Is there a discernible plan in all of this? We were just presented with a Form 10-Q and a press release discussing it that should have left us with an idea of what it might be. Instead.....
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First, to reiterate.
From the press release:
"The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates, as well as to advance at least one more drug candidate drug candidate towards initial human clinical trials."
"In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of "cold sores" (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of "genital lesions" caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV i.e the chickenpox virus)."
From the 10-Q:
"We anticipate that we have sufficient funding to take at least one of our drug candidates through initial Phase I and Phase II human clinical trials. At present, we believe that we may also have sufficient additional funding in hand to take at least one more drug candidate into an IND application stage."
"The Company is evaluating the possibility of performing Phase I and Phase II human clinical studies internationally. It is widely believed that Phase I studies can be performed in Australia more quickly than in the USA due to differences in regulatory procedures and guidelines."
"With our current funds we believe that we have sufficient funding available to perform Toxicology Package studies, and additional animal efficacy studies, to move at least one of our drug candidates into an Investigational New Drug Application (“IND”) with the US FDA or a similar application with an international regulatory agency, and to conduct Phase I and Phase IIa human clinical trials of at least one of our drug candidates."
"5. If and when we initiate human clinical trials for any one of the HerpeCide indications, we anticipate approximately $1 million in total costs for the Phase I clinical trials, and approximately $2 million for the Phase IIa (human efficacy study) clinical trials.
6. If and when we initiate human clinical trials for Injectable FluCide, we anticipate approximately $2 million in total costs for the Phase I clinical trials, and approximately $4 million for the Phase IIa (virus challenge human efficacy study) clinical trials.
We believe that we have sufficient funding available to accomplish the steps 1 through 6 listed above with our current available cash."
"In addition, in a subsequent year, if our anti-herpesvirus Phase I and Phase IIa are successful, we anticipate approximately $5 million for anti-herpesvirus Phase IIb (human efficacy study in a larger group of patients) human clinical trials. Further, in a subsequent year, if Phase I and Phase IIa of our Injectable FluCide drug candidate are successful, we anticipate approximately $7~8 million for Phase IIb human clinical trials."
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Let's start here:
"We anticipate that we have sufficient funding to take at least one of our drug candidates through initial Phase I and Phase II human clinical trials."
That seems simple enough, until they acknowledge that Phase II includes a Phase IIa and a Phase IIb....
"In addition, in a subsequent year, if our anti-herpesvirus Phase I and Phase IIa are successful, we anticipate approximately $5 million for anti-herpesvirus Phase IIb (human efficacy study in a larger group of patients) human clinical trials."
What can we conclude from the above? We can PROBABLY conclude that instead of "we have sufficient funding to take at least one of our drug candidates through initial Phase I and Phase II human clinical trials" they meant to say and should have said "we have sufficient funding to take at least one of our drug candidates through initial Phase I and Phase IIa human clinical trials.
Where will those tests take place?
"The Company is evaluating the possibility of performing Phase I and Phase II human clinical studies internationally. It is widely believed that Phase I studies can be performed in Australia more quickly than in the USA due to differences in regulatory procedures and guidelines."
This sentence first appeared in a 10-K in 2012:
"We are also engaged with Australian Biologics Pty, Ltd to help us with clinical trials and regulatory approvals in Australia. We believe that cGMP-like manufactured product is acceptable for entering human clinical trials in Australia."
That's four years worth of evaluating and the company is still at the "possibility" stage.
Which drugs?
From the previous 10-Q press release:
"The Company believes, based on various professional inputs it has obtained, that the different topical herpesvirus treatments would move towards the clinical stage faster than our Injectable FluCide™ for hospitalized patients. This is based on the limited studies needed for safety/toxicology, as well as for efficacy, for a topical drug against herpesviruses, as opposed to an injectable drug against the highly variable influenza viruses."
The latest:
"In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of "cold sores" (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of "genital lesions" caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV i.e the chickenpox virus)."
"The Company anticipates it will have sufficient access to capital even if it decides to develop ocular HerpeCide, dermal HerpeCide, or Injectable FluCide through Phase III on its own."
So when the company refers to "one of our drug candidates, as well as to advance at least one more drug candidate" it would seem to be referring to two of the five described above with the focus on the three in the last sentence. Can we assume that they won't be sidetracked by dengue (Orphan Drug Designation!!!), Zika ("if they would only give us the money") or maybe shingles (shingles is getting a lot of ink lately)? There's no chance that oral Flucide will be judged to have a quicker path to success than the injectible version, is there? History shows that NanoViricides has been in the "sidetracked business" for a long time, so I think that the answer is that we absolutely can't assume that they won't be sidetracked again. The point here, though, is that they haven't even been clear about what we can expect them to be sidetracked from.
In sum, all that was missing from the 10-Q and related press release that would have left us with the company's plan are three things...What, When and Where. I think I would have understood those things if they were clearly stated, even if I don't understand the How.
ps. I have consciously avoided discussing the details of the issue of "When"...just as the CEO did in the press release:
"We continue to make steady progress towards our goal of initiating human clinical trials of our first drug candidate in the near future," said Eugene Seymour, MD, MPH, CEO.......
Also note the use of the phrase "in a subsequent year" above without any reference to the specific year which the subsequent year is subsequent to. All the years starting with the one we are in are subsequent years.
Where's the guy who said that all the company's communications are clear? I'm sure he can make sense of all of this. By the way, I do understand that there has to be a certain measure of "we'll have to see how it goes" to this stuff....I think it's part of the scientific method....but I believe investors are entitled to some consistency and cohesion to corporate communications even when the science makes actual performance inherently unpredictable.
AI
