Hepion Pharmaceuticals(HEPA) - 2024 Q4 - Annual Report

Financial Performance - The company reported no revenues for the years ended December 31, 2024 and 2023, as it does not have any commercial biopharmaceutical products[292]. - The net loss for the year ended December 31, 2024 was $13.2 million, compared to a net loss of$48.9 million in 2023, reflecting a decrease of $21.3 million[292]. - As of December 31, 2024, the company had an accumulated deficit of$237.8 million and a working capital deficit of $1.5 million[289][307]. - As of December 31, 2023, the company had$14.8 million in cash, with net cash used in operating activities amounting to $40.9 million, primarily due to a net loss of$48.9 million[309]. Research and Development - Research and development expenses decreased from $35.6 million in 2023 to$11.8 million in 2024, a reduction of 23.8 million primarily due to decreased clinical trial costs[293]. - The company recorded a full impairment of its in-process research and development (IPR&D) asset valued at 3.2 million as of December 31, 2023, due to delays in clinical trials[325]. - The company does not expect to have any commercial biopharmaceutical products for several years, if at all, and expenses all research and development costs as incurred[321]. - Prepaid research and development costs decreased from $2.5 million in 2023 to$0 million in 2024[322]. Administrative Expenses - General and administrative expenses also decreased from $9.6 million in 2023 to$7.5 million in 2024, a reduction of $2.1 million[294]. Financing Activities - The company raised gross proceeds of$9 million from a registered offering on January 23, 2025, which was partially used to repay outstanding notes[288][297]. - Net cash provided by financing activities was $4.4 million for the year ended December 31, 2024, compared to$4.5 million in 2023, mainly from the exercise of warrants and equity issuance[311]. Clinical Trials - The company initiated wind-down activities for its ASCEND-NASH clinical trial due to insufficient funding, with the trial closing in August 2024[284]. - The Data and Safety Monitoring Board approved the continuation of the ASCEND-NASH Phase 2b study in June 2023, indicating no safety concerns[282]. Strategic Planning - The company plans to explore strategic and financing alternatives to maximize stockholder value amid ongoing financial challenges[283]. - The company incurred a one-time restructuring charge of approximately $0.7 million in Q4 2023 as part of a strategic restructuring plan[283]. Accounting and Tax - The company maintains a full valuation allowance for its U.S. and foreign net deferred tax assets, with income tax expense for 2024 and 2023 related to foreign operations[318]. - The company continues to evaluate significant accounting estimates that could materially impact its financial statements, particularly in areas such as fair value of financial instruments and research and development[313]. Other Financial Information - The fair value of contingent consideration related to the acquisition of Ciclofilin is zero for the year ended December 31, 2024, as management concluded that the milestones will not be achieved[315]. - The company had no off-balance sheet arrangements as of December 31, 2024[328].