22nd Century Group Expands VLN® Tobacco Growing Program to Support Anticipated Demand of the Company’s Reduced Nicotine Content Cigarettes

Rhea-AI Summary

22nd Century Group (XXII) announced a significant expansion of its growing program for VLN® reduced nicotine tobacco for the 2021 crop year. This increase aligns with favorable sales projections and supports the expected launch of VLN® cigarettes, which contain 95% less nicotine than conventional brands. The company is awaiting the FDA's authorization of its Modified Risk Tobacco Product application. The new planting will create income for American family farmers and aims to capture a share of the U.S. tobacco market, potentially leading to substantial revenue growth.

Positive

• Expansion of VLN® reduced nicotine tobacco planting aligns with positive sales forecasts.
• FDA's impending approval could significantly boost commercial sales and market share.
• Possibility of generating a new income stream for American family farmers.

Negative

• None.

Company will significantly increase planting in the 2021 crop year

WILLIAMSVILLE, N.Y., Jan. 11, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company will significantly expand its growing program for VLN^® reduced nicotine content tobacco based on the Company’s latest sales projections. This new planting for VLN^® tobacco is in addition to the Company’s sizeable inventory of VLN^® tobacco, which is earmarked for the launch and initial sales of 22nd Century’s VLN^® reduced nicotine content cigarettes. 22nd Century’s Modified Risk Tobacco Product (MRTP) application for VLN^® cigarettes is currently in the final stage of review with the U.S. Food and Drug Administration (FDA). Once authorization is granted, 22nd Century will begin marketing its VLN^® cigarettes, which contain 95% less nicotine than conventional cigarette brands. Having the only combustible cigarette with a modified exposure claim authorized by the FDA could serve as a catalyst for 22nd Century’s commercial sales as capturing even a small fraction of U.S. tobacco sales could result in exponential growth in the Company’s revenues and market capitalization.

“We are prepared to launch our VLN^® cigarettes within 90 days after receiving marketing authorization from the FDA,” said James A. Mish, chief executive officer of 22nd Century Group. “There are more than 34 million smokers in the United States and research shows that a majority of these smokers are looking for alternatives. When shown samples of VLN^®, 60 percent of adult smokers in our studies indicated an interest in using VLN^® cigarettes. Additionally, in a 2019 U.S. Center for Disease Control and Prevention (CDC) survey, 80 percent of U.S. smokers favored reducing nicotine levels in cigarettes. We believe adult smokers will be very interested in VLN^®, and this new crop of VLN^® tobacco will help us to fulfill the expected demand based on our latest sales projections.”

Mish continues, “In addition to introducing VLN^® to smokers in the U.S., we are absolutely committed to licensing our technology to every cigarette manufacturer, so that they can comply with the FDA’s plan to make all cigarettes non-addictive. We look forward to the tobacco industry joining our efforts to truly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.”

In partnership with select tobacco farmers, 22nd Century will plant this new VLN^® tobacco throughout the U.S. tobacco belt, thereby creating a new income stream for America’s struggling family farmers. The Company’s proprietary, reduced nicotine content tobacco contains, on average, just 0.5 milligrams of nicotine per gram of tobacco - a remarkable reduction in nicotine versus conventional cigarette tobaccos which often contain 20 mg to 30 mg nicotine per gram of tobacco.

With 95 percent less nicotine than typical cigarettes, VLN^® cigarettes will serve as a vanguard for the FDA’s ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation. Published in 2017, the plan aims to set a product standard for cigarettes that achieves “minimally or non-addictive” levels of nicotine. The FDA projects that within the first year of implementing a mandate, it will help more than five million adult smokers to quit smoking and will save more than eight million American lives by the end of the century.

Within 90 days of the FDA’s authorization of its MRTP application, the Company plans to rollout VLN^® King and VLN^® Menthol King cigarettes to retail tobacco outlets in the U.S. The launch of VLN^® will be paired with a compelling marketing campaign to introduce adult tobacco smokers to the world’s lowest nicotine content cigarette.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century’s primary mission in tobacco is to reduce the harm caused by smoking through the Company’s proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company’s primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 11, 2020 and in its subsequently filed Quarterly Report on Form 10-Q. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com

FAQ

What are the recent developments for 22nd Century Group (XXII) regarding VLN® tobacco?

22nd Century Group is expanding its VLN® tobacco planting for the 2021 crop year due to positive sales projections and is awaiting FDA approval for its Modified Risk Tobacco Product application.

How much less nicotine do VLN® cigarettes contain compared to conventional brands?

VLN® cigarettes contain 95% less nicotine than traditional cigarettes, averaging just 0.5 milligrams of nicotine per gram.

What is the current status of 22nd Century's application with the FDA?

22nd Century's Modified Risk Tobacco Product application for VLN® cigarettes is in the final review stage with the FDA, and they are prepared to launch within 90 days of approval.

How does 22nd Century Group plan to impact the U.S. tobacco market?

The company aims to capture a share of the U.S. tobacco market with its VLN® cigarettes, targeting adult smokers looking for lower nicotine options.

What benefits does the new VLN® tobacco planting bring to American farmers?

The new VLN® tobacco planting will create a new income stream for struggling American family farmers involved in the cultivation.