UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 4.01 Changes in Registrant’s Certifying Accountant.
| (a) | Replacement of Previous Independent Registered Public Accounting Firm |
On August 22, 2025, the Audit Committee (the “Committee”) of the Board of Directors (the “Board”) of 22nd Century Group, Inc. (the “Company”) approved the replacement of Freed Maxick P.C. (“FM”) as the Company’s independent registered public accounting firm, due to the acquisition of certain assets of FM by Withum Smith+Brown, PC (“Withum”), effective immediately, and informed FM of such replacement on the date thereof (the “Replacement”).
The reports of FM on the Company’s financial statements for the fiscal years ended December 31, 2023 and 2024 did not contain an adverse opinion or a disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles
During the Company’s fiscal years ended December 31, 2023 and 2024, and the subsequent interim period through August 22, 2025, (i) there were no “disagreements,” as defined in Item 304(a)(1)(iv) of Regulation S-K, with FM 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 FM, would have caused FM to make reference to the subject matter of the disagreements in connection with its reports on the Company’s consolidated financial statements for such period, and (ii) there were no “reportable events,” as defined in Item 304(a)(1)(v) of Regulation S-K.
The Company provided FM with a copy of the disclosures in this Current Report on Form 8-K and requested that FM furnish the Company with a letter addressed to the Securities and Exchange Commission stating whether or not it agrees with the Company’s statements herein. A copy of such letter, which is dated August 22, 2025, is attached as Exhibit 16.1 to this Current Report on Form 8-K.
| (b) | Appointment of New Independent Registered Public Accounting Firm |
In connection with the Replacement, on August 22, 2025, the Committee approved the engagement of Withum as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2025, effective immediately.
During the fiscal years ended December 31, 2023 and 2024, and the subsequent interim period through August 22, 2025, neither the Company nor anyone acting on its behalf consulted with Withum regarding (i) the application of accounting principles to any specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements, and neither a written report nor oral advice was provided to the Company that Withum concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue, or (ii) any matter that was either the subject of a “disagreement,” as defined in Item 304(a)(1)(iv) of Regulation S-K, or a “reportable event,” as defined in Item 304(a)(1)(v) of Regulation S-K.
Item 9.01(d): Financial Statements and Exhibits.
| Exhibit 16.1 | Letter of WithumSmith+Brown, PC dated August 22, 2025 | |
| Exhibit 104 | Cover Page Interactive Data File - The cover page XBRL tags are embedded within the inline XBRL document |
SIGNATURES
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.
| 22nd Century Group, Inc. | |
| /s/ Daniel A. Otto | |
| Date: August 25, 2025 | Daniel A. Otto |
| Chief Financial Officer |