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.
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:
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 , 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 . 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."