22nd Century Ltd, LLC (OTCBB: XXII; Twitter: $XXII) - Corporate Summary

Published by Redington, Inc. for investment professionals. All rights reserved. Newly-public 22nd Century Group, Inc. (XXII) has spent the past 13 years developing and acquiring the technology to genetically engineer nicotine levels in the tobacco plant; its new X-22™ prescription smoking-cessation aid in development is expected to enter pivotal Phase III clinical trials for FDA-approval by year end; a $5.4 million financing was completed on January 25, 2011; on May 16, 2011 Rodman & Renshaw initiated coverage with a rating of “Market Outperform/ Speculative Risk” and a 12-month price target of $5 per share. KEY CONSIDERATIONS (1) during the 1980s, has evolved to include patches, nasal sprays, inhalers and lozenges. In 2009, U.S. sales of NRT products totaled more than $500 million. (2) Z y b a n ® ( b u p r o p i o n ) a n d C h a n t i x ® (varenicline), in 2009 accounted for another $500 million in U.S. sales. Bupropion/ leader, Chantix®, blocks the nicotine receptors in the brain. In 2009, the FDA announced that it was requiring a “Boxed Warning,” the most serious prescription safety warning, for both of these products which highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs. Hundreds of suicides and attempted suicides have been associated with Chantix use. Prior to Chantix in the U.S. had been approaching $1 billion annually. Sales in the U.S. have subsequently fallen in 2010 to $330 million annually. International sales (outside the U.S.) in 2010 have grown to $425 million from $314 million. The Company believes that the limited effectiveness and/or serious side effects of available FDA-approved smoking cessation aids, have resulted in a huge unmet medical SMOKING CESSATION MARKET need. Smoking cessation products constitute a X-22: PRESCRIPTION SMOKING $1 billion market in the U.S. and a $3 billion CESSATION AID market globally. Datamonitor estimates that X-22™ is a six-week, prescription prescription-only smoking cessation sales, smoking-cessation treatment which utilizes in the top seven markets alone, will be $4.6 Very Low Nicotine (VLN) cigarettes to satisfy billion by 2016. There are 46 million Americans who smoke cigarettes and approximately half reducing nicotine exposure and nicotine attempt to quit smoking every year. Of these, dependence, as well as breaking the only 2-5% actually quit. It typically takes association between the act of smoking and eight to 11 serious attempts before a smoker the rapid delivery of nicotine. successfully stops smoking long-term. X-22 contains approximately 0.7 mg of FDA-approved smoking cessation nicotine per cigarette, only 5% of the 14 products fall into two categories. mg of the nicotine in commercial “light” respect to FDA approval and authorization of new products. We do not undertake, and we disclaim, any obligation to update any of the forward-looking statements or to announce revisions to any of the forward-looking statements. Actual results may differ materially from the forward-looking statements herein. The risks and uncertainties relating to the forward-looking statements include those described under “Risk Fac-equity interest in the company.

cigarettes, yet smokes, tastes and smells like the consumer, which saves smokers out-of-a regular cigarette. Importantly, X-22 does pocket costs of approximately $210 for their cigarette which contains 95% less nicotine not expose the smoker to any new drugs usual brand. As a prescription therapy, there than cigarettes which were previously or side effects, thereby eliminating serious are no tobacco taxes on X-22. marketed as “Light.” Clinical studies have safety concerns. Patients smoke X-22 VLN The Company believes that these factors – demonstrated that smokers who smoke VLN cigarettes without restriction during the six- improved effectiveness, substantially greater cigarettes smoke fewer cigarettes per day week period to facilitate the goal of quitting safety, lower pricing, and the fact that X-22 is by the end of the treatment period. the only smoking cessation aid that functions exposure, including “tar,” nicotine and A Phase II clinical trial conducted at exactly like a conventional cigarette – offer carbon monoxide. the University of Minnesota found that significant competitive advantages in the Brand B contains the lowest amount marketplace. of “tar” per milligram of nicotine in its proprietary tobacco were more effective mainstream smoke, 47% lower than MODIFIED RISK CIGARETTES Marlboro Light®. It allows the smoker to in assisting patients to quit smoking as compared to the use of FDA-approved achieve a satisfactory amount of nicotine risk tobacco products, a new product Commit® nicotine lozenges (4 mg) or per cigarette while inhaling less tar and less category falling under FDA regulation. These “low nicotine” cigarettes (containing carbon monoxide. products are expected to meet demand for approximately 6 times the nicotine of the Regulations and guidance regarding the cigarettes that reduce exposure to toxins. VLN cigarette). In 2009, the Tobacco Control Act granted The Phase II trial risk tobacco products are expected within the FDA regulatory authority over all tobacco included 165 randomly-assigned patients and months. The Company believes that the products. It establishes procedures for the was conducted by Dr. Dorothy Hatsukami, reductions to smoke exposure of Brand A and FDA to regulate the labeling and marketing Director of the National Transdisciplinary Brand B are very likely to fall within the FDA of modified risk tobacco products, which Tobacco Use Research Center (TTURC) includes cigarettes that (i) reduce exposure to at the University of Minnesota Masonic tobacco smoke toxins and/or (ii) pose lower Comprehensive Cancer Center and a current health risks, as compared to conventional The company reported Act also banned the use of “low tar,” “light” $167,000, including net sales of $117,000, Patients using the VLN cigarettes and “ultra-light” on cigarette labeling and compared with zero revenue for the same achieved a 43% quit rate (confirmed four- marketing effective June 2010. Those quarter in 2010. The company reported week continuous abstinence) compared to a products represent 75% of the $80 billion a first-quarter net loss of approximately quit rate of 35% for the group using a FDA- U.S. cigarette market. Industry analysts $652,000 or 3 cents per diluted common approved 4-mg nicotine lozenge (Commit®) believe the new FDA-approved Modified share, compared to a net loss of $305,000 and a 21% quit rate for the group using a low Risk category could take much of the market nicotine cigarette. share previously held by the various “light” common share. Smoking abstinence at the 6 week brands. follow-up (point prevalence) after the end of treatment rose to 47% for the VLN cigarette group, 37% for the nicotine lozenge group SUMMARY POINTSand 23% for the low nicotine cigarette group. The VLN cigarette was also associated symptoms and cravings than the 4-mg nicotine lozenge. In fact, cravings continued to decline for weeks after treatment, one reason the Company believes X-22 is more effective than all other approved therapies. 22nd Century will begin a Phase II-B Trial in July of 2011. X-22 is eligible for FDA “Fast Track” status and the Company has received initial FDA guidance for two concurrent Phase III Trials which it expects to begin in Q4 of 2011. A New Drug Application (NDA) is anticipated for Q3 of 2012 with resulting FDA approval and product launch expected in Q1 of 2013. X-22 will have a retail price of roughly $240 for the six-week treatment period, half the cost for Chantix® for its 12-week treatment protocol. The price for X-22 will be approximately the same as the national-average retail price of Marlboro® cigarettes over a six-week period. As an FDA-approved therapeutic for smoking cessation, X-22 will be covered by Medicare, state Medicaid programs and most private insurers – resulting in only a co-pay cost (e.g., $30) to For additional information, contact:

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22nd Century Ltd, LLC (OTCBB: XXII; Twitter: $XXII) - Corporate Summary

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