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Why 22nd Century Group Stock Briefly Spiked Monday
22nd Century Group may be ready to take flight as a result of the FDA's latest tobacco harm reduction initiative.
The Motley Fool George Budwell Oct 17, 2017 at 8:00AM
What happened
Shares of 22nd Century Group (NYSEMKT:XXII), a plant biotech company focusing on the development of low nicotine cigarettes and smoking cessation aids, jumped by as much as 10.7% yesterday before ultimately ending the day up 2.14%. This brief double-digit rally was sparked by a new 12-month price target from Chardan Capital Markets analyst James McIlree.
So what
What really appears to have caught investors' eye yesterday, however, was the magnitude of the price target increase. Specifically, Mcllree's new price target of $11.50 (up from $3.50) implies an upside potential of a whopping 310% compared to where the stock opened on Monday.
Now what
Although Mcllree's revised outlook was light on specifics, his central thesis appears to revolve around the latest tobacco harm reduction initiative from the U.S. Food and Drug Administration, or FDA. In short, 22nd Century Group's low nicotine cigarette platform may end up benefiting immensely from the FDA's new mandate, under the Family Smoking Prevention and Tobacco Control Act, calling for all combustible cigarettes sold in the United States to contain nicotine levels that are nonaddictive.
While 22nd Century Group does appear to be getting into the low nicotine cigarette game at almost the perfect time, there are still some good reasons to remain cautious with this speculative biotech stock right now. Big tobacco's ginormous lobbying machine, after all, could ultimately blunt the FDA's plans, and that would spell disaster for companies like 22nd Century Group that are counting on this latest regulatory overhaul to spur revenue growth in the years ahead. Thus, this promising small-cap biotech arguably isn't well suited for investors that are adverse to risk -- despite its tremendous upside potential.
George Budwell has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
https://www.fool.com/investing/2017/10/17/why-22nd-century-group-stock-briefly-spiked-today.aspx
Ha Ha is right….
“Ha Ha
Like I keep telling everyone.
This thing is going nowhere for 5 years.
2.48 after hours. Ouch.”
No, what you kept telling everyone was
that it was going to $0 .50
A BIG, BIG OUCH... Hee Haw….
Go XXII
FDA – Nicotine Reduction
This FDA decision adds a lot to XXII/s credibility and validity, and will help in many endeavors the company is seeking.
Worth noting is that other cigarette manufactures also have the means to lower nicotine levels without using XXII’s tobacco or patented processes.
“Nicotine levels in cigarettes can be reduced in different ways. Manufacturers can adjust the blend of tobacco leaves or use different types of paper or filters. Nicotine can also be stripped from the leaf in the manufacturing process.
Philip Morris Cos., the company now known as Altria, introduced an ultralow-nicotine cigarette called Next De-Nic, created through a process that stripped the majority of the nicotine from the tobacco leaf similar to the way caffeine is removed from coffee beans.“
Reference: FDA Seeks to Reduce Nicotine in Cigarettes to Non addictive Levels -- 5th Update. By Jennifer Maloney Published July 28, 2017 Dow Jones Newswires
Still a lengthy FDA process ahead but the future did get a lot brighter for XXII with this FDA announcement.
XXII’s tobacco and patents should have a important role in any final determination the FDA ends up with.
Your right. Typo.
“(Brand A)”, (5th paragraph down) should not be in my 35131 post.
X-22 stands alone as stop smoking aid.
XXII, Where are we?
Waiting on the FDA for approval of “Magic” to be sold in the US.
“22nd Century is the only company in the world capable of producing combustible tobacco cigarettes at this very low level of nicotine, without having to incorporate the inclusion of any artificial extraction or chemical processes into its manufacturing process”.
Yes, other companies can, and have produced low nicotine cigarettes without XXII’s patented approach.
How did the Magic sales do in other various countries?
Discovered how to manufacture low content THC in hemp.
“22nd Century believes it will be able to produce a commercially viable strain of industrial hemp without any THC.”
There are other hemp strains with very low levels of THC available.
XXII has patents for medical marijuana, “Through innovative research, the Company intends to cost-effectively produce commercial quantities of marijuana cannabinoids with low THC for research that show great promise in treating neurological disorders and other diseases.”
Dozens of States have legalized medical marijuana. Was this done in anticipation of XXII patented medical MJ products to be developed? No again. It’s already available.
20 dealers in NY State alone dispensing to those authorized to receive.
XXII is still waiting to submit the X-22, (brand A) package to the FDA. Studies are showing a “better smoking quit rate by decreasing the nicotine levels gradually vs other means”. Its submission was to occur by the end of the first quarter, 2017, now before the end of the first half of the year. This is only the first step for approval.
If approved, I believe this could be XXII’s near term money maker.
My views above are somewhat negative but any one of these endeavors with further development could be the game changer for XXII.
We need a saleable product. Customers are waiting.
I’m waiting………
X-22
Was there any conversation regarding the status for our application of the X-22 product at the meeting ?
Zacks Rank #2 (Buy)
Can The Uptrend Continue for 22nd Century Group (XXII)?
Zacks Equity Research April 06, 2017
Investors certainly have to be happy with 22nd Century Group Inc XXII and its short term performance.
After all, the stock has jumped by 36.9% in the past 4 weeks, and it is also above its 20 Day Simple Moving Average as well.
This is certainly a good trend, but investors are probably asking themselves, can this positive trend continue for XXII?
While we can never know for sure, it is pretty encouraging that estimates for XXII have moved higher in the past few weeks, meaning that analyst sentiment is moving in the right way.
Plus, the stock actually has a Zacks Rank #2 (Buy), so the recent move higher for this spotlighted company may definitely continue over the next few weeks.
2017- Cigarette State tax –
Overall All States’ Average: $1.69 per pack
Major Tobacco States’ Average: 48.5 cents per pack
Other States’ Average: $1.85 per pack
The highest combined state-local tax rate is $6.16 in Chicago, IL, with New York City second at $5.85 per pack.
If the States such as NY have truly raised the cost of cigs through taxes to reduce the number of smokers, then a argument to reduce this tax on reduced nicotine smokes would be valid.
The States might still say no to a tax reduction on cessation cigs, stating that any smoking is bad, to save their cig tax cash cow.
WNY Company grows marijuana without the high
WKBW Channel 7 News, Buffalo, NY
Looks like Chardan Capital Markets current target.
Their previous was $9.
I don’t see any other analysts covering XXII.
Todays intraday chart –>
The heart beat of a “Day Traders” computer program.
I too have been patient.
But the silence from XXII is now deafening to me. The MRTP application for “Brand A” is the only discussion from XXII.
Cannabis chatter all around us. What’s Anandia and Botanical Genetics doing?
How is Magic doing abroad? Five different countries now?
What about Sun?
How’s production at the N.C. plant?
X-22 making any progress?
Anything???
Put it out there… Keep us shareholders informed.
Question…
Is not XXII’s current application for approval of “modified risk tobacco product” labeling limited to “Brand A”?
And that Brand A contains the same nicotine levels as Magic, Magic 0 ?
Brand A and Magic are the same?
Insider Transaction…
Ist week of November, Moynihan sold (outright sale) 100,000 shares at average of $1.28 for $128,000. He holds 889,000 shares.
This is the only Insider sale this year.
From days gone by…
scottyb.... Post 19945.... 12/09/14
I have 15,000k since 2.89 and watched it rise to 6+ didn't sell a share. I was thinking of adding more myself. I know you guys are depressed but hold on. I didn't want to sell at 6.00 because of the tax situation. I want till wait till one year at least.
This should put me around end of March 2015.
I am a HTFBS sub and am still invested in DSNY and ANY.
You don't have to sell unless you really need the money.
Let’s see if I can follow this…. You spent $43k, Stock value went to $90k, but you held.
Then sold @ $0.86 (SP on March 31, 2015) for a $30k loss.
So, we should all heed your negative one liner posts to take advantage of your intuitive, prognostic advice?
That's what is "Not gonna happen"
Sorry for your losses. Geez….
Reality check ....
After July & August’s run from $ 0.81 to $1.02 (+25%) we've been treading water.
Share price (including Fridays $ 0.04 bump) is up but $0.05 in the last 60 calendar days.
I would have thought XXII would have been able to maintain a higher SP level in anticipation of the coming FDA news.
Not just let the big Traders feed themselves off the prior published news coverage.
Hoping the forth coming news will be the “game changer” that will finally vault the share price.
Trader$ Delight.........
Date Open High Low Close Volume
Oct 05 1.58 1.62 1.14 1.41 4,233,647
Oct 04 1.50 1.71 1.45 1.54 3,746,600
Oct 03 1.46 1.50 1.46 1.50 1,354,900
Sep 30 1.45 1.48 1.39 1.45 1,629,700
Sep 29 1.38 1.46 1.37 1.44 2,339,500
Sep 28 1.26 1.39 1.25 1.34 1,806,600
Sep 27 1.21 1.26 1.17 1.25 508,700
Sep 26 1.16 1.19 1.16 1.16 251,900
Long.... XXII
Same old....
Right back to where we were on May 20th, when the BIG boys came to play with their huge volumes.
Jack it up and back down.
Traders delight... $$$
“Consumer” in this endeavor will be scientific researchers.
XXII has launched a new line of Research Cigarettes with varying levels of nicotine. Similar to the Company’s SPECTRUM brand research cigarettes that are sold only to the National Institute on Drug Abuse (NIDA).
22nd Century’s new proprietary Research Cigarettes are available directly to accredited scientists, researchers, universities and governments – worldwide
22nd Century’s new research cigarettes will be available in any configuration and in any style requested by researchers.
Ban of Pharmacy sale of cigarettes…
Buffalo, NY - Erie County Executive proposes banning pharmacies across Erie County from selling tobacco products.
Poloncarz said the ban would apply to the sale of cigarettes and e-cigarettes in any pharmacy.
The legislation is sponsored by Peter Savage, who says he will present in the upcoming session. If it does pass, retailers would have 90 days to comply.
I wonder if XXII, (whose main office is in Erie Co.) is attempting to get a exemption for “smoke cessation cigarettes” before the vote?
SPECTRUM cigarettes feature 24 styles.
11 regular and 13 menthol versions.
8 different levels of nicotine content.
SPECTRUM is strictly for research purposes
and is not sold as a commercial cigarette.
ClinicalTrials.gov Id: NCT02139930
First received: May 12, 2014
Last updated: January 19, 2016
Last verified: January 2016
The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels.
Behavioral: Normal Nicotine Control Group
Behavioral: Immediate Nicotine Reduction Group
Behavioral: Gradual Nicotine Reduction Group
Detailed Description:
This project will be conducted to compare product use patterns and biomarkers of exposure between smokers who are assigned to:
a) gradual reduction in reduced nicotine content (RNC) cigarettes;
b) immediate reduction to very low nicotine content (VLNC) cigarettes or
c) normal nicotine content (NNC) cigarettes.
The outcomes from this study will provide information on different approaches to reducing levels of nicotine in cigarettes and will determine the approach with the most optimal outcomes taking into account the balance between overall risk reduction (possibly maximized by abrupt switching) and compliance and acceptability (possibly maximized by gradual reduction of RNC cigarettes).
I did read your first post....
After some more research through the SEC files,
I can’t find any tie in for any “continuation of the deal from last year”
And if a “continuation”, then why the huge bucks to Chardan?
xxiistrong, could you elaborate a bit on this?
Source of info?
I would actually feel way better if you were right.
What a deal! ..... Not!
Shares outstanding: 71 million
5 million shares offered out at $1.10
Add a 5.5 year Warrant deal with 2.5 million shares at $1.19
Chardan picks up a total of $440,000 (6% + 2%) as the deal maker.
XXII “The net proceeds of the financing will be used for general corporate purposes, including working capital.”
In October 2015, XXII states we had enough bucks to get through June 2016.
But Feb 2016, XXII needs to make a deal like this ?
I want to hear how Henry will explain this “deal” at the quarterly meeting.
To me it appears as a desperation move for $$$.
What changed so drastically in the past 3 months?
The bigger “Elephant in the room” for me is where is BAT in XXII’s evident time of need ?
I would think XXII’s first effort for cash would have been to approach BAT.
Are they still backing XXII?
Through June 2016
Post 29872
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119754322
.
Clinical Trial Update
Changes to Clinical Trials Identifier: NCT02139930 on 1-19-2016
This is the first online update to the study since last May 2015
(Actual start date was May 2014)
Still showing “This study is currently recruiting participants” for the 20 week trial period.
https://clinicaltrials.gov/ct2/show/record/NCT02139930
Quest start up history....
This article is 13 years old.
I find a lot of similarities to XXII in this story.
http://www.wired.com/2003/02/smoking/
80% of 4th Qtr 2015 SP gain is gone.
$0.85 to $1.50 to $0.98
Another $0.13 drop would finish it off.
Not pretty.
Apples to oranges:
S&P down 9% recently but down 1.7% from start of 4th Qtr
BAT $$$ not guaranteed……
From Qtr 3, 2015 Earnings Call Transcript
Chief Financial Officer, John Brodfuehrer.
“Not including the potential milestone payments of up to $7 million from BAT and not including deposits from potential strategic partnerships, we believe that the cash on hand at September 30, 2015 coupled with revenues from ongoing product sales will be adequate to sustain operations and meet all current obligations as they come due through June of 2016.”
FDA approval time frame....
While digging about I ran across this.
I don’t recall a length of time for approval more recently being mentioned. (Anyone?)
From the May 12, 2015 Conference Call
Henry Sicignano:
“We are very close, we believe, to our submission of our Brand A Modified Risk Application and with approval from the FDA… not this year, maybe not even next year, but possibly by the end of 2016 or the beginning of 2017, we will have perhaps the world's first and only approved modified risk, combustible cigarette. We think that is an outstanding opportunity.”
Again, this was last May.
“Fast tracking’ approval has been mentioned elsewhere, but was also talked about for X-22.
X-22
I too remember X-22 originally being designed with different levels of nicotine.
But I believe when it was submitted to FDA it was at one low level & was not approved
All I could dig up was this piece from 2011.
The 22nd Century Group is also applying for F.D.A. approval of its own test cigarette, called “X-22,” as a prescription-only smoking cessation device.
“No one has ever sought F.D.A. approval of a cigarette as a medical device,” Joseph Pandolfino, the founder and chief executive of 22nd Century, said in an interview. Preliminary studies show smokers can have an easier time quitting if they taper off the nicotine while still being able to do all the other things they do with cigarettes, he said, but larger studies are needed.
XXII 2015 performance: a loss of 15.6%
Posted Video.......
“The worlds first SAFE cigarette being sold in the U.S and World.” Geeeez !!
Nothing said about that in the shareholder letter I received today from Henry.
Someone best inform him. Surprised smile
The possibilities........
Looking at the article posted Monday, a portion of which I included below, we have a lot of pokes in the fire at this time.
A majority have missed “dead lines”and some for a great length of time.
Looking closer at all of the listed efforts of XXII below, they are mostly yet unattained but progressing.
Our thought way back when was if we could only fulfill a couple of our goals, we would be a success.
I still feel were on that path, slower than I anticipated, but moving forward.
Long XXII.........
22nd Century Group, Inc. (NYSE MKT: XXII) is a biopharmaceutical company founded in 1998 with proprietary technology in nicotine biosynthesis and tobacco plant-biotechnology. The company’s proprietary technology allows the company to increase or decrease levels of nicotine (and other nicotinic alkaloids) in the tobacco plant. More specifically, the company is engaged in the development of very low nicotine (VLN) tobacco, and produces a commercially-available cigarette called MAGIC® which yields approximately 95% less nicotine than other leading cigarettes previously marketed as “light” prior to The Family Smoking Prevention and Tobacco Control Act of 2009. The company also manufactures and commercializes an super-premium cigarette called Red Sun®, and provides contract manufacturing for other premium-brand cigarettes out of the company’s 61,000 square foot manufacturing facility in Mocksville, NC.
Beyond these commercially-available products, which I forecast to generate roughly $15 million in revenues in 2016, the company has publically announced that it will soon file an application with the U.S. FDA for a new VLN cigarette referred to as “Brand-A” that is expected to be the first U.S. FDA approved modified risk cigarette on the market. Recall, under the Tobacco Control Act of 2009, cigarettes are no longer allowed to be marketed as “light” or “ultra-light” or as having any reduced risk versus full flavor cigarettes without FDA approval. 22nd Century Group plans to file an application in December 2015 for Brand-A, which, if approved in 2016, will create a sizable competitive advantage for the company’s commercial marketing efforts. Another modified risk cigarette, “Brand-B”, is also under development. Unlike the VLN Brand-A cigarette designed to help people quit smoking, Brand-B is a low tar-to-nicotine ratio (TNR) cigarette designed to dramatically reduce the tar and smoke consumed by smokers, potentially reducing the risk of smoking-relating diseases, such as lung and esophageal cancers.
22nd Century Group is also working on a prescription-based cigarette, dubbed X-22, designed to help smokers quit smoking. The VLN tobacco cigarettes used in X-22 have shown efficacy helping smokers to quit smoking or to reduce the number of cigarettes smoked per day in numerous Phase 2 and Phase 3 independent clinical studies. The company is currently engaged in discussions with potential pharmaceutical partners to fund Phase 3 clinical trials using X-22. Once approved by the FDA, X-22 will compete against pharmaceutical products like Pfizer’s Chantix® (varenicline) or OTC nicotine replacement therapy (NRT) products (e.g. gums, patches, lozenges) in the $3 billion smoking-cessation market.
22nd Century Group already has an existing worldwide research and development licensing agreement in place with British American Tobacco, one of the four majors that dominate the global tobacco market, and a 5-year National Institute of Drug Abuse (NIDA) contract in place to provide its proprietary SPECTRUM® brand cigarettes for independent research ** (still looking for test subjects)** of smoking cessation and behavioral studies. Management has also partnered with distributors to introduce its Red Sun® brand to retailers in the United States and its MAGIC® cigarettes into Europe, and is working to introduce its products in the Middle East, and China, the world’s largest cigarette market by far.
Here it is...Link didn't open the article for me.
22nd Century Group to Open Laboratories to Lower Costs of Research and Speed Development of Important New Products
Company to Present at LD Micro Investor Conference on December 2nd
CLARENCE, N.Y. 11-24-2015 --(BUSINESS WIRE)--
22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that it will open specialized laboratories in Western New York dedicated to new scientific research at substantially lower costs than sponsored research projects at third-party universities. Paul J. Rushton, Ph.D., the Company’s recently appointed Cambridge and Max Planck Institute-educated Vice President of Plant Biotechnology, will lead this new scientific initiative. The new laboratories will accelerate the development of new nicotine-free tobacco varieties as well as the invention of important tobacco products.
Dr. Rushton explained, “This is a very exciting time for our Company. Our new laboratories will provide 22nd Century with the in-house capabilities to rapidly expand our genomics-based research and to accelerate commercialization of our technologies.”
“The new 22nd Century laboratories will enable us to continue to grow our patent portfolio – but at substantially reduced costs,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “What’s more, using our own labs will enable us to own, outright, the patents that we develop rather than having to license them from sponsored third-party researchers.”
In other news, 22nd Century announced today that the Company will present at the LD Micro Invitational Conference at the Luxe Sunset Boulevard Hotel, 11461 Sunset Boulevard, Los Angeles, California, on Wednesday, December 2, 2015 at 1:30 p.m. PST.
The LD Micro investor conference focuses on revealing to qualified investors promising, undervalued companies in the micro-cap space. Mr. Sicignano will provide attendees with a formal update, business overview, and highlights of recent 22nd Century Group activity. In addition, Mr. Sicignano will be available for one-on-one meetings at the conference.
Personal Op.......
Everyone was expecting a better report this past Monday. I sure was.
Anticipation (buyers) were there. Stock price was well up. We opened Monday @ $1.57. After the 3rd qtr report we were dropping fast. A few days later were @ $1.22. That’s 22% down. I didn’t hear anything suggesting near term increasing revs, so I’m inclined to believe XXII will continue down trying to find another bottom to rest on.
Magic 0 ‘s introduction in Spain (800 stores?) can only be described as a flop.
This could/should have been the accelerator in share price & a validity statement for XXII.
I don’t know if the “American taste” is the issue or if it’s not enough cigarette smokers wanting or willing to purchase a near 0 nicotine smoke to replace their higher dosed cigs, or other reasons. Whatever, time and $$$ wasted.
Most of the other future ventures are still out there, but as in the past, still hanging.
I hope Henry & crew can straighten out these issue & get us back on track.
November 10th Conference Call Details….
22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today that the Company will provide a business update for investors on a conference call to be held Tuesday, November 10th at 10:00 AM (EST).
Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group, together with John T. Brodfuehrer, Chief Financial Officer, will conduct the call. Interested parties are invited to participate in the call by dialing: 877-876-9175 and using Conference ID 3413780.
The conference call will consist of an overview summary of the financials presented in the Company's third quarter 2015 Form 10-Q and a discussion of business highlights and updates. Immediately thereafter, there will be a question and answer segment open to all callers.
XXII Earnings Date
Earnings announcement* for XXII: Nov 13, 2015
22nd Century Group, Inc is estimated to report earnings on 11/13/2015. The upcoming earnings date is derived from an algorithm based on a company's historical reporting dates. Our vendor, Zacks Investment Research, might revise this date in the future, once the company announces the actual earnings date.
Read more: http://www.nasdaq.com/earnings/report/xxii#ixzz3qYIstBAX
Onward....
We were at this PP level already twice this year. Mid Jan and mid Apr.
XXII was "toasted" after each of these moves up.
From Aug 26th’s .61 to our present 1.41 is a double plus.
I sure hope the quarterly is good enough to at least maintain the PP and we move on with some institutional buyers from here.
XXII’s number 1 is on hiatus.
hatexxii
Suspended Until 11/04/2015 03:12:36 PM
Gee, what brought that on.... Winking smile