8-K: Hepion Pharmaceuticals Faces Nasdaq Delisting Due to Non-Compliance with Listing Standards

Hepion Pharmaceuticals receives notification of delisting from Nasdaq due to failure to meet minimum bid price and concerns about being a public shell, transitioning to OTC Markets Group.

Summary

• Hepion Pharmaceuticals received a delisting notice from Nasdaq on May 9, 2025, because it didn't meet the minimum bid price of $1.00 per share and Nasdaq considers the company a public shell.
• Trading of Hepion's common stock on Nasdaq will be suspended at the open of trading on May 13, 2025.
• The company expects its stock to be quoted on the OTC Markets Group under the existing symbol HEPA.
• Hepion had previously been developing a treatment for NASH, HCC, and other chronic liver diseases but has transitioned to diagnostic tests.
• In April 2024, Hepion announced it was winding down its ASCEND-NASH clinical trial, which had enrolled 151 subjects out of a target of 336.
• Approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy.
• On May 9, 2025, Hepion entered into a license agreement 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.

Sentiment

Score: 3

Explanation: The sentiment is negative due to the delisting notice and the winding down of a clinical trial, offset slightly by the new diagnostic test licensing agreement. The company's future is uncertain.

Positives

• Hepion has transitioned to a developer and distributor of diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori and HCC.
• The company has entered into a license agreement with New Day Diagnostics LLC to in-license diagnostic tests.
• The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time.

Negatives

• Hepion Pharmaceuticals received a delisting notice from Nasdaq.
• The company failed to meet the minimum bid price requirement of $1.00 per share.
• Nasdaq believes the company is a public shell.
• The ASCEND-NASH clinical trial was wound down in April 2024.

Risks

• The company faces substantial competition.
• There is a risk related to the company's ability to continue as a going concern.
• The company needs additional financing.
• There are uncertainties of patent protection and litigation.
• There are risks associated with delays.
• There are uncertainties with respect to lengthy and expensive clinical trials.
• Results of earlier studies and trials may not be predictive of future trial results.
• There are uncertainties of government or third party payer reimbursement.
• The company has limited sales and marketing efforts and dependence upon third parties.
• There are risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.

Future Outlook

The company expects its Common Stock will be quoted under its existing symbol HEPA on the OTC Markets Group.

Industry Context

The transition from NASH treatment development to diagnostic tests reflects a strategic shift, possibly due to challenges in the NASH drug development landscape, which is known for high clinical trial failure rates. The move into diagnostic tests, particularly those with CE marks for European sales, suggests a focus on near-term revenue generation.

Comparison to Industry Standards

• Many biopharmaceutical companies face challenges in maintaining Nasdaq listing compliance, especially those with volatile stock prices or those undergoing significant strategic shifts.
• Companies like Intercept Pharmaceuticals and CymaBay Therapeutics, which are also focused on liver diseases, have faced their own clinical and regulatory hurdles.
• The transition to diagnostic tests is a common strategy for smaller biotech companies seeking to diversify revenue streams, similar to companies like Exact Sciences in the diagnostics space.

Stakeholder Impact

• Shareholders will likely experience a decrease in stock value and liquidity due to the delisting.
• Employees may face uncertainty due to the strategic shift and financial challenges.
• Customers and partners may be affected by the change in the company's focus from drug development to diagnostic tests.
• Creditors may be concerned about the company's ability to meet its financial obligations.

Next Steps

• The company expects its Common Stock will be quoted under its existing symbol HEPA on the OTC Markets Group.
• The company will focus on distributing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC).

Key Dates

Keywords

delisting, Nasdaq, Hepion Pharmaceuticals, OTC Markets Group, minimum bid price, public shell, diagnostic tests, ASCEND-NASH, Rencofilstat, celiac disease, respiratory multiplex, H. pylori, HCC