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Hepion Pharmaceuticals (HEPA) investor relations material

Hepion Pharmaceuticals Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary12 Nov, 2025

Executive summary

  • Transitioned from drug development to medical diagnostics, focusing on in-licensed diagnostic tests for celiac disease, respiratory multiplex, H. pylori, and HCC, with CE marks for EU sales but not US approval.

  • Wind-down and closure of ASCEND-NASH clinical trial due to insufficient funding; all clinical activities completed by August 2024.

  • Attempted merger with Pharma Two B Ltd. was terminated in December 2024 after Nasdaq declined to exclude historical losses from burn rate calculations.

  • Delisted from Nasdaq in May 2025 and transitioned to OTCQB Venture Market in June 2025.

Financial highlights

  • Net loss for Q3 2025 was $0.5 million, a significant improvement from $4.9 million loss in Q3 2024.

  • Net loss for the nine months ended September 30, 2025 was $7.6 million, compared to $11.6 million for the same period in 2024.

  • No revenues reported for the quarter or year-to-date; accumulated deficit reached $245.4 million as of September 30, 2025.

  • Research and development expenses dropped to $0.4 million for the nine months ended September 30, 2025, from $12.4 million in the prior year period, mainly due to clinical trial wind-down.

  • General and administrative expenses decreased to $2.2 million for the nine months ended September 30, 2025, from $5.7 million in the prior year period.

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

Outlook and guidance

  • Expects continued significant losses and negative cash flows; additional capital required to fund operations and development of newly acquired diagnostic assets.

  • Uncertainty remains regarding timing and amount of potential revenue from EU-eligible diagnostic products.

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Frequently asked questions

Hepion Pharmaceuticals Inc. is a biopharmaceutical company focused on developing treatments for liver diseases, particularly non-alcoholic steatohepatitis (NASH) and liver fibrosis. The company’s lead drug candidate, based on cyclophilin inhibition technology, aims to target inflammation, fibrosis, and viral infections affecting the liver. The company is headquartered in Edison, New Jersey, and its shares are listed on the NASDAQ.

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