Maze Therapeutics Reports First Quarter 2025 Financial Results and Reiterates Upcoming Milestones
Their lead candidate MZE829, an oral APOL1 inhibitor for APOL1 Kidney Disease (AKD), continues patient enrollment in Phase 2 HORIZON trial with initial data expected in Q1 2026. The trial targets a broad AKD population, including patients with diabetes and FSGS.
MZE782, their second program targeting SLC6A19, is in Phase 1 trials with healthy volunteers. Initial data, including biomarker results, is expected in Q3 2025. The drug aims to treat both CKD and PKU patients, potentially becoming first-in-class for CKD and best-in-class for PKU.
Q1 2025 financials show R&D expenses of $27.6M (up from $21.9M in Q1 2024) and G&A expenses of $7.8M (up from $6.1M). Net loss was $32.8M compared to $32.5M in Q1 2024.
Il candidato principale MZE829, un inibitore orale di APOL1 per la malattia renale APOL1 (AKD), continua il reclutamento di pazienti nella sperimentazione di Fase 2 HORIZON, con i primi dati attesi nel primo trimestre 2026. Lo studio coinvolge una vasta popolazione con AKD, inclusi pazienti diabetici e con FSGS.
MZE782, il secondo programma che mira a SLC6A19, è in fase 1 con volontari sani. I dati iniziali, inclusi i risultati dei biomarcatori, sono previsti per il terzo trimestre 2025. Il farmaco punta a trattare sia la CKD che la PKU, potenzialmente diventando il primo della sua classe per la CKD e il migliore per la PKU.
I dati finanziari del primo trimestre 2025 mostrano spese R&S di 27,6 milioni di dollari (in aumento rispetto ai 21,9 milioni del primo trimestre 2024) e spese amministrative di 7,8 milioni (in aumento rispetto ai 6,1 milioni). La perdita netta è stata di 32,8 milioni, rispetto ai 32,5 milioni del primo trimestre 2024.
Su candidato principal MZE829, un inhibidor oral de APOL1 para la enfermedad renal APOL1 (AKD), continúa con la inscripción de pacientes en el ensayo de Fase 2 HORIZON, con datos iniciales esperados en el primer trimestre de 2026. El ensayo abarca una amplia población con AKD, incluidos pacientes con diabetes y FSGS.
MZE782, su segundo programa dirigido a SLC6A19, está en ensayos de Fase 1 con voluntarios sanos. Se esperan datos iniciales, incluidos resultados de biomarcadores, en el tercer trimestre de 2025. El fármaco busca tratar tanto la CKD como la PKU, con potencial para ser el primero en su clase para CKD y el mejor en su clase para PKU.
Las finanzas del primer trimestre de 2025 muestran gastos en I+D de 27,6 millones (aumento desde 21,9 millones en el primer trimestre de 2024) y gastos generales y administrativos de 7,8 millones (aumento desde 6,1 millones). La pérdida neta fue de 32,8 millones frente a 32,5 millones en el primer trimestre de 2024.
주력 후보물질 MZE829는 APOL1 신장질환(AKD)을 위한 경구용 APOL1 억제제로, 2상 HORIZON 임상시험에서 환자 등록이 계속 진행 중이며, 초기 데이터는 2026년 1분기에 발표될 예정입니다. 이 임상시험은 당뇨병 및 FSGS 환자를 포함한 광범위한 AKD 환자군을 대상으로 합니다.
MZE782는 두 번째 프로그램으로 SLC6A19를 표적으로 하며, 건강한 지원자를 대상으로 1상 시험이 진행 중입니다. 바이오마커 결과를 포함한 초기 데이터는 2025년 3분기에 나올 예정입니다. 이 약물은 만성 신장질환(CKD)과 페닐케톤뇨증(PKU) 환자 치료를 목표로 하며, CKD에서는 퍼스트인클래스, PKU에서는 베스트인클래스가 될 가능성이 있습니다.
2025년 1분기 재무 결과는 연구개발비가 2,760만 달러(2024년 1분기 2,190만 달러에서 증가), 일반관리비가 780만 달러(6,100만 달러에서 증가)이며, 순손실은 3,280만 달러로 2024년 1분기 3,250만 달러와 비슷한 수준입니다.
Le candidat principal MZE829, un inhibiteur oral d'APOL1 pour la maladie rénale APOL1 (AKD), poursuit le recrutement de patients dans l'essai de phase 2 HORIZON, avec des données initiales attendues au premier trimestre 2026. L'essai cible une large population AKD, y compris des patients diabétiques et atteints de FSGS.
MZE782, leur second programme ciblant SLC6A19, est en phase 1 avec des volontaires sains. Les premières données, incluant les résultats des biomarqueurs, sont attendues au troisième trimestre 2025. Le médicament vise à traiter à la fois la CKD et la PKU, avec un potentiel pour devenir le premier de sa classe pour la CKD et le meilleur pour la PKU.
Les résultats financiers du T1 2025 montrent des dépenses R&D de 27,6 millions de dollars (en hausse par rapport à 21,9 millions au T1 2024) et des frais G&A de 7,8 millions (en hausse par rapport à 6,1 millions). La perte nette s'élève à 32,8 millions, contre 32,5 millions au T1 2024.
Ihr führender Kandidat MZE829, ein oraler APOL1-Inhibitor für APOL1-Nierenerkrankungen (AKD), setzt die Patienteneinschreibung in der Phase-2-HORIZON-Studie fort, erste Daten werden für das erste Quartal 2026 erwartet. Die Studie richtet sich an eine breite AKD-Patientengruppe, einschließlich Patienten mit Diabetes und FSGS.
MZE782, das zweite Programm, das auf SLC6A19 abzielt, befindet sich in Phase-1-Studien mit gesunden Freiwilligen. Erste Daten, inklusive Biomarker-Ergebnisse, werden für das dritte Quartal 2025 erwartet. Das Medikament soll sowohl CKD- als auch PKU-Patienten behandeln und könnte Erst-in-Klasse für CKD und Best-in-Klasse für PKU werden.
Die Finanzergebnisse für Q1 2025 zeigen F&E-Ausgaben von 27,6 Mio. USD (steigend von 21,9 Mio. USD im Q1 2024) und Verwaltungsaufwendungen von 7,8 Mio. USD (steigend von 6,1 Mio. USD). Der Nettoverlust betrug 32,8 Mio. USD im Vergleich zu 32,5 Mio. USD im Q1 2024.
- Strong cash position of $294.4M providing runway into H2 2027
- Two clinical programs actively progressing with clear timelines
- MZE782 shows potential to be first-in-class for CKD and best-in-class for PKU
- Large market opportunity with over 1M potential patients for AKD treatment in the US
- Increased R&D expenses by 26% YoY to $27.6M
- Higher G&A expenses, up 28% YoY to $7.8M
- Slightly increased net loss to $32.8M
- No revenue generation reported
Insights
Maze Therapeutics reports solid cash position, unchanged pipeline timelines, and slightly increased R&D expenses to advance two clinical-stage assets.
Maze Therapeutics' Q1 2025 financial report presents a steady clinical development trajectory with no timeline adjustments for their two key pipeline candidates. The company's $294.4 million cash position provides a substantial 2+ year runway into H2 2027, giving them adequate resources to reach several critical value-inflection points.
Their lead candidate MZE829 for APOL1 kidney disease (AKD) continues enrolling in the Phase 2 HORIZON trial, with initial data expected in Q1 2026. For context, AKD affects over 1 million patients in the US alone, representing a significant market opportunity. Notably, the trial's broad inclusion criteria (diabetic, non-diabetic, and FSGS patients) could potentially support a wide label if successful.
Their second asset, MZE782, targets SLC6A19 and is progressing through Phase 1 with initial biomarker data expected in Q3 2025. This compound has a compelling dual-indication strategy targeting both chronic kidney disease (CKD) and phenylketonuria (PKU). In CKD, they're positioning it as first-in-class for the ~5 million US patients who inadequately respond to current therapies – a substantial unmet need. For PKU, they're aiming for best-in-class status.
Financially, R&D expenses increased 26% year-over-year to $27.6 million, reflecting the expected higher costs of advancing two clinical programs. G&A expenses rose 28% to $7.8 million. Despite these increases, the quarterly net loss remained nearly flat at $32.8 million versus $32.5 million in Q1 2024, likely due to higher interest income from their post-IPO cash reserves.
The company's successful IPO has significantly strengthened their balance sheet from $196.8 million at year-end 2024 to the current $294.4 million, providing financial stability through multiple data readouts.
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026
MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025
Strong Balance Sheet with
SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones.
“With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.”
Key Anticipated Milestones
MZE829 for APOL1 Kidney Disease (AKD)
MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone.
- Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS).
- Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026.
MZE782 in CKD and Phenylketonuria (PKU)
MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies, as well as potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder.
- MZE782 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers.
- Maze expects to report initial data, including proof-of-mechanism biomarker results, in the third quarter of 2025.
- Based on Phase 1 results, Maze plans to initiate two separate Phase 2 clinical trials of MZE782 in CKD and PKU.
First Quarter 2025 Financial Results
Cash Position: Cash and cash equivalents were
Research & Development (R&D) Expenses: R&D expenses were
General & Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss 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 living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us 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 AKD or other indications, the ability of MZE782 to treat CKD, PKU 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 sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. 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.
IR/Corporate Contact:
Amy Bachrodt, Maze Therapeutics
abachrodt@mazetx.com
Media Contact:
Dan Budwick, 1AB
dan@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, | |||||||
| 2025 | 2024 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 27,580 | $ | 21,877 | |||
| General and administrative | 7,821 | 6,137 | |||||
| Total operating expenses | 35,401 | 28,014 | |||||
| Loss from operations | (35,401 | ) | (28,014 | ) | |||
| Interest and other income, net | 2,615 | 281 | |||||
| Change in fair value of convertible promissory notes | — | (4,761 | ) | ||||
| Net loss | $ | (32,786 | ) | $ | (32,494 | ) | |
| Net loss per share, basic and diluted | $ | (1.15 | ) | $ | (13.91 | ) | |
| Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted | 28,628,430 | 2,336,613 | |||||
| Condensed Balance Sheet Data | |||||||
| March 31, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Cash and cash equivalents | $ | 294,374 | $ | 196,812 | |||
| Total assets | $ | 332,840 | $ | 240,542 | |||
| Total liabilities | $ | 40,772 | $ | 43,638 | |||
| Total redeemable convertible preferred stock | $ | — | $ | 508,087 | |||
| Total stockholders’ equity (deficit) | $ | 292,068 | $ | (311,183 | ) | ||
FAQ
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