WEST HAVEN, Conn.--(NNVC) (the "Company"), said that it is in a financially sound position and has the resources to advance its drug pipeline through its first IND submission.)--NanoViricides, Inc. (OTC BB:
The Company reported that it had more than $11.7M in cash and current assets and only approximately 0.6M in current liabilities as of July 31, 2011, based on unaudited internal financial reports. The cash in hand includes the recent raise of $2.5M from an institutional investor. The Company has neither any long term debt, nor any short term debt, other than small working capital accounts payables.
The Company believes that it has cash in hand sufficient for more than 24 months to support its current initiatives and operational expenses. The Company reports that it has continued to successfully control its rate of total cash expenditures at less than $4.5M per annum, excluding one-time expenses. The Company believes it has adequate resources, according to its internal projections, to accomplish the tasks needed for its first IND submission.
The Company’s frugal management style has enabled it to maintain an expenditure rate that is far less than the industry standard in the Company’s sector of drug development.
The Company has controlled its rate of expenditure by adopting a number of cost control measures since as early as 2008. These measures include not engaging into expenditures that were not directly related to our immediate goals. In order to conserve cash, whenever possible, the Company employs stock-based compensation to vendors and service providers.
The Company has recently reported that it is making arrangements to obtain cGMP (current Good Manufacturing Practice) production facilities without incurring additional capital expenditures.
The Company reports that all of its drug development programs are progressing satisfactorily. The Company has recently engaged Biologics Consulting Group, Inc. (BCG) to help with the development of its first pre-IND application to the FDA. The Company intends to later perfect this pre-IND application into an IND application.
The Company recently reported that post-infection treatment with three different optimized FluCide™ drug candidates resulted in almost complete survival of animals for the duration of the study, a greater than 95% reduction in lung inflammation and necrosis, and a greater than 1000-fold reduction of viral load in the lungs of animals infected with lethal dose of influenza virus. In the same study, in contrast, animals treated with oseltamivir (Tamiflu®, Roche) died within 8.3 days, showed only a 50% reduction in lung inflammation and necrosis, and demonstrated only a 2-fold reduction in lung viral load. The Company therefore believes that it has extremely effective drug candidates against influenza.
The Company thus believes that its FluCide program is on course for further development towards an IND submission to the FDA.
The Company also reported that its current HIVCide™ drug candidate was found to be equal to a three drug HAART cocktail of anti-HIV drugs in a standard humanized mouse model called SCID hu-Thy/Liv mouse model. This study was designed to identify an anti-HIV nanoviricide ligand potentially superior to the ligands previously employed, and to substantiate the results of the previous study. The Company has reported that it was successful on both counts.
The Company believes that its current HIVCide drug candidate is likely to provide a “Functional Cure” of HIV/AIDS, either alone or in combination with existing anti-HIV drugs, based on the finding that the HIVCide candidate alone was as effective as the three-drug cocktail in the mouse model. This mouse model is generally deemed to be predictive of human efficacy of anti-HIV drugs by renowned scientists. At present the Company does not have the necessary resources to engage into fully committed anti-HIV drug development. Therefore the Company has elected to continue further SAR (structure-activity-relationship) optimization studies on HIVCide. This re-prioritization helps the Company to conserve resources and optimize its drug development program.
The Company currently has five commercially important drug candidates in its pipeline. These include FluCide™, HIVCide™, HerpiCide™, DengueCide™, 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. 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.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.