This Annual Report on Form 10-K contains forward-looking statements concerning our business, operations and financial performance and condition as well as our plans, objectives and expectations for our business operations and financial performance and condition that are subject to risks and uncertainties. All statements other than statements of historical fact included in this Annual Report on Form 10-K are forward-looking statements. You can identify these statements by words such as “aim,” “anticipate,” “assume,” “believe,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “potential,” “positioned,” “predict,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected, including the following summary of risks related to our business:
| ● | We have a history of losses, and we expect to incur significant expenses and continuing losses for the foreseeable future and there is substantial doubt regarding our ability to continue as a going concern. |
| ● | Our competitors generally have greater financial resources and name recognition than we do, and they may therefore develop products or other technologies similar or superior to ours or otherwise compete more successfully than we do. |
| ● | Our research and development process may not develop marketable products, which would result in the loss of our investment into such processes. |
| ● | We may be unsuccessful at commercializing our Reduced Nicotine Content (RNC) tobacco and the RNC cigarette brand, VLN®, using the reduced exposure claims authorized by the Food and Drug Administration (FDA). |
| ● | The manufacturing of tobacco products subjects us to significant governmental regulation and the failure to comply with such regulations could have a material adverse effect on our business and subject us to substantial fines or other regulatory actions. |
| ● | We may become subject to litigation related to cigarette smoking which could severely impair our results of operations and liquidity. |
| ● | The loss of a significant customer for whom we manufacture tobacco products could have an adverse impact on our results of operation. |
| ● | Tobacco is an agricultural product and is subject to conditions that may affect the annual harvest which would limit our ability to sell our products. |
| ● | Product liability claims, product recalls, or other claims could cause us to incur losses or damage our reputation. |
| ● | The FDA could force the removal of our products from the U.S. market. |
| ● | The States or NAAG may not approve our products in certain states which could have an adverse impact on our results of operations. |
| ● | Certain of our proprietary rights have expired or may expire or may not otherwise adequately protect our intellectual property. |
| ● | We license certain patent rights from third-party owners. If such owners do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects could be harmed. |
| ● | The failure of our information systems to function as intended or their penetration by outside parties with the intent to corrupt them could result in business disruption, litigation and regulatory action, and loss of revenue, assets, or personal or confidential data (cybersecurity). |
| ● | We may be unable to remain listed on the NASDAQ stock market. |
| ● | Our stock price may be highly volatile and could decline in value. |
| ● | We are a named defendant in certain litigation matters; if we are unable to resolve these matters favorably, then our business, operating results and financial condition may be adversely affected. |
| ● | Future sales of our common stock will result in dilution to our common stockholders. |
| ● | We do not expect to declare any dividends on our common stock in the foreseeable future. |
For the discussion of these risks and uncertainties and others that could cause actual results to differ materially from those contained in our forward-looking statements, please refer to “Risk Factors” in this Annual Report on Form 10-K. The forward-looking statements included in this Annual Report on Form 10-K are made only as of the date hereof. 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.
Unless the context otherwise requires, references to the “Company” “we” “us” and “our” refer to 22nd Century Group, Inc., a Nevada corporation, and its direct and indirect subsidiaries.
