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From yesterday's 10K
During the financial year ending June 30, 2015, we have continued to make significant progress in advancing our drug pipeline, improving our resources, as well as improving our corporate governance and executive capabilities. Significantly, in December 2014, NanoViricides completed purchase of the modern c-GMP-capable production and R&D facilities at 1 Controls Drive, Shelton, CT, from Inno-Haven, LLC, at cost (for details, see below). NanoViricides as well as our affiliates have added significant strength in our staffing, with the R&D staff more than doubling to over 20 persons this year. Our new campus in Shelton has enabled this substantial expansion of our capabilities. This expansion is necessary to accomplish the substantial amount of scientific investigations, process engineering, quality engineering, large scale production and document preparation that goes towards filing investigational new drug applications (IND’s) to the US Food and Drug Administration (“FDA”), and equivalent applications to regulatory agencies across the globe. This expansion has also enabled us to strengthen our novel platform technologies, and engage into further novel, application-oriented R&D work directed to the goal of eradication of viral diseases.
In addition to our anti-influenza drug for hospitalized, severely ill patients in the FluCide™ program, our herpeCide™ program has now advanced into a late pre-clinical stage, wherein optimization for various disease indications related to different herpesvirus infections is now being undertaken, such as eye drops and gel formulations for ocular herpes keratitis, skin creams for oral herpes “cold sores”, for genital herpes lesions, and for shingles (which is caused by the herpesvirus called Varicella-Zoster virus that also causes chickenpox in children).
It is believed that the development of the topical anti-herpes drug candidates may be significantly faster and easier than the development of the injectable FluCide that we are currently working on. Therefore, we have planned on continuing the development of the HerpeCide drug candidates as well as the FluCide drug candidate towards clinical trials in parallel. With the expanded R&D labs, Analytical Labs, the new Bio labs, the new Process Scale-Up production facility, and the new cGMP-capable manufacturing facility established at our new Shelton campus, we are in a much stronger position than ever to move our drug development programs into the clinic rapidly.
We now have two advanced pre-clinical drug candidates, namely, our injectable FluCide for severely ill patients, and our HerpeCide skin treatment for oral herpes cold sores. In addition, our HerpeCide program is poised to produce additional advanced candidates against ocular herpes and shingles. Our animal efficacy studies are performed by third parties. We opt into drug developments against specific disease indications for which we have appropriate partners that can perform the necessary cell culture and animal efficacy studies.
NanoViricides technology is now maturing rapidly toward the clinic, with the new facility, expanded staff, and the financial strength that we have attained since uplisting to NYSE-MKT.
We focused our drug development work plans primarily on our lead Influenza drug candidate, and our anti-Herpes-virus programs during the reporting financial year.
As part of the advanced IND–enabling development of our Injectable FluCide™ drug candidate, we performed initial safety-toxicology screening of an optimized FluCide® drug candidate in a GLPlike toxicology study in rats. We reported that a good safety profile was observed for this drug candidate in rats, around the end of January 2015. These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company’s positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.
These results are extremely important since they indicate that FluCide continuesto look very promising as one of the most advanced candidates in the Company’s drug development pipeline.
The next phase of the toxicology package studies for injectable FluCide will involve larger animals, and are estimated to require much larger quantities of the anti-influenza drug candidate. In order to accomplish this, we have continued to scale up our production processes for both the backbone polymer and the ligands at our new Shelton facility. We believe that we will be able to make as much as a few kilograms in a single batch in the new cGMP-capable facility. We have continued to work successfully towards large-scale production of this anti-Influenza drug candidate. The Scale-Up Laboratory in our new Shelton campus now has the necessary equipment for this scale up. During and after each step is completed at the large scale, we must maintain certain process controls, obtain relevant data, and thereafter characterize the resulting products by various methods. This is a tedious, laborious, and time-consuming process.
In addition, in August 2014, we restarted our anti-Ebola drug development program in response to the then raging Ebola epidemic in Africa. Our materials testing agreement with US Army Medical Research in Infectious Diseases (USAMRIID) unfortunately took substantial amount of time to restart. We executed a CRADA (Collaborative Research and Development Agreement for Material Transfer) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at the end of October, 2014. We were able to send a first panel of novel agents to USAMRIID at the end of January, 2015. We received initial test results in early March, 2015. The nanoviricides approach was found to be very promising in these cell culture studies. We mutually decided with
USAMRIID scientists that we should perform another round of improvement of the drug candidates. However, around this time, in early April 2015, the epidemic had begun to be brought under control by the international public health agencies with heroic efforts - despite the lack of treatments or vaccines - and the urgency of our Ebola program, which we engaged into because of the potential global epidemic threat, was no longer apparent. In addition, several drug candidates by other companies had been fortuitously advanced into various modified protocols of clinical trials by that time. With these changes in the global Ebola scenario, NanoViricides determined around May 2015 that we should re-focus our efforts on our commercially important priorities.
(These paragraphs in my opinion say that neither Nanoviricides nor any other candidates worked for Ebola)
We restarted the Ebola program based on our evaluation and belief that an optimized nanoviricide anti-Ebola drug candidate would have been the only viable option, had the epidemic continued to evolve into a global threat. Our belief is now supported by evidence. All of the anti-Ebola drug candidates that were advanced into clinical trials during the epidemic have been either rescinded by the sponsors or have not met statistically significant effectiveness end-points. These candidates include the siRNA therapeutics by Tekmira, antibody cocktail therapeutics by zMAPP, brincidofovir by Chimerix, and favipravir (T-705) by Takeda. In addition, Sarepta and BioCryst did not advance their anti-Ebola drug candidates into efficacy clinical trials.
This year, we also continued our work in our HerpeCide program, encouraged by results in animal studies. We are happy to report that our HerpeCide™ program is now maturing towards selection of final development candidates against several different indications.
In April 2015, we reported dramatic improvement in clinical symptoms associated with a herpes simplex virus dermal infection in recently completed studies in mice. The topical nanoviricide treatment significantly reduced the clinical disease, and led to >85% survival of the mice dermally infected with a highly aggressive, neurotropic, HSV-1 H129c strain, wherein all of the untreated mice had severe clinical morbidity and none of the untreated mice survived. Recently in August, we reported that these results were reproduced at a different laboratory, with 100% survival being observed.
The potential broad-spectrum nature of our anti-HSV drug candidates is expected to enable several antiviral indications. Thus, HSV-1 primarily affects skin and mucous membranes causing “cold sores”. HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases. In addition, human herpesvirus-3 (HHV-3) aka varicella-zoster virus (VZV) causes chickenpox in children and when reactivated in adults, causes shingles. Shingles breakouts are amenable to topical treatment, as are the HSV cold sores, genital lesions, and herpes keratitis of the eye. Most of these indications do not have satisfactory treatments at present, if any. Further, the treatment of herpesvirus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need.
Topical treatment of herpesvirus infection is important because herpesviruses become latent in neuronal cells or in ganglia, and cause periodic localized breakouts that appear as skin rashes and lesions. Systemic drug treatment results in side effects because of the high systemic drug concentrations that need to be achieved and the large drug quantities that must be administered. Since the virus remains mostly localized in the area of the rash and connected nerve apparatus, using high concentrations of drugs delivered in small quantities topically would allow maximizing the effectiveness while minimizing the side effects.
The current market size for drugs for the treatment of herpes infections is about $2~4B. We believe that when an effective topical treatment is introduced, the market size is likely to expand substantially.
The Nanoviricides® technology continues to receive substantial attention and recognition in the scientific world. The NanoViricides Executive Team is also receiving recognition for the Company’s achievements.
Our “Injectable FluCide™” drug candidate for severe influenza was chosen as one of the “Top Ten Infectious Diseases Projects to Watch” by a panel of industry experts assembled by Informa and the publishers of In Vivo, Startup and The Pink Sheet. As a result of this selection, Anil R. Diwan, PhD, President and Chairman of the Company, gave a company presentation at the Therapeutic Area Partnerships Meeting on November 20, 2014.
In addition, NanoViricides was selected as one of the top 20 finalists in the “technologies of Tomorrow” segment of the “Buzz of BIO” spot for the BIO2015 conference in Philadelphia, PA. While NanoViricides did not win the top spot in the final voting, the selection itself speaks to recognition of the Company in the prestigious pharmaceutical industry community.
NanoViricides continues to make strides in improving our corporate governance. To this end, we have engaged EisnerAmper LLP as our new public auditors, switching from the smaller firm of Li & Company. EisnerAmper LLP found that in the previous year, we had not accounted for the derivative effect of certain warrants and debentures issued last year according to the required rules. While this does not affect our core financial position, we have corrected this defect and this has resulted in amended and restated filings of previous annual report and two quarterly reports. In addition, we have recently added a new Accounting Manager to our finance department to strengthen the processes and to provide additional oversight.
I must admit my experience of scale ups is in Chemical processes only and I have not worked with equipment that deals with different chemical formulations. Do you have any experience in that arena? If so, will you please tell us what you think.
Seymour did not mention several viricides . I was merely quoting my understanding from last PR which says
In addition, the Company is also continuing to scale up the production level of its different drug candidates to 1kg/batch, in order to enable production of the large amount of injectable FluCide needed for the Tox Package studies.
I asked Dr. Seymour this question in an e-mail. His answer is
(1) 200 g scale up was done in the new facility.
(2) For him it is much simpler to spend the time to scale up to the 1 kg scale than try to make 12 batches of 200 g to complete 2.5 kg needed for Flucide TOX
This gives me a lot of confidence. All scale ups need time. NNVC is probably working diligently on the scale up and is now confident that they will be able to scale up to 1 kg level. 1 kg of nano material is a lot of drug. Also note now they have added several other nanoviricides in the scale up process to 1 kg scale. That is important because if you do not work on several formulations at once it is very difficult to understand the scale up process properly.
Seeker
Anybody understand these manufacturing issues? They say they have already scaled up to 200 g scale. If that is the case why can't they just make 12 batches and be done with the drug needed for Flucide TOX test. Looks like that is not possible. Which means that there is very high batch to batch variation in drug quality. We need to understand this better. Has somebody asked management?
The gang here must think Milton Boniuk MD is a complete fool for investing 7 million last year and now an additional $5 Million in NNVC. Wow , what an endorsement for the company startegy!
nanopatent - "The MAIN reason I bought NNVC in the first place back ~ 2005 was John Rossi's presence"
Could you please elaborate on John Rossi?
Therapeutic index question answered by Dr. Seymour
I could not resist asking the following question to Dr. Seymour. So my question and his answer are given below.
Dr. Seymour,
I read your letter about why we need so much drug for the TOX tests. It is unbelievable that FDA does not impose a limit on the amount of drug that needs to be dosed for TOX. For example, they could limit the max TOX test dosage to say 10 times of expected therapeutic dose. Looks like they do not have such limits since most drugs do have at least some side effects. Have you tried to request FDA to make an exception in case of Nanoviricides since this drug seems to have no known side effect and thus lethal dose may be very difficult to determine. If a personal meeting is hard to obtain may be they will answer your written request.
Thanks for the hard work by your team.
Best regards
..............................................................
Dr. Seymour's answer
It is rather bizarre, isn’t it?
We’re exploring other approaches with the assistance of our FDA consultants
In the meantime, the Aussies could care less, so by going there first, we can approach the FDA with solid human data that just may make a difference
This is the problem with any brand new technology
It’s all new ground and the FDA is a very risk-averse organization
The Thalidomide experience of 53 years ago still drives their thinking
Sincerely,
EUGENE SEYMOUR, MD, MPH
Hari, Could you give us a link for this study. I do not remember seeing anything about rabies.
There is not much that SEC or other agencies can do about such articles. We live in a free country and everybody can say what they want unless they say things which are against the law. Most of the stuff said in this article has been looked over by lawyers since it is already a part of an existing compalint to a court. So what can SEC, NYSE etc. do?
It is just shameful that shorts can use this strategy and steal maoney off those who do not do due diligence. This practise is quite popular in biotechs where stock price is not based on actual profits, but based on expectations of a future profit. What the shorts do is that when they see a stock has gone up quite a bit recently (NNVC has gone up several folds from its low in last one year) they just short the stock and then file a frivolous complaint somewhere. The complaint may be made to SEC or to a court to make it look legitimate. The complaint does not have to be real it just should seem plausible. Then they write an article in SA nd the stock goes down, they buy the stock back and have made their money. Now the investors can do what they want, the stock price is destroyed for the near term.
Usually when a major company press release is imminent it is likely to cause sharp stock price swings. So when such a press release is issued during market trading hours, the stock price is halted to avoid those who see the release first from benefitting.
Has to be due to those who have seen the company press release.
Halt must be because company is in the process of issuing a rebuttal. Seymour is good at rebuttals.
Few answers from Dr. Seymour
I e-mailed Dr. Seymour a few questions. His answers:
(1) They expect to do TOX tests in rats and dogs in addition to mice.
(2) They are still targeting for phase 1/2a start by end of 2014. However, many things can delay that date. From his answer it seemed to me that they are trying hard, but what can they say about factors like weather, FDA response etc.? This is very good news for me.
(3) They will try for breakthrough technology designation with FDA.
(4) Even while the initial trials may be in another country, they will continue pursuing FDA. They want drugs available for 2015 US Flu season. Must be two years from now because in one year they will just be starting phase 1.
Seeker
ZincFinger, Thanks. I have two more questions
(1) It seems from your answer that when the drug toxicity is very low, FDA may not require TOX studies in multiple animals. Is this correct?
(2) Once FDA approves clinical trials, will the compnay have to get further FDA approvals after each phase is complete? Or is it that if each phase achieves its objective, the next phase can be started without delay? As far as I know at least FDA consultation after each phase is required. If FDA approval is required after each phase it will add long time between the trials since FDA takes a huge amount of time to decide. NNVC trials themeselves may be short, but collecting all the data, properly analyzing it and FDA consultation will add much longer time than the trials themselves.
Zincfinger,
Will you please check that I have understood this correctly.
TOX studies involve
(a) Single dose acute toxicity studies - These studies need to be done for four weeks in at least three animal species, one being a non-rodent. NNVC has done this study in mice only, two other animals still need to be tested. What is your opinion about issues arising in other animals.
(b)High dose tox studies - This is already complete in mice. Does NNVC have to study this in other animals?
Then in phase 1 toxicity on humans will be checked. You think that the chances of toxicity in humans is low given the evidence so far.
The drug has shown very high efficacy in mice. You think that the chances of efficacy in humans is very high given the evidence so far.
Am I missing something?
Seeker
So maybe that is an answer. Maybe when the stock became avaialable on AMEX, it came in the sights of the shorts. Earlier it was very hard to short it on the BB. The short percentage being low may have attracted shorts to it. So whenever shorts find some shares to borrow, they go ahead and short them.
What would you consider to be a normal short interest?
NNVC shares now in demand for borrowing by shorts. I have an account with Fidelity from which Fidelity can lend my shares for shorting by shorts. I had never earlier seen my NNVC shares borrowed, but now my account shows borrowing. Mostly these shares are borrowed by Fidelity from me and then lent to shorts who short these shares. So looks like shorts are getting active on NNVC.
Thanks
five,
How do you generate this Elliot wave chart?
Ok. That is what you meant about $5.72
What is so significant about $5.72? I saw your earlier note, so now I understand
Looks like big traders have left. The volume seems to have cooled down. I could be wrong.
Lazed, Thanks for the example. Seeker
Nanotoday,
Excellent analysis. Thanks.
Seeker
When we are a S&P 500 stock I guess we can do reverse splits.
A reverse split has led to disastorous short term stock price results for penny stocks. Those who disagree please show us one small stock (less than $1 billion market cap) which benefitted from a reverse split. I do not think this is a logical decision on the part of investors, it is just a knee jerk reaction. Logically reverse splits should not effect stock prices. In reality lots of people sell on reverse split as knee jerk reaction. One example is in front of us today. We are down from above $5 to $3.75 or so today.
Seeker
Bumbling executives.
Just when the stock was in a sustained uptrend, they had to mess it up. If they had just let the stock run it would have cleared $2 and become eligible for listing on AMEX. They did two things at once:
(1) A secondary - This is reasonable since raising money is crucial whenever the stock price is good.
(2) A reverse split of 1:3.5. What? Just because they are scientist does not mean all Wall Street guys are. Do a reverse split of 1:5 or 1:10 which is easy to calculate. I would not have done any reverse split since the stock was already on the way to $2 and AMEX allows listing as long as price is above $2 for a sustained time period. Secondly, a reverse split has always been bad for stock prices on Wall Street. Don't they know that?
We have a management which is smart scientifically and clueless in Wall Street matters.
Seeker
A special meeting can be called anytime. I think we are in for a proxy fight.
Seeker
That is the spirit. Let us throw them out.
To me it seems like they have a big ego. Who is Platinum to give us a deadline? We will not respond, we have better things to do, such as manage ECTE. Etc. .....
What they need is a lawsuit.
Looks like it. What are they doing that is more important?
I called Trout, but nobody picked up the phone. Platinum has given a very short deadline (we had Labor day weekend in the middle). Management must be working hard to form a response. Given that Platinum made the offer publicly, management must also respond publicly.
In any case Platinum's deadline is 5 PM today. So the management will probably respond after the market closes. Trout is not picking up the phone probably because they cannot tell the investors anything new until the press release is made after close. In this case, management can (1) Reject Platinum's proposal (2) Accept the proposal or (3) Make a counter offer or (4) Most likely ask Platinum for more details.
In my opinion Platinum proposal looks very fair on the surface since it leaves details to be worked out afterwards. An intelligent board will ask Platinum to provide further details with the intention of accepting a fair proposal.
Seeker
No management response yet. EOM.
I expect an announcement by ECTE board tomorrow morning. Platinum has given a deadline of Wednesday evening to accept their offer. ECTE board cannot fail to respond, so I expect that they will have a press release tomorrow morning.
Seeker
Montaur-Platinum is the name of the hedge fund.
BooDog,
Thanks for taking the criticism in a professional manner
Seeker
You have a point in that the company has to have a plan. We have not yet seen any credible plan, except from the incompetent Mooney who destroyed the company.
However, you are wrong in that Platinum plan does not call for giving away half the company. If the company is taken as it is, it is worth zero since it has no income. What we would be giving away is a portion of the future profit. Mooney has done that numerous times, every time financing was raised through share sales. So the Platinum plan does not call for anything that is not in the plan.
Do you seriously think that the company can commercialize Symphony with current level of cash? More money needs to be raised no matter what. It can be raised through equity sales whether it is through Platinum plan or Mooney plan does not matter. Mooney plan has resulted is decimation of shareholder value.
In my opinion the best option to raise cash would have been sale of Symphony rights to some part of the world. The Platinum plan is more or less that - for selling rights in China. Better to sell rights in part of potential territory than to raise cash at such depressed levels. The worst would be to liquidate the company which is what has been happening for last one year.
In the absence of a better plan I fully support Platinum plan. Let us not talk in the air, if somebody has a better plan let us hear it. What is our highly paid leadership doing?
Seeker
Public release of the proposal by Montaur Platinum clearly indicates that Platinum has earlier proposed the same items to the board and the board had rejected it. Now that Mooney has been sacked, the board may be more amenable to the proposal. However, I do not think that is the case. If the board was agreeable to this proposal the discussions would have been completed by now and there would have been no need for Platinum to announce the proposal publicly. So I suspect that the board needs further persuation to accept this proposal. Public release of the proposal is a way to put extreme pressure on the board because if the board rejects it now and later the stock price plummets, the board will be fully responsible personally. All board members will face personal suits against them.
On the surface the proposal looks very good. I personally would approve the proposal based on my limited knowledge. Of course, we do not know all the details which must be worked out before acceptance of the proposal by the board. I am not at all sure that the proposal will be acceptable to this board. After all, this is the same board that presided on the destruction of the shareholder value.
Seeker
Starbuxsux - "We should be spiking...why arent we spiking"
My explanation is that ECTE needs to show a clear path to commercialization. Mooney, a definite roadblock, has now been removed. But just changing the CEO and not changing the policy will not lead to commercialization. This is the same board which had looked on passively while Mooney decimated shareholder equity. What needs to be shown is that the board has acted with determination to complete commercialization. If a new partner or financing is arranged quickly that will lead to rapid price appreciation. The easiest path in my opinion is to get Platinum back on board and define a financing mechanism. Platinum's objections mainly related to Mooney so it will now be easier to negotiate. I just hope that the board has a clear path in mind and has not just acted out in anger at Mooney.
Seeker
Mooney fired - finally the board takes action.