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

— 22nd Century Group, Inc. (NYSE American: XXII) (“22nd Century” or “the Company”), 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, today reported results for the second quarter ended June 30, 2020.

“Despite the unprecedented challenges brought on by COVID-19, I am pleased to report net sales revenue of $6.4 million for the second quarter of 2020, up 11% from the prior year, continued gross profit margin expansion, and improved operating loss. These results demonstrate our ability to execute on our initiatives to improve our margins and cost structure. Our financial position remains strong and we will continue to operate with strict cost controls, allocate our resources efficiently, and deploy capital where we believe it will give us the greatest return on our investments,” said James A. Mish, Chief Executive Officer of 22nd Century Group.

“With the comment period now closed on our Modified Risk Tobacco Product Application, the team is laser focused on setting the stage for a successful VLN^® launch upon the authorization of our MRTP Application by the FDA. I am exceedingly proud of the dedication and tremendous progress the team has made so far this year and believe we are well positioned to capitalize on the many opportunities ahead,” Mish added.

Business Highlights and Notable Events:

The Company appointed James A. Mish as its Chief Executive Officer, effective June 22, and John Franzino as its Chief Financial Officer, effective June 3. Mish has extensive global executive leadership experience leading science-driven organizations with a focus on the development, manufacturing, and commercialization of active pharmaceutical ingredients (“API”), including cannabinoids, and related consumer products. Franzino has extensive financial leadership experience in the tobacco and alcoholic beverage industries. Mish is reviewing the Company’s current strategy and objectives and is expected to provide an update in November during the Company’s third quarter earnings call.

The public comment period for the Company’s Modified Risk Tobacco Product (“MRTP”) Application for VLN^® closed on May 18, 2020. The application requests a modified exposure designation from the FDA to market the Company’s proprietary reduced nicotine content tobacco cigarettes in the U.S. under the proposed brand name of VLN^® with product labeling and advertising claims stating that VLN^®has 95% less nicotine than conventional cigarettes, as well as other claims related to reduced nicotine exposure. The closing of the public comment period marks an important milestone in the FDA’s ongoing scientific review of the Company’s MRTP Application.

The following information was filed by 22Nd Century Group, Inc. (XXII) on Thursday, August 6, 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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22Nd Century Group, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: XXII
CIK: 1347858
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-20-009503
Submitted to the SEC: Thu Aug 06 2020 7:30:44 AM EST
Accepted by the SEC: Thu Aug 06 2020
Period: Tuesday, June 30, 2020
Industry: Cigarettes

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22Nd Century Group, Inc. (XXII) SEC Filing 10-Q Quarterly report for the period ending Tuesday, June 30, 2020

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