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Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): November 21, 2022




22nd Century Group, Inc.

(Exact Name of Registrant as Specified in Charter)


Nevada 001-36338 98-0468420
(State or Other Jurisdiction of
(Commission File Number) (I.R.S. Employer
Identification No.)


500 Seneca Street, Suite 507, Buffalo, New York

(Address of Principal Executive Office)


(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))


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.     ¨


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 NASDAQ Capital Market





Item 8.01Other Events.


On November 21, 2022, 22nd Century Group, Inc. (the “Company”) issued a press release regarding its manufacturing facility located in Grass Valley, Oregon. The Company is attaching a copy of such press release as Exhibit 99.1 hereto, which is incorporated by reference herein.



Forward-Looking Statements


This report contains forward-looking statements and other information relating to matters that are not historical facts. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. These risks and uncertainties include the factors detailed from time to time in the reports we file with the SEC, including those described under “Risk Factors” in our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. These forward-looking statements speak only as of the date of this report. We expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.


Item 9.01(d).Financial Statements and Exhibits.


99.1Press Release, dated November 21, 2022.
104Cover Page Interactive Data File - The cover page XBRL tags are embedded within the inline XBRL document.







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/ Peter Ferola
Date:   November 21, 2022 Peter Ferola
  General Counsel and Secretary




EX-99.1 2 tm2231114d1_ex99-1.htm EXHIBIT 99.1


Exhibit 99.1


22nd Century Group Provides Update on Incident at Grass Valley Facility


Established backup plans implemented to ensure continuous customer delivery


BUFFALO, N.Y., November 21, 2022 (Globe Newswire) GVB Biopharma, a 22nd Century Group company (Nasdaq: XXII), today announced that a fire occurred at its GVB Biopharma distillate and isolate manufacturing facility located in Grass Valley, Oregon, on November 20, 2022. There were no reported life threatening injuries, but the fire damaged the facility.


"We want to thank the first responders who were able to quickly contain the fire and prioritize the safety of local residents during this event,” said James A. Mish, chief executive officer of 22nd Century Group. “Our first priority is the care of our employees who reported injuries and are receiving medical care.”


All Grass Valley manufacturing operations will be curtailed; however the Company is implementing backup production plans and believes its customers will experience no disruption in service or quality of products. 22nd Century is currently evaluating the extent of the damage resulting from the fire and the amount of loss is unknown at this time. The Company expects that losses resulting from the fire will be covered by its property and business interruption insurance policies.


Said Mish, “While the fire at our Grass Valley facility caused serious damage, we have backup plans in place to immediately ensure our customers receive product deliveries uninterrupted. We are also implementing our contingency plan, which includes at least five separate opportunities to rapidly continue the production of our distillate and isolate products. We will carefully evaluate these options for both immediate and longer term needs so as to mitigate any potential disruption from these events. Our team is moving rapidly to assess the extent of the damage, which we expect will be covered under our property and business interruption insurance policies.”


About GVB Biopharma

GVB Biopharma, a 22nd Century company, is a global-scale specialty ingredient supplier and contract development & manufacturing organization (CDMO) with manufacturing locations in Nevada and Oregon. GVB is the largest merchant provider of cannabinoid extracts and isolates in North America with a focus on cannabidiol (CBD) and cannabigerol (CBG) extracted and refined at an industrial scale into distillates and isolates. GVB Biopharma’s facilities are NSF International audited and are cGMP Registered for dietary supplements manufacturing. GVB is widely regarded as a best-in-class operator with a leading position in the hemp-derived active ingredients market, with around 15% market share and growing. GVB is also a white-label contract manufacturer of tinctures, gel capsules, gummies, mints, tablets, topical, and vape offerings.


About 22nd Century Group, Inc.

22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.


Learn more at xxiicentury.com, on 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. 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 1, 2022, and in the Company’s Quarterly Report filed on August 9, 2022. 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

22nd Century Group, Inc.

Director, Communications & Investor Relations



Darrow Associates Investor Relations

Matt Kreps





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