*Disseminated on behalf of 22nd Century Group
The 60,000 square foot facility in Mocksville, North Carolina has the capacity to produce more than 45 million cartons of combustible tobacco products annually
22nd Century Group is making meaningful regulatory progress with its VLN® products platform, as the FDA has formally accepted its MRTP renewal applications for scientific review
Pinnacle® VLN® is now in over 2,000 stores across 20 states
2025 Revenues Topped $17.5 Million as they look to Expand Rapidly in 2026
Read the Investor Presentation HERE
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Hello Everyone,
We are back for today’s session with another brand new profile. We want you to pull up XXII immediately.
XXII is THE true leader in the tobacco harm reduction movement with over 28 years under its belt. We often hear the phrase “Trust the Science.” The science behind VLN® cigarettes is proven. Their products and results have been recognized and documented by the FDA and the World Health Organization in their efforts to establish low-nicotine standards worldwide. Multiple scientific studies have consistently demonstrated the merits of their VLN® products. Using proprietary technology, they have created, and will continue to create, new strains of non-GMO low-nicotine tobacco to support their brands and other brands around the world as opportunities arise.
Smoking remains one of the most devastating public health crises in the United States, and the numbers tell a brutal story. There are 28.8 million active smokers in the country, and every single day 1,315 of them die from smoking-related health conditions — that is nearly one person per minute, every hour, every day, adding up to a staggering 480,000 deaths annually. To put that in perspective, smoking kills more Americans each year than alcohol, drugs, car accidents, and gun violence combined. And yet the industry generating this carnage pulls in $109 billion in annual sales, with $83 billion of that coming directly from cigarettes. The scale of addiction, death, and economic entrenchment makes it clear that the tobacco industry is not going away — which is exactly why a product like VLN® matters so much. The question has never been whether people will smoke; it is whether they will have access to a meaningfully less harmful way to do it.
Many studies show that at least 70% of smokers want to quit but can’t. As an ex-smoker I completely understand how hard it is and the health implications. That is a MASSIVE market for the company to target.
22nd Century Group is making meaningful regulatory progress with its VLN® platform, as the company announced just last Wednesday that the FDA has formally accepted its MRTP renewal applications for scientific review. This is a critical milestone — it confirms the applications met the FDA’s threshold to advance in the process and keeps the company on track to maintain its unique authorized modified risk marketing claims beyond the December 2026 expiration date. For a small company operating in the heavily regulated tobacco space, clearing this hurdle is no small feat.
What makes 22nd Century’s position genuinely compelling is that VLN® remains the only combusted cigarette in history ever authorized as a modified risk tobacco product. That is a defensible regulatory moat that competitors simply cannot replicate overnight. The FDA’s original findings — that VLN delivers at least 95% less nicotine than conventional cigarettes and helps smokers smoke less — give the company a scientifically validated foundation that most tobacco innovators can only dream about.
The renewal case appears even stronger now than it was in 2021. A 2024 real-world study involving more than 400 participants showed a 40% reduction in daily cigarette consumption over 12 weeks among VLN® users. That kind of behavioral data, layered on top of the original chemical and pharmacological evidence, gives the FDA a richer evidentiary record to work with and gives investors more confidence that the renewal is well-supported.
The bottom line is that 22nd Century has built something rare in the tobacco industry — a product with a legitimate harm-reduction story, regulatory backing, and a growing body of clinical evidence. If the FDA renewal goes through, the company will be positioned as the only player authorized to market combustible cigarettes with reduced-nicotine claims, a distinction that could prove enormously valuable as public health pressure on the tobacco industry continues to intensify.
The thesis
In a world where tobacco regulation is only tightening, most companies are playing defense. 22nd Century Group (Nasdaq: XXII) is playing offense — with a product that doesn’t just survive the regulatory tide, it was built for it.
VLN® cigarettes contain approximately 95% less nicotine than conventional cigarettes — validated by clinical science and already authorized by the FDA. While Big Tobacco lobbies against the FDA mandate, XXII is the mandate.
“VLN® isn’t a harm-reduction compromise. It’s the market leader in an entirely new category — one the FDA is actively pushing the industry toward.”
With distribution scaling, a partner brand strategy under the VLN® partner brand mode, the company is entering a pivotal inflection point.
#1RNC
Category leader
~95%
Less nicotine vs. conventional
5,000 Retail Outlet/Store locations by end of 2026
Proven science, live product
- Clinical validation in market — not a pipeline promise
- VLN® partner brand program accelerating reach
- Market leader in the Low Nicotine Content category
Growth engine in motion
- Portfolio built for cross-sell and gradual expansion
- Roadmap extends through 2026 into 2027
- Full alignment with FDA’s low nicotine mandate
R&D that doesn’t stop
- Ongoing development in low-nicotine crop strains
- Reduced-nicotine product pipeline expanding
- Growth through licensing and strategic partnerships
Path to profitability
- Dual-track portfolio: VLN + Partner Brands reduced nicotine content high margin products
- Scaling distribution + sell-through as key levers
Near-term catalysts to watch
01 FDA mandatory low-nicotine rule
If and when the FDA finalizes a low-nicotine product standard, XXII becomes the only major player with an already-authorized, commercially available product. First-mover positioning could be decisive.
02 Distribution scale milestones
Expanding retail footprint and sell-through velocity are the company’s stated key success metrics. Watch for distribution announcements and volume data through H2 2026.
03 VLN® partner brand growth
The licensing and co-branding model allows XXII to multiply reach without proportional capex. New partnership announcements signal accelerating commercialization.
04 5,000 Retail Outlet/Store locations by end of 2026
The company plans to expand its VLN® reduced-nicotine cigarette distribution to more than 5,000 retail store locations across the U.S. by the end of 2026 to increase national availability and product adoption.
Recent Business Highlights
- Continued to generate new retail store locations to expand market access to both VLN® and Partner VLN® products, as well as new natural style cigarette products.
- Achieved near national level state authorizations to support expanded access to the Company’s branded products.
- Continued to support Pinnacle® VLN® availability in now over 2,000 stores across 20 states, including in-store marketing materials and digital promotion programs to drive smoker awareness of Pinnacle® VLN® as an alternative to conventional nicotine cigarette products.
- Leveraged the Company’s ability to supply VLN® tobacco and manufacturing under license in discussions to expand VLN® distribution and launch additional VLN® partner brands, further diversifying the reduced nicotine content product category.
- Continued initiatives aimed at margin expansion through mix improvement while maintaining an efficient operating cost and capital allocation profile.
- Completed product prototyping and evaluations ahead of a planned PMTA authorization to introduce 100mm format VLN® cigarettes tailored to consumer preferences in those markets.
- Advanced long-term strategic initiatives to grow its unique product portfolio through the submission of multiple PMTAs across a broad range of combustible products, supporting diverse tobacco blends and components, a variety of product sizes, and multiple product formats, including filtered cigars.
22nd Century Group is absolutely leading the tobacco harm reduction movement. The market is naturally organizing itself into four distinct lanes — pouches and moist snuff, heated tobacco products, low-nicotine options like VLN®, and standard combustible cigarettes — and the first three are widely recognized as part of the harm reduction movement. This is a massive structural shift in how the industry and regulators are thinking about tobacco, and 22nd Century is uniquely positioned at the center of it.
VLN® competes directly with heated tobacco products for combustible smokers, targeting the enormous population of people who are not going to quit cold turkey but are open to a less harmful alternative. With 70% of smokers saying they want to quit, the demand for a product that meaningfully reduces nicotine dependence is not a niche opportunity — it is a mainstream one. VLN® does not just offer a less harmful cigarette; it actively helps break the cycle of addiction, which is what sets it apart from every other product in the harm reduction space.
Perhaps most importantly, the regulatory wind is at 22nd Century’s back. As the FDA moves toward implementing a nicotine standard that would force full-strength brands off the market or require reformulation, smokers will have no choice but to migrate toward reduced-nicotine options — and VLN® is the only combusted cigarette already authorized and waiting for them. Layer on top of that the company’s licensing and “VLN Inside” partnership strategy, and the growth runway becomes very compelling. 22nd Century is not just building a product; it is building the infrastructure for an entirely new category of tobacco harm reduction at exactly the right moment in history.
NEWS
1 day ago
22nd Century Group Reports First Quarter 2026 Financial Results
6 days ago
22nd Century Group to Announce First Quarter 2026 Results on May 7, 2026
May 4, 2026
22nd Century Group Shares 2026 Vision for VLN® Product Growth and Tobacco Harm Reduction Leadership
Apr 29, 2026
Apr 23, 2026
Apr 7, 2026
22nd Century Group Reports Fourth Quarter and Full Year 2025 Financial Results
Mar 26, 2026
22nd Century Group to Announce Fourth Quarter and Full Year 2025 Results on March 26, 2026
Mar 23, 2026
22nd Century Group Reports Continued Early Sales Momentum for VLN® Cigarette Products
Feb 23, 2026
22nd Century Group Preliminarily Reports Fourth Quarter and Full Year 2025 Financial Results
Feb 20, 2026
MANAGEMENT TEAM
Larry Firestone
Chief Executive Officer
Mr. Firestone brings over 40 years of enterprise, operations, and financial management experience in both public and private companies, including tenures as CEO, CFO and COO across multiple industry sectors. Mr. Firestone most recently served as Chief Financial Officer of Oakland Manager, a privately-held purveyor of cannabis with both retail and wholesale market penetration, and as Chairman of FirePower Technology, a privately held manufacturer of ATX power supplies for the IT and instrumentation markets. In the public company sector, Mr. Firestone has served as Chief Executive Officer of Eastside Distilling, Inc. (NASDAQ: EAST), Chief Executive Officer of Qualstar Corporation (NASDAQ: QBAK), Chief Financial Officer of Advanced Energy Industries (NASDAQ: AEIS), and Chief Financial Officer of Applied Films Corporation (NASDAQ: AFCO). He has served on numerous boards, including those of Eastside Distilling, Qualstar, CVD Equipment Corporation (NASDAQ: CVD), Amtech Systems, Inc. (NASDAQ: ASYS) and HyperSpace Communications, Inc. (NYSE: HYPR). Mr. Firestone received his Bachelor of Science in Business Administration with a concentration in Accounting from Slippery Rock University of Pennsylvania.
Robert Manfredonia
Executive Vice President of Sales
Mr. Manfredonia brings 30 years of experience in regulated consumer products sales and marketing experience in the adult beverage space both wholesaler and direct brands across the spirits, wine and beer categories. His experience brings a deep knowledge and comprehensive capabilities to expedite distribution, accelerate volume growth and build brand enterprise value. Along with large entities, he has developed start-up brands with channel segment strategic planning and development, tactical coordination and implementation, account programming, shelf standards and retail execution disciplines, with a particular interest in corporate retail channel development for new to market, early stage and mid-sized brands. He previously served as Senior Vice President of Retail Corporate Accounts for Bonavita Beverage Group since 2019, and in the same role at Eastside Distilling from 2015-2019. Prior to entering the beverage business with Miller Brewing Company in 1999, he was a chain manager at Southern Glazer’s Wine and Spirits and proudly served in the United States Air Force.
Daniel A. Otto
Chief Financial Officer (CFO) and Principal Accounting Officer
Daniel A. Otto is the Chief Financial Officer and Principal Accounting Officer of the company, having been appointed CFO in April 2024 after previously serving as Corporate Controller since July 2022. In his role, he oversees finance, accounting, SEC external reporting, treasury, tax, capital markets, and investor relations functions. Prior to joining the company, he spent over a decade at Deloitte & Touche LLP as a Senior Manager providing audit and accounting advisory services to public companies. He is a Certified Public Accountant and holds an MBA and a Bachelor’s degree in Accounting from Niagara University.
Scott Marion
Vice President of Operations
Scott joined 22nd Century Group in February 2023 as the VP of Operations. Prior to joining 22nd Century Group Scott was the head Manufacturing and Supply Chain Finance at Reynolds American – the United States 2nd largest tobacco company. Scott has over twenty years’ experience in the tobacco industry where he has held various management roles in finance working closely with manufacturing operations. Scott brings a unique blend of manufacturing and supply chain leadership grounded in lean manufacturing coupled with an understanding of the financial metrics driving the organization. He holds a Bachelor of Science Degree in Business Administration from High Point University and an MBA from Wake Forest University.
Jonathan Staffeldt
General Counsel
Jonathan Staffeldt is a seasoned attorney with a diverse professional background well suited for his role as General Counsel. After graduating from the University of Southern California with a degree in accounting, he decided to continue his education with a law degree from UCLA. Jonathan began his professional career as a corporate attorney working on a variety of transactional matters including mergers and acquisitions, contract negotiations, and debt and equity financings. Later, he practiced at a boutique litigation firm representing clients in complex civil matters. Jonathan then moved in-house as Assistant General Counsel at a medical company prior to joining GVB Biopharma as General Counsel in 2019. After 22nd Century’s acquisition of GVB Biopharma in 2022, Jonathan moved to an Associate Corporate Counsel position before becoming the General Counsel of 22nd Century in early 2024.
Dr. Kimberly Farr, Ph.D.
Director of Science & Technology
Dr. Farr is a scientist with a Ph.D. in Biology. Her work sits at the intersection of computational biology, molecular biology, and public health, with a focus on translating complex biological data into actionable solutions for tobacco product harm reduction. Since 2019, Dr. Farr has been a key member of the company’s scientific team, leading research initiatives in producing non-GMO reduced nicotine tobacco plants. She advances harm reduction efforts by applying cutting-edge molecular techniques and data analytics to decode biosynthesis pathways and identify strategic genetic targets in tobacco plants. In addition to her research leadership, Dr. Farr plays a central role in guiding the design and development of new technologies for next-generation, reduced-risk tobacco products. By integrating foundational science with hands-on innovation, Dr. Farr is instrumental in driving product development that meets regulatory standards and supports improved public health outcomes.
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Name of Issuer: 3rd party on behalf of 22nd Century Group
Amount of Cash Compensation: twenty two thousand five hundred usd
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