Hepion Pharmaceuticals, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsHepion Pharmaceuticals, Inc. is a medical diagnostic company that has pivoted from drug development to in-licensed diagnostic tests, with no revenue and a going concern doubt.
What they do
Hepion Pharmaceuticals is a medical diagnostic company headquartered in Morristown, New Jersey, that previously developed the cyclophilin inhibitor rencofilstat for chronic liver diseases. In May 2025, it in-licensed diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and hepatocellular carcinoma from New Day Diagnostics LLC. These tests have CE marks and are eligible for sale in the EU, but not the US. The company disposed of its rencofilstat assets in May 2025.
Revenue drivers
- Celiac disease diagnostic test — In-licensed from New Day Diagnostics, CE marked, eligible for sale in the EU; no sales reported.
- Respiratory multiplex test — In-licensed from New Day Diagnostics, CE marked, covers Covid/Influenza A/B and RSV; no sales reported.
- H. pylori diagnostic test — In-licensed from New Day Diagnostics, CE marked; no sales reported.
Recent performance
The company has no revenue in 2020-2023 and through Q2 2026. Net loss for 2025 was $8.3 million, improving from $13.2 million in 2024. Operating cash flow used was $3.3 million in 2025 versus $18.2 million in 2024. As of June 30, 2026, cash was $1.6 million and total assets were $1.9 million.
Strategy
Management is pivoting to diagnostics, having in-licensed CE-marked tests for sale in the EU. The company paid $525,000 cash and $270,629 in stock to New Day, with milestone payments up to $17.15 million contingent on regulatory and sales achievements. It wrote off the entire $815,045 cost of the license due to impairment and low probability of milestones. The company continues to seek capital to fund operations.
Risks
- Going concern — Substantial doubt about ability to continue as a going concern within one year without additional capital.
- No revenue — The company has no product sales and limited cash ($1.6M) to fund operations.
- License impairment — The New Day license was fully impaired and expensed, indicating projected cash flows are inadequate.
- Regulatory and market access — Tests are not approved in the US and require renewal of the license agreement after two years, limiting market potential.
Outlook
Management expects continued losses and the need for substantial additional capital. The company is focused on commercializing the in-licensed diagnostic tests in the EU, but has no assurance of market acceptance or regulatory success. No revenue guidance or timeline for sales has been provided.