Hepion Pharmaceuticals, Inc. SEC 10-Q Report

Hepion Pharmaceuticals, Inc., a biopharmaceutical company focused on developing treatments for liver diseases, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and significant operational changes during the reporting period.

Financial Highlights

Revenues: $0 million. The company did not generate any revenue during the reporting period as it does not currently have any commercial products.

Loss from operations: $(1.7) million. The loss from operations decreased significantly compared to the previous year due to reduced research and development expenses.

Net loss: $(1.0) million. The net loss improved compared to the previous year, primarily due to a decrease in operating expenses.

Net loss per common share: $(0.09). The net loss per share decreased significantly compared to the previous year, reflecting the reduced net loss and increased weighted-average common shares outstanding.

Business Highlights

Research and Development Focus: The company has shifted its focus from drug therapy development for chronic liver diseases to in-licensing diagnostic tests for celiac disease, respiratory multiplex, helicobacter pylori, and hepatocellular carcinoma. These tests have CE marks and are eligible for sale in the EU and certain other markets.

Clinical Trial Wind-Down: The ASCEND-NASH clinical trial was wound down due to insufficient funding, with all activities completed and the trial closed by August 2024.

License Agreement with New Day Diagnostics: A significant operational highlight is the license agreement with New Day Diagnostics, which includes in-licensing diagnostic tests. The company paid $525,000 in cash and $270,629 in common stock, with potential milestone payments up to $17.15 million.

Asset Impairment: An impairment loss of $402,746 was recorded due to delayed market entry affecting cash flow projections for the licensed assets, indicating challenges in realizing expected returns from the New Day licensing agreement.

Patent and Asset Sale: The company sold all patent assets related to Rencofilstat to Panetta Partners Limited, with Panetta assuming contingent consideration obligations, indicating a strategic shift away from drug development.

Reverse Stock Split: A reverse stock split at a ratio of one-for-fifty was effected on March 17, 2025, impacting the number of shares and exercise prices of stock options and warrants.

Nasdaq Delisting and OTCQB Transition: The company was delisted from Nasdaq due to non-compliance with listing standards and transitioned to the OTCQB Venture Market by June 25, 2025.

Future Outlook: The company faces substantial doubt about its ability to continue as a going concern without additional capital. It plans to focus on the commercialization of in-licensed diagnostic tests in eligible markets.

SEC Filing: Hepion Pharmaceuticals, Inc. [ HEPA ] - 10-Q - Aug. 14, 2025