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].

Company Overview - Hepion Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing treatments for chronic liver diseases, including non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) [3] - The company is headquartered in Edison, New Jersey and has been working on a cyclophilin inhibitor, rencofilstat, aimed at addressing multiple complex pathologies related to liver disease progression [3] Recent Developments - Hepion announced the termination of its merger agreement with Pharma Two B Ltd., which was originally established on July 19, 2024 [1] - No termination fees will be exchanged between the two parties as a result of this mutual decision [2] - The special meeting of Hepion's stockholders scheduled for December 12, 2024, has been cancelled, and the proposals in the Definitive Proxy Statement filed on November 8, 2024, have been withdrawn [2] Strategic Actions - In December 2023, Hepion's board approved a strategic restructuring plan aimed at preserving capital by reducing operating costs [3] - The company has initiated a process to explore various strategic and financing alternatives to maximize stockholder value in the current financial environment and NASH drug development landscape [3] - Hepion has completed wind-down activities for its ASCEND-NASH clinical trial, which has now been closed [3]

Pooled data analysis of efficacy and safety from Phase 2b and Phase 3 data sets in patients with early-stage Parkinson’s disease (PD) support P2B001 as a first line, once-daily treatment choice for early PD KIRYAT ONO, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Pharma Two B, a private, late-stage pharmaceutical company developing innovative combination drugs for neurological disorders, today announced a poster presentation of integrated safety and efficacy data on P2B001 from its Phase 2b and Phase 3 studies ...

Core Viewpoint - Hepion Pharmaceuticals is urging shareholders to approve its proposed merger with Pharma Two B, which is seen as the best option to maximize shareholder value and address the challenges faced by Hepion as a standalone company [2][6]. Group 1: Merger Rationale - The merger with Pharma Two B is positioned as a transformational opportunity for Hepion, allowing shareholders to benefit from the potential upside of Pharma Two B's late-stage candidate for treating Parkinson's Disease, P2B001 [4][7]. - Hepion's board concluded that remaining a standalone company would not be viable due to financial constraints and a lack of interest from the investment community in funding its drug pipeline [3][6]. Group 2: Financial Challenges - Hepion has faced significant challenges in funding its clinical trials, leading to a deteriorating risk profile and limited financial resources to advance its drug pipeline [3][6]. - If the merger does not receive shareholder approval, Hepion risks delisting from Nasdaq and potential bankruptcy due to its inability to fund ongoing development [6]. Group 3: Future Prospects - The post-merger entity is expected to be well-funded, with plans to advance clinical trials and file a New Drug Application with the FDA for P2B001 [7]. - Although Pharma Two B does not plan to advance Hepion's legacy drug pipeline, there remains a commitment to explore monetization opportunities for its value, which could provide additional upside for shareholders [5].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share HEPA The Nasdaq Capital Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commissio ...

KIRYAT ONO, ISRAEL and EDISON, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Pharma Two B Ltd. ("Pharma Two B"), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson's Disease ("PD") and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) ("Hepion"), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, tod ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share HEPA The Nasdaq Capital Market 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, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission Fil ...

KIRYAT ONO, ISRAEL and EDISON, N.J., July 22, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, today announced it has entered into a definitive merger agreement (the "Merger Agreement") with Pharma Two B Ltd., a late-clinical stage private Israeli company that is developing P2B001, an innovative com ...