22nd Century Group (XXII) investor relations material

Industry leadership and regulatory alignment

• Leading the tobacco harm reduction movement for 27 years, fully aligned with the FDA's low nicotine mandate issued in January 2025.

• Only company offering a choice for nicotine consumption in combustible cigarettes, with a unique portfolio of brands.

• FDA's proposed rule mandates 0.7 mg/g nicotine content per cigarette, matching the company's 95% less nicotine VLN products.

• VLN products are the only ones currently compliant with the new FDA standard.

• Extensive patent portfolio in low nicotine genetics and non-GMO processes, with ongoing R&D in plant genetics and TSNA reduction.

Market opportunity and product positioning

• Global tobacco market is $1.1 trillion, with $873 billion in annual cigarette sales and 1.1 billion smokers worldwide.

• US market is $110 billion in annual sales, with 28.8 million smokers and 480,000 annual deaths from smoking-related conditions.

• VLN products positioned in the low nicotine lane, directly competing with heat-not-burn and other harm reduction products.

• VLN cigarettes allow smokers to reduce dependence without changing form factor, eliminating need for alternative devices.

• Early adopters and partner brands are launching VLN products, with a soft launch in September and full launch in late September/early October.

Scientific validation and health impact

• Independent 2024 study showed 40% of subjects reduced cigarette consumption in 12 weeks using VLN cigarettes.

• Extrapolated, 11.5 million US smokers could dramatically change habits in a similar timeframe.

• VLN cigarettes contain 95% less nicotine; one pack equals the nicotine of one traditional cigarette.

• Ongoing research into reducing TSNAs (major carcinogens) in tobacco, with partnerships for disease-resistant strains.

• Focus on developing non-combustible low nicotine products and future FDA filings.