8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 5, 2021

22nd Century Group, Inc.

(Exact Name of Registrant as Specified in Charter)

Nevada	001-36338	98-0468420
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)
500 Seneca Street, Suite 507, Buffalo, New York (Address of Principal Executive Office)		14204 (Zip Code)
Registrant’s telephone number, including area code: (716) 270-1523

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which registered
Common Stock, $0.00001 par value	XXII	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company    ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐

Item 2.02 Disclosure of Results of Operations and Financial Condition

On August 5, 2021, 22nd Century Group, Inc. (the “Company”) issued an earnings release for the quarter ended June 30, 2021. A copy of the earnings release is furnished as Exhibit 99.1 to this report.

The information in this item shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of Section 18, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent, if any, expressly set forth by specific reference in such filing.

Item 9.01(d) Financial Statements and Exhibits

Exhibit 99.1 Earnings release dated August 5, 2021

Exhibit 99.2 Supplemental financial information for earnings release dated August 5, 2021

104 Cover Page Interactive Data File - The cover page XBRL tags are embedded within the inline XBRL document

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	22nd Century Group, Inc.
	/s/ James A. Mish
Date: August 5, 2021	James A. Mish
	Chief Executive Officer

EX-99.1

Exhibit 99.1

22nd Century Group Reports Business Highlights and Financial Results for the Second Quarter 2021

● 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

Tobacco Franchise

● 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.

● 22nd Century’s growth in tobacco contract manufacturing volumes and disciplined operations continued in the second quarter and confirms the readiness of the Company’s operations ahead of VLN^® launching:

- Higher volume of cigarette production with precise standards and higher gross profit margin.

- The assets needed to manufacture research cigarettes and VLN^® are paying for themselves, as well as capital investments in added manufacturing capacity and efficiency, ahead of MRTP authorization.

● The Company has completed an expansion of testing capabilities, which allows for rapid, in-house analysis of its tobacco. This will reduce the testing cost per VLN^® sample by approximately 90%, while also significantly reducing the lead time to uncover key data. Internal testing of the Company’s 2021 crop of VLN^® is scheduled to begin at the facility in August 2021, using the newly installed testing equipment.

● The Company has significantly expanded its VLN^® tobacco growing program based on the Company’s latest sales projections. Plans have been initiated with experienced growers in the southern hemisphere that will allow the Company to grow and harvest its VLN^® tobacco year-round. These new plantings are in addition to the Company’s sizeable inventory of VLN^® tobacco, which is earmarked for the launch and sales of VLN^® cigarettes.

● The Company has initiated the launch process for VLN^® in several countries where adult smokers have a strong affinity for new, reduced risk tobacco products and where the Company believes regulations will allow it to go to market with MRTP-type claims and minimal interaction with regulators. The Company plans to launch VLN^® outside the U.S. by first quarter 2022.

Hemp/Cannabis Franchise

● The Company expects to monetize its hemp/cannabis plant lines and IP beginning in the second half of 2021 with upfront license fees plus revenue from the current crop. Next generation, disruptive plant lines are being accelerated for 2022 and 2023 revenue programs.

● 22nd Century announced an agreement to extend and expand its successful plant research partnership with KeyGene, a global leader in plant research involving high-value genetic traits and increased crop yields. The new agreement extends the length of the collaboration the Company has with KeyGene to develop new, disruptive hemp/cannabis plants and intellectual property for the life science, medicinal, and pharmaceutical end-use markets. It also expands the partnership to include research and development activity for alternative tobacco plant applications, such as protein production, as well as 22nd Century’s third plant franchise.

● The Company has secured partnerships with highly specialized expert alkaloid-based plant breeders to support commercial scale-up and cultivation of disruptive plant lines far faster and beyond the capabilities of independent competitors or in-house breeding in consumer product companies. The newest addition is the world’s leading alkaloid plant breeder, Extractas Bioscience located in the southern hemisphere providing the Company with year-round growing capabilities.

● The Company now controls the most comprehensive and innovative upstream cannabinoid value chain in the industry, an asset critical to unlocking commercial success for large-scale cultivation and extraction as this emerging industry continues to scale with the continuing success of global legalization and commercialization efforts and the entrants of new players from adjacent industries including tobacco, pharmaceutical, and other consumer products companies. Components of 22nd Century’s proprietary value chain include: plant profiling tailored to the needs of customers (CannaMetrix), genetics to deliver differentiated traits to maximize yield of a specific cannabinoid or deliver a certain taste or fragrance profile (KeyGene), and commercial-scale plant breeding and cultivation of disruptive plant lines as well as year-round ingredient extraction/purification (Extractas Bioscience, Sawatch Agriculture, Folium Botanical, Aurora Cannabis, Needle Rock Farms, and Panacea).

Third Plant-Based Franchise

● 22nd Century Group will introduce its third franchise on August 30, 2021. The Company intends to outline its market opportunity, in a high-growth global market estimated at more than $500 billion annually, and articulate its strong competitive advantages in the industry. The Company will also summarize its global plan for the route to market and commercialization in this market, which is not as highly regulated as its first two franchises.

Corporate Business Highlights

● The Company will uplist its common shares to the Nasdaq Capital Market (“Nasdaq”) on Monday, August16, 2021, and will continue to trade under its current symbol, “XXII.” While remaining dedicated to its primary mission to reduce the harm caused by smoking, uplisting to the Nasdaq also aligns 22nd Century with other high-achieving, innovative, and growth-oriented global science and technology companies. The Company believes that joining the Nasdaq will enhance its visibility to a wide audience of institutional investors and increase our exposure to hemp/cannabis investors at this important time of industry progression toward mass production.

● New research coverage of the Company was initiated by Vivien Azer, a leading beverages, tobacco, and cannabis senior analyst at Cowen & Company, LLC.

● 22nd Century was added to the Russell 2000^®, Russell 3000^®, and Russell Global Indexes at the conclusion of the Russell U.S. Indexes annual reconstitution, effective at the opening of the U.S. equity markets on June 28, 2021. The Russell U.S. Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.

2021 Second Quarter Financial Results

● Net sales for the second quarter of 2021 were a record $8.4 million, an increase of greater than 30% from $6.4 million in the prior year period. The increase was primarily due to the combination of higher volume and additional price increases in the Company’s contract manufacturing business. This demonstrates the Company’s ability to generate new business in the tobacco category and produce growing volumes of cigarettes, confirming the Company’s readiness to launch VLN^®.

● Gross profit for the second quarter of 2021 improved by $385 thousand, or 192% to $586 thousand compared to the prior year period – a sixth consecutive quarter of year-over-year improvement in gross profit. The improvement in gross margin was primarily the result of higher volume, price increases, cost containment measures, and factory efficiencies in 2020 and 2021 that are delivering lower labor and overhead costs relative to volume.

● Total operating expenses for the second quarter of 2021 increased by $2.3 million compared to the prior year period. This was driven by the following:

o Sales, general and administrative expenses increased by $2.7 million compared to the prior year period. This was driven primarily by the addition of new members to the Company’s management team, including its newly appointed Chief Executive Officer, Chief Financial Officer, and General Counsel, as well as higher personnel, insurance, financial and strategic consulting costs, and marketing costs. These investments deployed to support, evaluate, and prepare for future opportunities are critical as the Company moves quickly to market readiness in both tobacco and hemp/cannabis.

o Research and development expense for the second quarter of 2021 was favorably lower by $215 thousand compared to the prior year period. This favorability was primarily driven by lower personnel and contract costs partially offset by higher costs for tobacco field trials and patent fees. The Company’s R&D investments are expected to grow in future quarters as the Company continues to accelerate the development of new, highly-differentiated hemp/cannabis plants and expand its R&D efforts to its third, plant-based franchise.

● Operating loss for the second quarter of 2021 was $(6.6) million, an increase of $1.9 million 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 in the second quarter of 2021.

● Net loss in the second quarter of 2021 was $(4.2) million, a favorable decrease of $883 thousand compared to the prior year period primarily due to favorable year-over-year comparison of non-cash charges off-set by benefits to other income and expenses, and representing a net loss per share of $(0.03). This compares to the second quarter of 2020 net loss of $(5.1) million, or $(0.04) per share.

Balance Sheet and Liquidity

● Gross proceeds of $40.0 million of growth capital secured in second quarter 2021 will be used to accelerate the Company’s revenue profile:

- Fuel VLN^® U.S. launch readiness and international market launches

- Accelerate hemp/cannabis commercialization of disruptive plant lines and intellectual property

- Launch third plant-based franchise

● For the first half of 2021, net cash used in operating activities was $12.3 million, compared to $11.5 million in the prior year period.

● The Company ended the quarter with a cash position of $62.3 million as of June 30, 2021, and the Company’s continued initiatives to manage expenses relative to net sales revenue should provide the Company with additional runway to execute for the foreseeable future.

Second Quarter Earnings Conference Call

22nd Century will host a live webcast today at 10:00 a.m. ET to discuss its second quarter 2021 financial results and business highlights. During the webcast, 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 review the Company’s 2021 second quarter results, growth opportunities, and innovative strategic plans and future initiatives in the more than $1.3 trillion global addressable markets.

Following prepared remarks, including an accompanying slide presentation, 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.

The live and archived webcast, interactive Q&A, and slide presentation will be accessible on the Events web page in the Company's Investor Relations section of the website, at www.xxiicentury.com/investors/events. An archived replay of the webcast and the event transcript will also 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 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.

This press release shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Below is a table containing information relating to the Company’s Adjusted EBITDA for the three months ended June 30, 2021 and 2020, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.

	Quarter Ended
	June 30,
	Dollar Amounts in Thousands ($000's)
						$ Change
	2021		2020			fav / (unfav)
Net loss	$	(4,174)	$	(5,057)	$	883
Adjustments:
Impairment of intangible assets		—		146		(146)
Impairment of Panacea investment		—		1,062		(1,062)
Amortization and depreciation		302		347		(45)
Unrealized loss (gain) on investment		176		(312)		488
Realized (gain) loss on short-term investment securities		—		(3)		3
Gain on Panacea investment conversion		(2,548)		—		(2,548)
Accretion of non cash interest expense		6		19		(13)
Equity-based employee compensation expense		1,245		376		869
Executive and board search fees		—		289		(289)
Interest income, net		(108)		(462)		354
Interest expense		8		—		8
Adjusted EBITDA	$	(5,093)	$	(3,595)	$	(1,498)

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

	Year-to-date Ended
	June 30,
	Dollar Amounts in Thousands ($000's)
						$ Change
	2021		2020			fav / (unfav)
Net loss	$	(9,204)	$	(9,086)	$	(118)
Adjustments:
Impairment of intangible assets		—		146		(146)
Impairment of Panacea investment		—		1,062		(1,062)
Amortization and depreciation		591		674		(83)
Unrealized loss (gain) on investment		140		133		7
Gain on Panacea investment conversion		(2,548)		—		(2,548)
Accretion of non cash interest expense		13		31		(18)
Equity-based employee compensation expense		1,752		856		896
Executive and board search fees		—		430		(430)
Interest income, net		(220)		(1,074)		854
Interest expense		8		—		8
Adjusted EBITDA	$	(9,468)	$	(6,828)	$	(2,640)

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

mkuo@xxiicentury.com

EX-99.2

Exhibit 99.2

SECOND QUARTER 2021 EARNINGS PRESENTATION August 5, 2021

CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements concerning our business operations, and financial performance and conditions, as well as our plans, objectives, and expectations for our business operations and financial performance and conditions that are subject to risks and uncertainties. All statements other than those of historical fact are forward-looking statements. These types of statements typically contain words such as “aim,” “anticipate,” “assume,” “believe,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “potential,” “positioned,” “predict,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends. Forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business, the industry in which we operate, and our management’s beliefs and assumptions. 2 These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those estimated. The contents of this presentation should be considered in conjunction with the risk factors, warnings, and cautionary statements contained in the Company’s annual, quarterly, and other reports filed with the U.S. Securities and Exchange Commission. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as required by law.

INITIATIVES Secure MRTP Authorization Launch VLN® in Select Global Markets Commence Hemp/Cannabis Revenue Recognition Announce Third Franchise August 30 RECENT ACCOMPLISHMENTS .. In regular contact with FDA and CTP through multiple channels at all levels .. Highly confident MRTP is in the documentation phase, readying for decision .. Leveraging all resources in support of MRTP authorization .. Will continue to escalate actions until MRTP success is achieved .. Initiated VLN® launch process in well - known global markets with limited regulatory hurdles .. Targeting international market sales by Q1 ‘22 .. MRTP catalyzes U.S. launch and additional international countries .. Planning southern hemisphere VLN® growing program .. Initial revenue to commence 2H 2021 from plant lines and IP (license, biomass and distillate/isolate sales) .. Accelerating 2022 and 2023 plant lines .. Secured expert breeder partners to create highly differentiated disruptive plant lines .. Large global market with lower regulatory barriers .. Completing IP and operating partnerships for announcement .. Will detail market opportunity, timing, path to revenue, and commercial partners at introduction Commence Nasdaq Trading on August 16, 2021 . Greater agility in the hemp/cannabis sector .. Greater recognition of our role as a leading plant science and technology company RECENT KEY GROWTH UPDATES 3

SMOKERS DESERVE A CHOICE 4 .. Federally funded studies clearly document the benefits of reduced nicotine content cigarettes .. VLN®’s PMTA affirms its importance to public health .. Highly confident MRTP is in the documentation phase of FDA’s review process .. 22nd Century is a leader and has expertise in this effort .. We are leveraging all available tools to balance leverage and collaboration toward a positive outcome

22ND CENTURY'S VLN® PILOT WILL EMPHASIZE TRIAL, REPEAT PURCHASE, AND ADVOCACY BY ADULT SMOKERS PILOT MARKETS ARE READY FOR LAUNCH Fully prepared for pilot launch leading to national rollout Launch-ready for commercial sales within 90 days of FDA MRTP authorization Identified both initial pilot and subsequent markets for launch Advanced discussions with multiple trade and retail partners Advancing marketing materials and other important aspects of the launch Pilot program enables 22nd Century to test, measure, and refine materials to maximize the commercial success of VLN® Fully Prepared For Commercial Launch of VLN® 5 * Trade dress subject to change

MANUFACTURING RAMP 6 62,000 sq. ft. manufacturing facility in NC Manufacturing capacity ~1% of the U.S. tobacco market; increasing to ~3% with minimal investment FDA inspected and cleared as part of the Premarket Tobacco Application (PMTA) process Significantly expanded 2021 VLN® growing program to ensure adequate leaf inventory for launch Established internal nicotine content test capabilities – 90% cost reduction, results in 1 day vs. 2 to 4 weeks 22nd Century can immediately manufacture VLN® cigarettes in commercial quantities Manufacturing Geared For Strong Commercial Launch New CMO facility or test facility image Convert leaf icon to white PRODUCTION RAMP IN Q2 ‘21 CONFIRMS READINESS TO SCALE VLN® FOR GLOBAL SALES

ACCELERATING INTERNATIONAL LAUNCH IN MULTIPLE MARKETS 7 .. Initiating launch process of VLN® in countries with lower regulatory hurdles .. Targeting launches by Q1 ‘22 .. Funded by proceeds from June 2021 capital raise .. Adding experienced growers in southern hemisphere for year-round growing of VLN®

. Rapidly increasing demand is driving the need for optimized plant genetics and proprietary, stable plant lines that deliver higher crop yield for commercial use .. Growing support for federal legalization and increased access for medicinal and recreational use 22nd Century Moving to Monetization: First Revenue From Our Hemp/Cannabis Franchise .. Plant lines and IP revenue commences in 2H ‘21 .. Accelerating next generation plant lines and IP for 2022 and 2023 22ND CENTURY HAS ESTABLISHED A LEADERSHIP POSITION IN GENETIC IP CRITICAL TO HEMP/CANNABIS ACHIEVING ITS FULL COMMERCIAL POTENTIAL THE CANNABIS MARKET IS ADVANCING RAPIDLY 8 22nd Century monetizing initial hemp/cannabis lines in 2021, readying 2022 and 2023 plants

22ND CENTURY HAS SECURED ALL OF THE KEY PARTNERSHIPS NEEDED TO MAXIMIZE AND SUPPORT EACH COMPONENT IN UPSTREAM SEGMENT OF THE CANNABINOID VALUE CHAIN. ACCELERATING COMMERCIALIZATION OF NEW, DISRUPTIVE HEMP/CANNABIS PLANTS 9 Plant Biotechnology Established proprietary bioinformatics platform and cutting-edge molecular breeding platform in partnership with KeyGene; capabilities include genetic engineering and plant line development. Plant Profile/ Roadmap CannaMetrix’s high-throughput proprietary, human cell-based cannabinoid assay technology serves as a roadmap for developing new hemp/cannabis plant lines with tailor-made cannabinoid & terpenoid profiles. Ingredient Extraction & Purification Panacea provides 22nd Century with extraction and purification services utilizing proprietary plant lines in development. Plant Breeding & Trials Multiple partnerships provide 22nd Century with both northern and southern hemisphere, indoor and outdoor, year-round plant breeding and trial capabilities. Plant Cultivation Colorado farm operations provide 22nd Century with operational assets including plant cultivation capabilities. Strategic partnerships enable 22nd Century to deliver valuable, commercial-scale plant lines, and IP in two-year cycles, the first of which is coming to completion.

22ND CENTURY GROUP NASDAQ UPLISTING 10 .. Nasdaq listing effective August 16, 2021 .. Symbol will remain “XXII” .. No action required of current investors

SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS 11 1. Gross profit margin is calculated by dividing net sales revenue by gross profit. Net Sales Gross Profit Gross Profit Margin Operating Loss 2Q 2021 $8.4M $586K 7.0% $(6.6)M 2Q 2020 $6.4M $201K 3.1% $(4.8)M +30% YOY NET SALES +390 BASIS POINTS YOY GROSS PROFIT MARGIN1

FINANCIAL SNAPSHOT 12 $ in millions Select Financials Three Months Ended June 30, 2021 2020 Net sales revenue $ 8.4 $ 6.4 Gross Profit Margin $ .6 $.2 Operating loss $ (6.6) $ (4.8) Net loss $ (4.2) $ (5.1) Net loss per common share - basic and diluted $ (0.03) $ (0.04) Weighted average common shares outstanding – basic and diluted (in thousands) 154,811 138,854 Summary Balance Sheet Items Quarter Ended June 30, 2021 December 31, 2020 Cash and cash equivalents1 $ 62.3* $22.3 Total assets2 $ 97.2 $51.7 Total liabilities3 $ 9.8 $7.6 Total shareholders' equity4 $ 87.4 $44.1 1. Cash and cash equivalents includes short-term investment securities. 2. Total assets is the sum of total current assets, total property, plant and equipment, and total other assets including intangible assets, net, Investments and convertible note. 3. Total liabilities includes current liabilities and long-term liabilities and excludes shareholders’ equity. 4. Total shareholders’ equity excludes any liabilities. *Additional $38.3M cash for growth capital from registered direct offering in June 2021

2021 PRIORITIES & AREAS OF FOCUS 13 Tobacco Franchise Hemp/Cannabis & Third Plant-based Franchise Financial Secure MRTP Authorization from FDA .. VLN® pilot programs ready to launch .. Engaging with multiple distribution partners to support national launch capabilities .. Ramping manufacturing capabilities .. Moving ahead with international launches 01 Complete upstream cannabinoid capabilities .. Monetize our hemp/cannabis IP beginning in 2021 and accelerating next generation plant lines for 2022 and 2023 .. Have now assembled the most complete upstream capability in the industry 03 04 Preparing to launch third plant-based franchise .. Securing IP and strategic partnerships to support development of this franchise .. Large, robust addressable market .. Faster route to commercialization than first two franchises Maintain efficient operating structure and balance sheet strength .. Strengthened balance sheet with $40 million in growth capital to accelerate product launch and commercialization .. Deploying capital to fuel U.S. VLN® launch readiness, commence international sales of VLN®, accelerate cannabis commercialization and launch third franchise 05 02 Support, advance, and advocate for proposed nicotine cap mandate for all combustibles .. Favorable political climate .. Advancing licensing and partnership initiatives to support industry adoption

14 Q&A

CONTACT INFORMATION INVESTOR RELATIONS & MEDIA CONTACT Mei Kuo Director, Communications & Investor Relations 22nd Century Group, Inc. (716) 300-1221 mkuo@xxiicentury.com

XML

Document and Entity Information	Aug. 05, 2021
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Aug. 05, 2021
Entity File Number	001-36338
Entity Registrant Name	22nd Century Group, Inc.
Entity Incorporation, State or Country Code	NV
Entity Tax Identification Number	98-0468420
Entity Address, Address Line One	500 Seneca Street
Entity Address, Adress Line Two	Suite 507
Entity Address, State or Province	NY
Entity Address, City or Town	Buffalo
Entity Address, Postal Zip Code	14204
City Area Code	716
Local Phone Number	270-1523
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.00001 par value
Trading Symbol	XXII
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false
Entity Central Index Key	0001347858
Amendment Flag	false