Thursday, December 17, 2009

2010 Stock of the Year - NanoViricides

NNVC


At the December 11, 2009 Equities Magazine Conference, Dr. Eugene Seymour, CEO of NanoViricides, eloquently set out the story underlying my passion for this Company and it's stock's price appreciation potential.  A poster on the iHub board has painstakingly put together some of the highlights from Dr. Seymour's presentation.  There is no better person, no better way, to make the case for NNVC then in hearing and understanding the story that follows.


I highly recommend that after reading this summary that all click on the iHub link which will take you to the original and complete audio recording of Dr. Seymour's talk.


This is my most important (and valuable) blog of the past three years.

A

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CEO Seymour's 12/11/2009 presentation in .mp3 format, annotated

I took the liberty of accessing the audio file of Dr. Seymour's December 11th, 2009 presentation to the Equities Magazine Conference that "leifsmith" so handily acquired and posted, and converting it from ".m4u" format to the more universally readable ".mp3" format. I also went through the presentation and pulled out and referenced what I consider to be some of it's most significant points.

The presentation runs 38:17, and has been uploaded to some server space that I rent:

http://www.MyDocsOnline.com/pub/DaysOnTheBeach/20091212-NanoViricides.mp3

While most of the material covered in the presentation is already known to those of us who closely follow the company, there are a few points that I don't think have been previously publicly disclosed (at least I'd never heard them before):

* The CDC has had initial success in it's testing of Rabicide, and additional tests are currently underway.

* The company intends to apply for uplisting off of the Bulletin Board exchange in the near future.

* The company is beginning a Hepititus C study soon.

* The prototype production facility has been physically built, and will begin production shortly. Guessing this is at TheraCour, with the money having been generated from the TheraCour limited share sales over the past year.

* Animal studies are already underway which hope to show whether NanoViricides has a "full cure" for HIV, not just a "functional cure" as has previously been reported.

* The "hint" that NanoViricides might believe they stand a good chance of getting a government grant relative to development of drugs for tropical viral diseases of Ebola, Marburg, and Dengue.

This is all pretty exciting stuff! Thanks to "leifsmith" for doing the work of obtaining the presentation audio!

Best to all.

Time-Referenced Annotation of Significant Points:

5:50 [Rabies and Ebola] "We've had very good success with a drug against Rabies, both in Vietnam and at the Centers for Disease Control [CDC], and we're currently working on the Ebola virus at the U.S. Army Medical Research Institute for Infectious Diseases [USAMRIID]"

6:58 [Description of how NanoViricides drugs might function to destroy viruses]

8:15 [Enumeration of past and ongoing animal pre-clinical studies] "... Swine Flu, Seasonal Flu, HIV, starting on Hepatitis, starting on Dengue, Ebola, Epidemic Keratoconjunctivitis [EKC] which is the Adenovirus, Herpes of the eye, and Rabies."

8:35 [Recap of results of recent in vivo influenza virus studies -- NanoViricides drug treated group superior to Tamiflu treated group and to controls]

9:43 [Recap of EKC in vivo studies showing significant therapeutic action in NanoViricides drug treated animals relative to controls]

10:38 [Reference to above EKC study] "We were able to eradicate evidence of [EKC] infection very quickly."

10:50 [Regarding HIV] "We're starting a big [HIV] study next month [i.e. January 2010]."

10:55 [Recap of HIV in vivo studies showing superiority for NanoViricides drug treated animals relative to "Triple Combo Cocktail" standard treatment group and to AZT control group].

11:50 [Regarding outcome of above HIV study] "We did extremely well."

12:00 [NanoViricides drug pipeline in development and in testing: Influenza-A, External viral diseases of the eye including Herpes and Adenovirus, HIV AIDS, Dengue, Rabies, Ebola, Marburg, and ability to rapidly create new drug in the field in response to novel infection or viral bioterrorist attack].

20:05 "Our plan is now to apply to a national exchange [i.e. uplist off of Bulletin Board]."

20:15 [Potential markets for Nanoviricides drugs] HIV $21B opportunity over next few years, and possibly much higher. Influenza [no figure given], viral eye drops $1B to $5B, Hepatitis C -- there are 175 million people infected with Hepatitis C. Mention of Dengue, Ebola and Marburg with no figures given.

21:45 [Plans for 2010] "We are applying to a national exchange, whether it will be NASDAQ or AMEX I'm not sure at this time." "We're working on an agreement for initiation of research coverage, we have no research coverage currently." "A new [web site] will be coming next month [i.e. January 2010]". "We've applied for a number of federal grants and I can't really talk about what the status of those grants are but you can see that the government is very interested in what we're doing and are doing a number of studies with our material in their [the government's] own laboratories."

22:40 [More Plans for 2010] "We're going to announce the results of various animal studies, a repeat of HIV, Ebola from the Army, and Marburg . . . and then Herpes Simplex infections of the skin and genitals, we have a study starting on cold sores, Dengue will be starting next month [i.e. January 2010], Rabies is underway [presumably at the CDC], Hepititus C starts at the beginning of the year [2010], Adenovirus / Herpes virus of the eye." "We have a lot of things in progress, and we've done this on a minimal amount of money. I think we've spent ten million dollars over four and a half years, and have nine drugs in various stages of [pre-clinical] animal trials."

23:30 [Toxicology Studies in Animals and Humans] "The important thing is [to] complete the first set of animal toxicity studies. We've already done 2000 animals [and] we've had no evidence of toxicity. We anticipate none in humans because the nanomicelle is made of a polymer that's been used in humans for years and it's non-toxic and biodegradable. We [our drugs] do not go into cells, we are not metabolized by the liver, because once we break down the virus this is just excreted by the kidneys. And then we have to set up our first meeting with the FDA."

24:05 [New Laboratory / Production Facility] "We have completed the physical space of a new 6,000 sq. ft. plant, and we're going to start our prototype manufacturing at the beginning of the year [presumably this is a TheraCour facility that was financed by recent TheraCour limited share sales as reported in numerous SEC Form 4 filings over the past year]."

25:30 [Audience Question -- Competitors and Human FDA Trial Length]
Q: "How large are our competitors?"
A: "We don't know anybody who's doing the same work we're doing in viruses using nanomedicine materials. There's a tremendous amount of work going on with cancer and nanomedicine . . . the problem with developing drugs for cancer is the clinical [FDA] trials run 5, 7, 8, 10 years, [while] a clinical trial for influenza could run a week, two weeks, you come to New York or the east coast during a flu epidemic and you can pick up all the cases you need, you treat half you don't treat [the other] half and you see who does what."

26:55 [HIV "Functional Cure"] "We have reported [previously] that we've achieved a 'functional cure' [for HIV] in the animal model, which is used as the model for all HIV drugs -- 'functional cure' means we've eradicated any evidence of the [HIV] virus in the circulation, essentially the people are now no longer contagious. The next step to go to a 'full cure' is to be able to eradicate the virus that's hidden inside what's know as the CD4 Lymphocytes, hidden within the lymph nodes, and that is now being tested during one of our studies."

27:30 [Regarding competition from other drug developers] "I'm not really concerned about competition, the [combined] market [for all of our target viral diseases] is well over $40B dollars."

27:40 [Audience Question -- Human FDA Trial Length]
Q: "You haven't done any human studies yet . . . you have to go through Phase I, II, and III, and that takes about ten years before anything's out on the market"
A: "It would take ten years if it were a cancer drug, but we can do the studies that we need to do for influenza in an extraordinarily short time because it's an acutely limited disease because it's an active infection. So, what you can do is combine the [FDA] Phase I [and] Phase II studies. . . . and then you go into an expanded Phase III trial. The estimates given to me by people in the industry is that we're looking at [potentially] no more than three years [to complete the full FDA approval process] but this is totally up to the FDA."

29:50 [Audience Question -- Timing of First IND]
Q: "What do you think will be the timing of your first successful IND and when do you think you would commercialize your first compound?"
A: "The idea is for our first meetings with the FDA to be next year [2010]. We're starting on the toxicity studies; I'm getting quotes right now. So, it depends on how fast they [the tox studies] go."

30:25 [Manufacturing Process] "I also have an agreement with a private pharma company who would be our manufacturing partners since we don't intend to manufacture . . . the way this is done it looks like a brewery . . . we estimate that four vats [12' tall by 8' in diameter] will make 150 million doses of whatever [NanoViricides drug] per year. . . if you want to make 3 billion doses you have 20 times as many clusters of vats. This is not a complex chemical type of manufacturing process. It's really adding various polymers into the mix and the nanomicelle self-assembles.

34:00 [Audience Question -- Funding]
Q: "Hopefully next year you are going to be beginning the process of moving into [FDA] clinical trials. That's very exciting it's also very expensive. What is your financial strategy moving forward?"
A: "Number one, partnering with a large phama. Our goal is to license each one of these drugs to a different pharma company in a partnership arrangement. Number two, the government is very interested in, for example with Ebola and Marburg, to take these through the FDA and get these approved because they're very concerned about this being a potential weaponized virus. I can't talk yet because I'm not really allowed to talk about it but let's just say that I have no interest in taking Ebola through the system personally and unless someone else pays for it, and we wouldn't do it, and you know who that 'someone else' is -- it's not a pharma company."

36:30 [Clarification on Drug Development and Pre-Clinical Trial Process] "We build the drugs, we design them using the computer, and we give you at the Army of you at Feinstein [Institute for Medical Research], you take the drug, we work on the protocol with you, you do the study and you report it to us, and then if modifications have to be made we modify it and give it back to you."

36:50 [Audience Question -- Financial Situation, Burn Rate, and Financing]
Q: "How much cash do you have on hand and what is your burn rate?"
A: "I think we had [in recent SEC filings] $4.2M dollars [cash], something like 18 months of cash. We burn about $200k to $250k a month. Obviously we're going to need more money. I'm looking for non-dilutive ways to get that money. The way to do it is through government grants or through partnerships with pharma companies. The problem with partnerships with the pharma companies is they want to take 85% of the sales revenue, on the other hand, if you have something that has value in the billions of dollars, then 15% of that number is not bad. For Gilead [pharma company] for example, they do $6B dollars in revenue from their AIDS drugs. Now, what if a product comes along that changes the game, makes it possible to eradicate the [HIV] virus, and their [existing] business goes away, you can imagine they'd be very interested in an acquisition."
/end

24 comments:

Anonymous said...

Wow ...Thanks Allan...looks like NNVC might be The Stock of The Century....not just Stock of the Year!!!Amazing technology....Dave

Anonymous said...

Doesn't the stock price need to be above a certain amount in order to be listed on amex or nas??

Thanks
jeff

Anonymous said...

I feel torn.

I want the stock price to go up while simultaneously hoping it dips back down again so I can by more.

I guess this is the stock pickers paradox...

Steve K.

Anonymous said...

if this is the real deal...why is the ceo pumping is so hard

"Now, what if a product comes along that changes the game, makes it possible to eradicate the [HIV] virus, and their [existing] business goes away, you can imagine they'd be very interested in an acquisition"

ERADICATE HIV??? ERADICATE THE MOST DEADLY AND INFAMOUS OF ALL DISEASES?

why be acquired when you have the real deal, if you have the real deal? why not quietly do your thing and let you (ceo), your family, your family's friends and relatives all quietly accumulate all the shares?

Scott said...

I truly think that NNVC.OB has a great product/products, but I am concerned that their only insider is selling shares almost daily.

I am going to give them the benefit of the doubt and assume this is a method of cash generation so they can finance their daily operations. Is this correct? I'm coming to the group that seems to know a lot about this stock to help me justify an investment.

And to respond to someone's question from above, yes I believe you have to have a minimal individual stock value to list on one of the big boards.

Allan said...

Scott:

Your facts are wrong. There are numerous, "Insiders," and only TheraCour is selling shares and then only so as to fund a manufacturing facility so the Company can avoid dilutive offerings in order to build their own.

We have completed the physical space of a new 6,000 sq. ft. plant, and we're going to start our prototype manufacturing at the beginning of the year [presumably this is a TheraCour facility that was financed by recent TheraCour limited share sales as reported in numerous SEC Form 4 filings over the past year]."

Indyfx said...

Hi Scott,

If you go to the iHub it says that the insider selling share is being done to fund the new 6,000 sq ft test production facility. So the shareholders are not diluted with an influx of external capital. Which is very kind of the insider shareholders given that they are dilluting their stake. Message # 25826 states that 1,592,045 shares have been sold and 207,955 remain to be sold as of 9th December 2009. It is my understanding that this facility is nearly complete see message # 25898

Scott said...

That is what I figured. I was using Yahoo! Finance to give me insider information. http://finance.yahoo.com/q/ir?s=NNVC.OB
They only list one insider which didn't make sense to me because I would assume the board and/or CEO would be an insider, but that is what you get when you are dealing with stocks that aren't listed on a big board. Public information can sometimes be sketchy. I like the company, but I am being careful because I have been burned on OTCs and pennies before.

Allan said...

Scott,

Anyone who has been trading stocks for awhile has been burned before, regardless of market cap or price levels (read: Bear Stearns). But sometimes the reward size of the the risk:reward equation is so compelling as to demand participation. That is the NNVC story, for better or for worse.

A

Anonymous said...

Thats true, remains in my portfolio only NNVC which is still profitable while all the rest are trading now at less than quarter of their original invest. Even more, NNVC gave me a chance lately to load a big bunch at $0.46 that made me compensate most of my loss. Long and strong NNVC .....
Thx Allan for NNVC
Serge

Anonymous said...

Re NNVC: Looks like selling by Theracour may have ended....per Yahoo finance no sales since December 3 whereas Theracour had been automatically selling practically every day or so. Now that the Lab is built, maybe it's ready to produce and is in fact paid off.Looks like an exciting 2010 for NNVC!!!

Sean said...

Alan, I've been in a company called Peregrine Pharmaceuticals (PPHM) for 10 years. The science is amazing; the management sucks. You're a professional investor. What's your take on management. Do they have a stake in the company (meaning owning a significant number of shares -- PPHM's doesn't? Are they Wall Street savvy?

Many thanks!

Sean

Allan said...

Sean,

Can't comment on specifics, but note that for first few years of start-up, Dr. Seymour and Dr. Diwan (two chief executives of NNVC) were paid in stock only for their full time positions with the company.

Both should be added to this list in the near future:

http://nobelprize.org/nobel_prizes/medicine/laureates/

Anonymous said...

? weekly NNVC chart suggests a bit overbot in here (as per stochastics); prolly gonna add more @ $0.74 (or $0.68).

NNVC weekly

Jackson Browne - Sky Blue And Black

Silence Dogood said...

Hey Guys... check out XRA. Big money moving in. Its up on huge volume.

Anonymous said...

my charting analysis also shows a key support for NNVC holding would be the .70 area
as a fair place to buy more .

but

I also didnt expect to see the price drop below .50 like it did,even though it made an immediate recovery .

so its a toss up. Imagine having another chance to buy at .50


But seeing .80 holding these days....
.70 cents looks like a fair deal.

Anonymous said...

This company may have merit, but one would think such heady scientists could make a more convincing case on the website.
I went to the NNVC website and they state how well one of their products treats conjunctivitis (pink eye) in rabbits by showing 'before and after' photos of an eye. The thing is, the coloring in both photos of the eye looks the same. They differ in that the whiteness of the 'before treatment' eye is interestingly hidden by a tuft of rabbit hair and not holding the eye open very wide, while the white in the 'after treatment' eye is displayed prominently.
This wouldn't have been done on purpose, would it?

Anonymous said...

nnvc is a scam

watch and learn

Anonymous said...

wascawy wabbit.....duh must be a scam

Allan said...

In 1928, Alexander Fleming discovered penicillin while working at a London hospital. Twelve years later, scientists at Oxford University made penicillin into a readily available medicine.

http://www.npr.org/templates/story/story.php?storyId=3616227

Twelve frickin' years. NNVC is trying to get this done and into the medical treatment world in less then five years.

Patience, grasshoppers.

Tom D said...

Dengue fever, also known as "bonebreak fever" because of the dreadful aching it causes, is high on CDC's watch list. Dengue has been endemic and intermittently epidemic in Cuba for well over a decade. It is also spreading elsewhere in the Caribbean and in moist hot mosquito coasts in Central and South America. Mexico and the US have similar regions where Aedes aegypti mosquitos roam. Dengue is not a big killer but can spread widely in mosquito areas and cause a lot of misery and hospitalizations.

I was an epidemiologist at CDC a long time ago, but I don't know about their actual ability to fund research. However, if the dengue drug looked promising they would certainly be "interested parties" in the application for approval of legal clinical studies.

Contrasted with dengue fever, Marburg and Ebola virus infections are thankfully quite rare but extremely big killers with frightful potentials. The story has been around for a long time that it has been looked at by the usual suspects as a biological warfare vehicle. I can't intelligently comment on whether that story is true or just another "jungle disease myth". Ebola is a similar virus to Marburg but has a competely different coat antigen so that immunity to one of them does not impart cross-immunity to the other. Research potentials against these two viruses would **definitely** be supported by government grants if they looked at all promising.

The question is are any of these suggestions by NNVC really that promising? To be amenable to so many common and not-so-common diseases that they have mentioned, NNVC's approach would have to be extremely generic. Personally I'm dubious by nature about biotech cure stories. Most of the early hype about the first generation biotech stocks sounded a lot like what NNVC dispenses. But most of the biotechs never came up with the hyped promises of an immunologic "magic bullet" for curing cancers. Instead most of them became diagnostic kit makers.

I don't own NNVC, although I could defend to myself "buying a cheap ticket to see the show" just in case they are for real, which I would put low odds on. However, their strategy of looking for government grants could speed up test cases for legitimacy of their claims. If they are real they should get some grants fairly quickly.

Allan said...

Tom:

Thank's for your contribution to this subject, your words are always welcome here.

For those who aren't aware, Tom is one of only five bloggers I have direct linked to AllAllan:

http://twocents.blogs.com/weblog/

As for NNVC, your skepticism is understandable, but as I have said so many times, the reward here so far out-shadows the risk that NanoViricides remains a compelling investment, bet, lottery ticket, or however you might want to characterize it.

Check out my post on Glenn Neely today, your opinion of his view of a 20 year bear would be a nice remembrance to the Long Waves board, debates and days.

A

Anonymous said...

Allan:

Isn't NNVC your stock of the year EVERY year? And didn't everybody get destroyed on that thing this year?

In fact hasn't NNVC WASTED more people economically than the virii its products are supposed to kill (emphasis on "supposed")have actually killed.

I'm shorting 20,000 on the open on Monday. Give me your second and third 2010 picks- my short portfolio has a lot of shorting power these days.

Thanks for the tip buddy!


GB (name witheld, hard core Cramer follower)

Allan said...

Isn't NNVC your stock of the year EVERY year? And didn't everybody get destroyed on that thing this year?

Before you go mouthing off, why don't you check the year-to-year return on holding NNVC for the past 12 months before making a fool of yourself and while you are at it, check my archives where you will find that NNVC has NOT been my stock of the year every year.