SHELTON, CONNECTICUT -- Tuesday, November 10, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") filed its quarterly report in a timely manner with the Securities and Exchange Commission on Monday, November 9th. The submission can be downloaded from the SEC website at (http://www.sec.gov/Archives/edgar/data/1379006/000114420415063679/v422773_10q.htm)
The Company estimates that it had approximately $29.7 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of September 30, 2015, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $1.65M, with an additional approximately $0.33M towards purchase of property and equipment. The Company reported a net loss of $0.02 per share for the quarter. Shareholder equity stood at approximately $30.71M for the quarter. The Company does not anticipate any major capital expenditures in the near future.
The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates, as well as to advance at least one more drug candidate drug candidate towards initial human clinical trials.
The Company reports that its HerpeCide™ program is advancing well. We anticipate developing topical drugs to control herpesvirus outbreaks for a number of indications under this program. These include oral lesions or "cold sores", usually caused by HSV-1, genital lesions, usually caused by HSV-2, and shingles outbreaks in adults, caused by reactivation of the chickenpox virus (varicella Zoster virus, or HHV-3). In addition, the Company is also developing eye drops for the treatment of herpes keratitis (HK) of the eye, and for epidemic adenoviral conjunctivitis (EKC). The Company believes, assuming the results from our animal studies are indicative of future human clinical success, that these various drug candidates under the HerpeCide program should result in extremely effective drugs.
The Company believes, based on various professional inputs it has obtained, that the different topical herpesvirus treatments would move towards the clinical stage faster than our Injectable FluCide™ for hospitalized patients. This is based on the limited studies needed for safety/toxicology, as well as for efficacy, for a topical drug against herpesviruses, as opposed to an injectable drug against the highly variable influenza viruses.
We continue to work on Injectable FluCide in parallel with the HerpeCide program drug candidates.
The Company has completed its transition to its new facilities at 1 Controls Drive, Shelton, CT. With this state of the art facility, NanoViricides, Inc. is now one of the very few small pharma drug developers that possess their own clinical quality drug manufacturing operations. NanoViricides now has the facilities to design, synthesize, scale-up, and manufacture any of our drug substances for IND submissions and for human clinical trials, and also has the capability to manufacture sufficient drug substance for initial market entry when the drug is licensed. The new facilities include a state of the art, highly customizable, c-GMP-capable drug production suite with clean rooms for the production of injectable drugs in multi-kilogram batches. (IND = "investigational New Drug", c-GMP = "current Good Manufacturing Practice"). All of the biological testing of our drug candidates continues to be performed by external collaborators.
The Company believes that the drug substance requirement for any of the topical herpecide drug candidates would be in the range of a few hundred grams. The Company has already scaled up certain production steps to 200g scale or better, and the remaining steps are being scaled up, while developing appropriate process controls and characterization methods alongside. Thus the Company believes it will soon have the ability to produce the HerpeCide drug candidates in quantities sufficient for the safety/toxicology studies, and will be able to make similar quantities of c-GMP-quality material later for human clinical trials when needed.
The Company continues further work to scale up the production to 500g, 1kg and larger batch quantities as feasible in the new facility. Injectable FluCide safety/toxicology studies have been estimated to require more than 2kg of material.
The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpes drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs.
The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.