89bio Reports Second Quarter 2025 Financial Results and Corporate Updates
89bio (NASDAQ: ETNB) reported Q2 2025 financial results and provided updates on its clinical programs. The company maintains a strong financial position with $561.2 million in cash and equivalents. Key clinical milestones include expected topline data from the Phase 3 ENTRUST trial for severe hypertriglyceridemia in Q1 2026, and Phase 3 ENLIGHTEN trials data for MASH treatment in 1H 2027 and 2028.
The company reported a net loss of $111.5 million for Q2 2025, with R&D expenses of $103.9 million, including a $42.4 million payment for a commercial-scale production facility. G&A expenses increased to $11.9 million, primarily due to higher personnel costs.
The ENLIGHTEN trials are designed to support accelerated approval for pegozafermin in both non-cirrhotic and cirrhotic MASH patients, with FDA and EMA alignment.
89bio (NASDAQ: ETNB) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti sui suoi programmi clinici. L'azienda mantiene una solida posizione finanziaria con 561,2 milioni di dollari in contanti e equivalenti. Tra i principali traguardi clinici, si prevede la pubblicazione dei dati principali del trial di Fase 3 ENTRUST per l'ipertrigliceridemia severa nel primo trimestre 2026, e i dati dei trial di Fase 3 ENLIGHTEN per il trattamento della MASH nella prima metà del 2027 e del 2028.
L'azienda ha riportato una perdita netta di 111,5 milioni di dollari per il secondo trimestre 2025, con spese di R&S pari a 103,9 milioni di dollari, inclusi 42,4 milioni di dollari destinati a un impianto di produzione su scala commerciale. Le spese generali e amministrative sono aumentate a 11,9 milioni di dollari, principalmente a causa di maggiori costi del personale.
I trial ENLIGHTEN sono progettati per supportare l'approvazione accelerata di pegozafermin sia nei pazienti con MASH non cirrotica che cirrotica, in accordo con FDA ed EMA.
89bio (NASDAQ: ETNB) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre sus programas clínicos. La empresa mantiene una posición financiera sólida con 561,2 millones de dólares en efectivo y equivalentes. Los hitos clínicos clave incluyen datos principales esperados del ensayo de Fase 3 ENTRUST para hipertrigliceridemia severa en el primer trimestre de 2026, y datos de los ensayos de Fase 3 ENLIGHTEN para el tratamiento de MASH en la primera mitad de 2027 y 2028.
La compañía reportó una pérdida neta de 111,5 millones de dólares en el segundo trimestre de 2025, con gastos de I+D de 103,9 millones de dólares, que incluyen un pago de 42,4 millones de dólares para una planta de producción a escala comercial. Los gastos generales y administrativos aumentaron a 11,9 millones de dólares, principalmente debido a mayores costos de personal.
Los ensayos ENLIGHTEN están diseñados para apoyar la aprobación acelerada de pegozafermin en pacientes con MASH no cirrótica y cirrótica, con alineación de FDA y EMA.
89bio (NASDAQ: ETNB)는 2025년 2분기 재무 결과를 발표하고 임상 프로그램에 대한 업데이트를 제공했습니다. 회사는 5억 6,120만 달러의 현금 및 현금성 자산을 보유하며 강력한 재무 상태를 유지하고 있습니다. 주요 임상 이정표로는 중증 고중성지방혈증에 대한 3상 ENTRUST 시험의 주요 데이터가 2026년 1분기에 예상되며, MASH 치료를 위한 3상 ENLIGHTEN 시험 데이터는 2027년 및 2028년 상반기에 발표될 예정입니다.
회사는 2025년 2분기에 1억 1,150만 달러의 순손실을 보고했으며, 연구개발비는 1억 390만 달러로 그중 4,240만 달러는 상업용 생산 시설 구축 비용에 포함되었습니다. 일반관리비는 주로 인건비 증가로 인해 1,190만 달러로 증가했습니다.
ENLIGHTEN 시험은 비경화성 및 경화성 MASH 환자 모두에서 페고자페르민의 가속 승인 지원을 위해 FDA 및 EMA와 협력하여 설계되었습니다.
89bio (NASDAQ : ETNB) a publié ses résultats financiers du deuxième trimestre 2025 et a donné des mises à jour sur ses programmes cliniques. L'entreprise maintient une position financière solide avec 561,2 millions de dollars en liquidités et équivalents. Les jalons cliniques clés incluent les données principales attendues de l'essai de phase 3 ENTRUST pour l'hypertriglycéridémie sévère au premier trimestre 2026, ainsi que les données des essais de phase 3 ENLIGHTEN pour le traitement de la MASH au cours du premier semestre 2027 et 2028.
L'entreprise a enregistré une perte nette de 111,5 millions de dollars au deuxième trimestre 2025, avec des dépenses de R&D de 103,9 millions de dollars, incluant un paiement de 42,4 millions de dollars pour une installation de production à l'échelle commerciale. Les frais généraux et administratifs ont augmenté à 11,9 millions de dollars, principalement en raison de coûts de personnel plus élevés.
Les essais ENLIGHTEN sont conçus pour soutenir l'approbation accélérée du pegozafermin chez les patients atteints de MASH non cirrhotique et cirrhotique, en alignement avec la FDA et l'EMA.
89bio (NASDAQ: ETNB) berichtete über die Finanzergebnisse des zweiten Quartals 2025 und gab Updates zu seinen klinischen Programmen bekannt. Das Unternehmen verfügt über eine starke finanzielle Position mit 561,2 Millionen US-Dollar an liquiden Mitteln und Äquivalenten. Wichtige klinische Meilensteine umfassen erwartete Topline-Daten der Phase-3-ENTRUST-Studie zur schweren Hypertriglyzeridämie im ersten Quartal 2026 sowie Daten der Phase-3-ENLIGHTEN-Studien zur MASH-Behandlung in der ersten Hälfte 2027 und 2028.
Das Unternehmen meldete einen Nettoverlust von 111,5 Millionen US-Dollar für das zweite Quartal 2025, mit F&E-Ausgaben von 103,9 Millionen US-Dollar, darunter eine Zahlung von 42,4 Millionen US-Dollar für eine Produktionsanlage im kommerziellen Maßstab. Die Verwaltungs- und Gemeinkosten stiegen auf 11,9 Millionen US-Dollar, hauptsächlich aufgrund höherer Personalkosten.
Die ENLIGHTEN-Studien sind darauf ausgelegt, eine beschleunigte Zulassung von Pegozafermin sowohl bei nicht-zirrhotischen als auch zirrhotischen MASH-Patienten zu unterstützen, in Abstimmung mit FDA und EMA.
- Strong cash position of $561.2 million provides runway for clinical development
- Phase 3 trials progressing with clear regulatory pathway for accelerated approval
- Commercial-scale production facility construction on schedule for BLA filing
- Dual development programs targeting both MASH and SHTG markets
- Net loss increased significantly to $111.5 million from $48.0 million year-over-year
- R&D expenses more than doubled to $103.9 million compared to previous year
- Long timeline for clinical data with key results not expected until 2027-2028
- Additional $13.5 million facility payment due in 2026
Insights
89bio reports strong cash position of $561.2M amid widening losses as they advance Phase 3 trials for pegozafermin in MASH and SHTG.
89bio's Q2 2025 earnings reveal a healthy cash position of
The significant increase in R&D expenses to
Notably, 89bio has structured its future manufacturing obligations intelligently, with just one remaining milestone payment of
G&A expenses increased to
– ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 topline histology data expected in 1H 2027 and in 2028, respectively; each trial designed to support accelerated approval to treat patients with metabolic dysfunction-associated steatohepatitis (MASH) –
– ENTRUST Phase 3 topline data in severe hypertriglyceridemia (SHTG) expected in 1Q 2026 –
– Cash, cash equivalents, and marketable securities totaled
SAN FRANCISCO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the second quarter ended June 30, 2025, and provided corporate updates.
“As we enter the second half of 2025, we remain diligently focused on execution across our three global Phase 3 trials for pegozafermin in MASH and SHTG. In SHTG, we continue to expect topline data from our Phase 3 ENTRUST trial in the first quarter of 2026,” said Rohan Palekar, Chief Executive Officer of 89bio. “In MASH, we expect topline histology data from ENLIGHTEN-Fibrosis in the first half of 2027, and ENLIGHTEN-Cirrhosis in 2028, underpinning our accelerated-approval filings for patients with F2-F3 and F4 MASH, respectively. As our clinical development program in MASH continues to progress, we believe pegozafermin is poised to potentially deliver best-in-class relative risk ratio on histology endpoints, a favorable safety and tolerability profile, and a convenient dosing approach to the large and underserved MASH patient population.”
Recent Highlights and Anticipated Milestones
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- The Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic (F2-F3) MASH and Phase 3 ENLIGHTEN-Cirrhosis trial in compensated cirrhotic (F4) MASH continue to enroll patients, with topline data from the histology cohorts of these trials expected in the first half of 2027 and in 2028, respectively.
- The Company anticipates data from the histology cohorts of the Phase 3 ENLIGHTEN trials to support accelerated approval in both non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, based on alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both trials will continue for outcomes, to potentially support full approval.
Severe Hypertriglyceridemia (SHTG)
- ENTRUST is a randomized, double-blind, placebo-controlled global study evaluating the efficacy, safety, and tolerability of pegozafermin in SHTG patients randomized to pegozafermin (30 mg, 20 mg) or placebo in a 3:3:2 ratio given once weekly (QW) for 52 weeks. The primary endpoint of the trial is the percent change from baseline in fasting triglycerides at Week 26 compared to placebo.
- Topline data from the Phase 3 ENTRUST trial in SHTG are expected in the first quarter of 2026.
Second Quarter 2025 Financial Results
Cash Position. As of June 30, 2025, 89bio had cash, cash equivalents, and marketable securities of approximately
Research and Development (R&D) Expenses. R&D expenses were
General and Administrative (G&A) Expenses. G&A expenses were
Net Loss. 89bio reported a net loss of
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The Company is in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The Company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the Company on LinkedIn.
Forward-looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the topline histology data from the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, topline results from the ENTRUST Phase 3 trial in SHTG and the possibility of obtaining accelerated approval in the United States and conditional approval in Europe in non-cirrhotic MASH (F2-F3) patients and compensated cirrhosis (F4) MASH patients and the possibility of outcomes data supporting full approval. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "anticipate," "goal," "opportunity," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of the ENLIGHTEN-Fibrosis Phase 3 trial and Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and ENTRUST Phase 3 trial in SHTG; 89bio's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 89bio's substantial dependence on the success of it lead product candidate; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally, including recently announced tariffs and potential additional tariffs; FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations; the sufficiency of 89bio's capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contacts:
Annie Chang
89bio, Inc.
investors@89bio.com
Eva Bilange
89bio, Inc.
eva.bilange@89bio.com
Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
| 89bio, Inc. | |||||||||||||||||
| Condensed Consolidated Statement of Operations and Comprehensive Loss | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 103,902 | $ | 44,865 | $ | 168,296 | $ | 92,293 | |||||||||
| General and administrative | 11,922 | 8,571 | 23,437 | 18,420 | |||||||||||||
| Total operating expenses | 115,824 | 53,436 | 191,733 | 110,713 | |||||||||||||
| Loss from operations | (115,824 | ) | (53,436 | ) | (191,733 | ) | (110,713 | ) | |||||||||
| Interest expense | (1,137 | ) | (874 | ) | (2,404 | ) | (1,737 | ) | |||||||||
| Interest income and other, net | 6,210 | 6,473 | 12,248 | 13,029 | |||||||||||||
| Net loss before income tax | (110,751 | ) | (47,837 | ) | (181,889 | ) | (99,421 | ) | |||||||||
| Income tax expense | (753 | ) | (134 | ) | (890 | ) | (231 | ) | |||||||||
| Net loss | $ | (111,504 | ) | $ | (47,971 | ) | $ | (182,779 | ) | $ | (99,652 | ) | |||||
| Comprehensive loss | $ | (111,767 | ) | $ | (48,135 | ) | $ | (183,220 | ) | $ | (100,525 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.71 | ) | $ | (0.48 | ) | $ | (1.20 | ) | $ | (1.02 | ) | |||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 157,880,203 | 99,831,111 | 152,154,469 | 97,838,926 | |||||||||||||
| 89bio, Inc. | ||||||
| Condensed Consolidated Balance Sheet Data | ||||||
| (Unaudited) | ||||||
| (In thousands) | ||||||
| June 30, | December 31, | |||||
| 2025 | 2024 | |||||
| Cash, cash equivalents and marketable securities | $ | 561,164 | $ | 439,955 | ||
| Total assets | 603,485 | 478,685 | ||||
| Total current liabilities | 39,611 | 36,129 | ||||
| Non current liabilities | 42,141 | 41,767 | ||||
| Total stockholders’ equity | 521,733 | 400,789 | ||||
| Total liabilities and stockholders' equity | $ | 603,485 | $ | 478,685 | ||
FAQ
When will 89bio (ETNB) report Phase 3 ENTRUST trial results for SHTG?
What is 89bio's (ETNB) cash position as of Q2 2025?
When will 89bio (ETNB) release ENLIGHTEN-Fibrosis Phase 3 trial results?
What was 89bio's (ETNB) net loss in Q2 2025?
What are the primary endpoints for 89bio's ENTRUST trial?
