Nasdaq panel delists Hepion Pharmaceuticals; company expects OTC quotation

The panel decision

Hepion Pharmaceuticals, Inc. said on May 12, 2025 that it had received written notice on May 9 from the Office of General Counsel of The Nasdaq Stock Market. The notice said the Nasdaq Hearings Panel had decided to delist the company's shares for failing to meet continued listing standards. Trading was due to be suspended at the open on Tuesday, May 13, 2025.

The Morristown, New Jersey company expects its common stock to be quoted under the existing symbol HEPA on the OTC Markets Group after the suspension. The announcement does not say when that quotation would begin.

The two findings

Hepion said it had not complied with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 a share. Nasdaq had also cited Listing Rule 5101, saying it believed the company is a public shell, meaning a listed company with few or no operations. The company says both points were disclosed before the May notice.

The trial behind the company

Hepion's lead asset, rencofilstat, is a cyclophilin inhibitor that was studied in chronic liver disease. Its Phase 2b trial, ASCEND-NASH, had a target enrollment of 336 subjects. Enrollment was paused in April 2023 with 151 subjects randomized. In April 2024 the company began winding down the trial, which closed in August 2024. The company says about 80 subjects had completed their Day 365 visits and were evaluable for safety and efficacy. The announcement gives no efficacy results from those visits. In its 2024 annual report, the company says it "did not have access to sufficient funding" to complete the study as designed.

Earlier, the company said in May 2023 that its ALTITUDE-NASH Phase 2a study met its primary endpoint, with improved liver function after four months of treatment in NASH subjects with stage 3 or greater fibrosis. The later Phase 2b trial was designed to dose for 12 months. The company began winding it down in April 2024.

Financing and the failed merger

On July 19, 2024 Hepion agreed to merge with Pharma Two B Ltd. through Pearl Merger Sub, Inc., and sold $2.9 million of original issue discount senior unsecured notes the same day. The merger agreement was terminated on December 10, 2024, after the parent told Hepion that Nasdaq would not exclude the company's historical losses from its burn rate calculation.

On January 23, 2025, Hepion completed a best efforts registered offering of 73,222 common shares, pre-funded warrants for 480,624 shares, and Series A and Series B warrants for 553,846 shares each. Gross proceeds were $9,000,000. A portion of the net proceeds repaid the notes and accrued interest.

A pivot to diagnostics

On May 9, 2025, the same day as the Nasdaq notice, Hepion entered into a license agreement with New Day Diagnostics LLC. Under the deal, Hepion in-licensed diagnostic tests for celiac disease, a respiratory multiplex panel covering Covid, influenza A and B and RSV, H. pylori and hepatocellular carcinoma. The company says it has transitioned to a developer and distributor of diagnostic tests.

The release says the celiac, respiratory multiplex and H. pylori tests carry CE marks and can be sold in Europe at present. It does not say whether any test has FDA clearance, and it gives no sales figures, revenue or distribution partner for the tests.

Risks the company names

The release's risk list includes the company's ability to continue as a going concern and its need for additional financing. It also names patent uncertainty, competition and the cost and length of clinical trials.

What comes next

The next date is the May 13, 2025 suspension. After that, the company expects quotation on the OTC Markets Group under HEPA. The announcement does not say how Hepion will address the public shell finding or how it will fund a diagnostics business.

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