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Dramatic Surge in Very Low Nicotine Tobacco Clinical Trials and Science

XXII | May 31, 2017

Dramatic Surge in Very Low Nicotine Tobacco Clinical Trials and Science

22nd Century to Meet with FDA Center for Tobacco Products in June about Proprietary “BRAND A” Very Low Nicotine Cigarettes

22nd Century Group, Inc. (NYSE MKT:XXII) announced today that there has been a dramatic surge in the number of publications relating to the Company’s proprietary Very Low Nicotine (VLN) cigarettes. The number of in-progress clinical trials using 22nd Century’s VLN cigarettes is also increasing. There are currently 25 Very Low Nicotine-related clinical trials in progress, which is almost triple the number of clinical trials completed over the entire preceding decade. All of these studies are independently funded by major collaborators on the projects including the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), The National Institute of Allergy and Infectious Diseases (NIAID), The National Institute on Drug Abuse (NIDA), and The National Cancer Institute (NCI).

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There has been a dramatic surge in the number of publications relating to 22nd Century's proprietary Very Low Nicotine (VLN) cigarettes. (Graphic: Business Wire)

Following publication of the landmark clinical study by Eric C. Donny, Ph.D., et al. in The New England Journal of Medicine, and the World Health Organization (WHO) Advisory Note entitled “Global Nicotine Reduction Strategy,” independent scientists have conducted and published a large and growing number of clinical trials and recommendations related to 22nd Century’s signature VLN tobacco technology. In the last sixteen months, there have been 33 new scientific publications relating to 22nd Century’s VLN tobacco – an 850% increase – reflecting an average of more than 2 new published papers per month.

The impressive increase in clinical trials utilizing the Company’s proprietary VLN tobacco has resulted in an increase in scientific commentaries and opinion pieces as scientists develop policy recommendations for the use of VLN cigarettes. Nine recent publications urged policymakers to incorporate Very Low Nicotine cigarettes as a tobacco control policy tool.

As independent research in 22nd Century’s proprietary Very Low Nicotine cigarettes surges, 22nd Century scientists are scheduled to meet in June with the FDA’s Center for Tobacco Products (CTP) to discuss the Company’s “BRAND A” Modified Risk Tobacco Product (MRTP) application. 22nd Century’s MRTP application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine. BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®.

With approximately 277 billion cigarettes manufactured in the U.S. in 2014 – representing more than $80 billion in sales – the cigarette market in the United States remains enormous. At present, however, the United States is completely devoid of any “reduced exposure cigarette” option. If 22nd Century’s application to the FDA is successful, the Company’s BRAND A Very Low Nicotine cigarettes will offer millions of American smokers a distinct reduced exposure product choice.

“We are looking forward to next month’s FDA meeting for our BRAND A Very Low Nicotine cigarettes; it is an important milestone for our Company,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “22nd Century is committed to providing American smokers with the choice of a Modified Risk Tobacco Product that significantly reduces smokers’ exposure to nicotine.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.