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    SEC Form 10-Q filed by 22nd Century Group Inc.

    5/13/25 6:30:33 AM ET
    $XXII
    Medicinal Chemicals and Botanical Products
    Health Care
    Get the next $XXII alert in real time by email
    22nd Century Group, Inc._March 31, 2025
    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    Table of Contents

    ​

    ​

    UNITED STATES

    SECURITIES AND EXCHANGE

    COMMISSION WASHINGTON, D.C. 20549

    ​

    FORM 10-Q

    ​

    ☒

    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

    ​

    For the Quarterly Period Ended March 31, 2025

    ​

    ☐

    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: 001-36338​

    22nd Century Group, Inc.

    (Exact name of registrant as specified in its charter)

    ​

    Nevada

        

    98-0468420

    (State or other jurisdiction

    ​

    (IRS Employer

    of incorporation)

    ​

    Identification No.)

    ​

    321 Farmington Road Mocksville, North Carolina 27028

    (Address of principal executive offices)

    ​

    (336) 940-3769

    (Registrant’s telephone number, including area code)

    ​

    Securities registered under Section 12(b) of the Act:

    ​

    Title of each class

        

    Ticker symbol

        

    Name of Exchange on Which Registered

    Common Stock, $0.00001 par value

     

    XXII 

     

    NASDAQ Capital Market

    ​

    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

    Yes  ⌧  No  ◻

    ​

    Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

    Yes  ⌧  No  ◻

    ​

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

    ​

    Large accelerated filer

    ☐

    Accelerated filer

    ☐

    Non-accelerated filer

    ☒

    Smaller reporting company

    ☒

     

    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. ◻

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

    Yes  ☐ No  ☒

    ​

    As of May 12, 2025, there were 11,507,622 shares of common stock issued and outstanding (including 5,139,211 shares held in abeyance).

    ​

    ​

    ​

    ​

    Table of Contents

    22nd CENTURY GROUP, INC.

    ​

    INDEX

    ​

    ​

    ​

     

     

    Page

    Number

    PART I.

    FINANCIAL INFORMATION

     

     

     

     

    Item 1.

    Financial Statements

     

     

     

     

    ​

    Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 (unaudited)

    3

    ​

     

     

    ​

    Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three

    Months ended March 31, 2025 and 2024 (unaudited)

    4

    ​

     

     

    ​

    Condensed Consolidated Statements of Changes in Shareholders’ Equity (Deficit) for the Three Months ended March 31, 2025 and 2024 (unaudited)

    5

    ​

     

     

    ​

    Condensed Consolidated Statements of Cash Flows for the Three Months ended March 31, 2025 and 2024 (unaudited)

    6

    ​

     

     

    ​

    Notes to Condensed Consolidated Financial Statements (unaudited)

    7

    ​

     

     

    Item 2.

    Management’s Discussion and Analysis of Financial Condition and Results of Operations

    30

    ​

    ​

    ​

    Item 3.

    Quantitative and Qualitative Disclosures about Market Risk

    38

     

     

     

    Item 4.

    Controls and Procedures

    38

     

     

     

    PART II.

    OTHER INFORMATION

    39

     

     

     

    Item 1.

    Legal Proceedings

    39

     

     

     

    Item 1A.

    Risk Factors

    39

     

     

     

    Item 2.

    Unregistered Sales of Equity Securities and Use of Proceeds

    39

     

     

     

    Item 3.

    Default Upon Senior Securities

    39

     

     

     

    Item 4.

    Mine Safety Disclosures

    39

     

     

     

    Item 5.

    Other Information

    39

     

     

     

    Item 6.

    Exhibits

    40

     

     

     

    SIGNATURES

    41

    ​

    ​

    ​

    ​

    ​

    2

    Table of Contents

    22nd CENTURY GROUP, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

    (amounts in thousands, except share and per-share data)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

        

    2025

        

    2024

    ASSETS

     

    ​

      

     

    ​

      

    Current assets:

     

    ​

      

     

    ​

      

    Cash and cash equivalents

    ​

    $

    1,133

    ​

    $

    4,422

    Accounts receivable, net

    ​

     

    4,322

    ​

     

    1,698

    Inventories

    ​

     

    2,555

    ​

     

    2,015

    Insurance recoveries

    ​

     

    768

    ​

     

    768

    GVB promissory note

    ​

     

    —

    ​

     

    500

    Prepaid expenses and other current assets

    ​

     

    1,559

    ​

     

    1,068

    Current assets of discontinued operations held for sale

    ​

     

    758

    ​

     

    1,051

    Total current assets

    ​

     

    11,095

    ​

     

    11,522

    Property, plant and equipment, net

    ​

     

    2,662

    ​

     

    2,773

    Operating lease right-of-use assets, net

    ​

     

    1,572

    ​

     

    1,639

    Intangible assets, net

    ​

     

    6,114

    ​

     

    5,724

    Other assets

    ​

    ​

    15

    ​

    ​

    15

    Total assets

    ​

    $

    21,458

    ​

    $

    21,673

    ​

    ​

     

      

    ​

     

      

    LIABILITIES AND SHAREHOLDERS' EQUITY

    ​

     

      

    ​

     

      

    Current liabilities:

    ​

     

      

    ​

     

      

    Notes and loans payable - current

    ​

    $

    —

    ​

    $

    254

    Current portion of long-term debt

    ​

    ​

    3,929

    ​

    ​

    1,500

    Operating lease obligations

    ​

     

    272

    ​

     

    261

    Accounts payable

    ​

     

    3,089

    ​

     

    2,401

    Accrued expenses

    ​

     

    2,121

    ​

     

    1,021

    Accrued litigation

    ​

     

    768

    ​

     

    768

    Accrued payroll

    ​

     

    208

    ​

     

    318

    Accrued excise taxes and fees

    ​

     

    3,849

    ​

     

    2,038

    Deferred income

    ​

    ​

    79

    ​

    ​

    20

    Other current liabilities

    ​

     

    1,223

    ​

     

    100

    Current liabilities of discontinued operations held for sale

    ​

     

    858

    ​

     

    1,281

    Total current liabilities

    ​

     

    16,396

    ​

     

    9,962

    Long-term liabilities:

    ​

     

      

    ​

     

      

    Operating lease obligations

    ​

     

    1,363

    ​

     

    1,437

    Long-term debt

    ​

    ​

    —

    ​

    ​

    5,165

    Other long-term liabilities

    ​

    ​

    74

    ​

    ​

    1,097

    Total liabilities

    ​

    ​

    17,833

    ​

    ​

    17,661

    Commitments and contingencies (Note 12)

    ​

     

    ​

    ​

     

    ​

    Shareholders' equity:

    ​

     

      

    ​

     

      

    Preferred stock, $.00001 par value, 10,000,000 shares authorized

    ​

     

      

    ​

     

      

    Common stock, $.00001 par value, 250,000,000 shares authorized

    ​

     

      

    ​

     

      

    Capital stock issued and outstanding:

    ​

     

      

    ​

     

      

    2,733,232 common shares (730,148 at December 31, 2024)

    ​

     

    ​

    ​

     

    ​

    Common stock, par value

    ​

    ​

    —

    ​

    ​

    —

    Capital in excess of par value

    ​

     

    401,824

    ​

     

    397,883

    Accumulated deficit

    ​

     

    (398,199)

    ​

     

    (393,871)

    Total shareholders' equity

    ​

     

    3,625

    ​

     

    4,012

    Total liabilities and shareholders’ equity

    ​

    $

    21,458

    ​

    $

    21,673

    ​

    ​

    See accompanying notes to Condensed Consolidated Financial Statements.

    ​

    3

    Table of Contents

    ​

    22nd CENTURY GROUP, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (amounts in thousands, except share and per-share data)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

        

    2024

    Revenues, net

    $

    5,956

    ​

    $

    6,469

    Cost of goods sold

    ​

    2,884

    ​

    ​

    4,213

    Excise taxes and fees on products

     

    3,681

    ​

     

    3,385

    Gross (loss) profit

     

    (609)

    ​

     

    (1,129)

    Operating expenses:

     

    ​

    ​

     

    ​

    Sales, general and administrative

     

    1,799

    ​

     

    2,906

    Research and development

     

    162

    ​

     

    425

    Other operating expense, net

     

    —

    ​

     

    (26)

    Total operating expenses

     

    1,961

    ​

     

    3,305

    Operating loss from continuing operations

     

    (2,570)

    ​

     

    (4,434)

    Other income (expense):

     

    ​

    ​

     

    ​

    Other income (expense), net

     

    (162)

    ​

     

    —

    Interest income, net

     

    16

    ​

     

    —

    Interest expense

     

    (558)

    ​

     

    (1,016)

    Total other income (expense), net

     

    (704)

    ​

     

    (1,016)

    Loss from continuing operations before income taxes

     

    (3,274)

    ​

    ​

    (5,450)

    Provision for income taxes

     

    —

    ​

     

    —

    Net loss from continuing operations

    $

    (3,274)

    ​

    $

    (5,450)

    ​

    ​

    ​

    ​

    ​

    ​

    Discontinued operations:

    ​

    ​

    ​

    ​

    ​

    Loss from discontinued operations before income taxes

    $

    (1,054)

    ​

    $

    (289)

    Provision for income taxes

    ​

    —

    ​

    ​

    —

    Loss from discontinued operations

    $

    (1,054)

    ​

    $

    (289)

    ​

    ​

    ​

    ​

    ​

    ​

    Net loss

    $

    (4,328)

    ​

    $

    (5,739)

    Comprehensive loss

    $

    (4,328)

    ​

    $

    (5,739)

    ​

    ​

    ​

    ​

    ​

    ​

    Net loss

    $

    (4,328)

    ​

    $

    (5,739)

    Deemed dividends

    ​

    —

    ​

    ​

    (3,589)

    Net loss available to common shareholders

    $

    (4,328)

    ​

    $

    (9,328)

    ​

    ​

    ​

    ​

    ​

    ​

    Basic and diluted loss per common share from continuing operations

    $

    (1.89)

    ​

    $

    (230.82)

    Basic and diluted loss per common share from discontinued operations

    $

    (0.61)

    ​

    $

    (12.25)

    Basic and diluted loss per common share from deemed dividends

    $

    —

    ​

    $

    (152.00)

    Basic and diluted loss per common share

    $

    (2.50)

    ​

    $

    (395.07)

    ​

    ​

    ​

    ​

    ​

    ​

    Weighted average shares outstanding - basic and diluted

    ​

    1,729,212

    ​

    ​

    23,612

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    See accompanying notes to Condensed Consolidated Financial Statements.

    ​

    4

    Table of Contents

    ​

    22nd CENTURY GROUP, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT)

    (Unaudited)

    (amounts in thousands, except share data)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended March 31, 2025

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Common

    ​

    Par Value

    ​

    Capital in

    ​

    ​

    ​

    ​

    Total

    ​

    ​

    Shares

    ​

    of Common

    ​

    Excess of

    ​

    Accumulated

    ​

    Shareholders’

    ​

        

    Outstanding*

        

    Shares*

        

    Par Value*

        

    Deficit

        

    Equity

    Balance at January 1, 2025

     

    730,148

    ​

    $

    —

     

    $

    397,883

     

    $

    (393,871)

    ​

    $

    4,012

    Stock issued in connection with settled indebtedness

    ​

    56,320

    ​

    ​

    —

    ​

    ​

    270

    ​

    ​

    —

    ​

    ​

    270

    Stock issued in connection with licensing arrangement

    ​

    47,804

    ​

    ​

    —

    ​

    ​

    230

    ​

    ​

    —

    ​

    ​

    230

    Stock issued in connection with warrant exercises

    ​

    1,380,360

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    —

    Stock issued upon conversion of Senior Secured Credit Facility

    ​

    518,600

    ​

    ​

    —

    ​

    ​

    3,132

    ​

    ​

    —

    ​

    ​

    3,132

    Conversion option remeasurement (Note 6)

    ​

    —

    ​

    ​

    —

    ​

    ​

    283

    ​

    ​

    —

    ​

    ​

    283

    Equity-based compensation

     

    —

    ​

     

    —

     

    ​

    26

     

    ​

    —

    ​

     

    26

    Net loss

     

    —

    ​

     

    —

     

    ​

    —

     

    ​

    (4,328)

    ​

     

    (4,328)

    Balance at March 31, 2025

    ​

    2,733,232

    ​

    $

    —

     

    $

    401,824

     

    $

    (398,199)

    ​

    $

    3,625

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    *Giving retroactive effect to the 1-for-16 reverse stock split on April 2, 2024 and 1-for-135 reverse stock split on December 17, 2024.

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended March 31, 2024

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Common

    ​

    Par Value

    ​

    Capital in

    ​

    ​

    ​

    ​

    Total

    ​

    ​

    Shares

    ​

    of Common

    ​

    Excess of

    ​

    Accumulated

    ​

    Shareholders’

    ​

        

    Outstanding*

        

    Shares*

        

    Par Value*

        

    Deficit

        

    Equity (Deficit)

    Balance at January 1, 2024

     

    20,313

    ​

    $

    —

     

    $

    370,297

     

    $

    (378,707)

    ​

    $

    (8,410)

    Stock issued in connection with RSU vesting, net of 3 shares withheld for taxes

     

    29

    ​

     

    —

     

    ​

    (1)

     

    ​

    —

    ​

     

    (1)

    Stock issued in connection with licensing arrangement

    ​

    86

    ​

    ​

    —

    ​

    ​

    100

    ​

    ​

    —

    ​

    ​

    100

    Stock issued in connection with warrant exercises, net of fees of $176

    ​

    5,538

    ​

    ​

    —

    ​

    ​

    2,245

    ​

    ​

    —

    ​

    ​

    2,245

    Equity-based compensation

     

    —

    ​

     

    —

     

    ​

    181

     

    ​

    —

    ​

     

    181

    Fractional shares issued for reverse stock split

     

    876

    ​

     

    —

     

    ​

    —

     

    ​

    —

    ​

     

    —

    Net loss

     

    —

    ​

     

    —

     

    ​

    —

     

    ​

    (5,739)

    ​

     

    (5,739)

    Balance at March 31, 2024

    ​

    26,842

    ​

    $

    —

     

    $

    372,822

     

    $

    (384,446)

    ​

    $

    (11,624)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    *Giving retroactive effect to the 1-for-16 reverse stock split on April 2, 2024 and 1-for-135 reverse stock split on December 17, 2024.

    ​

    See accompanying notes to Condensed Consolidated Financial Statements.

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    Table of Contents

    22nd CENTURY GROUP, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (Unaudited)

    (amounts in thousands)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    March 31, 

    ​

        

    2025

        

    2024

    Cash flows from operating activities:

     

    ​

      

     

    ​

      

    Net loss

    ​

    $

    (4,328)

    ​

    $

    (5,739)

    Adjustments to reconcile net loss to cash used in operating activities:

    ​

     

      

    ​

     

      

    Impairment of long-lived assets - held for sale

    ​

    ​

    293

    ​

    ​

    —

    Amortization and depreciation

    ​

     

    224

    ​

     

    266

    Amortization of right-of-use asset

    ​

     

    67

    ​

     

    62

    Provision for credit losses

    ​

    ​

    513

    ​

    ​

    2

    Loss on sale or disposal of machinery and equipment

    ​

     

    —

    ​

     

    65

    Debt related charges included in interest expense

    ​

    ​

    680

    ​

    ​

    807

    Equity-based compensation

    ​

     

    26

    ​

     

    181

    Change in fair value of warrant liabilities

    ​

    ​

    162

    ​

    ​

    —

    Change in fair value of derivative liability

    ​

    ​

    —

    ​

    ​

    82

    Change in inventory reserves

    ​

    ​

    (28)

    ​

    ​

    431

    Changes in operating assets and liabilities:

    ​

     

      

    ​

     

    ​

    Accounts receivable

    ​

     

    (2,638)

    ​

     

    (77)

    Inventories

    ​

     

    (512)

    ​

     

    1,026

    Prepaid expenses and other assets

    ​

     

    (491)

    ​

     

    486

    Accounts payable

    ​

     

    355

    ​

     

    632

    Accrued expenses

    ​

     

    1,067

    ​

     

    127

    Accrued payroll

    ​

     

    (111)

    ​

     

    (417)

    Accrued excise taxes and fees

    ​

     

    1,811

    ​

     

    291

    Other liabilities

    ​

    ​

    (66)

    ​

     

    (480)

    Net cash used in operating activities

    ​

     

    (2,976)

    ​

     

    (2,255)

    Cash flows from investing activities:

    ​

     

      

    ​

     

    ​

    Acquisition of patents, trademarks, and licenses

    ​

     

    (49)

    ​

     

    —

    Acquisition of property, plant and equipment

    ​

     

    (10)

    ​

     

    (7)

    Proceeds from the sale of property, plant and equipment

    ​

     

    —

    ​

     

    22

    Net cash (used in) provided by investing activities

    ​

     

    (59)

    ​

     

    15

    Cash flows from financing activities:

    ​

     

      

    ​

     

    ​

    Payments on notes payable

    ​

    ​

    (254)

    ​

    ​

    (545)

    Net proceeds from warrant exercise

    ​

    ​

    —

    ​

    ​

    2,245

    Taxes paid related to net share settlement of RSUs

    ​

    ​

    —

    ​

    ​

    (1)

    Net cash (used in) provided by financing activities

    ​

     

    (254)

    ​

     

    1,699

    Net decrease in cash and cash equivalents

    ​

     

    (3,289)

    ​

     

    (541)

    Cash and cash equivalents - beginning of period

    ​

     

    4,422

    ​

     

    2,058

    Cash and cash equivalents - end of period

    ​

    $

    1,133

    ​

    $

    1,517

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Supplemental disclosures of cash flow information:

    ​

     

      

    ​

     

      

    Non-cash transactions:

    ​

     

      

    ​

     

      

    Capital expenditures incurred but not yet paid

    ​

    $

    445

    ​

    $

    8

    Deemed dividends

    ​

    $

    —

    ​

    $

    3,589

    Stock issued in connection with settled indebtedness

    ​

    $

    270

    ​

    $

    —

    Non-cash licensing arrangement

    ​

    $

    230

    ​

    $

    —

    Equity conversion of Senior Secured Credit Facility

    ​

    $

    3,132

    ​

    $

    —

    Conversion option remeasurement

    ​

    $

    283

    ​

    $

    —

    ​

    ​

    ​

    ​

    See accompanying notes to Condensed Consolidated Financial Statements.

    ​

    ​

    ​

    6

    Table of Contents

    22nd CENTURY GROUP, INC.

    NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

    March 31, 2025

    (Unaudited)

    Amounts in thousands, except for share and per-share data

    NOTE 1. - NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

    Basis of Presentation – 22nd Century Group, Inc. (together with its consolidated subsidiaries, “22nd Century Group” or the “Company”) is a Nevada corporation publicly traded on the NASDAQ Capital Market under the symbol “XXII.” 22nd Century Group is a tobacco products company with sales and distribution of the Company’s own branded tobacco products and contract manufacturing services for third-party brands. The Company’s flagship product is a reduced nicotine combustible cigarette authorized by the FDA as a Modified Risk Tobacco Product.

    ​

    The accompanying Condensed Consolidated Financial Statements are presented in accordance with the rules and regulations of the United States ("U.S.") Securities and Exchange Commission ("SEC") and do not include all of the disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) as contained in the Company’s Annual Report on Form 10-K. Accordingly, these Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and notes thereto included in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

    ​

    In the opinion of management, the Condensed Consolidated Financial Statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. The results for interim periods are not necessarily indicative of results or trends that may be expected for the fiscal year as a whole. The Condensed Consolidated Financial Statements were prepared using U.S. GAAP, which require management to make estimates and assumptions that affect the reported amounts of assets, liabilities, certain components of equity, sales, expenses, and related disclosures at the date of the financial statements and during the reporting period. Actual results could differ materially from these estimates.

    Liquidity and Capital Resources – These Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

    The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue and profit in its tobacco business. The Company had negative cash flow from operations of $2,976 and $2,255 for the three months ended March 31, 2025 and 2024, respectively, and an accumulated deficit of $398,199 and $393,871 as of March 31, 2025 and December 31, 2024, respectively. As of March 31, 2025, the Company had cash and cash equivalents of $1,133.

    Given the Company’s projected operating requirements and its existing cash and cash equivalents, there is substantial doubt about the Company’s ability to continue as a going concern through one year following the date that the Condensed Consolidated Financial Statements are issued.

    In response to these conditions, management is currently evaluating different strategies for reducing expenses, as well as pursuing financing strategies which include raising additional funds through the issuance of debt or equity securities, asset sales, and through arrangements with strategic partners. If capital is not available to the Company when, and in the amounts needed, it could be required to liquidate inventory, cease or curtail operations, or seek protection under applicable bankruptcy laws or similar state proceedings. There can be no assurance that the Company will be able to raise the capital it needs to continue operations. Management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern through one year following the date that the Condensed Consolidated Financial Statements are issued.

    ​

    The Condensed Consolidated Financial Statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

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    Table of Contents

    Other Significant Risks and Uncertainties - The Company is subject to a number of risks, including, but not limited to, the lack of available capital; future covenant non-compliance with respect to the Company’s Senior Secured Credit Facility giving rise to an event of default; unsuccessful commercialization strategy and launch plans for the Company’s products or market acceptance of the Company’s products; risks inherent in litigation, including purported class actions; and protection of proprietary technology.

    ​

    Reverse Stock Split – In order to regain compliance with Nasdaq's continued listing requirements, the Company effected the following reverse stock splits:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Round up of

    Date

    ​

    Split

    ​

    fractional shares

    April 2, 2024

    ​

    1-for-16

    ​

    876

    December 17, 2024

    ​

    1-for-135

    ​

    126,818

    ​

    ​

    All share and per share amounts, and exercise prices of stock options, and warrants in the Condensed Consolidated Financial Statements and notes thereto have been retroactively adjusted for all periods presented to give effect to the reverse stock splits.

    ​

    Warrants - The Company accounts for stock warrants as either equity instruments, derivative liabilities, or liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (ASC 480) and ASC 815, Derivatives and Hedging (ASC 815) depending on the specific terms of the warrant agreement. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. 

    Warrants that the Company may be required to redeem through payment of cash or other assets outside its control are classified as liabilities pursuant to ASC 480 and are initially and subsequently measured at their estimated fair values. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of Capital in excess of par value at the time of issuance. For additional discussion on warrants, see Note 5 and Note 10.

    Deemed dividends associated with down round provisions (commonly referred to as “ratchets”) represent the economic transfer of value to holders of equity-classified freestanding financial instruments when these provisions are triggered. These deemed dividends are presented as a reduction in net income or an increase in net loss available to common stockholders and a corresponding increase to Capital in excess of par value resulting in no change to stockholders’ equity/deficit. See Note 10 “Capital Raises and Warrants for Common Stock.”

    ​

    Debt Issued with Detachable Warrants - The Company considers guidance within ASC 470-20, Debt (ASC 470), ASC 480, and ASC 815 when accounting for the issuance of debt with detachable warrants. As described above under the caption “Warrants”, the Company classifies stock warrants as either equity instruments, derivative liabilities, or liabilities depending on the specific terms of the warrant agreement. In circumstances in which debt is issued with detachable warrants, the proceeds from the issuance of the debt are first allocated to the warrants at their full estimated fair value with a corresponding debt discount. The remaining proceeds, as further reduced by discounts (including those created by the bifurcation of embedded derivatives), is allocated to the debt. The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount from the allocation of proceeds, to interest expense using the effective interest method over the expected term of the debt instrument pursuant to ASC 835, Interest (ASC 835).

    ​

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    Table of Contents

    Embedded Derivatives – The Company considers whether there are any embedded features in debt instruments that require bifurcation and separate accounting as derivative financial instruments pursuant to ASC 815. Embedded derivatives are initially and subsequently measured at fair value. With the exception of the embedded conversion option as described in Note 6 “Debt”, the embedded derivatives associated with the Company’s Senior Secured Credit Facility and Subordinated Note are not material.

    ​

    The Company accounts for its convertible debt instrument, for which the conversion option is not bifurcated and accounted for separately as a derivative and is modified or exchanged in a transaction that is not accounted for as an extinguishment, the accounting is determined based on whether there is an increase or decrease in the fair value of the embedded conversion option. The fair value is calculated as the difference between the fair value of the embedded conversion option immediately before and after the modification or exchange. An increase in fair value is recorded as a decrease to the carrying amount of the debt instrument with a corresponding increase to Capital in Excess of Par Value.

    ​

    Debt Issuance Costs and Discounts - Debt issuance costs and discounts associated with the issuance of debt by the Company are deferred and amortized over the term of the related debt. Debt issuance costs and discounts related to the Company’s Senior Secured Credit Facility and Subordinated Note are recorded as a reduction of the carrying value of the related debt and are amortized to Interest expense using the effective interest method over the period from the date of issuance to the maturity date, whichever is earlier. The amortization of debt issuance costs and discounts are included in Debt related charges included in interest expense in the Condensed Consolidated Statements of Cash Flows. Note 6 “Debt” contains additional information on the Company’s debt issuance costs and discounts.

    ​

    Impairment of Long-Lived Assets - The Company reviews all long-lived assets to be held and used for recoverability, when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the ability to recover the carrying value of the assets from the expected future cash flows (undiscounted and without interest expense) of the related operations. If these cash flows are less than the carrying value of such assets, an impairment loss for the difference between the estimated fair value and carrying value is recorded. The Company determined that there were no impairment indicators for continuing operations during the three months ended March 31, 2025.

    ​

    Gain and Loss Contingencies – The Company establishes an accrued liability for litigation and regulatory matters when those matters present loss contingencies that are both probable and estimable. In such cases, there may be an exposure to loss in excess of any amounts accrued. When a loss contingency is not both probable and estimable, the Company does not establish an accrued liability. As a litigation or regulatory matter develops, the Company, in conjunction with any outside counsel handling the matter, evaluates on an ongoing basis whether such matter presents a loss contingency that is probable and estimable. If, at the time of evaluation, the loss contingency related to a litigation or regulatory matter is not both probable and estimable, the matter will continue to be monitored for further developments that would make such loss contingency both probable and estimable. When a loss contingency related to a litigation or regulatory matter is deemed to be both probable and estimable, the Company will establish an accrued liability with respect to such loss contingency and record a corresponding amount of related expenses. The Company will then continue to monitor the matter for further developments that could affect the amount of any such accrued liability.

    ​

    In accordance with ASC 450-30, Gain Contingencies, gain contingencies are recognized when earned and realized, which typically will occur at the time of final settlement or when cash is received. Insurance recoveries may be realized earlier than cash receipt if a claim and amount of reimbursement is acknowledged by the insurance company that payment is due and collection is probable.

    ​

    The Company maintains general liability insurance policies for its property and facilities. Under the terms of our insurance policies, in the case of loss to a property, the Company follows the guidance in ASC 610-30, Other Income —Gains and Losses on Involuntary Conversions, for the conversion of nonmonetary assets (the properties) to monetary assets (insurance recoveries). Under ASC 610-30, once the recovery is deemed probable the Company recognizes an asset for the insurance recovery receivable in the Condensed Consolidated Balance Sheets, with corresponding income that is offsetting to the casualty losses recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss. If the insurance recovery is less than the amount of the casualty charges recognized, the Company will recognize a loss whereas if the insurance recovery is greater than the amount of casualty loss recognized, the Company will only recognize a recovery up to the amount of the casualty loss and will account for the excess as a gain contingency. Business interruption insurance is treated as a gain contingency.

    ​

    Refer to further discussion of all commitments and contingencies in Note 12.

    9

    Table of Contents

    ​

    Related Party Transaction - A related party is generally defined as (i) any person that holds 10% or more of the Company’s securities and their immediate families, (ii) the Company’s management, (iii) someone that directly or indirectly controls, is controlled by or is under common control with the Company, or (iv) anyone who can significantly influence the financial and operating decisions of the Company. A transaction is considered to be a related party transaction when there is a transfer of resources or obligations between related parties. The Company may conduct business with its related parties in the ordinary course of business.

    Beginning in the fourth quarter of 2024, the Company generated revenue from a related party contract manufacturing customer. During the three month period ended March 31, 2025, private label cigarette revenue, net and corresponding contract asset from the related party were not material.

    Revenue Recognition – The Company recognizes revenue when it satisfies a performance obligation by transferring control of the product to a customer. For additional discussion on revenue recognition, refer to Note 8 “Revenue Recognition”.

    Income Taxes - For interim income tax reporting, due to a full valuation allowance on net deferred tax assets, no income tax expense or benefit is recorded unless it is related to certain state, local, or franchise taxes, or an unusual or infrequently occurring items. The tax effects of unusual or infrequently occurring items, including changes in judgment about valuation allowances and effects of changes in tax laws or rates, are reported in the interim period in which they occur.

    ​

    Recently Issued Accounting Pronouncements –

    In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU requires additional disclosures regarding segment expenses and other items on an interim and annual basis. The amendments in ASU 2023-07 were adopted by the Company effective January 1, 2024. See Note 13 “Segment and Geographic Information.”

    In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740)-Improvements to Income Tax Disclosures. The ASU requires additional quantitative and qualitative income tax disclosures to allow readers of the consolidated financial statements to assess how the Company’s operations, related tax risks and tax planning affect its tax rate and prospects for future cash flows. For public business entities, the ASU is effective for annual periods beginning after December 15, 2024. The ASU did not have a material impact to the Condensed Consolidated Financial Statements.

    Accounting Guidance Not Yet Elected or Adopted

    ​

    We consider the applicability and impact of all ASUs. If the ASU is not listed above, it was determined that the ASU was either not applicable or would have an immaterial impact on our financial statements and related disclosures.

    ​

    ​

    10

    Table of Contents

    NOTE 2. DISCONTINUED OPERATIONS AND DIVESTITURES

    As of March 31, 2025 and December 31, 2024, all assets and liabilities of the former hemp/cannabis business are presented as current in the Condensed Consolidated Balance Sheets. The carrying amounts of the former hemp/cannabis assets and liabilities that were classified as assets and liabilities of discontinued operations held for sale were as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

    2025

    ​

    2024

    Property, plant and equipment, net

    $

    758

    ​

    $

    1,051

    Current assets of discontinued operations held for sale

    $

    758

    ​

    $

    1,051

    ​

    ​

    ​

    ​

    ​

    ​

    Accounts payable

    $

    840

    ​

    $

    1,210

    Accrued expenses

     

    18

    ​

     

    71

    Current liabilities of discontinued operations held for sale

    $

    858

    ​

    $

    1,281

    ​

    ​

    ​

    ​

    ​

    ​

    Net liabilities

    $

    (100)

    ​

    $

    (230)

    ​

    ​

    Net loss from discontinued operations for the three months ended March 31, 2025 and 2024 was as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

        

    2024

    Revenues, net

    $

    —

    ​

    $

    —

    Cost of goods sold

    ​

    —

    ​

    ​

    —

    Gross loss

    ​

    —

    ​

    ​

    —

    Operating expenses:

    ​

    ​

    ​

    ​

    ​

    Sales, general and administrative

    ​

    8

    ​

    ​

    67

    Research and development

    ​

    (337)

    ​

    ​

    48

    Other operating expense, net

    ​

    1,172

    ​

    ​

    99

    Total operating expenses

    ​

    843

    ​

    ​

    214

    Operating loss from discontinued operations

    ​

    (843)

    ​

    ​

    (214)

    Other income (expense):

    ​

    ​

    ​

    ​

    ​

    Interest expense

    ​

    (211)

    ​

    ​

    (75)

    Total other expense

    ​

    (211)

    ​

    ​

    (75)

    Loss from discontinued operations before income taxes

    ​

    (1,054)

    ​

    ​

    (289)

    Provision (benefit) for income taxes

    ​

    —

    ​

    ​

    —

    Loss from discontinued operations

    $

    (1,054)

    ​

    $

    (289)

    ​

    11

    Table of Contents

    During the three month periods ended March 31, 2025 and 2024, the Company settled outstanding obligations which resulted in reversals of previously accrued liabilities of $337 and $152, respectively. Additionally, for the three month period ended March 31, 2024, Other operating expense, net was comprised of $500 provision for credit loss for the GVB promissory note (see Note 6 “Debt”) and $293 of impairment charges related to the expected sale of Needle Rock Farms land property (see Note 14 “Subsequent Events”).

    Cash flow information from discontinued operations for the three months ended March 31, 2025 and 2024 was as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

        

    2024

    Cash used in operating activities

    $

    1,185

    ​

    $

    255

    Cash provided by investing activities

    $

    -

    ​

    $

    22

    ​

    ​

    ​

    ​

    ​

    ​

    Depreciation and amortization

    $

    -

    ​

    $

    -

    Capital expenditures

    $

    -

    ​

    $

    -

    ​

    ​

    ​

    ​

    NOTE 3. – INVENTORIES

    Inventories at March 31, 2025 and December 31, 2024 consisted of the following:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

        

    March 31, 

        

    December 31, 

    ​

        

    2025

        

    2024

    Raw materials

    ​

    $

    2,447

    ​

    $

    1,616

    Work in process

    ​

    ​

    1

    ​

    ​

    —

    Finished goods

    ​

     

    107

    ​

    ​

    399

    ​

    ​

    $

    2,555

    ​

    $

    2,015

    ​

    ​

    ​

    ​

    NOTE 4. – INTANGIBLE ASSETS, NET 

    Intangible Assets, Net

    Our intangible assets, net at March 31, 2025 and December 31, 2024 consisted of the following:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Gross

    ​

    Accumulated

    ​

     

    Net Carrying

    March 31, 2025

        

    Carrying Amount

        

    Amortization

    ​

     

    Amount

    Definite-lived:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Patent

    ​

    $

    2,960

    ​

    $

    (2,369)

    ​

    $

    591

    License fees

    ​

     

    4,894

    ​

    ​

    (2,060)

    ​

    ​

    2,834

    Total amortizing intangible assets

    ​

    $

    7,854

    ​

    $

    (4,429)

    ​

    $

    3,425

    Indefinite-lived:

    ​

     

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Trademarks

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    137

    MSA signatory costs

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    2,202

    License fee for predicate cigarette brand

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    350

    Total indefinite-lived intangible assets

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    2,689

    Total intangible assets, net

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    6,114

    ​

    ​

    ​

    12

    Table of Contents

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Gross

    ​

    Accumulated

     

    ​

    ​

    ​

    Net Carrying

    December 31, 2024

        

    Carrying Amount

        

    Amortization

     

    Impairment

    ​

    Amount

    Definite-lived:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Patent

    ​

    $

    2,948

    ​

    $

    (2,268)

    ​

    $

    (68)

    ​

    $

    612

    License fees

    ​

     

    4,415

    ​

    ​

    (1,990)

    ​

    ​

    -

    ​

    ​

    2,425

    Total amortizing intangible assets

    ​

    $

    7,363

    ​

    $

    (4,258)

    ​

    $

    (68)

    ​

    $

    3,037

    Indefinite-lived:

    ​

     

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Trademarks

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    135

    MSA signatory costs

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    2,202

    License fee for predicate cigarette brand

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    350

    Total indefinite-lived intangible assets

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    2,687

    Total intangible assets, net

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    $

    5,724

    ​

    ​

    Aggregate intangible asset amortization expense comprises of the following:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

        

    2024

    Cost of goods sold

    $

    3

    ​

    $

    3

    Research and development

     

    100

    ​

     

    101

    Total amortization expense

    $

    103

    ​

    $

    104

    ​

    Estimated future intangible asset amortization expense based on the carrying value as of March 31, 2025 is as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

     

    Remainder for 2025

     

    2026

     

    2027

    ​

    2028

    ​

    2029

    ​

    Thereafter

    Amortization expense

    ​

    $

    323

    ​

    $

    379

    ​

    $

    381

    ​

    $

    356

    ​

    $

    237

    ​

    $

    1,749

    ​

    ​

    ​

    ​

    ​

    NOTE 5. FAIR VALUE MEASUREMENTS

    Fair value measurement standards apply to certain financial assets and liabilities that are measured at fair value on a recurring basis (each reporting period). The Company does not have any nonfinancial assets or liabilities that are measured at fair value on a recurring basis.

    The following table presents information about our liabilities measured at fair value at March 31, 2025 and December 31, 2024, and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Fair Value

    ​

    ​

    March 31, 2025

    ​

        

    Level 1

        

    Level 2

        

    Level 3

        

    Total

    Liabilities

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Omnia 2024 warrants

    ​

    $

    —

    ​

    $

    —

    ​

    $

    1,185

    ​

    $

    1,185

    Total liabilities

    ​

    $

    —

    ​

    $

    —

    ​

    $

    1,185

    ​

    $

    1,185

    ​

    13

    Table of Contents

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Fair Value

    ​

    ​

    December 31, 2024

    ​

        

    Level 1

        

    Level 2

        

    Level 3

        

    Total

    Liabilities

     

    ​

      

     

    ​

      

     

    ​

      

     

    ​

      

    Omnia 2024 Warrants

    ​

    $

    —

    ​

    $

    —

    ​

    $

    1,023

    ​

    $

    1,023

    Total liabilities

    ​

    $

    —

    ​

    $

    —

    ​

    $

    1,023

    ​

    $

    1,023

    ​

    ​

    Warrants

    ​

    The following table sets forth a summary of the changes in fair value of the Company’s common stock warrants accounted for as liabilities (Level 3):

    ​

    ​

    ​

    ​

    ​

    Fair value measurement at January 1, 2025

    ​

    $

    1,023

    Fair value measurement adjustment

    ​

    ​

    162

    Fair value measurement at March 31, 2025

    ​

    $

    1,185

    ​

    ​

    ​

    The Omnia warrants were measured at March 31, 2025 and December 31, 2024 using a Monte Carlo valuation model with the following assumptions:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

    2025

    ​

    2024

    Risk-free interest rate per year

     

    3.9

    %

    ​

     

    4.3

    %

    Expected volatility per year

     

    124.2

    %

    ​

     

    119.0

    %

    Expected dividend yield

     

    —

    %

    ​

     

    —

    %

    Contractual expiration

     

    4.1

    years

    ​

     

    4.3

    years

    Exercise price

    $

    288.90

    ​

    ​

    $

    288.90

    ​

    Stock price

    $

    1.44

    ​

    ​

    $

    5.31

    ​

    ​

    The warrants are measured at fair value using certain estimated factors which are classified within Level 3 of the valuation hierarchy. Significant unobservable inputs that are used in the fair value measurement of the Company’s warrants include the volatility factor, anti-dilution provisions, and contingent put option. Significant increases or decreases in the volatility factor would have resulted in a significantly higher or lower fair value measurement. Additionally, a change in probability regarding the anti-dilution provision or put option would have resulted in a significantly higher or lower fair value measurement. The Omnia 2023 warrants were extinguished and the Omnia 2024 warrants were issued in April 2024. The Omnia 2024 warrants are classified as Other current liabilities on the Condensed Consolidated Balance Sheets.

    ​

    Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis

    ​

    Fair value standards also apply to certain assets and liabilities that are measured at fair value on a nonrecurring basis. During the three months ended March 31, 2025 and 2024, the Company did not have any financial assets or liabilities measured at fair value on a nonrecurring basis.

    ​

    ​

    ​

    ​

    14

    Table of Contents

    NOTE 6. DEBT

    ​

    The Company has a senior secured credit facility (the “Senior Secured Credit Facility”), which consists of Debentures (as defined below) and previously, a subordinated promissory note (the “Subordinated Note). The Debentures were issued at a 5% original issuance discount and are subject to a 5% exit payment. The Subordinated Note was extinguished in April 2024, as described below.

    ​

    Debt related to the Senior Secured Credit Facility as of March 31, 2025 and December 31, 2024 consists of the following:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

        

    2025

        

    2024

    Senior Secured Credit Facility

     

    $

    4,558

     

    $

    7,690

    Unamortized discount on loan and deferred debt issuance costs

    ​

    ​

    (629)

    ​

    ​

    (1,025)

    Total debt

    ​

    $

    3,929

    ​

    $

    6,665

    Current portion of long-term debt

    ​

    ​

    (3,929)

    ​

    ​

    (1,500)

    Total long-term debt

    ​

    $

    —

    ​

    $

    5,165

    ​

    ​

    Debentures

    ​

    On March 3, 2023, the Company entered into a Securities Purchase Agreement with each of the purchasers party thereto (collectively, the “Purchasers”) and JGB Collateral, LLC, as collateral agent for the Purchasers (the “Agent”) which pursuant to the agreement, the Company sold 5% original issuance discount senior secured debentures with an aggregate principal amount of $21,053. The Debentures bear interest at a rate of 7% per annum, payable monthly in arrears as of the last trading day of each month and on the maturity date. The Debentures mature on March 3, 2026. At the Company’s election, subject to certain conditions, interest can be paid in cash, shares of the Company’s common stock, or a combination thereof. The Debentures are subject to an exit payment equal to 5% of the original principal amount, or $1,053, payable on the maturity date or the date the Debentures are paid in full (the “Exit Payment”). The Company may at any time irrevocably elect to redeem all of the then outstanding principal amount of the Debentures for cash in an amount equal to the entire outstanding principal balance, including accrued and unpaid interest, the Exit Payment and a prepayment premium in an amount equal to 3% of the outstanding principal balance as of the prepayment date (collectively, the “Prepayment Amount”). Upon the entry into a definitive agreement that would effect a change in control (as defined in the Debentures) of the Company, the Agent may require the Company to prepay the outstanding principal balance in an amount equal to the Prepayment Amount. At its option, the holder of a Debenture may require the Company to redeem 2% of the original principal amount of the Debentures per calendar month which amount may at the Company’s election, subject to certain exceptions, be paid in cash, shares of the Company’s common stock, or a combination thereof.

     

    The Company’s obligations under the Debentures can be accelerated upon the occurrence of certain customary events of default. In the event of a default and acceleration of the Company’s obligations, the Company would be required to pay the Prepayment Amount, liquidated damages and other amounts owing in respect thereof through the date of acceleration.

    ​

    The Debentures contain customary representations, warranties and covenants including among other things and subject to certain exceptions, covenants that restrict the Company from incurring additional indebtedness, creating or permitting liens on assets, making or holding any investments, repaying outstanding indebtedness, paying dividends or distributions and entering into transactions with affiliates. Substantially all of the company’s assets, including intellectual property, are collateralized and at risk if Debenture obligation is not satisfied. In addition, the Company was required to maintain at least $7,500 on its balance sheet as restricted cash in a separate account and has financial covenants to maintain certain quarterly revenue targets.

    ​

    In connection with the sale of the Debentures, the Company issued warrants to purchase up to 155 shares of common stock for an exercise price of $41,310 per share (the “JGB Warrants”), which had an initial fair value of $4,475 net of issuance costs of $139. On June 22, 2023, as a result of the June 19, 2023 offering, the Company’s outstanding JGB warrants to purchase up to 155 shares of the Company’s common stock for an exercise price of $41,310 per share were automatically adjusted to be $27,708.48 exercise price for up to 231 shares of common stock. There are no further anti-dilution adjustments on such warrants.

    ​

    15

    Table of Contents

    On October 16, 2023, the Company entered into a Waiver and Amendment Agreement (the “October  Amendment”) with each of the subsidiaries of the Company executing the Debentures, the Holders and the Agent, pursuant to which, among other things, (a) the Holders waived an event of default under Section 7(d) of the Debentures which required the Company to achieve revenue of at least $18,500 for the quarter ended September 30, 2023 (the “waiver”), (b) the parties agreed to amend Schedule E of the Debentures to reduce the Revenue Target (as such term is defined in the Debentures), for the quarter ended December 31, 2023, to $15,500, and (c) the Company agreed to release to the Purchasers the $7,500 that the Company was required to maintain in a separate account (the “Escrow Funds”) which Escrow Funds were applied to, and reduce, the outstanding principal amount of the Debentures on a dollar-for-dollar basis.

    ​

    As additional consideration for the waiver, the Company agreed to assign, transfer and convey to the Agent, the Company’s entire right, title and interest in and to (i) the Promissory Note made by J&N Real Estate Company, L.L.C. (“J&N”) payable to the Company in the principal amount of $3,800 and (ii) the Deed of Trust, Assignment of Rents, Security Agreement and Fixture Filing dated June 30, 2021, between J&N, as borrower, for the benefit of the Company, as lender (collectively, the “Pledged Indebtedness”). Upon assignment of the Pledged Indebtedness, the Company recognized the $2,600 of consideration in exchange to be applied as a $2,000 reduction of the Put Price (as defined below), $600 reduction of the outstanding principal amount of Debentures and $895 loss on sale of financial asset.

    ​

    In connection with the waiver, the Company and Holders agreed to exercise the outstanding put provision to redeem 78 warrants for an aggregate put price equal to $2,500 (the “Put Price”), which was concurrently reduced by $2,000, as described above, with the remaining $500 payable by the Company on the Maturity Date recorded as Other long-term liabilities on the Condensed Consolidated Balance Sheets. No cash was exchanged as a result of executing the October 2023 Amendment.

    ​

    Subsequently, on December 22, 2023, the Company, the Holders and the Agent entered into an Amendment Agreement (the “December 2023 Amendment”) pursuant to which the Holders and the Agent consented to the Purchase Agreement, as amended by the GVB Amendment (see Note 2 “Discontinued Operations and Divestitures”). In consideration of the Holders and the Agents’ consent, the Company agreed to (i) pay to the Agent, a cash payment of $2,200 to reduce the outstanding principal of the Debentures (which includes the cash portion of the New Purchase Price paid directly to Agent by Buyer which consists of a cash payment of $1,100 and an additional $1,100 paid by the Company), (ii) a 12% secured promissory note issued to the Company’s senior lender, on behalf of and at the direction of the Company, in an aggregate principal amount of $2,000 (the “GVB Promissory Note”), (iii) assign the GVB Insurance Proceeds to the Agent until the outstanding aggregate principal amount of the Debentures, plus accrued and unpaid interest, has been repaid in full; provided that the first $1,000 of Insurance Proceeds in excess of $5,000 shall be applied as stated in the agreement, and (iv) post-closing enter into a deed in lieu of foreclosure agreement with respect to 224 acres of real property in Delta County, Colorado commonly known as Needle Rock Farms, resulting in a non-monetary exchange yielding additional debt reduction of $1,000.  See Note 14 “Subsequent Events.”

    ​

    Effective June 24, 2024, GVB Biopharma (“GVB”), the Company’s former subsidiary, made a scheduled principal and interest payment against the Company’s outstanding indebtedness to JGB, reducing the Company’s total outstanding principal indebtedness with JGB by $1,500. The remaining $500 payable by GVB under the GVB Promissory Note was initially extended to December 31, 2024 and subsequently to March 31, 2025. The GVB Promissory Note is in default with respect to payment at maturity of the contractual term and accordingly an allowance for credit loss was recorded as of March 31, 2025 in the amount of $500.

    ​

    As part of the December amendment, the Company, the Holders and the Agent also agreed to amend the Debentures to (i) allow the Holders to voluntarily convert the Debentures, in whole or in part, into shares of the Company’s common stock (“Voluntary Conversion Option”) on the earlier of (i) June 30, 2024 and (ii) the public announcement of a Fundamental Transaction at a conversion price equal to the lower of (x) $2,025.00 per share (reverse split adjusted) and (y) the closing sale price of the Company’s common stock on June 29, 2024 (the “Conversion Price”), and (ii) include a mandatory prepayment of the outstanding principal of the Debentures in an amount equal to 20% of the net cash proceeds of any issuance by the Company of any of its stock, or other Equity Interests (as defined in the Debentures) or the incurrence or issuance of any indebtedness.

    ​

    Additional terms of the December 2023 Amendment include a financial covenant holiday through the third quarter of 2024 and revised certain covenants thereafter to reflect the sale of the Purchased Interests, including lowering the Company’s quarterly revenue targets. As of March 31, 2025, the Company was in compliance with these financial covenants.

    ​

    16

    Table of Contents

    On April 8, 2024, the Company, the Holders and the Agent entered into that certain Letter Agreement to modify the terms of the Amendment Agreement, the JGB SPA and the Debentures, as amended (“April 2024 Amendment”).

     

    Under the terms of the Letter Agreement, the Holders are permitted to convert their debt to common stock at anytime and the Conversion Price (as defined in the Debentures) at which the Holders may convert the principal amount of their Debentures to the Company’s common stock is reduced to $288.90 per share in accordance with applicable Nasdaq rules through the conversion option reset date on June 28, 2024. The principal amount of the Debentures converted shall be applied to the Monthly Allowance (as defined in the Debentures) for that month, and any excess shall be applied to the Monthly Allowances for the succeeding months. The conversions will be a dollar for dollar reduction of the remaining outstanding obligation owed to the Holders. The Agent and Holders have also agreed to daily limits on trading volume and minimum conversion amounts. The Holders converted $428 of debt in exchange for 1,482 shares of common stock during the quarter-ended June 30, 2024.

    ​

     On May 10, 2024, the Company, the Holders and the Agent entered into that certain May 2024 Exchange Agreement and May 2024 Letter Agreement to modify the terms of the Amendment Agreement, the Securities Purchase Agreement and the Debentures, as amended (“May 2024 Amendment”).

     

    Under the terms of the May 2024 Amendment, the Company and Holders have agreed the Company shall incur an aggregate amendment charge to the undersigned holders equal to $275, which shall be added to the principal balance of the Debentures. Under the terms of the May 2024 Exchange Agreement, the Company and Holders exchanged an aggregate of $2,328 in principal, fees and expenses owed under the Debentures for 2,926 shares of common stock and 6,630 immediately exercisable pre-funded warrants to purchase shares of common stock at an exercise price of $.00001 (at an effective per share price of $228.15). All pre-funded warrants were subsequently exercised during the quarter-ended June 30, 2024.

     

    On August 27, 2024, the Company, the Holders and the Agent entered into that certain August 2024 Letter Agreement to modify the terms of the Amendment Agreement, the JGB SPA, and the Debentures, as amended (“August 2024 Amendment”).

    ​

    Under the terms of the August 2024 Agreement, each Holder agreed that it shall not exercise its Holder Redemption Right (as defined in the Debentures) for more than 50% of its Monthly Allowance (as defined in the Debentures) through and including July 2025. Further, the provisions in Section 3(c)(i) of the Debentures requiring 20% of any equity issuances to be paid to the Holders shall be suspended through December 31, 2024. In consideration for the amendments set forth in the August 2024 Amendment, the Company paid an amendment fee of $746, which was added to the aggregate principal amount of the Debentures. JGB subsequently issued a conversion notice for 3,260 shares of common stock equal to principal reduction of $328.

    ​

    On October 10, 2024, the Company, the Holders and the Agent entered into that certain October 2024 Letter Agreement to modify the terms of the Amendment Agreement, the JGB SPA, and the Debentures, as amended (“October 2024 Amendment”).

    ​

    Under the terms of the October 2024 Amendment, the Company will be able to reset the Conversion Price (as defined in the Debentures) currently in effect, at the discretion of the Board of Directors and on a one time basis, to an amount equal to the average of the daily VWAPs for each of the five (5) consecutive Nasdaq trading days immediately preceding the date on which the Conversion Price shall be reset. The reset Conversion Price shall in no event be greater than the Conversion Price in effect on the date of the Letter Agreement, which is $100.638.

    ​

    On January 13, 2025, the Board of Directors approved the reset of the Conversion Price to $6.04 per share. The change in conversion price resulted in an increase in fair value to the embedded conversion option, resulting in an increase in debt discount of $283 and a corresponding increase in capital in excess of par value. The Holders exercised conversion notices in the amount of $3,132 in January 2025 and the Company issued 518,600 shares of common stock.  

    ​

    In accordance with ASC 470-60 Troubled Debt Restructurings by Debtors and ASC 470-50, Debt Modifications and Extinguishment, the Company performed an assessment of whether the transaction was deemed to be a troubled debt restructuring, and if no, whether the transaction was deemed modification of existing debt, or an extinguishment of existing debt and new debt.

    ​

    17

    Table of Contents

    The October 2023 Amendment, April 2024 Amendment, May 2024 Amendment, and August 2024 Amendment were concluded to be a modification, and not an extinguishment, based on an analysis of the present value of future cash flows. A new effective interest rate was determined, and the debt continued to be amortized. The December 2023 Amendment was concluded to be an extinguishment, due to the addition of a substantive conversion option.

    ​

    The Company analyzed the conversion feature of the December 2023 Amendment for derivative accounting consideration under ASC 815-15 and determined that the embedded conversion features should be classified as a bifurcated derivative because the exercise price of these convertible notes are subject to a variable conversion rate. The Company has determined that the conversion feature is not considered to be solely indexed to the Company’s own stock and is therefore not afforded equity treatment. In accordance with ASC 815, the Company has bifurcated the conversion feature of the note and recorded a derivative liability at fair value in the amount of $557 as of March 31, 2024, respectively as a component of Other Long-Term Liabilities on the Consolidated Balance Sheet. Subsequently, during the year-ended December 31, 2024, the derivative liability related to the debentures and embedded conversion option was reclassified from Other Long-Term Liabilities to Capital in Excess of Par, based on the Company’s reassessment of the classification and conclusion the derivative met the ‘fixed for fixed’ criteria in ASC 815.

    ​

    Subordinated Note

    ​

    On March 3, 2023, the Company executed a Subordinated Promissory Note (the “Subordinated Note”) with a principal amount of $2,865 in favor of Omnia Ventures, LP (“Omnia”).

    ​

    In connection with the Subordinated Note, the Company issued to Omnia, warrants to purchase up to 2,813 shares of the Company’s common stock (the “2023 Omnia Warrants”). The 2023 Omnia Warrants were exercisable for seven years from September 3, 2023, at an exercise price of $205.248 per share, subject, with certain exceptions, to adjustments in the event of stock splits, dividends, subsequent dilutive offerings and certain fundamental transactions.

    ​

    On April 29, 2024, the Company entered into a General Release and Settlement Agreement (the “Omnia Agreement”) with Omnia Capital LP (“Omnia”). The Omnia Agreement settles and extinguishes all outstanding debt and interest owed to Omnia under the outstanding Subordinated Note and the put provision contained in the 2023 Omnia Warrants, amounting to a total of approximately $5,228, for (i) a cash payment of $249; (ii) 8,519 shares of common stock and 8,519 immediately exercisable pre-funded warrants to purchase shares of common stock at an exercise price of $0.0001 that are exercisable until May 1, 2029 (at an effective per share price of $2.14) and (iii) 460,000 immediately exercisable warrants to purchase an equal number of shares of common stock at an exercise price of $2.14 until May 1, 2029 (the “2024 Omnia Warrants”). The 2024 Omnia Warrants contain a put provision that permits the holder to require the Company to redeem the 2024 Omnia Warrants, no earlier than May 1, 2025, for a purchase price equal to $2.675 per warrant, and had an initial fair value of $1,515 (see Note 5). Subject to limited exceptions, a holder of pre-funded warrants and 2024 Omnia Warrants will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 19.99% of the number of shares of our common stock outstanding immediately after giving effect to such exercise. As part of the Omnia Agreement, the parties agreed to terminate and cancel the Old Note and the 2023 Omnia Warrants and released all debts, claims or other obligations against each other occurring prior to the date of the Omnia Agreement.  The total cash and non-cash consideration amounted to $5,628, resulting in extinguishment charges of $400 for the three months ended June 30, 2024, recorded in Interest expense in the Statement of Operations and Comprehensive Loss.

    ​

    Contractual Maturities

    ​

    As of March 31, 2025, contractual maturities under the Senior Secured Credit Facility for the remainder of 2025 and through maturity, excluding any discounts or premiums, were to be paid in 2025 of $0 and 2026 of $4,558. See Note 14 “Subsequent Events.”

    ​

    18

    Table of Contents

    Additionally, at its option, JGB may require the Company to redeem 2% of the original principal amount of the Debentures, as amended to be no more than 50% or $210 per calendar month through July 2025 and $421 per calendar month thereafter which amount may at the Company’s election, subject to certain exceptions, be paid in cash, shares of the Company’s common stock, or a combination thereof. JGB has not elected the monthly redemption feature during the three-month period ended March 31, 2025. If the redemption feature is elected, as of March 31, 2025, contractual maturities under the senior secured credit Facility for the remainder of 2025 are $2,948, and for 2026 are $1,610.

    ​

    Debt Issuance Costs

    ​

    The fair values of the warrants at issuance of $5,791, together with the Debentures original issuance discount of $1,053, Debentures exit payment of $1,053, and third-party debt issuance costs of $801, are being amortized using the effective interest method over the term of the respective debt instrument, recorded as Interest expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss. The components and activity of unamortized discount and deferred debt issuance costs related to the Senior Secured Credit Facility and Subordinated Note is as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Total

    January 1, 2025

    ​

    $

    1,025

    Amortization during the period

    ​

    ​

    (679)

    Conversion option remeasurement

    ​

    ​

    283

    March 31, 2025

    ​

    $

    629

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    NOTE 7. – NOTES & LOANS PAYABLE

    The table below outlines our notes and loans payable balances as of March 31, 2025 and December 31, 2024:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

        

    2025

        

    2024

    Insurance loans payable

    ​

    $

    —

    ​

    $

    254

    Total current notes and loans payable

    ​

    $

    —

    ​

    $

    254

    ​

    Insurance loans payable

    ​

    During the second quarter of 2024, the Company renewed its Director and Officer (“D&O”) insurance for a one-year policy premium totaling $866. The Company paid $147 as a premium down payment and financed the remaining $719 of policy premiums over ten months at a 8.3% annual percentage rate.

    ​

    The Company also has other insurance loans payable related to property and general liability across the Company.

    19

    Table of Contents

    ​

    ​

    NOTE 8. – REVENUE RECOGNITION

    The Company’s revenues are derived primarily from contract manufacturing organization (“CMO”) customer contracts that consist of obligations to manufacture the customers’ branded filtered cigars and cigarettes. Additional revenues are generated from sale of the Company’s proprietary low nicotine content cigarettes, sold under the brand name VLN®, or research cigarettes sold under the brand name SPECTRUM®.

    The Company recognizes revenue when it satisfies a performance obligation by transferring control of the product to a customer. For certain CMO contracts, the performance obligation is satisfied over time as the Company determines, due to contract restrictions, it does not have an alternative use of the product and it has an enforceable right to payment as the product is manufactured. The Company recognizes revenue under those contracts at the unit price stated in the contract based on the units to customers and is recognized net of cash discounts, sales returns and allowances. There was no allowance for discounts or returns at March 31, 2025 and December 31, 2024. Consideration payable to the customer is recorded net of the transaction price with a corresponding contract liability.

    Disaggregation of Revenue

    The Company’s net revenue is derived from customers located primarily in the United States and is disaggregated by the timing of revenue. Revenue recognized from Tobacco products transferred to customers over time represented substantially all net revenue and 60% for the three months ended March 31, 2025 and March 31, 2024 respectively.

    The following table presents net revenue by product line:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

    ​

    2024

    Contract Manufacturing

    ​

    ​

    ​

    ​

    ​

    Cigarettes

    $

    5,013

    ​

    $

    2,760

    Filtered Cigars

    ​

    1,103

    ​

    ​

    3,626

    Cigarillos

    ​

    (5)

    ​

    ​

    -

    Total Contract Manufacturing

    ​

    6,111

    ​

    ​

    6,386

    VLN®

    ​

    (155)

    ​

    ​

    83

    Total Product Line Revenues

    $

    5,956

    ​

    $

    6,469

    ​

    20

    Table of Contents

    The following tables present net revenues by significant customers, which are defined as any customer who individually represents 10% or more of disaggregated product line net revenues:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    March 31, 

    ​

    ​

    2025

    ​

    2024

    Customer A

    ​

    76.96

    %

    ​

    38.55

    %

    Customer B

    ​

    12.14

    %

    ​

    24.71

    %

    All other customers

    ​

    10.90

    %

    ​

    36.74

    %

    ​

    Contract Assets and Liabilities

    Unbilled receivables (contract assets) represent revenues recognized for performance obligations that have been satisfied but have not been billed. These receivables are included as Accounts receivable, net on the Condensed Consolidated Balance Sheets. Customer payment terms vary depending on the terms of each customer contract, but payment is generally due prior to product shipment or within credit terms up to 30 days after shipment. Deferred income (contract liabilities) relates to down payments received from customers in advance of satisfying a performance obligation and is included as Deferred income on the Condensed Consolidated Balance Sheets.

    Total contract assets and contract liabilities are as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31, 

    ​

    December 31, 

    ​

        

    2025

        

    2024

    Unbilled receivables

     

    $

    3,874

     

    $

    1,298

    Consideration payable to the customer

     

    ​

    (1,171)

     

    ​

    —

    Deferred income

    ​

    ​

    (79)

    ​

    ​

    (20)

    Net contract assets

    ​

    $

    2,624

    ​

    $

    1,278

    ​

    ​

    During the three months ended March 31, 2025 and 2024, the Company recognized $0 and $371 of revenue that was included in the contract liability balance as of December 31, 2024 and 2023.

    ​

    ​

    NOTE 9 – EQUITY BASED COMPENSATION

    The Company maintains certain stock-based compensation plans that were approved by the Company’s shareholders and are administered by the Compensation Committee of the Company’s Board of Directors. The stock-based compensation plans provide for the granting of stock options, time and performance based restricted stock units (RSU’s), among other awards to employees, non-employee directors, consultants, and service providers. As of March 31, 2025, the Company had available 4,694,636 shares remaining for future awards under its Omnibus Incentive Plans.

    21

    Table of Contents

    Compensation Expense – The Company recognized the following compensation costs, net of actual forfeitures, related to restricted stock units (“RSUs”) and stock options:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    ​

    March 31, 

    ​

    ​

        

    2025

        

    2024

    ​

    Sales, general, and administrative

    ​

    $

    24

    ​

    $

    140

    ​

    Research and development

    ​

     

    2

    ​

     

    41

    ​

    Total equity based compensation

    ​

    $

    26

    ​

    $

    181

    ​

    ​

    Restricted Stock Units – We typically grant RSUs to employees and non-employee directors. The following table summarizes the changes in unvested RSUs from January 1, 2025 through March 31, 2025.

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Unvested RSUs

    ​

    ​

    ​

    ​

    Weighted

    ​

    ​

    ​

    ​

    Average

    ​

    ​

    Number of

    ​

    Grant-date

    ​

        

    Shares

        

    Fair Value

    ​

    ​

    ​

    ​

    $ per share

    Unvested at January 1, 2025

     

    —

    ​

    $

    —

    Granted

     

    159,583

    ​

    ​

    2.01

    Unvested at March 31, 2025

    ​

    159,583

    ​

    $

    2.01

    ​

    As of March 31, 2025, unrecognized compensation expense for RSUs amounted to $314 which is expected to be recognized over a weighted average period of approximately 2.8 years.

    Stock Options – Our outstanding stock options were valued using the Black-Scholes option-pricing model on the date of the award. A summary of the status of stock options activity since January 1, 2025 and at March 31, 2025 is as follows:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Weighted

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Weighted

    ​

    Average

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Average

    ​

    Remaining

    ​

    Aggregate

    ​

    ​

    Number of

    ​

    Exercise

    ​

    Contractual

    ​

    Intrinsic

    ​

        

    Options

        

    Price

        

    Term

        

    Value

    ​

    ​

    ​

    ​

    $ per share

    ​

    ​

    ​

    ​

    ​

    ​

    Outstanding at January 1, 2025

     

    —

    ​

    $

    —

     

      

     

     

    $

    —

    Granted

     

    478,777

    ​

    ​

    2.01

     

      

     

     

    ​

      

    Outstanding at March 31, 2025

     

    478,777

    ​

    $

    2.01

     

    10.0

    years

     

    $

    —

    Exercisable at March 31, 2025

     

    —

    ​

    $

    —

     

    —

    years

     

    $

    —

    ​

    The intrinsic value of a stock option is the amount by which the current market value or the market value upon exercise of the underlying stock exceeds the exercise price of the option.

    As of March 31, 2025, unrecognized compensation expense for stock options amounted to $820 which is expected to be recognized over a weighted average period of approximately 2.8 years.

    ​

    22

    Table of Contents

    ​

    The weighted average of fair value assumptions used in the Black-Scholes option-pricing model for such grants were as follows:

    ​

    ​

    ​

    ​

    ​

    ​

        

    2025

    Grant date fair value

    ​

    $1.75

    ​

    Risk-free interest rate (1)

     

    4.07

    %

    Expected dividend yield (2)

     

    —

    %

    Expected volatility (3)

     

    114.32

    %

    Expected term of stock options (4)

     

    6.44

    years

    ​

    ​

    ​

    ​

    (1) The risk-free interest rate is based on the period matching the expected term of the stock options based on the U.S. Treasury yield curve in effect on the grant date.

    (2) The expected dividend yield is assumed as zero. The Company has never paid cash dividends nor does it anticipate paying dividends in the foreseeable future.

    (3) The expected volatility is based on historical volatility of the Company’s stock.

    (4) The expected term represents the period of time that options granted are expected to be outstanding based on vesting date and contractual term.

    ​

    ​

    ​

    ​

    NOTE 10. – CAPITAL RAISES AND WARRANTS FOR COMMON STOCK

    The following tables summarize the Company’s warrant activity:

    ​

    ​

    ​

    ​

    Warrants outstanding at January 1, 2025

    ​

    25,755,260

    Exercised

    ​

    (1,840,485)

    Warrants outstanding at March 31, 2025

    ​

    23,914,775

    23

    Table of Contents

    ​

    The following tables summarizes the Company’s outstanding warrants as of March 31, 2025:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    # of warrants outstanding

    ​

    Issue date exercise price

    ​

    Current exercise price (1)

    ​

    Expiration date

    July 2022 RDO warrants

    ​

    32

    ​

    $

    66,420.000

    ​

    $

    66,420.00

    ​

    July 25, 2027

    Senior Secured Credit Facility - JGB

    ​

    154

    ​

    $

    41,310.000

    ​

    $

    27,708.000

    ​

    September 3, 2028

    July 19, 2023 RDO warrants (3)

    ​

    209

    ​

    $

    5,227.200

    ​

    $

    4.3021

    ​

    July 20, 2028

    October 2023 CMPO warrants (3)

    ​

    93

    ​

    $

    1,134.000

    ​

    $

    4.3021

    ​

    October 19, 2028

    2023 Inducement warrants (3)

    ​

    19

    ​

    $

    464.400

    ​

    $

    4.3021

    ​

    February 15, 2029

    April 2024 RDO Placement Agent warrants (3)

    ​

    7,611

    ​

    $

    361.1250

    ​

    $

    4.3021

    ​

    April 8, 2029

    September 2024 Reg A+ warrants (3)

    ​

    2,012,723

    ​

    $

    135.000

    ​

    $

    4.3021

    ​

    December 6, 2029

    September 2024 RDO warrants (3)

    ​

    2,341,905

    ​

    $

    135.000

    ​

    $

    4.3021

    ​

    December 6, 2029

    September 2024 RDO Placement Agent warrants (3)

    ​

    87,216

    ​

    $

    168.750

    ​

    $

    4.3021

    ​

    December 6, 2029

    September 2024 Inducement warrants (3)

    ​

    2,220,465

    ​

    $

    135.000

    ​

    $

    4.3021

    ​

    December 6, 2029

    September 2024 Inducement Placement Agent warrants (3)

    ​

    85,960

    ​

    $

    168.750

    ​

    $

    4.3021

    ​

    December 6, 2029

    Omnia Pre-Funded Warrants

    ​

    8,519

    ​

    $

    0.00001

    ​

    $

    0.00001

    ​

    Not applicable

    Omnia warrants

    ​

    3,408

    ​

    $

    361.125

    ​

    $

    361.1250

    ​

    May 1, 2029

    October 2024 RDO (3)

    ​

    6,359,501

    ​

    $

    135.000

    ​

    $

    4.3021

    ​

    December 6, 2029

    October 2024 RDO Placement Agent Warrants (3)

    ​

    241,445

    ​

    $

    168.750

    ​

    $

    4.3021

    ​

    December 6, 2029

    October 2024 PIPE Warrants (3)

    ​

    9,886,420

    (4)

    $

    135.000

    ​

    $

    4.3021

    (4)

    (2)

    October 2024 PIPE Placement Agent Warrants (3)

    ​

    659,095

    (4)

    $

    168.750

    ​

    $

    4.3021

    (4)

    (2)

    ​

    ​

    23,914,775

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    (1) Warrant price adjusted as a result of anti-dilution or ratchet provisions.

    (2) Expiration date is 5-years following shareholder approval date.

    (3) The exercise prices of the warrants are subject to appropriate adjustment as a result of anti-dilution or ratchet protection provisions relating to subsequent equity sales of shares of the Company’s common stock or common stock equivalents at an effective price per share lower than the then effective exercise price of such warrants. Additionally, the warrant contains cashless and/or alternative cashless exercise features.
    ​

    (4) Reflects the number of warrants and exercise price assuming stockholder approval is obtained.

    ​

    ​

    See Note 14 “Subsequent Events” for additional information regarding outstanding warrants. 

    ​

    ​

    ​

    ​

    ​

    24

    Table of Contents

    ​

    NOTE 11. – LOSS PER COMMON SHARE

    The following table sets forth the computation of basic and diluted loss per common share for the three months ended March 31, 2025 and 2024, respectively. Outstanding warrants, options and RSUs were excluded from the calculation of diluted EPS as the effect was antidilutive to consolidated net loss. 8,519 pre-funded warrants are included in weighted average common shares outstanding – basic and diluted for purposes of calculating loss per common share for the three month period ended March 31, 2025.

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    March 31, 

    ​

        

    2025

        

    2024

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Net loss from continuing operations

    ​

    $

    (3,274)

    ​

    $

    (5,450)

    Net loss from discontinued operations

    ​

    ​

    (1,054)

    ​

    ​

    (289)

    Net loss

    ​

    ​

    (4,328)

    ​

    ​

    (5,739)

    Deemed dividends

    ​

    ​

    —

    ​

    ​

    (3,589)

    Net loss available to common shareholders

    ​

    $

    (4,328)

    ​

    $

    (9,328)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Basic and diluted loss per common share from continuing operations

    ​

    $

    (1.89)

    ​

    $

    (230.82)

    Basic and diluted loss per common share from discontinued operations

    ​

    ​

    (0.61)

    ​

    ​

    (12.25)

    Basic and diluted loss per common share from deemed dividends

    ​

    ​

    —

    ​

    ​

    (152.00)

    Basic and diluted loss per common share

    ​

    $

    (2.50)

    ​

    $

    (395.07)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Anti-dilutive shares are as follows as of March 31:

    ​

    ​

    ​

    ​

    ​

    ​

    Warrants (excluding pre-funded)

    ​

    ​

    23,906,256

    ​

    ​

    28,192

    Options

    ​

    ​

    478,777

    ​

    ​

    78

    Restricted stock units

    ​

    ​

    159,583

    ​

    ​

    33

    ​

    ​

    ​

    24,544,616

    ​

    ​

    28,303

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    NOTE 12. - COMMITMENTS AND CONTINGENCIES

    License agreements and sponsored research – The Company has entered into various consulting and license growing agreements (the “Agreements”) with various counter parties in connection with the Company’s business relating to tobacco. The schedule below summarizes the Company’s commitments, both financial and other, associated with each Agreement. Costs incurred under the Agreements are generally recorded as research and development expenses on the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss.

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Future Commitments

    ​

    Commitment

     

    Counter Party

     

    Commitment Type

     

    2025

     

    2026

     

    2027

     

    2028

    ​

    2029 & After

    ​

    Total

        

    License Agreement

    ​

    NCSU

    ​

    Minimum annual royalty

    ​

    $

    50

    ​

    $

    50

    ​

    $

    100

    ​

    $

    150

    ​

    $

    3,425

    ​

    $

    3,775

    (1)

    License Agreement

    ​

    NCSU

    ​

    Contract fee

    ​

    ​

    500

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    500

    (2)

    Consulting Agreements

    ​

    Various

    ​

    Contract fee

    ​

    ​

    919

    ​

    ​

    146

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    —

    ​

    ​

    1,065

    (3)

    ​

    ​

    ​

    ​

    ​

    ​

    $

    1,469

    ​

    $

    196

    ​

    $

    100

    ​

    $

    150

    ​

    $

    3,425

    ​

    $

    5,340

    ​

    ​

    ​

    ​

    (1)The minimum annual royalty fee is credited against running royalties on sales of licensed products. The Company is also responsible for reimbursing NCSU for actual third-party patent costs incurred, including capitalized patent costs and patent maintenance costs. These costs vary from year to year and the Company has certain rights to direct the activities that result in these costs.

    25

    Table of Contents

    (2)On November 1, 2023, the Company entered into a license agreement with NCSU for an exclusive sublicensable right and license under specific patent rights and plant variety rights for the field of use in specific licensed territories. Additional milestone fees could be required pending achievement of events pursuant to the agreement.
    (3)As a requirement for a modified risk tobacco product and condition of the marketing authorization by the FDA, the Company engaged various consulting firms to conduct post-market studies and research.

    Litigation - The Company is subject to litigation arising from time to time in the ordinary course of its business. The Company does not expect that the ultimate resolution of any pending legal actions will have a material effect on its consolidated results of operations, financial position, or cash flows. However, litigation is subject to inherent uncertainties. As such, there can be no assurance that any pending legal action, which the Company currently believes to be immaterial, will not become material in the future. In accordance with applicable accounting guidance, the Company establishes an accrued liability for litigation and regulatory matters when those matters present loss contingencies that are both probable and estimable. In such cases, there may be an exposure to loss in excess of any amounts accrued. When a loss contingency is not both probable and estimable, the Company does not establish an accrued liability. As a litigation or regulatory matter develops, the Company, in conjunction with any outside counsel handling the matter, evaluates on an ongoing basis whether such matter presents a loss contingency that is probable and estimable. If, at the time of evaluation, the loss contingency related to a litigation or regulatory matter is not both probable and estimable, the matter will continue to be monitored for further developments that would make such loss contingency both probable and estimable. When a loss contingency related to a litigation or regulatory matter is deemed to be both probable and estimable, the Company will establish an accrued liability with respect to such loss contingency and record a corresponding amount of related expenses. The Company will then continue to monitor the matter for further developments that could affect the amount of any such accrued liability. 

    ​

    Shareholder Derivative Cases

    On February 6, 2019, Melvyn Klein, a resident of Nassau County New York, filed a shareholder derivative claim against the Company, the Company’s then Chief Executive Officer, Henry Sicignano III, the Company’s Chief Financial Officer, John T. Brodfuehrer, and each member of the Company’s Board of Directors in the United States District Court for the Eastern District of New York entitled: Melvyn Klein, derivatively on behalf of 22nd Century Group v. Henry Sicignano, III, Richard M. Sanders, Joseph Alexander Dunn, Nora B. Sullivan, James W. Cornell, John T. Brodfuehrer and 22nd Century Group, Inc., Case No. 1:19 cv 00748. Mr. Klein brings this action derivatively alleging that (i) the director defendants supposedly breached their fiduciary duties for allegedly allowing the Company to make false statements; (ii) the director defendants supposedly wasted corporate assets to defend this lawsuit and the other related lawsuits; (iii) the defendants allegedly violated Section 10(b) of the Securities Exchange Act and Rule 10b 5 promulgated thereunder for allegedly approving or allowing false statements regarding the Company to be made; and (iv) the director defendants allegedly violated Section 14(a) of the Securities Exchange Act and Rule 14a 9 promulgated thereunder for allegedly approving or allowing false statements regarding the Company to be made in the Company’s proxy statement. Numerous other shareholder derivative cases were subsequently filed and consolidated into the main action.

    On December 5, 2023, the parties entered into a Memorandum of Settlement to fully resolve all claims. The Court preliminarily approved the settlement on April 7, 2025. pending the Court’s approval of a motion for preliminary approval of settlement, which was filed with the Court on March 6, 2025. The Company agreed to certain corporate governance reforms as part of the settlement. The settlement also includes amount is $768 related to plaintiffs attorney and legal fees and is fully covered by the Company’s insurance. Accordingly, the Company has recorded an accrual for litigation settlement and corresponding indemnification receivable on the Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024.

    ​

    Insurance Litigation 

    ​

    In November 2022, there was a fire at the Company’s Grass Valley manufacturing facility in Oregon, which resulted in a total loss of the facility. The Company submitted an insurance claim with Dorchester Insurance Company, Ltd. (“Dorchester”) for casualty loss and business interruption coverage which was acknowledged on November 23, 2022. Dorchester funded $5,000 of casualty loss insurance but has failed to issue any payments in connection with the Company’s business interruption claim.

    ​

    26

    Table of Contents

          On July 19, 2023, the Company filed a Complaint against Dorchester in the United States District Court for the District of Oregon, Pendleton Division, Case No. 2:23-cv-01057-HL. The Company is alleging breach of contract, breach of duty of good faith and fair dealing and negligence per se. The Company is seeking full recovery of its business interruption claim under the policy plus direct, indirect and consequential damages resulting from Dorchester’s continued delay in issuing coverage payments. Fact discovery is complete. Expert discovery is complete. The trial date is November 4, 2025.

    ​

    KeyGene Dispute

    On April 11, 2024 the Company received a Request for Arbitration from Keygene N.V. (“Keygene”) in connection with the Company’s termination of various framework collaborative research agreements. The parties resolved the matter and executed settlement documents in April 2025. The arbitration hearing date set for March 24, 2025 was taken off calendar as a result of the settlement.

    Cookies Retail Products Dispute

    ​

    On October 23, 2024, Cookies Retail Products, LLC (“CRP”) filed a complaint against the Company, a subsidiary of the Company (“PTB”), Cookies Creative Consulting & Promotions, Inc. (“CCC”), Cookies SF, LLC (“CSF”), GMLC WLNS, LLC (“GMLC”) and other defendants, Case No. 24STCV27828, Superior Court of California, County of Los Angeles.

    The complaint alleges three counts against all defendants: Count I for Breach of Contract related to a Settlement Agreement entered into between CRP, Paul Rock, CSF, GMLC, CCC and PTB (the “Settlement Agreement”), and a Purchase Agreement entered into between PTB and CRP (the “Purchase Agreement”); Count II for Fraud – False Promise related to the Settlement Agreement and Purchase Agreement; and Count III for Violation of Penal Code Section 496 related to the Purchase Agreement and a Licensing and Distribution Agreement between GMLC, CCC and PTB. CRP is seeking monetary damages.

    The Company filed a demurrer to the complaint on February 24, 2025. CRP then filed a first amended complaint on March 12, 2025. Discovery is ongoing. The Company filed a Special Motion to Strike the first amended complaint on March 27, 2025. At the April 28, 2025 hearing, the Court granted the Company’s Special Motion to Strike as to Count II and Count III in CRP’s first amended complaint, leaving only Count I. CRP will not have an opportunity to amend its complaint to replead Count II or Count III. CRP also filed an application for right to attach order and writ of attachment against PTB, and the hearing date for the application is scheduled for May 14, 2025.

    Employee Dispute

    On November 19, 2024, a former employee of the Company filed a complaint against the Company, two subsidiaries of the Company, and numerous other former subsidiaries of the Company that were part of the hemp/cannabis division that was divested in December 2023. The complaint was filed in the Circuit Court of the State of Oregon, County of Multnomah, Case No. 24CV55110.

    The complaint alleges three counts against all defendants: Count I for Premises Liability; Count II for Personal Injury – Employer Liability Law, and Count III for Negligence/Negligence Per Se, all related to the November 2022 fire at the Company’s Grass Valley manufacturing facility in Oregon. The former employee is seeking monetary damages.

    The Company has been served but has not yet filed its responsive pleading to the complaint. The Company believes it has substantial defenses to the claims and intends to defend itself vigorously.

    ​

    27

    Table of Contents

    ​

    NOTE 13. SEGMENT AND GEOGRAPHIC INFORMATION

    The Company has organized its business as a single reportable segment (“Reporting Segment”), tobacco, as it operates and derives all revenues from its tobacco operations and products. This segment structure reflects the financial information and reports used by the Company’s management, specifically its Chief Operating Decision Maker (“CODM”), to make decisions regarding the Company’s business, including resource allocations and performance assessments. The Company’s Chief Executive Officer serves as the CODM. The accounting policies of the Reporting Segment are the same as those described in the summary of significant accounting policies. See Note 1 for additional information about the Company's business and significant accounting policies.

    Consolidated net income (loss) from continuing operations, as presented on the Company's Consolidated Statements of Operations and Comprehensive Loss is a metric utilized by the CODM to assess the Reporting Segment's performance and allocate resources. Total consolidated assets, excluding assets held for sale, as presented on the Company's Consolidated Balance Sheets is used to measure the Reporting Segment's assets.

    The CODM uses Consolidated net income (loss) from continuing operations to evaluate profitability generated from segment assets in determining the strategic decisions of the Company with respect to utilizing its assets. Consolidated net income (loss) from continuing operations is also used to monitor budget versus actual results.

    The following table presents revenues and significant segment expenses from continuing operations for the three months ended March 31, 2025 and 2024:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    March 31, 

    ​

    2025

        

    2024

    Consolidated net revenue

    $

    5,956

    ​

    $

    6,469

    Less:

     

    ​

    ​

     

    ​

    Cost of goods sold

    ​

    2,761

    ​

    ​

    4,069

    Excise taxes

    ​

    3,681

    ​

    ​

    3,385

    Selling, general and administration

    ​

    1,799

    ​

    ​

    2,885

    Research and development

    ​

    61

    ​

    ​

    324

    Depreciation and amortization (1)

    ​

    224

    ​

    ​

    267

    Other segment items (2)

    ​

    146

    ​

    ​

    (27)

    Interest expense

    ​

    558

    ​

    ​

    1,016

    ​

    ​

    ​

    ​

    ​

    ​

    Segment net loss from continuing operations

    $

    (3,274)

    ​

    $

    (5,450)

    ​

    ​

    ​

    ​

    ​

    ​

    (1) For the three months ended March 31, 2025, depreciation and amortization was recognized as cost of goods sold of $123 and research and development of $101. For the three months ended March 31, 2024, depreciation and amortization was recognized as cost of goods sold of $145, sales, general and administrative of $21 and research and development of $101.

    (2) Other segment items include: other operating expenses, other (income) expense, interest income, and provision for income taxes.

    ​

    ​

    Geographic Area Information

    ​

    For the three months ended March 31, 2025 and 2024, substantially all third-party sales of product are shipped to customers in the United States. Additionally, as of March 31, 2025 and December 31, 2024, all long-lived assets are physically located or domiciled in the United States.

    ​

    28

    Table of Contents

    ​

    ​

    NOTE 14. SUBSEQUENT EVENTS

    ​

    April 2025 - Warrant Inducement & Amendment

     

    On April 29, 2025, the Company commenced a warrant inducement offering (the “Warrant Inducement”) with the holders of certain outstanding warrants to purchase up to an aggregate of 11,072,093 shares of common stock (collectively, the “Existing Warrants”), which Existing Warrants are exercisable at an exercise price of $4.3021. The Company offered the holders of the Existing Warrants an inducement period whereby the Company agreed to issue new warrants (the “Inducement Warrants”) to purchase up to a number of shares of common stock equal to 100% of the number of shares of common stock issued pursuant to the exercise by the holders of the Existing Warrants, for cash, at a reduced exercise price equal to $0.7893. Each holder agreed to exercise 60% of their Existing Warrants immediately (the “Initial Exercise”) and will exercise the remaining 40% within 30 calendar days following the Effectiveness Date (as defined below), provided that the Company’s stock price at such time equals or exceeds 90% of the Nasdaq Minimum Price on that date (the “Additional Exercise”). The Warrant Inducement closed on April 30, 2025.

     

    The Inducement Warrants will be issued on substantially the same terms as the Existing Warrants, except that the Inducement Warrants will be exercisable at any time on or after the Company’s stockholders approve the issuance of the Inducement Warrants and the shares of common stock upon the exercise thereof (the “Stockholder Approval Date”), have an expiration date of five years from the Stockholder Approval Date and have an exercise price equal to $4.3021. The exercise prices of the Inducement Warrants will be subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. In addition, the Inducement Warrants will contain anti-dilution protection provisions relating to a subsequent reverse stock splits and subsequent equity sales of shares of the Company’s common stock or common stock equivalents at an effective price per share lower than the then effective exercise price of such Inducement Warrants. The Company also agreed to hold a meeting of stockholders to approve the issuance of the shares of common stock underlying the Inducement Warrants pursuant to applicable Nasdaq rules.

     

    The Company received aggregate gross proceeds of approximately $5,438 from the initial exercise of 60% of the Existing Warrants and will receive $8,739 if all of the Existing Warrants are exercised.  Of the aggregate net proceeds, the Company was obligated under the Debentures of the convertible senior secured credit facility to repay outstanding debt in the amount of $1,017.

      

    Additionally, on April 29, 2025, the Company entered into amendments with the holders of the outstanding warrants issued on October 24, 2024, which adjusted the provisions of the warrants regarding recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock.

    ​

    Sale of Needle Rock Farms -

    ​

    On May 1, 2025, the Company entered into that certain Letter Agreement Amendment with the convertible senior secured credit facility holders, releasing and discharging from the Deed of Trust the real property of Needle Rock Farms. In consideration for the amendment, the Company paid an amendment fee equal to $250. On May 6, 2025, the Company subsequently closed the sale of the Needle Rock Farms land property and received cash proceeds of $770.

    ​

    ​

     

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    29

    Table of Contents

    Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

    For purposes of this Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”), references to the “Company,” “we,” “us” or “our” refer to the operations of 22nd Century Group, Inc. and its direct and indirect subsidiaries for the periods described herein. In addition, dollars are in thousands, except per share data or unless otherwise specified.

    The following MD&A should be read in conjunction with, our audited consolidated financial statements, the accompanying notes and the MD&A included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as our Condensed Consolidated Financial Statements and the accompanying notes included in Item 1 of this Form 10-Q. Note references are to the notes to consolidated financial statements included in Item 1 of this Form 10-Q.

    On December 17, 2024, we implemented a 1-for-135 reverse stock split and on March 28, 2024, we implemented a 1-for-16 reverse stock split. All historical share and per-share amounts reflected throughout this section have been adjusted to reflect the reverse stock splits. The par value per share of our common stock was not affected.

    ​

    Forward Looking Statements

    Except for historical information, all of the statements, expectations, and assumptions contained in this section are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Forward looking statements include, but are not limited to, statements regarding (i) our ability to continue as a going concern, (ii) our expectations regarding our debt obligations, (iii) our ability to remain listed on NASDAQ (iv) our financial and operating performance, (v) our strategic alternatives, including our cost savings initiatives, (vi) our expectations regarding regulatory enforcement (vii) our products, and (viii) the volatility of our common stock and warrants. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in our Annual Report on Form 10-K filed on March 20, 2025. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as otherwise required by law. All information provided in this quarterly report is as of the date hereof, and we assume no obligation to and do not intend to update these forward-looking statements, except as required by law.

    Our Business

    22nd Century Group, Inc. (NASDAQ: XXII) is an agricultural biotechnology company focused on tobacco harm reduction by offering tobacco products with 95% less nicotine, designed to improve health and wellness by giving smokers a choice to control their nicotine consumption.  Backed by comprehensive and extensively patented technologies that regulate nicotine biosynthesis activities in the tobacco plant, the Company has pioneered development of high-yield, proprietary reduced nicotine content (RNC) tobacco plants and clinically validated RNC cigarette products. The Company received the first and only FDA Modified Risk Tobacco Product (MRTP) authorization for a combustible cigarette in December 2021. The Company is a subsequent participating manufacturer under the Master Settlement Agreement ("MSA") and vertically integrated for the production of its both own products and contract manufacturing operations ("CMO"), which consist primarily of branded filtered cigars and conventional cigarettes.

    ​

    Financial Overview

    ●Net revenues for the first quarter of 2025 were $5,956, a decrease of 7.9% from $6,469 in the prior year period.
    oFirst quarter 2025 cartons sold of 476 compared to 628 in the comparable prior year period.
    ●Gross profit for the first quarter of 2025 was a loss of $609 compared to a loss of $1,129 in the prior year period.
    ●Total operating expenses for the first quarter of 2025 decreased to $1,961 compared to $3,305 in the prior year quarter driven by:

    30

    Table of Contents

    oSales, general and administrative expenses decreased to $1,799 compared to $2,906 in the prior year period, primarily driven by lower headcount (compensation and benefits), strategic consulting expenses, legal expenses and other expenses mainly due to a decrease in insurance premiums.
    oResearch development expenses decreased to $162, compared to $425 in the prior year period, driven by lower headcount (compensation and benefits costs), and other costs mainly due to a decrease in tobacco growing agreements in the current year period.
    ●Operating loss from continuing operations for the first quarter 2025 was $2,570, compared to a loss of $4,434 in the prior year period, primarily as a result of lower expenses.
    ●Net loss from continuing operations in the first quarter of 2025 was $3,274 and basic and diluted loss from continuing operations per common share was $1.89 compared with net loss from continuing operations in the first quarter of 2024 of $5,450, and basic and diluted net loss from continuing operations per common share of $230.82.
    ●As of March 31, 2025, we had $1,133 in cash and cash equivalents.

    ​

    Our Financial Results

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31 

    ​

    ​

    March 31 

    ​

    ​

    Change

    ​

        

    2025

        

    ​

    2024

    ​

    ​

    $

    ​

    %

    Revenues, net

    ​

    $

    5,956

    ​

    ​

    $

    6,469

    ​

    ​

    (513)

    ​

    (7.9)

    Cost of goods sold

    ​

    ​

    2,884

    ​

    ​

    ​

    4,213

    ​

    ​

    (1,329)

    ​

    (31.5)

    Excise taxes and fees on products

    ​

    ​

    3,681

    ​

    ​

    ​

    3,385

    ​

    ​

    296

    ​

    8.7

    Gross (loss) profit

    ​

    ​

    (609)

    ​

    ​

    ​

    (1,129)

    ​

    ​

    520

    ​

    (46.1)

    Gross (loss) profit as a % of revenues, net

    ​

    ​

    (10.2)

    %

    ​

    ​

    (17.5)

    %

    ​

    ​

    ​

    ​

    Operating expenses:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Sales, general and administrative ("SG&A")

    ​

    ​

    1,799

    ​

    ​

    ​

    2,906

    ​

    ​

    (1,107)

    ​

    (38.1)

    SG&A as a % of revenues, net

    ​

    ​

    30.2

    %

    ​

    ​

    44.9

    %

    ​

    ​

    ​

    ​

    Research and development ("R&D")

    ​

    ​

    162

    ​

    ​

    ​

    425

    ​

    ​

    (263)

    ​

    (61.9)

    R&D as a % of revenues, net

    ​

    ​

    2.7

    %

    ​

    ​

    6.6

    %

    ​

    ​

    ​

    ​

    Other operating expense, net ("OOE")

    ​

    ​

    -

    ​

    ​

    ​

    (26)

    ​

    ​

    26

    ​

    NM

    Total operating expenses

    ​

    ​

    1,961

    ​

    ​

    ​

    3,305

    ​

    ​

    (1,344)

    ​

    (40.7)

    Operating loss from continuing operations

    ​

    ​

    (2,570)

    ​

    ​

    ​

    (4,434)

    ​

    ​

    1,864

    ​

    (42.0)

    Operating loss as a % of revenues, net

    ​

    ​

    (43.1)

    %

    ​

    ​

    (68.5)

    %

    ​

    ​

    ​

    ​

    Other income (expense):

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Other income (expense), net

    ​

    ​

    (162)

    ​

    ​

    ​

    -

    ​

    ​

    (162)

    ​

    NM

    Interest income, net

    ​

    ​

    16

    ​

    ​

    ​

    -

    ​

    ​

    16

    ​

    NM

    Interest expense

    ​

    ​

    (558)

    ​

    ​

    ​

    (1,016)

    ​

    ​

    458

    ​

    (45.1)

    Total other income (expense), net

    ​

    ​

    (704)

    ​

    ​

    ​

    (1,016)

    ​

    ​

    312

    ​

    (30.7)

    Loss from continuing operations before income taxes

    ​

    ​

    (3,274)

    ​

    ​

    ​

    (5,450)

    ​

    ​

    2,176

    ​

    (39.9)

    Provision for income taxes

    ​

    ​

    -

    ​

    ​

    ​

    -

    ​

    ​

    -

    ​

    NM

    Net loss from continuing operations

    ​

    ​

    (3,274)

    ​

    ​

    ​

    (5,450)

    ​

    ​

    2,176

    ​

    (39.9)

    Net loss as a % of revenues, net

    ​

    ​

    (55.0)

    %

    ​

    ​

    (84.2)

    %

    ​

    ​

    ​

    ​

    Net loss per common share from continuing operations (basic and diluted)

    ​

    $

    (1.89)

    ​

    ​

    $

    (230.82)

    ​

    ​

    228.94

    ​

    (99.2)

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    NM - calculated change not meaningful

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    * Giving retroactive effect to the 1-for-16 reverse stock split on April 2, 2024 and 1-for-135 reverse stock split on December 17, 2024.

    31

    Table of Contents

    ​

    Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024

    Product line revenue, net

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    March 31, 

    ​

    ​

    ​

    ​

    ​

    2025

    ​

    2024

    ​

    Change

    ​

    ​

    $

    Cartons

    ​

    $

    Cartons

    ​

    $

    Cartons

    Contract Manufacturing

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Cigarettes

    ​

    5,013

    319

    ​

    2,760

    91

    ​

    2,253

    228

    Filtered Cigars

    ​

    1,103

    159

    ​

    3,626

    536

    ​

    (2,523)

    (377)

    Cigarillos

    ​

    (5)

    -

    ​

    -

    -

    ​

    (5)

    -

    Total Contract Manufacturing

    ​

    6,111

    478

    ​

    6,386

    627

    ​

    (275)

    (149)

    VLN®

    ​

    (155)

    (2)

    ​

    83

    1

    ​

    (238)

    (3)

    Total Product Line Revenues

    ​

    5,956

    476

    ​

    6,469

    628

    ​

    (513)

    (152)

    ​

    For the first quarter 2025, total product line revenue, net decreased to $5,956, compared to $6,469 in the prior year period and includes the following product line revenue, net highlights:

    ​

    ●Cigarette sales volume benefitted from new customer contracts with our largest CMO customer effective January 1, 2025, including the initial impact of accounting for revenue accruals recorded as over-time revenue recognition.

    ​

    ●Filtered cigars net revenues decreased to $1,103 from $3,626 in the prior comparable period, reflecting lower volumes as the Company implemented its plans to reprice customer contracts. New contracts were executed in the first quarter of 2025 and additional volume is expected to resume in the remainder of 2025.

    ​

    ●Cigarillo distribution net revenues for the first quarter were negligible, and reflect the time necessary for initial stocking orders in 2024 to be sold through our distributors before additional reorders are fulfilled in the second half of 2025.

    ​

    ●VLN® cigarette net revenues reflect return accruals for product previously shipped, as initial shipments begin to schedule for the rebranded product to be launched in the second quarter of 2025.

    ​

    ​

    32

    Table of Contents

    ​

    Gross (loss) profit

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    March 31 

    ​

    March 31 

    ​

        

    2025

    ​

    2024

    Gross (loss) profit

    ​

    $

    (609)

    ​

    ​

    $

    (1,129)

    ​

    Percent of Revenues, net

    ​

    ​

    (10.2)

    %

    ​

    ​

    (17.5)

    %

    ​

    ​

    Gross (loss) profit for the first quarter 2025 improved as compared to the prior year comparable period, primarily driven by stabilized volume under new customer contracts and the overall shift in product mix.

    ​

    Sales, general and administrative (“SG&A”) expense

    ​

    ​

    ​

    ​

    ​

        

    Changes From Prior Year

    ​

    ​

    Three Months Ended

    Compensation and benefits (a)

    ​

    $

    (406)

    Strategic consulting (b)

    ​

    ​

    (197)

    Legal (c)

    ​

    ​

    (301)

    Other expenses (d)

    ​

    ​

    (203)

    Net decrease in SG&A expenses

    ​

    $

    (1,107)

    ​

    (a) Compensation and benefits and equity compensation expense decreased for the three months ended March 31, 2025 compared to the prior year period due to a reduction of headcount.

    (b) Decreases of strategic consulting for the three months ended March 31, 2025 compared to the prior year periods were due to reduced spending related to investor relations expenses.

    (c) Legal expenses decreased for the three months ended March 31, 2025 compared to 2024 mainly due to an increase in regulatory legal in the prior year period.

    (d) Decreases in other expenses for the three month period ended March 31, 2025 compared to 2024 was driven by lower D&O and other insurance premiums offset by an increase in public company expenses in the current year due to waived board fees in the first quarter of 2024.

    33

    Table of Contents

    Research and development (“R&D”) expense

    ​

    ​

    ​

    ​

    Changes From Prior Year

    ​

    Three Months Ended

    Compensation and benefits (a)

    $

    (84)

    Contract, IP and other expenses (b)

    ​

    (179)

    Net decrease in R&D expenses

    $

    (263)

    ​

    (a)Decreased compensation and benefits for the three months ended March 31, 2025 are mainly related to the decrease in headcount in the current year periods compared to the prior year periods.
    (b)Decreases in Contract, IP and other expenses for the three month periods ended March 31, 2025 compared to the prior year period relate to decreases from tobacco growing agreements that were not entered into for the current year period.

    Other income (expense)

    ​

    ​

    ​

    ​

    ​

    ​

    Changes From Prior Year

    ​

        

    Three Months Ended

    Other income (expense), net (a)

    ​

    $

    (162)

    Interest income, net

    ​

    ​

    16

    Interest expense (b)

    ​

    ​

    458

    Net decrease in other expense

    ​

    $

    312

    ​

    ​

    (a)Other income (expense), net increased for the three months ended March 31, 2025, compared to the same prior year period, due to a loss resulting from change in fair value of warrant liabilities that did not occur in the prior year period.

    ​

    (b)For the three months ended March 31, 2025 compared to the prior year period, interest expense primarily decreased as a result of ongoing repayment and elimination of debt obligations on our balance sheet. Cash interest decreased $101 and non-cash interest amortization increased $601 recognized from the Senior Secured Credit Facility (of these totals, interest that was allocated to discontinued operations increased by $137), additional decreases of $82 as a result of change in fair value of conversion option derivative liability and other interest charges of $10. Additionally, interest expense decreased $729 from the Subordinated Note, which was extinguished prior to maturity in April 2024.

    ​

    ​

    Liquidity and Capital Resources

    We have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until such time that we can generate significant revenue and profit in our tobacco business. We had negative cash flow from operations of $2,976 for the three months ended March 31, 2025 and an accumulated deficit of $398,199 as of March 31, 2025. As of March 31, 2025, we had cash and cash equivalents of $1,133 and working capital deficit from continuing operations of ($5,201) (compared to working capital from continuing operations of $1,790 at December 31, 2024). Given our projected operating requirements and existing cash and cash equivalents, there is substantial doubt about our ability to continue as a going concern through one year following the date that the Condensed Consolidated Financial Statements herein are issued.

    In response to these conditions, management is currently evaluating different strategies for reducing expenses, as well as pursuing financing strategies which include raising additional funds through the issuance of securities, asset sales, and through arrangements with strategic partners. If capital is not available to the Company when, and in the amounts needed, it could be required to liquidate inventory or assets, cease or curtail operations, seek to negotiate new business deals with our business partners or seek protection under applicable bankruptcy laws or similar state proceedings. There can be no assurance that the Company will be able to raise the capital it needs to continue operations. Accordingly, there is substantial doubt regarding our ability to continue in operations. Management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern through one year following the date that the Condensed Consolidated Financial Statements are issued.

    34

    Table of Contents

    Our cash, and cash equivalents and working capital from continuing operations as of March 31, 2025 and December 31, 2024 are set forth below:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    March 31 

    ​

    December 31

    ​

        

    2025

        

    2024

    Cash and cash equivalents

    ​

    $

    1,133

    ​

    $

    4,422

    Working capital

    ​

    $

    (5,201)

     

    $

    1,790

    ​

    Subsequent to March 31, 2025, we received net proceeds of $5,112 from the inducement and exercise of 6,889,497 existing warrants for shares of common stock and issuance of 6,889,497 warrants to purchase common stock. Of the aggregate net proceeds, we were obligated under the Debentures of the convertible senior secured credit facility to repay outstanding debt in the amount of $1,017. See Note 14 “Subsequent Events.”

    ​

    Working Capital

    As of March 31, 2025, we had working capital deficit from continuing operations, excluding assets and liabilities held for sale, of approximately ($5,201) compared to working capital of approximately $1,790 at December 31, 2024 a decrease of $6,991. This decrease in working capital was primarily due to an increase in net current liabilities of $6,857 reflecting the reclassification of the convertible senior secured credit facility and the 2024 Omnia warrant liability to current, as the maturity date is within twelve months of the balance sheet date, offset by an increase of $134 in net current assets. Cash and cash equivalents decreased by $3,289 and the remaining net current assets increased by $3,655. As a result of the working capital balance, management has taken a number of steps to improve liquidity. Refer below to “Cash demands on operations.”

    Summary of Cash Flows

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Three Months Ended

    ​

    ​

    ​

    ​

    March 31, 

    ​

    Change

    ​

        

    2025

        

    2024

    ​

    $

    Cash provided by (used in):

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Operating activities

    ​

    $

    (2,976)

    ​

    $

    (2,255)

    ​

    (721)

    Investing activities

    ​

     

    (59)

     

     

    15

    ​

    (74)

    Financing activities

    ​

     

    (254)

     

     

    1,699

    ​

    (1,953)

    Net change in cash and cash equivalents

    ​

    $

    (3,289)

     

    $

    (541)

    ​

    ​

    ​

    Net cash used in operating activities

    Cash used in operating activities increased $721 from $2,255 in 2024 to $2,976 in 2025. The primary driver for this change was lower net loss of $1,411, an increase of $41 related to net adjustments to reconcile net loss to cash, and an increase in cash used for working capital components related to operations in the amount of $2,173 for the three months ended March 31, 2025, as compared to the three months ended March 31, 2024.

    Net cash (used in) provided by investing activities

    Cash used in investing activities amounted to $59 the three months ended March 31, 2025, as compared to cash provided by investing activities of $15 for the three months ended March 31, 2024. The decrease in cash provided by investing activities of $74 was primarily the result of a decrease of $22 of proceeds from the sale of property, plant and equipment and an increase of cash outflows of $52 related to the acquisitions of patents, trademarks, licenses and property, plant and equipment.

    35

    Table of Contents

    Net cash (used in) provided by financing activities

    During the three months ended March 31, 2025, cash provided by financing activities decreased by $1,953 from $1,699 in the prior year period, to cash used of $254, resulting from decreases in net proceeds from warrant exercise of $2,245 offset by decreases in cash outflows of note payable payments of $291 and taxes paid related to net share settlement of RSUs of $1.

    Cash demands on operations

    We have financed our operations to date primarily through the issuance of equity securities, proceeds from the exercise of warrants to purchase common stock and sale of debt instruments with various institutions, accredited investors, high net worth individuals and creditors.

    ​

    In April 2025, we received net proceeds of $5,112 from the inducement and exercise of 6,889,497 existing warrants for shares of common stock and issuance of 6,889,497 warrants to purchase common stock. An additional tranche of 4,232,191 existing warrants for shares of common stock are exercisable under the same terms, under the conditions as described in the warrant inducement agreement, for additional net proceeds of up $3,103. In connection with the warrant inducement transaction, the Company amended the October 2024 PIPE warrants. See Note 14 “Subsequent Events”.

    ​

    As of March 31, 2025, the remaining principal balance under our Senior Secured Credit Facility is $4,558, of which an additional $1,017 was repaid in April 2025. The Debentures under the Senior Secured Credit Facility allow the Holders to voluntarily convert the Debentures, in whole or in part, into shares of the Company’s common stock and the conversion option price in effect is $6.04.  During the first quarter of 2025, the Holders converted $3,132 of principal balance in exchange for 518,600 shares of common stock.

    ​

    Additionally, at its option, JGB may require the Company to redeem 2% of the original principal amount of the Debentures, as amended to be no more than 50% or $210 per calendar month through July 2025 and $421 per calendar month thereafter which amount may at the Company’s election, subject to certain exceptions, be paid in cash, shares of the Company’s common stock, or a combination thereof. JGB did not elect the monthly redemption feature during the three month period ended March 31, 2025. If the redemption feature is elected, as of March 31, 2025, contractual maturities under the senior secured credit Facility for the remainder of 2025 are $2,948, and for 2026 are $1,610.

    ​

    ​

    ​

     

    36

    Table of Contents

    Outstanding Warrants

    ​

    As of May 7, 2025, we had the following warrants outstanding:

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    # of warrants outstanding

    ​

    Issue date exercise price

    ​

    Current exercise price (1)

    ​

    Expiration date

    July 2022 RDO warrants

    ​

    32

    ​

    $

    66,420.00

    ​

    $

    66,420.00

    ​

    July 25, 2027

    Senior Secured Credit Facility - JGB

    ​

    154

    ​

    $

    41,310.00

    ​

    $

    27,708.00

    ​

    September 3, 2028

    July 19, 2023 RDO warrants (3)

    ​

    209

    ​

    $

    5,227.20

    ​

    $

    0.7893

    ​

    July 20, 2028

    October 2023 CMPO warrants (3)

    ​

    93

    ​

    $

    1,134.00

    ​

    $

    0.7893

    ​

    October 19, 2028

    2023 Inducement warrants (3)

    ​

    19

    ​

    $

    464.40

    ​

    $

    0.7893

    ​

    February 15, 2029

    April 2024 RDO Placement Agent warrants (3)

    ​

    7,611

    ​

    $

    361.125

    ​

    $

    0.7893

    ​

    April 8, 2029

    Omnia Pre-Funded Warrants

    ​

    8,519

    ​

    $

    0.00001

    ​

    $

    0.00001

    ​

    Not applicable

    Omnia warrants

    ​

    3,408

    ​

    $

    361.125

    ​

    $

    361.125

    ​

    May 1, 2029

    September 2024 Reg A+ warrants (3)

    ​

    685,089

    ​

    $

    135.00

    ​

    $

    0.7893

    ​

    December 6, 2029

    September 2024 RDO warrants (3)

    ​

    628,916

    ​

    $

    135.00

    ​

    $

    0.7893

    ​

    December 6, 2029

    September 2024 RDO Placement Agent warrants (3)

    ​

    34,886

    ​

    $

    168.75

    ​

    $

    0.7893

    ​

    December 6, 2029

    September 2024 Inducement warrants (3)

    ​

    845,958

    ​

    $

    135.00

    ​

    $

    0.7893

    ​

    December 6, 2029

    September 2024 Inducement Placement Agent warrants (3)

    ​

    34,384

    ​

    $

    168.75

    ​

    $

    0.7893

    ​

    December 6, 2029

    October 2024 RDO (3)

    ​

    1,887,382

    ​

    $

    135.00

    ​

    $

    0.7893

    ​

    December 6, 2029

    October 2024 RDO Placement Agent Warrants (3)

    ​

    96,578

    ​

    $

    168.75

    ​

    $

    0.7893

    ​

    December 6, 2029

    Amended October 2024 PIPE Warrants (3)

    ​

    55,884,163

    ​

    $

    135.00

    ​

    $

    0.7500

    (5)​

    (2)​

    Amended October 2024 PIPE Placement Agent Warrants (3)

    ​

    3,780,655

    ​

    $

    168.75

    ​

    $

    0.7500

    (5)​

    (2)​

    April 2025 Inducement Warrants (3) (4)

    ​

    6,889,495

    ​

    $

    4.3021

    ​

    $

    4.3021

    (5)​

    (2)​

    ​

    ​

    70,787,551

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    (1) Warrant price adjusted as a result of anti-dilution or ratchet provisions.

    (2) Expiration date is 5-years following shareholder approval date.

    (3) The warrants contain, subject to stockholder approval, anti-dilution protection provisions relating to subsequent equity sales of shares of the Company’s common stock or common stock equivalents at an effective price per share lower than the then effective exercise price of such warrants. Additionally, the warrant contains cashless and/or alternative cashless exercise features.

    ​

    (4) The exercise prices of the warrants are subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. In addition, subject to stockholder approval, the warrants will contain anti-dilution protection provisions relating to subsequent equity sales of shares of the Company’s common stock or common stock equivalents at an effective price per share lower than the then effective exercise price of such warrants.

    (5) Reflects the exercise price assuming stockholder approval is obtained

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    ​

    Critical Accounting Policies and Estimates

    ​

    The preparation of our Condensed Consolidated Financial Statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements and accompanying notes. Our estimates, assumptions and judgments are based on historical experience and various other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying amount of assets and liabilities that are not readily apparent from other sources. Making estimates, assumptions and judgments about future events is inherently unpredictable and is subject to significant uncertainties, some of which are beyond our control. Management believes the estimates, assumptions and judgments employed and resulting balances reported in the Condensed Consolidated Financial Statements are reasonable; however, actual results could differ materially.

    ​

    There have been no material changes to the information set forth in our Annual Report on Form 10-K for the year ended December 31, 2024.

    ​

    37

    Table of Contents

    Impact of Recently Issued Accounting Standards

    ​

    In the normal course of business, we evaluate all new accounting pronouncements issued by the FASB, SEC, or other authoritative accounting bodies to determine the potential impact they may have on our Condensed Consolidated Financial Statements. See Note 1 “Nature of Business and Summary of Significant Accounting Policies” of the Notes to Condensed Consolidated Financial Statements contained in Item 1 of this report for additional information about these recently issued accounting standards and their potential impact on our financial condition or results of operations.

    ​

    Off-Balance Sheet Arrangements

    ​

    We do not have any off-balance sheet arrangements as defined by Item 303(a)(4) of Regulation S-K.

    ​

    ​

    Item 3. Quantitative and Qualitative Disclosures about Market Risk

    There have been no material changes to the information set forth in our Annual Report on Form 10-K for the year ended December 31, 2024.

    Item 4. Controls and Procedures

    (a)

    Evaluation of Disclosure Controls and Procedures:

    The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in its Securities Exchange Act of 1934 (“Exchange Act”) reports are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including the Company’s chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

    Our chief executive officer and chief financial officer, after evaluating the effectiveness of the Company’s “disclosure controls and procedures” (as defined in the Exchange Act Rules 13a-15(e) or 15d-15(e)) as of the end of the period covered by this quarterly report, have concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Form 10-Q to ensure information required to be disclosed is recorded, processed, summarized and reported within the time period specified by SEC rules, based on their evaluation of these controls and procedures as required by paragraph (b) of Exchange Act Rules 13a-15 or 15d-15.

    (b)

    Changes in Internal Control over Financial Reporting:

    There were no changes in our internal control over financial reporting during the quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

    ​

    38

    Table of Contents

    ​

    Part II. OTHER INFORMATION

    Item 1. Legal Proceedings

    See Note 12 - Commitments and Contingencies – Litigation - to our Condensed Consolidated Financial Statements included in this Quarterly Report for information concerning our on-going litigation. In addition to the lawsuits described in Note 12, from time to time we may be involved in claims arising in the ordinary course of business. To our knowledge other than the cases described in Note 12 to our Condensed Consolidated Financial Statements, no material legal proceedings, governmental actions, investigations or claims are currently pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.

    ​

    Item 1A. Risk Factors

    There have been no material changes from the risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025.

    ​

    Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

    None

    ​

    ​

    Item 3. Default Upon Senior Securities.

    None

    ​

    Item 4. Mine Safety Disclosures

    None

    ​

    Item 5. Other Information

    During the three months ended March 31, 2025, there were no modifications, adoptions or terminations by any directors or officers to any contract, instruction or written plan for the purchase or sale of securities of the Company that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or non-Rule 10b5-1 trading agreements.

    ​

    ​

    39

    Table of Contents

    Item 6. Exhibits

    ​

    ​

    ​

    Exhibit 31.1

    Section 302 Certification - Chief Executive Officer

     

     

    Exhibit 31.2

    Section 302 Certification - Chief Financial Officer

     

     

    Exhibit 32.1

    Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002.

     

     

    101.INS

    Inline XBRL Instance Document

     

     

    101.SCH

    Inline XBRL Taxonomy Extension Schema Document

     

     

    101.CAL

    Inline XBRL Taxonomy Extension Calculation Linkbase Document

     

     

    101.DEF

    Inline XBRL Taxonomy Extension Definition Linkbase Document

     

     

    101.LAB

    Inline XBRL Taxonomy Extension Label Linkbase Document

     

     

    101.PRE

    Inline XBRL Taxonomy Extension Presentation Linkbase Document

    ​

    ​

    Exhibit 104

    Cover Page Interactive Data File (formatted as Inline XBRL)

    ​

    ​

    ​

    ​

    ​

    ​

    40

    Table of Contents

    ​

    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, thereunto duly authorized:

    ​

     

    22nd CENTURY GROUP, INC.

     

     

    Date: May 13, 2025

    /s/ Lawrence D. Firestone

     

    Lawrence D. Firestone

     

    Chief Executive Officer

     

    (Principal Executive Officer and Authorized Officer)

     

     

    Date: May 13, 2025

    /s/ Daniel A. Otto

     

    Daniel A. Otto

     

    Chief Financial Officer

     

    (Principal Accounting and Financial Officer)

    ​

    ​

    ​

    41

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      Year to Date Total Debt Reduction of approximately $3.8 Million MOCKSVILLE, N.C., May 07, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, today announced that has repaid an additional $1 million in debt to its senior lender. The Company's total debt principal outstanding now stands at approximately $3.9 million. "Our debt reduction progress has been outstanding and total debt principal is now less than $4 million, as compared with approximately $20 million of total debt obligations when I joined the Company in Decemb

      5/7/25 8:00:00 AM ET
      $XXII
      Medicinal Chemicals and Botanical Products
      Health Care

    $XXII
    Financials

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    • 22nd Century Group Reports First Quarter 2025 Financial Results

      Sales Increase Approximately 50% Sequentially as 2025 Growth Strategy Drives New Sales Activity with Both Internal and External Brand Assets Across Multiple Categories  Preparing First VLN® Partner Brand Shipments with Smoker Friendly and Others Filings Made for New Reduced Nicotine Content and Conventional Product Authorizations in All 50 States Launch of Smoker Friendly Black Label – Tobacco and Water natural style cigarettes MOCKSVILLE, N.C., May 13, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, today announ

      5/13/25 6:00:00 AM ET
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      Medicinal Chemicals and Botanical Products
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    • 22nd Century Group Completes Sale of Needle Rock Farms Assets

      Further Strengthens Balance Sheet Cash Position MOCKSVILLE, N.C., May 08, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, today announced closing of the sale of its Needle Rock Farms assets with net proceeds of approximately $770,000 after expenses. "The sale of unused assets such as Needle Rock Farms which was related to the hemp cannabis business that was sold in December 2023, enables us to redeploy capital into our current growth plans," said Larry Firestone, CEO of 22nd Century Group. "The additional $770,000 in

      5/8/25 5:07:00 PM ET
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      Medicinal Chemicals and Botanical Products
      Health Care
    • 22nd Century Group Further Reduces Debt by $1.0 Million Following Financing Transaction

      Year to Date Total Debt Reduction of approximately $3.8 Million MOCKSVILLE, N.C., May 07, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, today announced that has repaid an additional $1 million in debt to its senior lender. The Company's total debt principal outstanding now stands at approximately $3.9 million. "Our debt reduction progress has been outstanding and total debt principal is now less than $4 million, as compared with approximately $20 million of total debt obligations when I joined the Company in Decemb

      5/7/25 8:00:00 AM ET
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      Medicinal Chemicals and Botanical Products
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    $XXII
    SEC Filings

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    • SEC Form 10-Q filed by 22nd Century Group Inc.

      10-Q - 22nd Century Group, Inc. (0001347858) (Filer)

      5/13/25 6:30:33 AM ET
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      Medicinal Chemicals and Botanical Products
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    • 22nd Century Group Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

      8-K - 22nd Century Group, Inc. (0001347858) (Filer)

      5/13/25 6:03:02 AM ET
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    • SEC Form S-3 filed by 22nd Century Group Inc.

      S-3 - 22nd Century Group, Inc. (0001347858) (Filer)

      5/8/25 5:00:51 PM ET
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    Analyst Ratings

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    • Alliance Global Partners initiated coverage on 22nd Century Group with a new price target

      Alliance Global Partners initiated coverage of 22nd Century Group with a rating of Buy and set a new price target of $5.00

      7/21/22 9:12:19 AM ET
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    • Craig Hallum initiated coverage on 22nd Century Group with a new price target

      Craig Hallum initiated coverage of 22nd Century Group with a rating of Buy and set a new price target of $5.00

      6/15/22 7:42:24 AM ET
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      Medicinal Chemicals and Botanical Products
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    • Roth Capital initiated coverage on 22nd Century Group with a new price target

      Roth Capital initiated coverage of 22nd Century Group with a rating of Buy and set a new price target of $6.00

      3/8/22 9:21:23 AM ET
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      Medicinal Chemicals and Botanical Products
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    Insider Purchases

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    • Chief Executive Officer Firestone Lawrence bought $10,468 worth of shares (39,000 units at $0.27), increasing direct ownership by 256% to 54,250 units (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      9/12/24 5:00:14 PM ET
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      Medicinal Chemicals and Botanical Products
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    • Firestone Lawrence bought $9,829 worth of shares (9,000 units at $1.09), increasing direct ownership by 144% to 15,250 units (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      5/31/24 4:05:20 PM ET
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      Medicinal Chemicals and Botanical Products
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    • Arno Andrew bought $17,490 worth of shares (100,000 units at $0.17) (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      1/8/24 8:04:11 PM ET
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    Large Ownership Changes

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    • Amendment: SEC Form SC 13G/A filed by 22nd Century Group Inc.

      SC 13G/A - 22nd Century Group, Inc. (0001347858) (Subject)

      12/3/24 11:18:54 AM ET
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      Medicinal Chemicals and Botanical Products
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    • Amendment: SEC Form SC 13G/A filed by 22nd Century Group Inc.

      SC 13G/A - 22nd Century Group, Inc. (0001347858) (Subject)

      11/14/24 5:56:57 PM ET
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    • SEC Form SC 13G filed by 22nd Century Group Inc.

      SC 13G - 22nd Century Group, Inc. (0001347858) (Subject)

      10/23/24 7:27:00 AM ET
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      Medicinal Chemicals and Botanical Products
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    $XXII
    Insider Trading

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    • Director Johnson Anthony L. was granted 2,472 shares, increasing direct ownership by 35,314% to 2,479 units (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      3/12/25 5:37:14 PM ET
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      Medicinal Chemicals and Botanical Products
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    • Director Salhany Lucille S was granted 2,472 shares, increasing direct ownership by 49,440% to 2,477 units (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      3/12/25 5:35:14 PM ET
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    • Director Arno Andrew was granted 4,237 shares, increasing direct ownership by 9,015% to 4,284 units (SEC Form 4)

      4 - 22nd Century Group, Inc. (0001347858) (Issuer)

      3/12/25 5:30:19 PM ET
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      Medicinal Chemicals and Botanical Products
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    Leadership Updates

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    • 22nd Century Announces Resignation of John Miller as President of Tobacco

      Helped Establish National Scale Distribution and Launch VLN in More Than 5,000 Stores Across the CountryMocksville, North Carolina--(Newsfile Corp. - May 30, 2024) - 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company focused on nicotine harm reduction, today announced that John Miller has resigned as President of Tobacco, effective August 2, 2024. Said Larry Firestone, Chairman and CEO: "I want to thank John for the pivotal role he played in the launch of VLN®, leveraging his decades of industry experience to help us achieve national-scale distribution and establishing a retail presence in more than 5,000 stores across 26 states. He also played a key role in expanding our CMO

      5/30/24 4:05:00 PM ET
      $XXII
      Medicinal Chemicals and Botanical Products
      Health Care
    • 22nd Century Group (Nasdaq: XXII) Appoints Accomplished Media Executive Lucille S. Salhany to Its Board

      BUFFALO, N.Y., Sept. 12, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today announced the appointment of Lucie S. Salhany to its Board of Directors. Ms. Salhany is a highly accomplished media executive with extensive experience in assessing and understanding the consumer landscape, positioning unique products for successful launch utilizing digital media, corporate strategy, and entrepreneurial ventures. She is widely recognized for her appointment as the first woman chair of a major broadcast network, which was e

      9/12/22 4:05:00 PM ET
      $XXII
      Medicinal Chemicals and Botanical Products
      Health Care
    • 22nd Century Group (Nasdaq: XXII) Appoints R. Hugh Kinsman as CFO

      CFO of GVB Biopharma to Expand Role, Become CFO of 22nd Century GroupIntegration of GVB Biopharma Proceeding at a Rapid Pace BUFFALO, N.Y., June 16, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a leading agricultural biotechnology company), dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technology, today announced the appointment of R. Hugh Kinsman as Chief Financial Officer. Kinsman is currently CFO of GVB Biopharma, which 22nd Century acquired effective May 13, 2022. "The integration of GVB Biopharma is proceeding very well, and we are excited to build on Hugh's success at GVB by elevating his financial lea

      6/16/22 8:30:00 AM ET
      $XXII
      Medicinal Chemicals and Botanical Products
      Health Care