Rasagiline mesylate

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, today jointly announced the filing of a registration statement of Pharma Two B on Form F-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the “SEC”). The Registration Statement contains a proxy statement/prospectus in connection with the proposed merger transaction pursuant to the definitive agreement entered into between Pharma Two B and Hepion (the "Merger Agreement", and the proposed transactions contemplated thereby, the “Proposed Transaction”). While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Pharma Two B and Hepion and the Proposed Transaction. As announced on July 22, 2024, Pharma Two B intends to become a publicly traded company on Nasdaq through a merger transaction with Hepion. The Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B's ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the “Pharma Two B” name. A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P. Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. About Hepion Pharmaceuticals Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. Forward-Looking Statements Certain statements in this press release may be considered “forward-looking statements”. Forward-looking statements generally relate to future events or Hepion’s or Pharma Two B’s future financial or operating performance. For example, express or implied statements regarding Hepion and Pharma Two B's expectations with respect to the Proposed Transaction, including the timing of closing thereof and pro forma ownership of the combined company, the concurrent financing, the cash runway of the combined company; planned timing of New Drug Application (“NDA”) submission, P2B001 potential as a treatment for PD and label expansion, projected net revenues, and related matters, as well as all other statements other than statements of historical fact included in this press release, are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to Hepion or Pharma Two B, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, Hepion’s and Pharma Two B's management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in Hepion’s filings with the SEC. Most of these factors are outside the control of Hepion and/or Pharma Two B and are difficult to predict. In addition to factors disclosed in Hepion’s filings with the SEC, the following factors, among others, could cause actual results and the timing of events to differ materially from the anticipated results or other expectations expressed in the forward-looking statements: the risk that the Proposed Transaction may not be completed in a timely manner or at all, which may adversely affect the price of the securities of Hepion; the inability to meet the closing conditions to the Proposed Transaction, including the failure of Pharma Two B to meet Nasdaq initial listing standards in connection with the consummation of the Proposed Transaction; costs related to the Proposed Transaction and the failure to realize anticipated benefits of the Proposed Transaction or to realize estimated pro forma results with respect thereto as well as other risks associated with biopharmaceutical companies generally, including the risks of filing an NDA, obtaining regulatory approval for any product candidates, commercialization of any approved product, including P2B001 for PD, as well as the total addressable market and potential for success of P2B001, the presentation of financial information in U.S. GAAP, completion of a PCAOB audit of U.S. GAAP financials, as well as other risks set forth in more detail in the Registration Statement. The forward-looking statements are based upon management’s beliefs and assumptions; and other risks and uncertainties identified in the Registration Statement, including those under “Risk Factors” therein, and in other filings with the SEC made by Hepion. Each of Hepion and Pharma Two B undertake no obligation to update these statements for revisions or changes after the date of press release, except as required by law. No Offer or Solicitation This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with the Proposed Transaction or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act, and the Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act. Additional Information and Where to Find It In connection with the Proposed Transaction, Pharma Two B filed the Registration Statement with the SEC, which includes a preliminary prospectus with respect to its securities to be issued in connection with the Proposed Transaction, and a preliminary proxy statement with respect to Hepion’s stockholder meeting at which Hepion’s stockholders will be asked to vote on the proposed Proposed Transaction and related matters. Each of Hepion and Pharma Two B urge investors, stockholders, and other interested persons to read, when available, the Registration Statement including the proxy statement/prospectus, any amendments thereto, and any other documents filed with the SEC, before making any voting or investment decision because these documents will contain important information about the Proposed Transaction. After the Registration Statement has been declared effective, Pharma Two B and Hepion will mail the definitive proxy statement/prospectus to stockholders of Hepion as of a record date to be established for voting on the Proposed Transaction. Hepion’s stockholders will also be able to obtain a copy of such documents, without charge, by directing a request to: Executive Chairman at info@hepionpharma.com. Participants in the Solicitation Pharma Two B and Hepion and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Hepion’s stockholders in connection with the Proposed Transaction. Information about Hepion’s directors and executive officers and their ownership of Hepion’s securities is set forth in Hepion’s filings with the SEC. To the extent that holdings of Hepion’s securities have changed since the amounts printed in Hepion’s Annual Report on Form 10-K/A, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. A list of the names of such directors and executive officers and information regarding their interests in the Proposed Transaction is contained in the proxy statement/prospectus in the Registration Statement. You may obtain free copies of these documents as described in the preceding paragraph. Contact Information Hepion Pharmaceuticals732-902-4000info@hepionpharma.com Pharma Two B Ltd.Dan Teleman, CEOEmail: dan@pharma2b.comwww.pharma2b.com

The merged company will be led by Pharma Two B’s management. Having had to give up on its liver disease ambitions due to a lack of funds, Hepion Pharmaceuticals has decided that its best option is to merge into Israeli biotech Pharma Two B. Despite trying to slash its operating costs in half at the end of last year, Hepion announced in April that it was halting work on a phase 2 trial for its lead cyclophilins inhibitor in metabolic dysfunction-associated steatohepatitis (MASH), which it attributed to “resource constraints.” Throughout this period, the Nasdaq-listed biotech was exploring “strategic options” and has now made a decision—it will give up on its liver disease ambitions and merge into the privately owned Pharma Two B. The merged entity will carry the Pharma Two B name and list its shares on Nasdaq under the ticker symbol “PHTB.” The company will be focused on Pharma Two B’s late-stage asset, a pramipexole-rasagiline fixed-dose combination for Parkinson’s called P2B001. “As we advance P2B001’s development following the successful completion of our phase 3 clinical trial, we believe it is the right time to enter the public equity markets,” Pharma Two B CEO Dan Teleman said in the release. “Our company is in a stage that we believe meets the public market and investors' expectations,” Teleman added. “We are excited about Pharma Two B’s next growth phase, moving P2B001 towards an NDA submission targeted for the first half of 2026 and making this potential treatment available to patients.” John Brancaccio, executive chairman of Hepion’s board, explained in the release that the merger was the culmination of a “review of multiple strategic alternatives to identify paths to provide value to our stockholders.” “We believe the transaction we are announcing today with Pharma Two B presents an excellent opportunity for our shareholders to become a part of a company poised to file an NDA in a therapeutic area with a major unmet medical need,” Brancaccio added. The merger is likely to have a pro-forma equity value of around $58.5 million. The merged company will be led by Pharma Two B’s management, and the release made no mention of whether the Rehovot, Israel-based biotech will retain Hepion’s workforce. Alongside the merger—which is expected to close in the fourth quarter of 2024—Pharma Two B has agreed to sell $11.5 million of its ordinary shares and accompanying series A and B wants to a syndicate of new and existing investors. This money will go towards the development of P2B001 as well as repaying up to $2.9 million of Hepion’s outstanding senior unsecured notes. Once this financing is taken into account, Pharma Two B shareholders will own around 44.5% of the combined company, Hepion’s shareholders will own 7.8% and the remaining 47.7% will be owned by the participating investors. P2B001 combines low doses of the dopamine agonist pramipexole and the monoamine oxidase-B inhibitor rasagiline in an attempt to trigger better safety and efficacy outcomes than either of the approved drugs can achieve as a monotherapy. Pharma Two B’s approach is underpinned by a belief that the drugs have complementary mechanisms of action.