Fentanyl Citrate

- Acquisition adds GV104, a clinical-stage opioid countermeasure with a 505(b)(2) pathway and an active investigational new drug application, and GV023, an oral formulation of an approved anti-TNF antibody - - FDA has stated in writing that additional clinical studies do not appear to be necessary to define the prophylactic dosing window for GV104, placing the critical path in manufacturing rather than in new clinical work - - Transaction creates a three-program portfolio spanning therapeutics and diagnostics, and Hepion intends to advance its circulating tumor RNA diagnostic toward a laboratory-developed test in 2027 - RED BANK, NJ / ACCESS Newswire / October 14, 2026 / Hepion Pharmaceuticals, Inc. (OTCQB: HEPA ) ("Hepion" or the "Company"), a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases, today announced that it has completed the acquisition of Gravitas Life Sciences, LLC ("GLS"), a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation. The transaction closed on October 6, 2026, and GLS is now a wholly-owned subsidiary of the Company. GLS brings two licensed programs: GV104 is a transmucosal buccal film of an approved opioid antagonist in clinical development for the temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids . In March 2025 the U.S. Food and Drug Administration ("FDA") stated that "[a]dditional clinical studies do not appear to be necessary to define the prophylactic dosing window at this time." GV023 is an oral formulation of infliximab, an approved anti-tumor necrosis factor-alpha (anti-TNF) antibody and a gold standard for certain immunologic conditions. Anti-TNF antibodies are given by infusion or injection; the premise of GV023, not yet tested in humans, is to deliver an established anti-TNF to the inflamed tissue of the lower gut by mouth. GV023 is in near clinical development. "Hepion now holds a clinical-stage candidate, a near clinical program and a diagnostic, and one operating thesis stands behind all three," said Sireesh Appajosyula, PharmD, Chief Executive Officer of Hepion. "I have worked on the newly acquired programs since 2023, and bringing them into Hepion places them inside a public company with the governance, the reporting discipline and the access to capital to carry them to their next regulatory milestone. I am excited to be a part of the team at Hepion where execution to meet our goals is the singular focus." Strategic Benefits A clinical-stage lead program with a defined path. GV104 is developed under an already active investigational new drug application and is proposed for approval as a 505(b)(2) New Drug Application relying in part on the FDA's prior findings for an approved injectable product and the remaining work identified by the FDA is manufacturing rather than new clinical studies. Delivery innovation on proven molecules. Both acquired programs start from compounds already approved for human use; the technology applied in each case includes different delivery including thin film buccal composition of small molecules and oral formulation of large protein delivery, traditionally using injection methods. A portfolio across therapeutics and diagnostics. With the Company's in-licensed circulating tumor RNA program, Hepion now holds three assets and approaches serious disease from two directions: finding it earlier and delivering medicines with more convenience. Leadership On October 9, 2026, the Board of Directors appointed Dr. Appajosyula, the former Chief Executive Officer of GLS and a member of the Company's Board since March 2026, as Chief Executive Officer of the Company, and appointed Gary Stetz, the Company's former Interim Chief Executive Officer, as Chief Financial Officer. Dr. Appajosyula was a director of Canton Strategic Holdings Inc. from July 2021 until June 2026, serving as its Chief Operating Officer and later as its Chief Executive Officer, and spent approximately eight years at Salix Pharmaceuticals until its acquisition by Bausch Health in 2015. Mr. Stetz is a Certified Public Accountant with over 35 years of experience across accounting, finance, business valuation and corporate governance, and is Managing Partner of Stetz, Belgiovine, Manwarren and Wallis P.C. "Gary Stetz took the interim chief executive role in March 2026 and steadied this company," said Vincent LoPriore, Executive Chairman of Hepion. "He saw through the financings that recapitalized the balance sheet, brought real discipline to the asset register, and brought us to a transaction that gives Hepion a clinical-stage portfolio. I am pleased that he is staying as Chief Financial Officer because he carries that same discipline into the integration ahead." Priorities for 2027 GV104. The Company intends to complete the Chemistry, Manufacturing and Controls program and produce commercial-scale registration batches beginning in 2027, the gating requirement for the studies the FDA has identified and, in turn, for a New Drug Application. GV023. The Company intends to seek regulatory guidance in 2027 on initiation of a first-in-human study in Australia or the European Union while advancing Chemistry, Manufacturing and Controls and first-in-man planning. Diagnostics. The Company intends to complete analytical validation of its circulating tumor RNA assay and assess clinical utility in order to develop the diagnostic in a CLIA-certified laboratory and, on successful validation, to offer it as a laboratory-developed test, generating revenue and real-world clinical experience while a future regulatory submission is prepared. About GV104 In February 2023 the FDA approved an investigational new drug application for GV104, a transmucosal buccal film of an opioid antagonist first approved in the United States in 1995 and marketed in injectable and limited nasal presentations. The drug is absorbed across the buccal mucosa, potentially without first-pass hepatic metabolism, and GLS holds an exclusive, sublicensable, worldwide license to the relevant patent rights and technology. In a randomized, two-way crossover study in 20 healthy subjects, a 16 mg GV104 (nalmefene buccal film) compared against an approved 1 mg intravenous formulation reported an absolute bioavailability of 45.9 percent, a median Tmax of 2.0 hours and a mean half-life of 14 hours. In October 2025 the FDA endorsed the Company's pharmacokinetic-pharmacodynamic model and requested a validated worst-case fentanyl challenge dose; the completed cardiac-arrest simulation was submitted in July 2026. No clinical study is in progress or scheduled for the dosing window. About GV023 Under a Patent License Agreement with Intract Pharma Limited, dated September 11, 2024, GLS exclusively licensed GV023, an oral formulation of infliximab, with global development and commercialization rights outside South Korea to Intract's Soteria ® and Phloral ® delivery platforms and an existing supply agreement for infliximab. Initiation of a clinical study in Australia or the European Union requires the corresponding national process, on which the Company intends to obtain further guidance in 2027. About the Circulating Tumor RNA Diagnostic Program Hepion's diagnostic program is built on novel circulating tumor RNA technology, in-licensed from Cirna Diagnostics and co-invented at the Baruch S. Blumberg Institute. Rather than measuring proteins shed into the blood, the assay reads actively expressed tumor transcripts for the early detection of hepatocellular carcinoma in high-risk cirrhotic patients - a cancer that is curable when found early, and one that surveillance tools in routine use today miss in a substantial share of early-stage cases. The clinical performance of the assay has not been established and it has not been cleared or approved by the FDA. About Hepion Pharmaceuticals: Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) is a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases. Through its subsidiary Gravitas Life Sciences, LLC, a clinical-stage biotechnology company, Hepion is advancing therapeutic candidates in immunology and inflammation, including a transmucosal buccal film of an established opioid antagonist and an oral formulation of a validated anti-inflammatory antibody. The Company's diagnostic program is built on novel circulating tumor RNA technology, which reads actively expressed tumor transcripts for the early detection of hepatocellular carcinoma in high-risk cirrhotic patients, a cancer that is curable when found early. For more information please visit: . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, are forward-looking statements, including statements regarding the anticipated benefits of the acquisition of Gravitas Life Sciences, LLC, the timing and content of future regulatory submissions and communications, the development and manufacturing plans for GV104 and GV023, the analytical and clinical validation of the Company's circulating tumor RNA assay, the Company's intention to offer that assay as a laboratory-developed test and to generate revenue from doing so, the regulatory framework applicable to laboratory-developed tests, and the Company's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management. Words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, actual results or events could differ materially from them, and you should not place undue reliance on them. Factors that may cause such differences include, but are not limited to, those discussed under Risk Factors set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements represent the Company's views as of the date of this release and should not be relied upon as representing its views as of any subsequent date; the Company does not undertake and specifically disclaims any obligation to update or revise them, except as may be required by applicable law. Contacts: Hepion Investor Relations ir@hepionpharma.com SOURCE: Hepion Pharmaceuticals, Inc. View the original press release on ACCESS Newswire