22nd Century Group, Inc.

Except as set forth below, 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, 2025, as filed with the SEC on March 26, 2026.

Nasdaq may delist our common stock from trading on its exchange, which could limit investors’ ability to make transactions in our common stock, reduce the liquidity of our common stock and materially impair our ability to raise the additional capital necessary to continue our operations.

Our common stock is currently listed on the Nasdaq Capital Market (“Nasdaq”). To maintain that listing, we must satisfy Nasdaq’s continued listing requirements, including requirements relating to the minimum bid price of our common stock, the market value of our listed securities, stockholders’ equity, the market value of our publicly held shares, the number of publicly held shares and public holders, corporate governance and other matters. We cannot assure you that we will continue to satisfy all applicable Nasdaq continued listing requirements.

Under Nasdaq Listing Rule 5550(a)(2), the closing bid price of our common stock generally must be at least $1.00 per share. If the closing bid price is below $1.00 per share for 30 consecutive business days, Nasdaq may notify us that we no longer comply with the minimum bid-price requirement. Although Nasdaq’s rules may provide an eligible company with a compliance period in which to regain compliance, there can be no assurance that we would be eligible for any such period, that Nasdaq would grant us any additional time, or that we would regain or subsequently maintain compliance. Regaining compliance may require the closing bid price of our common stock to equal or exceed $1.00 per share for a specified number of consecutive business days, and Nasdaq may require a longer compliance period in its discretion.

Nasdaq has adopted a continued listing requirement that requires companies listed on the Nasdaq Capital Market to maintain a minimum market value of listed securities (“MVLS”) of at least $5 million. Under the rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq may issue a Staff Delisting Determination without providing the company with the traditional cure or compliance period available for certain other listing deficiencies. The rule also provides for the suspension of trading in the company’s securities during the pendency of an appeal of the Staff Delisting Determination, subject to the applicable Nasdaq rules and procedures. Although the new MVLS rule has been stayed by the SEC, we cannot predict whether the SEC will affirm, modify or set aside the rule, whether Nasdaq will further amend the rule, or when or whether the rule will again become effective. The stay could be lifted with little advance notice, and the rule could become applicable to us in its current or a modified form. If the stay is lifted and the rule becomes operative in its current or a substantially similar form, and our MVLS subsequently remains below $5 million for the applicable measurement period, our common stock could be suspended from trading and delisted without a traditional cure period.

During the past two years, we have received deficiency letters from the Nasdaq Listing Qualifications Department notifying us that we were not in compliance with certain Nasdaq continued listing requirements. Although we addressed those deficiencies and regained compliance, our prior compliance does not provide assurance that we will maintain compliance in the future. We may receive additional deficiency or delisting notices, and any compliance period or exception available under Nasdaq’s rules may be insufficient for us to regain compliance. Nasdaq may also amend its listing standards, adopt more stringent standards or alter the remedies available to a company that fails to comply.

If Nasdaq delists our common stock from trading on its exchange, we could face significant material adverse consequences, including:

A delisting or trading suspension could also materially impair our ability to raise capital. We have incurred significant losses and may require additional capital to fund our operations, satisfy our obligations, execute our business strategy and continue as a going concern. Investors may be unwilling to purchase our securities if they are not listed on a national securities exchange, and any financing that remains available may involve substantially higher costs, more restrictive terms, significant discounts, warrant coverage, senior or secured securities, or substantial dilution to existing stockholders. Delisting could also impair our ability to use an effective registration statement, access at-the-market or other public equity programs, or satisfy exchange-related conditions in existing or future financing agreements.

The occurrence of any of these events could materially and adversely affect the value and liquidity of our common stock, our business, financial condition and results of operations, and our ability to continue as a going concern.