Core Viewpoint - 22nd Century Group, Inc. is set to host a webcast on November 4, 2025, to discuss its third quarter results for 2025, highlighting its ongoing leadership in tobacco harm reduction and nicotine consumption control [1][2]. Company Overview - 22nd Century Group is a pioneer in the tobacco harm reduction movement, focusing on enabling smokers to manage their nicotine consumption [4]. - The company has developed proprietary non-GMO reduced nicotine tobacco plants that contain 95% less nicotine than traditional tobacco plants, supported by an extensive patent portfolio [5]. Products - The flagship product, VLN cigarette, utilizes low nicotine tobacco, providing traditional smokers with a familiar alternative that helps reduce nicotine consumption by 95% compared to regular cigarettes [6]. - VLN cigarettes are the only low nicotine combustible cigarettes authorized by the FDA in the United States [7]. Webcast Details - The webcast will feature Larry Firestone, CEO, and Dan Otto, CFO, who will review financial results and discuss recent progress and future plans for 2025 [2][3].

Core Viewpoint - The proposed FDA standard for nicotine yield in tobacco products could prevent 4.3 million deaths and save $600 billion annually in economic damages related to smoking [1][3]. Company Position - 22nd Century Group supports the FDA's proposed rule, emphasizing that it could lead to the complete replacement of conventional high-nicotine products with Very Low Nicotine Content (VLNC) products within two years [1][3]. - The company has developed proprietary non-GMO reduced nicotine tobacco plants, which contain 95% less nicotine than traditional tobacco, enabling the production of consumer-acceptable combusted tobacco products [8][9]. Health Impact - The FDA's population health model suggests that adopting the proposed rule could prevent smoking initiation in approximately 48 million youth and young adults and avert 1.8 million tobacco-related deaths by 2060 [3][4]. - Clinical evidence supports that limiting nicotine in combusted tobacco products leads to reduced cigarette consumption, decreased dependence on tobacco, and increased cessation attempts [3][4]. Industry Support - Over 75 health care organizations, including the American Medical Association and the American College of Cardiology, endorse the proposed rule, citing the urgent need for such a standard [4]. - Some organizations argue that the rule should extend to limit nicotine in Heated Tobacco Products (HTPs) as well [4]. Opposition - Major legacy tobacco producers oppose the proposed standard, citing concerns over economic disruption and potential illicit trade [5]. - The company argues that the opposition from these producers contradicts their stated goals of transitioning smokers to less harmful products [5].

Core Insights - 22nd Century Group has settled all claims related to the Grass Valley incident for a one-time payment of $9.5 million, which will be paid by insurers within 45 days [1][2] - The company is now debt-free, marking a transition from survival capital to growth capital, and is positioned to focus on driving profitability by 2026 [2] Company Overview - 22nd Century Group is a leader in the tobacco harm reduction movement, enabling smokers to manage their nicotine consumption [3] - The company has developed proprietary non-GMO reduced nicotine tobacco plants that contain 95% less nicotine than traditional tobacco [4] Product Information - The flagship product, VLN cigarette, is designed for traditional smokers, offering a combustible alternative with 95% less nicotine, proven to help reduce nicotine consumption [5] - VLN cigarette is the only low nicotine combustible cigarette authorized by the FDA in the United States [6]

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]