Restructuring program purpose is to preserve capital and optimize clinical development program
Management plans to continue to evaluate its Phase 2b ASCEND-NASH clinical trial taking in account current market environment
Cash runway extended into Q2 2025
EDISON, N.J., Dec. 07, 2023 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that its Board of Directors has approved a strategic restructuring plan with the objective of preserving capital by initially reducing operating costs by approximately 60% going forward. As a result, Hepion will incur a one-time restructuring charge of approximately $400 – $800 thousand that will be recorded in the fourth quarter of 2023.
Additionally, the Company has initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. Currently 131 patients are being treated in our Phase 2b (“ASCEND-NASH”) clinical trial. We intend on completing the treatment of such patients and will add additional patients once the clinical trial is fully funded or a strategic transaction has been entered into.
Potential strategic alternatives that may be considered by the Company as part of this process include an acquisition, merger, reverse merger, other business combination, sale of assets, licensing, and other strategic transactions. The Company intends to pursue this process, however, there can be no assurance that it will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful. The Company does not expect to provide incremental updates during the evaluation process unless and until the Board of Directors has concluded that disclosure is appropriate or required.
In addition, the Company announced that Dr. Robert Foster, the Company’s CEO, resigned from the Company as CEO and director for personal reasons, effective immediately. John Cavan, the Company’s CFO has been appointed as interim CEO.
“On behalf of the Board, I would like to thank Robert for his many contributions to the Company in working to advance the development of rencofilstat. Robert is leaving for personal reasons, and we wish him all the best,” commented Gary S. Jacob, Ph.D., Chairman of the Hepion Board.
Dr. Foster said “I sincerely enjoyed my tenure with the company over the past years. We put our hearts and souls into bringing rencofilstat into the ongoing Phase 2b clinical trials in NASH, and I wish the very best for the continued successes of the Company’s development program.”
With the organizational changes announced today and its ongoing cost management efforts, the Company now expects its current cash, cash equivalents and investments will be sufficient to fund its operations into Q2 2025.
