XXII News & Events

22nd Century announced an update on the advancement of a 100mm VLN reduced nicotine content cigarette. The company said, "The Company's proprietary reduced nicotine technology is designed to serve adult smokers who want to change their smoking habits by significantly reducing nicotine consumption. 22nd Century is focusing on smoker health and wellness by giving smokers an opportunity to control their tobacco consumption, rather than switching them to another highly addictive product like a vape or pouch. Previously announced as "Operation 100" in 2025, the Company's research and development team has completed product prototyping and initial analytical evaluations required for advancing to the next phase of regulatory submissions. 22nd Century Group believes that introducing a 100mm VLN reduced nicotine content cigarette - alongside its existing authorized 84mm king size VLN products - will expand access to reduced nicotine alternatives in the familiar form factors preferred by adult smokers. Notably, 22nd Century Group currently holds the only FDA-issued Premarket Tobacco Product Application authorization for a combustible reduced nicotine content cigarette, its VLN king size products. Building on this foundation, the Company is preparing a second PMTA application for authorization from the FDA for its new 100mm VLN cigarette. Management believes its prior PMTA experience, scientific data package, and regulatory engagement have positioned the Company to efficiently advance the 100mm submission process. The Company is also advancing its long-term strategic initiative to grow its unique product portfolio through the submission of multiple PMTAs across a broad range of combustible products. This initiative is designed to support diverse tobacco blends and components, a variety of product sizes, and multiple product formats, including filtered cigars. By building a robust portfolio of new tobacco product authorizations from the FDA spanning these categories, the Company intends to create a flexible and scalable platform that can accommodate evolving market preferences and regulatory requirements. All current and any newly authorized combustible tobacco products within this expanded portfolio will be available for licensing. This will provide other tobacco companies with compliant, ready-to-market product pathways and reinforcing the Company's position as a leader in regulatory-driven innovation within the combustible tobacco segment. We are open to licensing our low-nicotine technology more broadly within the industry, which we believe could significantly accelerate efforts to reduce smoking-related harm in a relatively short period of time."

22nd Century files $250M mixed securities shelf

Reports Q4 revenue $3.54M vs. $4.02M last year. "During 2025, we executed a strategic pivot toward higher-margin branded products, expanded partnerships with established retail chains, and developed a new tobacco harm reduction category, all of which we continue to build upon in 2026," said Larry Firestone, CEO. "Our strategy and business model now enable tobacco companies of any size to adopt a Partner VLN or licensing pathway with speed and scalability...We also made important progress in 2025 to strengthen our financial position as we shifted our focus from restructuring to growth. We exited the year debt-free, with a more efficient operating structure and sufficient capital to support our near-term growth objectives...As we move through 2026, we are executing with a clear strategic growth focus, supported by a strengthened financial and operational foundation. Our priorities include expanding VLN retail distribution and consumer awareness, scaling toward profitability, and maintaining active engagement with FDA regulators and public health stakeholders both domestically and internationally."

22nd Century announced continued early sales momentum for its VLN low nicotine cigarette products in the U.S. market. The company said, "In the fourth quarter of 2025, approximately 8,800 cartons of VLN low nicotine combustible cigarettes were distributed across approximately 1,700 new retail outlets nationwide. Initial sell-through data from participating retailers indicates encouraging early consumer adoption, with adult smokers now purchasing VLN products across all three brand presentations: 22nd Century VLN, Pinnacle VLN, and Smoker Friendly VLN. Smokers seeking greater control over nicotine intake are beginning to incorporate VLN products into their smoking journey, validating the Company's belief that a large, underserved segment of adult smokers is looking for meaningful alternatives. Expanding distribution across multiple classes of trade is central to unlocking this opportunity. By securing placement with large convenience store retailers, national and regional wholesalers, and independent chains, 22nd Century is broadening access, increasing visibility, and strengthening replenishment cycles. This diversified distribution strategy is designed to accelerate awareness, trial, and sustained adoption as retail points of distribution expand."