Core Viewpoint - The FDA has proposed a new Tobacco Product Standard that aims to significantly reduce nicotine levels in cigarettes and certain combusted tobacco products, which could lead to a decrease in smoking-related morbidity and mortality. 22nd Century Group's VLN products are highlighted as compliant with this new standard, positioning the company for potential growth in commercialization and distribution [1][2][6]. Group 1: FDA Proposed Standard - The proposed standard sets a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products, expected to take effect two years after final approval [2]. - The FDA anticipates that this standard could prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [6]. Group 2: 22nd Century Group's Position - 22nd Century Group's VLN products are the only combustible cigarettes authorized by the FDA as reduced nicotine content products, currently available in over 5,000 stores across the U.S. [2][3]. - The company has been committed to nicotine harm reduction for 26 years, and the FDA's proposal is seen as a significant opportunity for commercial adoption of its VLN products [3]. Group 3: Product and Manufacturing Capabilities - VLN cigarettes contain 95% less nicotine than traditional cigarettes and have been proven to reduce overall nicotine consumption [5]. - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combusted tobacco products annually, with room for expansion [7]. Group 4: Technological Innovation - 22nd Century Group utilizes patented technologies to create proprietary reduced nicotine tobacco blends, ensuring they have the only low nicotine combustible cigarette in the U.S. and critical international markets [8].

Industry Trends and Market Opportunity - The FDA estimates that 13 million smokers could benefit from reduced nicotine cigarette policies in the first five years, highlighting a significant public health opportunity [1] - The reduced nicotine cigarette market mirrors the growth of non-alcoholic beer and spirits, as consumers seek alternatives to traditional products [1] - The FDA's policy proposal to mandate reduced nicotine content in cigarettes has cleared review by the U.S. Office of Management and Budget, indicating regulatory progress [3] Company Overview and Product Innovation - 22nd Century Group is a pioneer in nicotine harm reduction, offering VLN cigarettes with 95% less nicotine than traditional cigarettes [2] - The company's proprietary technology regulates nicotine biosynthesis in tobacco plants, enabling full flavor and high yield with significantly reduced nicotine content [2][6] - VLN cigarettes are the only FDA-authorized combustible tobacco products under the Modified Risk Tobacco Product designation, available in over 5,000 stores nationwide [7] Manufacturing and Expansion Capabilities - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, with an annual production capacity of over 45 million cartons of combusted tobacco products [2] - The facility has additional space for expansion, supporting future growth in production [2] Regulatory and Policy Developments - The reduced nicotine cigarette policy, initiated during the Trump administration, has gained momentum under the Biden administration, reflecting bipartisan support for smoking harm reduction [7] - 22nd Century Group's VLN products have demonstrated commercial viability and effectiveness in controlling nicotine intake, countering skepticism from major tobacco companies [1][7] Market Positioning and Competitive Advantage - The company's extensive patent portfolio ensures it is the sole provider of low nicotine combustible cigarettes in the U.S. and key international markets [6] - 22nd Century Group collaborates with retailers to stock VLN products and other reduced nicotine cigarette brands, creating a new market category [1]

Core Viewpoint - The FDA's proposal to mandate reduced nicotine content in cigarettes has cleared the OMB review, which could significantly impact public health by reducing smoking-related harms [1][2]. Group 1: FDA Proposal and Company Position - The FDA's proposed tobacco product standard aims for a drastic reduction in nicotine levels in cigarettes, aligning with public health goals and the mission of 22nd Century Group [1][2]. - 22nd Century Group supports the FDA's initiative and emphasizes its role in research and development of reduced nicotine products, including the VLN brand [2][3]. Group 2: Product and Market Strategy - The VLN cigarette contains 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative that helps control nicotine consumption [3]. - The company plans to expand its product line with additional reduced nicotine content products and increase consumer awareness of low nicotine cigarettes as a distinct market category [2][3]. Group 3: Company Overview - 22nd Century Group is a pioneering company in nicotine harm reduction, with a manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of tobacco products annually [3]. - The company holds a comprehensive patent portfolio that ensures it is the only provider of low nicotine combustible cigarettes in the U.S. and key international markets [3].

Core Insights - 22nd Century Group has completed a new licensing and manufacturing agreement with Smoker Friendly, covering 11 existing brands and supporting the launch of 8 additional premium brands [1][2] - The agreement is set for five years and aims to expand both companies' business opportunities while enhancing Smoker Friendly's product offerings [1][3] Group 1: Agreement Details - The agreement includes 11 existing SF brands and plans for 8 new premium products focusing on the natural segment of the market [1][2] - The new products are expected to occupy a premium market position compared to lower-tier products, expanding Smoker Friendly's market opportunity [2] - The agreement builds on a decade-long relationship and secures a longstanding customer for 22nd Century [1][3] Group 2: Product Expansion and Strategy - The company plans to integrate Smoker Friendly's existing filtered cigar business and add a reduced nicotine content brand that complements the VLN product line [2][4] - The reduced nicotine content products are designed to help smokers control their nicotine intake, aligning with 22nd Century's mission of nicotine harm reduction [4][6] - The proprietary tobacco strains used in VLN products contain 95% less nicotine, which is considered non-addictive and has been shown to reduce smoking activity among adult smokers [4][6][9] Group 3: Company Background - 22nd Century Group is recognized as a pioneering nicotine harm reduction company in the tobacco industry, enabling smokers to take control of their nicotine consumption [5] - The company operates a facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combusted tobacco products annually [8] - The proprietary reduced nicotine tobacco blends are developed through patented technologies that regulate nicotine biosynthesis in the tobacco plant [9]

Mocksville, North Carolina--(Newsfile Corp. - December 13, 2024) - 22nd Century Group, Inc. (NASDAQ: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced that it will effect a reverse stock split of its outstanding shares of common stock, par value $0.00001 per share (the "Common Stock"), at a ratio of 1-for-135, to be effective as of December 17, 2024. The reverse stock split is intended for ...

22nd Century Applauds FDA Proposal to Mandate Reduced Nicotine Content in CigarettesRecent FDA Action Advances Policy Proposal That Originated During First Trump Administration and Continued to Progress Under Biden AdministrationDecember 12, 2024 11:31 AM EST | Source: 22nd Century GroupMocksville, North Carolina--(Newsfile Corp. - December 12, 2024) - 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have ...

Core Insights - 22nd Century Group reported a decrease in net revenues for Q3 2024, totaling $5.9 million, down 24.5% from $7.9 million in Q2 2024. The company aims to achieve cash positive operations by Q1 2025 [2][4][5]. Financial Performance - Net revenues decreased to $5.9 million from $7.9 million, with a gross profit loss of $(0.6) million compared to a profit of $0.6 million in the previous quarter [4][10]. - Operating loss increased to $3.4 million from $2.0 million, and net loss rose to $3.6 million from $2.2 million [4][10]. - Basic and diluted EPS decreased to $(0.27) from $(0.30) [4][10]. - Adjusted EBITDA loss increased to $3.2 million from a loss of $2.6 million [4][10]. Product Line Performance - Cigarette net revenues increased to $4.1 million, an 18% rise compared to $3.5 million in the prior year, despite a 22% decline in carton volumes [6][12]. - Filtered cigars net revenues decreased to $1.7 million from $4.1 million in the prior year, reflecting lower volumes due to the completion of last time buy orders [7][12]. - Cigarillo distribution net revenues amounted to $0.2 million, compared to $0 in the prior year quarter [8][12]. - VLN® cigarette net revenues were negligible in Q3 2024, with the company planning to rebrand and relaunch these products [9][12]. Strategic Initiatives - The company is transitioning from a financial focus to a growth strategy that leverages its manufacturing and brand assets [5][6]. - Plans to launch additional products, including VLN® SKUs, are underway to expand distribution and consumer awareness [6][12]. Debt and Liquidity - Net debt improved to $3.0 million from $7.0 million in the preceding quarter [4][10]. - Total debt decreased to $7.0 million from $13.9 million, with net total debt at $2.98 million [32]. Overall Outlook - The company remains focused on achieving EBITDA breakeven results in Q1 2025, with expectations for revenue growth driven by changes in its core CMO business [5][6].

22nd Century Group (XXII) to Announce Third Quarter 2024 Results on November 12, 2024November 07, 2024 4:05 PM EST | Source: 22nd Century GroupMocksville, North Carolina--(Newsfile Corp. - November 7, 2024) - 22nd Century Group, Inc. (NASDAQ: XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, will host a webcast on Wednesday, November 12, 2024, at 8:00 AM ET to discuss its 2024 thir ...

22nd Century Group to Present at the LD Micro Main Event XVII on October 30 in Los AngelesOctober 21, 2024 9:00 AM EDT | Source: 22nd Century GroupMocksville, North Carolina--(Newsfile Corp. - October 21, 2024) - 22nd Century Group, Inc. (NASDAQ: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced that it will be presenting at the LD Micro Main Event XVII investor conference to ...

● . . 22nd Century Continues CMO Business Expansion with Additional Filtered Cigar Volume CMO customer adds to previously announced cigarette export business with combined volume significantly adding to profitability September 25, 2024 8:00 AM EDT | Source: 22nd Century Group Mocksville, North Carolina--(Newsfile Corp. - September 25, 2024) - 22nd Century Group, Inc. (NASDAQ: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their ni ...