Maze Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
Maze Therapeutics (Nasdaq: MAZE) reported Q3 2025 results and pipeline updates on November 6, 2025. The company ended Q3 with $383.9 million in cash, cash equivalents and marketable securities and says this funding provides a runway into 2028. Maze reported positive first-in-human Phase 1 data for MZE782 showing dose-dependent increases in 24-hour urinary phenylalanine and glutamine, tolerability across doses, and an initial dose-dependent eGFR dip; two Phase 2 proof-of-concept trials in PKU and CKD are planned for 2026. Enrollment continues in the Phase 2 HORIZON trial of MZE829 with topline data for initial patients expected by the end of Q1 2026. Q3 YTD financials show higher R&D and G&A expense and a net loss of $96.6 million for the nine months ended September 30, 2025.
Maze Therapeutics (Nasdaq: MAZE) ha riportato i risultati del terzo trimestre 2025 e aggiornamenti della pipeline il 6 novembre 2025. L'azienda ha chiuso il terzo trimestre con 383,9 milioni di dollari in contanti, equivalenti di contante e titoli negoziabili e afferma che questa raccolta fornisce una linea di percorrenza fino al 2028. Maze ha riportato dati positivi di prima somministrazione nell'Fase 1 per MZE782 che mostrano aumenti dipendenti dalla dose in 24 ore di fenilalanina urinaria e glutamina, tollerabilità tra le dosi e un iniziale calo dipendente dalla dose dell'eGFR; due studi di fase 2 di proof-of-concept in PKU e CKD sono pianificati per il 2026. L'arruolamento continua nello studio di fase 2 HORIZON di MZE829 con dati principali per i primi pazienti attesi entro la fine del Q1 2026. I dati finanziari YTD del Q3 mostrano maggiori spese in R&D e G&A e una perdita netta di $96,6 milioni per i nove mesi terminati il 30 settembre 2025.
Maze Therapeutics (Nasdaq: MAZE) informó resultados del tercer trimestre de 2025 y actualizaciones de la pipeline el 6 de noviembre de 2025. La compañía terminó el tercer trimestre con 383,9 millones de dólares en efectivo, equivalentes de efectivo y valores negociables y afirma que estos fondos proporcionan una trayectoria hasta 2028. Maze reportó datos positivos de primera en humano de Fase 1 para MZE782 que muestran aumentos dependientes de la dosis en la fenilalanina urinaria y la glutamina de 24 horas, tolerabilidad entre las dosis y una primera caída de la eGFR dependiente de la dosis; se planean dos ensayos de Fase 2 de concepto en PKU y CKD para 2026. El reclutamiento continúa en el ensayo de Fase 2 HORIZON de MZE829 con datos principales para los primeros pacientes esperados para finales de Q1 2026. Las finanzas YTD del Q3 muestran mayores gastos en I+D y G&A y una pérdida neta de $96,6 millones para los nueve meses terminados el 30 de septiembre de 2025.
Maze Therapeutics (Nasdaq: MAZE)는 2025년 11월 6일 2025년 3분기 실적 및 파이프라인 업데이트를 발표했습니다. 회사는 3분기 말 현금, 현금등가물 및 시장성 있는 증권으로 383,9백만 달러를 보유했고 이 자금으로 2028년까지 운용 여유를 제공한다고 밝혔습니다. MZE782에 대한 1상 데이터는 용량 의존적으로 24시간 소변 페닐알라닌 및 글루타민이 증가하고, 용량 간 내약성 및 초기 용량 의존적 eGFR 감소를 보였으며, PKU와 CKD의 두 개의 2상 개념증명 시험이 2026년에 계획되어 있습니다. 2상 HORIZON 시험에 대한 MZE829의 등록은 계속 진행 중이며 초기 환자에 대한 topline 데이터는 2026년 1분기 말까지 기대됩니다. 3분기 누계 재무는 R&D 및 G&A 비용 증가와 2025년 9월 30일 종료된 9개월간 순손실 $96,6 million를 보여줍니다.
Maze Therapeutics (Nasdaq : MAZE) a publié les résultats du T3 2025 et les mises à jour du pipeline le 6 novembre 2025. L'entreprise a terminé le T3 avec 383,9 millions de dollars en liquidités, équivalents de liquidités et valeurs mobilières disponibles à la vente et indique que ce financement offre une marge de manœuvre jusqu'en 2028. Maze a présenté des données positives de première administration chez l'humain de la phase 1 pour MZE782 montrant des augmentations dépendantes de la dose en phénylalanine urinaire et en glutamine sur 24 heures, une tolérance entre les doses et une première baisse de l'eGFR dépendante de la dose ; deux essais de phase 2 proof-of-concept en PKU et CKD sont prévus pour 2026. Le recrutement se poursuit dans l'essai de phase 2 HORIZON de MZE829 avec des données de référence pour les premiers patients attendues d'ici la fin du Q1 2026. Les finances YTD du T3 montrent des dépenses accrues en R&D et G&A et une perte nette de $96,6 millions pour les neuf mois se terminant le 30 septembre 2025.
Maze Therapeutics (Nasdaq: MAZE) berichtete am 6. November 2025 über die Ergebnisse des Q3 2025 und Pipeline-Updates. Das Unternehmen beendete das Q3 mit 383,9 Millionen USD an Bargeld, Barbestand und marktgängigen Wertpapieren und sagt, dass diese Mittel eine Laufzeit bis 2028 ermöglichen. Maze meldete positive First-in-Human-Daten der Phase 1 für MZE782, die dosenabhängige Anstiege von 24-Stunden-Urinalphenylalanin und Glutamin, Verträglichkeit über die Dosen hinweg sowie einen anfänglichen dosenabhängigen Rückgang der eGFR zeigen; zwei Phase-2-Proof-of-Concept-Studien in PKU und CKD sind für 2026 geplant. Die Rekrutierung läuft im Phase-2-HORIZON-Studie von MZE829 weiter, mit ersten Patientendaten, die voraussichtlich bis Ende des Q1 2026 vorliegen. Die Finanzdaten des Q3 YTD zeigen höhere F&E- und G&A-Aufwendungen und einen Jahresfehlbetrag von $96,6 Millionen für die neun Monate bis zum 30. September 2025.
Maze Therapeutics (ناسداك: MAZE) أبلغت عن نتائج الربع الثالث 2025 وتحديثات خط الإمداد في 6 نوفمبر 2025. اختتمت الشركة الربع الثالث بوجود 383,9 مليون دولار نقداً، وما يعادله نقداً وأوراق مالية قابلة للتداول وتقول أن هذه التمويلات توفر قدرة على التمويل حتى 2028. أظهرت Maze نتائج واعدة من التجربة الأولى البشرية في المرحلة 1 لـ MZE782 التي تُظهر زيادات تعتمد على الجرعة في الفينيل ألانين البولية وغلوتامين على مدى 24 ساعة، وتحمل عبر الجرعات، وانخفاضاً ابتدائياً يعتمد على الجرعة في eGFR؛ كما تخطط تجربةان من المرحلة 2 لمفهوم الإثبات في PKU و CKD في عام 2026. يستمر التوظيف في تجربة المرحلة 2 HORIZON لـ MZE829 مع توقع بيانات رئيسية للمرضى الأوائل بنهاية Q1 2026. تُظهر نتائج مالية الربع الثالث حتى تاريخه ارتفاعاً في النفقات البحثية والتطويرية وG&A وخسارة صافية قدرها $96,6 مليون للمدة المنتهية في 30 سبتمبر 2025.
- $383.9M cash, runway into 2028
- Positive Phase 1 MZE782: dose-dependent urinary Phe increases and tolerability
- MZE829 Phase 2 topline data expected by end Q1 2026
- Nine-month net loss of $96.6M (through Sept 30, 2025)
- License revenue fell to $0 in Q3 2025 from prior year comparatives
- R&D spend increased to $80.9M for nine months, up from $61.3M in 2024
Insights
Positive Phase 1 safety and biomarker signals for MZE782, and near-term Phase 2 readouts for MZE829.
MZE782 showed tolerability and dose-dependent increases in 24-hour urinary phenylalanine and glutamine, confirming target engagement and SLC6A19 inhibition. The observed dose-dependent initial eGFR dip, described as similar to SGLT2 inhibitors and other standard agents, is presented as supporting a potential kidney protective effect in CKD.
Enrollment is ongoing in the Phase 2 HORIZON trial of MZE829 in broad APOL1-mediated kidney disease, with topline proof-of-concept data for initial patients expected by
Key dependencies and near-term items to watch include the
Balance sheet strength and successful private placement support a multi-year cash runway.
The company reported
Maze states this cash position funds operations into
First-in-human data from Phase 1 trial of MZE782 support best- and first-in-class potential; two Phase 2 proof-of-concept trials in phenylketonuria (PKU) and chronic kidney disease (CKD) expected to initiate in 2026
Enrollment ongoing in Phase 2 HORIZON trial of MZE829 in broad APOL1-mediated kidney disease (AMKD); topline data for initial patients expected by the end of Q1 2026
Strong balance sheet with
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (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, 2025, highlighting recent progress and business updates.
“We are proud to have delivered another strong quarter marked by continued execution across our pipeline and business. We are particularly thrilled with the positive first-in-human results from our Phase 1 trial of MZE782, which support the continued advancement of MZE782 in two Phase 2 trials in both PKU and CKD, and we look forward to initiating those planned trials in 2026,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We continue to actively enroll patients in our Phase 2 HORIZON trial of MZE829 and anticipate reporting topline proof-of-concept data on initial patients by the end of Q1 2026. These data, from a broad AMKD population, are expected to inform potential advancement into Phase 2b/3 planning. With a strong balance sheet, bolstered by our recently announced oversubscribed private placement, we are well-positioned for multiple milestones ahead.”
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.
- Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes patients with broad AMKD, including diabetic and non-diabetic patients and patients with severe focal segmental glomerulosclerosis (FSGS).
- Maze expects to report topline proof-of-concept data from the Phase 2 HORIZON trial by the end of the first quarter of 2026.
MZE782 in 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 approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies.
- In September 2025, Maze announced positive first-in-human results from the Phase 1 clinical trial evaluating MZE782 in healthy volunteers. MZE782 was well-tolerated across all doses and produced dose-dependent increases in 24-hour urinary excretion of phenylalanine (Phe) and glutamine across both single and multiple ascending dose cohorts, confirming target engagement and SLC6A19 inhibition. A dose-dependent initial eGFR dip similar to SGLT2 inhibitors, MRAs and RAAS inhibitors was also observed, supporting a potential kidney protective effect in CKD.
- Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782, evaluating plasma Phe reduction in PKU and proteinuria reduction in CKD, in 2026.
Recent Corporate Highlights
- In October 2025, Maze announced the appointment of Hervé Hoppenot as chairman of its board of directors, succeeding Charles Homcy, M.D., who continues to serve on the board. Mr. Hoppenot has over 30 years of experience in therapeutic development and commercial leadership, most recently as chief executive officer of Incyte Corporation.
- In September 2025, Maze announced an oversubscribed private placement for gross proceeds of approximately
$150.0 million , before deducting placement agent fees and other expenses. - In September 2025, Maze announced the appointment of Misbah Tahir as chief financial officer. Mr. Tahir brings over 20 years of financial and strategic experience in the biopharmaceutical industry to his position at Maze, most recently as CFO of IGM Biosciences, Inc.
Third Quarter 2025 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were
License Revenue: No license revenue was recognized during the three and nine months ended September 30, 2025. License revenue was
Research & Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2025 were
General & Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025 were
Net (Loss) Income: Net loss for the three and nine months ended September 30, 2025 was
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, including obesity. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow the company on LinkedIn and X.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
For further information, please contact:
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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| License revenue | $ | — | $ | 2,500 | $ | — | $ | 167,500 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 25,190 | 19,857 | 80,878 | 61,280 | ||||||||||||
| General and administrative | 7,775 | 6,872 | 23,962 | 18,908 | ||||||||||||
| Total operating expenses | 32,965 | 26,729 | 104,840 | 80,188 | ||||||||||||
| (Loss) income from operations | (32,965 | ) | (24,229 | ) | (104,840 | ) | 87,312 | |||||||||
| Interest and other income, net | 2,878 | 1,846 | 8,288 | 3,138 | ||||||||||||
| Change in fair value of convertible promissory notes | — | (2,648 | ) | — | (7,193 | ) | ||||||||||
| (Loss) income before income tax benefit (expense) | (30,087 | ) | (25,031 | ) | (96,552 | ) | 83,257 | |||||||||
| Income tax benefit (expense) | — | 279 | — | (1,447 | ) | |||||||||||
| Net (loss) income | $ | (30,087 | ) | $ | (24,752 | ) | $ | (96,552 | ) | $ | 81,810 | |||||
| Allocation of undistributed earnings to participating securities | — | — | — | (73,499 | ) | |||||||||||
| Net (loss) income attributable to common stockholders, basic | $ | (30,087 | ) | $ | (24,752 | ) | $ | (96,552 | ) | $ | 8,311 | |||||
| Net (loss) income attributable to common stockholders, diluted | $ | (30,087 | ) | $ | (24,752 | ) | $ | (96,552 | ) | $ | 9,031 | |||||
| Net (loss) income per share attributable to common stockholders: | ||||||||||||||||
| Basic | $ | (0.66 | ) | $ | (10.25 | ) | $ | (2.45 | ) | $ | 3.49 | |||||
| Diluted | $ | (0.66 | ) | $ | (10.25 | ) | $ | (2.45 | ) | $ | 2.67 | |||||
| Weighted-average shares of common stock outstanding used to compute net (loss) income per share attributable to common stockholders: | ||||||||||||||||
| Basic | 45,779,577 | 2,415,897 | 39,464,634 | 2,384,117 | ||||||||||||
| Diluted | 45,779,577 | 2,415,897 | 39,464,634 | 3,387,166 | ||||||||||||
| Condensed Balance Sheet Data | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents and marketable securities | $ | 383,935 | $ | 196,812 | ||||
| Total assets | $ | 422,058 | $ | 240,542 | ||||
| Total liabilities | $ | 42,622 | $ | 43,638 | ||||
| Total redeemable convertible preferred stock | $ | — | $ | 508,087 | ||||
| Total stockholders’ equity (deficit) | $ | 379,436 | $ | (311,183 | ) | |||
FAQ
What did Maze (MAZE) report for cash and runway in Q3 2025?
When will Maze (MAZE) report topline data from the MZE829 Phase 2 HORIZON trial?
What did the Phase 1 data show for MZE782 in the Maze (MAZE) Q3 2025 update?
What clinical milestones did Maze (MAZE) plan for MZE782 in 2026?
How did Maze’s profitability and revenue compare year-over-year in Q3 2025?
Did Maze (MAZE) complete any financing in 2025?
