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].

Financial Performance - The company has an accumulated deficit of $231.4 million as of June 30, 2024, with no revenue generated from operations since inception [95]. - The net loss for the six months ended June 30, 2024, was $6.8 million, significantly improved from a net loss of $27.3 million in the same period of 2023 [101]. - Net cash used in operating activities was $20.7 million for the six months ended June 30, 2023, primarily due to a net loss of $27.3 million [111]. - The company reported net cash used in operating activities of $14.5 million for the six months ended June 30, 2024, primarily due to a net loss of $9.9 million [110]. Expenses - Research and development expenses for the six months ended June 30, 2024, were $9.7 million, a decrease of $12.0 million compared to $21.7 million in the same period of 2023 [102]. - General and administrative expenses for the six months ended June 30, 2024, were $4.0 million, down from $5.7 million in 2023, reflecting a decrease of $1.7 million [102]. - The company incurred a one-time restructuring charge of approximately $0.7 million in Q4 2023 as part of a strategic restructuring plan [94]. Working Capital and Cash Position - As of June 30, 2024, the company had working capital of $4.5 million, a decrease of $7.7 million from $12.2 million as of December 31, 2023 [109]. - As of June 30, 2023, the company had $30.5 million in cash [111]. - Changes in working capital accounts positively impacted cash by $5.8 million, driven by a decrease in prepaid expenses and an increase in accounts payable [111]. Clinical Trials and Product Development - The company has initiated wind-down activities in its ASCEND-NASH clinical trial as of April 19, 2024 [94]. - The Data and Safety Monitoring Board approved the continuation of the ASCEND-NASH Phase 2b study without modifications in June 2023 [94]. - The company has no products approved for commercial sale and does not expect to have such products for several years [99]. Financing Activities - Net cash provided by financing activities was $1.8 million for the six months ended June 30, 2024, mainly from proceeds received from the exercise of warrants [111]. - There was no cash provided by or used in financing activities for the six months ended June 30, 2023 [111].

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]

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 ...

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, ...

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 ...

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 ...

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 June 30, 2023 46-2783806 (I.R.S. Employer Identification Number) 399 Thornall Street, First Floor Edison, New Jersey 08837 (Address of Principal Executive Offices) (732) 902-4000 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHA ...

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 March 31, 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 charte ...