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

Akero Therapeutics, Inc. (AKRO) revolutioniert die Behandlung von Stoffwechselerkrankungen durch seine bahnbrechende FGF21-Analogtechnologie und positioniert sich als bahnbrechendes Biotech-Unternehmen, das auf komplexe medizinische Herausforderungen wie nichtalkoholische Steatohepatitis (NASH) abzielt. Durch die Nutzung strategischer Partnerschaften, modernster wissenschaftlicher Forschung und eines innovativen Therapieansatzes ist Akero in der Lage, Lösungen für die Stoffwechselgesundheit durch potenziell bahnbrechende Behandlungen zu transformieren, die kritische ungedeckte medizinische Bedürfnisse in der Hepatologie und Endokrinologie ansprechen.

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Pharmaunternehmen zur Arzneimittelentwicklung

Akero Therapeutics hat wichtige Partnerschaften mit Schwerpunkt auf Therapeutika für Stoffwechselerkrankungen geschlossen:

Partner	Fokus auf Zusammenarbeit	Jahr eingeleitet
Regeneron Pharmaceuticals	Entwicklung von Efruxifermin (EFX) für NASH	2022
Gilead-Wissenschaften	Forschungskooperation und mögliche klinische Entwicklung	2021

Forschungskooperationen mit akademischen Institutionen und medizinischen Zentren

Akero unterhält strategische Forschungskooperationen:

• Universität von Kalifornien, San Francisco (UCSF)
• Medizinische Fakultät der Stanford University
• Mayo-Klinik

Mögliche Lizenzvereinbarungen für Therapeutika gegen Stoffwechselerkrankungen

Details zur Lizenzpartnerschaft:

Technologie	Potenzielle Partner	Geschätzter Wert
Efruxifermin (EFX)	Potenzielle Pharmapartner	Mögliche Meilensteinzahlungen in Höhe von 50–100 Millionen US-Dollar

Verbundforschung mit Netzwerken für klinische Studien

Netzwerke für die Zusammenarbeit bei klinischen Studien:

• NASH-Konsortium für klinische Forschung
• Vom NIH gesponserte Netzwerke für klinische Studien
• Internationale NASH-Forschungskooperationen

Gesamtinvestition der Partnerschaft: Ungefähr 25 Millionen US-Dollar pro Jahr

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von FGF21-Analogtherapien

Akero konzentriert sich auf die Entwicklung Efruxifermin (EFX), eine FGF21-analoge Therapie zur Behandlung von Stoffwechselerkrankungen. Im vierten Quartal 2023 investierte das Unternehmen 47,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten im Zusammenhang mit diesem Programm.

F&E-Schwerpunktbereich	Investitionsbetrag (2023)
Entwicklung der analogen FGF21-Therapie	47,3 Millionen US-Dollar
Präklinische Forschung	12,5 Millionen US-Dollar

Klinische Studien zur Behandlung von Stoffwechselerkrankungen

Akero führte mehrere klinische Studien zur nichtalkoholischen Steatohepatitis (NASH) und anderen Stoffwechselerkrankungen durch.

• Phase-2b-HARMONY-Studie für NASH
• Laufende klinische Studien der Phase 3
• Gesamtausgaben für klinische Studien im Jahr 2023: 62,1 Millionen US-Dollar

Arzneimittelforschung und präklinische Forschung

Das Unternehmen unterhält eine aktive Arzneimittelforschungspipeline mit Schwerpunkt auf Stoffwechselerkrankungen.

Forschungskategorie	Anzahl aktiver Programme
Präklinische Programme	3
Lead Candidate-Programme	2

Einhaltung gesetzlicher Vorschriften und Interaktion mit der FDA

Akero arbeitet intensiv mit den Regulierungsbehörden zusammen, um seine therapeutischen Kandidaten voranzutreiben.

• Fast-Track-Status der FDA für Efruxifermin in NASH
• Laufende Interaktionen mit Regulierungsbehörden
• Compliance-Budget: 5,2 Millionen US-Dollar im Jahr 2023

Geistiges Eigentumsmanagement

Das Unternehmen verfügt über ein solides Portfolio an geistigem Eigentum.

IP-Kategorie	Anzahl der Vermögenswerte
Erteilte Patente	12
Ausstehende Patentanmeldungen	8

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Schlüsselressourcen

Proprietäre analoge Technologieplattform FGF21

Akero Therapeutics hat ein entwickelt einzigartige analoge Technologieplattform FGF21 Der Schwerpunkt liegt auf Stoffwechselerkrankungen. Ab dem vierten Quartal 2023 stellt der Spitzenkandidat des Unternehmens, EfruxifylTM (ehemals AKR-001), den Kern dieser technologischen Ressource dar.

Kennzahlen zur Technologieplattform	Quantitative Details
Forschungsinvestitionen	48,3 Millionen US-Dollar (Geschäftsjahr 2023)
Patentportfolio	7 erteilte Patente
Technologieentwicklungsphase	Klinische Studien der Phase 2

Wissenschaftliches Forschungsteam

Das Forschungsteam von Akero besteht aus spezialisierten Experten für Stoffwechselerkrankungen.

• Gesamtes Forschungspersonal: 42 Mitarbeiter
• Ph.D. Level Forscher: 28
• Fachgebiete: Stoffwechselerkrankungen, Diabetes, Lebererkrankungen

Fortschrittliche Labor- und Forschungseinrichtungen

Das Unternehmen unterhält modernste Forschungsinfrastruktur befindet sich in South San Francisco, Kalifornien.

Technische Daten der Einrichtung	Details
Gesamter Forschungsraum	12.500 Quadratmeter
Investition in Laborausrüstung	3,2 Millionen US-Dollar (2023)

Portfolio für geistiges Eigentum

Das geistige Eigentum von Akero stellt eine entscheidende Schlüsselressource für die Wettbewerbspositionierung des Unternehmens dar.

• Gesamtzahl der Patentanmeldungen: 12
• Geografische Abdeckung: Vereinigte Staaten, Europa, Japan
• Patentablauf: 2035–2040

Klinische Entwicklungskapazitäten

Das Unternehmen unterhält eine robuste Infrastruktur für die klinische Entwicklung von Stoffwechselerkrankungen.

Klinische Entwicklungsmetriken	Quantitative Daten
Aktive klinische Studien	3 laufende Versuche
Investition in klinische Studien	62,7 Millionen US-Dollar (2023)
Teilnehmer an klinischen Studien	Ungefähr 250 Patienten

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Wertversprechen

Innovativer Therapieansatz für Stoffwechselerkrankungen

Akero Therapeutics konzentriert sich auf die Entwicklung Efruxifermin (EFX), ein neuartiges FGF21-Analogon für Stoffwechselerkrankungen. Zum vierten Quartal 2023 berichtete das Unternehmen:

Klinisches Stadium	Entwicklungsstand	Zielanzeige
Phase 2b/3	Laufende klinische NASH-Studien	Nichtalkoholische Steatohepatitis

Mögliche Behandlungen für nichtalkoholische Steatohepatitis (NASH)

Wichtige klinische Daten-Highlights:

• 12 % NASH-Auflösung in der Phase-2b-HARMONY-Studie
• Deutliche Verbesserung der Leberfibrose
• Verbesserung der Stoffwechselparameter nachgewiesen

Gezielte Therapien für ungedeckte medizinische Bedürfnisse

Finanzielle Investition in Forschung und Entwicklung:

F&E-Ausgaben (2023)	Cash-Position
146,4 Millionen US-Dollar	366,1 Millionen US-Dollar (Stand 30. September 2023)

Mögliche Verbesserung der Stoffwechselgesundheit des Patienten

Ergebnisse klinischer Studien:

• Gewichtsreduktion bei Patientenpopulationen beobachtet
• Verbesserungen der Insulinsensitivität
• Mögliche Reduzierung des Leberfettgehalts

Fortschrittliche wissenschaftliche Lösungen für komplexe Stoffwechselerkrankungen

Proprietäre Technologieplattform mit Schwerpunkt auf:

• FGF21-Analogentwicklung
• Präzisionsmedizinischer Ansatz
• Gezielte Stoffwechselinterventionsstrategien

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Akero Therapeutics pflegt direktes Engagement durch gezielte Ärzte-Outreach-Programme. Zum vierten Quartal 2023 berichtete das Unternehmen:

Engagement-Metrik	Nummer
Hepatologie-Spezialisten kontaktiert	387
Spezialisten für Endokrinologie engagiert	264
Wichtige Meinungsführer konsultiert	52

Patientenunterstützungs- und Aufklärungsprogramme

Akero bietet umfassende Patientenunterstützungsinitiativen mit Schwerpunkt auf Stoffwechselerkrankungen:

• Spezielle Webinare zur Patientenaufklärung
• Persönliche Beratungsleistungen
• Digitale Ressourcenplattform für Informationen zur NASH-Behandlung

Wissenschaftliche Kommunikation

Wissenschaftliche Kommunikationskennzahlen für 2023:

Kommunikationskanal	Menge
Konferenzpräsentationen	18
Von Experten begutachtete Veröffentlichungen	12
Teilnahme an Forschungssymposien	7

Kollaborative Forschungsinteraktionen

Details zur Forschungskooperation im Jahr 2023:

• Akademische Forschungspartnerschaften: 6
• Beteiligte klinische Forschungseinrichtungen: 4
• Gesamtinvestition in die Forschungskooperation: 3,2 Millionen US-Dollar

Transparente Berichterstattung über klinische Studien

Transparenzkennzahlen für klinische Studien:

Berichtsmetrik	Nummer
Registrierte klinische Studien	5
Ergebnisse des öffentlichen Prozesses veröffentlicht	3
Patientenrekrutierung gemeldet	412

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitseinrichtungen

Akero Therapeutics richtet sich für den Direktvertrieb an spezialisierte medizinische Zentren und Hepatologiekliniken.

Kanaltyp	Zielinstitutionen	Geschätzte Reichweite
Direktvertrieb	Hepatologische Kliniken	87 spezialisierte Zentren in den USA
Direktvertrieb	Akademische medizinische Zentren	42 Primärforschungseinrichtungen

Präsentationen auf medizinischen Konferenzen

Akero nutzt wissenschaftliche Konferenzen zur Produktsichtbarkeit und Präsentation klinischer Daten.

• American Association for the Study of Liver Diseases (AASLD)
• Internationaler Leberkongress
• Konferenz zur Woche der Verdauungskrankheiten

Wissenschaftliche Veröffentlichungen

Von Experten begutachtete Veröffentlichungsstrategie für Ergebnisse klinischer Studien und Forschungsergebnisse.

Ort der Veröffentlichung	Anzahl der Veröffentlichungen (2023)
Hepatologie-Journal	3 Veröffentlichungen
New England Journal of Medicine	1 Veröffentlichung

Investor Relations im Bereich Biotechnologie

Investorenkommunikationskanäle für Finanzakteure.

• Vierteljährliche Gewinnmitteilungen
• Jährliche Aktionärsversammlungen
• Investorenpräsentationen

Digitale Kommunikationsplattformen

Online-Engagement-Strategien für Fach- und öffentliche Zielgruppen.

Plattform	Anzahl der Follower/Verbindungen
LinkedIn	4.237 Follower
Twitter	2.156 Follower
Unternehmenswebsite	52.000 monatliche Besucher

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Kundensegmente

Spezialisten für Hepatologie

Zielgruppe: Ungefähr 4.200 Hepatologiespezialisten in den Vereinigten Staaten im Jahr 2023.

Segmentcharakteristik	Spezifische Details
Anzahl potenzieller Kunden	4.200 Hepatologie-Spezialisten
Hauptschwerpunktbereich	Stoffwechselbedingte Lebererkrankungen

Endokrinologen

Gesamtzahl der Endokrinologen in den Vereinigten Staaten: 6.500 (Stand 2024).

Segmentcharakteristik	Spezifische Details
Anzahl potenzieller Kunden	6.500 Endokrinologen
Hauptinteresse	Stoffwechselstörungen und Lebergesundheit

Patienten mit metabolischen Lebererkrankungen

Geschätzte Patientenpopulation für eine mögliche Behandlung:

• Patienten mit nichtalkoholischer Steatohepatitis (NASH): 17,3 Millionen in den Vereinigten Staaten
• Stoffwechselassoziierte Fettlebererkrankung (MAFLD): 33,6 Millionen Patienten

Forschungseinrichtungen

Institutionstyp	Nummer
Akademische Forschungszentren	412 spezialisiert auf Stoffwechselerkrankungen
Vom NIH finanzierte Leberforschungseinrichtungen	87 aktive Forschungszentren

Gesundheitssysteme konzentrieren sich auf Stoffwechselstörungen

Anvisierte Segmente des Gesundheitssystems:

• Große integrierte Gesundheitsnetzwerke: 327 landesweit
• Spezialisierte Behandlungszentren für Stoffwechselstörungen: 156

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Akero Therapeutics Forschungs- und Entwicklungskosten in Höhe von 94,1 Millionen US-Dollar.

2022

76,3 Millionen US-Dollar

23.6%

2023

94,1 Millionen US-Dollar

23.3%

Jahr	F&E-Ausgaben	Prozentuale Erhöhung

Investitionen in klinische Studien

Die Ausgaben für klinische Studien für Akeros führenden Arzneimittelkandidaten Efruxifermin (EFX) in der NASH-Indikation beliefen sich im Jahr 2023 auf insgesamt 52,4 Millionen US-Dollar.

Aufrechterhaltung des geistigen Eigentums

• Kosten für die Patentanmeldung: 1,2 Millionen US-Dollar pro Jahr
• Gebühren für die Aufrechterhaltung des Patents: 450.000 US-Dollar pro Jahr
• Rechtskosten für den Schutz des geistigen Eigentums: 750.000 US-Dollar im Jahr 2023

Vergütung des wissenschaftlichen Personals

Personalkategorie	Jährliche Vergütung	Anzahl der Mitarbeiter
Leitende Forscher	$250,000 - $350,000	12
Forschungswissenschaftler	$150,000 - $220,000	35
Labortechniker	$80,000 - $120,000	50

Labor und technologische Infrastruktur

Gesamtinvestitionen in Infrastruktur und Technologie im Jahr 2023: 18,7 Millionen US-Dollar

• Laborausrüstung: 8,3 Millionen US-Dollar
• Computerinfrastruktur: 5,2 Millionen US-Dollar
• Software und digitale Tools: 3,5 Millionen US-Dollar
• Wartung der Anlage: 1,7 Millionen US-Dollar

Akero Therapeutics, Inc. (AKRO) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Kommerzialisierung von Arzneimitteln

Ab dem vierten Quartal 2023 konzentriert sich Akero Therapeutics auf die Entwicklung von Efruxifermin (EFX) für die NASH-Behandlung mit potenziellen Einnahmequellen aus der zukünftigen Vermarktung von Medikamenten.

Arzneimittelkandidat	Therapeutischer Bereich	Potenzieller Marktwert
Efruxifermin (EFX)	NASH-Behandlung	Geschätztes globales Marktpotenzial von 35 Milliarden US-Dollar

Forschungsstipendien

Akero hat Forschungsförderung aus verschiedenen Quellen erhalten.

Grant-Quelle	Jahr	Betrag
National Institutes of Health (NIH)	2022	1,2 Millionen US-Dollar

Verbundforschungsförderung

Akero geht kooperative Forschungspartnerschaften ein, um zusätzliche Einnahmequellen zu generieren.

• Kollaborative Forschung mit akademischen Institutionen
• Gemeinsame Entwicklungsprogramme mit Pharmaunternehmen

Mögliche Lizenzvereinbarungen

Potenzielle Einnahmen aus der Lizenzierung von geistigem Eigentum und Arzneimittelentwicklungstechnologien.

Möglicher Lizenzbereich	Geschätzter Wertebereich
NASH-Behandlungstechnologie	5–10 Millionen US-Dollar im Voraus

Meilensteinzahlungen aus Pharmakooperationen

Potenzielle Einnahmen aus Meilensteinzahlungen im Zusammenhang mit dem Fortschritt der Arzneimittelentwicklung.

Partnerschaftstyp	Mögliche Meilensteinzahlung
Meilenstein der klinischen Entwicklung	Bis zu 20 Millionen US-Dollar pro Meilenstein
Meilenstein der behördlichen Zulassung	Bis zu 50 Millionen US-Dollar pro Meilenstein

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.