TobaccoReporter logo

Tag: 22nd Century Group

  • 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.”

  • John Miller Resigns from 22nd Century

    John Miller Resigns from 22nd Century

    John Miller (Photo: Swisher)

    John Miller has resigned as 22nd Century Group’s president of tobacco, effective Aug. 2, 2024.

    “I want to thank John for the pivotal role he played in the launch of VLN, leveraging his decades of industry experience to help us achieve national-scale distribution and establishing a retail presence in more than 5,000 stores across 26 states,” said Larry Firestone, chairman and CEO, in a statement.

    “He also played a key role in expanding our CMO business, including our exciting Pinnacle launch as a store brand for one of the top convenience store chains in the country. We are now well positioned to continue building on this incredible footprint as we work to achieve our company objectives.”

  • 22nd Century Eliminates $2.3 million of Debt

    22nd Century Eliminates $2.3 million of Debt

    22nd Century Group has entered into a binding letter of agreement to eliminate an additional $2.3 million in outstanding debt with JGB Capital.

    Under the terms of the agreement, the company and JGB Capital will exchange an aggregate of $2.3 million in principal, fees and expenses owed to JGB Capital for consideration of approximately 1.375 million shares of the company’s common stock and prefunded warrants. Additionally, the company will defer monthly amortization payments for an additional two months, resulting in no required further principal repayment until August 2024.

    “This agreement with JGB is another significant step in restoring strength to our balance sheet as we work toward becoming debt-free,” said 22nd Century Group chairman and CEO Larry Firestone in a statement.

    “This transaction also preserves our cash resources for commercial use as we work to become cash flow positive by the first quarter of 2025. We have made substantial progress on our commercial programs, including refining our revenue mix, implementing a lean operating cost profile and positioning the company to win new contracts, including the new CMO and distribution agreements announced recently, which are already advancing our sales in the second quarter.”

  • 22nd Century Eliminates Debt

    22nd Century Eliminates Debt

    Photo: Photo: Jade

    22nd Century Group has entered into a binding letter of agreement to redeem $5.2 million in outstanding principal and interest associated with the Omnia subordinated note and outstanding warrants.

    The agreement will exchange consideration of approximately $248,000 in cash, 1.15 million shares of common stock priced at $2.14 per share and 1.15 million shares of prefunded warrants priced at $2.14 per share as consideration of the debt. Additionally, the company will issue to Omnia 460,000 warrants with a term of five years and an exercise price of $2.14 per share.

    “Paying Omnia at maturity with equity greatly improves our balance sheet, preserves cash for growing our operating business and significantly increases shareholder equity,” said Chairman and CEO Larry Firestone in a statement. “This transaction also reduces our monthly interest expense and adds to the progress made on increasing sales and margin while reducing operating costs. This is a key milestone toward reaching our goal of being cash positive in the first quarter of 2025.”

  • Sullivan and Mish Resign From 22nd Century Group’s Board

    Sullivan and Mish Resign From 22nd Century Group’s Board

    Photo: Charnchai saeheng

    Nora Sullivan and James Mish have resigned as a directors of 22nd Century Group. In a press note, the company said it does not intend to fill the vacated seats and will instead reduce the board to four seats as part of its focus on corporate cost efficiency.

    “We thank Nora and Jim for their service to the company over the years,” said 22nd Century Group Chairman and CEO Larry Firestone.

    “We plan to reduce the size of the board in 2024, in addition to the previously announced reduction in board compensation, consistent with our efforts to achieve breakeven operations. In total, these changes to our board are expected to save more than $1 million annually.”

  • 22nd Century Signs New Manufacturing Deal

    22nd Century Signs New Manufacturing Deal

    Photo: thodonal

    22nd Century Group has expanded its Pinnacle private label brand to add distribution of cigarillo products to its existing Pinnacle cigarette products. Pinnacle products are currently sold as a private label brand in a leading U.S. gas station convenience store chain comprising approximately 1,700 stores in 26 states.

    According to 22nd Century Group, Pinnacle cigarette product re-order volumes are now achieving sustained sequential growth as the private label contract enters its second year with this top retail customer, which is itself seeing notable growth in its tobacco sales and gaining market share by offering value to its customers.

    “We are excited to expand our Pinnacle brand with new cigarillo products based on the successful sales growth of these private label cigarette products sold at one of the top U.S. c-store chains,” said 22nd Century Group Chairman and CEO Larry Firestone in a statement.

    “Agreements like this help us to further enhance revenue and profitability in our business as we work toward breakeven operations by the first quarter 2025.”

    The cigarillo expansion agreement is in addition to a recently announced new CMO customer contract that is expected to increase the 22nd Century Group’s contract manufacturing organization production volumes by at least 20 percent, with shipments commencing from the second quarter.

  • 22nd Century to Eliminate Senior Debt

    22nd Century to Eliminate Senior Debt

    Photo: Photo: Jade

    The step is part of an effort to put the company back on a path to growth, says CEO Firestone.

    22nd Century Group has entered into an agreement with its senior secured lender to eliminate all of its senior secured debt through potential debt for equity exchanges. Additionally, the company has entered into separate definitive agreements for the purchase of common stock and warrants.

    The company also announced the appointment of Daniel Otto as chief financial officer (CFO) and Jonathan Staffeldt as general counsel. Both are currently employed at 22nd Century Group, Otto as corporate controller and Staffeldt as vice president and deputy general counsel. R. Hugh Kinsman, the company’s current CFO, will leave the company on June 1, 2024.

    “We are putting 22nd Century back on a path to growth, and eliminating our debt is another key step in cutting our external operating cash needs,” said 22nd Century chairman and CEO Larry Firestone in a statement.

    “Combined with a new contract manufacturing customer announced last week that is expected to increase our CMO volumes by at least 20 percent and our plans to build a new tobacco harm reduction category around our FDA-authorized VLN products, we intend to become cash positive by the first quarter of 2025.

    “Dan and Jonathan have been key contributors to these turnaround efforts at 22nd Century, helping us to exit the hemp/cannabis business and significantly reduce our quarterly cash use as reported in our year-end results,” Firestone added. “I also want to thank Hugh for his hard work on behalf of 22nd Century, and in particular over the past several months as we worked to transform our financial footprint.”