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Tag: 22nd Century Group

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • 22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Group reported first-quarter 2026 revenue of $4.1 million, with a continued focus on expanding its reduced-nicotine VLN cigarette portfolio and distribution footprint. The company said it is gaining traction with adult smokers, with products now available in more than 2,000 stores across 20 states and targeting over 5,000 retail locations by the end of 2026.

    The company is positioning its proprietary low-nicotine technology as aligned with potential future FDA standards, while pursuing a broader product pipeline across cigarettes, filtered cigars and other formats. Despite ongoing net losses, 22nd Century said it is prioritizing distribution growth, regulatory engagement, and margin improvement, with plans to expand licensing opportunities and advance multiple PMTA submissions to support long-term growth.

  • 22nd Century Announced May 7 Financial Call

    22nd Century Announced May 7 Financial Call

    22nd Century Group, Inc. announced that it will host a webcast on May 7 at 8 a.m. ET to discuss its first-quarter 2026 financial results, which are scheduled to be released earlier that day. Company executives, including CEO Larry Firestone and CFO Dan Otto, will review performance, outline progress during the quarter, and provide an update on plans for the remainder of 2026.

    The webcast will be available live and archived on the company’s investor relations website, with participants encouraged to register in advance.

  • 22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Group entered a testing services agreement with North Carolina State University to validate new low-nicotine tobacco varieties designed to improve yield and leaf quality while maintaining reduced nicotine levels, the company said. The research will evaluate genetic traits, crop performance, and commercial scalability as the company looks to strengthen its supply chain.

    The initiative builds on 22nd Century’s proprietary reduced-nicotine platform, which underpins its FDA-authorized VLN cigarette products. The company said the collaboration is aimed at supporting long-term production efficiency and aligning with evolving regulatory focus on nicotine reduction.

  • 22nd Century Debt-Free in Announcing 2025 Results

    22nd Century Debt-Free in Announcing 2025 Results

    22nd Century Group, Inc. reported its fourth-quarter and full-year 2025 results, highlighting strategic growth and a strengthened financial position. The company emphasized expansion of its VLN and Partner VLN product lines, increased retail distribution, and progress toward profitability. CEO Larry Firestone noted that 2025 saw a shift to higher-margin branded products, partnerships with major retailers, and the development of a tobacco harm-reduction category. The company ended 2025 debt-free with $7.1 million in cash and eliminated over $8 million in legacy debt, also receiving a $9.5 million insurance settlement from its 2022 Grass Valley facility fire.

    Financially, fourth-quarter net revenues were $3.5 million, down from $4 million in Q3, while net loss improved to $2.8 million versus $3.8 million previously. Adjusted EBITDA loss narrowed to $2.4 million. For the full year, net revenues were $17.6 million, down 28% from 2024, with a net loss of $13.1 million. Product-wise, cigarette sales increased slightly to $2.6 million in Q4, VLN product sales continued to grow with 8,800 cartons shipped, and Pinnacle VLN expanded to nearly 1,500 stores in a top-5 convenience chain.

    Looking ahead, 22nd Century plans to expand retail availability, increase consumer awareness, scale VLN distribution globally, and maintain active engagement with FDA regulators and public health stakeholders.

  • 22nd Century Group to Announce Q4, FY25 Results March 26

    22nd Century Group to Announce Q4, FY25 Results March 26

    22nd Century Group, Inc. announced it will host a webcast on March 26 at 8 a.m. ET to discuss its fourth-quarter and full-year 2025 financial results, which will be released earlier that morning. Chairman and CEO Larry Firestone and CFO Dan Otto will review performance, outline recent progress, and provide an update on the company’s 2026 plans.

  • 22nd Century Reports Momentum for VLN Products

    22nd Century Reports Momentum for VLN Products

    22nd Century Group touted early sales momentum for its VLN low-nicotine cigarettes, distributing approximately 8,800 cartons to about 1,700 new retail outlets nationwide in the fourth quarter of 2025, with initial sell-through data indicating growing adoption across its 22nd Century VLN, Pinnacle VLN, and Smoker Friendly VLN brands. The company said expanding retail placement across convenience stores, wholesalers, and independent chains supports its plan to exceed 5,000 points of distribution in 2026.

    22nd Century positioned its progress alongside regulatory developments, including a January 2025 proposed rule by the U.S. Food and Drug Administration to cap nicotine levels in cigarettes at 0.7 mg per gram of tobacco, and broader global support for nicotine reduction under the World Health Organization Framework Convention on Tobacco Control.

  • 22nd Century Files PMTA Renewal

    22nd Century Files PMTA Renewal

    22nd Century Group, Inc. announced it has filed a renewal application with the U.S. Food and Drug Administration for its Modified Risk Tobacco Product authorization covering VLN reduced nicotine content cigarettes. The original authorization, granted in December 2021, expires in December 2026.

    22nd Century says VLN remains the first and only combustible cigarette authorized by the FDA to reduce the health harms of smoking, with approved claims including “95% less nicotine” and statements that it helps reduce nicotine consumption and smoking frequency. The company cited decades of independent clinical research supporting VLN products, including evidence that lowering nicotine content reduces smoking rates and increases quit attempts. Company CEO Larry Firestone said the renewal builds on FDA recognition that reducing nicotine directly can alter smoking behavior and improve public health outcomes, adding that VLN products align with the FDA’s proposed low-nicotine standard issued in January 2025.

  • 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 Net Loss Widens

    22nd Century Net Loss Widens

    Photo: crizzystudio

    22nd Century Group reported net revenues of $5.9 million for the quarter that ended Sept. 30, 2024, down from $7.9 in last year’s comparable quarter. Net loss increased to $3.6 million, compared with $2.2 million in the 2023 quarter.

    “Having joined this company just under a year ago, we have transitioned from a purely financial focus to the next phase of 22nd Century Group’s turnaround plans, which includes deploying our extensive asset base of manufacturing, brand, customer relationship and distribution resources to build a sustainable and self-funding growth business,” said Chairman and CEO Larry Firestone in a statement.  

    “While the third quarter results reflect the operational adjustments that I spoke to on our last report intended to address underperforming results in the filtered cigar business, we remain focused on our goal of EBITDA breakeven results in the first quarter of 2025. We expect that the changes in our core CMO business will drive revenue growth going forward at appropriate margin levels.

    “I am also excited to announce that we are now moving ahead on our plans to launch additional products, including VLN SKUs within key customer brand families, as part of our drive to expand the distribution of reduced nicotine content cigarettes manufactured by 22nd Century.

    “Adding VLN within other brand families is a straightforward way to reduce our time to market, increase consumer awareness and expand the VLN footprint. This is really the beginning for 22nd Century as the synchronicity between the CMO business and VLN is progressing as planned and is the foundation for our growth plans for 2025 and beyond.”