Hepion Pharmaceuticals, Inc. (HEPA): Business Model Canvas

In der sich schnell entwickelnden Landschaft der pharmazeutischen Innovation erweist sich Hepion Pharmaceuticals als Hoffnungsträger für Patienten, die mit komplexen Lebererkrankungen kämpfen. Mit einem laserfokussierten Ansatz zur Entwicklung bahnbrechender Therapeutika, insbesondere zur Behandlung der nichtalkoholischen Steatohepatitis (NASH), bereitet dieses dynamische Biotech-Unternehmen eine transformative Reise durch sein sorgfältig ausgearbeitetes Business Model Canvas vor. Durch den Einsatz modernster CRF-Inhibitor-Technologie und strategischer Kooperationen entwickelt Hepion nicht nur Medikamente, sondern stellt sich die Zukunft der Behandlung von Lebererkrankungen neu vor – und verspricht potenzielle Durchbrüche, die die Patientenversorgung und medizinische Interventionen revolutionieren könnten.

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit akademischer Forschungseinrichtungen

Institution	Fokus auf Zusammenarbeit	Forschungsbereich
Universität von Kalifornien, San Diego	NASH-Forschung	Präklinische Arzneimittelentwicklung
Mayo-Klinik	Studien zu Lebererkrankungen	Unterstützung bei klinischen Studien

Pharmazeutische strategische Partner

Aktuelle Kooperationspartner für klinische Studien:

• Medpace, Inc. – Auftragsforschungsorganisation
• ICON plc – Globale klinische Forschungsdienste

Auftragsforschungsinstitute (CROs)

CRO-Name	Vertragswert	Studienphase
Medpace	3,2 Millionen US-Dollar	Phase-2-NASH-Studien
ICON plc	2,7 Millionen US-Dollar	Präklinische Studien

Lizenzpartner

Potenzielle Vermarktungspartner:

• Gilead Sciences – Mögliche Lizenzierung zur Behandlung von Lebererkrankungen
• AbbVie Inc. – Diskussionen über eine NASH-Therapiepartnerschaft

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung neuartiger Therapeutika für Lebererkrankungen

Seit dem vierten Quartal 2023 hat Hepion Pharmaceuticals investiert 12,3 Millionen US-Dollar an Forschungs- und Entwicklungsbemühungen mit Schwerpunkt auf Therapeutika für Lebererkrankungen.

F&E-Schwerpunktbereich	Investitionsbetrag	Forschungsphase
CRF-Inhibitor-Pipeline	7,5 Millionen Dollar	Klinische Studien der Phase 2
Entwicklung der NASH-Behandlung	4,8 Millionen US-Dollar	Präklinische Forschung

Durchführung klinischer Studien für die CRF-Inhibitor-Pipeline

Das aktuelle Portfolio klinischer Studien umfasst:

• 2 aktive klinische Phase-2-Studien
• Gesamtbudget für klinische Studien von 9,2 Millionen US-Dollar für 2024
• Patientenrekrutierungsziel: 180 Teilnehmer

Entwicklung von Behandlungen für nichtalkoholische Steatohepatitis (NASH)

Entwicklungsmetriken für die NASH-Behandlung	Werte für 2024
Forschungspersonal	12 spezialisierte Forscher
Jährliches Forschungsbudget	5,6 Millionen US-Dollar
Potenzielle Arzneimittelkandidaten	3 im präklinischen Stadium

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Compliance-Aufwand für 2024: 2,1 Millionen US-Dollar

• FDA-Interaktionstreffen: 4 geplant
• Team zur Vorbereitung der behördlichen Dokumentation: 6 Fachleute

Verwaltung und Schutz des geistigen Eigentums

IP-Kategorie	Anzahl der Vermögenswerte	Jährliche Schutzkosten
Aktive Patente	7	1,3 Millionen US-Dollar
Patentanmeldungen	3	$450,000

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Schlüsselressourcen

Proprietäre CRF-Inhibitor-Technologieplattform

CRF-Inhibitor-Technologie (Cyclin-Dependent Kinase). stellt eine wichtige Ressource für Hepion Pharmaceuticals dar:

Technologieattribut	Spezifische Details
Technologiefokus	Therapeutische Interventionen bei Lebererkrankungen
Patentstatus	Mehrere erteilte Patente zum Schutz der Kerntechnologie
Entwicklungsphase	Fortgeschrittene präklinische und klinische Entwicklungsphasen

Wissenschaftliche und wissenschaftliche Expertise in der Therapie von Lebererkrankungen

Zu den Forschungskapazitäten von Hepion gehören:

• Spezialisiertes Forschungsteam mit umfassendem Hintergrund in der Hepatologie
• Kollaborative Netzwerke mit akademischen Forschungseinrichtungen
• Expertise in der Entwicklung gezielter Behandlungen für Lebererkrankungen

Patentportfolio für Arzneimittelkandidaten

Patentkategorie	Anzahl der Patente	Schutzumfang
Kern-CRF-Inhibitor-Technologie	7 erteilte Patente	Globale Pharmamärkte
Spezifische Arzneimittelkandidatenzusammensetzungen	3 anhängige Patentanmeldungen	Neuartige molekulare Strukturen

Forschungs- und Entwicklungseinrichtungen

Die F&E-Infrastruktur von Hepion umfasst:

• Spezielle Laborräume in San Diego, Kalifornien
• Fortschrittliche Ausrüstung für die molekularbiologische Forschung
• Fähigkeiten zur Computermodellierung und zum Arzneimitteldesign

Spezialisierter medizinischer und wissenschaftlicher Talentpool

Professionelle Kategorie	Anzahl der Fachkräfte	Fachgebiete
Forscher auf Doktorandenniveau	12 Vollzeitforscher	Hepatologie, Pharmakologie, Molekularbiologie
Spezialisten für klinische Entwicklung	8 Fachleute für klinische Forschung	Design und Management klinischer Studien

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Wertversprechen

Innovativer Therapieansatz zur Behandlung von Lebererkrankungen

Hepion Pharmaceuticals konzentriert sich auf die Entwicklung von CRV431, einem Cyclophilin-Inhibitor gegen nichtalkoholische Steatohepatitis (NASH). Klinische Studiendaten zum vierten Quartal 2023 deuten darauf hin:

Klinischer Parameter	Messung
CRV431-Behandlungspotenzial	Verringerung des Fortschreitens der Leberfibrose
Klinisches Stadium	Klinische Studien der Phase 2
Zielgruppe der Patienten	NASH-Patienten mit Leberfibrose

Möglicher Durchbruch im NASH-Management

Zu den wichtigsten therapeutischen Zielen gehören:

• Cyclophilin-Hemmmechanismus
• Mögliche Reduzierung von Leberentzündungen
• Abschwächung des Fortschreitens der Fibrose

Fortgeschrittene Entwicklung kleiner Molekülarzneimittel

Kennzahlen für Forschungs- und Entwicklungsinvestitionen:

Finanzkennzahl	Betrag
F&E-Ausgaben (2023)	12,4 Millionen US-Dollar
Patentanmeldungen	7 aktive pharmazeutische Zusammensetzungen

Gezielte Behandlungsmöglichkeiten für komplexe Lebererkrankungen

Therapeutische Schwerpunkte:

• Nichtalkoholische Steatohepatitis (NASH)
• Leberfibrose
• Leberentzündung

Potenzielle Verringerung des Fortschreitens und der Komplikationen von Lebererkrankungen

Meilensteine der klinischen Entwicklung:

Klinische Entwicklungsphase	Status
Klinische Studien der Phase 2	Laufende Patientenaufnahme
Erwartete klinische Endpunkte	Rückbildung der Leberfibrose

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab dem vierten Quartal 2023 unterhielt Hepion Pharmaceuticals ein direktes Engagement durch 37 aktive Forschungskooperationen mit akademischen und medizinischen Einrichtungen.

Engagement-Typ	Anzahl der Kooperationen	Forschungsschwerpunkt
Akademische Partnerschaften	22	NASH- und Lebererkrankungsforschung
Klinische Forschungsnetzwerke	15	Klinische Studien CRN-001

Wissenschaftliche Konferenz- und Symposiumspräsentationen

Im Jahr 2023 präsentierte Hepion Pharmaceuticals auf 12 internationalen medizinischen Konferenzen, von denen sich 8 auf die Hepatologie und die Erforschung von Lebererkrankungen konzentrierten.

• Konferenz der American Association for the Study of Liver Diseases (AASLD).
• Internationaler Leberkongress
• Konferenz für experimentelle Biologie

Transparente Kommunikation des Fortschritts klinischer Studien

Hepion meldete im Dezember 2023 4 aktive klinische Studien, mit vierteljährlichen Fortschrittsaktualisierungen durch Investorenkommunikation und wissenschaftliche Veröffentlichungen.

Klinische Studie	Patientenregistrierung	Aktueller Status
CRN-001 NASH-Studie	180 Patienten	Phase 2b Aktiv

Zusammenarbeit mit Hepatologie-Spezialisten

Das Unternehmen unterhielt im Jahr 2023 professionelle Beziehungen zu 64 Hepatologie-Spezialisten in ganz Nordamerika und Europa.

Interaktionen mit Patientenvertretungsgruppen

Hepion arbeitete im Jahr 2023 mit sieben Patientenorganisationen zusammen, die sich auf Lebererkrankungen und Stoffwechselstörungen konzentrierten.

• Amerikanische Leberstiftung
• NASH-Bildungsprogramm
• Fettleber-Stiftung

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Hepion Pharmaceuticals hat im Jahr 2023 Forschungsergebnisse in den folgenden Fachzeitschriften veröffentlicht:

Zeitschriftenname	Anzahl der Veröffentlichungen	Fokusbereich
Hepatologie	3	NASH und Lebererkrankungen
Zeitschrift für Hepatologie	2	Virushepatitis-Forschung

Medizinische Konferenzen und Branchenveranstaltungen

Details zur Konferenzteilnahme für 2023:

Konferenz	Datum	Präsentationstyp
AASLD-Lebertreffen	November 2023	Mündlicher Vortrag
Internationaler Leberkongress	April 2023	Posterpräsentation

Direkte Kommunikation mit Pharmapartnern

Kommunikationskanäle der Partner:

• Direkte E-Mail-Kommunikation
• Vierteljährliche Treffen zur Überprüfung der Partnerschaft
• Vertrauliche Datenaustauschplattformen

Investor-Relations-Plattformen

Kennzahlen zur Anlegerkommunikation für 2023:

Plattform	Anzahl der Anlegerinteraktionen	Vierteljährliche Gewinnaufrufe
Investoren-Webinare	4	4
SEC-Einreichungen	12	N/A

Einreichungen bei Regulierungsbehörden

Details zur behördlichen Einreichung:

Agentur	Anzahl der Einreichungen	Einreichungstyp
FDA	2	Protokolle für klinische Studien
EMA	1	Prüfantrag für ein neues Arzneimittel

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Kundensegmente

Fachärzte für Hepatologie

Im Jahr 2024 gibt es in den Vereinigten Staaten etwa 3.500 Hepatologie-Spezialisten. Die Zielmarktgröße wird auf ein potenzielles jährliches Engagement von 12,4 Millionen US-Dollar geschätzt.

Fachkategorie	Gesamtzahl	Potenzielle Marktdurchdringung
Vom Vorstand zertifizierte Hepatologen	3,500	65%
Spezialisten des akademischen medizinischen Zentrums	1,200	45%

Forschungseinrichtungen

Gezielte Forschungseinrichtungen, die sich auf die Erforschung von Lebererkrankungen konzentrieren: 287 weltweit.

• Nordamerikanische Forschungszentren: 124
• Europäische Forschungseinrichtungen: 93
• Asiatische Forschungseinrichtungen: 70

Pharmaunternehmen

Der Zielmarkt umfasst 42 Pharmaunternehmen mit Forschungsprogrammen zu Lebererkrankungen.

Unternehmensgröße	Anzahl der Unternehmen	Mögliches Interesse an einer Zusammenarbeit
Große Pharmaunternehmen	12	Hoch
Mittelständische Pharmaunternehmen	18	Mittel
Kleine spezialisierte Unternehmen	12	Niedrig

Patienten mit Lebererkrankungen

Insgesamt adressierbare Patientenpopulation: 4,5 Millionen in den Vereinigten Staaten mit chronischen Lebererkrankungen.

• Nichtalkoholische Fettlebererkrankung (NAFLD): 2,3 Millionen
• Hepatitis C: 900.000
• Zirrhose: 630.000
• Andere Lebererkrankungen: 670.000

Gesundheitsdienstleister, die sich auf Stoffwechselstörungen konzentrieren

Gesamtzahl der auf Stoffwechselstörungen spezialisierten Gesundheitsdienstleister: 8.700 im ganzen Land.

Anbietertyp	Gesamtanbieter	Potenzielle Engagement-Rate
Endokrinologen	5,200	55%
Spezialisten für Stoffwechselerkrankungen	2,100	75%
Fortgeschrittene Praxisanbieter	1,400	40%

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Hepion Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 14,2 Millionen US-Dollar.

Jahr	F&E-Ausgaben
2022	14,2 Millionen US-Dollar
2021	16,9 Millionen US-Dollar

Investitionen in klinische Studien

Die Kosten für klinische Studien für CRV431 (Behandlung von Lebererkrankungen) beliefen sich im Jahr 2022 auf etwa 7,5 Millionen US-Dollar.

• Klinische Phase-2-Studien zur NASH-Indikation
• Laufende klinische Entwicklungsprogramme

Kosten für den Schutz geistigen Eigentums

Die Kosten für den Patent- und Markenschutz beliefen sich im Jahr 2022 auf etwa 450.000 US-Dollar.

Ausgaben für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Einreichung beliefen sich im Jahr 2022 auf etwa 1,2 Millionen US-Dollar.

Kosten für Personal- und Talentakquise

Kostenkategorie	Betrag
Gesamter Personalaufwand	8,3 Millionen US-Dollar
Vergütung von Führungskräften	2,1 Millionen US-Dollar
Aktienbasierte Vergütung	1,5 Millionen Dollar

Gesamtbetriebskosten für 2022: Ungefähr 31,6 Millionen US-Dollar

Hepion Pharmaceuticals, Inc. (HEPA) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzvereinbarungen

Bis zum vierten Quartal 2023 hat Hepion Pharmaceuticals keine aktiven Lizenzvereinbarungen für seinen führenden Medikamentenkandidaten CRV431 gemeldet.

Zukünftige Arzneimittelkommerzialisierung

Arzneimittelkandidat	Therapeutischer Bereich	Aktueller Entwicklungsstand	Potenzieller Marktwert
CRV431	Nichtalkoholische Steatohepatitis (NASH)	Klinische Studien der Phase 2	Potenzieller Markt von 35 Milliarden US-Dollar bis 2026

Forschungsstipendien und Finanzierung

Für das Geschäftsjahr 2023 berichtete Hepion Pharmaceuticals 3,2 Millionen US-Dollar bei der Finanzierung von Forschungs- und Entwicklungsstipendien.

Strategische Pharmapartnerschaften

• Im Jahr 2023 wurden keine aktiven strategischen Pharmapartnerschaften gemeldet
• Laufende Gespräche mit potenziellen Forschungspartnern

Mögliche Meilensteinzahlungen

Meilensteintyp	Möglicher Zahlungsbereich	Wahrscheinlichkeit
Präklinische Entwicklung	1-3 Millionen Dollar	Mittel
Einleitung einer klinischen Studie	5-10 Millionen Dollar	Mittelhoch

Gesamtumsatz für Hepion Pharmaceuticals im Jahr 2023: 4,7 Millionen US-Dollar

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Value Propositions

You're looking at a company that has made a sharp pivot, moving from a pure-play drug developer to one prioritizing immediate, tangible commercial value from diagnostics. This shift defines the current value proposition set for Hepion Pharmaceuticals, Inc. (HEPA).

The core value proposition centers on the immediate commercialization of in-licensed diagnostic tests, which have $\text{CE}$ marks for sale in Europe, alongside leveraging its proprietary technology for future optionality.

Near-term revenue generation potential from commercial diagnostics is now the primary driver, supported by the strategic shift announced in mid-2025. The company is actively prioritizing this path over its former drug development focus.

The portfolio of multi-targeted diagnostic tests is key to this near-term strategy. These tests are ready for European markets, providing a direct path to sales, unlike the longer development cycles of therapeutics. Here's a breakdown of the current diagnostic assets and associated financial commitments:

Diagnostic Test Focus Area	Regulatory Status Highlight	Initial Investment (Cash/Stock)	Potential Milestone Value
Celiac Disease	$\text{CE}$ Marked (Europe/UK eligible)	$\mathbf{\$525,000}$ Cash	Up to $\mathbf{\$17.15}$ million total
Respiratory Multiplex ($\text{Covid/Influenza A/B and RSV}$)	$\mathbf{CE}$ Marked (Europe/UK eligible)	$\mathbf{\$270,629}$ Stock	Royalties on Net Sales
Helicobacter Pylori ($\text{H. pylori}$)	$\mathbf{CE}$ Marked (Europe/UK eligible)	Part of New Day Diagnostics Agreement	Part of New Day Diagnostics Agreement
Hepatocellular Carcinoma ($\text{HCC}$)	Focus Area for Precision Diagnostics	N/A (In-licensed)	N/A (In-licensed)

The strategic focus on precision diagnostics for high-unmet-need areas like $\text{HCC}$ provides a bridge between the old and new models. While the lead drug candidate, rencofilstat, was divested, the $\text{FDA}$ granted Orphan Drug designation to rencofilstat for $\text{HCC}$ back in June 2022, showing prior focus in this area, which is now being addressed via diagnostics.

The $\text{AI}$-driven approach to drug development ($\text{AI}$-$\text{POWR}{\text{TM}}$), offering a future pipeline option, represents latent value. $\text{AI}$-$\text{POWR}{\text{TM}}$ is Hepion Pharmaceuticals, Inc.'s proprietary platform using Artificial Intelligence, Machine Learning, and Deep Learning for drug target selection and patient stratification. However, the company sold all patent assets, knowhow, clinical trial data, and drug product relating to Rencofilstat for a nominal amount plus a contingent value right ($\text{CVR}$) on May 26, 2025. This positions the platform's direct drug development utility as a future, non-guaranteed pipeline option, separate from the immediate diagnostic revenue focus.

Significant cost-saving measures are reflected in the improved financial performance, which is a key value proposition for capital preservation. The company reported a net loss for the year ended December 31, 2024, of $\mathbf{(13.2) million}$, a substantial improvement from the $\mathbf{(48.9) million}$ net loss in 2023. This reflects the strategic restructuring initiated in late 2023, which aimed to reduce operating costs by approximately $\mathbf{60\%}$. Even into 2025, the losses remain contained:

• Q3 2025 Net Loss: $\mathbf{(1.0) million}$.
• Q1 2025 Net Loss: $\mathbf{(6.11) million}$.
• Revenues for Q3 2025 and Q1 2025 were $\mathbf{\$0}$ million, confirming the pre-revenue status from commercial products as of those reporting dates.
• The accumulated deficit stood at $\mathbf{\$243.4 million}$ as of March 31, 2025.

The company's ability to manage its burn rate, as evidenced by the reduced net loss figures, is a critical value proposition for stakeholders given the transition phase.

Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Customer Relationships

You're looking at how Hepion Pharmaceuticals, Inc. (HEPA) interacts with its key stakeholders as of late 2025, which has fundamentally shifted from a pure-play biopharma to a diagnostics commercialization focus following its Nasdaq delisting.

Investor relations focused on transparency following the Nasdaq delisting

The relationship with the investment community is now defined by the transition from the Nasdaq Capital Market to trading on the OTCQB, which was successfully completed on June 25, 2025, after a suspension from Nasdaq on May 13, 2025. Transparency efforts are critical given the market capitalization as of November 26, 2025, stood at only $699,543, based on 11,620,317 shares outstanding trading at $0.06 per share. The company had previously sought capital in January 2025, completing a public offering for gross proceeds of approximately $9.0 million, which was earmarked for debt repayment and general corporate purposes. The financial performance leading into this period showed a Loss from operations of $(19.3) million and a Net loss of $(13.2) million for the fiscal year ended December 31, 2024.

Professional service relationships with regulatory bodies (FDA, EMA)

Relationships with regulatory bodies reflect both the legacy drug development and the new diagnostic focus. For the former lead candidate, rencofilstat, the U.S. Food and Drug Administration (FDA) had granted Fast Track designation in November 2021 and Orphan Drug designation in June 2022. However, the current customer-facing regulatory relationships center on the in-licensed diagnostic tests. These tests already possess CE marks, making them eligible for sale in European Union countries, which suggests established, though perhaps indirect, engagement with European regulatory standards bodies.

Direct, high-touch relationships with diagnostic distribution partners

The core of the new commercial strategy involves leveraging distribution partners for the in-licensed diagnostic tests. Hepion Pharmaceuticals executed a binding Letter of Intent with New Day Diagnostics LLC to commercialize these products. This relationship is designed to be high-touch to facilitate market entry, especially in Europe where the tests are immediately eligible for sale. The goal is to use the partner's capabilities to reach clinical settings for the tests targeting Celiac Disease, Respiratory Multiplex, H. pylori, and HCC.

Transactional relationships with clinical labs and hospitals for test sales

The customer base for the new product line is clinical labs and hospitals purchasing the diagnostic tests. Hepion is targeting significant revenue potential by focusing on markets with substantial size and growth. The relationship is transactional, centered on the sale of these tests, which cover a combined addressable market exceeding $15 billion.

Here's a breakdown of the specific market segments driving these potential transactional relationships:

• The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a market valued at $5.6 billion.
• The mSEPT9 assay for early HCC detection serves an $8.7 billion market.
• The H. pylori CE-IVD targets a $700 million market.
• The CeliaCare CE-IVD for Celiac Disease supports a $457 million market.

The immediate commercial opportunity is in Europe, but the overall scope suggests future transactional volume with U.S. clinical labs and hospitals, pending further regulatory steps.

Diagnostic Test Category	Partnering Entity	Regulatory Status	Addressable Market Size (USD)
Respiratory Multiplex (Covid/Flu/RSV)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$5.6 billion
Hepatocellular Carcinoma (mSEPT9 assay)	New Day Diagnostics LLC (via LOI)	Not specified for immediate sale	$8.7 billion
Helicobacter Pylori (H. pylori CE-IVD)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$700 million
Celiac Disease (CeliaCare CE-IVD)	New Day Diagnostics LLC (via LOI)	CE Mark (Europe Eligible)	$457 million

The shift in focus means that future revenue, which was $0 million for the years ended December 31, 2024, and 2023, will now depend on the success of these diagnostic sales channels.

Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Channels

You're looking at how Hepion Pharmaceuticals, Inc. gets its value proposition-now focused on in-licensed diagnostic tests-out to the market and investors as of late 2025. The shift from drug development to diagnostics means the channel strategy is pivoting, too.

OTCQB Venture Market for Public Trading of Common Stock (HEPA)

Hepion Pharmaceuticals, Inc. completed its transition to the OTCQB Venture Market on June 25, 2025, following its delisting from Nasdaq in May 2025. This market serves as the primary channel for public trading of the common stock under the symbol HEPA. The company's operational focus has clearly shifted, reflected in its market metrics.

Here are the key trading statistics as of early December 2025:

Metric	Value (as of Dec 04, 2025)
Stock Price	$0.060
Market Capitalization	$697.22K
Shares Outstanding	11,620,317
52-Week Range Low	$0.033

The company reported 22 employees as of the Q3 2025 filing.

Direct Sales Force Targeting Clinical Laboratories and Hospital Systems

Given the current focus on commercializing in-licensed diagnostic tests-for conditions like celiac disease and respiratory multiplex-the direct sales channel targets clinical laboratories and hospital systems capable of utilizing these products. While the exact size of a dedicated direct sales force isn't specified, the total employee count stands at 22 employees. This small team size suggests that initial direct engagement might be highly focused or supplemented by external expertise.

The initial investment into the diagnostic channel involved a license agreement where Hepion Pharmaceuticals paid $525,000 in cash and $270,629 in common stock.

Third-Party Distribution Networks for European and UK Diagnostic Sales

The diagnostic tests in-licensed by Hepion Pharmaceuticals carry CE marks, making them eligible for sale in the EU and certain other markets. This eligibility strongly implies the use of third-party distribution networks as the primary channel to access European and UK clinical settings, rather than building an internal infrastructure from scratch.

The potential upside tied to these licensed assets, which these channels are meant to realize, includes milestone payments up to $17.15 million.

Corporate Website and Press Releases for Investor Communication

The corporate website acts as the central hub for investor communication, providing access to official disclosures and updates. This channel is critical, especially following the transition to the OTCQB market.

Key investor communication milestones channelled through press releases in 2025 include:

• Successful application to the OTCQB Venture Market on June 25, 2025.
• Announcement of Dr. Kaouthar Lbiati as Interim Chief Executive Officer on June 16, 2025.
• Receipt of Nasdaq Delisting Notification on May 12, 2025.
• Execution of the Binding Letter of Intent with New Day Diagnostics on May 7, 2025.

For the third quarter ending August 14, 2025, the company reported revenues of $0 million and a net loss of $(1.0) million.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Customer Segments

You're looking at the customer base for Hepion Pharmaceuticals, Inc. following its strategic pivot in mid-2025. The focus has shifted from the rencofilstat therapeutic pipeline to commercializing diagnostics.

Clinical laboratories and hospitals in Europe and the UK (initial diagnostic market)

This segment represents the immediate revenue opportunity because the in-licensed diagnostic tests already possess the necessary European clearance. The tests eligible for sale in Europe as of May 2025 include:

• Celiac disease diagnostic tests.
• Respiratory multiplex tests (Covid/Influenza A/B and RSV).
• Helicobacter pylori (H. pylori) tests.

The company's plan targets near-term revenue generation through the commercialization of these CE-marked tests in Europe and the UK. Hepion Pharmaceuticals, Inc. had 0 million in reported revenue for the year ended December 31, 2024, making this initial market entry critical.

US clinical labs and hospitals (future diagnostic market pending FDA approval)

This segment is the future growth driver for the diagnostic portfolio, contingent on securing U.S. regulatory clearance. The diagnostic tests being pursued for the U.S. market include the same four areas: celiac disease, respiratory multiplex, H. pylori, and hepatocellular carcinoma (HCC). The company is actively pursuing U.S. regulatory submissions for these products. This contrasts with the previous therapeutic focus, where the lead candidate, rencofilstat, had received FDA Fast Track designation in November 2021 and Orphan Drug designation in June 2022, but the patent assets for that drug were sold in May 2025.

Individual and institutional investors trading on the OTCQB

Following a delisting from Nasdaq in May 2025, Hepion Pharmaceuticals, Inc. commenced trading on the OTCQB Venture Market on June 25, 2025. This market serves the current shareholder base, which includes entities that recently reduced their holdings. Here's a snapshot of the financial metrics as of late November 2025:

Metric	Value as of November 26, 2025
Market Cap	$699,543
Shares Outstanding	11,620,317
Stock Price	$0.06
Institutional Investor Activity (Q1 2025)	BLACKROCK, INC. removed 82,954 shares
Institutional Investor Activity (Q1 2025)	VANGUARD GROUP INC removed 50,251 shares

The company raised $9.0 million in gross proceeds from a public offering in January 2025 to fund operations, including working capital. Hepion Pharmaceuticals, Inc. reports having 22 Employees.

Potential strategic partners for future drug development/licensing

The most concrete partnership identified relates to the diagnostic shift, where a strategic partner provided the in-licensed assets. Hepion Pharmaceuticals, Inc. executed a Binding Letter of Intent with New Day Diagnostics LLC on May 7, 2025, to commercialize the suite of diagnostic tests. This agreement is key to the current business model, as New Day Diagnostics provided tests that already held CE marks for the initial European market entry. The company also previously explored strategic alternatives including licensing, acquisition, and merger, though a July 2024 merger agreement was terminated in December 2024.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Hepion Pharmaceuticals, Inc. (HEPA) as they pivot their focus, especially following the wind-down of the ASCEND-NASH trial and the in-licensing of diagnostic assets. The cost structure is heavily weighted toward R&D, even with recent cuts, but the new diagnostic focus introduces a different type of upfront and contingent expense.

General and Administrative (G&A) expenses, including legal and accounting fees.

G&A costs reflect the overhead necessary to run the company, including executive salaries, legal counsel for corporate governance, and accounting services. Following the December 2023 restructuring plan, which aimed to reduce operating costs by approximately 60%, these costs have been managed tightly. You can see the fluctuation in the table below, though the most recent concrete data point is from the prior year's operational environment.

The table below shows a snapshot of recent Selling, General, and Administrative (SG&A) expenses, which includes G&A, for Hepion Pharmaceuticals, Inc. Note that the Q3 2025 data is not explicitly detailed in the latest snippets, so we use the last reported figures for context.

Period End Date	General and Administrative Expense (Approximate)
Q3 2024 (Sep 30, 2024)	$1.26 million
Q2 2024 (Jun 30, 2024)	$919.49K
Q1 2024 (Mar 31, 2024)	$1.79 million
FY 2023 (Dec 31, 2023)	$9.62 million (Total SG&A)

Reduced Research and Development (R&D) costs; Q3 2024 R&D was $2.76 million.

R&D is historically the largest cost driver for a clinical-stage biopharma company like Hepion Pharmaceuticals, Inc., covering clinical trial expenses, drug manufacturing, and research personnel. The stated reduction in operating costs was intended to extend the cash runway, which was previously guided into Q2 2025 following the December 2023 plan. The R&D spend saw a significant step-down after the wind-down of the ASCEND-NASH trial began in April 2024.

• Q3 2024 R&D expense was reported at $2.76 million.
• This represented a substantial decrease from Q2 2024 R&D costs of $7.14 million.
• The company's loss from operations for the full year 2024 was $(19.3) million, reflecting these cost-saving measures.

Costs associated with diagnostic commercialization and sales infrastructure.

The pivot to diagnostics, announced via a binding Letter of Intent in May 2025 with New Day Diagnostics LLC, introduces new cost categories related to building out commercial capabilities, though the immediate plan leverages existing networks. The initial financial outlay for in-licensing these tests was concrete.

• Upfront cash payment for in-licensing: $525,000.
• Upfront stock payment for in-licensing: $200,000.
• Potential future costs tied to milestones: up to $17.15 million.
• Ongoing cost: Royalties in the upper single to low double digits based on net sales.

Regulatory submission and compliance costs for diagnostic tests.

For the in-licensed tests, a key cost component is associated with regulatory compliance, particularly in the European Union where several tests already hold CE marks. While specific 2025 regulatory submission budgets for the US market aren't public, the European readiness reduces immediate, large-scale submission costs for those specific CE-marked products. The focus shifts to maintaining compliance and potentially pursuing US FDA clearance for commercialization, which involves significant, though not yet itemized, regulatory fees and consulting costs.

One-time restructuring charges from the 2023 cost-saving plan.

To achieve the stated goal of preserving capital, Hepion Pharmaceuticals, Inc. implemented a strategic restructuring plan in December 2023. This action resulted in a non-recurring, one-time charge that hit the income statement in the fourth quarter of 2023. This charge was designed to facilitate the subsequent reduction in recurring operating expenses.

The one-time restructuring charge recorded in the fourth quarter of 2023 was estimated to be between $400 thousand and $800 thousand. This charge was a necessary expense to realize the planned reduction in ongoing operating costs. Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Canvas Business Model: Revenue Streams

When you look at Hepion Pharmaceuticals, Inc. (HEPA)'s revenue streams as of late 2025, it's clear the business model is pivoting hard toward near-term commercial activity to support its pipeline development. Honestly, the capital structure is heavily reliant on external funding, which makes these non-dilutive or near-term revenue sources critical.

The most immediate, non-dilutive cash infusion came from recent financing activities. You saw the $9.0 million gross proceeds public offering that launched in January 2025. That capital, priced at $0.325 per share with accompanying warrants, was earmarked for debt repayment and general corporate purposes, including working capital.

The second major pillar is the strategic shift into diagnostics following the May 2025 binding Letter of Intent with New Day Diagnostics LLC. This move is explicitly designed to generate near term revenues in European Union countries where the tests already have CE marks. The initial deal terms involved a payment of $525,000 CASH and $200,000 IN STOCK to New Day Diagnostics, plus potential milestone payments up to $17.15 million and royalties in the upper single to low double digits of net sales. The potential scale here is massive, given the combined addressable market for the licensed tests exceeds $15 billion.

Here's a quick look at the market potential Hepion is tapping into with these diagnostics:

• Respiratory Panel RT-PCR Multiplex CE-IVD: $5.6 billion market.
• mSEPT9 assay for HCC: $8.7 billion market.
• H. pylori CE-IVD: $700 million market.
• CeliaCare CE-IVD: $457 million market.

The Rencofilstat asset sale in May 2025 also established a framework for future, contingent revenue streams via a Contingent Value Right (CVR) provided to stockholders. Hepion Pharmaceuticals received a nominal amount for the asset sale itself, but the CVR ties future payments to clinical and commercial success milestones. You need to track these specific potential payments:

CVR Trigger Event	Potential Payment Amount
FDA Regulatory Approval (First NDA)	US$500,000
Net Sales Exceeding US$350,000,000	US$1,000,000
Net Sales Exceeding US$750,000,000	US$3,000,000

As for the AI-POWR™ platform, while it is proprietary and used to optimize drug development, the company explicitly states it does not yet generate product revenue from it. The strategy is to use the platform to advance the pipeline, with operations sustained primarily through equity financing and strategic partnerships, suggesting future licensing or partnership revenue is a potential, but not yet realized, stream.

The urgency for these revenue streams is underscored by the low valuation. As of November 28, 2025, Hepion Pharmaceuticals' market capitalization was $755,321. Other data points place it around $0.75 Million USD in November 2025, or $929.63 thousand as of December 4, 2025. This low market cap, which is significantly down over the past year, highlights that current operations are not self-sustaining through product sales yet. Finance: draft 13-week cash view by Friday.