Akero Therapeutics, Inc. (AKRO): Business Model Canvas [Jan-2025 Mis à jour]

Akero Therapeutics, Inc. (AKRO) révolutionne le traitement des maladies métaboliques grâce à sa technologie analogique révolutionnaire FGF21, se positionnant comme une entreprise biotechnologique pionnière ciblant des défis médicaux complexes comme la stéatohépatite non alcoolique (NASH). En tirant parti des partenariats stratégiques, de la recherche scientifique de pointe et d'une approche thérapeutique innovante, Akero est sur le point de transformer des solutions de santé métaboliques avec des traitements potentiellement révolutionnaires qui répondent aux besoins médicaux critiques non satisfaits en hépatologie et en endocrinologie.

Akero Therapeutics, Inc. (AKRO) - Modèle commercial: partenariats clés

Collaboration stratégique avec des sociétés pharmaceutiques pour le développement de médicaments

Akero Therapeutics a établi des partenariats clés axés sur la thérapie des maladies métaboliques:

Partenaire	Focus de la collaboration	Année initiée
Regeneron Pharmaceuticals	Efruxifermin (EFX) Développement de Nash	2022
Sciences de Gilead	Collaboration de recherche et développement clinique potentiel	2021

Partenariats de recherche avec les établissements universitaires et les centres médicaux

Akero maintient des collaborations de recherche stratégique:

• Université de Californie, San Francisco (UCSF)
• École de médecine de l'Université de Stanford
• Clinique de mayo

Accords de licence potentiels pour la thérapeutique des maladies métaboliques

Détails du partenariat de licence:

Technologie	Partenaires potentiels	Valeur estimée
Efruxifermine (EFX)	Partenaires pharmaceutiques potentiels	50 à 100 millions de dollars de paiement potentiel

Recherche collaborative avec les réseaux d'essais cliniques

Réseaux de collaboration des essais cliniques:

• Consortium de recherche clinique NASH
• Réseaux d'essais cliniques parrainés par le NIH
• Collaborations internationales de recherche Nash

Investissement total de partenariat: environ 25 millions de dollars par an

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: activités clés

Recherche et développement des thérapies analogiques FGF21

Akero se concentre sur le développement efruxifermine (EFX), une thérapie analogique FGF21 ciblant les maladies métaboliques. Au quatrième trimestre 2023, la société a investi 47,3 millions de dollars dans les dépenses de R&D liées à ce programme.

Zone de focus R&D	Montant d'investissement (2023)
Développement de la thérapie analogique FGF21	47,3 millions de dollars
Recherche préclinique	12,5 millions de dollars

Essais cliniques pour les traitements de maladies métaboliques

Akero a effectué plusieurs essais cliniques ciblant la stéatohépatite non alcoolique (NASH) et d'autres conditions métaboliques.

• Phase 2B Prise harmonielle pour Nash
• Études cliniques de phase 3 en cours
• Dépenses totales d'essais cliniques en 2023: 62,1 millions de dollars

Découverte de médicaments et recherche préclinique

La société maintient un pipeline de découverte de médicaments actif en mettant l'accent sur les maladies métaboliques.

Catégorie de recherche	Nombre de programmes actifs
Programmes précliniques	3
Diriger les programmes des candidats	2

Conformité réglementaire et interaction FDA

Akero s'engage largement avec les autorités réglementaires pour faire avancer ses candidats thérapeutiques.

• Désignation FDA Fast Track pour l'efruxifermin à Nash
• Interactions en cours avec les organismes de réglementation
• Budget de conformité: 5,2 millions de dollars en 2023

Gestion de la propriété intellectuelle

La société maintient un portefeuille de propriété intellectuelle robuste.

Catégorie IP	Nombre d'actifs
Brevets délivrés	12
Demandes de brevet en instance	8

Akero Therapeutics, Inc. (AKRO) - Modèle commercial: Ressources clés

Plateforme de technologie analogique FGF21 propriétaire

Akero Therapeutics a développé un Plateforme de technologie analogique FGF21 unique axé sur les maladies métaboliques. Depuis le quatrième trimestre 2023, le candidat principal de la société EfruxifyLtm (anciennement AKR-001) représente le cœur de cette ressource technologique.

Métriques de la plate-forme technologique	Détails quantitatifs
Investissement en recherche	48,3 millions de dollars (2023 Exercice)
Portefeuille de brevets	7 brevets accordés
Étape de développement technologique	Essais cliniques de phase 2

Équipe de recherche scientifique

L'équipe de recherche d'Akero comprend des experts spécialisés sur les maladies métaboliques.

• Personnel de recherche total: 42 employés
• doctorat Chercheurs de niveau: 28
• Domaines d'expertise: maladies métaboliques, diabète, maladies hépatiques

Installations avancées de laboratoire et de recherche

La société maintient infrastructure de recherche de pointe Situé à South San Francisco, en Californie.

Spécifications de l'installation	Détails
Espace de recherche total	12 500 pieds carrés
Investissement de l'équipement de laboratoire	3,2 millions de dollars (2023)

Portefeuille de propriété intellectuelle

La propriété intellectuelle d'Akero représente une ressource clé critique pour le positionnement concurrentiel de l'entreprise.

• Demandes totales de brevet: 12
• Couverture géographique: États-Unis, Europe, Japon
• Plage d'expiration des brevets: 2035-2040

Capacités de développement clinique

La société maintient une infrastructure de développement clinique robuste ciblant les maladies métaboliques.

Métriques de développement clinique	Données quantitatives
Essais cliniques actifs	3 essais en cours
Investissement en essai clinique	62,7 millions de dollars (2023)
Participants à l'essai clinique	Environ 250 patients

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: propositions de valeur

Approche thérapeutique innovante pour les maladies métaboliques

Akero Therapeutics se concentre sur le développement efruxifermine (EFX), un nouvel analogue FGF21 pour les maladies métaboliques. Au quatrième trimestre 2023, la société a rapporté:

Étape clinique	Statut de développement	Indication cible
Phase 2B / 3	Essais cliniques de Nash en cours	Stéatohépatite non alcoolisée

Traitements potentiels pour la stéatohépatite non alcoolique (NASH)

Faits saillants clés des données cliniques:

• Résolution de 12% NASH dans l'essai d'harmonie de phase 2B
• Amélioration significative de la fibrose hépatique
• Amélioration des paramètres métaboliques démontré

Thérapies ciblées répondant aux besoins médicaux non satisfaits

Investissement financier dans la recherche et le développement:

Dépenses de R&D (2023)	Poste de trésorerie
146,4 millions de dollars	366,1 millions de dollars (au 30 septembre 2023)

Amélioration potentielle de la santé métabolique des patients

Résultats des essais cliniques:

• Réduction de poids observée dans les populations de patients
• Améliorations de sensibilité à l'insuline
• Réduction potentielle de la teneur en matières grasses du foie

Solutions scientifiques avancées pour des conditions métaboliques complexes

La plate-forme technologique propriétaire s'est concentrée sur:

• Développement analogique FGF21
• Approche de la médecine de précision
• Stratégies d'intervention métabolique ciblées

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Akero Therapeutics maintient un engagement direct grâce à des programmes ciblés de sensibilisation des médecins. Au quatrième trimestre 2023, la société a rapporté:

Métrique de l'engagement	Nombre
Des spécialistes de l'hépatologie contactés	387
Spécialistes de l'endocrinologie engagés	264
Les principaux leaders d'opinion consultés	52

Programmes de soutien aux patients et d'éducation

Akero fournit des initiatives complètes de soutien aux patients axées sur les maladies métaboliques:

• Webinaires dévoués de l'éducation des patients
• Services de conseil en tête-à-tête
• Plateforme de ressources numériques pour les informations de traitement NASH

Communication scientifique

Métriques de communication scientifique pour 2023:

Canal de communication	Quantité
Présentations de conférence	18
Publications évaluées par des pairs	12
Participation des symposiums de recherche	7

Interactions de recherche collaborative

Détails de la collaboration de recherche en 2023:

• Partenariats de recherche universitaire: 6
• Organisations de recherche clinique engagées: 4
• Investissement total de collaboration de recherche: 3,2 millions de dollars

Rapports d'essais cliniques transparents

Métriques de transparence des essais cliniques:

Métrique de rapport	Nombre
Essais cliniques enregistrés	5
Résultats d'essai publics publiés	3
Les inscriptions des patients signalées	412

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Akero Therapeutics cible des centres médicaux spécialisés et des cliniques d'hépatologie pour l'engagement des ventes directes.

Type de canal	Institutions cibles	Portée estimée
Ventes directes	Cliniques d'hépatologie	87 centres spécialisés aux États-Unis
Ventes directes	Centres médicaux académiques	42 institutions de recherche primaires

Présentations de la conférence médicale

Akero utilise des conférences scientifiques pour la visibilité des produits et la présentation des données cliniques.

• Association américaine pour l'étude des maladies du foie (AASLD)
• Congrès international du foie
• Conférence de la Semaine des maladies digestives

Publications scientifiques

Stratégie de publication évaluée par des pairs pour les résultats des essais cliniques et les résultats de la recherche.

Lieu de publication	Nombre de publications (2023)
Journal d'hépatologie	3 publications
Journal de médecine de la Nouvelle-Angleterre	1 publication

Biotechnology Investor Relations

Canaux de communication des investisseurs pour les parties prenantes financières.

• Appels de résultats trimestriels
• Réunions annuelles des actionnaires
• Présentations des investisseurs

Plateformes de communication numérique

Stratégies d'engagement en ligne pour le public professionnel et public.

Plate-forme	Nombre de suiveurs / de connexions
Liendin	4 237 abonnés
Gazouillement	2 156 abonnés
Site Web de l'entreprise	52 000 visiteurs mensuels

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: segments de clientèle

Spécialistes de l'hépatologie

Population cible: environ 4 200 spécialistes de l'hépatologie aux États-Unis en 2023.

Caractéristique du segment	Détails spécifiques
Nombre de clients potentiels	4 200 spécialistes de l'hépatologie
Domaine d'intervention primaire	Maladies hépatiques métaboliques

Endocrinologues

Total des endocrinologues aux États-Unis: 6 500 en 2024.

Caractéristique du segment	Détails spécifiques
Nombre de clients potentiels	6 500 endocrinologues
Intérêt primaire	Troubles métaboliques et santé hépatique

Patients atteints de maladies hépatiques métaboliques

Population estimée des patients pour un traitement potentiel:

• Patients non alcooliques de stéatohépatite (NASH): 17,3 millions aux États-Unis
• Maladie hépatique associée au métabolique (MAFLD): 33,6 millions de patients

Institutions de recherche

Type d'institution	Nombre
Centres de recherche universitaires	412 spécialisé dans les maladies métaboliques
Institutions de recherche hépatique financées par les NIH	87 centres de recherche actifs

Les systèmes de soins de santé se sont concentrés sur les troubles métaboliques

Segments ciblés du système de soins de santé:

• Grands réseaux de soins de santé intégrés: 327 à l'échelle nationale
• Centres de traitement des troubles métaboliques spécialisés: 156

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Akero Therapeutics a déclaré des dépenses de R&D de 94,1 millions de dollars.

2022

76,3 millions de dollars

23.6%

2023

94,1 millions de dollars

23.3%

Année	Dépenses de R&D	Pourcentage d'augmentation

Investissements d'essais cliniques

Les dépenses d'essai cliniques pour le candidat principal d'Akero, Efruxifermin (EFX), dans l'indication de NASH, ont totalisé 52,4 millions de dollars en 2023.

Maintenance de la propriété intellectuelle

• Coûts de dépôt de brevets: 1,2 million de dollars par an
• Frais d'entretien des brevets: 450 000 $ par an
• Dépenses juridiques pour la protection IP: 750 000 $ en 2023

Compensation du personnel scientifique

Catégorie de personnel	Compensation annuelle	Nombre d'employés
Chercheurs principaux	$250,000 - $350,000	12
Chercheur	$150,000 - $220,000	35
Techniciens de laboratoire	$80,000 - $120,000	50

Infrastructure de laboratoire et technologique

Investissement total d'infrastructure et de technologie en 2023: 18,7 millions de dollars

• Équipement de laboratoire: 8,3 millions de dollars
• Infrastructure informatique: 5,2 millions de dollars
• Outils logiciels et numériques: 3,5 millions de dollars
• Entretien des installations: 1,7 million de dollars

Akero Therapeutics, Inc. (AKRO) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le quatrième trimestre 2023, Akero Therapeutics se concentre sur le développement de l'efruxifermine (EFX) pour le traitement NASH, avec des sources de revenus potentielles de la commercialisation future des médicaments.

Drogue	Zone thérapeutique	Valeur marchande potentielle
Efruxifermine (EFX)	Traitement de Nash	Potentiel estimé de 35 milliards de dollars sur le marché mondial

Subventions de recherche

Akero a reçu un soutien au financement de la recherche de diverses sources.

Source d'octroi	Année	Montant
National Institutes of Health (NIH)	2022	1,2 million de dollars

Financement de recherche collaborative

Akero s'engage dans des partenariats de recherche collaborative pour générer des sources de revenus supplémentaires.

• Recherche collaborative avec les établissements universitaires
• Programmes de développement conjoints avec des sociétés pharmaceutiques

Accords de licence potentiels

Revenus potentiels provenant de l'octroi de licences sur la propriété intellectuelle et les technologies de développement de médicaments.

Zone de licence potentielle	Plage de valeur estimée
Technologie de traitement de Nash	5 à 10 millions de dollars

Payments d'étape provenant des partenariats pharmaceutiques

Les revenus potentiels des paiements d'étape associés aux progrès du développement des médicaments.

Type de partenariat	Paiement de jalon potentiel
Étape du développement clinique	Jusqu'à 20 millions de dollars par étape
Jalon d'approbation réglementaire	Jusqu'à 50 millions de dollars par étape

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Akero Therapeutics, Inc. believes its lead candidate, efruxifermin (EFX), stands out for patients suffering from Metabolic Dysfunction-associated Steatohepatitis (MASH). The value centers on addressing the severe, life-threatening progression of this disease, especially in later stages where options are nonexistent.

The data supports the potential for EFX to be a first- and best-in-class therapy. For patients with compensated cirrhosis (F4) due to MASH, the Phase 2b SYMMETRY trial showed statistically significant reversal of this advanced scarring. Specifically, in subjects with baseline and week 96 biopsies, 39% treated with the 50mg dosage achieved cirrhosis reversal without worsening of MASH, compared to 15% on placebo. For the Intent to Treat (ITT) population, 29% showed this reversal. This is a major differentiator; patients with cirrhosis due to MASH face a 50 percent chance of dying within five years without a liver transplant.

The therapy addresses a population in urgent need. By 2030, an estimated 3 million Americans are projected to have MASH-related cirrhosis. Furthermore, EFX has shown promise in earlier stages. In the Phase 2b HARMONY trial for pre-cirrhotic MASH (F2-F3), 35% of patients on 50mg EFX met a composite endpoint of MASH resolution and at least a one-stage fibrosis improvement, versus only 7% for placebo. Almost one-third of participants on the 50mg dose saw near complete disease reversal.

Here's a quick look at how the Phase 2b data stacks up for these critical endpoints:

Patient Group/Endpoint	Treatment Group	Response Rate
Compensated Cirrhosis (F4) Reversal (Completers)	EFX 50mg	39%
Compensated Cirrhosis (F4) Reversal (Completers)	Placebo	15%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	EFX 50mg	35%
Pre-cirrhotic MASH (F2-F3) MASH Resolution + $\geq$1 Fibrosis Stage Improvement (mITT)	Placebo	7%

The approach is holistic, aiming to treat the multi-system nature of MASH. EFX has been shown to improve liver histology, resolve MASH, reduce non-invasive markers of liver injury, and improve insulin sensitivity and lipoprotein profile. New analyses also reinforced statistically significant improvements in noninvasive measures linked to a lower risk of liver-related events and clinically significant portal hypertension (CSPH) in compensated cirrhosis (F4c).

Convenience is built into the commercial plan. Patients in the ongoing Phase 3 studies self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use. EFX is designed for convenient once-weekly dosing. This planned delivery mechanism supports long-term use, which the data suggests is important for sustained response. To support this development, Akero Therapeutics reported cash, cash equivalents, and short and long-term marketable securities of $1,086.2 million as of June 30, 2025. That's a solid war chest for a company pushing through Phase 3 trials; defintely a sign of confidence in the path forward.

The value proposition can be summarized by the functional benefits:

• Potential for first- and best-in-class MASH therapy.
• Statistically significant reversal of compensated cirrhosis (F4).
• Addresses high unmet need in advanced-stage MASH.
• Convenient once-weekly subcutaneous self-administration.
• Improves liver histology and multiple metabolic biomarkers.

Finance: draft 13-week cash view by Friday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Relationships

You're looking at the relationships Akero Therapeutics, Inc. (AKRO) maintained with key stakeholders as of late 2025, which is a critical period following major data releases and a significant corporate event.

High-touch collaboration with clinical investigators and trial sites

The relationship with clinical investigators is centered on advancing the Phase 3 SYNCHRONY program, which builds upon the robust Phase 2 program. This collaboration is essential for gathering the data needed for marketing authorization applications.

The Phase 3 program consists of three trials, all designed in consultation with global regulatory authorities:

• SYNCHRONY Histology, for pre-cirrhotic (F2-F3) MASH.
• SYNCHRONY Real-World, for noninvasively diagnosed MASH or MASLD (F1-F4).
• SYNCHRONY Outcomes, for compensated cirrhosis (F4) due to MASH.

The SYNCHRONY Real-World and SYNCHRONY Histology studies began enrolling patients in the fourth quarter of 2023, while SYNCHRONY Outcomes began enrolling in the third quarter of 2024. The SYMMETRY Phase 2b trial, which informed this Phase 3 design, was a multicenter trial that enrolled 182 patients.

Direct, authoritative communication with regulatory agencies (FDA, EMA)

Akero Therapeutics, Inc. maintains direct engagement with regulatory bodies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding efruxifermin (EFX). The Phase 3 SYNCHRONY studies were specifically designed in consultation with global regulatory authorities. EFX is noted as being under review by the FDA for Non-alcoholic steatohepatitis (NASH). New findings presented on November 7, 2025, showed EFX led to statistically significant reductions in clinically significant portal hypertension risk, as measured by Baveno criteria, which is a key regulatory consideration for advanced liver disease.

Investor Relations (IR) via presentations at major healthcare conferences (e.g., J.P. Morgan 2025)

Investor relationships are managed through frequent, high-profile presentations to the financial community. The company presented at several key 2025 healthcare conferences:

Conference Name	Date of Presentation (2025)	Time/Time Zone
J.P. Morgan Healthcare Conference	January 14	11:15 a.m. Pacific Time
BofA Securities Health Care Conference	May 13	1:40 p.m. P.T.
Jefferies Global Healthcare Conference	June 4	8:45 AM EDT
Goldman Sachs 46th Annual Global Healthcare Conference	June 10	2:40 PM EDT
Morgan Stanley 23rd Annual Global Healthcare Conference	September 8	10:45 a.m. E.T.

The company's cash, cash equivalents, and marketable securities stood at $1,086.2 million as of June 30, 2025. This followed a follow-on public offering in January 2025 that raised gross proceeds of approximately $402.5 million. The stock price on November 25, 2025, was $54.32.

Scientific engagement through peer-reviewed publications (e.g., New England Journal of Medicine in May 2025)

Scientific engagement is validated through top-tier peer-reviewed publications and major medical society presentations. A significant milestone was the publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine on May 9, 2025.

Key efficacy data from the SYMMETRY study (evaluating EFX in compensated cirrhosis F4) included:

• Among patients with baseline and week 96 biopsies (N=134), 39% of the 50mg EFX group showed $\geq$1-stage fibrosis improvement without MASH worsening, versus 15% for placebo.
• Using an intent-to-treat analysis (N=181), 29% of the 50mg EFX group showed reversal of cirrhosis with no worsening of MASH, versus 12% for placebo.

Further data reinforcing the anti-fibrotic activity of EFX across MASH stages were presented at the 76th Annual AASLD The Liver Meeting® 2025 in November 2025.

Future commercial sales force and patient support programs post-approval

Preparation for a potential commercial launch was explicitly stated as a use of proceeds from the January 2025 financing, which generated gross proceeds of approximately $350.0 million. The company has a Senior VP of Commercial Strategy, Patrick Lamy. The cash position as of June 30, 2025, of $1,086.2 million was believed sufficient to fund the current operating plan into 2028, which includes preparing for a potential commercial launch.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Channels

You're looking at how Akero Therapeutics, Inc. gets its science and, eventually, its drug, efruxifermin (EFX), out to the world. For a clinical-stage company, the channels are heavily weighted toward scientific validation and physician education right now, with commercial distribution being a future, planned channel.

Global network of clinical trial sites for patient enrollment

The current channel for patient access is through the ongoing Phase 3 SYNCHRONY clinical trial program. This network is designed to support the progression of EFX toward potential marketing authorization.

• SYNCHRONY Histology and SYNCHRONY Real-World studies began enrolling patients in the fourth quarter of 2023.
• SYNCHRONY Outcomes began enrolling patients in the third quarter of 2024.
• The double-blind portion of SYNCHRONY Real-World completed enrollment with 601 patients as of January 13, 2025.
• The Phase 2b SYMMETRY study, which informed the Phase 3 design, enrolled 182 patients.

Scientific and medical journals for data dissemination to physicians

Dissemination of trial results through peer-reviewed publications is a critical channel for establishing scientific credibility with the broader medical community. The 96-week results from the Phase 2b SYMMETRY study were supported by a peer-reviewed publication in the New England Journal of Medicine.

Medical conferences (AASLD, EASL) for direct physician education

Direct engagement with key opinion leaders and practicing physicians happens at major liver disease congresses. Akero Therapeutics utilized these forums extensively in 2025 to present data on EFX.

Akero Therapeutics presented new analyses from the Phase 2b SYMMETRY and HARMONY trials at the 76th Annual AASLD The Liver Meeting® 2025, held in Washington, D.C., from November 7-11, 2025. This included two oral and two poster presentations. Furthermore, new 96-week SYMMETRY findings were presented at the EASL Congress 2025 in Amsterdam, the Netherlands, from May 7-10, 2025.

Here's a look at the 2025 conference channel activity:

Conference Name	Date(s) in 2025	Presentation Type Count	Key Data Presented
AASLD The Liver Meeting® 2025	November 7-11, 2025	2 Oral, 2 Poster	96-week SYMMETRY and HARMONY results
EASL Congress 2025	May 7-10, 2025	Oral and Poster (Count not specified)	New 96-week SYMMETRY findings

Future specialty pharmacy and distribution networks for drug delivery

While EFX is not yet commercially available, the company is preparing its supply chain, evidenced by activities related to manufacturing clinical supplies for potential marketing applications. The preparation for commercial launch will involve establishing relationships within the specialty distribution ecosystem.

For context on the market Akero Therapeutics is preparing to enter, specialty pharmaceuticals represent nearly 55% of the drug market as of 2025, with an estimated 2,000 unique specialty pharmacy locations in the U.S.. Akero Therapeutics is currently manufacturing clinical supplies for Phase 3 and potential marketing applications.

Investor relations website and SEC filings for financial communication

The Investor Relations website serves as the primary digital channel for communicating financial health and corporate progress to stockholders and analysts. The company provided updates through its quarterly filings and participation in investor conferences throughout 2025.

Key financial and communication data points as of late 2025:

• Cash, cash equivalents, and marketable securities as of June 30, 2025: $1,086.2 million.
• Projected funding sufficiency: Into 2028.
• R&D expenses for the three months ended June 30, 2025: $69.3 million.
• R&D expenses for the three months ended March 31, 2025: $69.6 million.
• Investor conferences attended in 2025 include the Morgan Stanley Global Healthcare Conference on September 8, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Customer Segments

You're looking at the core groups Akero Therapeutics, Inc. (AKRO) needs to satisfy to get efruxifermin (EFX) to market and generate revenue. This isn't just about patients; it's about the entire ecosystem that validates and prescribes the therapy.

Patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3 fibrosis)

This group is targeted by the SYNCHRONY Histology Phase 3 trial, building on the Phase 2b HARMONY study data. The overall US adult population with MASH and clinically significant fibrosis (stage $\geq$F2) was projected to increase to 11.7 million cases by 2050 from 6.7 million in 2020.

Patients with compensated cirrhosis (F4) due to MASH

This is a high-need segment where EFX showed a defining result in the Phase 2b SYMMETRY study. The US adult population with MASH cirrhosis (F4) was projected to increase from 1.147 million in 2020 to 2.192 million by 2050. The 96-week data from SYMMETRY showed 39% of patients on the 50 mg EFX dose achieved $\geq$1 stage improvement in fibrosis with no worsening of MASH, compared to 15% on placebo. This trial is supported by the SYNCHRONY Outcomes Phase 3 study.

Here's a quick look at the patient focus areas for the SYNCHRONY Phase 3 program, which involves approximately N~3,500 patients globally.

Customer Sub-Segment	Fibrosis Stage Target	Key Clinical Trial Support	Observed Efficacy (50mg EFX vs Placebo)
Pre-cirrhotic MASH Patients	F2-F3	HARMONY (Phase 2b), SYNCHRONY Histology (Phase 3)	Corroborated fibrosis improvements via conventional and AI-based pathology analysis
Compensated Cirrhosis Patients	F4	SYMMETRY (Phase 2b), SYNCHRONY Outcomes (Phase 3)	39% vs 15% for $\geq$1 stage fibrosis improvement at 96 weeks

The overall MASH market opportunity is substantial, with estimates suggesting it could reach $16 billion by 2033.

Hepatologists, gastroenterologists, and endocrinologists treating MASH/MASLD

These are the prescribers. Their segment needs compelling data showing meaningful clinical benefit, especially in advanced stages like F4, which was previously managed only by transplant. The data showing statistically significant improvements in clinically significant portal hypertension (CSPH) risk in F4 patients is critical for this group. The company's financial position, with $176.03 million in cash and cash equivalents as of September 30, 2025, allows for the continued execution of the Phase 3 program to generate the necessary data for adoption. Research and development expenses for the three months ended September 30, 2025, were $78.88 million, reflecting the investment needed to deliver this data.

Global regulatory bodies (FDA, EMA) as primary gatekeepers for market access

These bodies require robust safety and efficacy data from the three ongoing Phase 3 SYNCHRONY trials to support marketing applications for both F2-F3 and F4 MASH populations. The company is positioning EFX as a potential first- and best-in-class therapy with disease-modifying activity, especially in advanced-stage MASH. The company's valuation as of November 2025 was $4.32 billion, and a potential transaction mentioned was up to $5.2 billion, indicating market confidence in the regulatory pathway.

• SYNCHRONY Real-World preliminary results expected in the first half of 2026.
• SYNCHRONY Histology readout expected in the first half of 2027.

Akero Therapeutics, Inc. believes its current funding is sufficient to fund its operating plan into 2028.

Finance: finalize the projected peak sales model based on F2-F3 and F4 patient segment sizes by end of Q4 2025.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Akero Therapeutics, Inc. (AKRO) as they push efruxifermin (EFX) through late-stage development. The cost structure is heavily weighted toward clinical execution right now, which is typical for a clinical-stage biotech.

Dominant Research and Development (R&D) expenses for Phase 3 trials represent the largest single cost driver. For the three-month period ended June 30, 2025, Research and development expenses totaled $69.3 million. This spending reflects the intensity of the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Manufacturing costs for clinical trial materials and commercial scale-up are embedded within the R&D spend. Specifically, the increase in R&D was attributable to the 'manufacture of clinical supplies for Phase 3 and potential marketing applications.' This shows Akero Therapeutics is already spending to secure supply chains ahead of potential approval.

General and Administrative (G&A) overhead, including personnel and public company costs, is the next significant category. For the same period ending June 30, 2025, General and administrative expenses were $11.6 million. These costs cover personnel increases, professional services, and the general overhead associated with operating as a public company.

The total operating expenses for the second quarter of 2025 reached $80.9 million. This is a clear picture of where the cash is going before any potential revenue generation. Honestly, the burn rate is dictated by the Phase 3 timeline.

Here's a quick look at the recent operating expense trend:

Metric (USD Millions)	Q1 2025	Q2 2025
Research & Development (R&D)	69.6	69.3
General & Administrative (G&A)	11.3	11.6
Total Operating Expenses	80.9	80.9

Intellectual property maintenance and licensing fees are necessary costs to protect the efruxifermin asset. While not broken out separately in the latest public filings, these are ongoing, non-discretionary expenses required to maintain the patent estate surrounding EFX.

Pre-commercialization and market access planning costs are also factored into the current operating expenses, primarily within G&A. As Akero Therapeutics moves closer to potential launch, these costs will likely increase, covering activities like:

• Building out commercial infrastructure planning.
• Engaging with payers for market access strategies.
• Developing medical affairs capabilities.

To be fair, the company's cash position as of June 30, 2025, was $1,086.2 million in cash, cash equivalents, and marketable securities, which they believe funds the current operating plan into 2028. Finance: draft the projected OpEx for Q3 2025 based on current run-rate by next Tuesday.

Akero Therapeutics, Inc. (AKRO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Akero Therapeutics, Inc. (AKRO) as of late 2025. Since this is a clinical-stage biotech, the revenue picture is entirely focused on financing the pipeline, not product sales yet. It's all about the burn rate versus the runway funded by capital markets and investment returns.

Zero current product revenue; the company is clinical-stage

Honestly, this is the expected reality for a company deep in Phase 3 trials. Akero Therapeutics, Inc. is not selling a commercial product right now. For the third quarter of 2025, GAAP Revenue was reported as $0.0. Similarly, for the second quarter of 2025, GAAP Revenue was also $0.0. The focus remains entirely on advancing efruxifermin (EFX) through the SYNCHRONY program to achieve regulatory approval for MASH.

The current revenue streams are purely financial, supporting the high Research and Development expenses, which hit $69.3 million for the three months ended June 30, 2025.

Capital raised through equity offerings

The primary source of operational funding comes from successful equity financing events. The most significant recent infusion was in the first quarter of 2025. Akero Therapeutics, Inc. closed an underwritten public offering on January 30, 2025, securing substantial non-dilutive funding.

Here's the quick math on that January 2025 raise:

Metric	Amount/Price
Total Gross Proceeds	$402.5 million
Common Stock Price	$48.00 per share
Pre-Funded Warrant Price (Effective)	Approximately $47.9999 per warrant

This capital influx was critical for funding the ongoing Phase 3 SYNCHRONY Histology, Real-World, and Outcomes studies.

Interest income from substantial cash and marketable securities

Holding a large cash balance generates a secondary, passive revenue stream through interest income. You want to see this number high, as it means the company has a long runway without needing to tap the markets again soon. Akero Therapeutics, Inc. maintains a significant war chest from prior financing activities.

• Cash, cash equivalents, and short- and long-term marketable securities as of June 30, 2025: $1,086.2 million.
• Cash, cash equivalents, and short- and long-term marketable securities as of March 31, 2025: $1,128.3 million.

Management has stated that this cash position is expected to fund the current operating plan into at least 2028. The interest earned on this balance is a non-operating revenue component.

Future potential milestone payments or royalties from licensing deals (pre-acquisition)

As of late 2025, this remains a contingent, non-realized revenue stream. Akero Therapeutics, Inc. has not announced any specific, realized milestone payments or royalty income streams tied to EFX or other assets from licensing agreements. This category represents potential upside if the company enters into a partnership before a full commercial launch or acquisition.

Future revenue from commercial sales of EFX post-regulatory approval (projected)

The ultimate revenue stream is the commercial sale of efruxifermin (EFX) following regulatory clearance. This is entirely forward-looking and dependent on clinical success. Preliminary topline results from the SYNCHRONY Real-World study are expected in the first half of 2026, with the SYNCHRONY Histology readout targeted for the first half of 2027. Successful outcomes in these Phase 3 trials are the gate to generating product sales revenue.

The company's strategy is built on EFX potentially becoming a first- and best-in-class therapy for MASH, especially given the published data showing reversal of compensated cirrhosis (F4) due to MASH.

Finance: draft 13-week cash view by Friday.