Hepion Pharmaceuticals, Inc. (HEPA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de l'innovation pharmaceutique en évolution, Hepion Pharmaceuticals apparaît comme un phare d'espoir pour les patients luttant contre les maladies hépatiques complexes. Avec une approche axée sur le laser sur le développement de la thérapie révolutionnaire, ciblant en particulier la stéatohépatite non alcoolique (NASH), cette entreprise de biotechnologie dynamique pionnière un voyage transformateur à travers sa toile de modèle commercial méticuleusement conçu. En tirant parti de la technologie des inhibiteurs du CRF de pointe et des collaborations stratégiques, Hepion ne développe pas seulement des médicaments, mais réinvente l'avenir du traitement des maladies du foie - promettant des percées potentielles qui pourraient révolutionner les soins aux patients et les interventions médicales.

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: partenariats clés

Collaboration des institutions de recherche universitaire

Institution	Focus de la collaboration	Domaine de recherche
Université de Californie, San Diego	Nash Research	Développement de médicaments précliniques
Clinique de mayo	Études de maladie du foie	Soutien en essai clinique

Partenaires stratégiques pharmaceutiques

Partners de collaboration en cours cliniques actuels:

• Medpace, Inc. - Organisation de recherche sur les contrats
• Icon PLC - Services de recherche clinique mondiale

Organisations de recherche contractuelle (CROS)

Nom de CRO	Valeur du contrat	Phase d'étude
Medpace	3,2 millions de dollars	Essais de phase 2 NASH
Icône plc	2,7 millions de dollars	Études précliniques

Partenaires de licence

Partners de commercialisation potentiels:

• Gilead Sciences - Licence de traitement des maladies du foie potentielle
• AbbVie Inc. - Nash Therapeutic Partnership Discussion

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: activités clés

Recherche et développement de nouvelles thérapies pour les maladies hépatiques

Au quatrième trimestre 2023, Hepion Pharmaceuticals a investi 12,3 millions de dollars Dans la recherche et les efforts de développement axés sur la thérapeutique des maladies du foie.

Zone de focus R&D	Montant d'investissement	Étape de recherche
Pipeline d'inhibiteur du CRF	7,5 millions de dollars	Essais cliniques de phase 2
Développement du traitement de Nash	4,8 millions de dollars	Recherche préclinique

Effectuer des essais cliniques pour le pipeline d'inhibiteur du CRF

Le portefeuille actuel des essais cliniques comprend:

• 2 essais cliniques de phase active 2
• Budget total des essais cliniques de 9,2 millions de dollars pour 2024
• Objectif d'inscription des patients de 180 participants

Élaboration de traitements pour la stéatohépatite non alcoolique (NASH)

Nash Treatment Development Metrics	2024 valeurs
Personnel de recherche	12 chercheurs spécialisés
Budget de recherche annuel	5,6 millions de dollars
Candidats à la drogue potentiels	3 au stade préclinique

Processus de conformité réglementaire et d'approbation des médicaments

Dépenses de conformité pour 2024: 2,1 millions de dollars

• Réunions d'interaction FDA: 4 programmées
• Équipe de préparation de la documentation réglementaire: 6 professionnels

Gestion et protection de la propriété intellectuelle

Catégorie IP	Nombre d'actifs	Coût de protection annuel
Brevets actifs	7	1,3 million de dollars
Demandes de brevet	3	$450,000

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: Ressources clés

Plateforme de technologie de l'inhibiteur du CRF propriétaire

Technologie des inhibiteurs du CRF (cycline dépendante de la kinase) représente une ressource critique pour Hepion Pharmaceuticals:

Attribut technologique	Détails spécifiques
Focus technologique	Interventions thérapeutiques des maladies du foie
Statut de brevet	Plusieurs brevets émis protégeant la technologie de base
Étape de développement	Phases avancées de développement préclinique et clinique

Expertise scientifique et de recherche dans la thérapeutique des maladies du foie

Les capacités de recherche de Hepion comprennent:

• Équipe de recherche spécialisée avec une vaste expérience en hépatologie
• Réseaux collaboratifs avec des établissements de recherche universitaires
• Expertise dans le développement de traitements ciblés sur les maladies hépatiques

Portefeuille de brevets pour les candidats à la drogue

Catégorie de brevet	Nombre de brevets	Champ de protection
Technologie de base de l'inhibiteur du CRF	7 brevets délivrés	Marchés pharmaceutiques mondiaux
Compositions spécifiques des candidats médicaments	3 demandes de brevet en instance	Nouvelles structures moléculaires

Installations de recherche et de développement

L'infrastructure de R&D de Hepion comprend:

• Espaces de laboratoire dédiés à San Diego, Californie
• Équipement de recherche de biologie moléculaire avancée
• Modélisation informatique et capacités de conception de médicaments

Pool de talents médical et scientifique spécialisé

Catégorie professionnelle	Nombre de professionnels	Domaines d'expertise
Chercheurs au niveau du doctorat	12 chercheurs à temps plein	Hépatologie, pharmacologie, biologie moléculaire
Spécialistes du développement clinique	8 professionnels de la recherche clinique	Conception et gestion des essais cliniques

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: propositions de valeur

Approche thérapeutique innovante pour le traitement des maladies du foie

Hepion Pharmaceuticals se concentre sur le développement de CRV431, un inhibiteur de la cyclophiline ciblant la stéatohépatite non alcoolique (NASH). Les données des essais cliniques au T4 2023 indiquent:

Paramètre clinique	Mesures
Potentiel de traitement CRV431	Réduction de la progression de la fibrose hépatique
Étape clinique	Essais cliniques de phase 2
Cible de la population de patients	Patients NASH atteints de fibrose hépatique

Percée potentielle dans la gestion de Nash

Les cibles thérapeutiques clés comprennent:

• Mécanisme d'inhibition de la cyclophiline
• Réduction potentielle de l'inflammation du foie
• Atténuation de la progression de la fibrose

Développement avancé de médicament à petites molécules

Métriques d'investissement de recherche et développement:

Métrique financière	Montant
Dépenses de R&D (2023)	12,4 millions de dollars
Demandes de brevet	7 compositions pharmaceutiques actives

Options de traitement ciblées pour les conditions hépatiques complexes

Domaines d'intervention thérapeutique:

• Stéatohépatite non alcoolique (NASH)
• Fibrose hépatique
• Inflammation hépatique

Réduction potentielle de la progression et des complications des maladies hépatiques

Jalons de développement clinique:

Étape de développement clinique	Statut
Essais cliniques de phase 2	Inscription en cours des patients
Points de terminaison cliniques prévus	Régression de la fibrose du foie

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Hepion Pharmaceuticals a maintenu l'engagement direct grâce à 37 collaborations de recherche active avec des établissements universitaires et médicaux.

Type d'engagement	Nombre de collaborations	Focus de recherche
Partenariats académiques	22	Recherche de la Nash et du foie
Réseaux de recherche clinique	15	Essais cliniques CRN-001

Présentations de conférence scientifique et de symposium

En 2023, Hepion Pharmaceuticals a présenté 12 conférences médicales internationales, avec 8 axées sur l'hépatologie et la recherche sur les maladies du foie.

• American Association for the Study of Liver Diseases (AASLD) Conférence
• Congrès international du foie
• Conférence de biologie expérimentale

Communication transparente des progrès des essais cliniques

Hepion a signalé 4 essais cliniques actifs en décembre 2023, avec des mises à jour de progrès trimestriels partagés par le biais des communications des investisseurs et des publications scientifiques.

Essai clinique	Inscription des patients	État actuel
CRN-001 Nash Trial	180 patients	Phase 2B active

Collaboration avec des spécialistes de l'hépatologie

La société a maintenu des relations professionnelles avec 64 spécialistes de l'hépatologie à travers l'Amérique du Nord et l'Europe en 2023.

Interactions du groupe de défense des patients

Hepion s'est engagé dans 7 organisations de défense des patients axées sur les maladies du foie et les troubles métaboliques en 2023.

• American Liver Foundation
• Programme d'éducation Nash
• Fondation hépatique gras

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Hepion Pharmaceuticals a publié des recherches dans les revues suivantes en 2023:

Nom de journal	Nombre de publications	Domaine de mise au point
Hépatologie	3	Nash et maladie du foie
Journal of Hepatology	2	Recherche d'hépatite virale

Conférences médicales et événements de l'industrie

Détails de la participation de la conférence pour 2023:

Conférence	Date	Type de présentation
Réunion du foie Aasld	Novembre 2023	Présentation orale
Congrès international du foie	Avril 2023	Présentation de l'affiche

Communication directe avec les partenaires pharmaceutiques

Canaux de communication partenaires:

• Communications par e-mail directes
• Réunions de revue de partenariat trimestriel
• Plateformes confidentielles de partage de données

Plateformes de relations avec les investisseurs

Métriques de communication des investisseurs pour 2023:

Plate-forme	Nombre d'interactions d'investisseurs	Appels de résultats trimestriels
Webinaires des investisseurs	4	4
Dépôts de la SEC	12	N / A

Soumissions d'agence de réglementation

Détails de la soumission réglementaire:

Agence	Nombre de soumissions	Type de soumission
FDA	2	Protocoles d'essais cliniques
Ema	1	Application de médicament enquête

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: segments de clientèle

Spécialistes de l'hépatologie

En 2024, environ 3 500 spécialistes de l'hépatologie aux États-Unis. Taille du marché cible estimé à 12,4 millions de dollars d'engagement annuel potentiel.

Catégorie spécialisée	Nombre total	Pénétration potentielle du marché
Hépatologues certifiés du conseil d'administration	3,500	65%
Spécialistes du centre médical universitaire	1,200	45%

Institutions de recherche

Des institutions de recherche ciblées axées sur la recherche sur les maladies du foie: 287 dans le monde.

• Centres de recherche nord-américains: 124
• Institutions de recherche européennes: 93
• Installations de recherche asiatique: 70

Sociétés pharmaceutiques

Le marché cible comprend 42 sociétés pharmaceutiques ayant des programmes de recherche sur les maladies du foie.

Taille de l'entreprise	Nombre d'entreprises	Intérêt potentiel de collaboration
Grandes sociétés pharmaceutiques	12	Haut
Sociétés pharmaceutiques de taille moyenne	18	Moyen
Petites entreprises spécialisées	12	Faible

Patients atteints de maladies du foie

Population totale de patients adressables: 4,5 millions aux États-Unis atteints de maladies hépatiques chroniques.

• Maladie hépatique non alcoolique (NAFLD): 2,3 millions
• Hépatite C: 900 000
• Cirrhose: 630 000
• Autres conditions hépatiques: 670 000

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

Total des prestataires de soins de santé spécialisés dans les troubles métaboliques: 8 700 à l'échelle nationale.

Type de fournisseur	Total des prestataires	Taux d'engagement potentiel
Endocrinologues	5,200	55%
Spécialistes des maladies métaboliques	2,100	75%
Fournisseurs de pratique avancée	1,400	40%

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Hepion Pharmaceuticals a déclaré des dépenses de R&D de 14,2 millions de dollars.

Année	Dépenses de R&D
2022	14,2 millions de dollars
2021	16,9 millions de dollars

Investissements d'essais cliniques

Les coûts des essais cliniques pour CRV431 (traitement des maladies du foie) étaient d'environ 7,5 millions de dollars en 2022.

• Phase 2 essais cliniques pour l'indication NASH
• Programmes de développement clinique en cours

Coûts de protection de la propriété intellectuelle

Les frais de protection des brevets et des marques étaient d'environ 450 000 $ en 2022.

Dépenses de conformité réglementaire

Les frais de conformité et de soumission réglementaires ont totalisé environ 1,2 million de dollars en 2022.

Frais d'acquisition du personnel et des talents

Catégorie de coûts	Montant
Total des dépenses du personnel	8,3 millions de dollars
Rémunération des dirigeants	2,1 millions de dollars
Compensation en stock	1,5 million de dollars

Coûts opérationnels totaux pour 2022: environ 31,6 millions de dollars

Hepion Pharmaceuticals, Inc. (HEPA) - Modèle d'entreprise: Strots de revenus

Accords de licence potentiels

Depuis le quatrième trimestre 2023, Hepion Pharmaceuticals n'a signalé aucun accord de licence actif pour son candidat principal du médicament CRV431.

Future commercialisation des médicaments

Drogue	Zone thérapeutique	Étape de développement actuelle	Valeur marchande potentielle
CRV431	Stéatohépatite non alcoolique (NASH)	Essais cliniques de phase 2	Marché potentiel de 35 milliards de dollars d'ici 2026

Subventions et financement de recherche

Pour l'exercice 2023, Hepion Pharmaceuticals a rapporté 3,2 millions de dollars dans le financement des subventions de la recherche et du développement.

Partenariats pharmaceutiques stratégiques

• Aucun partenariat pharmaceutique stratégique actif signalé en 2023
• Discussions en cours avec des collaborateurs de recherche potentiels

Paiements de jalons potentiels

Type d'étape	Fourchette de paiement potentielle	Probabilité
Développement préclinique	1 à 3 millions de dollars	Moyen
Initiation des essais cliniques	5-10 millions de dollars	Moyen-élevé

Revenus totaux pour Hepion Pharmaceuticals en 2023: 4,7 millions de dollars

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.