Maze Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights
Maze Therapeutics (NASDAQ:MAZE) reported Q2 2025 financial results and clinical progress updates. The company maintains a strong financial position with $264.5 million in cash, providing runway into H2 2027. Key clinical developments include:
The company's lead programs are advancing with MZE782 Phase 1 trial in healthy volunteers for PKU and CKD, expecting proof of mechanism data in Q3 2025, and MZE829 Phase 2 HORIZON trial for APOL1-mediated kidney disease, with initial data expected in Q1 2026.
Financial results showed R&D expenses of $28.1 million and net loss of $33.7 million for Q2 2025, compared to net income of $139.1 million in Q2 2024, which included $165 million in license revenue from Shionogi and Trace partnerships.
Maze Therapeutics (NASDAQ:MAZE) ha comunicato i risultati finanziari del Q2 2025 e aggiornamenti sul progresso clinico. L’azienda mantiene una solida posizione finanziaria con 264,5 milioni di dollari in contanti, che garantiscono la copertura fino al secondo semestre 2027. I principali sviluppi clinici includono:
I programmi di punta stanno progredendo: il trial di Fase 1 MZE782 su volontari sani per PKU e malattia renale cronica (CKD), con dati di dimostrazione del meccanismo attesi nel Q3 2025; e lo studio di Fase 2 HORIZON MZE829 per la malattia renale mediata da APOL1, con i primi dati previsti nel Q1 2026.
I risultati finanziari mostrano spese di R&S per 28,1 milioni di dollari e una perdita netta di 33,7 milioni di dollari per il Q2 2025, rispetto a un utile netto di 139,1 milioni di dollari nel Q2 2024, che includeva 165 milioni di dollari di ricavi da licenza derivanti dalle partnership con Shionogi e Trace.
Maze Therapeutics (NASDAQ:MAZE) anunció los resultados financieros del 2T 2025 y actualizaciones sobre su progreso clínico. La compañía mantiene una posición financiera sólida con 264,5 millones de dólares en efectivo, lo que proporciona financiación hasta la segunda mitad de 2027. Los principales avances clínicos incluyen:
Los programas principales avanzan: el ensayo de Fase 1 MZE782 en voluntarios sanos para PKU y enfermedad renal crónica (CKD), con datos de prueba del mecanismo previstos en el 3T 2025; y el ensayo de Fase 2 HORIZON MZE829 para la enfermedad renal mediada por APOL1, con los primeros datos esperados en el 1T 2026.
Los resultados financieros mostraron gastos de I+D por 28,1 millones de dólares y una pérdida neta de 33,7 millones de dólares en el 2T 2025, frente a un beneficio neto de 139,1 millones de dólares en el 2T 2024, que incluyó 165 millones de dólares en ingresos por licencias procedentes de las asociaciones con Shionogi y Trace.
Maze Therapeutics (NASDAQ:MAZE)는 2025년 2분기 재무 실적과 임상 진행 상황을 발표했습니다. 회사는 현금 2억6,450만 달러로 2027년 하반기까지 자금 여유를 확보하고 있습니다. 주요 임상 진전 사항은 다음과 같습니다:
주요 파이프라인이 진전 중입니다: PKU 및 만성 신장질환(CKD) 대상 건강한 지원자를 대상으로 한 MZE782 1상 시험은 작용 기전 확인 데이터가 2025년 3분기에 예상되며, APOL1 매개 신장질환을 대상으로 한 MZE829 2상 HORIZON 시험의 초기 데이터는 2026년 1분기에 예정되어 있습니다.
재무 실적은 2025년 2분기 연구개발비 2,810만 달러와 순손실 3,370만 달러를 기록했으며, 이는 2024년 2분기에 Shionogi 및 Trace 파트너십으로부터의 1억3,910만 달러 순이익(그 중 1억6,500만 달러의 라이선스 수익 포함)과 대비됩니다.
Maze Therapeutics (NASDAQ:MAZE) a publié ses résultats financiers du T2 2025 et des mises à jour sur ses avancées cliniques. La société présente une situation financière solide avec 264,5 millions de dollars de liquidités, offrant une visibilité financière jusqu'au second semestre 2027. Les développements cliniques clés comprennent :
Les programmes phares progressent : l'essai de Phase 1 MZE782 chez des volontaires sains pour la PKU et la maladie rénale chronique (CKD), avec des données de preuve de mécanisme attendues au T3 2025 ; et l'essai de Phase 2 HORIZON MZE829 pour la maladie rénale médiée par APOL1, dont les premières données sont prévues au T1 2026.
Les résultats financiers indiquent des dépenses de R&D de 28,1 millions de dollars et une perte nette de 33,7 millions de dollars pour le T2 2025, contre un résultat net de 139,1 millions de dollars au T2 2024, qui incluait 165 millions de dollars de revenus de licences issus des partenariats avec Shionogi et Trace.
Maze Therapeutics (NASDAQ:MAZE) veröffentlichte die Finanzergebnisse für Q2 2025 sowie klinische Fortschrittsinformationen. Das Unternehmen verfügt über eine starke Finanzposition mit 264,5 Millionen US-Dollar in bar, was Mittel bis ins zweite Halbjahr 2027 sichert. Zu den wichtigsten klinischen Entwicklungen zählen:
Die führenden Programme werden vorangetrieben: die MZE782 Phase‑1‑Studie in gesunden Freiwilligen für PKU und chronische Nierenerkrankung (CKD), wobei Daten zum Wirknachweis im Q3 2025 erwartet werden; sowie die MZE829 Phase‑2 HORIZON‑Studie für APOL1‑vermittelte Nierenerkrankungen, deren erste Daten im Q1 2026 erwartet werden.
Finanziell meldete das Unternehmen F&E‑Aufwendungen von 28,1 Millionen US-Dollar und einen Nettoverlust von 33,7 Millionen US-Dollar für Q2 2025, im Vergleich zu einem Nettoergebnis von 139,1 Millionen US-Dollar im Q2 2024, das 165 Millionen US-Dollar an Lizenzumsätzen aus Partnerschaften mit Shionogi und Trace einschloss.
- Strong cash position of $264.5 million, providing runway into H2 2027
- Two clinical-stage programs progressing on schedule
- MZE829 addresses large market opportunity with over 1 million AMKD patients in US
- MZE782 has potential to be first-in-class for CKD and best-in-class for PKU
- Increased net loss of $33.7 million in Q2 2025 vs net income in Q2 2024
- R&D expenses increased 44% to $28.1 million year-over-year
- G&A expenses increased 42% to $8.4 million year-over-year
- No license revenue in Q2 2025 compared to $165 million in Q2 2024
Insights
Maze demonstrates solid clinical progress with two pipeline candidates while maintaining strong $264.5M cash position extending runway into H2 2027.
Maze Therapeutics continues to build momentum with its precision medicine pipeline targeting kidney and metabolic diseases. The company has $264.5 million in cash and equivalents as of June 30, 2025, a significant increase from $196.8 million at the end of 2024, providing runway into H2 2027. This extended cash runway is critical as it fully funds multiple clinical readouts without immediate financing pressure.
The company is advancing two key clinical programs with near-term catalysts. MZE782, targeting the SLC6A19 transporter, is positioned as a potential first-in-class treatment for CKD patients unresponsive to current therapies (estimated 5 million patients in the US) and as a best-in-class option for PKU. Importantly, proof-of-mechanism data from the Phase 1 healthy volunteer trial is expected in Q3 2025, which will be critical in determining the compound's future in both indications.
Meanwhile, MZE829, an oral APOL1 inhibitor for APOL1-mediated kidney disease (affecting over 1 million people in the US), continues enrollment in the Phase 2 HORIZON trial. The trial's design is noteworthy for its breadth, including patients with diabetes, non-diabetic kidney disease, and severe FSGS. Initial proof-of-concept data is expected in Q1 2026.
The financial results show increased R&D expenses ($28.1M for Q2 2025 vs. $19.5M in Q2 2024) and G&A expenses ($8.4M vs. $5.9M), reflecting the advancing clinical programs. The company reported a net loss of $33.7M for Q2 2025, compared to net income of $139.1M in Q2 2024, but the prior year figure included $165M in one-time license revenue from deals with Shionogi and Trace Neuroscience. The current burn rate appears manageable given the cash position, allowing Maze to focus on clinical execution rather than immediate fundraising needs.
Maze's transition from revenue-generating licensing deals to clinical-stage execution introduces near-term cash burn but positions for long-term value creation.
Maze Therapeutics presents an intriguing financial narrative as it transitions from a company generating substantial licensing revenue in 2024 to one focused on advancing its clinical programs in 2025. The company's $264.5 million cash position (up from $196.8 million at end-2024) provides approximately two years of runway based on current burn rate, creating a strong operational foundation.
The financial dynamics reveal important strategic shifts. In Q2 2024, Maze reported $165 million in license revenue from agreements with Shionogi ($150M) and Trace Neuroscience ($15M). This year's Q2 shows no license revenue, resulting in a net loss of $33.7 million compared to last year's $139.1 million net income. This transition reflects management's focus on developing wholly-owned assets rather than out-licensing programs.
The increased R&D spend ($28.1 million in Q2 2025 vs. $19.5 million in Q2 2024) demonstrates disciplined capital allocation toward clinical advancement. The 44% increase in R&D expense reflects manufacturing scale-up and expanded clinical activities for both lead programs. G&A expenses showed a more modest increase of 42% to $8.4 million, maintaining a healthy ratio of R&D to G&A expenditure.
Maze's clinical programs target substantial market opportunities. APOL1-mediated kidney disease affects over 1 million patients in the US alone, while the CKD program targets 5 million patients who respond inadequately to current therapies. The PKU market, though smaller, represents a high-value rare disease opportunity where novel mechanisms can command premium pricing.
The near-term clinical catalysts in Q3 2025 (MZE782 biomarker data) and Q1 2026 (MZE829 proof-of-concept data) represent critical value inflection points that could drive partnership interest or validate Maze's independent development strategy. The company appears well-positioned to reach these milestones without additional financing, preserving equity value for existing shareholders.
MZE782 Phase 1 Trial in Healthy Volunteers to Provide Proof of Mechanism Data for Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) Expected in Q3 2025
MZE829 Phase 2 HORIZON Trial Actively Enrolling Patients with APOL1-Mediated Kidney Disease; Initial Data Expected in Q1 2026
Strong Balance Sheet with
SOUTH SAN FRANCISCO, Calif., Aug. 12, 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 second quarter ended June 30, 2025, highlighting recent progress and business updates.
“With two clinical-stage programs advancing, Maze continues to execute with focus and discipline,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We remain on track to report key mechanistic biomarker data from our Phase 1 study of MZE782 in Q3, a significant milestone toward initiating Phase 2 trials in PKU and CKD. In addition, we continue to enroll our Phase 2 HORIZON trial of MZE829 in APOL1-mediated kidney disease, keeping us on track for an initial proof-of-concept readout in Q1 2026. With a strong balance sheet and cash runway into the second half of 2027, we’re well-positioned to deliver meaningful impact for patients and value for shareholders.”
Program Progress and Anticipated Milestones
MZE829 for APOL1-Mediated Kidney Disease (AMKD)
MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of 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 a broad population of patients with AMKD, 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 biomarker and proof-of-mechanism results relevant for both indications, 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 in 2026.
Second Quarter 2025 Financial Results
Cash Position: Cash and cash equivalents were
License Revenue: No license revenue was recognized during the three and six months ended June 30, 2025. License revenue was
Research & Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2025, were
General & Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2025, were
Net (Loss) Income: Net loss for the three and six months ended June 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. Guided by its Compass platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance oral small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, an oral APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease, and MZE782, an oral SLC6A19 inhibitor advancing through Phase 1 with the potential to treat both chronic kidney disease (CKD) and phenylketonuria (PKU). 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 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:
Amanda Lazaro, 1AB
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 | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| License revenue | $ | — | $ | 165,000 | $ | — | $ | 165,000 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 28,108 | 19,546 | 55,688 | 41,423 | |||||||||||
| General and administrative | 8,366 | 5,899 | 16,187 | 12,036 | |||||||||||
| Total operating expenses | 36,474 | 25,445 | 71,875 | 53,459 | |||||||||||
| (Loss) income from operations | (36,474 | ) | 139,555 | (71,875 | ) | 111,541 | |||||||||
| Interest and other income, net | 2,795 | 1,011 | 5,410 | 1,292 | |||||||||||
| Change in fair value of convertible promissory notes | — | 216 | — | (4,545 | ) | ||||||||||
| (Loss) income before income tax expense | (33,679 | ) | 140,782 | (66,465 | ) | 108,288 | |||||||||
| Income tax expense | — | (1,726 | ) | — | (1,726 | ) | |||||||||
| Net (loss) income and comprehensive (loss) income | $ | (33,679 | ) | $ | 139,056 | $ | (66,465 | ) | $ | 106,562 | |||||
| Allocation of undistributed earnings to participating securities | — | (124,912 | ) | — | (95,824 | ) | |||||||||
| Net (loss) income attributable to common stockholders, basic | $ | (33,679 | ) | $ | 14,144 | $ | (66,465 | ) | $ | 10,738 | |||||
| Net (loss) income attributable to common stockholders, diluted | $ | (33,679 | ) | $ | 13,884 | $ | (66,465 | ) | $ | 10,415 | |||||
| Net (loss) income per share attributable to common stockholders: | |||||||||||||||
| Basic | $ | (0.77 | ) | $ | 5.92 | $ | (1.83 | ) | $ | 4.54 | |||||
| Diluted | $ | (0.77 | ) | $ | 3.22 | $ | (1.83 | ) | $ | 3.18 | |||||
| Weighted-average shares of common stock outstanding used to compute net (loss) income per share attributable to common stockholders: | |||||||||||||||
| Basic | 43,797,421 | 2,389,119 | 36,254,828 | 2,362,866 | |||||||||||
| Diluted | 43,797,421 | 4,314,359 | 36,254,828 | 3,270,120 | |||||||||||
| Condensed Balance Sheet Data | |||||||
| June 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Cash and cash equivalents | $ | 264,541 | $ | 196,812 | |||
| Total assets | $ | 303,519 | $ | 240,542 | |||
| Total liabilities | $ | 41,281 | $ | 43,638 | |||
| Total redeemable convertible preferred stock | $ | — | $ | 508,087 | |||
| Total stockholders’ equity (deficit) | $ | 262,238 | $ | (311,183 | ) | ||
FAQ
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