Hepion Pharmaceuticals

What Hepion Pharmaceuticals does

Hepion Pharmaceuticals is a precision diagnostics company that has undergone a strategic transformation from clinical-stage biopharmaceutical drug development to liquid biopsy diagnostics for early cancer detection. Originally spun off from Synergy Pharmaceuticals in 2014 as ContraVir Pharmaceuticals, the company originally advanced the cyclophilin inhibitor rencofilstat (CRV431) for NASH and hepatocellular carcinoma, supported by FDA Fast Track (November 2021) and Orphan Drug (June 2022) designations — assets that were ultimately divested in May 2025 for nominal consideration plus a contingent value right. Following the wind-down of its Phase 2b ASCEND-NASH trial in April 2024 and the termination of a proposed merger with Pharma Two B Ltd. in December 2024, the company pivoted toward liquid biopsy diagnostics for early hepatocellular carcinoma (HCC) detection in high-risk cirrhosis patients.

The company's current diagnostic portfolio comprises two complementary platforms: a clinically validated methylated DNA SEPT9 (mSEPT9) PCR-based assay positioned for near-term commercialization, and a circulating tumor RNA (ctRNA) biomarker assay in-licensed from Cirna Diagnostics LLC in March 2026 that detects mutant tumor-shed RNA variants with broader solid-tumor potential. The ctRNA platform addresses a documented surveillance gap where current HCC surveillance methods miss up to 75% of early-stage cancers. Hepion retains proprietary AI expertise through its AI-POWR™ platform, which historically integrated multi-omics data (genomics, proteomics, metabolomics, transcriptomics, lipidomics) for NASH patient stratification, although its forward deployment against the diagnostic franchise is unconfirmed. The company has a binding letter of intent with New Day Diagnostics (May 2025) covering celiac, respiratory multiplex, H. pylori and HCC tests, and has secured extension rights for additional ctRNA indications.

Hepion is pre-revenue and pursues a partnership-driven commercialization model: the planned go-to-market pathway begins with CLIA lab partnerships, progresses to pharma companion diagnostics collaborations, and culminates in co-development/co-commercialization agreements ahead of FDA regulatory submission. The company trades on the OTCQB Venture Market under symbol HEPA (transferred from Nasdaq in June 2025 following a delisting notification), is headquartered in Morristown, New Jersey, and operates with 11-50 employees. Leadership has been turbulent, with Gary Stetz appointed interim CEO in April 2026 following the resignation of Dr. Kaouthar Lbiati, who herself had replaced John Brancaccio on an interim basis in June 2025.

Name

Hepion Pharmaceuticals

Legal name

Hepion Pharmaceuticals, Inc.

Website

https://hepionpharma.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

Hepion Pharmaceuticals is a pre-revenue precision diagnostics company developing liquid biopsy tests (mSEPT9 and ctRNA biomarker assays) for early hepatocellular carcinoma detection in cirrhosis patients. The company plans commercialization through CLIA lab and pharma partnerships following a 2026 pivot from NASH drug development.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Hepatology & Liver Disease (HLAKAEAB)

Keywords

• Liquid biopsy diagnostics
• Hepatocellular carcinoma detection
• Circulating tumor RNA assay
• Methylated DNA diagnostics
• Precision cancer diagnostics

Headquarters

HQ city

Morristown

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Diagnostic Test Commercialization: Hepion is positioning to commercialize liquid biopsy diagnostic tests including the mSEPT9 PCR-based assay and ctRNA biomarker assay. The company plans to pursue CLIA lab partnerships, pharma companion diagnostics collaborations, and co-development/co-commercialization agreements.
2. Equity/Debt Securities Offering: Company raises capital through exempt offerings of securities including equity, debt, and warrants. Recent offerings include $2.9M offering connected to business combination, $2M from warrant exercises, $5M registered direct offering, and $9M public offering.
3. Patent/CVR Monetization: On May 26, 2025, Hepion sold all patent assets, knowhow, clinical trial data and drug product relating to Rencofilstat for a nominal amount plus a contingent value right (CVR) to stockholders.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

Hepion Pharmaceuticals is a precision diagnostics company developing liquid biopsy tests for early detection and surveillance of hepatocellular carcinoma (HCC) in patients with cirrhosis. Its portfolio comprises a clinically validated methylated DNA (SEPT9) PCR-based biomarker assay for near-term CLIA commercialization and an in-licensed circulating tumor RNA (ctRNA) biomarker assay that detects actively expressed tumor signatures, with broader potential application across solid tumors. The company is pursuing a regulatory roadmap from CLIA launch to FDA approval via lab partnerships, pharma companion diagnostics collaborations, and co-development agreements.

Product overview

Hepion Pharmaceuticals is a precision diagnostics company that has undergone a strategic shift from therapeutic drug development to liquid biopsy diagnostics. The company is advancing two complementary platforms for early hepatocellular carcinoma (HCC) detection: the clinically validated methylated DNA (SEPT9) biomarker PCR-based assay for near-term commercialization, and the in-licensed circulating tumor RNA (ctRNA) biomarker assay with broader solid tumor potential. Together, these platforms are designed to address a critical surveillance gap where current HCC methods miss up to 75% of early-stage cancers.

Differentiator

Problem solved

Functional benefit

Products and services

• ctRNA Biomarker Assay (Circulating Tumor RNA Assay) A next-generation, non-invasive blood-based liquid biopsy test that detects mutant circulating tumor RNA (ctRNA) shed by tumors to facilitate early diagnosis of hepatocellular carcinoma in high-risk patients with cirrhosis. The assay captures actively expressed tumor signatures and cancer-specific mutant RNA variants, providing earlier detection and improved specificity compared to DNA-based approaches. The platform has been validated across multiple independent HCC cohorts with standardized RNA extraction and HCC-specific variants integrated into a single multiparametric blood test.
• mSEPT9 PCR-Based Assay (Methylated DNA SEPT9 Biomarker Test) A clinically validated methylated DNA (SEPT9) biomarker blood test for early detection of hepatocellular carcinoma in people with cirrhosis. The PCR-based liquid biopsy test is positioned for near-term commercialization through a CLIA lab launch and FDA approval pathway.
• Hepatocellular Carcinoma (HCC) Diagnostics Portfolio Hepion's HCC diagnostic portfolio comprises the mSEPT9 PCR-based assay and the ctRNA biomarker assay as complementary platforms for early liver cancer detection and surveillance in high-risk patients with cirrhosis. The portfolio addresses the surveillance gap where current HCC methods miss up to 75% of early-stage cancers through non-invasive liquid biopsy approaches.

Quantifiable outcome

• Current HCC surveillance methods miss up to 75% of early-stage cancers
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

Seven partnerships are on record, tiered core, major and minor.

• Cirna Diagnostics LLCcoreOEM/ Whitelabel/ Licensing Partner · 3 March 2026Hepion in-licensed from Cirna Diagnostics LLC a novel circulating tumor RNA (ctRNA) biomarker assay that detects mutant circulating tumor RNA to facilitate early diagnosis of hepatocellular carcinoma in high-risk patients with cirrhosis. The platform was co-invented by Timothy Block (Hepion board member) and Aejaz Sayeed (Cirna chief scientific officer). Hepion also secured extension rights for other indications as the technology matures.
• Hepatitis B Foundation / Baruch S. Blumberg Institute / Pennsylvania Biotechnology CentercoreStrategic or Co-development Partner · 3 March 2026The ctRNA platform was co-invented by Timothy Block, PhD, who is co-founder and President of the Hepatitis B Foundation and its Baruch S. Blumberg Institute, and President/CEO of the Pennsylvania Biotechnology Center created by the HBF. Louis P. Kassa III leads all three organizations and Cirna Diagnostics.
• New Day DiagnosticsmajorStrategic or Co-development Partner · 7 May 2025Hepion executed a binding letter of intent with New Day Diagnostics to commercialize diagnostic tests for celiac disease, respiratory multiplex (COVID/Influenza A&B/RSV), H. pylori, and HCC.
• Summit Clinical ResearchcoreImplementation/ SI/ Consulting Partner · 12 September 2022Collaboration for ALTITUDE-NASH Phase 2 liver function trial, conducted at up to 20 sites within Summit's Integrated Research Organization, evaluating rencofilstat's impact on hepatic function and NASH biomarkers.
• HepQuantcoreTechnology or Integration · 3 May 2022Clinical collaboration where HepQuant provides its proprietary SHUNT test for evaluating liver function and health in patients with chronic liver diseases. Hepion incorporated the HepQuant SHUNT test into its ALTITUDE-NASH Phase 2 clinical trial to measure hepatic function and correlation with clinical outcomes.
• FibroFind LtdminorStrategic or Co-development Partner · 26 January 2022Nonclinical research collaboration with FibroFind Ltd (Newcastle, UK) and Professor Derek Mann's team at Newcastle University to study rencofilstat's synergistic anti-tumor activity with immune checkpoint inhibitors.
• Applied Pharmaceutical Innovation, University of AlbertaminorStrategic or Co-development Partner · 31 July 2019Research partnership with the Faculty of Pharmacy & Pharmaceutical Sciences at University of Alberta for drug development research activities.

Scale indicators11 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Natera: Natera develops cell-free DNA and RNA-based liquid biopsy tests for oncology, including tumor monitoring and MRD applications. Its Signatera and related oncology assays compete in the same blood-based cancer detection market as Hepion's ctRNA platform.
• Guardant Health: Guardant Health is a leading liquid biopsy company offering blood-based cancer diagnostics, including oncology screening and monitoring tests. It directly competes with Hepion's ctRNA-based approach in the liquid biopsy space for solid tumor detection.
• NeoGenomics: NeoGenomics is a cancer-focused clinical laboratory services company offering oncology diagnostic and monitoring tests, including liquid biopsy. It serves a similar hospital/clinic customer base and competes in the oncology diagnostics market Hepion is targeting.

Broad incumbents

• Foundation Medicine: Foundation Medicine (a Roche subsidiary) provides comprehensive genomic profiling and companion diagnostic services for solid tumors. It is a broad incumbent in molecular oncology diagnostics with overlapping liquid biopsy capabilities.
• Exact Sciences: Exact Sciences is a major cancer diagnostics company with established blood-based screening (Cologuard) and oncology liquid biopsy products (Oncotype DX, Oncodetect). It is a broad incumbent in non-invasive cancer diagnostics with overlapping go-to-market in hepatology-adjacent indications.
• Bio-Techne: Bio-Techne is a life science tools company providing reagents, assays, and diagnostic instruments, including cancer biomarker and liquid biopsy-related products. It is comparable as an established diagnostics tools provider with overlapping oncology biomarker capabilities.

Emerging players

• Personalis: Personalis is a cancer genomics company offering liquid biopsy assays for MRD and tumor profiling via its NeXT Personal test. It competes in oncology molecular diagnostics and is comparable to Hepion in using blood-based approaches for solid tumor applications.
• Tempus AI: Tempus AI is a precision medicine company combining multiomics data and AI to support cancer diagnostics and therapy selection. It is comparable to Hepion for its AI-driven approach to biomarker interpretation and its presence in precision oncology diagnostics.
• Freenome: Freenome is an emerging liquid biopsy company developing multiomics blood tests for early cancer detection, including colorectal cancer screening with expansion into other solid tumors. It is comparable to Hepion as a single-cancer-focused liquid biopsy startup with broader pipeline ambitions.

Others

• Bio-Rad Laboratories: Bio-Rad is a life science research and clinical diagnostics company offering PCR-based diagnostic platforms and reagents, including droplet digital PCR technologies used in liquid biopsy workflows. It is an adjacent supplier enabling technologies comparable to Hepion's PCR-based mSEPT9 assay.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/hepion
• Xx.com/HepionPharma

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds12 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Hepion Pharmaceuticals