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Tag: 22nd Century

  • 22nd Century to File New PMTA for 100mm VLN

    22nd Century to File New PMTA for 100mm VLN

    22nd Century Group, Inc. said it will submit an additional premarket tobacco product application to the U.S. Food and Drug Administration for a new 100mm version of its VLN reduced-nicotine cigarette, building on its status as “the only company with FDA authorization for a low-nicotine combustible product.” The company’s existing 84mm king-size VLN cigarettes received PMTA authorization in 2021.

    The new product, developed under its “Operation 100” initiative, is designed to offer adult smokers a familiar format while significantly lowering nicotine intake. 22nd Century said expanding into the 100mm size responds to retailer and consumer feedback and could widen access to reduced-nicotine alternatives without requiring smokers to switch to non-combustible products.

    Beyond the single submission, the company outlined plans to pursue multiple PMTAs across different combustible formats, blends, and sizes, including filtered cigars, creating a broader portfolio that can be licensed to other tobacco companies. Management said this strategy is intended to accelerate retail penetration of VLN products and to position the company as a provider of regulatory pathways for reduced-nicotine tobacco offerings.

  • 22nd Century Sees 28% Revenue Drop in Preliminary Report

    22nd Century Sees 28% Revenue Drop in Preliminary Report

    22nd Century Group, Inc. reported preliminary, unaudited results for the fourth quarter and full year ended December 31, 2025, showing continued losses but improved operating metrics and a debt-free balance sheet. The company expects Q4 net revenues of about $3.6 million, down from $4 million in Q3, with full-year revenues of approximately $17.6 million versus $24.4 million in 2024. Fourth-quarter gross loss is projected at $0.8 million, with an operating loss of $2.8 million and net loss from continuing operations of $2.8 million; full-year net loss from continuing operations is expected to narrow to $13.1 million from $15.5 million in 2024. Carton shipments totaled roughly 0.3 million in Q4 and 2.1 million for the year, flat year over year. The company ended 2025 with $7.1 million in cash, no long-term debt after extinguishing its senior secured obligations, and inventory of $4.3 million following harvest of its reduced nicotine tobacco crop. Management said it is focused on expanding distribution of its VLN brands, maintaining cost discipline and advancing toward profitability. The company plans to release its final numbers March 31.

  • 22nd Century to Participate in the Needham Annual Growth Conference

    22nd Century to Participate in the Needham Annual Growth Conference

    22nd Century Group, Inc. announced that CEO Larry Firestone and CFO Dan Otto will present as part of the Needham Growth Conference taking place January 16. The management team will be available for virtual one-on-one meetings.

    Investors interested in booking meetings can register for the conference and arrange a time through their Needham representative or the Company’s investor relations at investorrelations@xxiicentury.com.

  • 22nd Century Expands VLN to 140 C-Stores in Illinois

    22nd Century Expands VLN to 140 C-Stores in Illinois

    22nd Century Group, Inc. announced the launch of its VLN reduced-nicotine content cigarettes with 140 Circle K locations in Illinois, marking another step in the company’s nationwide rollout. The products, designed to contain 95% less nicotine, are now authorized for sale in 45 states, with approvals in the remaining five expected soon.

    Chief Executive Officer Larry Firestone said the expansion returns the brand to its first launch market. “We know there are VLN smokers who will appreciate the new branding and product rollout in Illinois,” Firestone said. “Once we achieve authorization and distribution in all 50 states, we will demonstrate the large-scale feasibility of our VLN low-nicotine products and alignment with the FDA’s new low-nicotine mandate.”

  • 22nd Century Group Backs FDA’s Proposed Reduced Nicotine Standard

    22nd Century Group Backs FDA’s Proposed Reduced Nicotine Standard

    22nd Century Group, Inc. submitted public comments in support of the U.S. FDA’s proposed rule to mandate very low nicotine levels in cigarettes and other combusted tobacco products. CEO Larry Firestone said the evidence shows such a standard could save millions of lives and transform the market within two years, with the company’s VLNC technology already proven to deliver consumer-acceptable products.

    22nd Century criticized Big Tobacco’s stance as contradictory, arguing that support for a reduced nicotine mandate would align with industry claims of pursuing a “smoke-free future.” The company pledged to continue backing the rule, calling it a landmark public health measure.

    “The evidence is overwhelming that a reduced nicotine yield standard for combusted tobacco products has the potential to save millions of lives and trillions of dollars cumulatively in the U.S. alone,” said Firestone. “From both a public health and commercial standpoint, the only barrier left to the most transformative public health policy of a generation is the willingness to move forward with this mandate.”

  • 22nd Century Settles $9.5M Insurance Claim, Eyes 2026 Profitability

    22nd Century Settles $9.5M Insurance Claim, Eyes 2026 Profitability

    22nd Century Group, Inc. announced it reached a settlement with its insurers for $9.5 million in cash to resolve all business interruption claims related to a fire at the company’s Grass Valley facility in November 2022. The insurers are required to remit the payment within 45 days of the agreement’s effective date.

    “We are very excited to close this chapter and finally settle with our insurance carrier for the full amount we targeted,” CEO Larry Firestone said. “Additionally, because the company is now debt free, this marks a major transition from survival capital to growth capital.”

    The company highlighted that over the past 22 months it has addressed legacy financial challenges, cleaning up its balance sheet. With these matters resolved, 22nd Century Group plans to focus on expanding distribution for its VLN and partner VLN products and is targeting profitability in 2026.

  • 22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Group, Inc. is doubling down on its push for very low nicotine (VLN) products, highlighting new partnerships, regulatory momentum, and expanded product development in a shareholder letter released yesterday (August 19). CEO Larry Firestone said the company’s VLN cigarettes, the first FDA-authorized combustible products designed to reduce smoking harms, are gaining traction through stocking orders with Smoker Friendly and Pinnacle, with more partners expected.

    A looming FDA proposal, set for September 15, could mandate a cap of 0.7 mg/g nicotine yield in cigarettes, a standard built on 22nd Century’s own clinical trials. Firestone said the move “could be the most groundbreaking and effective tobacco regulation in a generation.”

    Beyond cigarettes, 22nd Century is developing VLN filtered cigars, 100mm formats, and international variants, supported by ongoing FDA filings. The company is also studying whether its low-nicotine genetics reduce cancer-causing TSNAs.

    With a growing IP portfolio in plant genetics, the company said it is aiming to cement its position as the leader in tobacco harm reduction. Firestone framed the mission as both business and public health: “Our technology and products have the capability to dramatically improve public health and the welfare of smokers worldwide – hopefully even save lives.”

  • 22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group reported second-quarter 2025 revenues of $4.1 million, down from $6 million in the first quarter, with a net loss holding steady at $3.3 million. Operating loss widened to $3 million, while adjusted EBITDA loss came in at $2.6 million. The company reduced its debt by an additional $1 million, bringing total debt down to $3.8 million.

    CEO Larry Firestone highlighted the momentum behind the company’s FDA-authorized VLN reduced-nicotine cigarettes, which now have authorization for sale in 44 states. Partner brands, including Pinnacle VLN, are expanding distribution, with nearly 1,000 stores across 12 states expected to begin selling the product September 1. The company is also advancing new SKUs, including Pinnacle moist snuff, and preparing an FDA submission for a new 100mm VLN cigarette by year-end.

    Despite financial challenges, Firestone emphasized that 22nd Century is entering a “profitable growth phase” built on its proprietary low-nicotine tobacco technology. He said VLN® products are positioned to align with the FDA’s proposed nicotine standards, giving the company a first-mover advantage in the harm reduction market.

  • 22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group, Inc. announced the first shipments of its new Pinnacle VLN Gold and Pinnacle VLN Menthol reduced-nicotine content cigarettes will be available September 1 at nearly 1,000 convenience store locations across 12 states.

    Company CEO Larry Firestone said Pinnacle’s conventional cigarettes have built strong customer loyalty, and the new VLN line offers smokers a choice to significantly reduce nicotine intake—about a 95% reduction compared to traditional cigarettes.

    The company plans to expand the Pinnacle VLN range into more states and stores while continuing to supply other Pinnacle products, including conventional cigarettes, cigarillos, and moist snuff. Firestone emphasized 22nd Century’s commitment to lead the tobacco harm reduction movement by increasing access to these reduced-nicotine products.

  • 22nd Century Advances FDA Renewal for VLN

    22nd Century Advances FDA Renewal for VLN

    22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.

    First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.

    “Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.

    “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”