Maze Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 9 November 2026: press release. Guidance figures: 4 kept. The quarter’s numbers.

Key takeaways

Net loss widened year on year: The company reported a third-quarter net loss of $48.0 million, or $0.79 per share, against $30.1 million, or $0.66 per share, a year earlier. The nine-month net loss was $116.9 million, or $2.02 per share. Source
HORIZON enrollment completed above target: Enrollment in the Phase 2 HORIZON trial of MZE829 is complete, with more than 50 patients across three cohorts. The company said this exceeded the 10-15 patients per cohort target. Source
Final HORIZON data moved to early 2027: Final data are expected in early 2027 for AMKD without diabetes, AMKD with diabetes, and AMKD with FSGS. The prior quarter had given a window of late 2026 or early 2027. Source
CKD Phase 2 start on track for H1 2027: A Phase 2 proof-of-concept trial of MZE782 in CKD, measuring proteinuria reduction, is planned to start in the first half of 2027. Management described this as on track. Source
R&D rose on MZE829 and MZE782 work: R&D expenses were $40.2 million in the quarter, against $25.2 million a year earlier. The company attributed the increase to MZE829 and MZE782 clinical development and higher personnel costs, including stock-based compensation. Source
Cash declined from second quarter: Cash, cash equivalents and marketable securities were $477.0 million at September 30, 2026. That compares with $494.9 million at June 30, 2026 and $360.0 million at December 31, 2025. Source
Cash expected to fund operations into 2029: Management said current cash, cash equivalents and marketable securities will fund operations into 2029 based on the current business plan, unchanged from the prior quarter. Source

“Completing enrollment in HORIZON with more than 50 patients across three cohorts marks an important milestone for MZE829”
Jason Coloma, Ph.D., chief executive officer of Maze

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	Into 2029	into 2029	Kept
MZE829 HORIZON final data Source	Early 2027	early 2027
MZE829 pivotal trial start Source	First half of 2027	first half of 2027	Kept
MZE782 CKD Phase 2 start Source	First half of 2027	first half of 2027	Kept
MZE782 CIPheR topline data Source	2027	2027	Kept

What changed from last quarter

Ended: HORIZON enrollment, which the prior quarter described as ongoing, is now complete with more than 50 patients across three cohorts.
New: Two directors were added to the Board of Directors in August 2026. Source
New: The company delivered an oral presentation of previously reported HORIZON data at ASN Kidney Week in October 2026, and presented two MZE782 preclinical posters there. Source
Guidance kept: The MZE782 CKD Phase 2 trial remains on track to start in the first half of 2027, the same timing as the prior quarter.
Guidance kept: Cash runway into 2029 is unchanged from the prior quarter, based on the current business plan.

Quarterly results and other income

Net loss widened year on year: The company reported a third-quarter net loss of $48.0 million, or $0.79 per share, against $30.1 million, or $0.66 per share, a year earlier. The nine-month net loss was $116.9 million, or $2.02 per share. Source
Shionogi milestone drove nine-month revenue: No license revenue was recognized in the third quarter. The nine-month total of $20.0 million reflects a first-quarter 2026 milestone under the Shionogi license for MZE001, a GYS1 inhibitor for Pompe disease. Source
Other income offset part of expenses: Interest and other income, net, was $4.5 million in the quarter, and interest expense was $1.0 million. Total other income, net, was $3.5 million. Source

MZE829 development in AMKD

HORIZON enrollment completed above target: Enrollment in the Phase 2 HORIZON trial of MZE829 is complete, with more than 50 patients across three cohorts. The company said this exceeded the 10-15 patients per cohort target. Source
Final HORIZON data moved to early 2027: Final data are expected in early 2027 for AMKD without diabetes, AMKD with diabetes, and AMKD with FSGS. The prior quarter had given a window of late 2026 or early 2027. Source
Interim uACR reductions reported earlier: Previously reported interim HORIZON data showed uACR reductions at 12 weeks among 12 efficacy-evaluable patients. The company presented these data at ASN Kidney Week in October 2026. Source
Pivotal trial planned for first half 2027: Maze plans to start a pivotal trial of MZE829 in the first half of 2027. The plan depends on regulatory feedback, and management said the final HORIZON results will inform the pivotal program. Source

“We are encouraged by the previously reported clinically meaningful uACR reductions demonstrated among 12 efficacy-evaluable patients in an interim data cut from HORIZON”
Jason Coloma, Ph.D., chief executive officer of Maze

MZE782 in PKU and CKD

CIPheR enrollment continues in PKU: Enrollment continues in the Phase 2 CIPheR trial of MZE782 in PKU, which measures reduction in plasma phenylalanine. Topline data are expected in 2027. Source
CKD Phase 2 start on track for H1 2027: A Phase 2 proof-of-concept trial of MZE782 in CKD, measuring proteinuria reduction, is planned to start in the first half of 2027. Management described this as on track. Source
Preclinical CKD posters at ASN: In October 2026 the company presented two posters on preclinical research into SLC6A19 inhibition as a potential CKD approach, at ASN Kidney Week. Source

Operating expenses and spending drivers

Operating expenses rose on R&D and G&A: Total operating expenses were $51.5 million for the quarter, against $33.0 million a year earlier. With no license revenue in the quarter, the loss from operations was also $51.5 million. Source
R&D rose on MZE829 and MZE782 work: R&D expenses were $40.2 million in the quarter, against $25.2 million a year earlier. The company attributed the increase to MZE829 and MZE782 clinical development and higher personnel costs, including stock-based compensation. Source
G&A rose on personnel and professional fees: G&A expenses were $11.3 million in the quarter, against $7.8 million a year earlier. The increase reflects personnel costs, including non-cash stock-based compensation, and professional services. Source

“look forward to reporting the complete HORIZON dataset in early 2027, and plan to use these results to inform our pivotal program”
Jason Coloma, Ph.D., chief executive officer of Maze

Cash, runway and balance sheet

Cash declined from second quarter: Cash, cash equivalents and marketable securities were $477.0 million at September 30, 2026. That compares with $494.9 million at June 30, 2026 and $360.0 million at December 31, 2025. Source
Cash expected to fund operations into 2029: Management said current cash, cash equivalents and marketable securities will fund operations into 2029 based on the current business plan, unchanged from the prior quarter. Source
Quarter-end balance sheet totals: At September 30, 2026, total assets were $511.6 million, total liabilities were $83.0 million, and stockholders' equity was $428.5 million. Source

Platform, board and MZE782 potential

Two directors added in August: In August 2026 the company appointed Paula Johnson, M.D., M.P.H., and Sophie Kornowski, Pharm.D., M.B.A., to its Board. The company said both bring decades of biopharmaceutical industry and clinical experience. Source
Compass platform drives target selection: The company describes its Compass platform as pursuing genetically validated targets to discover small molecule programs with first- or best-in-class potential. Source
MZE782 potential in PKU and CKD: Management describes MZE782 as potentially best-in-class for PKU and as a first-in-class treatment for CKD patients who inadequately respond to currently available therapies. Source

Coming up, as management said on 9 November 2026

Final HORIZON data in early 2027: The company expects to announce final HORIZON data for MZE829 across three AMKD subgroups in early 2027. Source
Pivotal MZE829 trial start: Management plans to initiate a pivotal MZE829 trial in the first half of 2027, subject to regulatory feedback. Source
MZE782 CKD Phase 2 trial start: A Phase 2 proof-of-concept trial of MZE782 evaluating proteinuria reduction in CKD is planned to start in the first half of 2027. Source
CIPheR topline data in 2027: Topline data from the Phase 2 CIPheR trial of MZE782 in PKU are expected in 2027, after enrollment completes. Source

Figures management reported

Figure	Reported
R&D expenses, nine months 2026 Source	$109.3 million
HORIZON enrollment Source	More than 50 patients across three cohorts, complete

Risks management discussed

Regulatory: The timing of the MZE829 pivotal trial depends on regulatory feedback that the company has not yet received. Source

Earlier plans management reported on

Met: Management said HORIZON enrollment exceeded the 10-15 patients per cohort target it had previously guided. Source
On track: The company described the CKD Phase 2 initiation as on track for the first half of 2027. Source
Not stated: The prior quarter guided to HORIZON data in late 2026 or early 2027. The current quarter gives early 2027 and does not describe the change. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Maze Therapeutics Reports Third Quarter 2026 Financial Results and Recent Highlights

Enrollment completed in Phase 2 HORIZON trial of MZE829; data from all three cohorts expected in early 2027

Enrollment ongoing in Phase 2 CIPheR trial of MZE782 in PKU; topline data expected in 2027

Phase 2 trial of MZE782 in CKD on track for H1 2027 initiation

Strong balance sheet with $477 million in cash, cash equivalents and marketable securities as of September 30, 2026 supports expected runway into 2029

SOUTH SAN FRANCISCO, Calif., November 9, 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 third quarter ended September 30, 2026, highlighting recent progress and business updates.

“Completing enrollment in HORIZON with more than 50 patients across three cohorts marks an important milestone for MZE829 and exceeded our target enrollment of 10-15 patients per cohort,” said Jason Coloma, Ph.D., chief executive officer of Maze. “HORIZON gives us the opportunity to generate a robust dataset across three distinct AMKD patient populations, including patients with and without diabetes and those with FSGS, and provide a comprehensive view of MZE829’s potential as a best-in-class therapy for a broad AMKD population, supported by its differentiated dual mechanism of action. We are encouraged by the previously reported clinically meaningful uACR reductions demonstrated among 12 efficacy-evaluable patients in an interim data cut from HORIZON, look forward to reporting the complete HORIZON dataset in early 2027, and plan to use these results to inform our pivotal program. We are also making strong progress with MZE782 with respect to both continued enrollment in the Phase 2 CIPheR trial in PKU and advancement of our plans to initiate a Phase 2 CKD trial in the first half of 2027.”

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.

Enrollment for the Phase 2 HORIZON trial evaluating MZE829 in more than 50 patients in a broad AMKD population is complete and exceeded the target enrollment range of 10-15 patients per cohort as previously guided.

Previously reported interim HORIZON data demonstrated clinically meaningful uACR reductions at 12 weeks among 12 efficacy-evaluable AMKD patients.

In early 2027, Maze expects to announce the final data from HORIZON which is designed to evaluate the potential of MZE829 to treat each of three AMKD patient subgroups: AMKD without diabetes, AMKD with diabetes and AMKD with focal segmental glomerulosclerosis (FSGS).

Subject to regulatory feedback, Maze plans to initiate a pivotal trial in the first half of 2027.

In October 2026, Maze delivered an oral presentation of previously reported data from the Phase 2 HORIZON trial at the American Society of Nephrology (ASN) Kidney Week, held October 21 - 25, 2026, in Denver, Colorado.

MZE782 for Phenylketonuria (PKU) and CKD

MZE782 is an oral, small molecule targeting the solute transporter SLC6A19, which, in previously reported Phase 1 results, demonstrated a 42-fold increase in urinary phenylalanine excretion in healthy volunteers and a dose-dependent eGFR dip suggestive of kidney-protective potential. These data along with other preclinical supporting evidence suggest that MZE782 has the potential to be both 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.

Enrollment is ongoing in the Phase 2 CIPheR proof-of-concept trial of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU. Topline data from the trial is expected in 2027.

Maze plans to initiate a Phase 2 proof-of-concept trial of MZE782 evaluating proteinuria reduction in CKD in the first half of 2027.

In October 2026, Maze presented two posters highlighting preclinical research further supporting MZE782’s mechanism of SLC6A19 inhibition as a potential therapeutic approach for CKD at ASN Kidney Week.

Recent Corporate Highlights

In August 2026, Maze announced the appointments of Paula Johnson, M.D., M.P.H., and Sophie Kornowski, Pharm.D., M.B.A., to its Board of Directors. Dr. Johnson and Dr. Kornowski each bring decades of biopharmaceutical industry and clinical experience.

Third Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $477.0 million as of September 30, 2026, compared to $360.0 million as of December 31, 2025. Maze expects that its current cash, cash equivalents and marketable securities will fund operations into 2029 based on its current business plan.

License Revenue: No license revenue and $20.0 million in license revenue was recognized for the three and nine months ended September 30, 2026, respectively, and no license revenue was recognized for the same periods in 2025. License revenue recognized in 2026 reflects the achievement of a milestone in the first quarter of 2026 pursuant to the exclusive license agreement with Shionogi & Co., Ltd. for the rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor that aims to address Pompe disease by limiting disease-causing glycogen buildup.

Research & Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2026 were $40.2 million and $109.3 million, respectively, and $25.2 million and $80.9 million for the same periods in 2025. The increase primarily reflects higher expenses related to the progression of our MZE829 and MZE782 clinical development programs and higher personnel-related costs, including non-cash stock-based compensation expense.

General & Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2026 were $11.3 million and $36.8 million, respectively, and $7.8 million and $24.0 million for the same periods in 2025. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and costs for professional services.

Net Loss: Net loss for the three and nine months ended September 30, 2026 was $48.0 million, or $0.79 per share, and $116.9 million, or $2.02 per share, respectively, compared to net loss of $30.1 million, or $0.66 per share, and $96.6 million, or $2.45 per share, for the same periods in 2025.

About Maze Therapeutics

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

Forward Looking Statements

Forward-looking statements notice

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

IR/Corporate Contact:

Argot Partners maze@argotpartners.com

Select Condensed Financial Information

(in thousands, except share and per share amounts)

(unaudited)

	Three Months Ended		Nine Months Ended
	September 30,		September 30,
	2026	2025	2026	2025
Condensed Statements of Operations
License revenue	$ -	$ -	$20,000	$ -
Operating expenses:
Research and development	40,220	25,190	109,308	80,878
General and administrative	11,297	7,775	36,797	23,962
Total operating expenses	51,517	32,965	146,105	104,840
Loss from operations	(51,517)	(32,965)	(126,105)	(104,840)
Other income (expense):
Interest and other income, net	4,523	2,878	11,973	8,288
Interest expense	(975)	-	(2,772)	-
Total other income, net	3,548	2,878	9,201	8,288
Net loss	$(47,969)	$(30,087)	$(116,904)	$(96,552)
Net loss per share, basic and diluted	$(0.79)	$(0.66)	$(2.02)	$(2.45)
Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted	60,864,851	45,779,577	57,944,856	39,464,634

	September 30,	December 31,
	2026	2025
Condensed Balance Sheet Data
Cash, cash equivalents and marketable securities	$476,982	$360,031
Total assets	$511,557	$397,127
Total liabilities	$83,012	$42,161
Total stockholders’ equity	$428,545	$354,966

Contacts
Amanda Lazaro, 1AB Media amanda@1ABMedia.com
Maze Therapeutics, Inc.