SHELTON, CONNECTICUT -- Wednesday, September 16, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that it has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) on Monday, September 14, 2015 in a timely manner. The report can be accessed at the SEC website (http://www.sec.gov/Archives/edgar/data/1379006/000114420415054864/v418491_10k.htm.)
NanoViricides, Inc. is a leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
Our anti-viral therapeutics, that we call "nanoviricides®" are designed to look to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
We recently completed acquisition at cost of a kg-scale c-GMP-capable manufacturing facility for injectable nanomedicines. This new facility in Shelton, CT also houses a production scale-up laboratory, a large chemistry synthesis lab, and more than 180 linear feet of advanced, state of the art analytical instrumentation lab for nanomedicines characterization.
We believe that our new facility makes NanoViricides unique in development stage pharma companies in that we now possess fully integrated drug development capability from design/discovery, synthesis, characterization, scaling up for clinical drug development, and c-GMP-capable manufacturing to support initial market entry, when licensed, for any of our nanoviricides drug candidates. All of our operations have moved to this new facility already.
The Company reported that, as of June 30, 2015, we have $31,467,748 in hand, and additional assets of $214,425 in the form of prepaid expenses. Property, plant and equipment now stand at $11,962,648 (net of accumulated depreciation of $1,534,203) with the acquisition of the 1 Controls Drive facility at cost from Inno-Haven, and with additional equipment purchases. Long term Liabilities were at $11,800,327 and the Shareholder Equity stood at $31,785,867 as of June 30, 2015. In comparison, as of June 30, 2014, we had cash in hand of approximately $36,700,000 and additional assets of approximately $1,300,000 in the form of prepaid expenses, other assets and security deposits. As of June 30, 2014, Long term Liabilities were at $19,972,953 and the Shareholder Equity stood at $23,369,303.
During the reporting period we spent $6,212,332 in cash toward operating activities and approximately $5,760,109 in capital investment. In contrast, we spent $6,333,625 in cash toward operating activities and approximately $5,231,094 in capital investment during the previous year. We do not anticipate any major capital costs going forward in the near future. Based on the current rate of expenditures (excluding capital costs), we believe that we have sufficient funds in hand to last more than two years. In addition, in order to conserve cash expenditures, we also pay compensation in stock and stock instruments to various parties.
Thus, the Company has ended the year on a strong financial footing. We have not engaged in any additional raises after the old warrant conversion that closed in September 2014. We believe that we will not need to raise additional capital in the near future. We project, based on various estimates that we have obtained, that our current available financing is sufficient for accomplishing the goal of filing one or possibly two IND or equivalent regulatory applications, and initial human clinical trials in at least one of our drug programs.
We currently have more than six commercially important drug programs in development, namely, Injectable FluCide™ for hospitalized patients with severe influenza, Oral FluCide for out-patients, HerpeCide™ topical treatment program, HIVCide™, DengueCide™, and eye drops for viral infections of the external eye, including ocular herpes keratitis and epidemic kerato-conjunctivitis (EKC). These programs address a market size in the range of $40 Billion to $70 Billion by various estimates.
Two of our drug programs, namely Injectable FluCide, and HerpeCide skin cream, are now in the late pre-clinical or IND-enabling studies stage. We anticipate that these drug candidates will move forward into IND or equivalent regulatory filings, and ensuing human clinical trials. As these drug candidates are advancing into the clinic, we believe that our additional drug candidates will also move forward into IND-enabling studies. The HerpeCide program is likely to expand into multiple indications that include skin cream or lotion for treatment of cold sores, skin cream for the treatment of genital herpes lesions, skin cream or lotion for the treatment of shingles breakouts, and ocular herpes keratitis, to name a few. We are thus poised for strong growth with a number of drug candidates in a number of disease indications.
"We have made substantial progress in this financial year, with our new state of the art, c-GMP manufacturing capable campus, and further progress in our HerpeCide program which is now at advanced pre-clinical stage, and additional strong safety data on injectable FluCide which is in IND-enabling studies," said Eugene Seymour, MD, MPH, adding, "The topical HerpeCide program is developing in parallel with our injectable FluCide. The HerpeCide program is likely to move faster towards clinical trials, because of the inherent advantages in the nature of topical drug development."About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.