes, regulatory decisions and company value.
fsgs medical
"In patients with severe focal segmental glomerulosclerosis (FSGS), treatment with MZE829 led..."
Focal segmental glomerulosclerosis (FSGS) is a kidney disease in which small sections of the organ’s filtering units become scarred, lowering their ability to remove waste and manage fluids. Investors care because drug candidates, diagnostics, or clinical trial results addressing FSGS can meaningfully affect a biotech or pharmaceutical company’s revenue prospects and regulatory outlook—like fixing a specific engine fault that can restore performance and change a vehicle’s value.
phenylketonuria 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, an inherited metabolic disorder..."
A rare inherited metabolic disorder in which the body cannot break down the amino acid phenylalanine, causing it to build up and potentially damage the brain if not detected and managed. It matters to investors because newborn screening, lifelong dietary management, prescription medical foods, enzyme therapies, and emerging gene or drug treatments create ongoing markets and regulatory milestones that can affect companies’ revenues and valuation. Think of it as a clogged filter that needs special maintenance to prevent harm.
ckd medical
"a first-in-class treatment for the estimated five million U.S. patients with CKD who inadequately respond..."
Chronic kidney disease (CKD) is a long-term condition where the kidneys gradually lose their ability to filter waste and fluids from the blood, like household filters that slowly clog and underperform over time. It matters to investors because CKD drives demand for drugs, medical devices, diagnostics and dialysis services, influences healthcare spending and reimbursement decisions, and creates regulatory or clinical-trial risks and market opportunities across the healthcare sector.
slc6a19 medical
"MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential..."
slc6a19 is the gene that encodes a protein acting like a doorway for certain amino acids, shuttling them across cell membranes in the intestine and kidney so the body can absorb and reuse these building blocks. Investors watch it because changes or drugs that target this transporter can affect nutrient absorption, disease risk, or become the basis for therapies and diagnostics, which can influence a biotech company's value.
pre-funded warrants financial
"registered offering of its common stock and pre-funded warrants for gross proceeds of approximately $150 million..."
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
phase 2 medical
"Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD..."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

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Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD provide proof-of-concept and support advancement into pivotal trial; additional HORIZON data expected in late 2026 or early 2027

Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD on track to initiate in 2026

Strong balance sheet with $528 million in cash, cash equivalents and marketable securities; inclusive of net proceeds from the $150 million registered offering and $20 million MZE001 milestone payment in April 2026; cash runway expected to extend into 2029

SOUTH SAN FRANCISCO, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the first quarter ended March 31, 2026, highlighting recent progress and business updates.

“We continue to execute across our clinical pipeline in 2026, and with positive topline data reported from our Phase 2 HORIZON trial of MZE829 in broad AMKD in the first quarter, we are more confident than ever in our potential to harness the power of genetics to transform the lives of patients,” said Jason Coloma, Ph.D., chief executive officer of Maze. “Looking ahead to the rest of the year, we remain on track to initiate a Phase 2 trial of MZE782 in PKU around the middle of this year with topline data expected in 2027, and an additional Phase 2 study is expected to initiate in CKD in the second half of this year. We also look forward to reporting additional results from the HORIZON study in late 2026 or early 2027, and to advancing MZE829 into a pivotal trial in moderate AMKD patients without diabetes, including those with FSGS. With a strong balance sheet and expected cash runway into 2029, we continue to focus on clinical execution and pivotal study preparation.”

Program Progress and Anticipated Milestones

MZE829 for APOL1-Mediated Kidney Disease (AMKD)

MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone.

  • In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD, representing the first-ever clinical proof-of-concept data in this genetically-defined, broad AMKD population. The results demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12 in broad AMKD patients, with 50% of patients achieving a greater than 30% reduction in uACR. In patients with severe focal segmental glomerulosclerosis (FSGS), treatment with MZE829 led to a mean reduction in uACR of 61.8%. In patients with AMKD without diabetes, treatment with MZE829 resulted in a clinically meaningful mean reduction in uACR of 48.6%. In patients with AMKD with diabetes, five patients were evaluable per protocol for efficacy, with two patients achieving at least a 30% reduction in uACR. No serious adverse events or severe treatment-related adverse events were observed.
  • Based on the topline results from HORIZON, Maze plans to initiate a pivotal trial in patients with moderate AMKD without diabetes, including those with FSGS, in the first half of 2027, subject to regulatory feedback.

MZE782 for Phenylketonuria (PKU) and CKD

MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class treatment for the estimated five million U.S. patients with CKD who inadequately respond to currently available CKD therapies.

  • Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU and proteinuria reduction in CKD by mid-2026 and in the second half of 2026, respectively. Topline data from the PKU Phase 2 trial is expected in 2027.

Recent Corporate Highlights

  • In April 2026, Maze completed a registered offering of its common stock and pre-funded warrants for gross proceeds of approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses payable by Maze.

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $362.9 million as of March 31, 2026, compared to $360.0 million as of December 31, 2025. Maze expects that its cash, cash equivalents and marketable securities as of March 31, 2026, together with the proceeds from the registered offering completed in April 2026 and a $20 million milestone payment received from Shionogi & Co., Ltd. in April 2026, will fund operations into 2029 based on its current business plan.

License Revenue: License revenue was $20.0 million for the quarter ended March 31, 2026. No license revenue was recognized for the quarter ended March 31, 2025. License revenue recognized in the first quarter of 2026 reflects the achievement of a milestone pursuant to the exclusive license agreement with Shionogi & Co., Ltd. for the rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor that aims to address Pompe disease by limiting disease-causing glycogen buildup.

Research & Development (R&D) Expenses: R&D expenses were $34.1 million and $27.6 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher clinical trial expenses for the Phase 2 trial of MZE829 in AMKD and start-up activities for the planned Phase 2 trial of MZE782 in PKU and higher personnel-related costs, including non-cash stock-based compensation expense.

General & Administrative (G&A) Expenses: G&A expenses were $12.4 million and $7.8 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and costs for professional services.

Net Loss: Net loss was $24.2 million, or $0.45 per share, and $32.8 million, or $1.15 per share, for the quarter ended March 31, 2026 and 2025, respectively.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow Maze on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

IR/Corporate Contact:
Amy Bachrodt, Maze Therapeutics
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
 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

What were Maze Therapeutics (MAZE) Q1 2026 financial results?

Maze Therapeutics reported a Q1 2026 net loss of $24.2 million, or $0.45 per share. According to Maze Therapeutics, the quarter included $20 million in license revenue, with R&D and G&A expenses of $34.1 million and $12.4 million, respectively.

What did the Phase 2 HORIZON trial of MZE829 show for Maze Therapeutics (MAZE)?

The Phase 2 HORIZON trial of MZE829 in broad AMKD showed a 35.6% mean uACR reduction at week 12. According to Maze Therapeutics, 50% of patients achieved over 30% uACR reduction and no serious or severe treatment-related adverse events were observed.

When will Maze Therapeutics (MAZE) start the pivotal trial of MZE829 in AMKD?

Maze Therapeutics plans to initiate a pivotal trial of MZE829 in moderate AMKD without diabetes, including FSGS, in the first half of 2027. According to Maze Therapeutics, this timing is subject to regulatory feedback and follows positive Phase 2 HORIZON results.

What are the plans for Maze Therapeutics (MAZE) MZE782 trials in PKU and CKD?

Maze Therapeutics expects to start two Phase 2 proof-of-concept trials of MZE782 in 2026, one in PKU and one in CKD. According to Maze Therapeutics, the PKU study will assess plasma phenylalanine reduction, with topline data anticipated in 2027.

How much cash runway does Maze Therapeutics (MAZE) report after its April 2026 financing?

Maze Therapeutics expects its cash, cash equivalents and marketable securities, plus April 2026 proceeds, to fund operations into 2029. According to Maze Therapeutics, pro forma cash totals about $528 million, including a $150 million registered offering and $20 million milestone payment.

What was the impact of the Shionogi milestone on Maze Therapeutics (MAZE) Q1 2026 results?

Maze Therapeutics recognized $20 million in license revenue in Q1 2026 from achieving a milestone under its MZE001 agreement with Shionogi. According to Maze Therapeutics, this milestone relates to an exclusive license for an investigational GYS1 inhibitor targeting Pompe disease.

How does the April 2026 $150 million offering affect Maze Therapeutics (MAZE) shareholders?

Maze Therapeutics raised about $150 million in gross proceeds through a registered offering of common stock and pre-funded warrants. According to Maze Therapeutics, these funds strengthen the balance sheet but issuing equity and warrants increases share count, diluting existing shareholders’ ownership percentages.