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|●||Initiated International Launch Process For VLN®, First Sales Planned by First Quarter 2022|
|●||First Revenue From Hemp/Cannabis Franchise to Commence in Second Half of 2021|
|●||Third Plant-Based Franchise to be Introduced on August 30, 2021|
|●||Uplisting common shares to the Nasdaq Capital Market (“Nasdaq”) and will continue to trade under current symbol, “XXII”|
|●||Record Second Quarter Net Sales of $8.4 Million, Up Greater Than 30% From the Second Quarter of 2020|
|●||Executing From a Strong Financial Position with Cash and Cash Equivalents of $62.3 Million as of June 30, 2021.|
BUFFALO, N.Y., August 5, 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, today reported results for the second quarter ended June 30, 2021, and provided an update on recent business highlights. The Company will provide an additional business update for investors on a live audio webcast to be held today at 10:00 a.m. ET.
“We remain highly confident in a positive outcome for our Modified Risk Tobacco Product (MRTP) application, and based on continued engagement and very recent feedback from the FDA, we believe that our application has completed the scientific review process and is in the documentation process,” said James A. Mish, chief executive officer of 22nd Century Group. “I recognize that the delay by the FDA in authorizing our VLN® product is incredibly frustrating for all of us. Our application will be the first and likely the only MRTP for a combustible cigarette that the FDA will ever authorize, which means this is a complex process for the Agency that they want to be sure to get right. Our reduced nicotine content (RNC) cigarettes have been used in clinical studies that are estimated to have cost over $100 million funded by several U.S. federal government agencies, including the FDA. The benefits of our RNC cigarettes have been well documented and the FDA has already confirmed that they are appropriate for the protection of public health in our positive PMTA designation. We possess the expertise to have progressed this far and have the know-how to cross the finish line using all of our available tools, partners, and advocates to balance leverage and collaboration with the FDA to continue advancing the process forward to a successful conclusion.”
Mish added, “Our record second quarter and first half net sales were a result of the investments to scale-up our tobacco contract manufacturing capabilities and confirms our ability to generate new business and operate at scale ahead of VLN® launches in the U.S. and internationally.”
Mish concluded, “In our hemp/cannabis franchise, we have secured all key partnerships needed to maximize and support what we believe is the most comprehensive and innovative upstream cannabinoid value chain in the industry, enabling the rapid development of new disruptive plant lines and genetics critical to unlocking commercial success for large-scale cultivation and extraction across this emerging industry. Along with new lines currently growing at our farm in Colorado, we also have plant lines and IP completing the initial two-year development cycle. We look forward to the monetization of these lines and our current hemp/cannabis portfolio with our first revenue from our hemp/cannabis franchise expected to commence in the second half of 2021, while we continue the rapid development of next generation, disruptive plant lines for our 2022 and 2023 revenue programs.”
Key Business and Financial Highlights
|●||Securing MRTP designation for VLN® is 22nd Century’s number one priority. The Company remains highly confident in a positive outcome with the FDA. There continues to be no outstanding requests for information from the FDA, and based on the most recent interactions with the Agency, the Company believes that its MRTP application has completed the scientific review process and is now in the documentation process, the final stage before FDA announces its decision. The Company is in regular contact with officials at the highest levels of the Agency and continues to highlight the public health importance of the Company’s MRTP application to encourage a positive outcome. 22nd Century possesses the expertise to navigate the MRTP application process to a successful conclusion with a balance of leverage and collaboration with the FDA.|
|●||VLN® is market ready. The Company’s U.S. pilot program and manufacturing capabilities are in place to launch VLN® in the U.S. within 90 days of receiving MRTP designation. The Company’s leadership has successfully launched several tobacco and other plant-based consumer products, provides critical insight into the importance of a well-planned market entry and solid supply chain. The Company plans to position VLN® in the premium pricing segment of the cigarette market and, therefore, expects it to deliver corresponding margins.|
The following information was filed by 22Nd Century Group, Inc. (XXII) on Thursday, August 5, 2021 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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