22nd Century Group Stock Quote

Bank of America Investment Report Highlights the Value in 22nd Century Group(0)

Early this week, Bank of America/Merrill Lynch published an analyst report on Modified Risk Tobacco Products (MRTPs) detailing the significant impact that MRTPs will have on the $748 billion annual worldwide tobacco industry. “We are on the eve of what we all believe could be a paradigm shift for our industry,” Philip Morris International (NYSE: PM) CEO, Louis Camilleri was quoted. The new products have “the very real potential to not only be a game-changer, but also be the key to unlock several hitherto virgin territories, most notably the huge Chinese market.”

Indeed MRTPs could revolutionize the tobacco industry and generate untold profits for the most innovative, consumer-acceptable products. BOA goes into great detail describing “Modified Smoking” products which mimic smoking such as e-cigarettes and heat, not burn, products, and “Alternatives to Smoking” such as snus, dissolvables and nicotine replacement products. Examples are these products are marketed at Read More

Smoking Cessation Clinical Trial Results Fast Approaching for 22nd Century Group(0)

22nd Century Group Inc. (OTCBB:XXII) has developed what may prove the world’s most effective, most consumer-acceptable – and perhaps most valuable – smoking cessation aid. The company’s flagship product, X-22, is a patented very low nicotine (VLN) cigarette that facilitates smoking cessation at remarkably effective rates.

Enrollment was completed in late September for the company’s Phase II-B clinical trial. 234 smokers were randomized in the double-blind, active-controlled, multi-center smoking cessation study, representing the largest study of its type in the world to date. Primary endpoint results of the study, 4 straight weeks of not smoking (chemically verified), will be released in early December 2011. No industry peers, regardless of market cap, have a smoking cessation product in such advanced stages of clinical development. No other company has such a fundamentally novel smoking cessation therapy in the pipeline.

22nd Century public filings state that X-22 has the lowest nicotine content of any cigarette in the world; 97% less nicotine than Marlboro^® Gold, formerly known as Marlboro^® “Lights.”

Detailing the cessation process, XXII’s management explains that X-22 (over the 6-week treatment period) satisfies smokers’ cravings for cigarettes while separating the act of smoking from the rapid delivery of nicotine. X-22 is the only smoking cessation product that directly addresses the behavioral aspects of smoking. Lending credence to 22nd Century’s novel strategy, former FDA Commissioner, Dave Kessler has declared publically that mandating a reduction in nicotine levels in cigarettes to “non-addictive levels” is the “ultimate harm reduction strategy.”

While other companies, such as Star Scientific, Inc. (NASDAQ: CIGX) and Swedish Match AB (NASDAQ QMX Stockholm: SWMA), have pursued smoking cessation products in the form of tobacco lozenges and snus in trials which have proven to show little to no deviation from controls, cigarettes made from 22nd Century’s patented VLN tobacco have produced strong results in independently-sponsored trials. In a groundbreaking 3-arm Phase II clinical trial with 165 participants (Hatsukami, et al 2010), point-prevalence abstinence at 6 weeks after the end of treatment was a stellar 47% for the group using the VLN cigarette.

The company also reports that smokers find it far preferable to quit smoking with a VLN cigarette rather than taking their chances with nicotine patches, gums or lozenges, or with prescription drugs that can have serious side effects.

Anticipating efficacy rates for the 22nd Century Phase II-B trial that are similar to the Hatsukami data, 22nd Century reports that the company intends to file for Fast Track designation with the US Food and Drug Administration to expedite research towards bringing their product to market.

In recent Company press, 22nd Century CEO Joseph Pandolfino stated, “We believe X-22 will be granted Fast Track status by the FDA after completing our company-sponsored Phase II-B clinical trial because, as in other Phase II trials with VLN cigarettes, we expect X-22 to demonstrate one or more advantages (over currently approved smoking cessation products) in the following areas: efficacy, safety, compliance and convenience.”

On the whole, X-22 seems to demonstrate better quit rates than other smoking cessation products, presents no new side effects to existing smokers, and could actually encourage more smokers to try quitting with a novel product that is understandably palatable to smokers. For all these reasons, X-22 may in fact represent a multi-billion dollar market-cap opportunity for tiny 22nd Century.

Shares of XXII have only traded since early in 2011, where they were valued in the area of $1.20-1.40. Though there has been no change to the company’s capital structure throughout the year, in the midst of the market’s general exodus from biotech microcaps, XXII shares slid to $0.60 before getting a nice bounce back up to $0.90 after an article in the New York Times put a spotlight on corporate developments and products. SEC filings also show that XXII insiders, including President Henry Sicignano III, have snagged more than 100,000 shares above the $1.00 mark this year, giving credence to the plausibility that 22nd Century is significantly undervalued. (Rodman & Renshaw biotech analyst, Elemer Piros, PhD, has placed a $5.00 near term price target on XXII.)

Moreover, 22nd Century is actually generating revenue; the company shipped more than 9 million of its SPECTRUM research cigarettes (450,000 packs) in the third quarter 2011 to the National Institute on Drug Abuse (“NIDA”), a component of the National Institutes of Health (“NIH”). The fact that 22nd Century was chosen to supply its proprietary SPECTRUM research cigarettes as a subcontractor under a 5-year federal government contract further validates the company’s products and technology.

With the potential to lengthen hundreds of thousands of lives each year – while dramatically decreasing health care costs incurred by the 20% of Americans who smoke cigarettes – 22nd Century has the opportunity to do well for its shareholders… as it does good for smokers. The company has developed a remarkable product, under a strong international patent portfolio, that could actually revolutionize the multi-billion dollar smoking cessation industry. Though this innovative microcap is still under the radar of the broader investment community, it is likely only a matter of time until Big Pharma realizes that X-22’s efficacy, lack of side effects, and very high level of acceptability with potential consumers makes 22nd Century ripe for a buyout. This scenario – combined with the company’s lucrative international licensing possibilities – appears to give XXII massive upside potential at this point.

22nd Century Group (XXII) Stock Quote and News:

Disclaimer: Neither http://www.otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters (“us” or “we”) is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/?page_id=190.

22nd Century Cigarettes Could Help Smokers Kick the Habit(0)

Sound like a paradox? Not upon a closer look at a recent NY Times article featuring 22nd Century Group, Inc. (OTCBB:XXII) and their genetically-altered tobacco. 22nd Century Group holds 98 patents for genetic manipulation of tobacco plants to reduce or increase the amount of nicotine in cigarettes. The company’s technology can dramatically lower the nicotine levels in cigarettes while preserving all the other tastes and smells, giving those looking to quit a fighting chance against the lung and brain-gripping addiction. On the flipside, it can also boost the nicotine levels, a quality that is being developed as a “modified risk” tobacco product because smokers can take fewer puffs to obtain the same amount of nicotine.

22nd Century produces its cigarettes in varying tar and nicotine levels, many of which are actually being purchased by the federal government for research purposes. With the passing of a law in 2009 (The Tobacco Control Act), the U.S. Food and Drug Administration cannot completely ban nicotine, but it does have complete regulatory authority over all tobacco products; meaning that it could mandate an extremely low level of nicotine in smokes if it deems it a benefit to public health.

In fact, Harvard Professor of Public Health and former member of the FDA Tobacco Products Scientific Advisory Committee Dr. Gregory Connolly is publicly calling for the FDA to mandate a massive reduction of nicotine levels in cigarettes – to approximately 0.3 milligrams per cigarette. At this date, XXII is the only company in the world capable of manufacturing tobacco cigarettes with this minute level of the addictive chemical. And indeed, if the FDA does in fact mandate such extremely low levels of nicotine content in cigarettes sold in the U.S., tiny XXII could command a market cap well in excess of $2 billion (more than 100 times its current $18MM valuation).

As the NY Times article goes on to explain,

The National Institutes of Health bought nine million of these [XXII] cigarettes, marked ‘for research purposes only,’ from the 22nd Century Group as part of a broadening scientific effort to find ways to regulate cigarettes so that they are non-addictive. The Spectrum brand test cigarettes have eight different levels of nicotine for research, from a nicotine content of 3 percent to 100 percent of the nicotine in the best-selling Marlboro Gold, though a 97 percent reduction is the most common level.

The experts all seem to agree that more research with larger groups is required to get a more thorough assessment of the cigarettes as a smoking cessation product and its potential benefits within the cigarette industry. That data is coming, though. 22nd Century is near concluding a company-sponsored Phase II clinical trial testing the X-22 cigarettes as a smoking cessation product and plans Phase III trials in 2012 to test safety and efficacy. Moreover, the F.D.A. and National Institute of Health are beginning a $118 million, multi-year study to track approximately 44,000 people and all things pertaining to their smoking habits.

While there are certainly humanitarian benefits, it cannot be overlooked that this is business. Big business, as tobacco represents an $80 billion industry. Realizing the revenues that can be generated from smoking cessation products, many companies have chased their tails to a certain extent trying to develop products such as lozenges and gums with limited success. 22nd Century may be hitting the nail right on the head with its unique approach. As 22nd Century Chief Executive Officer Joseph Pandolfino states, “No one has ever sought F.D.A. approval of a cigarette as a medical device.” With multi-million dollar orders already having been delivered and a multi-year supply contract, 22nd Century Group seems to be moving its way toward the catbird’s seat of the industry. With a current share price of just $0.60, Elemer Piros, PhD, puts a $5.00 near-term price target on XXII. Given that the results of the company’s pivotal Phase II-B trials will be reported in December, it may be possible for investors to net strong gains in the short-term with this intriguing microcap.

22nd Century Group (XXII) Stock Quote and News:

Disclaimer: Neither http://www.otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters (“us” or “we”) is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/?page_id=190.

22nd Century Delivers 9 Million Research Cigarettes to U.S. Government(0)

Shares of 22nd Century Group, Inc. (OTCBB:XXII) got a boost in volume and share price today after the Company released news of shipping more than 9 million SPECTRUM® research cigarettes to the U.S. government. Consisting of a variety of styles as referenced in our last article on 22nd Century as a value proposition, the cigarettes are for research purposes and not for commercial sale in the United States.

The shipment is part of a five-year federal contract for which 22nd Century, the only producer in the world of the proprietary very low nicotine (VLN) products, is supplying the cigarettes with a fixed tar level, but a variety of nicotine levels in both regular and menthol flavors. The contract was finalized after a series of meetings with government officials from the National Institute on Drug Abuse (NIDA), U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC). The government will be researching the SPECTRUM® cigarettes to collect and evaluate a wide array of data including:

smoking cessation studies
exposure studies comparing how different nicotine levels in cigarettes affect smoking behavior and exposure to smoke toxins
studies to determine whether there is a threshold nicotine level in cigarettes which does not produce dependence.

Founder and CEO of 22nd Century Joseph Pandolfino commented,

Working with these researchers and officials from federal public health agencies has been a terrific experience. Throughout the process, the investigators provided 22nd Century input on their research objectives and shared insights into what types of cigarettes would best facilitate their independent studies. 22nd Century is pleased that SPECTRUM® will be used to provide answers to important research questions likely to affect tobacco public policy for years to come. I am optimistic that the results of these studies will be applied to reduce the harm caused by smoking-the leading cause of preventable death in the U.S. and the world, according to the CDC and the World Health Organization.

More information on the public outcry for lower nicotine levels in cigarettes can be found in our June 14^th article.

22nd Century Group, Inc. (XXII) Stock Quote and News:

Disclaimer: Neither http://www.otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters (“us” or “we”) is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/?page_id=190.

22nd Century Group Presents Opportunity on a Price Dip(0)

Reading a recent article on Seeking Alpha by Dr. John Faessel on Star Scientific (NASDAQ: CIGX) spurred my research on potential value propositions of Star and its competitors. While Faessel’s article was focused on Star’s NF-kB inhibitor Anatabloc™, the company is also known for its CigRx smoking cessation product and its legal battle with tobacco giant RJ Reynolds. Often times a drama-filled stock, CIGX on Yahoo Finance includes an article from the Motley Fool expressing an opinion to avoid Star Scientific stock. A lesser-known firm that could be positioned to burst onto the scene and that deserves some time in front of investors for its advancements in the field of smoking cessation and tobacco harm reduction products is 22nd Century Group, Inc. (OTCBB:XXII). Though SEC filings show that management has made 6-figure purchases of 22nd Century stock in recent months, this week 22nd Century’s share price dipped below $1 for the first time since XXII began trading in January 2011… potentially representing a significant “buy the dip” opportunity.

There appears to be no real justification for the slide in share price given that corporate developments seem to be progressing and there have been no changes in capital structure.

Financially speaking, revenue reported on August 15, 2011 for the six months ended June 30, 2011 totaled $416,000, including net sales of $272,000. 2011 second quarter net sales increased 32% over the first quarter of 2011 primarily attributable to sales related to SPECTRUM, a research cigarette manufactured for the U.S. government for which 22nd Century Group has been contracted to supply its proprietary very low nicotine (VLN) product. For the first six months of 2011, 22nd Century posted a net loss of $1.75 million (primarily attributable to costs involved with its Phase IIB clinical trial). In comparison, Star Scientific posted six-month net sales of $418,000 and a net loss of $11.08 million.

22nd Century is in partnership with RTI International - pursuant to RTI’s 5-year contract with the National Institute on Drug Abuse (NIDA) - to supply the SPECTRUM modified nicotine cigarettes (8 different nicotine levels from very low to high encompassing 22 brand styles with 11 different tar yields in both regular and menthol) to NIDA. The contract has only recently commenced which bodes well for future revenues for XXII. What’s more, considering the long-term NIDA contract – combined with the fact that dozens of independent researchers and public health officials are conducting their own clinical trials with SPECTRUM cigarettes – suggests that momentum is building for 22nd Century’s revolutionary smoking cessation therapy.

Indeed the near term future holds tremendous promise for 22nd Century Group; the Company is in a Phase II-B clinical trial for its X-22 cigarettes, a prescription smoking cessation aid in development. Allowing smokers to smoke during the six week treatment period, the Phase IIB is a pivotal three-site, double-blind, 216-patient trial. An X-22 cigarette contains roughly the same amount of nicotine as a tomato, which equates to 97 percent less nicotine than a Marlboro Gold® cigarette (formerly called Marlboro Lights), the most purchased cigarette in the U.S. Research has provided potent data as to quit rates which are expected to be validated in company-sponsored studies under FDA protocol. Results from the Phase IIB trial are expected at the end of November 2011.

With a staggering IP portfolio (98 patents in 79 countries on every gene in the tobacco plant that controls nicotine production), 22nd Century is well-positioned to capture a large share of the $3 billion worldwide smoking cessation market. With over 6 million people dying each year of tobacco-related disease according to the World Health Organization and nearly half of all smokers trying to quit annually (only 2-5 percent quit successfully), the opportunity is there to capitalize on a very lucrative industry while providing a better quality of life for millions of people around the world.

XXII only has 27.9 million shares outstanding (insiders and affiliates hold more than 50 percent of those) and has a miniscule market cap of less than $30 million. What’s more, note:

Three independent Phase II trials have already demonstrated efficacy of very low nicotine cigarettes for smoking cessation,
XXII is already generating revenue,
Operating losses are minimal,
22nd Century sponsored mid-stage clinical trials are well underway, and
“apples for apples” competition in a multi-billion dollar industry is nil.
Elemer Piros (ranked #1 U.S. stock picker for the biotechnology industry by Financial Times Analyst Awards) puts a $5.00 target on the sub $1.00 stock…

Now, that’s upside potential.

22nd Century Group (XXII) Stock Quote and News:

Star Scientific (CIGX) Stock Quote and News:

Disclaimer: Neither http://www.otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters (“us” or “we”) is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/?page_id=190.

22nd Century Enroll Patients for Phase II-B Smoking Cessation Trial(0)

In its ongoing efforts to revolutionize smoking cessation products, 22^nd Century Group, Inc. (OTCBB:XXII) has taken one more step with the announcement of enrollment of patients in its Phase II-B clinical trial testing the efficacy of its Very Low Nicotine (VLN) X-22 cigarettes as a prescription smoking cessation aid. The X-22 smokes contain roughly the same amount of nicotine as a common tomato which represents 97 percent less than Marlboro Gold cigarettes (formerly known as Marlboro Lights). For the Phase II-B trials, subjects are assigned to smoke X-22’s for a six-week period with the ultimate goal of quitting smoking by the end of the term.

More than 200 smokers will be enrolled in the multicenter Phase II-B clinical trial by the end of August 2011. The primary endpoint of the study is four weeks of continuous abstinence from smoking. The results are expected to be available in late November 2011. Comparisons of quit rates of patients using X-22 cigarettes to quit rates of those using active control cigarettes with standard nicotine content will be measured. Additionally, follow-ups will be conducted at two and three months to evaluate quit rates.

22^nd Century has applied for “Fast Track” status to expedite development of the VLN cigarettes by the U.S. Food and Drug Administration and has been informed by the government agency that it will make a decision on granting the desired status by September 2011. Viable and proven solutions to assist in smokers kicking the habit certainly should qualify as an area of unmet need given the magnitude of deaths attributed to smoking cigarettes each year and the fact that present day therapies have simply proven relatively ineffective or have demonstrated some serious side effects.

This low volume, low float play (12.5 million in the float) continues to skirt the attention of investors for moving rapidly through clinical trials with very strong data being accumulated in early research by both the Company and independent firms. Zyban and Chantix both now have to carry government-ordered warnings as to the possible strong side effects and nicotine alternatives still do not carry heavy success rates, which moves these turbo-low nicotine smokes - if approved - could make a significant impact on the Company’s tiny $33 million market capitalization.

22nd Century Group, Inc. (XXII) Stock Quote and News:

Disclaimer: Neither http://www.otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters (“us” or “we”) is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/?page_id=190.