Pharma Two B & Hepion Pharmaceuticals Announce Filing of Registration Statement on Form F-4 Related to Proposed Merger

Pharma Two B Ltd. and Hepion Pharmaceuticals, Inc. recently announced the filing of a registration statement of Pharma Two B on Form F-4 with the US Securities and Exchange Commission.

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.

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, visit: www.pharma2b.com.

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.

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.