Hepion Pharmaceuticals, Inc.

Hepion Pharmaceuticals, Inc. is a U.S.-based biopharmaceutical company that has historically focused on developing drug candidates and, more recently, has expanded into in-licensed diagnostic tests. The company has no approved commercial pharmaceutical products and is still in a development-stage, capital-dependent profile, with operations funded primarily through equity, warrants, and other financing instruments.

10.25

— Hepion Pharmaceuticals, Inc.
	%
Clinical-stage pharmaceutical programs	0% Research, preclinical work, and clinical development of drug candidates and related technologies.
In-licensed diagnostics	100% Diagnostic tests licensed from New Day Diagnostics, including celiac, respiratory multiplex, H. pylori, and HCC tests.
Regulatory and commercialization rights	0% Rights to sell CE-marked diagnostic products in Europe and pursue regulatory, sales, and reimbursement milestones.

Hepion’s historical customer base is not a traditional recurring buyer base because the company has not generated...

European diagnostic buyersprimary
Hospitals, labs, and distributors that can purchase CE-marked celiac, respiratory multiplex, and H. pylori tests for immediate sale in Europe.
Healthcare providers and labsprimary
Clinical end users that would adopt the tests based on workflow fit, turnaround time, and disease screening needs.
Payers and reimbursement bodiessecondary
Organizations that affect pricing, reimbursement, and scale-up of diagnostic sales in target markets.
Future pharmaceutical prescribers and patientsemerging
Potential end users of any approved drug candidate from Hepion’s development pipeline.

Hepion is headquartered in the United States, but its disclosed near-term commercialization opportunity is in Europe...

•United States is the corporate base and historical R&D center
•Europe is the near-term commercial market for CE-marked diagnostics
•No approved commercial products in the U.S. today
•European revenue depends on regulatory, sales, and reimbursement execution
•Geographic expansion is tied to licensing and commercialization milestones

Hepion’s strategy has shifted from a pure drug-development model toward strategic alternatives and in-licensed...

Launch and monetize licensed diagnostics in Europeshort-term

These products are the only disclosed near-term revenue opportunity and can generate sales before any drug approval.

Secure additional financingshort-term

The company has no operating revenue and must fund ongoing development, licensing, and commercialization activities.

Reduce operating burnshort-term

Lower cash usage extends runway and supports execution while the company transitions its business model.

Retain strategic optionalitymedium-term

Management continues to evaluate acquisitions, licensing, and other alternatives to rebuild the pipeline.

Hepion remains a high-risk, development-stage company with no approved commercial products and a history of operating...

critical

Going-concern and liquidity risk

The company has no approved products and expects continued losses, so it may need additional capital to operate.

Scope: All operations
Materiality: high

high

Regulatory approval and compliance risk

Commercialization depends on meeting FDA and foreign regulatory requirements, and approvals can be delayed, limited, or withdrawn.

Scope: Drug candidates and diagnostics
Materiality: high

high

Commercialization and reimbursement risk

Even CE-marked products may not generate meaningful revenue if adoption, pricing, or reimbursement is weak.

Scope: European diagnostics
Materiality: high

high

Dilution risk from capital raises

Funding has come from equity, warrants, and preferred stock, which can dilute existing shareholders.

Scope: Capital structure
Materiality: high

high

Development failure risk

Pharmaceutical candidates can fail in preclinical or clinical testing or prove unsafe or ineffective.

Scope: Pipeline assets
Materiality: high

Fair value of derivative financial instruments

Reported net loss can change materially period to period

Contingent consideration

Can increase liabilities and create volatility in other income/expense

Asset impairment

Can reduce asset values and increase operating loss

Equity-linked financing accounting

Important for per-share metrics and capital structure interpretation

Hepion Pharmaceuticals, Inc.

Going-concern and liquidity risk

Regulatory approval and compliance risk

Commercialization and reimbursement risk

Dilution risk from capital raises

Development failure risk

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