89bio Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates
89bio (ETNB) reported financial results for Q4 and full year 2024, highlighting progress in its clinical trials. The company's Phase 3 ENLIGHTEN trials for MASH patients continue advancing, with topline histology data expected in 1H 2027 for non-cirrhotic patients and 2028 for cirrhotic patients. The Phase 3 ENTRUST trial in severe hypertriglyceridemia completed enrollment with 369 patients, with topline data now expected in Q1 2026.
Financial highlights include cash position of $440.0 million as of December 31, 2024, with additional gross proceeds of $287.5 million from a follow-on offering in Q1 2025. R&D expenses increased to $345.0 million for 2024, up from $122.2 million in 2023. The company reported a net loss of $367.1 million for 2024, compared to $142.2 million in 2023.
89bio (ETNB) ha riportato i risultati finanziari per il quarto trimestre e l'intero anno 2024, evidenziando i progressi nei suoi studi clinici. Gli studi di Fase 3 ENLIGHTEN per i pazienti con MASH continuano ad avanzare, con i dati istologici preliminari attesi nella prima metà del 2027 per i pazienti non cirrotici e nel 2028 per i pazienti cirrotici. Lo studio di Fase 3 ENTRUST per l'ipertrigliceridemia severa ha completato l'arruolamento con 369 pazienti, con i dati preliminari ora attesi nel primo trimestre del 2026.
I risultati finanziari includono una posizione di cassa di 440,0 milioni di dollari al 31 dicembre 2024, con ulteriori proventi lordi di 287,5 milioni di dollari da un'offerta successiva nel primo trimestre del 2025. Le spese per R&S sono aumentate a 345,0 milioni di dollari per il 2024, rispetto ai 122,2 milioni di dollari nel 2023. L'azienda ha riportato una perdita netta di 367,1 milioni di dollari per il 2024, rispetto ai 142,2 milioni di dollari nel 2023.
89bio (ETNB) informó sobre los resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en sus ensayos clínicos. Los ensayos de Fase 3 ENLIGHTEN para pacientes con MASH continúan avanzando, con datos histológicos preliminares esperados en la primera mitad de 2027 para pacientes no cirróticos y en 2028 para pacientes cirróticos. El ensayo de Fase 3 ENTRUST en hipertrigliceridemia severa completó la inscripción con 369 pacientes, y se esperan datos preliminares en el primer trimestre de 2026.
Los aspectos financieros incluyen una posición de efectivo de 440,0 millones de dólares al 31 de diciembre de 2024, con ingresos brutos adicionales de 287,5 millones de dólares de una oferta secundaria en el primer trimestre de 2025. Los gastos de I+D aumentaron a 345,0 millones de dólares para 2024, en comparación con 122,2 millones de dólares en 2023. La empresa reportó una pérdida neta de 367,1 millones de dólares para 2024, en comparación con 142,2 millones de dólares en 2023.
89bio (ETNB)는 2024년 4분기 및 연간 재무 결과를 보고하며 임상 시험에서의 진전을 강조했습니다. MASH 환자를 위한 3상 ENLIGHTEN 시험이 계속 진행 중이며, 비간경변 환자를 위한 2027년 상반기와 간경변 환자를 위한 2028년에 주요 조직학 데이터가 예상됩니다. 중증 고트리글리세리드혈증에 대한 3상 ENTRUST 시험은 369명의 환자로 등록을 완료했으며, 주요 데이터는 2026년 1분기에 예상됩니다.
재무 하이라이트에는 2024년 12월 31일 기준 4억 4천만 달러의 현금 보유액이 포함되며, 2025년 1분기에 후속 공모를 통해 2억 8천7백5십만 달러의 추가 총 수익이 발생했습니다. R&D 비용은 2024년에 3억 4천5백만 달러로 증가했으며, 2023년에는 1억 2천2백20만 달러였습니다. 회사는 2024년에 3억 6천7백1십만 달러의 순손실을 보고했으며, 이는 2023년의 1억 4천2백20만 달러에 비해 증가한 수치입니다.
89bio (ETNB) a rapporté les résultats financiers du quatrième trimestre et de l'année entière 2024, mettant en avant les progrès de ses essais cliniques. Les essais de Phase 3 ENLIGHTEN pour les patients atteints de MASH continuent d'avancer, avec des données histologiques préliminaires attendues au premier semestre 2027 pour les patients non cirrhotiques et en 2028 pour les patients cirrhotiques. L'essai de Phase 3 ENTRUST sur l'hypertriglycéridémie sévère a terminé son recrutement avec 369 patients, les données préliminaires étant désormais attendues au premier trimestre 2026.
Les points financiers incluent une position de trésorerie de 440,0 millions de dollars au 31 décembre 2024, avec des produits bruts supplémentaires de 287,5 millions de dollars provenant d'une offre secondaire au premier trimestre 2025. Les dépenses en R&D ont augmenté à 345,0 millions de dollars pour 2024, contre 122,2 millions de dollars en 2023. L'entreprise a déclaré une perte nette de 367,1 millions de dollars pour 2024, par rapport à 142,2 millions de dollars en 2023.
89bio (ETNB) hat die finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seinen klinischen Studien hervorgehoben. Die Phase-3-Studien ENLIGHTEN für MASH-Patienten schreiten weiter voran, wobei die vorläufigen histologischen Daten für nicht-zirrhotische Patienten in der ersten Hälfte von 2027 und für zirrhotische Patienten im Jahr 2028 erwartet werden. Die Phase-3-Studie ENTRUST bei schwerer Hypertriglyceridämie hat die Rekrutierung mit 369 Patienten abgeschlossen, wobei die vorläufigen Daten nun im ersten Quartal 2026 erwartet werden.
Finanzielle Höhepunkte umfassen eine Bargeldposition von 440,0 Millionen Dollar zum 31. Dezember 2024, mit zusätzlichen Bruttoeinnahmen von 287,5 Millionen Dollar aus einer Folgeangebot im ersten Quartal 2025. Die F&E-Ausgaben stiegen auf 345,0 Millionen Dollar für 2024, im Vergleich zu 122,2 Millionen Dollar im Jahr 2023. Das Unternehmen berichtete von einem Nettoverlust von 367,1 Millionen Dollar für 2024, verglichen mit 142,2 Millionen Dollar im Jahr 2023.
- Strong cash position of $440.0M plus $287.5M from follow-on offering
- Completed enrollment in Phase 3 ENTRUST trial with 369 patients
- Obtained FDA and EMA feedback for marketing authorization requirements
- Net loss increased to $367.1M in 2024 from $142.2M in 2023
- R&D expenses tripled to $345.0M in 2024 from $122.2M in 2023
- ENTRUST trial data delayed to Q1 2026 from previous timeline
– ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) metabolic dysfunction-associated steatohepatitis (MASH) continue to advance with topline histology data expected in 1H 2027 and 2028, respectively –
–The Phase 3 ENTRUST trial in severe hypertriglyceridemia (SHTG) will be unblinded after study completion at Week 52 vs. Week 26 following discussions with the U.S. Food and Drug Administration (FDA); topline data are now expected in 1Q 2026 –
– Cash, cash equivalents, and marketable securities totaled
SAN FRANCISCO, Feb. 27, 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 fourth quarter and full year ended December 31, 2024, and provided corporate updates.
“2024 marks a tremendous year of execution and progress for 89bio, highlighted by the initiation of two global pivotal trials targeting advanced MASH patients, as well as completion of enrollment in our Phase 3 ENTRUST trial in SHTG,” stated Rohan Palekar, Chief Executive Officer of 89bio. “As we look toward 2025 and beyond, we look forward to executing on our clinical trials and completing all scale-up and regulatory activities to position us for a successful Biologics License Application (BLA) filing, pending positive results in the Phase 3 trials. With its robust fibrosis benefit shown in clinical trials to date, potential best-in-class tolerability and safety profile, and convenient dosing, pegozafermin has the potential to significantly impact the lives of patients suffering from advanced MASH including those with cirrhosis, as well as SHTG.”
Recent Highlights and Anticipated Milestones
Metabolic dysfunction-associated steatohepatitis (MASH)
- The Company initiated the Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic (F2-F3) MASH and Phase 3 ENLIGHTEN-Cirrhosis trial in compensated cirrhotic (F4) MASH in the first half of 2024. 89bio expects topline data from the histology cohorts of ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis in the first half of 2027 and 2028, respectively.
- The data from the histology cohorts of both trials are intended to support accelerated approval in the United States and conditional approval in Europe in their respective indications, based on previously obtained alignment with the FDA and European Medicines Agency (EMA). Both trials will continue for outcomes, to potentially support full approval.
- Data analyses from the Phase 2b ENLIVEN trial highlighting the potential anti-fibrotic effects and the potential utility of non-invasive tests correlating with histological endpoints were presented at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November 2024.
Severe Hypertriglyceridemia (SHTG)
- Enrollment has been completed in the Phase 3 ENTRUST trial with a total of 369 patients. ENTRUST is a randomized, double-blind, placebo-controlled global trial evaluating the efficacy, safety and tolerability of pegozafermin in SHTG patients randomized into pegozafermin (30 mg, 20 mg) or placebo in a 3:3:2 ratio given once weekly (QW) for 52 weeks.
- The trial will now be unblinded after study completion at Week 52 vs. Week 26 following discussions with the FDA. The primary endpoint remains percentage change from baseline in fasting triglycerides (TG) at Week 26 compared to placebo, but it will now be analyzed after study unblinding at Week 52 to minimize any potential bias that may be introduced due to the unblinding of data prior to completion of the trial. As a result, 89bio now expects to report topline data from ENTRUST in the first quarter of 2026. This approach is aligned with the company’s strategy of prioritizing MASH and filing for SHTG after MASH.
Corporate Updates
- Completed follow-on equity offerings in 4Q 2024 and 1Q 2025 for gross proceeds of
$143.7 million and$287.5 million , respectively. - Obtained regulatory feedback from the FDA and the EMA on clinical, nonclinical, as well as Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The Company remains on track for potential BLA and Marketing Authorization Application (MAA) filings, pending positive clinical data.
Fourth Quarter and Full Year 2024 Financial Results
Cash Position. As of December 31, 2024, 89bio had cash, cash equivalents and marketable securities totaling
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, 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, and plans for scale-up and regulatory activities ahead of a potential BLA filing. 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; the sufficiency of 89bio's capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio’s Quarterly Report on Form 10-Q for the quarter ended November 30, 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 Contact:
Annie Chang
89bio, Inc.
annie.chang@89bio.com
PJ Kelleher
LifeSci Advisors, LLC
+1-617-430-7579
pkelleher@lifesciadvisors.com
Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
| 89bio, Inc. Condensed Consolidated Statement of Operations Data (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 111,303 | $ | 33,592 | $ | 345,037 | $ | 122,230 | ||||||||
| General and administrative | 10,702 | 7,614 | 39,619 | 28,974 | ||||||||||||
| Total operating expenses | 122,005 | 41,206 | 384,656 | 151,204 | ||||||||||||
| Loss from operations | (122,005 | ) | (41,206 | ) | (384,656 | ) | (151,204 | ) | ||||||||
| Interest expense | (1,191 | ) | (866 | ) | (5,290 | ) | (4,794 | ) | ||||||||
| Interest income and other, net | 5,099 | 5,704 | 23,559 | 17,676 | ||||||||||||
| Net loss before income tax | (118,097 | ) | (36,368 | ) | (366,387 | ) | (138,322 | ) | ||||||||
| Income tax expense | (257 | ) | (3,867 | ) | (692 | ) | (3,867 | ) | ||||||||
| Net loss | $ | (118,354 | ) | $ | (40,235 | ) | $ | (367,079 | ) | $ | (142,189 | ) | ||||
| Comprehensive loss | $ | (119,060 | ) | $ | (39,498 | ) | $ | (366,706 | ) | $ | (141,649 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.02 | ) | $ | (0.50 | ) | $ | (3.51 | ) | $ | (2.00 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 115,955,933 | 80,696,621 | 104,714,613 | 71,172,870 | ||||||||||||
| 89bio, Inc. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) | |||||||
| December 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash, cash equivalents and marketable securities | $ | 439,955 | $ | 578,870 | |||
| Total assets | 478,685 | 596,269 | |||||
| Total current liabilities | 36,129 | 29,611 | |||||
| Non-current liabilities | 41,767 | 30,352 | |||||
| Total stockholders’ equity | 400,789 | 536,306 | |||||
| Total liabilities and stockholders' equity | $ | 478,685 | $ | 596,269 | |||
FAQ
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