Core Viewpoint - Hepion Pharmaceuticals is implementing a 1-for-50 reverse stock split to increase its common stock bid price and regain compliance with Nasdaq's minimum bid price requirement of $1.00 for continued listing [2][10]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 4:01 p.m. Eastern Time on March 17, 2025, with trading on a split-adjusted basis starting on March 18, 2025 [1][2]. - The number of issued and outstanding shares will decrease from approximately 54.25 million to about 1.08 million [4]. - No fractional shares will be issued; fractional interests will be rounded up to the next whole share [3][6]. Group 2: Impact on Stockholders - The reverse stock split will not change stockholders' percentage ownership or voting power, except for minor changes due to fractional shares [3]. - Proportionate adjustments will be made to the exercise prices and number of shares underlying outstanding stock options and warrants [5]. Group 3: Company Background - Hepion Pharmaceuticals is focused on developing treatments for chronic liver diseases, including non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) [1][8]. - The company's primary asset, Rencofilstat, has received Fast Track and Orphan Drug designations from the FDA for treating NASH and HCC, respectively [8].

Core Viewpoint - Hepion Pharmaceuticals, Inc. has announced a public offering of 27,692,310 shares of common stock, aiming to raise approximately $9.0 million for debt repayment and general corporate purposes, including working capital and operating expenses [1][3]. Group 1: Offering Details - The public offering includes each share of common stock or pre-funded warrant accompanied by series A and series B common warrants, both with an exercise price of $0.40 per share [1]. - The combined offering price for each share of common stock is $0.325, while the pre-funded warrant is priced at $0.3249 [1]. - The closing of the public offering is expected around January 23, 2025, pending customary closing conditions [1]. Group 2: Company Background - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and hepatocellular carcinoma tumor burden in experimental models [5]. - Rencofilstat received Fast Track designation from the FDA for NASH treatment in November 2021 and Orphan Drug designation for HCC in June 2022 [5]. Group 3: Clinical Trial Update - In April 2024, Hepion announced the winding down of its ASCEND-NASH clinical trial, which was a Phase 2b study aimed at evaluating Rencofilstat's safety and efficacy [6]. - The trial had a target enrollment of 336 subjects, but enrollment was paused in April 2023 after 151 subjects were randomized [6]. - Approximately 80 subjects have completed their Day 365 visits, contributing to the safety and efficacy evaluation, with an additional 40 subjects expected to provide significant safety data [6].

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]

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]

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].

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].

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]

Financial Performance - The company reported no revenues for the three months ended March 31, 2024, and 2023, as it does not have any commercial biopharmaceutical products[132]. - The company incurred a net loss of $2.9 million for the three months ended March 31, 2024, compared to a net loss of $13.3 million for the same period in 2023, reflecting an improvement of $10.4 million[132]. - As of March 31, 2024, the company had an accumulated deficit of $227.5 million and expects to continue incurring significant losses for the foreseeable future[136]. Expenses - Research and development expenses decreased to $2.5 million in Q1 2024 from $9.8 million in Q1 2023, a reduction of $7.3 million primarily due to decreased clinical trial costs[133]. - General and administrative expenses decreased to $2.6 million in Q1 2024 from $3.4 million in Q1 2023, a reduction of $0.8 million mainly due to lower salaries and stock-based compensation costs[134]. - Net cash used in operating activities was $3.6 million for Q1 2024, compared to $8.2 million for Q1 2023, indicating improved cash flow management[143]. Working Capital and Financing - The company had working capital of $12.9 million as of March 31, 2024, an increase of $0.7 million from $12.2 million as of December 31, 2023[142]. - The company received $1.8 million in net cash from financing activities for the three months ended March 31, 2024, primarily from warrant exercises[146]. Clinical Trials - The Data and Safety Monitoring Board approved the continuation of the ASCEND-NASH Phase 2b study without modifications, indicating positive progress in clinical trials[126]. Internal Controls and Compliance - The company identified a material weakness in internal controls related to the design and implementation of controls over complex accounting transactions[151]. - A material weakness was also noted regarding the income tax provision and management's review, with insufficient controls over completeness and accuracy[151]. - The company plans to increase personnel to ensure proper segregation of duties in the future[151]. - External consultants are being utilized for non-routine and technical accounting issues as they arise[151]. - The company aims to enhance the review process for complex accounting transactions by improving access to accounting literature and identifying third-party professionals[151]. - Management will evaluate the processes around tax provision and internal control design gaps with third-party assistance[151]. - Enhancements and process improvements will be implemented, including well-defined controls regarding income tax provision and disclosures[151]. - A detailed timeline for the tax provision calculation will be developed to ensure sufficient time is allocated for completion[151]. - The company is committed to remediating identified material weaknesses and improving internal control over financial reporting[148]. - There have been no changes in internal controls over financial reporting that materially affect the reporting during the three months ended March 31, 2024[150]. Strategic Restructuring - The board approved a strategic restructuring plan in December 2023, incurring a one-time restructuring charge of approximately $0.7 million[127].

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 ...

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, ...