22Nd Century Group, Inc. (XXII) 10-Q Quarterly Report May 2020

WILLIAMSVILLE, N.Y., May 7, 2020 — 22nd Century Group, Inc. (NYSE American: XXII) (“22nd Century” or “the Company”), a leading plant biotechnology company focused on reduced nicotine tobacco and hemp/cannabis plant genetics research and development, today reported results for the first quarter ended March 31, 2020.

“We are very pleased with the solid start to 2020 with revenue increasing 12% over last year. We believe the Company is well positioned to execute on its strategies despite a challenging backdrop due to COVID-19. Our manufacturing facility has remained open and has been able to fulfill orders without any backlog. The improvements we made to our cost structure in 2019 have started to pay off in the first quarter with a 16% reduction in operating expenses compared to the same quarter last year,” said Mike Zercher, President and Chief Operating Officer of 22nd Century Group.

“Additionally, the U.S. Food and Drug Administration (“FDA”) recently announced a deadline for public comments on the Company’s Modified Risk Tobacco Product (“MRTP”) application. This moves our MRTP application one step closer to an FDA authorization decision for the Company’s proprietary, reduced nicotine content tobacco cigarettes. Bringing these products to market is an important and exciting prospect for the Company and public health,” Zercher added.

Recent Accomplishments and Notable Events:

On February 14, 2020, the Company presented data to FDA’s Tobacco Products Scientific Advisory Committee (“TPSAC”) in support of our MRTP application for our reduced nicotine content tobacco cigarettes. 22nd Century’s MRTP application seeks a reduced exposure marketing authorization from the FDA to allow its reduced nicotine content cigarettes to be marketed under the brand name “VLN®,” with pack and advertising claims stating that the product contains 95% less nicotine than conventional tobacco cigarettes, as well as related claims regarding reduced nicotine exposure. This meeting was the first time that TPSAC considered an MRTP application for a modified exposure claim and was also TPSAC’s first discussion of an application for a combustible tobacco product.

On March 11, 2020, the Company announced in partnership with KeyGene that it has assembled, in just under three months, high-quality genome sequences of two hemp/cannabis lines and established a new, proprietary hemp/cannabis bioinformatics platform. Both are believed to be among the highest quality, hemp/cannabis reference genomes in the world. The establishment of a comprehensive bioinformatics platform is the first step in building out the Company’s hemp/cannabis knowledge foundation. Further work is underway to enhance the platform with additional plant lines. The Company has also made significant achievements in rapid cycle breeding and metabolomics with both high-CBD and oil-seed hemp/cannabis plant lines widely used in the hemp/cannabis industry.

On April 30, 2020, the Company announced that it and North Carolina State University (“NCSU”) have completed successful research field trials that have validated new non-GMO (genetically modified organism) methodologies for reducing nicotine in tobacco plants. As an alternative to older, genetic-engineering technologies that result in the creation of plants regulated as GMOs, the NCSU researchers used newer, non-CRISPR, non-GMO, gene editing technologies to consistently achieve reductions in nicotine levels of as much as 99%, when compared to conventional tobacco plants. This reduction in nicotine levels is believed to be caused by the inactivation of several genes believed to encode for enzymes involved in nicotine biosynthesis in the plant. 22nd Century has earlier filed a patent application with the U.S. Patent and Trademark Office to secure intellectual property rights for this non-GMO genetic approach that achieves very low nicotine content (VLNC) levels in tobacco plants using non-GMO methodologies.

The following information was filed by 22Nd Century Group, Inc. (XXII) on Thursday, May 7, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Ticker: XXII
CIK: 1347858
Form Type: 10-Q Quarterly Report
Accession Number: 0001104659-20-057913
Submitted to the SEC: Thu May 07 2020 12:03:18 PM EST
Accepted by the SEC: Thu May 07 2020
Period: Tuesday, March 31, 2020
Industry: Cigarettes

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22Nd Century Group, Inc. (XXII) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

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