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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): September 21, 2026
Hepion
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-36856 |
|
46-2783806 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(Commission
File
Number) |
|
(IRS
Identification
No.) |
34
Shrewsbury Ave., Suite 1D
Red
Bank, NJ 07701
(Address
of principal executive offices)
(732)
902-4000
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
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
communications 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)) |
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, par value $0.0001 per share |
|
HEPA |
|
OTC
QB |
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 4.01 |
Changes in Registrant’s Certifying Accountant. |
On
September 21, 2026, the audit committee of the Board of Directors of Hepion Pharmaceuticals, Inc. (the “Company”) approved
the dismissal of Grassi & Co., CPAs, P.C. (“Grassi”) as the Company’s independent registered public accounting
firm and approved the engagement of Rosenberg Rich Baker Berman P.A. (“RRBB”) as the Company’s independent registered
public accounting firm to audit the Company’s consolidated financial statements for the year ended December 31, 2026. Accordingly,
on September 22, 2026, Grassi was informed that it would be dismissed as the Company’s independent registered public accounting
firm, effective immediately.
The
report of Grassi on the Company’s consolidated balance sheets as of December 31, 2025 and 2024, and the related consolidated statements
of operations, comprehensive loss, changes in stockholders’ equity and cash flows for the years then ended did not contain an adverse
opinion or a disclaimer of opinion, nor was it qualified or modified as to uncertainty, audit scope or accounting principles, except
that such reports contained an explanatory paragraph which noted that there was substantial doubt as to the Company’s ability to
continue as a going concern because the Company has suffered significant operating losses and negative
cash flows from operations since inception.
During
the fiscal years ended December 31, 2025 and 2024, and the subsequent interim period through September 21, 2026, there have been no “reportable
events” (as defined in Item 304(a)(1)(v) of Regulation S-K), except for the material weaknesses in the Company’s internal
control over financial reporting described in Part II, Item 9A, “Controls and Procedures,” in the Company’s annual
reports on Form 10-K for the years ended December 31, 2025 and 2024, respectively and in Part I, Item 4, “Controls and Procedures,”
in the Company’s quarterly reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026 filed with the SEC on May
14, 2026 and August 13, 2026, respectively. The Audit Committee has discussed the material weaknesses in the Company’s internal
control over financial reporting with Grassi and has authorized Grassi to respond fully to the inquiries of RRBB, the Company’s
new independent registered public accountants, concerning such weakness.
During
the years ended December 31, 2025 and 2024 through September 21, 2026, there were no disagreements between the Company and Grassi on
any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements,
if not resolved to the satisfaction of Grassi, would have caused it to make reference to the subject matter of the disagreement in connection
with its report covering such period.
During
the years ended December 31, 2025 and 2024 and through September 21, 2026, the date the audit committee of the Board approved the engagement
of RRBB as the Company’s independent registered public accounting firm, neither the Company nor anyone on the Company’s behalf
consulted with RRBB regarding (i) the application of accounting principles to a specified transaction, either completed or proposed,
or the type of audit opinion that might be rendered on the Company’s financial statements, and no written report or oral advice
was provided to the Company by the Company that the Company concluded was an important factor considered by the Company in reaching a
decision as to the accounting, auditing or financial reporting issue; or (ii) any matter that was either the subject of a disagreement,
as that term is described in Item 304(a)(1)(iv) of Regulation S-K under the Exchange Act, or a reportable event, as that term is defined
in Item 304(a)(1)(v) of Regulation S-K under the Exchange Act.
The
Company provided Grassi with a copy of the foregoing disclosures prior to the filing of this Report and requested that Grassi furnish
the Company with a letter addressed to the SEC stating whether it agrees with the statements made by the Company set forth above. A copy
of Grassi’s letter, dated September 24, 2026, is attached as Exhibit 16.1 to this Report.
| Item 9.01 |
Financial Statements and Exhibits |
(d)
Exhibits
| 16.1 |
Letter from Grassi & Co., CPAs, P.C. to the Securities and Exchange Commission dated September 24, 2026. |
| 107 |
Cover
Page Interactive Data File (embedded within the Inline 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:
September 28, 2026
| |
HEPION PHARMACEUTICALS, INC. |
| |
|
|
| |
By: |
/s/ Gary Stetz |
| |
|
Gary Stetz |
| |
|
Interim Chief Executive Officer |
