22nd Century Group Installs State-of-the-Art Nicotine Testing Equipment to Enhance VLN® Production

Rhea-AI Summary

22nd Century Group (NYSE American: XXII) announced significant advancements in its testing capabilities, estimating a 90% reduction in costs and a turnaround time improvement from weeks to hours for its VLN® reduced nicotine tobacco products. The new in-house laboratory will enhance product quality and testing consistency while supporting the anticipated demand for VLN® cigarettes. In preparation for the FDA's Modified Risk Tobacco Product (MRTP) application, the company aims for ISO/IEC 17025 accreditation, demonstrating its commitment to high-quality testing standards.

Positive

• 90% reduction in testing costs for VLN® products.
• Turnaround time for test results improved from weeks to hours.
• Enhanced ability to monitor and control product quality in-house.
• Preparation for FDA MRTP application expected to boost market readiness.
• Working towards ISO/IEC 17025 accreditation, enhancing credibility.

Negative

• None.

Investment in New Lab Capabilities Will Reduce Testing Costs by 90% and Improve Turnaround Time from Weeks to Hours

BUFFALO, N.Y., May 05, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and hemp/cannabis research, announced today that it is advancing and expanding capabilities in its in-house laboratory, located in its cigarette manufacturing facility in Mocksville, North Carolina, for testing of its VLN^® reduced nicotine content (RNC) tobacco and cigarettes. The Company estimates that its cost per VLN^® sample will improve by more than 90% and the lead time for key data will take less than a day compared to using a third-party testing service that can take weeks.

“This is an important investment and milestone for 22nd Century, as it is imperative to the launch of VLN^® and the future of the organization that we have the ability to rapidly conduct high-precision analysis of our own products at higher testing volumes,” says James A. Mish, chief executive officer of 22nd Century Group. “With these expanded capabilities in place, we have a fully integrated business unit, able to monitor and control the results from growing, blending, and manufacturing of our reduced nicotine content cigarettes. In addition, by having the entire testing process managed within 22nd Century, it will improve testing consistency and give us greater ability to manage product quality in-house. By making this investment now, we will be well-positioned for the FDA’s authorization of our Modified Risk Tobacco Product (MRTP) application to market our VLN^® cigarettes to the public.”

22nd Century now has the same lab testing equipment and capabilities as outside facilities. The Company is also working toward receiving ISO/IEC 17025 accreditation, which grants international recognition of an organization’s commitment to quality, competency, and reliable results. This accreditation demonstrates to customers and industry that 22nd Century has the technical competence to provide reliable and accurate test results even at the lowest nicotine levels. The new laboratory is starting operations at an opportune time, as earlier this year 22nd Century announced that it has significantly expanded its tobacco growing program to support the anticipated demand for its VLN^® cigarettes.

“As we start to receive tobacco from growers, we will be able to test every bale of tobacco in-house to ensure that it meets the stringent requirements established by 22nd Century. We will now receive test results much faster and at lower cost, which will help us to better meet the expected demand for our product,” says Michael Zercher, chief operating officer at 22nd Century.

Made from proprietary tobacco engineered to contain 95% less nicotine than conventional cigarette tobacco, 22nd Century’s RNC cigarettes are the only combustible tobacco products able to meet the nicotine levels proposed in the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) for a tobacco product standard that requires all combustible cigarettes to contain “minimally or non-addictive” levels of nicotine. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company is highly confident that its MRTP application for VLN^® is in the final stages of the FDA’s review process. This important designation will allow 22nd Century to communicate key features of VLN^® King and VLN^® Menthol King, including a headline claim of “95% less nicotine.” Although VLN^® contains just 0.5 milligrams of nicotine per gram of tobacco, VLN^® tastes, smells, and smokes like a conventional cigarette. This disruptive product is an innovative alternative to addictive, conventional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN^® cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN^® brand and tobacco franchise. The Company remains willing to license its RNC tobacco technology to every cigarette manufacturer, including Altria, Reynolds American, and other Big Tobacco companies, so that the entire industry can join 22nd Century’s effort to reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

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, 2021. 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

How much will testing costs decrease for XXII's VLN® products?

22nd Century Group estimates a 90% reduction in testing costs for its VLN® products.

What is the turnaround time for testing results after the new lab capabilities are implemented?

The turnaround time for testing results will improve from weeks to hours.

When is XXII expecting to launch VLN® cigarettes?

22nd Century is ready to launch VLN® cigarettes within 90 days of receiving FDA authorization.

What accreditation is XXII pursuing for its new laboratory?

22nd Century is working towards ISO/IEC 17025 accreditation for its new laboratory.