Hepion Pharmaceuticals (HEPA) Q4 2025 earnings summary

Executive summary

• Transitioned from drug development to a medical diagnostics focus after winding down the ASCEND-NASH clinical trial due to insufficient funding; all clinical activities ceased by August 2024.

• Entered new licensing agreements in 2025 and 2026 for diagnostic assets, including a major deal with Cirna Diagnostics for liver disease diagnostics and with New Day Diagnostics for CE-marked tests in the EU.

• Attempted a merger with Pharma Two B in 2024, which was terminated in December 2024; related notes were repaid with proceeds from a $9M equity offering in January 2025.

Financial highlights

• No revenue generated in 2025 or 2024; accumulated deficit reached $246.1 million as of December 31, 2025.

• Net loss for 2025 was $8.3 million, a significant improvement from $13.2 million in 2024, primarily due to reduced R&D and G&A expenses after clinical program wind-down.

• Research and development expenses dropped to $0.4 million in 2025 from $11.8 million in 2024, reflecting the halt in clinical activities.

• General and administrative expenses decreased to $3.3 million in 2025 from $7.5 million in 2024.

• Asset impairment loss of $0.4 million in 2025 related to the New Day Diagnostics license.

• Cash balance at year-end 2025 was $1.8 million, with working capital of $2.8 million.

Outlook and guidance

• Management expects continued operating losses and negative cash flows, with substantial doubt about the ability to continue as a going concern beyond Q3 2026 without additional capital.

• No commercial products in the U.S.; future revenue depends on successful commercialization of licensed diagnostics, primarily in the EU.

• Additional financing is required to sustain operations and pursue commercialization.