NanoViricides progresses towards initial FDA submission

Anti-viral drug developer NanoViricides (OTCBB:NNVC) reported Monday it is in a "financially sound" position, with enough resources to advance its drug pipeline through its first Investigational New Drug (IND) submission.
West Haven, Connecticut-based NanoViricides said that based on unaudited financial reports, it had cash and assets of $11.7 million and about $0.6 million in liabilities as of the end of July.
The cash in hand includes a recent $2.5 million capital raise from an institutional investor, the company said. It also does not have long or short term debt, other than small working capital accounts payables.
The company develops nanoviricide drugs using nanomaterials for the treatment of a wide variety of viral diseases, designed to attack enveloped virus particles and to dismantle them.
Its nanoviricide class of drugs are being developed for H1N1 swine flu, H5N1 bird flu, seasonal Influenza, oral and genital Herpes, viral Hepatitis C, and Ebola virus, among others.
The company's FluCide drug candidate has previously tested positively in pre-clinical animal studies to combat against flu, and NanoViricides said it is on track with the development of the product.
Indeed, to facilitate the FDA review and approval process for FluCide, the company enlisted the services of Biologics Consulting Group last month for the development of its first pre-investigational new drug application.
Biologics will advise the company on its application, and provide  assistance in the design and implementation of additional pre-clinical development activities that are necessary for the IND application.
NanoViricides has also made certain leasing arrangements for standard approved manufacturing facilities in its efforts to produce certain quantities of its drug candidates under "current good manufacturing practices" (cGMP), as necessary for the application, at no extra capital costs.
The company currently has five drug candidates in the pipeline. These include FluCide, HIVCide, HerpCide, DengueCide and a wide-range of nanoviricide eye drop formulations against viral infections of the eye.
The drug maker's current cash expenditures are less than $4.5 million per year, excluding one-time expenses.  Since 2008, NanoViricides has adopted a number of control measures to keep expenditure costs down, including cutting down on expenses unrelated to its immediate goals, and employing stock-based compensation to vendors and service providers to conserve cash.