89bio Reports Second Quarter 2024 Financial Results and Corporate Updates
89bio (Nasdaq: ETNB) reported Q2 2024 financial results and corporate updates. The company is advancing three Phase 3 trials for pegozafermin in MASH (metabolic dysfunction-associated steatohepatitis) and SHTG (severe hypertriglyceridemia). Key highlights include:
1. Initiated ENLIGHTEN-Cirrhosis Phase 3 trial for MASH patients with compensated cirrhosis (F4).
2. Ongoing enrollment in ENLIGHTEN-Fibrosis for non-cirrhotic MASH and ENTRUST for SHTG.
3. Cash position of $531.4 million as of June 30, 2024.
4. Q2 2024 net loss of $48.0 million, up from $38.4 million in Q2 2023.
5. R&D expenses increased to $44.9 million in Q2 2024 from $34.9 million in Q2 2023.
The company expects topline data from the ENTRUST trial in 2025 and is preparing for potential commercialization of pegozafermin.
89bio (Nasdaq: ETNB) ha riportato i risultati finanziari e gli aggiornamenti aziendali del secondo trimestre del 2024. L'azienda sta portando avanti tre studi di Fase 3 per pegozafermin in MASH (steatoepatite associata a disfunzione metabolica) e SHTG (ipertrigliceridemia severa). I punti salienti includono:
1. Inizio del trial di Fase 3 ENLIGHTEN-Cirrhosis per pazienti MASH con cirrosi compensata (F4).
2. Reclutamento in corso nel trial ENLIGHTEN-Fibrosis per MASH non cirrotici e ENTRUST per SHTG.
3. Posizione di cassa di 531,4 milioni di dollari al 30 giugno 2024.
4. Perdita netta del secondo trimestre 2024 di 48,0 milioni di dollari, in aumento rispetto ai 38,4 milioni di dollari del secondo trimestre 2023.
5. Le spese di R&D sono aumentate a 44,9 milioni di dollari nel secondo trimestre 2024, rispetto ai 34,9 milioni di dollari nel secondo trimestre 2023.
L'azienda si aspetta dati preliminari dal trial ENTRUST nel 2025 e si sta preparando per una potenziale commercializzazione di pegozafermin.
89bio (Nasdaq: ETNB) informó sobre los resultados financieros y las actualizaciones corporativas del segundo trimestre de 2024. La empresa está avanzando en tres ensayos de Fase 3 para pegozafermin en MASH (esteatohepatitis asociada a disfunción metabólica) y SHTG (hipertrigliceridemia severa). Los aspectos destacados incluyen:
1. Inicio del ensayo de Fase 3 ENLIGHTEN-Cirrhosis para pacientes de MASH con cirrosis compensada (F4).
2. Inscripción en curso en ENLIGHTEN-Fibrosis para MASH no cirróticos y ENTRUST para SHTG.
3. Posición de efectivo de 531,4 millones de dólares a 30 de junio de 2024.
4. Pérdida neta del segundo trimestre de 2024 de 48,0 millones de dólares, un aumento desde los 38,4 millones de dólares en el segundo trimestre de 2023.
5. Los gastos en I+D aumentaron a 44,9 millones de dólares en el segundo trimestre de 2024 desde los 34,9 millones de dólares en el segundo trimestre de 2023.
La empresa espera datos preliminares del ensayo ENTRUST en 2025 y se está preparando para la posible comercialización de pegozafermin.
89bio (나스닥: ETNB)는 2024년 2분기 재무 결과 및 기업 업데이트를 보고했습니다. 회사는 MASH(대사 기능 장애 관련 지방간염) 및 SHTG(중증 고트리글리세리드혈증)를 위한 3개의 3상 시험을 진행하고 있습니다. 주요 하이라이트는 다음과 같습니다:
1. 보상성 간경변(F4)이 있는 MASH 환자를 위한 ENLIGHTEN-Cirrhosis 3상 시험을 시작했습니다.
2. 비간경변 MASH와 SHTG를 위한 ENLIGHTEN-Fibrosis의 지속적인 등록.
3. 2024년 6월 30일 현재 현금 보유액은 5억 3,140만 달러입니다.
4. 2024년 2분기 순손실이 4,800만 달러로, 2023년 2분기 3,840만 달러에서 증가했습니다.
5. 연구개발비가 2023년 2분기 3,490만 달러에서 2024년 2분기 4,490만 달러로 증가했습니다.
회사는 2025년에 ENTRUST 시험의 주요 데이터를 기대하고 있으며, pegozafermin의 상용화를 위한 준비를 하고 있습니다.
89bio (Nasdaq: ETNB) a annoncé ses résultats financiers du deuxième trimestre 2024 ainsi que des mises à jour d'entreprise. L'entreprise avance trois essais de Phase 3 pour pegozafermin dans le cadre de MASH (stéato-hépatite associée à une dysfonction métabolique) et de SHTG (hypertriglycéridémie sévère). Les points clés incluent :
1. Lancement de l'essai de Phase 3 ENLIGHTEN-Cirrhosis pour les patients MASH avec cirrhose compensée (F4).
2. Inscription en cours dans ENLIGHTEN-Fibrosis pour les MASH non cirrhotiques et ENTRUST pour SHTG.
3. Position de liquidités de 531,4 millions de dollars au 30 juin 2024.
4. Perte nette de 48,0 millions de dollars pour le deuxième trimestre 2024, en hausse par rapport à 38,4 millions de dollars au deuxième trimestre 2023.
5. Les dépenses en R&D ont augmenté à 44,9 millions de dollars au deuxième trimestre 2024, contre 34,9 millions de dollars au deuxième trimestre 2023.
L'entreprise s'attend à des données finales de l'essai ENTRUST en 2025 et se prépare à une éventuelle commercialisation de pegozafermin.
89bio (Nasdaq: ETNB) hat die Finanzberichte und Unternehmensupdates für das zweite Quartal 2024 veröffentlicht. Das Unternehmen führt drei Phase-3-Studien für Pegozafermin bei MASH (metabolisch bedingte Steatohepatitis) und SHTG (schwere Hypertriglyceridämie) durch. Die wichtigsten Highlights sind:
1. Beginn der Phase-3-Studie ENLIGHTEN-Cirrhosis für MASH-Patienten mit kompensierter Zirrhose (F4).
2. Laufende Einschreibung in ENLIGHTEN-Fibrosis für nicht-zirrhotisches MASH und ENTRUST für SHTG.
3. Cash-Position von 531,4 Millionen Dollar zum 30. Juni 2024.
4. Nettogewinn im 2. Quartal 2024 von 48,0 Millionen Dollar, ein Anstieg von 38,4 Millionen Dollar im 2. Quartal 2023.
5. Die F&E-Ausgaben stiegen im 2. Quartal 2024 auf 44,9 Millionen Dollar, verglichen mit 34,9 Millionen Dollar im 2. Quartal 2023.
Das Unternehmen erwartet 2025 primäre Daten aus der ENTRUST-Studie und bereitet sich auf eine mögliche Kommerzialisierung von Pegozafermin vor.
- Initiated ENLIGHTEN-Cirrhosis Phase 3 trial for MASH patients with compensated cirrhosis
- Strong cash position of $531.4 million as of June 30, 2024
- Increased net interest income to $6.5 million in Q2 2024 from $4.6 million in Q2 2023
- Advancing three Phase 3 trials simultaneously in MASH and SHTG
- Preparing for potential commercialization of pegozafermin
- Net loss increased to $48.0 million in Q2 2024 from $38.4 million in Q2 2023
- R&D expenses rose to $44.9 million in Q2 2024 from $34.9 million in Q2 2023
- G&A expenses increased to $8.6 million in Q2 2024 from $7.2 million in Q2 2023
89bio's Q2 2024 results reveal a mixed financial picture. While R&D expenses increased by
The widening net loss of
89bio's progress in MASH (Metabolic dysfunction-Associated SteotoHepatitis) trials is noteworthy. The initiation of two Phase 3 trials - ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis - targets both non-cirrhotic MASH and MASH with compensated cirrhosis. This comprehensive approach addresses a significant unmet medical need, particularly for patients with advanced fibrosis and cirrhosis.
The potential for accelerated approval using histology in both trials is promising. The ENLIGHTEN-Cirrhosis trial's design, with its dual endpoint strategy (fibrosis regression at 24 months and a clinical outcome composite), aligns with regulatory pathways for both accelerated and full approval. This strategy could expedite market entry while gathering long-term efficacy data, potentially positioning pegozafermin as a leading treatment in the evolving MASH landscape.
–The Phase 3 ENLIGHTEN-Fibrosis trial in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and the Phase 3 ENLIGHTEN-Cirrhosis trial in patients with compensated cirrhosis (F4) are enrolling patients–
–Phase 3 ENTRUST trial for patients with severe hypertriglyceridemia (SHTG) continues to enroll patients and topline data is expected in 2025–
SAN FRANCISCO, Aug. 05, 2024 (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, 2024.
“We are thrilled to have initiated two pivotal Phase 3 trials addressing non-cirrhotic MASH (ENLIGHTEN-Fibrosis in F2-F3) and MASH with compensated cirrhosis (ENLIGHTEN-Cirrhosis in F4), which have the potential for accelerated approval using histology in both trials,” stated Rohan Palekar, CEO of 89bio. “In parallel to executing on three Phase 3 trials in both MASH and SHTG, we continue to take important steps forward that we believe will strategically enhance our preparedness for potential commercialization of pegozafermin including commercial manufacturing readiness. We believe in the prospects of pegozafermin in MASH, given the urgent medical need for more severe patients with advanced fibrosis and cirrhosis, in addition to the significant opportunity in SHTG to help patients who are refractory to current standard of care."
Recent Highlights and Anticipated Milestones
Metabolic dysfunction-associated steatohepatitis (MASH)
- ENLIGHTEN-Cirrhosis, a Phase 3 trial of pegozafermin in MASH patients with compensated cirrhosis (F4), was initiated in the second quarter.
- ENLIGHTEN-Cirrhosis is a global Phase 3, randomized, double-blind, placebo-controlled trial evaluating pegozafermin for the treatment of MASH patients with compensated cirrhosis (F4). The trial will enroll approximately 760 patients, who will be randomized in a 1:1 ratio to either receive 30mg of pegozafermin administered weekly or a placebo. A subset of the 760 patients will be evaluated at 24 months to assess fibrosis regression, potentially supporting an accelerated approval filing in the United States and conditional approval in Europe. The primary endpoint of fibrosis regression is defined as an improvement in fibrosis from F4 to an earlier stage. The primary endpoint for the final analysis will be a clinical outcome composite and is expected to form the basis for confirmatory or full approval.
- Data from the ENLIVEN Phase 2b trial was presented at the European Association for the Study of the Liver Congress (EASL) and was selected for the Poster Tour, a dedicated discussion session.
Severe Hypertriglyceridemia (SHTG)
- Enrollment is ongoing in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG.
- Topline results from this trial are expected to be reported in 2025.
Corporate Update
- Dr. Charles McWherter joined the Board of Directors, effective July 30, 2024. Dr. McWherter most recently served as Chief Scientific Officer and President of Research and Development of CymaBay Therapeutics, until it was acquired by Gilead Sciences in March 2024.
Second Quarter 2024 Financial Results
Cash Position. As of June 30, 2024, 89bio had cash, cash equivalents and marketable securities of
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 studies for its lead candidate, pegozafermin, 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 ENTRUST Phase 3 trial in SHTG. 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 March 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.
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, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 44,865 | $ | 34,915 | $ | 92,293 | $ | 57,221 | ||||||||
General and administrative | 8,571 | 7,214 | 18,420 | 13,432 | ||||||||||||
Total operating expenses | 53,436 | 42,129 | 110,713 | 70,653 | ||||||||||||
Loss from operations | (53,436 | ) | (42,129 | ) | (110,713 | ) | (70,653 | ) | ||||||||
Interest expense | (874 | ) | (894 | ) | (1,737 | ) | (2,969 | ) | ||||||||
Interest income and other, net | 6,473 | 4,630 | 13,029 | 6,393 | ||||||||||||
Net loss before income tax | (47,837 | ) | (38,393 | ) | (99,421 | ) | (67,229 | ) | ||||||||
Income tax expense | (134 | ) | — | (231 | ) | — | ||||||||||
Net loss | $ | (47,971 | ) | $ | (38,393 | ) | $ | (99,652 | ) | $ | (67,229 | ) | ||||
Comprehensive loss | $ | (48,135 | ) | $ | (38,747 | ) | $ | (100,525 | ) | $ | (67,473 | ) | ||||
Net loss per share, basic and diluted | $ | (0.48 | ) | $ | (0.52 | ) | $ | (1.02 | ) | $ | (1.06 | ) | ||||
Weighted-average shares used to compute net loss per share, basic and diluted | 99,831,111 | 74,126,569 | 97,838,926 | 63,706,856 | ||||||||||||
89bio, Inc. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) | |||||||
June 30, | December 31, | ||||||
2024 | 2023 | ||||||
Cash, cash equivalents and marketable securities | $ | 531,384 | $ | 578,870 | |||
Total assets | 582,138 | 596,269 | |||||
Total current liabilities | 41,653 | 29,611 | |||||
Non current liabilities | 25,568 | 30,352 | |||||
Total stockholders’ equity | 514,917 | 536,306 | |||||
Total liabilities and stockholders' equity | $ | 582,138 | $ | 596,269 | |||
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
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FAQ
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