Rencofilstat

MORRISTOWN, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a binding letter of intent (“LOI”) with New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time. The diagnostic tests covered under the LOI represent a combined addressable market exceeding $15 billion. The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion market, growing at 6.6% annually through 2029, by enabling efficient, simultaneous detection of COVID-19, Influenza A/B, and RSV from a single sample. The H. pylori CE-IVD targets the $700 million market for early, non-invasive detection of infections that can lead to gastric ulcers and cancer, with 6.0% projected growth through 2032. CeliaCare CE-IVD supports rapid screening for celiac disease—an underdiagnosed autoimmune condition—in a $457 million market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma (HCC) in high-risk patients, serves an $8.7 billion market projected to grow 6.7% annually through 2030. Collectively, these diagnostics offer clinical utility across multiple conditions while opening access to meaningful commercial opportunities in global markets. John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion expressed his enthusiasm about this licensing opportunity: “The CE marked tests provide Hepion with the ability to generate near term revenues in European Union countries by leveraging the existing distributor network relationships that New Day Diagnostics has established. We are excited by this opportunity and look forward to working with New Day to maximize value.” “This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world,” said Eric Mayer, CEO of New Day Diagnostics. “We’re excited to partner with Hepion to expand the reach of these CE-marked tests, bring them to the United States, and unlock new opportunities to improve early detection and outcomes across multiple disease areas.” About Hepion Pharmaceuticals Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. Hepion has been considering a number of assets to in-license and develop and Hepion’s Board of Directors believes that the opportunity offered by New Day Diagnostics presents a great opportunity to benefit Hepion’s stockholders. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Hepion Pharmaceuticalsinfo@hepionpharma.com

Shares Expected to Begin Trading on Split-Adjusted Basis on March 18, 2025 MORRISTOWN, N.J., March 14, 2025 (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 that it will implement a 1-for-50 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on March 17, 2025. The Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on March 18, 2025, and will continue to trade on The Nasdaq Capital Market under the symbol “HEPA.” The new CUSIP number for the common stock will be 426897 401. The reverse stock split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company’s stockholders authorized the reverse stock split at the Company’s annual meeting of stockholders held on March 10, 2025. When the reverse stock split becomes effective, every 50 shares of the Company’s common stock issued and outstanding or held by the Company in treasury will automatically be combined and reclassified into one share of common stock. No fractional shares will be issued as a result of the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will instead automatically have their fractional interests rounded up to the next whole share, after aggregating all the fractional interests of a holder resulting from the reverse stock split. The reverse stock split will affect all stockholders uniformly and will not change any stockholder’s percentage ownership interest or any stockholder’s proportionate voting power, except for immaterial changes that may result from the treatment of fractional shares. The reverse stock split will not change the number of authorized shares of the Company’s common stock or the par value per share of the Company’s common stock. The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 54.25 million to approximately 1.08 million. As a result of the reverse stock split, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, as well as to the number of shares available for future awards granted under the Company’s stock incentive plans. In addition, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock. The combination of, and reduction in, the issued shares of common stock as a result of the reverse stock split will occur automatically at the effective time of the reverse stock split without any additional action on the part of the Company’s stockholders. The Company's transfer agent, Pacific Stock Transfer Company, is acting as the exchange agent for the reverse stock split and will send stockholders of record holding their shares electronically in book-entry form a transaction notice indicating the number of shares of common stock held after the reverse stock split. Stockholders who hold their shares through a broker, bank, or other nominee will have their positions adjusted to reflect the reverse stock split, subject to their broker, bank, or other nominee’s particular processes, and are not expected to be required to take any action in connection with the reverse stock split. Additional information regarding the reverse stock split can be found in the Company’s definitive proxy statement for the annual meeting of stockholders of the Company held on March 10, 2025, which was filed with the U.S. Securities and Exchange Commission on February 7, 2025, a copy of which is available at www.sec.gov and on the Company's website. About Hepion Pharmaceuticals Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was followed in June 2022 by the FDA’s granting of Orphan Drug designation to rencofilstat for the treatment of HCC. In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to Hepion’s existing safety database. Forward-Looking Statements The Company cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the timing, completion and effect of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price requirement and continue to have its common stock listed on The Nasdaq Capital Market. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, the risk that Nasdaq may not process the reverse stock split on the expected timeline; the risk that after the reverse stock split the closing bid price of the Company’s common stock is not at least $1.00 per share for a minimum of ten consecutive trading sessions; the potential for Nasdaq to suspend trading in or to delist the Company’s common stock. Forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of risks and uncertainties the Company faces, you are encouraged to review the documents the Company files with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For further information, please contact:Hepion Pharmaceuticalsinfo@hepionpharma.com