MORRISTOWN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (OTC:HEPA), a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC), today announced that Dr. Kaouthar Lbiati has been named as interim Chief Executive Officer, effective June 16, 2025. Dr. Lbiati is replacing John Brancaccio, who is retiring for p ...

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 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].

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]

Core Insights - Pharma Two B presented integrated safety and efficacy data for P2B001, a combination drug for early-stage Parkinson's disease, at the Parkinson's Study Group Annual Meeting [1][2] - P2B001 is a once-daily, low-dose extended-release combination of pramipexole (0.6 mg) and rasagiline (0.75 mg) [1][7] - The data supports P2B001 as a potential first-line treatment option for early Parkinson's disease patients [2][3] Efficacy and Safety Data - P2B001 showed significant improvement in Unified Parkinson's Disease Rating Scale (UPDRS) scores, particularly in Activities of Daily Living (Part II) and Motor (Part III) compared to placebo [2] - The efficacy of P2B001 was comparable to individually titrated pramipexole ER (PramiER) [2] - P2B001 resulted in less daytime sleepiness and fewer sleep-related adverse events compared to PramiER [2] Company Developments - Pharma Two B is focused on completing a merger with Hepion Pharmaceuticals, which is expected to close in Q4 2024 [3][5] - The merger has been approved by both companies' boards and is subject to stockholder and regulatory approvals [5] - Following the merger, Pharma Two B plans to submit a New Drug Application (NDA) for P2B001 [3] Product Information - P2B001 is designed for early-stage Parkinson's disease and aims to improve patient quality of life with a favorable safety profile [4][7] - The drug combines previously approved oral medications, offering potential clinical benefits and enhanced convenience [4][8] - Pharma Two B holds worldwide patents for P2B001's composition and treatment method [8]

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].

Financial Performance - The company reported no revenues for the three months ended September 30, 2024, and 2023, as it does not have any commercial biopharmaceutical products[121]. - The company incurred a net loss of $4.9 million for Q3 2024, compared to a net loss of $10.5 million for Q3 2023, an improvement of $5.7 million[121]. - The company had an accumulated deficit of $236.3 million as of September 30, 2024, with significant losses expected to continue in the foreseeable future[129]. Research and Development Expenses - Research and development expenses decreased from $8.5 million in Q3 2023 to $2.8 million in Q3 2024, a reduction of $5.8 million primarily due to decreased clinical trial costs[122]. - For the nine months ended September 30, 2024, research and development expenses totaled $12.4 million, down from $30.2 million in the same period of 2023, a decrease of $17.8 million[125]. General and Administrative Expenses - General and administrative expenses for Q3 2024 were $1.7 million, down from $2.1 million in Q3 2023, reflecting a decrease in salaries due to reduced headcount[124]. Cash and Working Capital - The company reported working capital of $0.8 million as of September 30, 2024, a decrease of $11.4 million from $12.2 million as of December 31, 2023[136]. - As of September 30, 2024, the company had $0.8 million in cash, with net cash used in operating activities amounting to $17.1 million, primarily due to a net loss of $11.6 million[137]. - For the nine months ended September 30, 2023, the company reported $19.3 million in cash, with net cash used in operating activities of $31.9 million, mainly driven by a net loss of $37.9 million[138]. - The company experienced a negative impact of $2.7 million on cash from changes in working capital accounts for the nine months ended September 30, 2024[137]. Financing Activities - Net cash provided by financing activities for the nine months ended September 30, 2024, was $4.3 million, mainly from proceeds received from the exercise of warrants and equity issuance[139]. - There were no cash flows from financing activities for the nine months ended September 30, 2023[140]. Strategic Initiatives - The board approved a strategic restructuring plan in December 2023, incurring a one-time restructuring charge of approximately $0.7 million[116]. - The company has initiated wind-down activities for its ASCEND-NASH clinical trial, which was closed in August 2024[116]. - The company expects to require additional financing to continue operations, with substantial doubt about its ability to continue as a going concern without additional capital[134]. Investing Activities - In 2024, net cash used in investing activities was $600,000, primarily due to a note receivable from Pharma Two B[139].