89bio Provides Business Update and Outlook for 2025
89bio (ETNB) provided a corporate update and business outlook for 2025, highlighting key developments in their clinical programs. The company completed enrollment in the Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG), with topline 26-week data expected in H2 2025. The Phase 3 ENLIGHTEN program for MASH (metabolic dysfunction-associated steatohepatitis) continues patient enrollment across both trials.
The company strengthened its financial position with $440 million in cash and equivalents as of December 31, 2024, bolstered by a $143.8 million equity offering and a credit facility up to $150 million with K2 HealthVentures. 89bio received regulatory feedback from FDA and EMA regarding pegozafermin's marketing requirements and enhanced its leadership team with four industry veterans in key positions.
89bio (ETNB) ha fornito un aggiornamento aziendale e le prospettive per il 2025, evidenziando i principali sviluppi nei loro programmi clinici. L'azienda ha completato l'arruolamento nella fase 3 dello studio ENTRUST per l'ipertrigliceridemia severa (SHTG), con i dati preliminari delle 26 settimane attesi per il secondo semestre del 2025. Il programma ENLIGHTEN di fase 3 per la MASH (steatoepatite associata a disfunzione metabolica) continua con l'arruolamento dei pazienti in entrambi gli studi.
L'azienda ha rafforzato la propria posizione finanziaria con 440 milioni di dollari in contante e equivalenti al 31 dicembre 2024, sostenuta da un'offerta di capitale di 143,8 milioni di dollari e una linea di credito di fino a 150 milioni di dollari con K2 HealthVentures. 89bio ha ricevuto feedback normativi dalla FDA e dall'EMA riguardo ai requisiti di commercializzazione di pegozafermin e ha potenziato il proprio team di leadership con quattro esperti del settore in posizioni chiave.
89bio (ETNB) proporcionó una actualización corporativa y perspectivas comerciales para 2025, destacando los desarrollos clave en sus programas clínicos. La compañía completó la inscripción en el ensayo ENTRUST de fase 3 para la hipertrigliceridemia severa (SHTG), con datos preliminares de 26 semanas esperados para el segundo semestre de 2025. El programa ENLIGHTEN de fase 3 para la MASH (esteatohepatitis asociada a disfunción metabólica) continúa con el reclutamiento de pacientes en ambos ensayos.
La empresa fortaleció su posición financiera con 440 millones de dólares en efectivo y equivalentes al 31 de diciembre de 2024, respaldada por una oferta de acciones de 143,8 millones de dólares y una línea de crédito de hasta 150 millones de dólares con K2 HealthVentures. 89bio recibió comentarios regulatorios de la FDA y la EMA sobre los requisitos de comercialización de pegozafermin y fortaleció su equipo directivo con cuatro veteranos de la industria en posiciones clave.
89bio (ETNB)는 2025년을 위한 기업 업데이트 및 비즈니스 전망을 제공하며 임상 프로그램의 주요 발전 사항을 강조했습니다. 이 회사는 심각한 고중성지방혈증(SHTG)을 위한 3상 ENTRUST 시험의 등록을 완료했으며, 26주간의 주요 데이터는 2025년 하반기에 예상됩니다. MASH(대사 질환 관련 지방간염)를 위한 3상 ENLIGHTEN 프로그램은 두 시험 모두에서 환자 등록을 계속하고 있습니다.
회사는 2024년 12월 31일 현재 4억 4천만 달러의 현금 및 현금성 자산으로 재무 상태를 강화하였으며, 1억 4천380만 달러의 주식 공급 및 K2 HealthVentures와의 최대 1억 5천만 달러의 신용 시설로 지원을 받았습니다. 89bio는 pegozafermin의 마케팅 요건에 대해 FDA와 EMA로부터 규제 피드백을 받았으며, 주요 직위에 업계 베테랑 4명을 영입하여 리더십 팀을 강화했습니다.
89bio (ETNB) a fourni une mise à jour de l'entreprise et des perspectives commerciales pour 2025, mettant en évidence les principaux développements de ses programmes cliniques. La société a terminé le recrutement dans l'essai de phase 3 ENTRUST pour l'hypertriglycéridémie sévère (SHTG), avec des données préliminaires de 26 semaines attendues pour le second semestre 2025. Le programme ENLIGHTEN de phase 3 pour la MASH (stéatohépatite associée à une dysfonction métabolique) continue le recrutement de patients dans les deux essais.
L'entreprise a renforcé sa position financière avec 440 millions de dollars en espèces et équivalents au 31 décembre 2024, soutenue par une offre d'actions de 143,8 millions de dollars et une ligne de crédit allant jusqu'à 150 millions de dollars avec K2 HealthVentures. 89bio a reçu des retours réglementaires de la FDA et de l'EMA concernant les exigences de marketing de pegozafermin et a renforcé son équipe de direction avec quatre vétérans de l'industrie à des postes clés.
89bio (ETNB) hat ein Unternehmensupdate und einen wirtschaftlichen Ausblick für 2025 gegeben, in dem wichtige Entwicklungen in ihren klinischen Programmen hervorgehoben werden. Das Unternehmen hat die Einschreibung in die Phase-3-Studie ENTRUST zur schweren Hypertriglyceridämie (SHTG) abgeschlossen, und die vorläufigen 26-Wochen-Daten werden für das zweite Halbjahr 2025 erwartet. Das Phase-3-Programm ENLIGHTEN für MASH (metabolisch bedingte Steatohepatitis) führt weiterhin die Patientenanmeldung in beiden Studien durch.
Das Unternehmen stärkte seine finanzielle Position mit 440 Millionen Dollar an Bargeld und Äquivalenten zum 31. Dezember 2024, unterstützt durch ein Aktienangebot über 143,8 Millionen Dollar und eine Kreditlinie von bis zu 150 Millionen Dollar mit K2 HealthVentures. 89bio erhielt regulatorisches Feedback von der FDA und der EMA zu den Vermarktungsanforderungen für Pegozafermin und verstärkte sein Führungsteam mit vier Branchenveteranen in Schlüsselpositionen.
- Strong cash position of $440 million as of December 31, 2024
- Successful completion of Phase 3 ENTRUST trial enrollment
- Secured $143.8 million through equity offering
- Obtained additional $150 million credit facility
- Received positive FDA and EMA feedback for marketing authorization requirements
- Phase 3 trial results not expected until second half of 2025
- Still in clinical-stage with no approved products
Insights
The business update reveals a strong financial position with
The dual-track Phase 3 program targeting both MASH and SHTG represents significant market opportunities. MASH affects approximately 10% of U.S. adults, while SHTG affects roughly 4 million Americans. Successful trial outcomes could position pegozafermin as a first-in-class therapy in these underserved markets.
The completion of enrollment in the ENTRUST Phase 3 trial for SHTG marks a important milestone, with topline data expected in H2 2025. This timing suggests patient follow-up is progressing as planned. The parallel progression of ENLIGHTEN trials in both non-cirrhotic and cirrhotic MASH patients demonstrates strategic trial execution, targeting different patient populations to maximize potential therapeutic reach.
Regulatory feedback from both FDA and EMA on clinical and CMC requirements provides clear pathways for potential BLA and MAA submissions. The development of commercial-scale manufacturing capabilities alongside clinical progression indicates strong preparation for potential market entry. The appointment of experienced regulatory leadership (Dr. Perney) strengthens the company's ability to navigate the complex approval process.
– Completed enrollment in Phase 3 ENTRUST trial in patients with severe hypertriglyceridemia (SHTG); topline 26-week data expected in the second half of 2025 –
– The Phase 3 ENLIGHTEN program in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) metabolic dysfunction-associated steatohepatitis (MASH) continues to enroll patients across both trials –
– Cash, cash equivalents, and marketable securities totaled approximately
SAN FRANCISCO, Jan. 13, 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 provided a corporate update and business outlook for 2025.
“Looking ahead to 2025, we are well-positioned to build on the momentum from the initiation and ongoing enrollment of our ENLIGHTEN Phase 3 program in MASH and the successful completion of enrollment in our ENTRUST Phase 3 trial in SHTG and expect to announce topline data from the Company’s first Phase 3 trial in the second half of 2025,” said Rohan Palekar, CEO of 89bio. “We remain confident in pegozafermin’s potential as a potent anti-fibrotic agent with broad cardio-metabolic benefits. With a strengthened leadership team, commercial-scale manufacturing available, and a bolstered financial position, we continue to advance our Phase 3 programs toward potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings, aiming to transform care for patients living with MASH and SHTG.”
Key 2024 Highlights
- Completed enrollment in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG. 89bio expects to report topline 26-week data from this trial in the second half of 2025.
- Initiated ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, the Phase 3 trials in non-cirrhotic (F2-F3) MASH patients with fibrosis and in compensated cirrhotic (F4) MASH patients, in March and May of 2024, respectively. Both MASH studies continue to enroll patients globally.
- Obtained regulatory feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on clinical as well as Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The Company remains on track for potential BLA and MAA filings, pending positive clinical data.
- Bolstered its balance sheet through the completed equity follow-on offering for
$143.8 million in gross proceeds and an amended credit facility with K2 HealthVentures, providing an aggregate principal of up to$150.0 million . Cash, cash equivalents, and marketable securities totaled approximately$440 million as of December 31, 2024 (preliminary unaudited). - Strengthened its executive leadership team and Board of Directors with four seasoned industry veterans. Appointments include Teresa Perney, Ph.D., Chief Regulatory and Quality Officer; Francis Sarena, Chief Operating Officer; Charles McWherter, Ph.D., Board of Directors; and Martin Babler, Board of Directors. These additions bring extensive operational, clinical, regulatory, and commercial expertise to 89bio.
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 focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) 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 results from the ENTRUST Phase 3 trial in SHTG and enrollment in clinical trials, including enrollment of the Phase 3 ENLIGHTEN-Fibrosis trial and Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and 89bio’s potential BLA and MAA filings. 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 September 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
FAQ
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