22nd Century Group Receives Order for 2.4 Million SPECTRUM® U.S. Government Research Cigarettes

CLARENCE, N.Y.--()--22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is focused on tobacco harm reduction and cannabis research, announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, received a new purchase order for agencies of the U.S. federal government for 2.4 million of the Company’s proprietary SPECTRUM research cigarettes. SPECTRUM brand cigarettes are an important tool in clinical research for investigating the impact of reduced nicotine levels for cigarette addictiveness and cessation success. As recently reported, scientists have dramatically increased the number of clinical trials investigating the important applications of Very Low Nicotine cigarettes. New and on-going independent clinical trials have increased demand for 22nd Century’s proprietary SPECTRUM research cigarettes.

In-progress clinical research incorporating the use of SPECTRUM cigarettes includes: (i) exposure studies comparing how different nicotine levels in cigarettes affect smoking behavior, (ii) smoking cessation studies, and (iii) studies to determine the nicotine addiction threshold of cigarettes. Most notable is a newly completed, but not yet published, Phase III study featuring 1,250 participants and funded by the National Institute on Drug Abuse (NIDA). This study is comparing two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels versus a gradual reduction in nicotine content in cigarettes to non-addictive levels. This seminal Phase III study is expected to determine the nicotine reduction approach that demonstrates the most favorable outcomes for smokers; no matter which approach prevails, 22nd Century’s Very Low Nicotine tobacco and technology will be a key component.

22nd Century developed SPECTRUM in partnership with independent researchers and officials from the NIDA, the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC). The main SPECTRUM product line, which can only be produced by 22nd Century, consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than conventional brands) to relatively high nicotine yields. SPECTRUM features 24 styles, in both regular and menthol versions, with 8 different levels of nicotine in its tobacco. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUM brand styles.

Including this new order, Goodrich Tobacco has received orders for more than 24 million SPECTRUM cigarettes. SPECTRUM cigarettes are not sold commercially; they are produced by 22nd Century for exclusive use in independent clinical research.

“Today there are at least 25 ongoing clinical trials using 22nd Century’s proprietary Very Low Nicotine cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We expect that this new order of SPECTRUM research cigarettes will facilitate critical additional research… and will ultimately lead to 22nd Century making Very Low Nicotine cigarettes available to smokers around the world.”

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.

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com

Release Summary

22nd Century Group Receives Order for 2.4 Million SPECTRUM® U.S. Government Research Cigarettes

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com