Hepion Pharmaceuticals, Inc. (HEPA): Business Model Canvas [Dec-2025 Updated]

You're looking at Hepion Pharmaceuticals, Inc. (HEPA) in late 2025, and honestly, it's a company that has completely flipped the script from its old drug development days. As an analyst who's seen a few dramatic turnarounds in my two decades, this pivot to precision diagnostics-backed by a recent $9 million equity raise in January 2025-is the defining feature now. It's a total reset. We need to map out exactly how they plan to generate revenue from CE-marked European test sales and that AI-POWR platform while keeping their net loss down to $(13.2) million. Below, I break down the nine essential building blocks of this new Hepion Pharmaceuticals, Inc. (HEPA) business model so you can see the immediate opportunities and the real risks involved.

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

You're hiring before product-market fit, so securing the right external expertise and market access is critical for Hepion Pharmaceuticals, Inc. (HEPA). Here's a look at the key external relationships shaping the business model as of late 2025.

New Day Diagnostics for commercializing diagnostic tests

Hepion Pharmaceuticals, Inc. entered a binding Letter of Intent (LOI) with New Day Diagnostics LLC on May 7, 2025, to in-license several diagnostic tests. This move allows Hepion Pharmaceuticals, Inc. to generate near-term revenues in European Union countries by leveraging New Day Diagnostics' established distributor network. The in-licensed portfolio covers Celiac Disease, Respiratory Multiplex (Covid/Influenza A/B and RSV), Helicobacter Pylori (H. Pylori), and Hepatocellular Carcinoma (HCC).

The combined addressable market for these diagnostics exceeds $15 billion.

Contract Research Organizations (CROs) for any remaining or new clinical work

Following the pause of the ASCEND-NASH clinical trial in April 2024, any remaining data analysis or future clinical work for Rencofilstat would necessitate CRO engagement. The Phase 2b study had a target enrollment of 336 subjects, with 151 subjects randomized before the pause. To date, approximately 80 subjects provided Day 365 visit data, which is evaluable for both safety and efficacy.

Academic and research institutions for AI-POWR™ platform development

Hepion Pharmaceuticals, Inc. utilizes its proprietary Artificial Intelligence - Precision Medicine; Omics; World database access; and Response and clinical outcomes (AI-POWR™) platform. The platform integrates proprietary data with publicly-available multi-omic databases. The omics components include:

• Genomics
• Proteomics
• Metabolomics
• Transcriptomics
• Lipidomics

The platform's initial rollout was announced on October 5, 2020.

Specialized distributors for diagnostic test kits in Europe and the UK

The binding LOI with New Day Diagnostics on May 7, 2025, specifically notes that the Celiac, Respiratory Multiplex, and H. Pylori tests currently hold CE marks, making them eligible for sale in Europe. Hepion Pharmaceuticals, Inc. plans to generate near-term revenues in EU countries by leveraging New Day Diagnostics' existing distributor network relationships.

Investment banks for capital raises, like the $9 million offering in January 2025

Laidlaw & Company (UK) Ltd. acted as the sole placement agent for the public offering announced on January 22, 2025. The offering was expected to generate gross proceeds of approximately $9.0 million before fees and expenses. The combined offering price for each unit of common stock plus accompanying warrants was $0.325. The expected closing date was on or about January 23, 2025. The gross proceeds were earmarked for debt repayment and general corporate purposes, including working capital. The offering involved 27,692,310 shares of common stock or pre-funded warrants.

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

Commercializing CE-marked diagnostic tests in Europe and the UK.

Pursuing US regulatory submissions (FDA) for diagnostic products.

Managing the Contingent Value Right (CVR) from the Rencofilstat asset sale.

• Rencofilstat for NASH received FDA Fast Track designation in November 2021.
• Rencofilstat for HCC received FDA Orphan Drug designation in June 2022.

Maintaining and evolving the proprietary AI-POWR™ platform.

General corporate and financial management to sustain operations.

The execution of a Binding Letter of Intent with New Day Diagnostics occurred on May 7, 2025, for commercializing diagnostic tests covering Celiac Disease, Respiratory Multiplex, H. Pylori, and HCC.

The company announced a receipt of a Delisting Notification from Nasdaq on May 12, 2025, with trading suspension effective May 13, 2025, followed by a successful application to the OTCQB on June 25, 2025.

The following table details key financial metrics as of late 2025 data points:

The company announced a $9.0 Million Public Offering on March 14, 2025.

The AI-POWR™ platform is designed to detect a priori patients who will respond to rencofilstat, aiming to speed up drug development.

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

You're looking at the core assets Hepion Pharmaceuticals, Inc. (HEPA) is leaning on as of late 2025, especially after the leadership shift and recent financing. These aren't just line items; they are the tangible and intangible things that make the business run right now.

The company's financial runway got a boost in early 2025, which is critical for any clinical-stage entity. The leadership team, now under a new interim CEO, is focused on leveraging these assets, particularly the diagnostic portfolio, which seems to be the immediate strategic pivot.

The intellectual property isn't just about the drug candidate anymore; it's heavily weighted toward the diagnostics pipeline, which signals a near-term focus on revenue generation, as Dr. Lbiati noted.

• Diagnostic tests in development/commercialization focus: Celiac disease.
• Diagnostic tests in development/commercialization focus: Respiratory multiplex (Covid/Influenza A/B and RSV).
• Diagnostic tests in development/commercialization focus: Helicobacter pylori (H. pylori).
• Diagnostic tests in development/commercialization focus: Hepatocellular carcinoma (HCC).

The AI-POWR™ platform remains a foundational asset, designed to integrate diverse data types to de-risk development. It's a complex system built on several core technologies.

• Platform components: Artificial Intelligence.
• Platform components: Machine Learning.
• Platform components: Deep Learning.
• Data inputs: Proprietary pre-clinical and clinical data.
• Data inputs: Publicly-available multi-omic databases.
• Omics data types used: Genomics, proteomics, metabolomics, transcriptomics, and lipidomics.

When you look at the Rencofilstat know-how, you see a history of clinical work, even with the wind-down of the larger trial. The data generated is still a resource, showing proof-of-concept in certain endpoints.

The ASCEND-NASH trial, though shelved in April 2024, enrolled 151 subjects against a target of 336, but the data from that, and the earlier Phase 2a AMBITION study, provides safety and efficacy signals for the molecule, which inhibits Cyclophilin B.

Specifically, Rencofilstat treatment in an earlier study showed a significant reduction in liver stiffness (FibroScan) in MASH subjects with advanced F3 fibrosis after 17 weeks of treatment. That kind of hard data is what the know-how represents.

Leadership continuity and experience are key, especially with a new leader taking the helm. Dr. Lbiati has a track record that includes contributing to the launch of breakthrough treatments like Jevtana®, Votrient®, Blincyto®, Filgotinib®, and Symbicort® across various therapeutic areas.

The company's stock listing is also a resource detail; as of the June 16, 2025, CEO announcement, Hepion Pharmaceuticals, Inc. was trading on the OTC market.

Finance: draft 13-week cash view by Friday.

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:

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.

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:

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:

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.

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:

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.