Form 8-K

8-K — 22nd Century Group, Inc.

Accession: 0001493152-26-040928

Filed: 2026-09-01

Period: 2026-09-01

CIK: 0001347858

SIC: 2111 (CIGARETTES)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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): September

1, 2026

22nd

Century Group, Inc.

(Exact

Name of Registrant as Specified in Charter)

Nevada

001-36338

98-0468420

(State

or Other Jurisdiction

Incorporation)

(Commission

File

Number)

(I.R.S.

Employer

Identification

No.)

321

Farmington Rd,

Mocksville,

North

Carolina

27028

(Address

of Principal Executive Office)

(Zip

Code)

Registrant’s

telephone number, including area code: (336)

940-3769

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 Exchange on Which Registered

Common

Stock, $0.00001 par value per share

XXII

Nasdaq

Capital Market

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 ☐

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

7.01 Regulation FD Disclosure.

September 1, 2026, the Company issued a press release providing a mid-year update to shareholders, which press release is attached hereto

as Exhibit 99.1 and is incorporated herein by reference.

The

information in this item (including the exhibit) 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. Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit No.

Description

99.1

Press Release

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/

Lawrence D. Firestone

Date:

September 1, 2026

Lawrence

D. Firestone

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

22nd

Century CEO & Chairman Larry Firestone: Improved Gross Margin, ~5,000 Retail Outlets and >$50B Market Opportunity Highlight Mid-Year

Stockholder Letter

VLN®

Category Leader Accelerates 2H 2026 Growth Phase as Same-Store Sales Climb

22nd

Century Accelerates 2H 2026 Commercial Execution

MOCKSVILLE,

N.C., September 1, 2026 — 22nd Century Group, Inc. (Nasdaq: XXII), the leader in low-nicotine tobacco, low-nicotine cigarettes

and the only tobacco products company focused on reducing the harms of smoking through nicotine reduction, today issued the following

letter to stockholders from Lawrence Firestone, the Chief Executive Officer of 22nd Century Group, Inc.:

2026

Mid-Year Strategic Update Shareholder Letter

Dear

Shareholders,

22nd Century Group, we believe long-term shareholder value is created when a company has a clear mission, a differentiated product and

strategy, and the discipline to execute. Our mission remains unchanged: to help adult smokers combat the harms of tobacco and nicotine.

As the architect of the newest category for smoking harm reduction, the low-nicotine category, our strategy is rooted in our proprietary

low-nicotine tobacco platform that fills a unique place in the market, the industry and society. Our VLN® cigarettes remain the first

and only low-nicotine combustible cigarette authorized by the U.S. Food and Drug Administration specifically to reduce the harms of smoking

by helping smokers smoke less.

Over

the past several months, we have been setting that foundation through disciplined execution, expanding the classes of trade we sell through,

strengthening retail availability and consumer awareness, improving our product portfolio, and continuing to invest in low-nicotine technology.

Today our focus is squarely on execution: expanding commercialization of our Pinnacle and VLN® brands, improving the economics of

the business, and positioning the Company for sustainable, profitable growth.

This

is how we win and how we create long-term shareholder value and, over time, increased market capitalization.

Win by Expanding Our Retail Presence — 2,000 Outlets Today, ~5,000 by Year-End

Consumers

are already supporting our brands in approximately 2,000 retail outlets across the US and several of our newest adult consumers have

told us how satisfied they are with switching to VLN® cigarettes. The word has begun to travel through consumers and our marketing

initiatives will continue to drive awareness and trial.

build on that demand, we recently launched Pinnacle Pure alongside Pinnacle VLN® in states that have authorized these products, broadening

the value-driven Pinnacle brand. We are now taking both product families into California through an initial retail trial, as well as

into the high-visibility markets of metro New York and northern New Jersey. This will be followed in the fourth quarter of 2026 with

a new digital convenience platform offering direct to consumer home delivery of our products.

Investors

will see additional announcements in the second half of 2026 on wins by expanding our distribution network. As our footprint grows to

approximately 5,000 outlets by year-end, we are strengthening not only the category itself, but also 22nd Century’s leadership

position within it.

Win by Driving Commercial Execution That Can Scale

Winning

in this business requires more than innovation. It requires execution in distribution, on the shelf, and through consumer adoption and

repeat purchase. That is why we remain focused on building a stronger branded products business with increasing retail presence, led

by our Pinnacle portfolio, better trade execution, and stronger support for our commercial partners.

offer the only low-nicotine cigarette which is in a familiar form to smokers, and with a recognizable brand, national distribution and

disciplined shelf placement, this will enable the opportunity for trial and improve repeat purchase and revenue over time for our VLN®

cigarette products.

are now measuring early data on rate of sale. Since the beginning of the year, same-store sales have been growing each month, and we

have seen VLN® cigarette trial turn into carton purchases rather than individual packs. Data from retail point-of-sale is showing

that volume has grown consistently by an average of 10% per month in non-promotion periods, and we estimate now that active VLN®

user trial exceeds 5,000 cases and continues to grow monthly.

Our

goal is to build consumer awareness, smoking consumer adoption and brand loyalty. Then while rate of sale improves, reorder patterns

and revenue will become more consistent, our platform will become increasingly more valuable to customers, retailers, and shareholders

alike.

Win by Improving the Economics — Gross Margin

One

of our most important priorities has been improving the economic quality of our revenue. Shifting the mix of our revenue to our branded

portfolio is our primary focus. Then, as we grow our branded products that carry positive gross margins will continue to drive profitability.

This shift is occurring in the third quarter 2026 and will continue as we go forward, but remains dependent on consistent volume for

our factory of our branded products.

Win by Building More Than a Single Product

Our

long-term opportunity extends beyond our current family of VLN® products and will leverage our robust IP portfolio. We are building

a broader platform appealing to different consumer brand choices. This will allow us to grow the low-nicotine category by expanding our

VLN® product offerings and form factors, supporting additional partner opportunities, and selectively pursuing ways to leverage our

proprietary low-nicotine technology more broadly.

believe this platform approach is important because it creates multiple paths to value. It allows us to drive toward the long-term strategic

value in the foundation that we have built. Over time, we believe successful execution across these fronts can translate into stronger

business performance, broader investor recognition, and a more appropriate market valuation for the Company.

This

Is How We Create Long-Term Shareholder Value in the >$50 Billion US Market

Our

path forward is grounded in a large, unserved market of smokers seeking a low-nicotine combustible alternative to their current brands,

a market we currently serve alone. Consumers have found our products on the shelf, and adoption is growing each month. With a base of

repeat consumers in place, we will introduce marketing and consumer engagement programs to drive accelerated awareness and adoption while

maintaining pricing discipline.

While

building a new category takes persistence, 22nd Century is the clear leader and has a real opportunity to capture a meaningful portion

of the estimated >$50 billion annual US combustible cigarette market at retail. Every pack we sell to build the low nicotine category

is a share shift. We do not view our initiatives as isolated efforts. Rather, they are connected parts of one overarching value creation

strategy.

behalf of the Board of Directors and the entire 22nd Century team, thank you for your continued support and confidence.

Sincerely,

Lawrence

D. Firestone

Chairman

and Chief Executive Officer

22nd

Century Group, Inc.

About

22nd Century Group, Inc.

22nd

Century Group is pioneering the tobacco harm reduction movement by enabling smokers to take control of their nicotine consumption.

Our

Technology is Tobacco

Our

proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis

activities resulting in a tobacco plant that contains 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio

has been developed to ensure that our high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual

property to ensure our ongoing leadership in the tobacco harm reduction movement.

Our

Products

created our flagship product, the VLN® cigarette using our low nicotine tobacco, to give traditional cigarette smokers an authentic

and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN®

cigarettes have 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their

nicotine consumption.

FDA

Authorized

Our

VLN® cigarette is the only low nicotine combustible cigarette authorized by the FDA in the United States.

VLN®

is a registered trademark of 22nd Century Limited LLC.

Learn

more at xxiicentury.com, on X (formerly Twitter), on LinkedIn, and on YouTube.

Learn

more about VLN® at tryVLN®.com.

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, including but not limited to our full year business outlook. 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. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives,

(ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, and (iii)

our financial and operating performance. 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 20, 2026, and Quarterly Reports on Form 10-Q on May 7, 2026 and August 14, 2026. 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

Daniel

Otto

Chief

Financial Officer & Investor Relations

22nd

Century Group

investorrelations@xxiicentury.com

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