HEPA Hepion Pharmaceuticals Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 10, 2024

 

Hepion Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-36856		46-2783806
(State or other jurisdiction		(Commission		IRS Employer
of incorporation or organization)		File Number)		Identification No.)

 

399 Thornall Street, First Floor

Edison, NJ 08837

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (732) 902-4000

 

 

(Former name or former address, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:		Trading Symbol(s)		Name of each exchange on which registered:
Common Stock		HEPA		Nasdaq Capital Market

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

	☐	Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

 

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. ☐

 

 

 

Item 1.02 Termination of Material Definitive Agreement.

 

As previously disclosed on July 19, 2024, Hepion Pharmaceuticals, Inc. (the “Company”) entered into an Agreement and Plan of Merger with Pharma Two B Ltd., a company organized under the laws of the State of Israel (“Pharma Two B”) and Pearl Merger Sub, Inc., a Delaware corporation (“Pearl”) and an indirect wholly owned subsidiary of Pharma Two B (the “Merger Agreement”).

 

Pharma Two B has informed the Company that Nasdaq will not exclude historical losses of the Company from its burn rate calculation and as a result on December 10, 2024, the Company, Pharma Two B and Pearl entered into an agreement to terminate the Merger Agreement (the “Termination Agreement”). Pursuant to the Termination Agreement, the Merger Agreement was terminated.

 

The summary of the Termination Agreement set forth under this Item 1.02 is qualified in its entirety by reference to the complete terms and conditions of the Termination Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 8.01 Other Events.

 

On December 11, 2024, the Company announced (i) the termination of the Merger Agreement and (ii) that its previously announced special meeting of its stockholders scheduled for December 12, 2024 has been cancelled and that it has withdrawn from consideration by the Company’s stockholders the proposals set forth in the Company’s Definitive Proxy Statement on Form F-4 filed with the U.S. Securities and Exchange Commission on November 8, 2024. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

10.1	Termination Agreement, dated as of December 10, 2024 by and between Hepion Pharmaceuticals, Inc., Pharma Two B Ltd. and Pearl Merger Sub, Inc.
99.1	Press Release dated as of December 11, 2024.
104	Cover Page Interactive Data File (embedded within the XBRL document)

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: December 11, 2024

 

	HEPION PHARMACEUTICALS, INC.
	By:	/s/ John Brancaccio
		John Brancaccio
		Interim Chief Executive Officer

 

 

 

Exhibit 10.1

 

TERMINATION AGREEMENT

 

This TERMINATION AGREEMENT (this “Agreement”) is made as of December 10, 2024 by and between Pharma Two B Ltd. (the “Company”), Hepion Pharmaceuticals, Inc. (“Hepion”) and Pearl Merger Sub, Inc. (“Merger Sub”) (the Company, Hepion and Merger Sub collectively, the “Parties” and individual a “Party”).

 

RECITALS

 

Reference is made to the Agreement and Plan of Merger by and between the Parties dated as of July 19, 2024 (the “Merger Agreement”). Capitalized terms used herein and not otherwise defined herein shall have the meanings assigned to them in the Merger Agreement. The Parties wish to terminate the Merger Agreement on the terms and conditions set forth herein.

 

NOW THEREFORE, in consideration of the foregoing and the mutual covenants and agreements herein contained, and intending to be legally bound hereby, the Parties hereby agree as follows:

 

1. Termination of the Merger Agreement. In accordance with Section 10.01(a) of the Merger Agreement, the Parties hereby agree to terminate the Merger Agreement in its entirety effective immediately upon the execution of this Agreement by each of the Parties, and the Merger Agreement shall be null and void and of no further force or effect. No Party shall have any further rights or obligations thereunder or with respect thereto, except as specifically set forth herein.

 

2. Releases. Upon the termination of the Merger Agreement, each of the Parties, on its own behalf and on behalf of its principals, affiliates, subsidiaries, directors, officers, stockholders, employees, agents, representatives, and successors and assigns of each of them, hereby irrevocably, fully and unconditionally releases and forever discharges the other party and each of its past or present principals, affiliates, directors, officers, stockholders, employees, agents, representatives, and successors and assigns of each of them, from and against any and all present and future claims, counterclaims, demands, actions, suits, causes of action, damages, controversies and liabilities, including, without limitation, any costs, expenses, bills, penalties or attorneys’ fees, whether know or unknown, contingent or absolute, foreseen or unforeseen, and whether in law, equity or otherwise, that could have been asserted in any court or forum and relating in any way to any conduct, occurrence, activity, expenditure, promise or negotiation arising from or relating to the Merger Agreement.

 

3. Promissory Note. Notwithstanding anything contained in this Agreement, it is expressly acknowledged and agreed that that certain Promissory Note, dated July 19, 2024, from the Company and payable to Hepion, in the original principal amount of $600,000 (the “Promissory Note”), remains in full force and effect. Pursuant to the terms of the Promissory Note, upon execution of this Agreement, the Promissory Note becomes immediately due and all outstanding principal and interest shall be paid from the Company to Hepion.

 

4. Representations and Warranties. Each of the Parties hereby represents and warrants to the other Parties that: (a) it has full power and authority to enter into this Agreement and to perform its obligations hereunder in accordance with the provisions of this Agreement, (b) this Agreement has been duly authorized, executed and delivered by such party, and (c) this Agreement constitutes a legal, valid and binding obligation of such party, enforceable in accordance with its terms.

 

 

5. Entire Agreement. This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof and supersede all prior agreements, understandings, discussions and representations, oral or written, with respect to such matters.

 

6. Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without regard to the principles of conflicts of law thereof.

 

7. Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective heirs, executors, administrators, legal representatives, successors and permitted assigns. Except as expressly provided herein, this Agreement may not be assigned by any Party without the prior written consent of the remaining Parties. Any assignment in violation of this paragraph will be null and void.

 

8. Execution. This Agreement may be executed in one or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each Party and delivered to the remaining Parties, it being understood that all Parties need not sign the same counterpart. In the event that any signature is delivered by facsimile or e-mail transmission, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or e-mail signature page were an original thereof.

 

9. Future Assurances. At the request of any Party hereto, and without further consideration, the remaining Parties hereto will execute and deliver such other documents, forms, agreements, or instruments as may be reasonably requested for the completion of the transactions contemplated hereby.

 

[Signature Page Follows]

 

 

IN WITNESS WHEREOF, the Parties have executed and delivered this Agreement, or caused it to be executed and delivered by their duly authorized officers, as of the date first above written.

 

Pharma Two B Ltd.
By:	/s/ Dan Teleman
Name:	Dan Teleman
Title:	Chief Executive Officer
Hepion Pharmaceuticals, Inc.
By:	/s/ John Brancaccio
Name:	John Brancaccio
Title:	Executive Chairman
Pearl Merger Sub, Inc.
By:	/s/ Dan Teleman
Name:	Dan Teleman
Title:	President

 

 

 

Exhibit 99.1

 

Hepion Pharmaceuticals, Inc. Announces Termination of Merger Agreement with Pharma Two B Ltd.

 

EDISON, N.J., December 11, 2024 —Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (the “Company” or “Hepion”), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a termination agreement with Pharma Two B Ltd. which terminates the merger agreement between the two parties that was previously entered into on July 19, 2024.

 

Neither party will be required to pay the other a termination fee as a result of the mutual decision to terminate the agreement.

 

Hepion also announced that its previously announced special meeting of its stockholders scheduled for December 12, 2024 has been cancelled and that it has withdrawn from consideration by its stockholders the proposals set forth in the Company’s Definitive Proxy Statement on Form F-4 filed with the U.S. Securities and Exchange Commission on November 8, 2024.

 

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 which wind-down activities have since been completed and the trial has been closed. 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 are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Hepion’s future financial or operating performance. 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 identify forward-looking statements. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission.

 

Contact Information

 

Hepion Pharmaceuticals

 

info@hepionpharma.com

 

 

v3.24.3

Cover	Dec. 10, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Dec. 10, 2024
Entity File Number	001-36856
Entity Registrant Name	Hepion Pharmaceuticals, Inc.
Entity Central Index Key	0001583771
Entity Tax Identification Number	46-2783806
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	399 Thornall Street
Entity Address, Address Line Two	First Floor
Entity Address, City or Town	Edison
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08837
City Area Code	(732)
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	HEPA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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