WEST HAVEN, CONNECTICUT -- August 17, 2011 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company"), reports that it has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) on Thursday, October 13, in a timely manner. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114036111049401/form10k.htm.)
The Company estimates that the cash in hand at year end is sufficient for an additional eighteen months or more of operational expenses. The Company also believes that it now has sufficient financing to advance its drug pipeline further into the Food and Drug Administration (FDA) approval process.
The Company had a cash, cash equivalents, and prepaid expenses balance of approximately $9.556 Million at the end of the year (June 30, 2011), as compared to approximately $7.456M one year ago. The Company spent $4.156M in R&D and $2.273M in General and Administrative (G&A) costs in the reporting period, compared to $3.367M and $1.735M, respectively, one year ago.
The Company reported that it is now focusing on advancing its drug candidates towards the regulatory process. The Company has declared a clinical candidate in its anti-influenza program, FluCide™, after the financial year (FY) end. The Company has also reported significant progress in achieving cGMP manufacturing capability for its drug candidates, subsequent to the FY end. The Company has also reported that it is working diligently towards filing a pre-IND application (pre-Investigational New Drug) to the FDA for FluCide.
Subsequent to year end, the Company raised an additional $2.5 Million through the sale of the Company’s Series B Convertible Preferred Stock to Seaside 88, LP, as previously reported. Seaside has funded the Company in the amount of $15,000,000 to date. The sales of these securities have been described previously. This investment has put the Company on a strong financial footing, enabling us to advance our drug candidates further into the FDA regulatory process.
The Company now has five commercially important drug development programs in its pipeline. FluCide™ is a single drug in development against all forms of influenza A including bird flu, high path influenzas, epidemic influenzas, seasonal influenzas, and potentially any novel influenza A strains. HIVCide™ is a drug in development against HIV/AIDS that shows the promise of becoming a “Functional Cure” against HIV/AIDS, based on available animal studies data in the standard humanized mouse model of HIV-1 infection in human T cells. This model is known to be predictive of successful anti-HIV drug development. The Company is also developing a single topical solution nanoviricide to attack most viral infections of the eye including Epidemic Kerato-Conjunctivitis (EKC) and Herpes Keratitis. The Company has successfully developed initial drug candidates against Oral “Cold Sores” and Genital Herpes. The Company has also developed initial drug candidates against Dengue Viruses.
The Company believes that it has a robust, strong, and wide drug pipeline that is advancing satisfactorily towards clinical trials.
“We have continued to obtain very strong results in our pre-clinical studies,” said Anil R. Diwan, PhD, President and Chairman of the Company, adding, “The financing we have accomplished is now enabling us to move these drugs towards FDA regulatory approval. The pre-IND application for Influenza will enable us to have a dialog with the FDA for furthering the drugs into an IND stage.”
“We have also taken steps to enable cGMP manufacturing of drug candidates with limited capital costs to the Company,”, said Eugene Seymour, MD, MPH, CEO of the Company, adding, “We believe we now have the financial ability to overcome the remaining hurdles in pushing our drug candidates into the FDA regulatory process”.