NanoViricides Inc. (NNVC)

[leifsmith]

April 2014 NR: Enough cides for tox

The News Release of 16 April 2014 has been used to attempt to establish the untrustworthiness of the management of NNVC. I disagree with that assessment. Here's why:

A link to the release at the basis of the problem:

http://www.businesswire.com/news/home/20140416005705/en/NanoViricides-Won-IAIR-AWARD-North-American-Company#.VbhIJHj-3vg

A few days ago I sent the following to Dr. Seymour:

I’m interested in what happened to cause this statement of April 16, 2014 to fail to represent the current state of affairs. (My emphasis in red)

"The Company also reported that it is producing Injectable FluCide™, our most advanced drug candidate, at its existing facilities, in the large quantity needed for the Safety and Toxicology ("Tox Package") study. The strong safety observed in preliminary safety studies resulted in requirement of a very large quantity for the Tox Package study. Notably, the drug candidate was found to be safe even at the maximum feasible dosage level in a small animal study. The Company reports that it has successfully scaled up the production of injectable FluCide at its current facility.” -NNVC release of April 16, 2014

We were told that the quantity needed for the tox package was available, but today we must face the fact that it was not. It seems to me that the discrepancy between the expectation created and the current reality has been harmful to the company’s reputation and stock price.

I’m curious about how this came about, because I’m confident there was no intention to be deceptive. What happened?

Dr. Seymour responded today (quoted with permission):

This was before we found out that we needed 2.5kilograms of material. This only became apparent after the two initial animal studies were done by BASi. This amount was way beyond what we ever dreamed that we would need

We had successfully scaled up from 100g/batch to 200g/batch that was all we thought we would need

The preliminary safety studies were done early in the year by us in anticipation of the start of the tox studies later in the year when we had enough material

This PR went out in April 2014 and the material wasn’t sent to BASi until September 2014

Strong safety observed in preliminary safety studies resulted in requirement of a very large quantity (200grams or so we thought at the time) for the Tox Package study.

The 200gram/batch is what was initially sent to BASi and after their preliminary work, it was determined that they would need 12X as much for the large animals

Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
[e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

Later, Dr. Seymour commented that it was misleading to post things ignoring relevant dates and discovery sequence.