UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (Address of Principal Executive Offices) (732) 902 ...

Core Viewpoint - Hepion Pharmaceuticals has successfully transitioned to the OTCQB Venture Market, with its common stock trading under the symbol HEPA starting June 25, 2025 [1]. Company Overview - Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing and commercializing diagnostic tests for various conditions, including celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC) [2].

Core Insights - Hepion Pharmaceuticals has appointed Dr. Kaouthar Lbiati as interim CEO, effective June 16, 2025, replacing John Brancaccio who is retiring for personal reasons [1][2] - Dr. Lbiati's leadership is expected to focus on strategic renewal and innovation in diagnostics for unmet clinical needs, including celiac disease, respiratory multiplex testing, H. pylori, and HCC [2][4] - Dr. Lbiati has over 15 years of experience in biotech and pharmaceuticals, having held significant roles in advancing therapies from preclinical development to commercialization [3] Company Strategy - The company aims to reposition itself as a leader in precision diagnostics, targeting underdiagnosed conditions and leveraging scalable technologies [4] - Hepion plans to prioritize immediate revenue generation and long-term innovation, focusing on clinical utility for patients at risk of liver cancer and their caregivers [4] Recent Developments - In April 2024, Hepion announced the winding down of its ASCEND-NASH clinical trial, which had a target enrollment of 336 subjects but was paused with 151 subjects randomized [6] - On May 26, 2025, Hepion entered into an agreement to sell all patent assets and related data for Rencofilstat for a nominal amount, along with a contingent value right for stockholders [7]

Financial Performance - The company reported no revenues for the three months ended March 31, 2025, and 2024, maintaining an accumulated deficit of $243.4 million[147][156]. - The net loss for the three months ended March 31, 2025, was $6.1 million, compared to a net loss of $2.9 million in the same period of 2024, representing an increase in loss of approximately 115%[151]. - The company anticipates continuing to incur significant losses for the foreseeable future, with substantial doubt about its ability to continue as a going concern without additional capital[162][163]. Expenses - Research and development expenses decreased to $22,235 in Q1 2025 from $2.5 million in Q1 2024, a reduction of approximately 99% due to decreased clinical trial costs and reduced headcount[152]. - General and administrative expenses fell to $1.3 million in Q1 2025 from $2.6 million in Q1 2024, a decrease of approximately 50% attributed to lower employee compensation expenses[153]. - Adjusted non-cash charges for Q1 2025 were $4.8 million, including $20,783 for stock-based compensation, while in Q1 2024, non-cash charges increased by $1.4 million[165][166]. Cash Flow and Working Capital - The company experienced a cash outflow from operating activities of $1.1 million in Q1 2025, compared to an outflow of $3.6 million in Q1 2024, indicating improved cash management[164]. - As of March 31, 2025, the company had working capital of $5.4 million, an increase of $3.9 million from a working capital deficit of $1.5 million as of December 31, 2024[164]. - Net cash used in operating activities for Q1 2025 was $1.1 million, compared to $3.6 million in Q1 2024, reflecting a net loss of $6.1 million in 2025 versus $2.9 million in 2024[165][166]. - Changes in working capital had a positive impact of $0.2 million on cash in Q1 2025, while in Q1 2024, it had a negative impact of $2.1 million[165][166]. - Net cash provided by financing activities was $5.3 million in Q1 2025, primarily from warrant exercises and equity issuance, compared to $1.8 million in Q1 2024[168]. Financing Activities - The company raised gross proceeds of $9 million from a registered offering on January 23, 2025, which was partially used to repay existing notes[143][155]. - The company made a $2.9 million payment on notes payable during Q1 2025[168]. Licensing and Product Development - The company entered into a License Agreement with New Day Diagnostics LLC, involving an upfront payment of $525,000 and potential milestone payments of up to $17.15 million[144][145]. - The company has no products approved for commercial sale in the U.S., but three diagnostic tests related to the New Day licensing agreement have CE marks and are eligible for sale in Europe[156]. Cash Position - As of March 31, 2025, the company had $4.6 million in cash, down from $13.1 million as of March 31, 2024[165][166]. - There were no cash flows from investing activities in both Q1 2025 and Q1 2024[167].

Core Viewpoint - Hepion Pharmaceuticals has transitioned from developing treatments for chronic liver diseases to focusing on diagnostic tests, while facing delisting from Nasdaq due to non-compliance with listing standards [1][2]. Company Overview - Hepion Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that was previously developing treatments for non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) [1]. - The company's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and HCC tumor burden in experimental models [3]. Recent Developments - On May 9, 2025, the company received a notice from Nasdaq indicating that its shares would be delisted due to failure to maintain a minimum bid price of $1.00 per share and being classified as a public shell [1]. - Following the suspension of trading on Nasdaq, the company's shares are expected to be quoted on the OTC Markets Group under the existing symbol "HEPA" [2]. - Hepion announced a license agreement with New Day Diagnostics LLC on May 9, 2025, to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and HCC, with some tests already having CE marks for sale in Europe [5]. Clinical Trials - In April 2024, Hepion decided to wind down its ASCEND-NASH clinical trial, which was a Phase 2b study aimed at evaluating the safety and efficacy of Rencofilstat over 12 months, with a target enrollment of 336 subjects [4]. - Enrollment in the trial was paused in April 2023 after 151 subjects were randomized, and approximately 80 subjects have completed their Day 365 visits [4].

Core Insights - Hepion Pharmaceuticals has entered into a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases, including celiac disease and hepatocellular carcinoma [1][2][3] - The combined addressable market for these diagnostic tests exceeds $15 billion, with significant growth projections across multiple segments [2] Company Developments - The diagnostic tests include CE-marked products that are eligible for sale in Europe, allowing Hepion to generate near-term revenues through existing distributor networks [3] - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and tumor burden in experimental models [4] - The company previously announced the winding down of its ASCEND-NASH clinical trial, which was paused in April 2023 after randomizing 151 subjects [5][6] Market Opportunities - The Respiratory Panel RT-PCR Multiplex CE-IVD targets a $5.6 billion market, growing at 6.6% annually through 2029, while the H. pylori test addresses a $700 million market with a 6.0% growth rate projected through 2032 [2] - The celiac disease screening test operates in a $457 million market, expected to grow at 10.4% annually through 2034, and the mSEPT9 assay for HCC detection serves an $8.7 billion market with a 6.7% growth rate projected through 2030 [2]

Core Insights - Hepion Pharmaceuticals has entered into a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases, including celiac disease and hepatocellular carcinoma [1][2][3] - The combined addressable market for these diagnostic tests exceeds $15 billion, with significant growth projections across multiple segments [2] Company Developments - The diagnostic tests include CE-marked products that are eligible for sale in Europe, allowing Hepion to generate near-term revenues through existing distributor networks [3] - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown promise in reducing liver fibrosis and tumor burden in experimental models [4] - The company previously announced the winding down of its ASCEND-NASH clinical trial, which was paused in April 2023 after randomizing 151 subjects [5] Market Opportunities - The Respiratory Panel RT-PCR Multiplex CE-IVD targets a $5.6 billion market, growing at 6.6% annually through 2029 [2] - The H. pylori CE-IVD addresses a $700 million market with a projected growth rate of 6.0% through 2032 [2] - The CeliaCare CE-IVD supports a $457 million market growing at 10.4% annually through 2034 [2] - The mSEPT9 assay for early detection of hepatocellular carcinoma serves an $8.7 billion market projected to grow at 6.7% annually through 2030 [2] Strategic Partnerships - The partnership with New Day Diagnostics is viewed as a strategic step to enhance the accessibility of high-impact diagnostics globally [3][6] - The collaboration aims to expand the reach of CE-marked tests into the United States, unlocking new opportunities for early detection and improved patient outcomes [3]

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].

Core Viewpoint - Hepion Pharmaceuticals is implementing a 1-for-50 reverse stock split to increase its common stock bid price and regain compliance with Nasdaq's minimum bid price requirement of $1.00 for continued listing [2][10]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 4:01 p.m. Eastern Time on March 17, 2025, with trading on a split-adjusted basis starting on March 18, 2025 [1][2]. - The number of issued and outstanding shares will decrease from approximately 54.25 million to about 1.08 million [4]. - No fractional shares will be issued; fractional interests will be rounded up to the next whole share [3][6]. Group 2: Impact on Stockholders - The reverse stock split will not change stockholders' percentage ownership or voting power, except for minor changes due to fractional shares [3]. - Proportionate adjustments will be made to the exercise prices and number of shares underlying outstanding stock options and warrants [5]. Group 3: Company Background - Hepion Pharmaceuticals is focused on developing treatments for chronic liver diseases, including non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) [1][8]. - The company's primary asset, Rencofilstat, has received Fast Track and Orphan Drug designations from the FDA for treating NASH and HCC, respectively [8].

Core Viewpoint - Hepion Pharmaceuticals, Inc. has announced a public offering of 27,692,310 shares of common stock, aiming to raise approximately $9.0 million for debt repayment and general corporate purposes, including working capital and operating expenses [1][3]. Group 1: Offering Details - The public offering includes each share of common stock or pre-funded warrant accompanied by series A and series B common warrants, both with an exercise price of $0.40 per share [1]. - The combined offering price for each share of common stock is $0.325, while the pre-funded warrant is priced at $0.3249 [1]. - The closing of the public offering is expected around January 23, 2025, pending customary closing conditions [1]. Group 2: Company Background - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and hepatocellular carcinoma tumor burden in experimental models [5]. - Rencofilstat received Fast Track designation from the FDA for NASH treatment in November 2021 and Orphan Drug designation for HCC in June 2022 [5]. Group 3: Clinical Trial Update - In April 2024, Hepion announced the winding down of its ASCEND-NASH clinical trial, which was a Phase 2b study aimed at evaluating Rencofilstat's safety and efficacy [6]. - The trial had a target enrollment of 336 subjects, but enrollment was paused in April 2023 after 151 subjects were randomized [6]. - Approximately 80 subjects have completed their Day 365 visits, contributing to the safety and efficacy evaluation, with an additional 40 subjects expected to provide significant safety data [6].