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Tag: 22nd Century

  • 22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Group, Inc. is doubling down on its push for very low nicotine (VLN) products, highlighting new partnerships, regulatory momentum, and expanded product development in a shareholder letter released yesterday (August 19). CEO Larry Firestone said the company’s VLN cigarettes, the first FDA-authorized combustible products designed to reduce smoking harms, are gaining traction through stocking orders with Smoker Friendly and Pinnacle, with more partners expected.

    A looming FDA proposal, set for September 15, could mandate a cap of 0.7 mg/g nicotine yield in cigarettes, a standard built on 22nd Century’s own clinical trials. Firestone said the move “could be the most groundbreaking and effective tobacco regulation in a generation.”

    Beyond cigarettes, 22nd Century is developing VLN filtered cigars, 100mm formats, and international variants, supported by ongoing FDA filings. The company is also studying whether its low-nicotine genetics reduce cancer-causing TSNAs.

    With a growing IP portfolio in plant genetics, the company said it is aiming to cement its position as the leader in tobacco harm reduction. Firestone framed the mission as both business and public health: “Our technology and products have the capability to dramatically improve public health and the welfare of smokers worldwide – hopefully even save lives.”

  • 22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group reported second-quarter 2025 revenues of $4.1 million, down from $6 million in the first quarter, with a net loss holding steady at $3.3 million. Operating loss widened to $3 million, while adjusted EBITDA loss came in at $2.6 million. The company reduced its debt by an additional $1 million, bringing total debt down to $3.8 million.

    CEO Larry Firestone highlighted the momentum behind the company’s FDA-authorized VLN reduced-nicotine cigarettes, which now have authorization for sale in 44 states. Partner brands, including Pinnacle VLN, are expanding distribution, with nearly 1,000 stores across 12 states expected to begin selling the product September 1. The company is also advancing new SKUs, including Pinnacle moist snuff, and preparing an FDA submission for a new 100mm VLN cigarette by year-end.

    Despite financial challenges, Firestone emphasized that 22nd Century is entering a “profitable growth phase” built on its proprietary low-nicotine tobacco technology. He said VLN® products are positioned to align with the FDA’s proposed nicotine standards, giving the company a first-mover advantage in the harm reduction market.

  • 22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group, Inc. announced the first shipments of its new Pinnacle VLN Gold and Pinnacle VLN Menthol reduced-nicotine content cigarettes will be available September 1 at nearly 1,000 convenience store locations across 12 states.

    Company CEO Larry Firestone said Pinnacle’s conventional cigarettes have built strong customer loyalty, and the new VLN line offers smokers a choice to significantly reduce nicotine intake—about a 95% reduction compared to traditional cigarettes.

    The company plans to expand the Pinnacle VLN range into more states and stores while continuing to supply other Pinnacle products, including conventional cigarettes, cigarillos, and moist snuff. Firestone emphasized 22nd Century’s commitment to lead the tobacco harm reduction movement by increasing access to these reduced-nicotine products.

  • 22nd Century Advances FDA Renewal for VLN

    22nd Century Advances FDA Renewal for VLN

    22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.

    First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.

    “Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.

    “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”

  • 22nd Century Sees 50% Jump from Q4 2024 to Q1 2025

    22nd Century Sees 50% Jump from Q4 2024 to Q1 2025

    22nd Century Group, Inc. today (May 13) announced results for the first quarter, ended March 31, and provided an update on recent business highlights. Compared to the fourth quarter 2024, first quarter 2025 saw net revenues increase from $4 million to $6 million and gross profit losses declined from $1.3 million to $600,000. Operating expenses decreased from $2.8 million to $2 million, the lowest quarterly amount since company restructuring began in 2023, and operating losses decreased from $4.1 million to $2.6 million.

    “Our first quarter results demonstrate the positive trends we expect to build on in 2025 as we secure new opportunities to drive volume across our VLN, core CMO and filtered cigar businesses, with a particular emphasis on leveraging both our own and customer driven campaigns for partner branded products,” said Larry Firestone, CEO of 22nd Century Group. “We are excited about the upcoming launch of now two partner-branded VLN products, both for chains with substantial retail store counts, bringing additional partner-supported marketing and outreach activity to grow sales volumes in the VLN category. We are moving ahead on these and other opportunities ahead as we continue to execute our growth strategy in 2025.”

    View the full financial report here.

  • 22nd Century Further Reduces Debt by $1M

    22nd Century Further Reduces Debt by $1M

    22nd Century Group, Inc. today (May 7) announced that repaid an additional $1 million in debt to its senior lender. The company’s total debt principal outstanding now stands at approximately $3.9 million.

    “Our debt reduction progress has been outstanding and total debt principal is now less than $4 million, as compared with approximately $20 million of total debt obligations when I joined the company in December 2023,” said Larry Firestone, CEO of 22nd Century Group. “We are on our way to becoming debt-free, which will allow us to focus our resources on growth opportunities we see across our contract manufacturing business, as well as reduced nicotine content and branded products.”

    22nd Century will report its complete first quarter results on May 13 with a conference call the same day.

  • VLN Relaunch in Korea

    VLN Relaunch in Korea

    Image: Tobacco Reporter archive

    22nd Century Group announced a new agreement for full-scale commercial rollout of its VLN reduced-nicotine content cigarettes in South Korea. The new agreement with 22nd Century’s local partner, Nico-Tech Korea Inc., follows an initial test launch conducted in 2022 that identified product updates needed to align with local South Korean cigarette characteristics and appeal to the specific preferences of adult smokers in Korea.

    “South Korea is a unique market characterized by high smoking rates and a corresponding high commitment from its government to reduce the harms of smoking,” said Larry Firestone, chairman and CEO, in a statement. “Based on the pilot launch in 2022, we made key product modifications to better align with specific characteristics of combusted cigarettes preferred by South Korea’s adult smokers. We have made those changes and are now ready to fully enter the market with VLN export shipments to South Korea anticipated to begin later this year.

    “This relaunch with our original partner, Nico-Tech, demonstrates their commitment to smoking harm reduction and making VLN products a key part of the South Korean market through the diverse array of local retail channels they serve. We are working with Nico-Tech to plan a full launch event for the fall of 2024, including on-site support.”

    South Korea represents an estimated $1.6 billion tobacco market and was the first international market to commence sales of VLN reduced-nicotine content cigarettes. While tobacco product use has declined since signing into law the 1995 National Health Promotion Act and subsequent government actions, the prevalence of smoking remains high in certain segments of the South Korean population. It is estimated that one in three adult men in South Korea are smokers, and an estimated 6 percent of adult women smoke.

    Nico-Tech will be responsible for all local marketing activities to generate consumer demand and awareness in South Korea. The new agreement includes minimum order quantities to support the initial stocking and restocking needs of the planned South Korean distribution.

  • 22nd Ups Performance on Lower Cost

    22nd Ups Performance on Lower Cost

    Photo: 22nd Century Group

    22nd Century Group reported an operating loss of $4.4 million for the first quarter of 2024 compared with $10.4 million in the comparable period of the previous year. Net loss from continuing operations for the first quarter of 2024 decreased to $5.5 million compared with $10.8 million in the prior-year comparative period.

    Adjusted earnings before interest, taxes, depreciation and amortization declined to a loss of $3.5 million from a loss of $9 million in the prior-year comparative period.

    Net revenue from continuing operations was $6.5 million, as the company further refined its revenue mix away from negative margin filtered cigars in favor of higher margin VLN and conventional cigarettes.

    “The first quarter and subsequent events in Q2 2024 demonstrate that we are rapidly transforming 22nd Century’s operating results as we shift our revenue mix and implement a lean operating cost mantra across the company, and strengthening the balance sheet,” said 22nd Century Group chairman and CEO Larry Firestone in a statement.

    “Operating costs declined dramatically, to just $3.3 million, well below our target of $4 million. We also recently announced two significant new customer contracts to drive additional revenue and improve our margin profile, including a 20 percent increase in our CMO production unit volumes. Those contracts commenced in April 2024 with revenue ramping in the second quarter.”

  • 22nd Adjourns Meeting for Shares Proposal

    22nd Adjourns Meeting for Shares Proposal

    Image: mojo_cp

    22nd Century Group conducted its Jan. 24, 2024, special meeting of stockholders and adjourned the meeting solely with respect to Proposal 2 set forth in its Definitive Proxy Statement previously filed with the Securities and Exchange Commission. Proposal 2 is a proposal to increase the number of authorized number of shares of common stock. All other proposals were passed at the special meeting with strong support from stockholders.

    “We sincerely appreciate the support of our stockholders on these important items as we work to swiftly effect a turnaround of the business,” said Larry Firestone, chairman and CEO of 22nd Century, in a statement. “In the seven weeks since I joined the company, we have fully focused the business on our tobacco operations, implemented aggressive operating cost reductions and extended our balance sheet runway. We are also actively working to improve our tobacco business margins and increase the returns from those assets as we work to make this company self-sufficient, including efforts to increase the channels and channel support for VLN sales.

    “While I am pleased with the progress on these and other initiatives we have underway, Proposal 2 is still critically important to ensuring that the company can address any strategic needs as we bridge to self-sustaining operations as quickly as possible. We hope that the adjournment will enable additional shareholders to vote for this proposal, or those who may have voted against to reverse their vote and support our efforts to complete the turnaround process.”

    The company has adjourned the special meeting solely with respect to Proposal 2 to provide its stockholders additional time to vote on Proposal 2. The special meeting will resume with respect to Proposal 2 at 11:00 a.m. Eastern Time on Feb. 15, 2024. The reconvened meeting will be held at 11988 El Camino Real, Suite 400, San Diego, California, 92130. The record date for determining stockholders eligible to vote at the special meeting will remain the same. To date, more than 48 percent of all shares outstanding as of the record date have voted in favor of the proposal.

    Stockholders as of close of business on Dec. 6, 2023, the record date for the special meeting, who have not yet voted are encouraged to vote over the internet at http://www.proxyvote.com/.

  • 22nd Century to Host Fireside Chat Event

    22nd Century to Host Fireside Chat Event

    Image: connected2000

    22nd Century Group will host a fireside chat event on Wednesday, Jan. 17, 2024, beginning at 1:00 p.m. Eastern Time. The event will be hosted by a covering research analyst and feature interactive Q&A with Larry Firestone, who was appointed chairman and CEO in December 2023.

    Firestone will address the new corporate strategy to create a lean operating cost structure focused on the company’s tobacco manufacturing and tobacco harm reduction products, return the company to growth and strengthen the balance sheet to ultimately self-fund the company’s development plans.

    “We have made significant progress at 22nd Century in a very short time, demonstrating our shared commitment to streamline the business, reduce costs and position the company on sustainable growth strategies that can lead to positive cash flows,” said Firestone in a statement. “We are by no means finished with our efforts and expect to further reduce costs, pay off our debt and diversify our continuing operations as the year progresses. This will enable the company to fully focus on the best path to achieving commercial success, particularly with our FDA [U.S. Food and Drug Administration]-authorized VLN harm reduction products.”

    A webcast link to join the live webcast or a replay of the event will be available on the investor relations section of the 22nd Century Group website at https://ir.xxiicentury.com under “Events and Presentations.”