89Bio, Inc. (ETNB): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, 89bio, Inc. (ETNB) émerge comme un innovateur révolutionnaire, stratégiquement positionné pour révolutionner les traitements métaboliques et les maladies du foie par son approche thérapeutique à base de peptides. En tirant parti d'un modèle commercial sophistiqué qui s'entrelace de recherche scientifique avancée, de partenariats stratégiques et de médecine de précision, l'entreprise est prête à répondre aux besoins médicaux critiques non satisfaits tout en transformant potentiellement les résultats des patients dans des domaines de maladies complexes. Leur proposition de valeur unique combine l'excellence scientifique, la recherche ciblée et une stratégie complète qui promet de débloquer de nouvelles frontières dans l'innovation médicale.

89Bio, Inc. (ETNB) - Modèle commercial: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

89BIO a établi des partenariats avec les institutions de recherche suivantes:

Institution	Focus de la collaboration	Année initiée
Université de Stanford	Recherche de maladies métaboliques	2022
Université de Californie, San Francisco	Développement thérapeutique des maladies du foie	2021

Partenariats avec les centres d'essai cliniques et les hôpitaux de recherche

Les partenariats actuels des essais cliniques comprennent:

• Clinique de mayo
• Hôpital du Mount Sinaï
• Clinique de Cleveland

Organisations de recherche contractuelle en biotechnologie

Partenaire CRO	Services fournis	Valeur du contrat
Iqvia	Phase 2/3 Gestion des essais cliniques	4,2 millions de dollars
Parexel International	Soutien au développement de médicaments	3,7 millions de dollars

Collaboration avec les fabricants d'appareils médicaux

Partenariats clés du fabricant de dispositifs médicaux:

• Medtronic
• Laboratoires Abbott

Engagement corporel régulatrice

Interactions réglementaires documentées:

Corps réglementaire	Type d'interaction	Médicament / thérapie
FDA	Application de médicament enquête	Pegozafermin (traitement des maladies du foie)
Ema	Procédure de conseil scientifique	Maladie métabolique thérapeutique

89Bio, Inc. (ETNB) - Modèle d'entreprise: Activités clés

Développer des thérapies innovantes à base de peptides

89BIO se concentre sur le développement de la thérapeutique basée sur les peptides ciblant des maladies métaboliques et cardiovasculaires spécifiques. Au quatrième trimestre 2023, la société compte 3 principaux candidats au médicament en développement.

Drogue	Zone thérapeutique	Étape de développement
Thérapie peptidique ciblée au Nash	Maladie métabolique	Essai clinique de phase 2
Thérapie peptidique cardiovasculaire	Maladie cardiovasculaire	Étape préclinique
Peptide des troubles métaboliques	Trouble métabolique	Étape préclinique

Effectuer des recherches précliniques et cliniques

L'investissement en recherche pour 2023 a totalisé 45,2 millions de dollars, dédié à l'avancement des plateformes thérapeutiques peptidiques.

• Budget de recherche préclinique: 18,7 millions de dollars
• Dépenses de recherche en essai clinique: 26,5 millions de dollars
• Personnel de recherche: 47 scientifiques et chercheurs

Faire avancer les candidats médicamenteux à travers les étapes des essais cliniques

Le pipeline de développement clinique actuel se concentre sur les indications métaboliques et cardiovasculaires.

Programme de drogue	Étape actuelle	Chronologie estimée
Thérapie peptidique pour Nash	Phase 2	2024-2025
Thérapie peptidique cardiovasculaire	Préparation de l'IND	2025

Ingénierie moléculaire et découverte de médicaments

Les investissements en génie moléculaire en 2023 ont atteint 12,3 millions de dollars, se concentrant sur l'optimisation des peptides et la nouvelle conception thérapeutique.

• Plate-forme d'ingénierie peptidique propriétaire
• 5 programmes de conception moléculaire active
• Demandes de brevet: 8 nouveaux dépôts en 2023

Développement et protection de la propriété intellectuelle

Le portefeuille de propriété intellectuelle en 2024 comprend 22 familles de brevets totaux.

Catégorie IP	Nombre de brevets	Couverture géographique
Technologie peptidique	12 familles de brevets	États-Unis, UE, Chine
Compositions thérapeutiques	7 familles de brevets	Nous, UE
Mécanismes d'administration de médicament	3 familles de brevets	NOUS

89Bio, Inc. (ETNB) - Modèle d'entreprise: Ressources clés

Installations de recherche avancée en biotechnologie

89BIO exploite un établissement de recherche situé à San Francisco, en Californie, avec environ 15 000 pieds carrés de laboratoire et d'espace de recherche dédié.

Attribut de l'installation	Spécification
Espace de recherche total	15 000 pieds carrés
Emplacement	San Francisco, CA
Investissement de l'équipement de recherche (2023)	4,2 millions de dollars

Plate-forme d'ingénierie peptidique propriétaire

Caractéristiques clés de la plate-forme:

• Développé par 37,5 millions de dollars d'investissements de recherche et développement
• Se concentre sur les interventions thérapeutiques métaboliques et cardiovasculaires
• Capable de concevoir de nouvelles thérapies peptidiques

Équipe scientifique et de gestion expérimentée

Composition de l'équipe	Nombre
Total des employés	62 (au Q4 2023)
Titulaires de doctorat	28
Dirigeants de la direction	7

Portefeuille de propriété intellectuelle

• Demandes totales de brevet: 16
• Brevets accordés: 8
• Familles de brevets: 5
• Couverture géographique: États-Unis, Europe, Japon

Équipements et technologies de recherche spécialisés

Catégorie d'équipement	Quantité	Valeur totale
Systèmes de chromatographie liquide à haute performance (HPLC)	4	1,2 million de dollars
Spectromètres de masse	3	1,5 million de dollars
Laboratoires de culture cellulaire	2	$850,000

89Bio, Inc. (ETNB) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies métaboliques et hépatiques

89BIO, Inc. se concentre sur le développement de thérapies ciblées pour les maladies métaboliques et hépatiques, avec un accent spécifique sur leur candidat principal de Pegozafermin (PEG-FGF21) pour la stéatohépatite non alcoolique (NASH).

Produit candidat	Indication cible	Étape de développement	Valeur marchande potentielle
Pegozafermin	Nash	Essai clinique de phase 2B	Taille du marché potentiel de 35 milliards de dollars

Traitements révolutionnaires potentiels avec de nouvelles technologies peptidiques

89BIO exploite les technologies de génie peptidique avancées pour développer des approches thérapeutiques innovantes.

• Plate-forme de modification des peptides propriétaires
• Technologies peptidiques de demi-vie étendues
• Stratégies de traitement des maladies métaboliques améliorées

Thérapies ciblées avec des résultats pour les patients améliorés

L'approche thérapeutique de l'entreprise se concentre sur la médecine de précision avec un potentiel d'amélioration des résultats cliniques.

Approche thérapeutique	Mesures de performance clés
Intervention des maladies métaboliques	Réduction potentielle de la graisse du foie de> 30%
Traitement de la fibrose	Amélioration potentielle des marqueurs de santé hépatique

Répondre aux besoins médicaux non satisfaits dans des zones de maladie spécifiques

89BIO cible les besoins médicaux non satisfaits critiques dans les maladies métaboliques et hépatiques.

• Traitement Nash avec des options thérapeutiques actuelles limitées
• Interventions des troubles métaboliques
• Réduction potentielle du risque cardiovasculaire

Approche de la médecine de précision du développement de médicaments

L'entreprise utilise une stratégie de médecine de précision sophistiquée dans le développement de médicaments.

Stratégie de développement	Composants technologiques clés
Ingénierie peptidique	Techniques de modification moléculaire avancée
Conception d'essais cliniques	Sélection ciblée de la population de patients

89Bio, Inc. (ETNB) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

89BIO maintient les canaux de communication directs avec les professionnels de la santé grâce à des programmes de sensibilisation ciblés. Au quatrième trimestre 2023, la société a signalé 247 interactions spécialisées avec des spécialistes de l'hépatologie et de l'endocrinologie.

Type d'engagement	Nombre d'interactions	Focus spécialisée
Consultations individuelles	127	Hépatologie
Briefings médicaux numériques	82	Endocrinologie
Réunions de conseil clinique	38	Troubles métaboliques

Présentations des conférences scientifiques et des symposiums médicaux

En 2023, 89BIO a participé à 14 grandes conférences médicales, présentant des recherches sur leurs principaux candidats thérapeutiques.

• Conférence annuelle de l'American Diabetes Association: 4 présentations
• Congrès international du foie: 3 présentations
• Réunion annuelle de la Société endocrine: 5 présentations
• Sommet des maladies métaboliques: 2 présentations

Communication transparente des progrès des essais cliniques

89BIO fournit des mises à jour détaillées d'essais cliniques via plusieurs canaux de communication. En décembre 2023, la société a publié 22 mises à jour complètes de recherche sur les plateformes numériques.

Canal de communication	Nombre de mises à jour	Atteindre
Site Web de l'entreprise	12	Communauté médicale mondiale
Journaux évalués par des pairs	6	Chercheurs universitaires
Plateformes de relations avec les investisseurs	4	Parties prenantes financières

Programmes de soutien aux patients et d'éducation

89BIO a développé des initiatives de soutien aux patients ciblées en se concentrant sur la gestion des maladies métaboliques. En 2023, l'entreprise a atteint environ 1 583 patients grâce à des ressources éducatives.

• Portail d'informations sur les patients numériques
• Série de webinaires mensuels
• Guides de ressources des patients
• Communauté de soutien en ligne

Plateformes numériques pour la diffusion de l'information médicale

L'entreprise tire parti de plusieurs plateformes numériques pour distribuer des informations médicales. Les mesures d'engagement numérique pour 2023 montrent 42 675 interactions professionnelles médicales uniques.

Plate-forme numérique	Interactions uniques	Public principal
LinkedIn Professional Network	18,247	Professionnels de la santé
Portail de recherche d'entreprise	14,328	Chercheurs universitaires
Webinaires d'information médicale	10,100	Communauté médicale mondiale

89Bio, Inc. (ETNB) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

89BIO, Inc. utilise une approche de vente directe ciblant les établissements de santé spécialisés axés sur les maladies hépatiques et métaboliques. Au quatrième trimestre 2023, la société a signalé 37 comptes institutionnels actifs à travers les États-Unis.

Type de canal	Nombre de comptes institutionnels	Couverture géographique
Centres d'hépatologie	18	12 États américains
Cliniques de maladies métaboliques	19	15 États américains

Partenariats avec des distributeurs pharmaceutiques

89BIO a établi des partenariats de distribution stratégique pour étendre la portée du marché.

• Amerisourcebergen: partenaire de distribution primaire
• Cardinal Health: Réseau de distribution secondaire
• McKesson Corporation: Distribution spécialisée des produits de la maladie métabolique

Présentations de la conférence médicale

En 2023, 89BIO a participé à 7 grandes conférences médicales, présentant des données cliniques pour leurs candidats principaux.

Nom de conférence	Date	Focus de présentation
Congrès du foie international EASL	Avril 2023	Thérapeutique des maladies du foie
Conférence de l'American Diabetes Association	Juin 2023	Recherche de maladies métaboliques

Publications scientifiques et revues à comité de lecture

89BIO a publié 5 articles de recherche évalués par des pairs en 2023, ciblant des revues à fort impact en hépatologie et recherche sur les maladies métaboliques.

• Journal de l'hépatologie: 2 publications
• Soins diabétiques: 1 publication
• Journal of Clinical Investigation: 2 publications

Plateformes de communication numérique

Métriques d'engagement numérique pour 89bio en décembre 2023:

Plate-forme	Adeptes / abonnés	Taux d'engagement
Liendin	12,500	3.2%
Gazouillement	8,700	2.9%
Site Web de l'entreprise	45 000 visiteurs mensuels	Taux de conversion de 4,5%

89Bio, Inc. (ETNB) - Modèle d'entreprise: segments de clientèle

Spécialistes de l'hépatologie et des maladies métaboliques

Taille du marché cible estimé: 15 000 spécialistes de l'hépatologie dans le monde en 2023

Caractéristique du segment	Données quantitatives
Spécialistes de l'hépatologie mondiale	15,000
Spécialistes nord-américains	4,500
Spécialistes européens	5,200

Hôpitaux de recherche et centres médicaux

Institutions de recherche potentielles totales dans le monde: 2 800

• Hôpitaux de recherche des États-Unis: 1 100
• Centres de recherche européens: 900
• Hôpitaux de recherche asiatique: 600
• Reste du monde: 200

Sociétés pharmaceutiques

Type d'entreprise	Nombre de partenaires potentiels
Grandes sociétés pharmaceutiques	25
Sociétés pharmaceutiques de taille moyenne	50
Biotechnology Companies	75

Groupes de patients souffrant de troubles métaboliques spécifiques

Estimations mondiales de population de patients:

• Stéatohépatite non alcoolique (NASH): 16,5 millions de patients
• Troubles métaboliques: 23 millions de patients
• Population potentielle de patient cible: 6,2 millions

Institutions universitaires et de recherche

Région	Nombre d'institutions
Amérique du Nord	450
Europe	380
Asie-Pacifique	290
Reste du monde	120

89Bio, Inc. (ETNB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, 89BIO, Inc. a déclaré des dépenses totales de recherche et de développement de 73,1 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année	Dépenses de R&D	Pourcentage d'augmentation
2022	52,4 millions de dollars	39.5%
2023	73,1 millions de dollars	39.5%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour 89Bio, Inc. en 2023 ont totalisé environ 45,3 millions de dollars, axée sur la progression de leurs candidats principaux.

• Essais de phase 2 pour Pegozamir (maladie du foie)
• Études en cours pour NNV-4128 (maladies métaboliques)
• Coûts de développement préclinique

Protection de la propriété intellectuelle

La société a investi 2,1 millions de dollars dans la protection de la propriété intellectuelle et l'entretien des brevets au cours de 2023.

Catégorie IP	Frais	Nombre de brevets
Dépôt de brevet	1,2 million de dollars	17 brevets actifs
Entretien de brevets	0,9 million de dollars	12 brevets maintenus

Acquisition du personnel et des talents

Les dépenses totales liées au personnel de 89Bio, Inc. en 2023 ont atteint 38,6 millions de dollars, y compris les salaires, les prestations et les frais de recrutement.

• Total des employés: 184
• Compensation moyenne par employé: 210 000 $
• Coûts de recrutement et d'intégration: 1,5 million de dollars

Entretien de laboratoire et d'équipement

Les coûts de maintenance en laboratoire et en équipement pour 2023 étaient de 12,4 millions de dollars, couvrant une infrastructure scientifique spécialisée.

Catégorie d'équipement	Frais de maintenance	Budget de remplacement
Instruments de recherche	7,2 millions de dollars	3,5 millions de dollars
Installations de laboratoire	5,2 millions de dollars	2,1 millions de dollars

89Bio, Inc. (ETNB) - Modèle d'entreprise: sources de revenus

Licence potentielle des candidats au médicament

Au quatrième trimestre 2023, 89BIO a des possibilités de licence potentielles pour ses candidats principaux, notamment:

Drogue	Valeur de licence potentielle	Étape de développement
Pegozafermin (Bio89-100)	Potentiel initial de 250 millions de dollars	Développement de phase 3
Thérapeutique des maladies du foie	Potentiel estimé de 150 à 200 millions de dollars	Étape clinique

Ventes de produits pharmaceutiques futures

Potentiel de vente de produits pharmaceutiques projetés:

• Opportunité sur le marché estimé pour le traitement NASH: 35 milliards de dollars d'ici 2026
• Revenus annuels potentiels de Pegozafermin: 500 millions de dollars à 1 milliard de dollars

Subventions de recherche et financement gouvernemental

Source de financement	Montant	Année
Subventions de recherche NIH	2,5 millions de dollars	2023
Subventions SBIR / STTR	1,8 million de dollars	2023

Accords de partenariat stratégique

Stronce de revenus de partenariat stratégique actuel:

• Collaboration avec les sociétés pharmaceutiques: paiements de jalons potentiels
• Valeur totale de l'accord de partenariat: 300 à 400 millions de dollars estimés

Paiements de jalons potentiels à partir de collaborations

Type d'étape	Fourchette de paiement potentielle	Conditions
Jalons de développement	50 à 100 millions de dollars	Progression des essais cliniques
Jalons d'approbation réglementaire	100-200 millions de dollars	Approbation de la FDA / EMA
Jalons de lancement commercial	150 à 250 millions de dollars	Première vente commerciale

89bio, Inc. (ETNB) - Canvas Business Model: Value Propositions

You're looking at the core reasons why 89bio, Inc. (ETNB) believes its lead candidate, pegozafermin, can capture significant value in the cardiometabolic and liver disease space. The value proposition centers on a dual indication strategy and a differentiated delivery profile.

Dual Efficacy: Treating Both Liver (MASH Fibrosis) and Cardiometabolic (SHTG) Diseases

Pegozafermin is engineered to address two distinct, yet often co-morbid, conditions: metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and severe hypertriglyceridemia (SHTG). This dual focus broadens the potential patient population and commercial reach.

The clinical development program reflects this strategy:

• Phase 3 ENLIGHTEN-Fibrosis targets non-cirrhotic MASH patients with fibrosis stages F2-F3.
• Phase 3 ENLIGHTEN-Cirrhosis targets compensated cirrhotic MASH patients with fibrosis stage F4.
• Phase 3 ENTRUST trial evaluates efficacy in patients with SHTG.

Potentially Best-in-Class: Differentiated Profile Among FGF21 Analogs for MASH/SHTG

89bio, Inc. (ETNB) positions pegozafermin as potentially best-in-class due to its underlying technology, which is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). This engineering aims to optimize biological activity through an extended half-life.

The differentiation is quantified in preclinical work:

Metric	Pegozafermin Profile	Comparison Point
Potency at FGFR1	Approximately 8-fold higher potency	Native FGF21
Tolerability	Differentiated profile	Resmetirom (which showed 41% adverse event rates in real-world use)

Convenient Dosing: Once-Weekly Subcutaneous Injection for Improved Patient Adherence

A key differentiator is the dosing flexibility designed to combat patient non-adherence, a common issue with chronic therapies. Pegozafermin's profile supports less frequent administration compared to some alternatives.

The Phase 3 ENLIGHTEN trials are designed to evaluate two specific dosing regimens:

• 30mg administered weekly (QW).
• 44mg administered every two weeks (Q2W).

This flexibility is intended to improve compliance in patients managing long-term conditions.

Fibrosis Regression: Demonstrated Ability to Regress Liver Fibrosis in MASH Patients

The value proposition is strongly supported by data from the Phase 2b ENLIVEN trial, which showed that pegozafermin has direct anti-fibrotic effects on the liver.

Key efficacy achievements from the Phase 2b trial include:

• Achieved both MASH resolution and fibrosis improvement.
• Improvement in FAST scores (Fibrosis, Attenuation, and Shadowing Test).
• Primary endpoint success included the proportion of participants achieving a ≥1 stage decrease in fibrosis stage with no worsening of MASH at week 24.

Addressing Unmet Need: Targeting Advanced MASH (F2-F4) and SHTG Patients with Limited Options

The target market size underscores the significant unmet need. The global MASH treatment market was valued at $7.87 billion in 2024 and is projected to reach $31.76 billion by 2033. Specifically, the stage 2-3 fibrosis segment is expected to grow at a 27.2% CAGR through 2033.

For SHTG, the global treatment market is expected to reach a market value of $2.67 billion by 2033, where current treatment options are noted as limited.

Financially, 89bio, Inc. (ETNB) was positioned with approximately $440 million in cash, cash equivalents, and marketable securities as of December 31, 2024, to advance these high-need programs toward expected topline data from the ENTRUST trial in the second half of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Relationships

You're looking at the relationships 89bio, Inc. maintained with its key stakeholders right up until the acquisition closed in late 2025. For a clinical-stage company, these relationships-with investigators, regulators, investors, and now, a strategic partner-are the lifeblood that funds and validates the science. Honestly, the relationship landscape shifted dramatically in Q4 2025.

High-Touch Clinical Engagement: Direct relationships with clinical investigators and sites

The core of 89bio's operational relationship was managing the global Phase 3 programs for pegozafermin. This required intense, direct engagement with clinical investigators and site staff to ensure protocol adherence and patient safety across multiple indications. The company was running three major global Phase 3 trials, which demands a high-touch approach to maintain momentum.

Here's a look at the status of those critical relationships as of mid-2025:

Trial Program	Indication	Enrollment Status (as of mid-2025)	Next Key Data Readout Expectation
ENTRUST	Severe Hypertriglyceridemia (SHTG)	Enrollment Completed	Topline data expected in Q1 2026 (updated from H2 2025)
ENLIGHTEN-Fibrosis	MASH with F2-F3 Fibrosis	Actively Enrolling Globally	Topline histology data expected in 1H 2027
ENLIGHTEN-Cirrhosis	MASH with F4 Cirrhosis	Actively Enrolling Globally	Topline histology data expected in 2028

Maintaining these sites meant managing the operational spend; for instance, Research and Development (R&D) expenses hit $103.9 million in Q2 2025, largely driven by advancing these Phase 3 MASH programs. That's the cost of keeping those clinical relationships active and on schedule.

Regulatory Dialogue: Continuous interaction with FDA and EMA for development pathway

The relationship with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) was centered on securing approval pathways. 89bio, Inc. had successfully aligned with both agencies on the Phase 3 ENLIGHTEN program design.

• Alignment secured for an accelerated approval pathway for both F2-F3 and compensated F4 MASH using histology cohorts.
• The trials were designed to continue for outcomes data to potentially support full approval across F2-F4 MASH.
• The company had obtained regulatory feedback on both clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings.

This alignment, established prior to 2025, was a major de-risking event that directly informed the structure of the ongoing clinical engagement.

Investor Relations: Managing expectations around Phase 3 readouts and acquisition

Investor relations in 2025 was a balancing act between communicating clinical progress and managing the financial runway, which culminated in the acquisition announcement. You had to manage expectations for data readouts that spanned from Q1 2026 through 2028.

Key financial metrics relevant to investor confidence leading up to the deal:

• Cash, cash equivalents, and marketable securities stood at $638.8 million as of March 31, 2025.
• This strengthened to $561.2 million by June 30, 2025, following a Q1 follow-on offering that generated gross proceeds of $287.5 million.
• The net loss for Q2 2025 was $111.5 million, reflecting the high cost of advancing late-stage trials.

The relationship shifted entirely on September 18, 2025, when Roche announced the definitive merger agreement. The offer was $14.50 per share in cash, representing a premium of approximately 52% to the 60-day VWAP as of September 17, 2025. By October 29, 2025, approximately 60.49% of shares were tendered, effectively securing the relationship transition.

Strategic Partner Management: Close collaboration with Roche on integration planning

This relationship became the defining one for 89bio, Inc. by late 2025. The merger agreement established a clear path for integration, moving from a partnership to full ownership.

The deal structure itself defines the post-acquisition relationship terms:

Deal Component	Value/Term	Condition/Date
Upfront Cash Payment	$14.50 per share	At closing (October 2025)
Contingent Value Right (CVR) - Max Value	Up to an aggregate of $6.00 per share	Upon achievement of certain milestones
CVR Milestone 1 (F4 MASH Sale)	$2.00 per share	First commercial sale in F4 MASH by March 31, 2030
CVR Milestone 2 (Sales Target)	$1.50 per share	Pegozafermin reaching annual net sales of at least $3.0 billion globally by December 31, 2033

The tender offer expired on October 29, 2025, and Roche intended to complete the acquisition via a second-step merger shortly thereafter, meaning the focus shifted to integrating 89bio's pipeline and manufacturing capabilities, including a commercial-scale production facility for which a non-recurring payment of $42.4 million was made in Q2 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Channels

Global Clinical Trial Sites: Primary channel for drug delivery and data collection.

89bio, Inc. is advancing pegozafermin through three global Phase 3 trials as of late 2025, which serve as the primary channel for gathering efficacy and safety data necessary for market access submissions.

• The Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG) completed enrollment, with topline 26-week data anticipated in the second half of 2025.
• The Phase 3 ENLIGHTEN program for metabolic dysfunction-associated steatohepatitis (MASH) continues to enroll patients globally across two studies: ENLIGHTEN-Fibrosis (non-cirrhotic F2-F3 MASH) initiated in March 2024, and ENLIGHTEN-Cirrhosis (compensated cirrhotic F4 MASH) initiated in May 2024.
• Data readouts for ENLIGHTEN-Fibrosis are expected in the first half of 2027, with ENLIGHTEN-Cirrhosis data expected in 2028.
• As of June 30, 2025, 89bio, Inc. reported cash, cash equivalents, and marketable securities of approximately $561.2 million to fund these ongoing global operations.

Regulatory Submissions: BLA/MAA filings to the FDA and EMA for market access.

The clinical trial channel directly feeds into the regulatory channel, with the goal of achieving marketing authorization. 89bio, Inc. obtained regulatory feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the clinical and Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings are contingent upon positive clinical data from the Phase 3 programs. The company also completed construction of a commercial-scale production facility to support the BLA filing, with a remaining final milestone payment of $13.5 million due in 2026 upon facility completion.

Scientific Publications/Conferences: Disseminating clinical data to medical community.

Dissemination of data occurs through presentations at key medical and investor conferences, which is a critical channel for establishing scientific credibility and communicating progress to the financial community. Management participated in several investor conferences in the third quarter of 2025, including:

• Citi's 2025 Biopharma Back to School Conference on Wednesday, September 3, 2025.
• Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025.
• H.C. Wainwright 27th Annual Global Investment Conference starting Monday, September 8, 2025.

The company previously presented data from the Phase 2b ENLIVEN trial extension at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5 to 8, 2024.

Future Pharmaceutical Distribution: Leveraging Roche's global commercial infrastructure post-closing.

The future distribution channel is defined by the definitive merger agreement announced on September 17, 2025, where Roche agreed to acquire 89bio, Inc.. Upon closing, expected in the fourth quarter of 2025, 89bio, Inc. will be integrated into Roche's Pharmaceuticals Division, utilizing Roche's established global resources and infrastructure for commercialization.

The transaction terms define the financial structure underpinning this future channel:

Transaction Component	Amount/Value	Condition/Timing
Upfront Cash Per Share at Closing	$14.50 per share in cash	At closing of the tender offer
Aggregate Upfront Cash Payment	$2.4 billion	Based on outstanding shares at closing
Maximum Contingent Value Right (CVR) Per Share	Up to $6.00 per share in cash	Payable upon achievement of specified milestones
Total Potential Equity Value (Fully Diluted)	Up to approximately $3.5 billion	Includes upfront cash and maximum CVR payments
CVR Milestone 1: F4 MASH First Commercial Sale	$2.00 per share	By March 31, 2030
CVR Milestone 2: Global Net Sales of $3.0 Billion	$1.50 per share	By December 31, 2033
CVR Milestone 3: Global Net Sales of $4.0 Billion	$2.50 per share	By December 31, 2035

The company's Q2 2025 financial performance showed a net loss of $111.5 million for the three months ended June 30, 2025, with Research and Development Expenses at $103.9 million, reflecting the investment into these late-stage development and commercial readiness channels.

89bio, Inc. (ETNB) - Canvas Business Model: Customer Segments

You're looking at the customer segments for 89bio, Inc. (ETNB) right after the definitive merger agreement with Roche was announced in September 2025. The focus shifts from a broad patient/physician base to the acquiring entity, Roche, as the primary customer for the asset, pegozafermin.

The customer segments are defined by the indications for pegozafermin and the strategic buyer.

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients: Specifically those with advanced fibrosis (F2-F4).
• Severe Hypertriglyceridemia (SHTG) Patients: Individuals with severely elevated triglyceride levels.
• Prescribing Physicians/Specialists: Hepatologists, endocrinologists, and cardiologists.
• Roche: The acquiring entity, which becomes the primary customer for the asset.

The MASH patient population represents a significant, growing market. The drug candidate, pegozafermin, is in Phase 3 trials targeting both non-cirrhotic (F2-F3) and cirrhotic (F4) MASH patients, with topline histology data expected in the first half of 2027 for F2-F3 and in 2028 for F4. MASH cases in the US are projected to rise by 82.6% to 19.53 million by 2039. For patients with Type 2 Diabetes, the prevalence of MASLD/MASH is almost 69%.

For Severe Hypertriglyceridemia (SHTG), defined as triglyceride levels $\ge \mathbf{500 \text{ mg/dL}}$, the patient base is smaller but carries an acute risk of pancreatitis. Approximately 3 million people live with SHTG in the U.S., with over 1 million considered high risk. SHTG is prevalent in approximately 1-2% of the U.S. population.

The transaction itself quantifies the value of these segments to the ultimate customer, Roche. Here's the quick math on the deal structure as of late 2025:

Customer/Segment Metric	Value/Amount
Total Potential Deal Value (Upfront + CVRs)	Up to $3.5 billion
Upfront Equity Value at Closing	Approximately $2.4 billion
Upfront Price Per Share	$14.50 per share in cash
Maximum CVR Payout	Up to an aggregate of $6.00 per share (or up to $1.1 billion total)
MASH Patient Projection (US, by 2039)	19.53 million cases
SHTG Patient Population (US Estimate)	Approximately 3 million people

The prescribing physicians-Hepatologists, endocrinologists, and cardiologists-are the gatekeepers who will write the prescriptions for pegozafermin, which is being tested for dosing every one or two weeks depending on the indication. Post-acquisition, these physicians will interact with Roche's commercial organization, which gains the asset after 89bio, Inc. (ETNB) reported cash, cash equivalents, and marketable securities of approximately $561.2 million as of June 30, 2025.

Roche, as the acquiring entity, is the final customer segment, purchasing the asset for its CVRM (Cardiovascular, Renal, and Metabolic Diseases) pipeline. The deal is expected to close in the fourth quarter of 2025.

89bio, Inc. (ETNB) - Canvas Business Model: Cost Structure

You're looking at the cost side of 89bio, Inc. (ETNB) as they push pegozafermin through late-stage trials and prepare for a potential acquisition by Roche. The costs are heavily weighted toward R&D, which is typical for a clinical-stage biopharma, but you can see clear investments in future commercial readiness, too.

The total Research and Development (R&D) spend for the first half of 2025 really shows the intensity of their current operations. For the six months ended June 30, 2025, the combined R&D expenses reached exactly $168.3 million. This number is the sum of the Q1 2025 R&D expense of $64.4 million and the Q2 2025 R&D expense of $103.9 million. That jump in Q2 is significant, reflecting escalating clinical activity.

Here is a breakdown of the key cost drivers based on the first half of 2025 reporting periods:

• The 1H 2025 R&D expense totaled $168.3 million.
• Net loss for Q2 2025 widened to $111.5 million, up from $48.0 million year-over-year.
• Cash, cash equivalents, and marketable securities stood at $561.2 million as of June 30, 2025.

Clinical trial costs are a massive component within that R&D figure. 89bio, Inc. is currently funding three global Phase 3 programs simultaneously. You need to keep an eye on the timelines for data readouts, as those often correlate with spending peaks and troughs. The ENTRUST trial for Severe Hypertriglyceridemia (SHTG) is expected to report topline data in the first quarter of 2026. The MASH trials, ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, are tracking for data in the first half of 2027 and 2028, respectively.

Manufacturing Costs show a clear commitment to commercial scale-up, even before final approval. In the second quarter of 2025 alone, R&D included a substantial $42.4 million non-recurring payment directly tied to the construction of the commercial-scale production facility for pegozafermin. This is a capital outlay to de-risk the supply chain for a future Biologics License Application (BLA). To be fair, the company noted that the remaining obligation for this facility is limited to one final milestone payment of $13.5 million, which is due in 2026.

General and Administrative (G&A) Expenses are steadily climbing as 89bio, Inc. scales its organization to support global Phase 3 execution and prepare for potential commercialization. For Q2 2025, G&A hit $11.9 million, up from $8.6 million in the prior year period. Similarly, Q1 2025 G&A was $11.5 million, an increase from $9.8 million in Q1 2024. This increase is defintely driven by higher personnel-related expenses, including stock-based compensation, reflecting a higher headcount across the board.

The Roche Acquisition represents a major, near-term financial event that will fundamentally change the cost structure post-close in Q4 2025. While the specific legal and financial advisory fees paid by 89bio, Inc. aren't itemized in the public filings, the deal terms themselves define the ultimate cost/value realization event. The upfront cash payment is set at $14.50 per share, equating to approximately $2.4 billion in equity value at the time of the announcement. Furthermore, shareholders are eligible for a non-tradeable Contingent Value Right (CVR) of up to $6.00 per share, bringing the total potential deal value up to $3.5 billion.

You can see the cost structure elements summarized here:

Cost Category	Specific Financial Data Point (Q1/Q2 2025)	Context/Driver
Research & Development (R&D)	$168.3 million (1H 2025 Total)	Phase 3 ENLIGHTEN (MASH) and ENTRUST (SHTG) trials advancement.
Manufacturing Investment	$42.4 million (Non-recurring payment in Q2 2025)	Cost of construction for commercial-scale production facility.
General & Administrative (G&A)	$11.9 million (Q2 2025)	Increased personnel costs and stock-based compensation due to higher headcount.
Clinical Trial Spending	Included in R&D, significant for three global Phase 3 trials.	Enrollment and execution across ENLIGHTEN and ENTRUST programs.
Acquisition Value (Roche)	Upfront: $14.50 per share (approx. $2.4 billion total equity value)	Defines the ultimate value realization event and shifts future costs to Roche.

The company is clearly spending heavily to get to the data readouts, which is the primary cost driver right now. Finance: draft 13-week cash view by Friday.

89bio, Inc. (ETNB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for 89bio, Inc. (ETNB) right at the cusp of its acquisition by Roche, which is a massive shift in the financial structure. Before the deal closed in October 2025, the company was entirely reliant on financing its clinical pipeline; after the close, the revenue stream becomes the acquisition consideration itself. Here's the quick math on what drove the top line before the finalization of the merger.

The primary financial events driving 89bio, Inc.'s capital base in 2025 were equity raises to fund its late-stage development programs, followed by the definitive acquisition agreement with Roche Holding AG.

The structure of the Roche transaction is the most significant element defining the revenue streams as of late 2025, as it essentially locks in the value derived from the pegozafermin asset.

Transaction Component	Upfront Value / Per Share Amount	Maximum Potential Value / Per Share Amount
Upfront Cash Payment	$14.50 per share in cash	N/A
Aggregate Upfront Equity Value	Approximately $2.4 billion	N/A
Contingent Value Right (CVR)	N/A	Up to $6.00 per share in cash
Total Headline Equity Value	N/A	Up to approximately $3.5 billion

The Contingent Value Rights (CVR) are key because they represent potential future revenue tied directly to the success of pegozafermin post-acquisition. These are non-tradeable rights granted to stockholders.

• Milestone 1: $2.00 per CVR upon first sale for F4 MASH by March 31, 2030.
• Milestone 2: $1.50 per CVR if global yearly sales reach at least $3.0 billion by December 31, 2033.
• Milestone 3: $2.50 per CVR if global yearly sales reach at least $4.0 billion by December 31, 2035.

Before the acquisition closed, 89bio, Inc. relied on equity financing to keep the lights on and fund its Phase 3 trials. This capital inflow was substantial, demonstrating investor confidence in the pipeline leading up to the deal announcement.

The company successfully executed a follow-on equity offering in the first quarter of 2025, which provided a critical cash infusion to support operations and clinical development.

• Equity Financing Gross Proceeds (Q1 2025): $287.5 million.
• Another earlier offering in early 2025 raised approximately $143.8 million in gross proceeds.

As a clinical-stage biopharmaceutical company, 89bio, Inc. had no product sales revenue in 2025, which is standard for a company advancing a lead candidate through late-stage trials. The cash balance at various points in 2025 was substantial, which would have generated minor interest income.

• Cash, cash equivalents, and marketable securities as of March 31, 2025: Approximately $638.8 million.
• Cash, cash equivalents, and marketable securities as of June 30, 2025: Approximately $561.2 million.

Interest income is generated from this balance, though it is a secondary, minor stream compared to the financing and acquisition proceeds. You can see the R&D expenses were high, reaching $103.9 million in Q2 2025 alone, which these financing events were designed to cover.