Proposed FDA Standard Could Avert 4.3 Million Deaths, $600 Billion in Annual Economic Damage Linked to Smoking VLNC Products Could Fully Supplant Conventional Highly Addictive Combusted Products in as Little as Two Years MOCKSVILLE, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today announced submission of public comments ...

Non-dilutive Cash Puts Growth Capital and Runway to Breakeven on the Balance Sheet Company is Positioned to Drive to Profitability in 2026 MOCKSVILLE, N.C., Sept. 24, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today announced that it has reached an agreement to settle all claims for business interruption related to the Grass Valley inci ...

Core Insights - 22nd Century Group has successfully repaid $3.9 million in senior secured debt, significantly reducing ongoing cash needs and operating costs by eliminating cash interest and amortization expenses [1][2] - The company has eliminated over $20 million in senior secured and subordinated debt since the current CEO joined, positioning itself for growth with a debt-free balance sheet [2] - The completion of the Series A convertible preferred stock offering and debt repayment has resulted in an approximate $9.1 million increase in adjusted pro forma net tangible book value, equating to about $1.05 per share [2] Financial Position - The company’s balance sheet now reflects working capital that supports the purchase of low nicotine leaf crops, enabling the production of more than 1 million cartons of VLN products [1][2] - Plans are in place to deploy a portion of capital to expand the inventory of very low nicotine tobacco leaf in Q4 2025 [2] Product and Technology - 22nd Century Group is pioneering the tobacco harm reduction movement with its proprietary non-GMO reduced nicotine tobacco plants, which contain 95% less nicotine than traditional tobacco [4][5] - The flagship product, VLN cigarettes, provide traditional smokers with a familiar alternative that helps them control their nicotine consumption [5][6] - VLN cigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States [6]

Core Insights - 22nd Century Group, Inc. is leading the nicotine harm reduction movement in the tobacco industry, focusing on helping smokers control their nicotine consumption [3][4] - The company will host investor meetings on September 9, 2025, during the HC Wainwright Conference in New York [1][2] Company Overview - 22nd Century Group has developed the VLN cigarette, which contains 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative to manage their nicotine intake [4][5] - The company utilizes proprietary non-GMO reduced nicotine tobacco blends, supported by patented technologies that regulate nicotine biosynthesis in tobacco plants, ensuring a full flavor experience with lower nicotine levels [5] Product Details - VLN cigarettes are designed to allow consumers to significantly reduce their nicotine consumption while still enjoying a combustible cigarette format [4] - The extensive patent portfolio of 22nd Century Group secures its position as the only provider of low nicotine combustible cigarettes in the United States and key international markets [5]

Core Viewpoint - 22nd Century Group, Inc. is leading the nicotine harm reduction movement in the tobacco industry, focusing on providing smokers with alternatives to manage their nicotine consumption effectively [3][4]. Group 1: Company Overview - 22nd Century Group, Inc. has been at the forefront of combating the harms of smoking due to nicotine addiction for 27 years [1]. - The company is set to present at the Emerging Growth Virtual Investor Conference on August 20, 2025, at 1:10 PM Eastern Time [1]. - The flagship product, VLN cigarettes, contains 95% less nicotine than traditional cigarettes, allowing smokers to significantly reduce their nicotine intake [4]. Group 2: Product Details - VLN cigarettes are designed to provide an authentic smoking experience while enabling smokers to take control of their nicotine consumption [4]. - The company utilizes proprietary non-GMO reduced nicotine tobacco blends, supported by patented technologies that regulate nicotine biosynthesis in tobacco plants [5]. - The extensive patent portfolio ensures that 22nd Century Group holds the only low nicotine combustible cigarette in the United States and key international markets [5].

Core Insights - 22nd Century Group, Inc. is expanding its VLN product line with new partner brands and increased state authorizations, positioning itself as a leader in tobacco harm reduction [1][3][2] - The company reported a decrease in net revenues for Q2 2025, with a focus on profitable growth through its branded products [5][9] Business Highlights - The company commenced shipments of Pinnacle VLN products to nearly 1,000 locations, with additional locations expected [1][5] - State authorizations for VLN products have significantly increased, with 44 states now allowing sales of VLN products and 30 states for partner VLN products [5][10] - The company is working on developing additional tobacco products to cater to users seeking lower nicotine options [3][10] Financial Performance - Net revenues for Q2 2025 were $4.1 million, down 48.6% from $7.9 million in Q2 2024 [9] - Operating loss increased to $3.0 million compared to $2.6 million in the previous quarter, while net loss remained stable at $3.3 million [5][9] - Adjusted EBITDA loss was $2.6 million, slightly worse than the loss of $2.3 million in the previous quarter [5][9] Product Line Developments - Cigarette net revenues decreased to $2.7 million from $5.0 million in Q1 2025, despite an increase in carton volumes to 594 thousand [10] - Filtered cigar net revenues increased to $1.3 million, reflecting stabilized volume from new contracts [10] - The company announced new branding for its VLN products and two new partner brand VLN product families, with initial shipments expected in Q3 2025 [10][12] Balance Sheet Overview - Total debt was approximately $3.9 million at the end of Q2 2025, with net debt reduced to $0.7 million [7][9] - Cash reserves stood at approximately $3.1 million, down from $4.4 million at the end of 2024 [7][25]

Core Viewpoint - 22nd Century Group, Inc. is the only tobacco company authorized by the FDA to produce reduced nicotine content combustible cigarettes, specifically their VLN products, which align with the proposed FDA standard for nicotine yield [1][4]. Group 1: Public Health Impact - Smoking in the U.S. results in over 480,000 deaths and costs more than $600 billion annually, significantly reducing life expectancy by 10 years [2]. - The proposed FDA standard aims to limit nicotine in combusted tobacco products to less than 0.7mg per gram, addressing public health issues related to nicotine addiction [2][9]. Group 2: Industry Position and Product Offering - 22nd Century Group's VLN products contain 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative that allows for better control over nicotine consumption [6][7]. - The company has developed proprietary non-GMO reduced nicotine tobacco blends through patented technologies, ensuring they hold a unique position in the market with the only low nicotine combustible cigarette in the U.S. and key international markets [7]. Group 3: Support from Medical Community - The American Academy of Family Physicians, representing over 128,300 family physicians, supports the FDA's proposed nicotine yield standard, emphasizing its importance in combating tobacco dependence [3][9].

Core Viewpoint - 22nd Century Group is leading the initiative to reduce smoking rates and health harms through the adoption of its VLN reduced nicotine content products, which contain 95% less nicotine than conventional cigarettes [1][3][8] Group 1: Product and Technology - VLN products are manufactured in the USA and are the only combustible cigarette products authorized by the FDA to meet the proposed nicotine standard of 0.7 mg per gram, averaging 0.5 mg per gram [3][5] - The proprietary technology used in VLN products allows for the regulation of nicotine biosynthesis in tobacco plants, resulting in high yield and full flavor with significantly reduced nicotine content [9] Group 2: Market and Regulatory Context - The recent partnerships with brands like Smoker Friendly VLN and Pinnacle VLN indicate a growing commitment among tobacco brands to comply with the FDA's proposed Tobacco Product Standard for Nicotine Yield [2][3] - The FDA's proposed standard aims to curb smoking-related harms and is expected to prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [4][6] Group 3: Company Strategy and Vision - The company is actively monitoring the comment submissions regarding the proposed rule and plans to submit its own feedback, reflecting its commitment to influence regulatory outcomes [5] - The CEO of 22nd Century Group emphasized that the commercial launches of VLN products will enhance market availability and provide consumers with choices to control their nicotine consumption [3][4]

Core Insights - 22nd Century Group, Inc. is leading the fight against smoking-related health harms through its VLN reduced nicotine content products, which are the first and only combustible cigarettes authorized by the FDA to reduce health risks associated with smoking [1][2][4] Product Overview - VLN cigarettes contain 95% less nicotine than conventional cigarettes, supported by decades of independent clinical research demonstrating their effectiveness in reducing nicotine consumption, smoking rates, and increasing quit attempts [2][4] - The VLN product line is designed to provide smokers with non-addictive alternatives, allowing them to control their nicotine intake and potentially reduce tobacco use [2][4] Regulatory Status - The VLN product was originally authorized in December 2021, with a renewal process due in December 2026, and the company expects full FDA support for this renewal based on its compliance with the FDA's low nicotine mandate issued in January 2025 [2][4] Research and Development - The company is committed to ongoing R&D programs aimed at advancing reduced nicotine content in tobacco and introducing additional VLN-based products to offer more health-oriented alternatives to traditional tobacco products [2][4] Company Mission - 22nd Century Group aims to empower smokers to make informed choices regarding their nicotine consumption, promoting a healthier lifestyle by providing options that help avoid addictive levels of nicotine altogether [4][5]

Core Insights - 22nd Century Group, Inc. is launching new Pinnacle VLN and moist snuff products in over 1,700 stores across 27 states, marking a significant expansion in its product offerings [1][2] - The new products include Pinnacle VLN Gold and Menthol VLN cigarettes, which are expected to begin sales in late summer and early fall of 2025 [2][4] - The company aims to leverage its established Pinnacle brand, which has a strong sales track record, to drive success in the new product categories [2][5] Product Launch Details - The launch includes four new Pinnacle SKUs, with two specifically in the low nicotine category [1] - The moist snuff products will feature straight and wintergreen flavors, expected to be available in the second half of 2025 [4] - The manufacturing of these products will utilize proprietary VLN tobacco strains and will be distributed through existing national-scale distribution agreements [5][6] Company Background - 22nd Century Group is recognized as a pioneering nicotine harm reduction company, focusing on enabling smokers to control their nicotine consumption [7] - The flagship VLN cigarette contains 95% less nicotine than traditional cigarettes, providing an alternative for smokers looking to reduce their nicotine intake [8][10] - The company operates a facility in Mocksville, North Carolina, with the capacity to produce over 45 million cartons of combustible tobacco products annually [9]