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 set to discuss its second quarter results for 2025 during a webcast on August 14, 2025, highlighting its ongoing efforts in nicotine harm reduction and the introduction of its VLN® cigarette product [1][2]. Company Overview - 22nd Century Group is a leader in the nicotine harm reduction movement within the tobacco industry, focusing on enabling smokers to manage their nicotine consumption [4]. - The company has developed the VLN® cigarette, which contains 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative to help reduce their nicotine intake [5]. Product Details - The VLN® cigarette is designed to allow consumers to make informed choices regarding their nicotine consumption, potentially avoiding addictive levels altogether [5]. - The proprietary reduced nicotine tobacco blends are created using patented technologies that regulate nicotine biosynthesis in tobacco plants, ensuring full flavor and high yield while maintaining low nicotine levels [6]. Webcast Information - The webcast will feature Larry Firestone, CEO, and Dan Otto, CFO, who will review financial results and discuss the company's progress and plans for 2025 [2][3]. - The live and archived webcast will be available on the company's Investor Relations website [3].

Core Insights - 22nd Century Group, Inc. has launched its new Pinnacle VLN® Gold and Pinnacle VLN® Menthol reduced nicotine content cigarettes, with initial shipments supporting a sales launch on September 1, 2025, at nearly 1,000 locations across 12 states for a top-5 U.S. convenience store chain [1][2] - The Pinnacle VLN® products represent a significant innovation in the tobacco industry, offering a 95% reduction in nicotine compared to traditional cigarettes, aligning with the FDA's proposed low nicotine mandate [2][4] - The company aims to expand the reach of its VLN® products to promote harm reduction in smoking habits, backed by extensive clinical research [4][6] Product Details - VLN® products utilize proprietary tobacco that has 95% reduced nicotine content, making them the first combusted tobacco products compliant with the FDA's proposed new Tobacco Product Standard for Nicotine Yield [3][7] - The VLN® cigarette is designed to provide traditional smokers with a familiar alternative that allows them to control their nicotine consumption [6][7] - The company holds a comprehensive patent portfolio, ensuring it remains the only provider of low nicotine combustible cigarettes in the U.S. and critical international markets [7] Market Strategy - The launch of Pinnacle VLN® products is expected to enhance brand loyalty among customers of the convenience store chain, reinforcing the company's position in the tobacco harm reduction movement [2][4] - The company plans to continue adding more states and locations for Pinnacle VLN® products, along with re-ordering inventory through the distributor [2]

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 Insights - 22nd Century Group, Inc. has announced a significant increase in state authorizations for the sale of its VLN® reduced nicotine content cigarettes and other products, enabling new sales activities and product launches [1][2][3] - The company aims to achieve nationwide availability of VLN® products across all 50 states, demonstrating compliance with the FDA's Low Nicotine Mandate [3][4] - The company has over 2,000 partner VLN® retailers preparing to implement sales, with expectations for further growth in the second half of 2025 [3][4] Product and Market Expansion - The increase in state authorizations allows for the launch of new partner brands and private label VLN® products in large, untapped markets across the U.S. [4] - There are over 272,000 retail outlets in the U.S. selling tobacco products, presenting a substantial market opportunity for both VLN® and conventional products [4] - Key state authorizations include VLN® Gold and Green in 41 states, VLN® Red in 21 states, and various Smoker Friendly and Pinnacle® products across multiple states [8] Harm Reduction and Innovation - 22nd Century Group has been a leader in the tobacco harm reduction movement for 27 years, focusing on reducing smoking rates and health harms through its VLN® products [5][6] - VLN® cigarettes contain 95% less nicotine than traditional cigarettes, supported by decades of peer-reviewed studies indicating reduced smoking rates and health risks [5][7][10] - The company utilizes proprietary technologies to create reduced nicotine tobacco blends, ensuring a unique position in the market with its patented products [10]

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 is expanding the availability of its VLN® reduced nicotine content products through partnerships with multiple tobacco brands, aiming to reduce smoking rates and related health harms [1][2][3] - The FDA's proposed Tobacco Product Standard for nicotine yield, which sets a maximum nicotine content of 0.7 mg per gram of tobacco, is driving interest in VLN products, which average 0.5 mg per gram [3][4][5] - The implementation of the FDA's proposal could prevent approximately 48 million youth and young adults from starting to smoke by the year 2100 [4][6] Company Overview - 22nd Century Group is recognized as a pioneering company in nicotine harm reduction, providing smokers with options to control their nicotine consumption [7][8] - The VLN® cigarette is designed to offer a familiar alternative for traditional smokers, containing 95% less nicotine than conventional cigarettes [8][9] - The company holds a comprehensive patent portfolio that ensures it has the only low nicotine combustible cigarette in the U.S. and critical international markets [9]

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 is advancing a 100mm VLN® reduced nicotine content cigarette, targeting an FDA submission by Q4 2025, expanding its product line aimed at nicotine harm reduction [1][4] - The new 100mm product is designed to appeal to approximately half of the U.S. smoking population who prefer this size, enhancing the reach of VLN® products [3][4] - The company emphasizes that its proprietary reduced nicotine content tobacco has been validated through independent clinical studies, demonstrating effectiveness in reducing smoking behaviors [3][6] Product Development - The 100mm VLN® cigarette will be available under both VLN® branding and partner brands like Smoker Friendly and Pinnacle, if authorized [2] - The VLN® cigarette contains 95% less nicotine than traditional cigarettes, which has been shown to help smokers reduce consumption and increase quit attempts [6][9] Market Position - 22nd Century Group is positioned as a pioneering company in nicotine harm reduction within the tobacco industry, focusing on providing smokers with choices to control their nicotine consumption [5][7] - The company operates a manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combustible tobacco products annually, with room for expansion [8]

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]