NanoViricides Files Annual Report - Reports Having Sufficient Funds for Current Goals and For Advancing Its Robust Drug Pipeline
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTCBB: NNVC) (the "Company"), reports that it has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) in a timely manner on Monday, October 15. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114420412056152/v325626_10k.htm).
The Company estimates that the cash in hand at year end is sufficient for an additional up to eighteen months or more of operational expenses at the current rate. 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 and cash equivalents balance of approximately $14.275 Million at the end of the year (June 30, 2012), as compared to approximately $9.556M one year ago. The Company spent $4.234M in R&D and $1.855M in General and Administrative (G&A) costs in the reporting period, compared to $4.156M and $2.273M, respectively, one year ago.
This year, the Company has announced certain important issuances of patents on the TheraCour® technology underlying our nanoviricides® drugs. Most importantly, a fundamental patent on the polymeric micelles composition, structure and uses was issued in the USA with substantially broad claims. This validates the novelty of our approach as well as our leadership position in the nanomedicines based on polymeric micelle technologies. All of the patent applications have been filed internationally. To date 17 patent grants have occurred and additional grants continue as the applications progress through review.
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 fiscal year (FY) end, and held a pre-IND meeting with the US FDA about the same. The Company has successfully developed an oral version of its influenza drug FluCide subsequent to the FY. The Company now intends to advance the oral FluCide for out-patient influenza and also develop a concentrated solution suitable for "piggy-back" infusion with saline for hospitalized and immune-compromised patients with influenza-like illness (ILI). Subsequent to the end of the FY, the Company also reported that its oral anti-influenza drug candidate was successful against a different type of influenza, namely H3N2, than the one we had been using for development, namely H1N1, in the same lethal mouse model of influenza post-infection treatment. The Company also reported that this anti-influenza drug candidate was substantially superior to oseltamivir (Tamiflu) against both of these viruses. This is an important indication that the Company's FluCide drug is likely to have a very broad spectrum of activity against the many different influenza viruses.
The Company has retained Biologics Consulting Group to help with our US FDA regulatory filings. In addition, the Company has retained Australian Biologics Pty, Ltd, to help with the regulatory process for human trials in Australia.
The Company has also reported significant progress in achieving cGMP manufacturing capability for its drug candidates.
We have taken an important step towards improving our corporate governance this year. On June 22, 2012, we appointed Mr. Stanley Glick, CPA, as an independent Director of the Company and the Chairman of its Audit Committee.
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, and we are successfully advancing towards filing an IND application for our anti-influenza drug candidate," said Anil R. Diwan, PhD, President and Chairman of the Company, adding, "The financing we have accomplished is now enabling us to move our drugs towards FDA regulatory approval. We intend to seek a multi-national approach towards regulatory process in order to speed up the timeline to approval of our first drug."
NanoViricides, Inc.(www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral 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 pre-clinical 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.
Amanda Schuon, 310-550-7200
KEYWORDS: United States North America Connecticut
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