NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), reports that it has filed its financial year end annual report (Form 10K) with the Securities and Exchange Commission (SEC) yesterday in a timely manner. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114036110041099/form10k.htm).
“We now have the financial strength needed for the first step in advancing our drug candidates into the FDA regulatory process”
The Company reports that it is in the best financial condition it has ever been. The Company continues to control its operations and maintain a low rate of expenditures. 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 FDA approval process.
The Company had a cash and cash equivalents balance of approximately $7 Million at the end of the year (June 30, 2010). This was due to a successful raise of approximately $3.2 Million in private placements ended in September 2009, and another approximately $5 million raised from the sale of registered securities to Seaside 88 LP ("Seaside") in May, 2010. The Company filed its first "Universal Form S-3 Shelf Registration" with the Securities and Exchange Commission (SEC) for the sale from time to time of up to $40 million of its securities in March 2010. This registration became effective in April and remains effective. Subsequently, the Company has raised an additional approximately $5 Million through the sale of its registered stock in September, 2010 from Seaside. This sale of securities has been described previously. Midtown Partners served as the investment broker and a commission of 8% of raise in cash was paid to them as and when earned. There were no warrants issued to Seaside or other parties in this transaction.
The Company also reported a significant expansion of its drug pipeline. The Company added two new drug programs and validated drug candidates to its pipeline, for Herpes Simplex Viruses and Dengue Viruses. The Company now has five commercially important drug development programs. FluCide(™)-I 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(™)-I is a drug in development against HIV/AIDS that shows the promise of becoming a "Functional Cure" against HIV/AIDS, based on available data. 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. In addition, this year, the Company has successfully developed initial drug candidates against Oral "Cold Sores" and Genital Herpes. The Company also developed initial drug candidates against Dengue Viruses. These early drug candidates have already exhibited a substantial in vivo effectiveness of 50% survival of animals in an ADE-challenge model. ADE stands for antibody-dependent enhancement of dengue infection. This is a very serious effect which leads to severe dengue and fatalities in large numbers of patients that contract dengue virus of a different type after having had a dengue infection previously. There are currently no treatments or vaccines available for dengue or dengue hemorrhagic fever. We plan to improve these early anti-dengue and anti-HSV candidates further in the ensuing year and then advance into pre-IND application stage.
The Company believes that it has a robust, strong, and wide drug pipeline now.
"We have continued to obtain very strong results in our pre-clinical studies even as we engage new virus targets every year," said Anil R. Diwan, PhD, President and Chairman of the Company, adding, "This has demonstrated the strength of our technology, and enabled us to obtain further financing. We now plan to focus our work on advancing certain of our drug candidates into pre-IND applications. The pre-IND will enable us to have a dialog with the FDA for furthering the drugs into an IND stage."
"We now have the financial strength needed for the first step in advancing our drug candidates into the FDA regulatory process," said Eugene Seymour, MD, MPH, CEO of the Company.