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Hepion Pharmaceuticals, Inc. Announces Termination of Merger Agreement with Pharma Two B Ltd.
GlobeNewswire News Room· 2024-12-11 13:00
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12, 2024, has been cancelled, and the proposals in the Definitive Proxy Statement filed on November 8, 2024, have been withdrawn [2] Strategic Actions - In December 2023, Hepion's board approved a strategic restructuring plan aimed at preserving capital by reducing operating costs [3] -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]
Pharma Two B Announces Poster Presentation on P2B001 at the Annual Meeting of the Parkinson's Disease Study Group
GlobeNewswire News Room· 2024-12-05 13:30
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]
Hepion Pharmaceuticals Issues Letter to Shareholders Urging Support for Proposed Merger with Pharma Two B
GlobeNewswire News Room· 2024-12-02 13:00
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].
Pharma Two B and Hepion Pharmaceuticals, Inc. Announce Filing of Registration Statement on Form F-4 Related to Proposed Merger
GlobeNewswire News Room· 2024-09-04 13:25
Core Viewpoint - Pharma Two B Ltd. and Hepion Pharmaceuticals, Inc. have announced the filing of a registration statement with the SEC for a proposed merger, which is expected to close in the fourth quarter of 2024, subject to various approvals and conditions [1][2][4]. Company Overview - Pharma Two B is a late-stage pharmaceutical company focused on developing innovative combination drugs for neurological disorders, particularly Parkinson's Disease, with its lead product candidate being P2B001 [6]. - Hepion Pharmaceuticals is a clinical-stage biopharmaceutical company that has been developing treatments for chronic liver diseases, including non-alcoholic steatohepatitis and hepatocellular carcinoma [9]. Proposed Transaction - The merger transaction has been approved by the boards of directors of both companies and is contingent upon stockholder approval, regulatory approval, and the listing of Pharma Two B's shares on Nasdaq under the ticker symbol "PHTB" [4]. - The registration statement includes a proxy statement/prospectus related to the merger and provides essential information about both companies and the proposed transaction [2][13]. Product Information - P2B001 is an investigational combination of pramipexole and rasagiline, designed for the treatment of Parkinson's Disease, and has shown comparable benefits to marketed doses while minimizing side effects in clinical trials [7][8]. - Pharma Two B holds worldwide patents for the pharmaceutical composition and treatment method associated with P2B001 [8]. Financial and Legal Advisors - A.G.P./Alliance Global Partners is serving as the financial advisor to Hepion, while Laidlaw & Company (UK) Ltd. is acting as the financial advisor to Pharma Two B [5].
Pharma Two B Announces Plans to Go Public via Merger with Hepion Pharmaceuticals, Inc. and Concurrent $11.5 Million Private Placement
Newsfilter· 2024-07-22 12:00
Merger Overview - Hepion Pharmaceuticals has entered into a definitive merger agreement with Pharma Two B Ltd, which will result in Hepion becoming an indirectly wholly-owned subsidiary of Pharma Two B [1] - The merger is valued at an estimated pro-forma implied equity value of approximately $58.5 million [8] - Following the merger, the combined company will continue to operate under the "Pharma Two B" name and will apply to list its ordinary shares on Nasdaq under the ticker symbol "PHTB" [1][8] Financial Details - Hepion has announced a private placement of $2.9 million in non-convertible senior notes to qualified institutional investors, which are unsecured and interest-free [4] - Pharma Two B has entered into a securities purchase agreement for an $11.5 million private placement of ordinary shares and accompanying warrants [5][6] - The merger is expected to close in the fourth quarter of 2024, subject to approval by Hepion's stockholders and regulatory approval [16] Product Development - Pharma Two B is developing P2B001, an innovative combination product candidate for the treatment of Parkinson's Disease, which aims to provide a safe, once-daily treatment with a lower incidence of excessive daytime sleepiness [2][19] - The NDA submission for P2B001 is targeted for the first half of 2026 [2][26] - P2B001 has demonstrated benefits comparable to marketed doses of pramipexole while minimizing side effects [20] Ownership Structure Post-Merger - Upon completion of the merger, current Pharma Two B equity-holders will own approximately 85% of the combined company, while current Hepion equity-holders will own approximately 15% on a pro forma basis [26] - After the closing of the $11.5 million concurrent private financing, ownership will adjust to approximately 44.5% for Pharma Two B equity-holders, 7.8% for Hepion equity-holders, and 47.7% for investors in the private financing [26]
Hepion Pharmaceuticals(HEPA) - 2024 Q1 - Quarterly Report
2024-05-21 21:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________ FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) For the Quarterly Period Ended March 31, 2024 46-2783806 (I.R.S. Employer Identification Number) Or 399 Thornall Street, First Floor Edison, New Jersey 08837 (Ad ...
Why Is Hepion Pharmaceuticals (HEPA) Stock Down 41% Today?
InvestorPlace· 2024-04-22 12:56
Hepion Pharmaceuticals (NASDAQ:HEPA) stock is diving on Monday after the biopharmaceutical company announced plans to wind down a clinical trial.A press release from the company notes that it is winding down it Phase 2b ASCEND-NASH study. The failure of the study comes as it couldn’t reach the planned 336 patients. Instead, it only got to 151 patients.On top of this, Hepion Pharmaceuticals is struggling with resources as the company is exploring strategic alternatives. This didn’t leave it with enough room ...
Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b 'ASCEND-NASH' Trial
Newsfilter· 2024-04-19 20:30
EDISON, N.J., April 19, 2024 (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 has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced in December 2023. ASCEND-NASH is a Phase 2b, randomized, multi-center, ...
Hepion Pharmaceuticals(HEPA) - 2023 Q4 - Annual Report
2024-04-16 20:53
FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No x If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o Indicate by check mark whether ...
Hepion Pharmaceuticals(HEPA) - 2023 Q3 - Quarterly Report
2023-11-20 20:59
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________ FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36856 HEPION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its ch ...