NYSE: XXII

BUFFALO, N.Y., April 15, 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 it is fully prepared to support New Zealand in its efforts to become a smoke-free nation by 2025. This follows the release of a new proposal by the New Zealand Ministry of Health Manatū Hauora that calls for reducing the amount of nicotine allowed in smoked tobacco products to “minimal levels.” When enacted, the proposal will help existing adult smokers to reduce their consumption or switch to alternative products and would protect young people from cigarette addiction.

“We applaud the New Zealand government for the proactive approach they are taking to help their citizens break their cigarette addiction. We were expecting this proposal and are fully prepared to help New Zealand to reach its goal,” said James A. Mish, chief executive officer of 22nd Century Group. “New Zealand has made great progress since announcing their goal of becoming smoke-free by 2025, but in order for the country to finally achieve success it is imperative that the amount of nicotine in cigarettes is reduced 95% to ‘minimal levels.’ We are pleased to see that the New Zealand government recognizes the technical feasibility of this approach.”

22nd Century initially engaged with public health researchers in New Zealand in 2016, when the country announced its goal of becoming smoke-free, leading the New Zealand Medical Journal to publish a letter recommending 22nd Century’s reduced nicotine content (RNC) cigarettes as an “important smoking reduction tool.” Given its position as the sole supplier of RNC cigarettes used in public health research, the authorization by FDA of its Premarket Tobacco Application (PMTA) for RNC cigarettes, and its readiness to commercialize RNC cigarettes at commercial scale, 22nd Century is well-positioned to supply RNC cigarettes to the New Zealand market in support of the implementation of its 2025 initiative.

New Zealand has played a key role in past smoking reduction initiatives that have eventually been adopted globally. 22nd Century also expects other countries, including Australia and Canada as well as the World Health Organization (WHO), will call to reduce the amount of nicotine allowed in cigarettes sold in their countries and around the world. “New Zealand has so often been at the vanguard of the right policy for a just and thriving society, being the first self-governing nation to give women the vote in 1893, and it continues to this day to provide inspirational leadership. We recognize the disproportionate burden that cigarette addiction has on minority and vulnerable communities in New Zealand, as it does in the U.S., and stand ready to play our part in addressing this key societal and health issue,” added John Pritchard, vice president of regulatory science at 22nd Century Group.

“We know other countries and the WHO will be further encouraged by New Zealand, and 22nd Century has already advanced dialogue with a number of these interested parties. With the U.S. Food and Drug Administration [FDA] continuing its review of the ANPRM, to see another country putting forward such proposals is a significant development for global public health and our commercial interest. I am confident that the FDA will move quickly to enact its mandate to reduce the nicotine content in all cigarettes sold in the U.S. to ‘minimally or non-addictive levels,’ as it proposed in its 2017 Comprehensive Plan for Tobacco and Nicotine Regulation,” said Mish.

22nd Century’s VLN^® RNC cigarettes contain just 0.5 milligrams of nicotine per gram of tobacco, 95% less nicotine than conventional cigarette brands, which is exactly in line with the New Zealand proposal. It is the only combustible tobacco product that complies with the FDA’s proposed nicotine rule and has already been authorized to be sold in the U.S. through the FDA’s PMTA pathway. Numerous independent scientific studies, funded largely by the FDA, the (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 believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for its RNC cigarette, VLN^®. The 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 it 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 alternative to addictive, traditional 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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/04/15/2211315/0/en/22nd-Century-Stands-Fully-Prepared-to-Enable-New-Zealand-Proposal-to-Advance-Nationwide-Smoke-Free-Action-Plan.html

BUFFALO, N.Y., April 08, 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’s Vice President of Regulatory Science, John Pritchard, will represent 22nd Century as a new member of the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Committee. The Committee brings together a diverse group of stakeholders, including public health researchers, leaders of non-governmental organizations, and members of the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to discuss tobacco product regulation and policy.

“We are proud that John has been invited to serve on the highly regarded FDLI Tobacco and Nicotine Product Committee and to represent 22nd Century in this forum,” said James A. Mish, chief executive officer of 22nd Century Group. “Our organization is fortunate to have a number of experts on our leadership team, and it is important that we play an active role in moving the tobacco industry forward to reduce the harm caused by smoking. The status quo of cigarette addiction must end, and we are delighted that John will serve on this committee to educate the industry about 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application for our VLN^® reduced nicotine content cigarettes, which we are highly confident is in the final stages of review by the FDA. John will also spend this year supporting the committee’s programs and advocating for the FDA to implement the Agency’s proposed mandate to set a maximum level of nicotine in cigarettes of 0.5 milligrams of nicotine per gram of tobacco, a level already achieved in our VLN^® cigarettes, and previously deemed by the FDA to ‘minimize addictiveness’.”

The FDA’s proposed tobacco product standard for nicotine level of combustible cigarettes, which was published in March 2018 as an Advance Notice of Proposed Rulemaking (ANRPM), is the cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation. The FDA’s plan seeks to lower the nicotine content of all cigarettes to a “minimally or non-addictive” level. The creation of a proposed nicotine cap could decrease the chances that future generations become addicted to cigarettes and could make it easier for currently addicted smokers to quit. Public health researchers project that the enactment of a nicotine cap would help more than five million people to quit smoking within the first year of implementation and save more than eight million American lives by the end of the century. A recent survey reported by the Centers for Disease Control and Prevention (CDC) found that 80% of adults in the United States are in favor of lowering nicotine levels in cigarettes to make them less addictive.

“With respiratory health front and center in everyone’s minds, there has never been a more critical time to advance effective public health policy and regulation in the area of tobacco control. Cigarette addiction is the leading cause of preventable death in the United States and having the opportunity for multi-stakeholder dialogue is an essential part of achieving this,” said Pritchard. “I have a tremendous amount of respect for the FDLI, and I look forward to contributing my experience to the organization.”

Pritchard started in his regulatory role at 22nd Century in 2019 and brings more than 20 years of scientific and regulatory experience in the tobacco and pharmaceutical industries, as well as public health experience, to the committee. At 22nd Century, he oversees global regulatory and compliance activities, which includes stewardship of the Company’s MRTP application for its VLN^® cigarettes.

Made from proprietary tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN^® is the only combustible tobacco product that complies with the FDA’s proposed nicotine cap. 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 it is in the final stages of the FDA’s application process to obtain a MRTP designation for VLN^®. The 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 technology to enable every cigarette manufacturer to comply with the FDA’s proposed nicotine cap that will significantly 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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/04/08/2206881/0/en/22nd-Century-Group-Regulatory-Science-VP-Joins-FDLI-Tobacco-and-Nicotine-Products-Committee.html

• 22nd Century’s Proprietary VLN^® King and VLN^® Menthol King Poised to Play a Central Role in Making FDA’s Reduced Nicotine Mandate Feasible
• MRTP Authorization of VLN^® King and VLN^® Menthol King Will Serve as a Major Catalyst for the FDA to Accelerate Rule
• Containing 95% Less Nicotine than Traditional Cigarettes, VLN^® is the Only Combustible Tobacco Product that Complies with the FDA’s Proposed Nicotine Cap

WILLIAMSVILLE, N.Y., April 01, 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 it continues to be confident on the renewal of the FDA’s proposed reduced nicotine mandate that would make all cigarettes “minimally or non-addictive.” By way of support, four former U.S. Food and Drug Administration (FDA) commissioners, Robert M. Califf, M.D. MACC; Scott Gottlieb, M.D.; Peggy Hamburg, M.D.; and, Jane Henney, M.D., spoke on a recent panel and were vocal in their endorsement of the mandate to limit the amount of nicotine in cigarettes to levels already achieved by 22nd Century’s reduced nicotine content cigarettes, VLN^®.

During the panel discussion, Dr. Gottlieb, who first established the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation in 2017, remarked: “[c]ertainly if a Republican administration can begin a process to regulate nicotine in combustible tobacco, I suspect that it’s going to be taken forward by a Democratic administration.” Dr. Hamburg also pointed out that, “[n]ow is the time…to really address a whole range of [tobacco] issues that [the] FDA is now empowered to act on.”

“Coming from such a group of experienced and authoritative assembly of public health figures, the comments made during the STAT webcast are a powerful endorsement of the FDA’s plan to implement a reduced nicotine product standard,” said James A. Mish, chief executive officer at 22nd Century. “Over the past year, COVID-19 has brought the criticality of respiratory health to the forefront of public concerns. The FDA has the authority and responsibility to change the trajectory of public health in the U.S., save millions of lives, and protect future generations from addiction by enacting a reduced nicotine mandate. We believe that the Agency will advance their Comprehensive Plan and soon announce its simple, yet powerful reduced nicotine product standard. This will be a grand slam for 22nd Century.”

22nd Century shares the former FDA Commissioners’ enthusiasm. With the recent change in administration at the White House, and Democratic control of both the Senate and the House of Representatives, the Company believes there will be a high focus on improving public health moving forward. The Biden administration is placing public health as a top priority and recently issued a proclamation “strongly committing to improving the prevention and treatment of cancer.” In addition, the appointment of Xavier Becerra as Secretary of the U.S. Department of Health and Human Services (HHS), a long-time proponent of tougher regulation for the tobacco industry, further points to a favorable political climate for the renewal of the reduced nicotine mandate that is projected to help more than five million people to quit smoking within the first year of implementation and save more than eight million American lives by the end of the century.

Made from tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN^® is the only combustible product that complies with the FDA’s proposed nicotine cap. 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 believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for VLN^®. The 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, traditional 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 also remains willing to license its technology to enable every cigarette manufacturer to comply with the FDA’s proposed nicotine cap that will significantly 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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/04/01/2203438/0/en/Multiple-Former-FDA-Commissioners-Voice-Support-for-Reduced-Nicotine-Mandate-Proposed-Legislation-Would-Be-Game-Changing-for-22nd-Century.html

WILLIAMSVILLE, N.Y., March 19, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today congratulated Xavier Becerra as the new Secretary of the U.S. Department of Health and Human Services (HHS). The Company believes that Becerra’s confirmation may reignite the U.S. Food and Drug Administration’s (FDA) ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to render all cigarettes “minimally or non-addictive.”

“We congratulate Secretary Becerra on his well-deserved confirmation to this critically important role,” said James A. Mish, chief executive officer of 22nd Century. “Among his many accomplishments, Secretary Becerra has demonstrated leadership when it comes to one of the most important public health crises of our time: tackling cigarette addiction. 22nd Century urges the HHS to continue this important work by implementing a nicotine cap for all combustible cigarettes to a ‘minimally or non-addictive’ level. We look forward to joining Secretary Becerra, the HHS, and the FDA on tackling the pressing public health tragedy caused by addictive cigarettes that is costing millions of Americans lives and billions of dollars each year.”

Secretary Becerra is a long-time proponent of a reduced nicotine cap for cigarettes and tougher regulation for the tobacco industry. While serving as the attorney general of California in 2018, Becerra and five other attorney generals wrote a letter in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM), strongly supporting a tobacco product standard for nicotine level of combusted cigarettes. In the letter, Becerra, and others highlighted their “extensive interest in and engagement with tobacco policy, regulation, and enforcement” and their “substantial experience and expertise regulating the tobacco industry”. They also “applaud[ed] FDA for considering a nicotine product standard” and stated that “[t]he nicotine standard should apply to all combusted products.” The appointment of Becerra as Secretary of HHS is yet another signal from the Biden Administration that points to a favorable political climate for the renewal of the reduced nicotine mandate and a continued outsized focus on improving public health. Public health researchers project that the enactment of a nicotine cap will help more than five million people to quit smoking within the first year of implementation and will save more than eight million American lives by the end of the century.

Engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN® is the only combustible product that complies with the FDA’s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the (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 believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for VLN®. The 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 it 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 alternative to addictive, traditional 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 committed to licensing its technology to every cigarette manufacturer so that Big Tobacco can join in the 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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/03/19/2196360/0/en/Becerra-Confirmation-Boosts-22nd-Century-s-Position-to-Disrupt-Tobacco-Industry.html

WILLIAMSVILLE, N.Y., March 12, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today announced that it has received an additional $3.7 million, for total net proceeds of $11.8 million, from the completion of the cash exercise of warrants during February and March of 2021. Following this transaction, the Company is free of any outstanding warrants.

“We are pleased to further strengthen our balance sheet from the complete exercise of these remaining warrants while simplifying and effectively managing our capital structure,” said James A. Mish, chief executive officer of 22nd Century Group. “We intend to use these proceeds in support of near-term, disruptive growth opportunities in both our tobacco and hemp/cannabis franchises. These include sales, licensing, and partnership opportunities upon securing Modified Risk Tobacco Products (MRTP) authorization for VLN^® and further development of our upstream capabilities in the cannabinoid value chain.”

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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/03/12/2192175/0/en/22nd-Century-Group-Receives-Additional-3-7-Million-from-Cash-Exercise-of-Outstanding-Warrants.html

Key Business and Financial Highlights

• 22nd Century has a tremendous global commercial opportunity in the more than $800 billion markets across the tobacco and hemp/cannabis industry.
• Securing Modified Risk Tobacco Product (MRTP) authorization for VLN^® remains 22nd Century’s number one priority. The Company is highly confident that the FDA is in the final stages of the review process related to its application.
• 22nd Century is fully prepared and eager to launch VLN^® King and VLN^® Menthol King within 90 days of receiving MRTP designation. MRTP designation is a catalyst for the VLN^® brand and tobacco franchise via partnerships and licensing agreements in the U.S. and internationally.
• 22nd Century believes that recent political changes will likely be highly favorable to its business prospects from a policy priority and regulatory standpoint. The Company believes that, under the new administration, the FDA will now be re-energized in implementing its ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to cap the amount of nicotine in combustible cigarettes to a “minimally or non-addictive” level.
• The Company has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the hemp/cannabis value chain. The partnerships will enable 22nd Century to accelerate the new development of valuable, commercial hemp/cannabis lines and intellectual property to market in two years while it monetizes a portion of the Company’s current portfolio of intellectual property (IP) from its previous license agreement with Anandia Laboratories. 22nd Century is also in final discussions with top-tier plant breeders that will be announced soon.
• Net sales revenue of $7.3 million for the fourth quarter was consistent over the prior-year period and improved by 8.8% to $28.1 million for the full-year.
• Gross profit for the fourth quarter improved by $364 thousand and by $1.4 million for the full-year; gross profit margin improved by 500 basis points for both periods.
• Net loss increased by $207 thousand for the fourth quarter. For the full-year, net loss improved by $6.8 million.
• Adjusted EBITDA was unfavorable by $1.3 million for the fourth quarter. For the full-year Adjusted EBITDA improved by $1.8 million.
• The Company’s balance sheet is well funded with $22.3 million at the end of full-year 2020. Additional cash of $11.8 million received from warrants exercised in February and March 2021 will provide the Company with additional runway to fuel current operations, strategy, and growth initiatives. 22nd Century does not have any outstanding warrants following these transactions.

Note: All financials referenced in this release are in conformity with U.S. Generally Accepted Accounting Principles (“GAAP”) and comparisons in this release are to the same period in the prior year unless otherwise noted.

WILLIAMSVILLE, N.Y., March 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 filed its Annual Report on Form 10-K with the U.S. Securities and Exchange Commission. The Company will provide a business update for investors on a live audio webcast to be held today at 8:00 a.m. ET.

James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, president and chief operating officer, and John Franzino, chief financial officer, will host the webcast. Interested parties are invited to participate by visiting the Events section on the Company’s Investor Relations website at www.xxiicentury.com/investors/events. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from industry analysts. Investors, shareholders, and members of the media will also have the opportunity to submit their questions through the interactive webcast.

“Since joining 22nd Century Group in June, we have communicated our strategic plan and go forth strategy. Our stock price has increased significantly since reporting third quarter earnings demonstrating our commitment to our shareholders,” said James A. Mish, chief executive officer of 22nd Century Group. “As we look to 2021, we see tremendous commercial opportunity for our tobacco and hemp/cannabis franchises. Our focus remains on our primary mission: to reduce the harm caused by smoking. Once we secure MRTP designation, we will capitalize on our VLN^® brand and begin to build our tobacco franchise through licensing and partnership opportunities in the U.S. and internationally. We have made significant progress in our hemp/cannabis research and look forward to monetizing a portion of our hemp/cannabis IP this year. With the majority of our hemp/cannabis operational partnerships now in place, we believe we will be able to commercialize our new disruptive, commercially valuable hemp/cannabis plants in development in two years.”

Tobacco Franchise Highlights and Recent Key Events

• Over the past several months, 22nd Century has been executing on the strategic plan that it announced on its third quarter earnings call in November 2020. The Company continues to focus on its primary mission and highest, near-term priority of securing MRTP authorization for its proprietary, reduced nicotine content tobacco cigarettes, VLN^®. The Company is maintaining its dialogue with the FDA and is highly confident that the Agency is in the final stages of the review process related to its application. In addition to its ongoing contact with the FDA, 22nd Century has been and continues working with various legal advisers, regulatory consultants, and government affairs specialists to highlight the public health importance of its MRTP application to encourage a near-term authorization of its application.
• 22nd Century is fully prepared to make VLN^® available to adult smokers in the U.S. within 90 days of receiving MRTP authorization from the FDA and is in advanced discussions with potential partners in the independent, regional, and national retail trade. The Company anticipates a phased roll out of VLN^® in select geographies and plans to position VLN^® in the premium pricing segment of the cigarette market and, therefore, expects it to deliver corresponding margins. On January 11, 2021, 22nd Century announced that it will significantly expand its growing program and an increase in planting in the 2021 crop year for VLN^® based on the Company’s latest sales projections. This new planting is in addition to the Company’s sizeable inventory of VLN^® tobacco, which is earmarked for the launch and initial sales of VLN^® cigarettes.
• The Company believes that recent political changes will likely be highly favorable to its business prospects from a policy priority and regulatory standpoint. It also believes that the new administration will likely have an impact on the timing of its MRTP application based on the Company’s positive and relentless approach with the FDA through multiple channels. 22nd Century has already begun work to align with the new administration and to encourage their support.
• Additionally, the Company believes that under the new administration, the FDA will now be re-energized in implementing its ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to cap the amount of nicotine in combustible cigarettes to a “minimally or non-addictive” level. 22nd Century believes that the MRTP authorization and the launch of VLN^® will serve as a vanguard for the FDA’s proposed mandate and maintains its bullish outlook on the implementation of a nicotine cap for combustible cigarettes.
• The Company’s research cigarettes, SPECTRUM^®, continue to fuel numerous independent, scientific studies to validate the enormous public health benefit identified by the FDA and others of implementing a national standard requiring all cigarettes to contain “minimally or non-addictive” levels of nicotine. On December 8, 2020, 22nd Century announced that the FDA in coordination with the National Institute on Drug Abuse (NIDA) and others, submitted an order to 22nd Century for 3.6 million variable nicotine research cigarettes. In March 2021, the Company will fulfill the order bringing the total number of research cigarettes provided for public health research to more than 31 million cigarettes.
• 22nd Century believes that its next-generation, non-GMO, plant research is the key to commercializing its reduced nicotine content tobacco and technology in international markets where non-GMO products are preferred, or GMO products are banned. It continues to make significant progress in its non-GMO tobacco research. During the fourth quarter of 2020, 22nd Century confirmed that it has successfully applied its non-GMO technology to Bright and Burley varieties of tobacco and has developed a VLN^® 2.0 prototype cigarette. The Company is also using its non-GMO technology to introduce reduced nicotine traits into Oriental varieties of tobacco. 22nd Century believes that decades of experience with the tobacco plant will provide it with the ability to accelerate the development of additional tobacco-based technologies for multiple applications across various end-use markets beyond reduced nicotine content tobacco products.

Hemp/Cannabis Franchise Highlights and Recent Key Events

• Since reporting third quarter earnings, 22nd Century continues to place a renewed emphasis on its hemp/cannabis strategy to target the upstream segments of the cannabinoid value chain, in particular, in the areas of plant biotechnology research, gene modification and engineering, modern plant breeding and development, and extraction. The Company believes that it can differentiate itself in the hemp/cannabis industry by building upon its core strength and expertise in plant science and in the ingredient value chain and through its operational partnerships; including the addition of its new operational partner, CannaMetrix. 22nd Century continues to shift its focus away from the already saturated U.S. consumer market of cannabidiol (CBD) and hemp-based products and has refocused its partnership with Panacea, through a non-binding agreement, to provide ingredient cultivation capabilities and extraction and purification services. The agreement will provide the Company with operational assets, including Needle Rock Farms and various extraction and distillation equipment.
• Over the past year, the Company has made tremendous progress with KeyGene in its hemp/cannabis research. In March 2020, the Company announced that it has built its proprietary bioinformatics platform and can begin monetizing a portion the vast knowledge foundation and intellectual property it has developed over the past year. 22nd Century believes that its collaborative efforts with KeyGene enable the Company to modify and improve the hemp/cannabis plant using the fastest and most cost-effective methods available. The Company continues to target and develop hemp/cannabis lines with select agronomic traits including lines with stable, ultra-high tetrahydrocannabinol (THC) levels, lines with higher levels of rare cannabinoids, and lines with ultra-low terpene levels.
• On February 10, 2021, 22nd Century Group announced that it has developed and launched a new, cutting-edge technology platform that will enable the Company and its strategic partners to quickly identify and incorporate commercially valuable traits of hemp/cannabis plants to create new, stable hemp/cannabis lines. The platform, developed in collaboration with researchers at KeyGene, incorporates a suite of proprietary molecular tools and a large library of genomic markers and gene-trait correlations. 22nd Century has already characterized millions of high-value single nucleotide polymorphisms (SNPs). By targeting these newly identified SNPs, the Company has been able to locate and isolate specific sections of genetic code from genome assemblies present in the Company’s state-of-the-art hemp/cannabis bioinformatics database. This major breakthrough enables 22nd Century Group to quickly and easily identify the genes responsible for specific traits in a plant and is a powerful tool for the Company and the hemp/cannabis industry. The Company has already begun discussions to license this platform to strategic partners to help them improve their plant breeding techniques and optimize their hemp/cannabis lines.
• The Company continues to secure commercially valuable patents and intellectual property through its internal research capabilities and external research partnerships. On December 17, 2020, the Company announced that it was granted a new U.S. Patent No. 10,787,674 B2 entitled “Trichome specific promoters for the manipulation of cannabinoids and other compounds in glandular trichomes.” This new intellectual property enables 22nd Century to develop and deliver new hemp/cannabis plants that are designed to produce cannabinoids more efficiently by activating the molecular promoters, “on/off switches,” specifically and only in the plant’s trichomes where the majority of cannabinoids are produced. The patent application describes eight promoters covering all of the major steps in the cannabinoid biosynthesis pathway and is related to the control of cannabinoid and terpene production. The Company believes it can monetize a portion of its existing hemp/cannabis intellectual property in 2021 and will continue to bring new, disruptive technology forward.
• On March 3, 2021, 22nd Century announced that it has secured an exclusive agreement with CannaMetrix, LLC for the use of their proprietary, human cell-based testing CannaMetrix EC50Array™ technology that will enable it to accelerate the commercialization of new, disruptive hemp/cannabis plant lines and intellectual property. CannaMetrix’s proprietary CannaMetrix EC50Array™ technology serves as a high-throughput roadmap for developing new hemp/cannabis plant lines with tailor-made cannabinoid and terpenoid profiles for use in the life science, consumer product, and pharmaceutical markets. The human cell-based assay has the ability to measure and validate the potency and efficacy of cannabinoids and/or terpenoids through defined biomarkers and receptor activity, and can rapidly identify optimum plant profiles by measuring the potency and effect on the human cell system.
• 22nd Century believes that it can accelerate the development of commercially, valuable hemp/cannabis lines and related intellectual property through selective partnerships and has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant cultivation (Panacea-Needle Rock Farms), and ingredient extraction/purification (Panacea). The Company is also in final discussions with top-tier, plant breeders that will be announced soon. The new partnership with CannaMetrix combined with 22nd Century’s worldwide, exclusive agreement with KeyGene, and the refocused strategy with its partnership with Panacea will enable the Company to bring new commercially valuable hemp/cannabis plant lines to market in as quickly as two years.

2021 Priorities and Areas of Focus

1. 22nd Century remains focused on securing FDA authorization for VLN^®, the only reduced nicotine content combustible cigarette in the world that will receive a MRTP designation from FDA. The Company plans to execute a commercial product launch and will seek licensing and partnership initiatives within 90 days of authorization.
2. The Company believes that an equally important first priority initiative is to support and advance the FDA’s plan to require all cigarettes sold in the U.S. be made “minimally or non-addictive” by limiting their nicotine content to just 0.5 milligrams of nicotine per gram of tobacco.
3. 22nd Century continues to target the upstream segment of the cannabinoid value chain by creating proprietary, commercially valuable new plant lines and related intellectual property with stabilized genetics to harness and optimize hemp/cannabis plant potential. The Company expects to monetize a portion of its existing hemp/cannabis IP in 2021 and will continue to bring disruptive technology forward.
4. The Company will turn attention to the development of a third, plant-based franchise after securing MRTP authorization for VLN^®. 22nd Century will leverage its plant science expertise to develop and secure valuable intellectual property and sign lucrative strategic partnerships to support the development of this franchise.
5. 22nd Century will maintain diligent financial execution, efficient operating structure, and balance sheet strength to support its growth initiatives.

Fourth Quarter and Full-Year 2020 Financial Results

• Net sales revenue for the fourth quarter of 2020 increased $46 thousand, or 0.6% to $7.3 million compared to the prior-year period. For full-year 2020, net sales revenue increased $2.3 million, or 8.8% to $28.1 million compared to the prior-year. The increase for both periods was primarily driven by higher volume and increased pricing in the Company’s contract manufacturing business.
• Gross profit for the fourth quarter improved by $364 thousand, or 161.8% to $588 thousand compared to the prior-year period. For full-year 2020, gross profit improved by $1.4 million, or 9,413% to $1.4 million. The improvement in gross margin was primarily the result of higher volume, price increases, and lower labor and overhead costs driven by factory efficiencies implemented in 2020.
• Total operating expenses for the fourth quarter of 2020 increased by $1.1 million compared to the prior-year period. For full-year 2020, operating expenses decreased by $3.0 million compared to the prior-year. This was driven by the following:
  • Research and development expense for the fourth quarter of 2020 was favorable by $127 thousand compared to the prior year period. For full-year 2020, research and development expense was also favorable by $2.3 million compared to the prior year. This was primarily driven by a reduction in personnel expense, lower license and contract costs, and the absence of a one-time impairment charge taken on research tobacco leaf inventory in the prior year.
  • Research and development expense related to the MRTP application was favorable by $205 thousand for the fourth quarter compared to the prior year period. For full-year 2020, research and development expense related to the MRTP application was favorable by $1.6 million compared to the prior year. The favorability was primarily the result of expenses incurred in 2019 that were associated with the preparation for the Company’s Tobacco Products Scientific Advisory Committee (TPSAC) hearing which occurred on February 14, 2020.
  • For the fourth quarter of 2020, sales, general and administrative expense increased by $1.3 million compared to the prior year period. This was driven primarily by higher insurance, consulting, and personnel expense which were partially offset by lower legal fees.
  • For the full-year 2020, sales, general and administrative expense increased by $2.0 million compared to the prior year. This was driven primarily by insurance expenses, consulting and professional services, and the addition of new members to the Company’s management team, including its newly appointed Chief Executive Officer and Chief Financial Officer. The increase was partially offset by a decrease in one-time severance and equity compensation expenses that occurred in 2019, legal fees, and travel and entertainment savings as a result of the COVID-19 pandemic.
  • Impairment of intangible assets for the fourth quarter of 2020 increased by $30 thousand compared to the prior year period. For full-year 2020, impairment of intangible assets decreased by $966 thousand compared to the prior year. The decrease year-over-year was related to an intellectual property portfolio rationalization that resulted in higher impairment in 2019.
• For the fourth quarter of 2020, operating loss was unfavorable by $696 thousand compared to the prior year period. This was primarily driven by an increase in SG&A and was partially offset by higher gross profit and lower research and development spend related to the MRTP application in 2019.
• For full-year 2020, operating loss improved by $4.4 million to $(19.2) million compared to the prior year driven by the combination of higher gross profit of $1.4 million and lower total operating expenses of $20.6 million. The decrease in operating expenses were primarily driven by a decrease in research and development expenses related to the MRTP application in 2019, a reduction in personnel expense, and an intellectual property portfolio rationalization that resulted in higher impairment in the prior year.
• Net loss for the fourth quarter of 2020 was $(6.4) million, representing a net loss per share of $(0.05) as compared to a net loss of $(6.2) million, or a net loss per share of $(0.05) for the fourth quarter of 2019.
• Net loss for full-year 2020 improved by $6.8 million to $(19.7) million, representing a net loss per share of $(0.14) as compared to a net loss of $(26.6) million, or a net loss per share of $(0.21). In addition to the improvement in operating loss of $4.4 million, other income and expense improved by $2.5 million primary due to a $1.9 million litigation expense and a reduction in the unrealized loss on Aurora warrants of $2.4 million recorded in the prior year. This was partially offset in the current year by an impairment charge of $1.7 million related to the Panacea stock warrant investment.
• Adjusted EBITDA was $(5.4) million for the fourth quarter of 2020 compared to Adjusted EBITDA of $(4.1) million for the fourth quarter 2019.
• Adjusted EBITDA was $(15.6) million for full-year 2020, an improvement of $1.8 million compared to Adjusted EBITDA of $(17.5) million for full-year 2019.

Balance Sheet and Liquidity

• For twelve months 2020, net cash used in operating activities was approximately $15.6 million, compared to approximately $14.6 million for the twelve months in 2019.
• The Company’s liquidity remains strong with cash, cash equivalents, and short-term investment securities totaling approximately $22.3 million as of December 31, 2020.
• The Company does not have any plans or need to raise capital at this time. It believes the continued improvement in quarterly cash burn rate, an ongoing reduction in costs, a healthy cash position, and the addition of $11.8 million to its balance sheet from an exercise on previously issued stock warrants should provide the Company with additional runway to execute for the foreseeable future.

Fourth Quarter Earnings Conference Call

22nd Century will host a live audio webcast today at 8:00 a.m. ET to discuss its full-year 2020 financial results and business highlights. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from interested analysts. Investors, shareholders, and members of the media will also have the opportunity to pose questions to management by submitting questions through the interactive webcast during the event.

James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, chief operating officer, and John Franzino, chief financial officer, will host the webcast. Interested parties are invited to participate by visiting the Events section on the Company’s Investor Relations website at www.xxiicentury.com/investors/events.

An archived replay of the webcast and the event transcript will be available shortly after the live event has concluded.

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 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.

Below is a table containing information relating to the Company’s Adjusted EBITDA for the three and twelve months ended December 31, 2020 and 2019, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.

¹Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA

¹Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA

Adjusted EBITDA, which the Company defines as earnings before interest, taxes, depreciation and amortization, as adjusted by the Company for certain non-cash and non-operating expenses, as well as certain one-time expenses, is a financial measure not prepared in accordance with generally accepted accounting principles (“GAAP”). In order to calculate Adjusted EBITDA, the Company adjusts the net (loss) income for certain non-cash and non-operating income and expense items listed in the table above in order to measure the Company’s operating performance. The Company believes that Adjusted EBITDA is an important measure that supplements discussions and analysis of its operations and enhances an understanding of its operating performance. While management considers Adjusted EBITDA to be important, it should be considered in addition to, but not as a substitute for or superior to, other measures of financial performance prepared in accordance with GAAP, such as operating loss, net (loss) income and cash flows from operations. Adjusted EBITDA is susceptible to varying calculations and the Company’s measurement of Adjusted EBITDA may not be comparable to those of other companies.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/03/11/2191199/0/en/22nd-Century-Group-Reports-Business-Highlights-and-Financial-Results-for-the-Fourth-Quarter-and-Full-Year-2020.html

WILLIAMSVILLE, N.Y., March 05, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today announced that members of its management team will participate in three investor conferences during March 2021.

Institutional investors and those invited to attend these virtual conference events may request one-on-one meetings with representatives of the Company through the respective conference hosts or by contacting 22nd Century Group’s investor relations via [email protected].

Events 22nd Century Group will participate in include:

The DA Davidson 4th Annual Consumer Growth Conference, March 11, 2021
One-on-one meetings will be available on the afternoon of Thursday, March 11. To request a meeting, please contact your DA Davidson sales representative.

The 33rd Annual Roth Conference, March 15-17, 2021
One-on-one and small group meetings will be available on Tuesday, March 16. Additional times may be available to accommodate meeting requests as needed. To request a meeting, please contact your Roth sales representative.

The Investor Summit Virtual Conference, March 23-25, 2021
James A. Mish, chief executive officer of 22nd Century, will provide an overview presentation of the Company. An audio webcast of the presentation will be available through 22nd Century’s Events web page in the Company’s Investor Relations section of the website, at www.xxiicentury.com/investors/events. One-on-one meetings will be available on Tuesday, March 23. To request a meeting, please contact your Investor Summit Group representative.

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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/03/05/2188033/0/en/22nd-Century-Group-to-Participate-in-Investor-Conferences-in-March-2021.html

WILLIAMSVILLE, N.Y., March 04, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today announced that it has received net proceeds of $8.1 million from the cash exercise of outstanding warrants during February and March of 2021. The remaining warrants, if exercised for cash, will bring additional net proceeds of $3.7 million in cash to the Company. Following the above transaction, the Company will no longer have any outstanding warrants.

“We are pleased to further strengthen our balance sheet with $8.1 million from the exercise of these existing warrants that were already a consideration in our fully diluted capital structure,” said James A. Mish, chief executive officer of 22nd Century Group. “The capital will provide us with additional runway to further fuel our current operations, strategy, and growth initiatives including near-term opportunities in both our tobacco and hemp/cannabis franchises. We look forward to securing Modified Risk Tobacco Products (MRTP) authorization, launching VLN^®, and building the VLN^® brand. The additional cash will also support our hemp/cannabis R&D initiatives and the development of our third franchise in 2021.”

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
[email protected] 

Published on : http://www.globenewswire.com/news-release/2021/03/04/2187254/0/en/22nd-Century-Group-Receives-8-1-Million-from-Cash-Exercise-of-Outstanding-Warrants.html

WILLIAMSVILLE, N.Y., March 03, 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 it has secured an exclusive agreement with CannaMetrix, LLC for the use of their proprietary, human cell-based testing CannaMetrix EC50Array™ technology that will enable 22nd Century to accelerate the commercialization of new, disruptive hemp/cannabis plant lines and intellectual property.

Since reporting third quarter earnings, 22nd Century has refocused its hemp/cannabis strategy to target the upstream segments of the cannabinoid value chain. In particular, the Company seeks to accelerate the delivery of valuable, commercial-scale plant lines and intellectual property for the life science, consumer product, and pharmaceutical end-use markets. With the addition of CannaMetrix, 22nd Century has now secured four out of the five key partnerships needed to maximize each component in the upstream segment of the cannabinoid value chain: plant profiling (CannaMetrix), plant biotechnology (KeyGene), plant cultivation (Panacea-Needle Rock Farm), and ingredient extraction/purification (Panacea). The Company is also in final discussions with top-tier, plant breeders that will be announced soon.

“22nd Century is extremely excited to add CannaMetrix into our secured network of value chain partners to increase the speed at which we develop and offer disruptive plant lines and intellectual property for the hemp/cannabis industry. For example, a plant line that would typically take ten years or longer to develop can now be achieved in two years,” said James A. Mish, chief executive officer of 22nd Century Group. “As we monetize our current IP portfolio starting in 2021, our upstream hemp/cannabis partnerships will enable us to rapidly offer additional disruptive, commercially valuable plant lines at large scale and increased, stable yields to very attractive hemp/cannabis end-use markets. We are excited and absolutely confident in the future innovation and value creation that will stem from these coordinated strategic partnerships.”

“We are thrilled to collaborate with 22nd Century Group,” stated Harold Smith, Ph.D. founder, and chief executive officer of CannaMetrix. “They are the ideal partner, bringing decades-long experience in plant biotechnology with unmatched ability in developing valuable, commercial plant lines. We believe that through this exclusive partnership the development of new hemp/cannabis lines for large-scale cultivation and production will advance at a rapid pace and transform the hemp/cannabis industry.”

CannaMetrix’s proprietary CannaMetrix EC50Array™ technology serves as a high-throughput roadmap for developing new hemp/cannabis plant lines with tailor-made cannabinoid and terpenoid profiles for use in the life science, consumer product, and pharmaceutical markets. The human cell-based assay has the ability to measure and validate the potency and efficacy of cannabinoids and/or terpenoids through defined biomarkers and receptor activity, and can rapidly identify optimum plant profiles by measuring the potency and effect on the human cell system.

About CannaMetrix, LLC.
Founded in 2016, CannaMetrix, LLC is a leader in gene and cell engineering. Their method development has focused on rapid, human cell-based testing with their proprietary CannaMetrix EC50Array™ technology. This technology measures, validates, and quantifies the potency and efficacy of cannabinoids and terpenoids derived from plants or synthetic products in living human cells. CannaMetrix addresses an unmet need in the industry with their rapid test of cannabis product potency based on actual biological responses to products that currently can only be inferred from chemical composition analyses of plant materials. Characterizing products by their chemical content and ability to evoke defined biological effects will be crucial to the development of differentiated products for the consumer end-market. The EC50Array™ technology will help accelerate development and calibrate cannabis lines for specific applications.

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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/03/03/2186301/0/en/22nd-Century-Group-Secures-Exclusive-Agreement-with-CannaMetrix-to-Accelerate-Commercialization-of-New-Disruptive-Hemp-Cannabis-Plant-Lines-and-Intellectual-Property.html

纽约州威廉斯维尔, Jan. 13, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc.（NYSE American: XXII）是一家领先的植物性生物技术公司，专注于减少烟草危害的超低尼古丁含量烟草和大麻研究。该公司今天宣布，依据其最新的销售预测结果，公司将显著扩大VLN^®低尼古丁含量烟草的种植计划。VLN^®烟草的增加种植是该公司已经具备相当规模的VLN^®存量的补充，这种烟草被指定用于22nd Century的VLN^®低尼古丁含量香烟的推出和初始销售。22nd Century关于VLN^®香烟的的风险改良烟草产品（MRTP）申请目前正在接受美国食品药品管理局（FDA）最后阶段审查。一旦获得授权，22nd Century将开始销售其VLN^®香烟。与传统香烟品牌相比，这种香烟的尼古丁含量减少了95% 。届时22nd Century将拥有获FDA认可改良风险声称的唯一可燃性香烟产品，而这可能成为22nd Century商业销售的一个催化剂，即使只获取美国烟草销售中的一小部分，也可能使该公司的收入和市值呈指数级增长。

“我们准备在获得FDA市场营销授权后90天内推出我们的VLN®香烟”，22nd Century集团首席执行官James A. Mish表示。“美国有超过3400万吸烟者。研究表明，这些吸烟者中的大多数都在寻找替代产品。在看到展示的VLN^®样品后，我们研究项目中60%的成人吸烟者表示有意使用VLN^®香烟。此外，2019年美国疾病控制和预防中心（CDC）的一项调查发现，80%的美国吸烟者赞成减少香烟中的尼古丁含量。我们相信成人吸烟者将对VLN^®非常感兴趣，而这种新的VLN^®烟草将帮助我们实现基于最新销售预测的预期需求。”

Mish还表示：“除了向美国吸烟者推出VLN^®之外，我们还坚定致力于向每一家香烟制造商发放我们的技术许可，以便他们能够遵循FDA实现所有香烟“不致瘾”的计划。我们期待着烟草行业能够和我们一道真正减少吸烟所造成的危害，保护子孙后代免遭烟瘾之害。”

22nd Century与选定烟草种植方合作，在整个美国烟草种植带推广新的VLN^®烟草，为美国处境艰难的家庭农户创造一项新的收入来源。该公司的专有技术低尼古丁含量烟草平均每克仅含0.5毫克尼古丁，与每克烟草含20到30毫克尼古丁的传统烟草相比，含量显著降低。

VLN^®香烟的尼古丁含量比典型香烟减少95%，将成为FDA开创性的烟草和尼古丁监管综合计划的先锋产品。于2017年公布的这项计划旨在为香烟设定一项产品标准，以实现“极少或不会致瘾”的尼古丁水平。FDA预测，指令执行的第一年将帮助超过500万成年吸烟者戒烟，到本世纪末前可挽救超过800万美国人的生命。

该公司计划在FDA批准其MRTP申请的90天内将VLN^® King和VLN^® Menthol King香烟推向美国的烟草零售商家。VLN^®的推出将配合一项引人注目的推广活动，向成年吸烟者介绍世界上尼古丁含量最低的香烟。

关于22nd Century Group, Inc.
22nd Century Group, Inc.（NYSE American：XXII）是一家领先的植物生物技术公司，专注于通过基因工程、基因编辑和现代植物育种技术来改变烟草植物中的尼古丁水平和大麻植物中的大麻素水平。22nd Century Group的首要使命是通过该公司低尼古丁含量香烟专有技术（尼古丁含量比传统香烟减少95%）减少吸烟造成的危害。公司在大麻领域的首要使命是开发出包含有价值大麻成分和理想农业特性的专有技术大麻植物并实现商业化。

如需了解更多信息，请访问xxiicentury.com，或关注推特：@_xxiicentury及领英。

关于前瞻性陈述的警示说明
除历史资料外，本新闻稿所载的所有声明、预期和假设均为前瞻性陈述。前瞻性陈述通常包括“预期”、“相信”、“考虑”、“继续”、“可能”、“估计”、“预计”、“探索”、“预见”、“目标”、“指导”、“打算”、“有可能”、“可以”、“计划”、“潜在”、“预报”、“初步”、“很可能”、“预测”、“有希望”、“寻求”、“应该”、“将会”、“将要”以及类似的表达。实际结果可能与前瞻性陈述中明示或暗示的结果存在重大差异。可能导致实际结果发生重大差异的重要因素列于公司2020年3月11日提交的10-K表格年度报告和随后提交的10-Q季度报告中的“风险因素”部分。本新闻稿中提供的所有信息均为截至本文发布日期之信息，除非法律要求，否则本公司没有义务或意向更新上述前瞻性陈述。

投资者关系与媒体联系人：
Mei Kuo
传播与投资者关系总监
22nd Century Group, Inc.
(716) 300-1221
[email protected] 

Published on : http://www.globenewswire.com/news-release/2021/01/13/2157569/0/zh-hans/22nd-Century-Group%E6%89%A9%E5%B1%95VLN-%E7%83%9F%E8%8D%89%E7%A7%8D%E6%A4%8D%E8%AE%A1%E5%88%92%E4%BB%A5%E6%94%AF%E6%8C%81%E5%AF%B9%E8%AF%A5%E5%85%AC%E5%8F%B8%E4%BD%8E%E5%B0%BC%E5%8F%A4%E4%B8%81%E5%90%AB%E9%87%8F%E9%A6%99%E7%83%9F%E7%9A%84%E9%A2%84%E6%9C%9F%E9%9C%80%E6%B1%82.html

紐約州威廉維爾, Jan. 13, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (NYSE American: XXII) 是以植物為本的領先生物技術公司，專注於減少煙草造成的傷害、尼古丁含量極低的煙草和火麻／大麻研究，其今天宣佈根據公司的最新銷售預測，將大幅擴大 VLN^® 低尼古丁含量香煙的種植計劃。22nd Century 已有庫存數量可觀的 VLN^® 香煙作為 VLN®^® 低尼古丁含量香煙推出和首次銷售，而這次新種植將可增加其數量。美國食品和藥物管理局 (FDA) 目前正就 22nd Century 為 VLN^® 香煙提出的「風險改良煙草產品」(MRTP) 申請進行最後階段的審查。 獲得授權後，22nd Century 將開始銷售其 VLN^® 香煙，其尼古丁含量比傳統香煙品牌低 95%。擁有唯一具有 FDA 授權的改良煙草產品聲明的可燃香煙，將成為 22nd Century 商業銷售的催化劑，因為即使只佔美國煙草銷售的一小部分，也可能為公司收入和市值帶來可觀增長。

22nd Century Group 行政總裁 James A. Mish 表示：「我們準備在獲得 FDA 營銷授權後 90 天內推出我們的 VLN® 香煙。美國有超過 3,400 萬名吸煙者，研究顯示當中大部分正在尋找替代產品。在看到 VLN^® 樣本後，參與我們研究的 60% 成人吸煙者對使用 VLN^® 香煙感興趣。此外，美國疾病控制與預防中心 (CDC) 2019 年的一項調查顯示，80% 的美國吸煙者希望能降低香煙的尼古丁含量。我們相信成人吸煙者將會對 VLN^® 非常感興趣，而根據最新銷售預測，新種植的 VLN^® 煙草有助我們滿足預期需求。」

Mish 續稱：「除了向美國的吸煙者介紹 VLN^® 外，我們致力向各香煙製造商授權我們的技術，以便他們遵從 FDA 的計劃，使所有香煙都無法令人成癮。我們期待煙草業與我們攜手，真正降低吸煙造成的傷害，以及預防未來幾代人因香煙成癮。」

22nd Century 與一部分煙草農夫合作，將在整個美國煙草帶種植這種新 VLN^® 煙草，從而為美國面臨困境的家族農場創造新的收入來源。公司的專有低尼古丁含量煙草每克煙草平均僅含 0.5 毫克尼古丁，與通常含有 20 至 30 毫克尼古丁的傳統香煙相比，其尼古丁含量顯著降低。

VLN^® 的尼古丁含量比傳統香煙的低 95%，將成為 FDA 突破性的煙草和尼古丁全面監管計劃的先鋒。該計劃於 2017 年發佈，旨在為香煙設定產品標準，以實現「最低限度或不成癮」的尼古丁含量。FDA 計劃在執行授權的第一年內，將協助 500 多萬成人吸煙者戒煙，並將於本世紀末拯救 800 多萬名美國人的性命。

在 FDA 授權其 MRTP 申請的 90 天內，22nd Century 計劃向美國的零售煙草商店推出 VLN^® King 和 VLN^® Menthol King 香煙，並將結合引人注目的營銷活動，向成人吸煙者介紹全球尼古丁含量最低的香煙。 

關於 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) 是領先的植物生物技術公司，致力透過基因工程、基因編輯和現代植物育種，改變煙草植物的尼古丁含量和火麻／大麻類植物中的大麻素含量。22nd Century 在煙草領域的主要使命是透過該公司的專有低尼古丁含量煙草減少吸煙所造成的危害，其尼古丁含量比傳統香煙低 95%。公司在火麻／大麻領域的主要使命是開發和商業化具有寶貴大麻素特徵和理想農學特徵的專有火麻／大麻類植物。

如欲了解更多資訊，請瀏覽 xxiicentury.com，以及在 Twitter（@_xxiicentury）和 LinkedIn 上關注我們。

關於前瞻性陳述的警告說明
除了歷史上的資訊，所有在新聞稿中的陳述、期望和假設均為前瞻性陳述。前瞻性陳述通常包括「預料」、「相信」、「考慮」、「繼續」、「將能」、「估計」、「預期」、「探索」、「預見」、「目標」、「指導」、「打算」、「可能」、「可會」、「計劃」、 「潛力」、「預計」、「初步」、「或許」、「預測」、「可為」、「尋求」、「應該」、「將」、「會」和類似的用詞作表達。實際結果可能與前瞻性陳述中明確或隱含的結果不同。在 2020 年 3 月 11 日提交的公司 10-K 表格年度報告以及隨後提交的 10-Q 表格季度報告中，「風險因素」列出了可能導致實際結果產生重大差異的重要因素。本新聞稿中提供的所有資訊均截至本文發佈之日，並且除法律要求外，公司不承擔任何義務，也無意更新這些前瞻性陳述。

投資者關係與媒體聯絡：
Mei Kuo
董事、傳訊和投資者關係
22nd Century Group, Inc.
(716) 300-1221
[email protected] 

Published on : http://www.globenewswire.com/news-release/2021/01/13/2157569/0/zh-hant/22nd-Century-Group-%E6%93%B4%E5%A4%A7-VLN-%E7%85%99%E8%8D%89%E7%A8%AE%E6%A4%8D%E8%A8%88%E5%8A%83-%E4%BB%A5%E5%8D%94%E5%8A%A9%E5%85%AC%E5%8F%B8%E6%BB%BF%E8%B6%B3%E9%A0%90%E6%9C%9F%E5%B8%82%E5%A0%B4%E5%B0%8D%E4%BD%8E%E5%B0%BC%E5%8F%A4%E4%B8%81%E5%90%AB%E9%87%8F%E9%A6%99%E7%85%99%E7%9A%84%E9%9C%80%E6%B1%82.html

WILLIAMSVILLE, N.Y., Jan. 12, 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
[email protected]

Published on : http://www.globenewswire.com/news-release/2021/01/13/2157570/0/en/22nd-Century-Group-Expands-VLN-Tobacco-Growing-Program-to-Support-Anticipated-Demand-of-the-Company-s-Reduced-Nicotine-Content-Cigarettes.html