Hepion Pharmaceuticals Executes Binding Letter of Intent with New Day Diagnostics to Commercialize Diagnostic Tests for Celiac Disease, Respiratory Multiplex, H. Pylori and HCC

Rhea-AI Summary

Hepion Pharmaceuticals (NASDAQ:HEPA) has signed a binding letter of intent with New Day Diagnostics LLC to in-license diagnostic tests for multiple conditions. The agreement covers tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and hepatocellular carcinoma (HCC).

The combined addressable market for these diagnostics exceeds $15 billion, with individual markets showing significant growth potential: Respiratory Panel ($5.6B market, 6.6% annual growth), H. pylori detection ($700M market, 6.0% growth), CeliaCare ($457M market, 10.4% growth), and mSEPT9 for HCC ($8.7B market, 6.7% growth). The celiac, respiratory multiplex, and H. pylori tests already have CE marks and can be sold in Europe through New Day's existing distributor network.

Positive

• Access to multiple diagnostic tests with CE marks, enabling immediate revenue generation in European markets
• Large combined addressable market exceeding $15 billion
• Strong growth potential across all test markets, ranging from 6.0% to 10.4% annually
• Leverage existing distributor network relationships in Europe

Negative

• Company pivot from NASH treatment development to diagnostic commercialization indicates potential issues with previous business model
• Tests still require US market approval
• High competition in diagnostic markets may affect market penetration

Insights

Healthcare/Biotech Industry Analyst

Hepion's in-licensing of four diagnostic tests with CE marks enables immediate European revenue opportunities across multiple disease areas worth $15+ billion collectively.

Hepion Pharmaceuticals' binding letter of intent with New Day Diagnostics marks a strategic expansion into diagnostic testing, potentially transforming their business model. By in-licensing four diagnostic tests—three already CE-marked and eligible for European commercialization—Hepion gains access to near-term revenue opportunities across multiple high-growth markets.

The diagnostic portfolio addresses diverse clinical needs with substantial market potential:

• Respiratory Multiplex PCR Test ($5.6 billion market, 6.6% annual growth) enables efficient detection of COVID-19, Influenza A/B, and RSV from a single sample
• H. pylori test ($700 million market, 6.0% growth) provides non-invasive detection of infections linked to gastric ulcers and cancer
• CeliaCare ($457 million market, 10.4% growth) supports screening for underdiagnosed celiac disease
• mSEPT9 assay for hepatocellular carcinoma detection ($8.7 billion market, 6.7% growth) maintains connection to Hepion's liver disease focus

This expansion significantly accelerates Hepion's potential timeline to revenue. While therapeutic development typically requires years of clinical trials, these CE-marked diagnostics can be commercialized immediately in Europe through New Day's established distributor networks. The HCC diagnostic particularly complements Hepion's existing expertise in liver disease.

Investors should note this binding LOI represents a preliminary step toward a definitive agreement. Key details around financial terms, US market entry strategy, and how Hepion will develop commercial capabilities remain undefined. However, the immediate European market access and diversification across multiple diagnostic segments represents a meaningful opportunity for a company previously focused solely on therapeutic development.

MORRISTOWN, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a binding letter of intent (“LOI”) with New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time.

The diagnostic tests covered under the LOI represent a combined addressable market exceeding $15 billion. The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion market, growing at 6.6% annually through 2029, by enabling efficient, simultaneous detection of COVID-19, Influenza A/B, and RSV from a single sample. The H. pylori CE-IVD targets the $700 million market for early, non-invasive detection of infections that can lead to gastric ulcers and cancer, with 6.0% projected growth through 2032. CeliaCare CE-IVD supports rapid screening for celiac disease—an underdiagnosed autoimmune condition—in a $457 million market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma (HCC) in high-risk patients, serves an $8.7 billion market projected to grow 6.7% annually through 2030. Collectively, these diagnostics offer clinical utility across multiple conditions while opening access to meaningful commercial opportunities in global markets.

John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion expressed his enthusiasm about this licensing opportunity: “The CE marked tests provide Hepion with the ability to generate near term revenues in European Union countries by leveraging the existing distributor network relationships that New Day Diagnostics has established. We are excited by this opportunity and look forward to working with New Day to maximize value.”

“This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world,” said Eric Mayer, CEO of New Day Diagnostics. “We’re excited to partner with Hepion to expand the reach of these CE-marked tests, bring them to the United States, and unlock new opportunities to improve early detection and outcomes across multiple disease areas.”

About Hepion Pharmaceuticals

Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models.

In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy.

Hepion has been considering a number of assets to in-license and develop and Hepion’s Board of Directors believes that the opportunity offered by New Day Diagnostics presents a great opportunity to benefit Hepion’s stockholders.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Hepion Pharmaceuticals
info@hepionpharma.com

FAQ

What diagnostic tests did Hepion Pharmaceuticals (HEPA) acquire through the New Day Diagnostics agreement?

Hepion acquired licenses for diagnostic tests covering celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and hepatocellular carcinoma (HCC).

What is the total market size for HEPA's newly licensed diagnostic tests?

The combined addressable market for the diagnostic tests exceeds $15 billion, including Respiratory Panel ($5.6B), H. pylori ($700M), CeliaCare ($457M), and HCC detection ($8.7B).

Which of Hepion's new diagnostic tests are currently approved for sale in Europe?

The celiac disease, respiratory multiplex, and H. pylori tests have CE marks and are eligible for immediate sale in European markets.

What is the projected growth rate for HEPA's celiac disease diagnostic market?

The celiac disease diagnostic market is projected to grow at 10.4% annually through 2034, representing the highest growth rate among the licensed tests.

How will Hepion Pharmaceuticals distribute its diagnostic tests in Europe?

Hepion will leverage New Day Diagnostics' existing distributor network relationships in European Union countries.