Hepion Pharmaceuticals(HEPA) - 2025 Q3 - Quarterly Report

Financial Performance - The company has an accumulated deficit of $245.4 million and has not generated any revenue from operations as of September 30, 2025[151]. - For the three months ended September 30, 2025, the company reported total operating expenses of $527,902, a decrease of $3.9 million from $4.5 million in the same period of 2024[155]. - For the nine months ended September 30, 2025, total operating expenses were $3.6 million, down from $18.1 million in 2024, reflecting a decrease of $14.6 million[158]. - The company incurred a net loss of $7.6 million for the nine months ended September 30, 2025, compared to a net loss of $11.6 million in 2024, an improvement of $4.0 million[158]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $17.1 million, primarily due to a net loss of $11.6 million[174]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $0 million, down from $2.8 million in 2024, primarily due to a decrease in clinical trial costs[156]. - The company has significant future capital requirements that depend on various factors, including R&D costs and regulatory approvals[168]. Cash Flow and Financing - Net cash used in operating activities for the nine months ended September 30, 2025, was $2.9 million, primarily due to a net loss of $7.6 million[173]. - Net cash provided by financing activities was $5.0 million for the nine months ended September 30, 2025, primarily from equity issuance[176]. - The company completed a registered offering on January 23, 2025, raising gross proceeds of $9 million, part of which was used to repay existing notes[147][163]. - The company incurred net cash used in investing activities of $132,117 for the nine months ended September 30, 2025, related to the acquisition of licenses[175]. Assets and Liabilities - The company had working capital of $3.4 million as of September 30, 2025, an increase of $4.9 million from a working capital deficit of $1.5 million as of December 31, 2024[172]. - An asset impairment loss of $0.4 million was recorded for the nine months ended September 30, 2025, related to the asset acquired in the license agreement[161]. Business Operations and Market Presence - The company has three products with CE marks eligible for sale in the EU, but currently has no commercial products available in the U.S.[155]. - The company has no products approved for commercial sale in the United States but has three products with CE marks eligible for sale in the EU[164]. - The company entered into a license agreement with New Day Diagnostics LLC, paying $525,000 in cash and $200,000 in common stock, with potential milestone payments of up to $17.15 million[148][149]. Future Outlook and Concerns - As of September 30, 2025, the company had an accumulated deficit of $245.4 million and expects to continue incurring significant losses in the foreseeable future[164]. - The company may face substantial doubt about its ability to continue as a going concern without additional capital[170]. - The company anticipates that unforeseen expenses and difficulties may adversely affect its business and future growth[165].