VLN® to Commence Sales at Circle K Locations in Illinois, Now Authorized in 45 States and Counting MOCKSVILLE, N.C., Oct. 23, 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 the launch of VLN® reduced nicotine content cigarettes at approximately 140 Circle K locations in Illinois. VLN® cigarettes are now authorized for sale i ...

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].

NIAGARA FALLS, N.Y.--(BUSINESS WIRE)--Cabbacis (OTCQB: CABI), a U.S. federally-licensed tobacco- product manufacturer focused on harm-reduction products being developed under the iBlendâ"¢ brand name, today announced that management will attend the upcoming Noble Capital Markets October 2025 Emerging Growth Virtual Equity Conference, on October 8th and 9th 2025. Share About Cabbacis Cabbacis (OTCQB: CABI) is focused on commercializing groundbreaking, patented harm-reduction tobacco products for the world's ...

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]

Summary of 22nd Century Group (XXII) Conference Call - August 20, 2025 Company Overview - **Company Name**: 22nd Century Group Inc. - **Ticker Symbol**: XXII - **Industry**: Tobacco, specifically focused on nicotine harm reduction - **Market Position**: Leader in the tobacco harm reduction movement since 1998, aligned with FDA's low nicotine mandate [1][2][3] Key Industry Insights - **Tobacco Market Size**: - Global market: $1.1 trillion in annual sales, with $873 billion from cigarette sales [4] - U.S. market: $109 billion in annual sales, with $83 billion from cigarette sales [4] - **Smoker Statistics**: - 1.1 billion smokers globally, with 28.8 million in the U.S. [4] - 8 million annual deaths globally due to smoking-related health conditions [4] - U.S. smoking-related deaths: approximately 480,000 annually [4] - **Market Growth**: U.S. tobacco industry projected to grow to $180 billion by 2030, representing an 8.15% CAGR [5] Core Company Strategies - **Product Focus**: - Emphasis on low nicotine (VLN) products, which are positioned to compete with traditional combustible cigarettes and other nicotine delivery systems [11][12] - Development of a diverse portfolio including VLN cigarettes, moist snuff, and other tobacco products [26] - **Regulatory Alignment**: - Fully compliant with FDA's proposed rule for low nicotine content (0.7 mg/g), which is expected to significantly reduce nicotine addiction [14][42] - **Research and Development**: - Ongoing research into non-GMO low nicotine tobacco and its potential to lower harmful nitrosamines [16][30] - Independent studies showing that 40% of participants reduced their smoking habits using VLN products [17] Financial Strategy and Performance - **Shift in Business Model**: - Transitioning away from high-volume, low-margin contract manufacturing to focus on branded products [25][31] - Anticipated lower revenues in the short term as the company prioritizes gross profit and margins [25] - **Future Financial Goals**: - Targeting cash flow breakeven by 2026 [48] - Maintaining operating expenses around $2 million per quarter [31] Market Launch and Distribution - **Product Launch**: - VLN products are set to launch in 2,000 retail outlets across 30 states, with plans for nationwide distribution [27][39] - Marketing strategies include extensive consumer communication and in-store promotions [22] - **Retail Partnerships**: - Engaging with major retailers for broader distribution once state approvals are secured [39][28] Additional Insights - **Public Health Concerns**: - Addressing issues of nicotine addiction and the impact of smoking on public health, particularly among youth [6][8] - **Industry Dynamics**: - The company positions itself as a leader in the transition towards reduced nicotine products, similar to the shift from leaded to unleaded gasoline [47] - **Government Support**: - No direct government funding anticipated; the company relies on independent research to validate its products [37][38] Conclusion - **Outlook**: - The company is optimistic about its future, focusing on growth in the VLN segment and aligning with regulatory changes to capture market share [32][50]

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]

Financial Data and Key Metrics Changes - Adjusted diluted earnings per share increased by 8.3% to $1.44 in the second quarter and by 7.2% for the first half [19] - Adjusted operating companies income in the Smokable Products segment grew by 4.2% to $2.9 billion in the second quarter and by 3.5% to $5.5 billion in the first half [19] - Adjusted OCI margins expanded to 64.5% for both the second quarter and the first half [20] Business Line Data and Key Metrics Changes - In the Smokable Products segment, domestic cigarette volumes declined by 10.2% in the second quarter and 11.9% for the first half [20] - Oral nicotine pouches, particularly ON!, reported a shipment volume increase of 26.5% to 52.1 million cans in the second quarter [11] - Adjusted OCI for the Oral Tobacco Products segment grew by 10.9% in the second quarter and 5.5% in the first half [23] Market Data and Key Metrics Changes - The e-vapor category included over 20.5 million vapers, up by over 1.9 million year over year [14] - Disposable vapers increased by an estimated 2.7 million to approximately 14.4 million, representing over 60% of the e-vapor category [14] - Domestic cigarette volumes at the industry level declined by an estimated 8.5% in the second quarter [20] Company Strategy and Development Direction - The company aims to shape a fully regulated industry and provide expanded product choices for adult nicotine consumers [8] - Continued focus on driving trial, building long-term equity, and increasing profitability in the ON! brand [12] - The company is actively exploring potential next steps regarding the nJoy e-vapor product line, including an appeal against patent disputes [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of operating companies despite challenging market conditions [18] - The macroeconomic environment remains dynamic, with inflation and consumer confidence being key factors to monitor [32] - The company raised the lower end of its 2025 guidance range, expecting adjusted diluted EPS in the range of $5.35 to $5.45 [25] Other Important Information - The company returned over $4 billion to shareholders through dividends and share repurchases in the first half of the year [8] - The total debt to EBITDA ratio as of June 30 was 2.0 times, in line with the target [26] - The company is advocating for more coordinated actions against illicit e-vapor products to clean up the marketplace [16] Q&A Session Summary Question: Insights on the raised guidance range and consumer environment - Management highlighted the dynamic market and the need to monitor adult tobacco consumer behaviors due to inflationary pressures [31] Question: Update on nJoy e-vapor product development - Management confirmed that product development for the nJoy ACE device is progressing, with plans to file for FDA approval [35] Question: Long-term EPS growth outlook - Management remains confident in achieving mid-single-digit EPS growth through FY 2028, despite economic strains on consumers [44] Question: Strategy for the Basic brand - The company is using targeted analytics to maintain consumer loyalty and expand the Basic brand's presence in discount segments [49] Question: Impact of illicit vape crackdowns - Management noted that while enforcement actions are increasing, it is too early to determine their overall impact on the market [58] Question: Tariff impacts on business - Tariffs have had some impact on costs, particularly in supply chain materials, but are not viewed as material to overall business performance [98]

Financial Data and Key Metrics Changes - Adjusted diluted earnings per share increased by 8.3% to $1.44 in Q2 2025 and by 7.2% for the first half, driven by robust adjusted operating companies income growth and share repurchases [19][25] - Adjusted operating companies income for the Smokable Products segment grew by 4.2% to $2.9 billion in Q2 and by 3.5% to $5.5 billion in the first half [19][20] - Adjusted OCI margins expanded to 64.5% for both Q2 and the first half [20] Business Line Data and Key Metrics Changes - Oral nicotine pouches, particularly ON!, were the primary growth driver, with reported shipment volume increasing by 26.5% to 52.1 million cans year-over-year [9][23] - Domestic cigarette volumes in the Smokable Products segment declined by 10.2% in Q2 and 11.9% for the first half, with adjusted estimates showing declines of approximately 10.5% [20][21] - The Oral Tobacco Products segment saw adjusted OCI grow by 10.9% in Q2, primarily driven by ON!'s strong performance [23] Market Data and Key Metrics Changes - The e-vapor category included over 20.5 million vapers, up by 1.9 million year-over-year, with disposable vapers increasing to approximately 14.4 million [14][15] - The flavored disposable market continues to drive e-vapor category growth, representing over 60% of the category [15][16] Company Strategy and Development Direction - The company is focused on shaping a fully regulated industry and expanding product choices for adult nicotine consumers, while also advocating for enforcement against unregulated products [7][14] - The strategy includes targeted launches and promotions for the Basic brand to retain consumers in the portfolio while addressing macroeconomic pressures [21][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance of operating companies despite challenging market conditions and inflationary pressures [18][32] - The company raised the lower end of its 2025 guidance range, expecting adjusted diluted EPS to be in the range of $5.35 to $5.45, reflecting a growth rate of 3% to 5% from 2024 [25][26] Other Important Information - The company returned significant value to shareholders, paying approximately $3.5 billion in dividends and repurchasing 10.4 million shares for $600 million in the first half of the year [26][27] - The total debt to EBITDA ratio as of June 30 was 2.0 times, in line with the target [27] Q&A Session Summary Question: Discussion on the raised guidance range and expectations for the second half - Management acknowledged the strong first half results and the dynamic market conditions, emphasizing the need to monitor consumer behavior amid inflation [30][32] Question: Update on nJoy e-vapor product development - Management confirmed that product development for the new nJoy device is progressing, with plans to file for FDA approval once ready [34][36] Question: Long-term EPS growth outlook - Management remains confident in achieving mid-single-digit EPS growth through FY 2028, despite current economic strains on consumers [43][44] Question: Strategy for the Basic brand and discount share - The company is strategically repositioning Basic as a discount brand while using data analytics to target consumers effectively [49][50] Question: Impact of enforcement on illicit vapes and cigarette volumes - Management noted that while enforcement actions are increasing, it is too early to determine their full impact on the market [55][58] Question: Clarification on tariff impacts - Management indicated that while tariffs have affected costs, they do not view them as material to overall business performance [96][97]

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]