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].

Financial Data and Key Metrics Changes - Net revenue for Q2 2025 was $4 million, a decrease from $6 million in Q1 2025, with total cartons sold increasing to 779,000 from 478,000 in the previous quarter [33] - Gross margin remained consistent at a loss of $600,000, with total operating expenses rising to $2.3 million from $2 million in the previous quarter [34] - Net loss from continuing operations was approximately $3.3 million, consistent with Q1 2025, while adjusted EBITDA was a loss of $2.6 million compared to a loss of $2.3 million in Q1 2025 [35] Business Line Data and Key Metrics Changes - The company is shifting focus from low-margin CMO business to high-margin branded products, which is expected to improve gross margins despite a potential decline in top-line revenue in the near term [23][31] - The introduction of VLN products is anticipated to drive revenue growth and gross margin expansion, although initial financial results may not reflect this until Q3 2025 [31] Market Data and Key Metrics Changes - The company has begun shipping Pinnacle VLN products in August 2025, with initial stocking orders exceeding 3,000 cartons, indicating a positive market entry for the new product line [32] - The FDA's proposed low nicotine mandate is expected to create a competitive environment for VLN products, positioning the company favorably against traditional combustible cigarettes [24][28] Company Strategy and Development Direction - The company aims to lead the tobacco harm reduction movement by leveraging its proprietary low nicotine tobacco technology, which is compliant with the FDA's new standards [25][26] - A strategic shift towards higher-margin products is underway, with plans to phase out low-margin CMO products to enhance profitability [23][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledges challenges in achieving profitability due to delays in launching high-margin products, projecting a timeline into 2026 for breakeven on EBITDA [32] - The company is optimistic about the market potential for VLN products, emphasizing the importance of scaling and rate of sale as key metrics for future success [49] Other Important Information - The company is actively pursuing a lawsuit against Dorchester Insurance Company for $9 million in business interruption insurance, with a trial date set for November 2025 [35] - The company has reduced debt by approximately $1 million and improved working capital by tightening inventory [33] Q&A Session Summary Question: When might the company achieve breakeven on a quarterly basis for EBITDA? - Management indicated that they are looking at the first half of 2026, with a focus on the timing of branded product launches and sales rates to determine if breakeven can be achieved in Q1 or Q2 [41] Question: Is the current cash position sufficient to reach breakeven, or will additional share issuance be necessary? - Management noted that while the current cash of $3 million is being managed carefully, there may be a need for additional fundraising, though it would be less than previous amounts [42][43] Question: What are the plans regarding the outstanding debt rolling over in March 2026? - Management is in discussions with creditors about paying off the debt and plans to allocate part of any new fundraising towards extinguishing it [44] Question: Is there a chance that the MRTP for VLN would not be renewed? - Management expressed confidence that the MRTP would be renewed, given compliance with the FDA's recent mandates [45]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) Nevada 98-0468420 (S ...

Exhibit 99.1 22nd Century Group Reports Second Quarter 2025 Financial Results VLN® Early Adoption Commercial Activity Expands with Two Partner Brand Launches in Progress – Smoker Friendly and Pinnacle Commenced Pinnacle VLN® Stocking Shipments for Almost 1,000 Locations of Top-5 C-Store Customer, Additional Locations to Come Significantly Expanded State Authorizations for both Reduced Nicotine Content and Conventional Products High Margin Branded Products Business Model Set to Grow Profitably MOCKSVILLE, N. ...

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]