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Safe Harbor Statement
This document is based on information provided by 22nd Century Group, Inc. (the “Company”) and other sources that the Company believes are reliable. Nothing in this document is, or may be relied upon as, a promise or representation by the Company as to the past or the future.
This document contains statements that the Company believes to be “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that is not a statement of historical fact, including, without limitation, statements regarding the Company’s business strategy and plans and objectives of management for future operations or that may predict, forecast, indicate or imply future results, performance or achievements. The words “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such words or words or expressions of similar meaning are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, and all such forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors including but not limited to the factors set forth in the “Risk Factors” section of this document and the “Risk Factors” disclosed in the Company’s reports filed with the Securities and Exchange Commission. Additional information concerning these and other factors is contained in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements and other information in this document speak only as of the date of this document. The delivery of this document at any time does not imply that the information contained herein is correct as of any time subsequent to the date hereof. We do not undertake, and we disclaim, any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.
The risks and uncertainties relating to the forward-looking statements in this presentation include those described under “Risk Factors” in the Company’s Form S-1 filed on April 8, 2011 with the Securities and Exchange Commission. The below summary is not complete and does not contain all the information that should be considered before investing in our common stock.
We will require additional capital in the future to complete the Phase III clinical trials for our X-22 smoking cessation product and the FDA authorization process for our Modified Risk tobacco Cigarettes, and we may not be able to obtain additional debt or equity financing on favorable terms, if at all.
There can be no assurance that our X-22 smoking cessation aid will be approved by the FDA, European Medicines Agency (“EMA”), or any other governmental body, and there can be no assurance that we will receive FDA authorization to market BRAND A and BRAND B as Modified Risk Cigarettes. In addition, there can be no assurance that all necessary regulatory approvals will be granted for our potential products or that review or actions will not involve delays caused by requests for additional information or testing that could adversely affect the time to market for and sale of our potential products.
We face intense competition in the market for our RED SUN and MAGIC cigarettes, and our failure to compete effectively could have a material adverse effect on our profitability and results of operations. We also face significant governmental action, especially in the U.S. pursuant to the Tobacco Control Act, including but not limited to efforts aimed at reducing the incidence of tobacco use, restricting marketing and advertising, and imposing regulations on products and packaging.
Our common stock is a “penny stock,” which is likely to limit its liquidity. The market price of our common stock is, and will likely remain for the foreseeable future, less than $5.00 per share, and therefore will be a “penny stock” according to SEC rules, unless our common stock is listed on a national securities exchange. The OTC Bulletin Board is not a national securities exchange. Because of such expected illiquidity, it will likely be difficult to re-sell shares of our common stock as desired.