Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential opportunities for traders [1] Premarket Gainers - PepGen Inc. (PEPG) is up 151% at $6.68 [3] - 22nd Century Group, Inc. (XXII) is up 27% at $1.93 [3] - Immuneering Corporation (IMRX) is up 23% at $11.36 [3] - uniQure N.V. (QURE) is up 10% at $52.58 [3] - Lithium Americas Corp. (LAC) is up 9% at $6.60 [3] - Jasper Therapeutics, Inc. (JSPR) is up 9% at $2.55 [3] - American Shared Hospital Services (AMS) is up 8% at $2.75 [3] - PSQ Holdings, Inc. (PSQH) is up 7% at $3.06 [3] - K Wave Media Ltd. (KWM) is up 7% at $2.48 [3] - ClearPoint Neuro, Inc. (CLPT) is up 5% at $20.48 [3] Premarket Losers - Transocean Ltd. (RIG) is down 14% at $3.11 [4] - Cyclerion Therapeutics, Inc. (CYCN) is down 12% at $2.83 [4] - CarMax, Inc. (KMX) is down 11% at $50.38 [4] - ARB IOT Group Limited (ARBB) is down 11% at $10.45 [4] - SHF Holdings, Inc. (SHFS) is down 10% at $6.49 [4] - Digital Brands Group, Inc. (DBGI) is down 10% at $6.21 [4] - Aqua Metals, Inc. (AQMS) is down 9% at $5.29 [4] - Akanda Corp. (AKAN) is down 8% at $3.96 [4] - Galecto, Inc. (GLTO) is down 8% at $3.88 [4] - Platinum Analytics Cayman Limited (PLTS) is down 7% at $11.12 [4]

Core Insights - 22nd Century Group Inc. shares surged 39.07% in pre-market trading to $2.10 following a $9.5 million insurance settlement that resolves business interruption claims from the Grass Valley incident in November 2022 [1][2] Financial Position - The settlement signifies a pivotal moment for the company, which is now debt-free, with CEO Larry Firestone stating that the balance sheet has been cleaned up over the past 22 months [2] - The company aims to achieve profitability by 2026, transitioning from survival capital to growth capital, focusing on expanding distribution for its VLN-branded products and partnerships [2] Settlement Details - The insurers are required to pay the $9.5 million settlement within 45 days of the agreement's effective date [3] Market Performance - The stock reached a one-month peak of $1.97 on September 19 but closed at $1.51, reflecting a decline of approximately 23.35% from that high [4] - Over the past year, the stock has seen a dramatic loss of 99.82%, with a 52-week trading range of $1.51 to $978.08 [4] - The company's market capitalization is currently $5.71 million, with an average daily trading volume of 1.19 million shares [4] Price Action - On the last trading day, the stock closed at $1.51, down 4.43% [5] - Benzinga's Edge Stock Rankings indicate a negative price trend for XXII across all time frames [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 Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - AGM Group Holdings Inc. (AGMH) increased by 185% to $6.36 [3] - AlphaVest Acquisition Corp (ATMV) rose by 77% to $26.80 [3] - Brera Holdings PLC (BREA) saw a 20% increase to $30.00 [3] - Asset Entities Inc. (ASST) gained 18% to $4.54 [3] - 22nd Century Group, Inc. (XXII) also increased by 18% to $2.08 [3] - Millennium Group International Holdings Limited (MGIH) rose by 16% to $2.84 [3] - Robo.ai Inc. (AIIO) increased by 11% to $2.17 [3] - Butterfly Network, Inc. (BFLY) saw a 10% rise to $2.10 [3] - GrafTech International Ltd. (EAF) increased by 9% to $13.91 [3] - Cardlytics, Inc. (CDLX) rose by 8% to $2.99 [3] Premarket Losers - ECD Automotive Design, Inc. (ECDA) decreased by 14% to $3.70 [4] - Champions Oncology, Inc. (CSBR) fell by 8% to $6.11 [4] - Beam Global (BEEM) saw an 8% decline to $2.79 [4] - Fathom Holdings Inc. (FTHM) decreased by 8% to $2.19 [4] - Ventyx Biosciences, Inc. (VTYX) fell by 7% to $2.20 [4] - SciSparc Ltd. (SPRC) decreased by 6% to $4.35 [4] - Lightwave Logic, Inc. (LWLG) fell by 6% to $3.45 [4] - Jasper Therapeutics, Inc. (JSPR) decreased by 6% to $2.43 [4] - StableX Technologies, Inc. (SBLX) fell by 5% to $5.67 [4] - Galecto, Inc. (GLTO) decreased by 5% to $2.70 [4]

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 - Emerging Growth Research released a quarterly update report on 22nd Century Group, indicating that the company missed expectations for Q2 2025 due to slower CMO stabilization and VLN® rollout timing, with EBITDA breakeven now projected for Q2 2026 [1][3]. Financial Performance - Q2 2025 revenue was $4.1 million, a decline of 49% year-over-year from $7.9 million in Q2 2024 and a 31% sequential decrease from $6.0 million in Q1 2025 [8]. - Gross loss remained stable at $(0.6) million compared to $(0.6) million in Q1 2025 [8]. - Operating loss increased to $(3.0) million from $(2.6) million in Q1 2025 due to higher VLN® promotional spending [8]. - EBITDA was $(2.8) million compared to $(2.5) million in Q1 2025 [8]. - Net debt was significantly reduced to $0.7 million from $3.3 million in Q4 2024 following a warrant exercise that generated $5.1 million in proceeds [4][8]. Strategic Focus and Growth Potential - The company is focusing on higher-margin operations and has significant long-term growth potential, with revenue growth expectations of +127% in 2026, +68% in 2027, and +39% in 2028 driven by VLN® market penetration in the $12 billion tobacco market [5][3]. - VLN® cigarettes are now shipping following state registrations, with management noting that only 223,000 cartons (5% of production capacity) are needed for breakeven profitability [4]. Management and Restructuring - New management has undertaken operational restructuring since 2023, divesting certain business lines to concentrate on contract manufacturing operations (CMO) and the VLN® product line [9]. - The company is positioned as a pure-play contract manufacturer for combustible tobacco products and the sole provider of VLN® reduced-nicotine cigarettes [9].

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]

Core Viewpoint - 22nd Century Group, Inc. is leading the tobacco harm reduction movement with its VLN products, which are designed to significantly reduce nicotine consumption and help smokers manage their addiction [1][14]. Group 1: Product Development and Market Adoption - The company has successfully launched VLN cigarettes, which contain 95% less nicotine than traditional cigarettes, and have been proven to reduce nicotine consumption [14][15]. - Early adoption of VLN products has been seen with partner brands Smoker Friendly and Pinnacle, with initial stocking orders shipped in August 2025 [2][7]. - The company is expanding its product offerings to include 100mm cigarettes and international versions tailored to consumer preferences [9]. Group 2: Regulatory Landscape - The FDA has proposed a new Tobacco Product Standard for Nicotine Yield, setting a maximum nicotine content of 0.7mg/g, which is supported by clinical documentation and real-world testing of VLN products [4][5]. - The proposed regulation has garnered strong support from public health advocates, emphasizing the importance of reducing nicotine levels in tobacco products [6]. Group 3: Research and Development - Ongoing research is investigating the link between non-GMO low nicotine tobacco genetics and lower levels of harmful Tobacco-Specific Nitrosamines (TSNAs), which are potent carcinogens [11]. - The company is committed to expanding its intellectual property portfolio in low nicotine genetics, enhancing its leadership in tobacco harm reduction [12]. Group 4: Future Outlook - The company aims to continue its mission of providing low nicotine technology and products that can improve public health and potentially save lives [13].

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].