Phase II Clinical Trial Featuring 22nd Century’s Very Low Nicotine Tobacco Accepted for Publication

Source:  22nd Century Group, Inc.

Very Low Nicotine Cigarettes Reduce Frequency and Urges to Smoke, Help Smokers Quit

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today that an independent Phase II clinical trial conducted at Queen Mary University of London that explored the efficacy of the Company’s proprietary very low nicotine tobacco as a smoking cessation aid when combined with pharmacotherapy has been accepted for publication in Nicotine & Tobacco Research. The study was supported by a grant from the Global Research Awards for Nicotine Dependence (GRAND) funded by Pfizer, Inc.

The results of this study once again confirm the effectiveness of 22nd Century’s very low nicotine tobacco cigarettes as a smoking cessation aid. The Company’s very low nicotine cigarettes satisfy the behavioral aspect of smoking while delivering only trace amounts of nicotine. Indeed, it is 22nd Century’s fundamental assertion that very low nicotine cigarettes uncouple the behavioral/sensory aspects of smoking from the rapid delivery of nicotine.

The Queen Mary researchers noted: “[Very low nicotine cigarettes] have been shown to be satisfying... [and] were also shown to reduce tobacco withdrawal symptoms, including urges to smoke and low mood.” The clinical trial compared the combination of very low nicotine cigarettes together with two other treatments: 1) varenicline (Pfizer’s Chantix), and 2) nicotine replacement therapies (patches, lozenges, etc.). In each case, 22nd Century’s proprietary tobacco cigarettes provided smokers with a substantial boost in their efforts to stop smoking. Despite providing patients with only a 2-week supply of 22nd Century’s very low nicotine cigarettes (a separately published Phase II clinical trial used a 6 week treatment period) researchers found that participants who received very low nicotine cigarettes had higher quit rates at 1-week, 4-weeks, 6-weeks, and at the study’s maximum 12-weeks. However, due to the size of the study, researchers were unable to achieve statistically significant results at 6 and 12 weeks.

Although the study refers to 22nd Century’s cigarettes as “de-nicotinised cigarettes,” or DNCs, 22nd Century does not “de-nicotinise” or chemically strip tobacco to remove the nicotine. Instead, the Company’s proprietary very low nicotine tobacco, when grown and processed in the same manner as conventional tobacco, contains 95% less nicotine.

As the Queen Mary clinical trial was initiated in 2011, researchers used 22nd Century’s first generation very low nicotine tobacco. Accordingly, it is not surprising that these first generation cigarettes were not well suited to British consumer tastes. More recently, 22nd Century has developed very low nicotine tobacco blends designed according to consumer tastes in each of Europe, Asia, and the Americas that the Company believes will be very satisfying to smokers.

The Queen Mary trial highlights one of the important applications of 22nd Century’s proprietary very low nicotine tobacco. Another application of the novel technology is demonstrated by 22nd Century’s MAGIC 0 brand (0.04 mg nicotine yield; a 95% reduction in nicotine) which is the world’s only tobacco cigarette brand to provide smokers with the choice of a product which separates the rapid delivery of nicotine from the act of smoking. Sales of MAGIC 0 brand and MAGIC 2 brand have recently commenced in Europe and will be available in several additional countries by the end of 2015. 22nd Century does not represent that any of its current commercial brands are intended to be used as smoking cessation aids.

The Queen Mary study concludes: “The most pragmatic approach may be to offer an ongoing supply of [very low nicotine cigarettes] to those who want to continue using them.” This conclusion echoes Former US FDA Commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.” Indeed, 22nd Century is deeply committed to commercializing this approach and remains the only company in the world capable of producing virtually nicotine-free tobacco.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Obtains Cigarette Distribution Licenses in New York State

Source:  22nd Century Group, Inc.

RED SUN Approval Secured in All 50 States

22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, LLC, has been granted both a New York State Cigarette Stamping Agent license and a New York State Wholesale Cigarette Dealer license. With these licenses, the Company gains the ability to distribute its RED SUN cigarettes across New York State without the need to use a middle-man distributor.

In addition, 22nd Century has secured approval for RED SUN to be sold in all 50 states plus the District of Columbia. Few of the nation’s small, independent cigarette makers – commonly referred to as “microsmokes” – can claim to have such complete coverage. Gaining nationwide approval is especially impressive given that it has been only 10 months since 22nd Century became the first company in more than six years to be approved as a new signatory to the Master Settlement Agreement between the tobacco industry and the 46 Settling States (as a result of the Company’s strategic acquisition of NASCO Products, LLC).

“The New York State Stamping Agent and Wholesale Dealer licenses give us the flexibility to supply New York retail stores directly,” said Karen Delaney, 22nd Century Group’s Tax Compliance Manager. “Though we consider our relationships with other New York distributors very important, by securing our own licenses in New York, we gain control over distribution of our products in a key strategic region for our Company.”

The acquisition of licenses and state directory listings highlights the rapid expansion of RED SUN availability across the United States. After launching RED SUN in January 2015, 22nd Century has grown its retail store count to well over 300, including hundreds of stores specifically listed on its www.redsuncigarettes.com website. Retail stores in the Portland, Oregon region – a part of the Rich & Rhine distribution network – are also coming online quickly and should increase the store count to more than 500. Other distributors, currently ramping up stock and training their sales representatives, could double the RED SUN store count to more than 1,000 retail locations by the end of the third quarter.

“Securing approval for RED SUN in all 50 states is an important milestone for the Company,” remarked Henry Sicignano III, President and Chief Executive Officer. “I am extremely pleased with the rapid growth of our retail network and look forward to achieving 1,000 RED SUN retail stores very soon.”

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Announces Closing of $6 Million Registered Direct Offering

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company whose mission is to reduce the harm caused by smoking, announced today that it has closed the previously announced registered direct offering of common stock and warrants consisting of 6,000,000 shares of the Company’s common stock and 66-month warrants to purchase 3,000,000 shares of common stock at an exercise price of $1.25 per share (not exercisable for six months from issuance). The stock and warrants were sold for $1.00 per unit. The net proceeds of the offering, excluding any proceeds that may be received from the exercise of warrants, are approximately $5.6 million and will be used for general corporate purposes, including working capital. Chardan Capital Markets, LLC acted as the sole placement agent for this transaction.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents plus an additional 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Announces $6 Million Registered Direct Offering

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company whose mission is to reduce the harm caused by smoking, announced today that it has entered into an agreement with a single institutional investor to receive $6 million in gross proceeds in a registered direct offering through the sale of common stock and warrants consisting of 6,000,000 shares of the Company’s common stock and 66-month warrants to purchase 3,000,000 shares of common stock at an exercise price of $1.25 per share (not exercisable for six months from issuance). If the warrants are exercised for cash in full, the Company would receive additional gross proceeds of approximately $3.75 million.

The offering is expected to close on or about June 2, 2015, subject to customary closing conditions. The net proceeds of the financing will be used for general corporate purposes, including working capital. 

Henry Sicignano III, President and Chief Executive Officer of 22nd Century, commented, "We are preparing for an exciting second half of 2015 on multiple fronts. Our key priorities remain the successful launch of RED SUN in the U.S. and MAGIC in Europe; signing agreements with leading distributors in the U.S. and abroad; potential strategic partnerships for X-22, the Company’s novel smoking cessation aid in development; submission of a modified risk tobacco product application with the FDA for very low nicotine Brand A cigarettes; joint venture partnerships in Asia; and the continuation of our world renowned research in tobacco technology." Mr. Sicignano continued, "We believe this capital raise – with a single institutional investor – is a strong vote of confidence in 22nd Century and an important step forward in executing our strategy."

Chardan Capital Markets, LLC acted as the sole placement agent for this transaction.

The securities described above are being offered by 22nd Century through a prospectus supplement pursuant to 22nd Century’s shelf registration statement on Form S-3 as previously filed and declared effective by the Securities and Exchange Commission and the base prospectus contained therein (Registration No. 333-195386). A prospectus supplement related to the offering will be filed with the Securities and Exchange Commission. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities are being be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, by contacting Chardan Capital Markets, LLC, 150 East 58th Street, 28th Floor, New York, NY 10155, at (646) 465-9028, or the Securities and Exchange Commission's website at http://www.sec.gov.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents plus an additional 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Announces Launch of “0.0 mg Nicotine” MAGIC Cigarettes in the United Kingdom

Source:  22nd Century Group, Inc.

Desires Approval to Label and Launch “Nicotine-Free” Cigarettes in the U.S.

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, today announced the launch of MAGIC cigarettes in more than 150 U.K. specialty tobacco shops across England, Wales, and Scotland. Starting June 15, 2015, MAGIC 0, the world’s only “0.0mg nicotine” tobacco cigarette, will be available to U.K. consumers.

Featuring an authentic, natural tobacco taste, MAGIC O cigarettes are made with the world’s lowest nicotine tobacco. Without any artificial extraction or chemical processes, 22nd Century has developed the novel technology which makes possible very low nicotine tobacco. The proprietary tobacco used in MAGIC cigarettes is grown on independently-owned farms in the United States and results in an extraordinary cigarette with all of the taste of a conventional cigarette, but MAGIC 0 yields only 0.04 mg of nicotine per cigarette − 95% less nicotine than conventional cigarettes. No other company can grow tobacco with such low nicotine content.

In accordance with European regulations which require cigarette manufacturers to list the nicotine yield directly on each pack of cigarettes and to round the yield to the nearest 1/10 place, MAGIC 0 packs prominently feature the words: “0.0 mg nicotine.” MAGIC 2 packs read “0.2 mg nicotine.” 22nd Century is proud to make these disclosures and believes all tobacco companies should be required by the FDA to make similar disclosures for cigarettes sold in the United States.

“The public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is proud to be in a position to bring such an important product to market,” explained Henry Sicignano III, President and Chief Executive Officer. “I hope someday soon 22nd Century will be allowed to bring a similar product – properly labelled as a very low nicotine cigarette – to consumers in the United States.”

TOR Imports, the distributor for MAGIC cigarettes in the U.K., has taken pre-orders for MAGIC brand cigarettes at more than 150 tobacconists and expects to place MAGIC in over 300 tobacconists by the end of the summer. Targeting tobacconists in the U.K. is critical to the successful launch of a new cigarette brand. Unlike conventional grocers, tobacconists in the U.K. are permitted to display cigarette advertising and packaging directly to consumers.

Mr. Scott Vines, owner of TOR Imports explained, “MAGIC, 0.0 mg nicotine cigarettes… That says it all! TOR Imports is placing MAGIC cigarettes in nearly 100% of the specialty tobacco stores across the U.K. We are very excited to be able to offer U.K. smokers the unprecedented choice of smoking nicotine-free tobacco cigarettes!”

The April launch of MAGIC cigarettes in Spain, and now their introduction in the U.K., highlights 22nd Century’s plans for rapid introduction of MAGIC brand cigarettes across Europe. By autumn, the Company expects to secure MAGIC distribution in at least four more European countries.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.