WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") has filed its quarterly report with the Securities and Exchange Commission on Wednesday, May 15th, in a timely fashion. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420413029691/v345261_10q.htm .
An amendment to the submission was filed on Monday May 20th, 2013, to correct certain numerical errors. The amended quarterly report can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420413030526/v345375_10qa.htm
The Company reported that it had approximately $16.999M in current assets (cash, cash equivalents, collateral advance, and prepaid expenses) as of March 31, 2013, the end of the reporting quarter. The shareholder equity stood at approximately $10.122M. In comparison, the Company had approximately $14.681M in current assets and approximately $15.612M in shareholder equity as of December 31, 2012, the previous reporting quarter. The Company spent approximately $1.359M in Research and Development expenses (R&D) and approximately $831,400 in General and Administrative expenses (G&A), including stock-based expenses, in the reported quarter. The Company’s rate of expenditure was in line with the Company’s budgeted targets. The Company reported that it had raised $6M from three family offices and a charitable foundation in February, as announced previously. No third parties were retained and no commissions were paid to complete this financing. Subsequently, the Company announced full retirement of its Series C convertible preferred stock held by Seaside 88, LP, with a cash payment of approximately $2.01M.
The Company estimates that it currently has sufficient cash in hand to support operations for at least two years from reported period at the current rate of cash expenditure. NanoViricides, Inc. also estimates that it has sufficient cash in hand to support initial human clinical trials of its first drug candidate, a broad-spectrum anti-influenza drug in its FluCide™ program. The Company ‘s recently issued Series B Convertible Debentures represents the Company’s only long term debt. Short term debt consists of accounts payable and accrued expenses of approximately $1 M, . The Company’s estimates are based on its current rate of expenditure and also on certain approximate estimates for clinical development of its drug candidate as gleaned from discussions with various contract research organizations.
The Company reports that all of its drug development programs are progressing satisfactorily.
In particular, the Company is advancing its oral broad-spectrum anti-influenza drug candidate, NV-INF-2, towards IND-enabling studies. This may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.
In addition, the Company continues to develop its injectable anti-influenza drug, NV-INF-1, towards IND-enabling studies. This drug candidate has much greater activity than the oral drug, and is intended for use in hospitalized patients with influenza or potentially influenza-like illness. The Company believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication. Both of these drugs in the anti-influenza FluCide™ program have demonstrated very high effectiveness in a lethal influenza animal model, routinely showing substantial superiority to oseltamivir (Tamiflu®), the current standard of care. The Company believes that these drugs will be useable against most if not all types of influenza viruses, including seasonal (such as H1N1, H3N2), epidemic (such as H1N1/2009 “swine flu”, H3N2/2012), novel strains such as H7N9 that is currently circulating in China, and bird flu (such as H5N1, various clades). In addition, both of these drugs have shown extremely good safety profile in all of the animal studies that have been performed to date. This strong safety profile has necessitated a substantial scale-up in the Company’s current synthesis capabilities prior to commissioning a formal GLP safety and toxicology (“Tox Package”) study. The Company is in the process of developing the necessary scale-up synthesis laboratory.
In addition, the Company is also working on acquiring cGMP manufacturing capability for these and other nanoviricides drug candidates.
The Company reported in April 2013 that the engineering design of its cGMP manufacturing plus laboratory facility is substantially complete and work has begun.
The Company previously held a pre-IND meeting with the US FDA for its anti-influenza drug candidate, NV-INF-1, in the FluCide program on March 29, 2012. The Company believes it has received valuable input from the US FDA, applicable to the development of its anti-influenza drug candidates.
With the current strong cash position, the Company believes that it has sufficient funds available to perform the necessary IND enabling studies for its anti-influenza drug programs, to file an Investigational New Drug Application (“IND”) with the US FDA, and to conduct initial human clinical trials of its first anti-influenza drug. The Company’s estimates are based on information it has obtained from reliable sources, confidential cost estimates from consultants and service providers, and other sources. There is no guarantee that this information is accurate. The Company will continue to refine its estimates as the development programs progress further.
Including the Flucide program, the Company currently has six commercially important drug candidates in its pipeline. These include the aforementioned drugs against all Influenzas, HIVCide™, HerpiCide™, DengiCide™, and a broad-spectrum nanoviricide eye drop formulation against viral infections of the eye. These programs are based on the Company’s platform technology that enables specifically targeting a particular type of virus with a novel mechanism of action. In addition, the Company continues its other research and development programs. These include (a) broad-spectrum nanoviricides against a number of Neglected Tropical Diseases, and (b) its novel ADIF™ (“Accurate Drug In Field”™) technologies which promise a way to attack novel viruses, whether man-made (bioterrorism) or natural (such as SARS), before they cause a pandemic.