SHELTON, CONNECTICUT -- February 10, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") filed its quarterly report in a timely manner with the Securities and Exchange Commission on Tuesday, February 9th. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420416079966/v429785_10q.htm.
NanoViricides reported that it had approximately $28.3 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2015, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $1.22M. Shareholder equity stood at approximately $28.38M for the quarter (unaudited figures). 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's expenditures during the reported period were on track with this expectation.
NanoViricides, Inc. is one of a few bio-pharma companies that have all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. With the completion of and relocation to our new campus at 1 Controls Drive, Shelton, CT, we now possess state of the art nanomedicines characterization facilities that enable us to perform IND-enabling nanomedicine analysis and characterization studies of any of our various drug candidates in house. All of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO).
With the recent success of our anti-HSV drug development program, the Company has re-prioritized to focus on topical drug development against several indications related to infections by herpes family viruses. These topical drugs are expected to provide a significantly faster path to human clinical stage than injectable drugs.
In the HerpeCide™ program, the Company is currently developing drugs against four different topical indications, namely: (a) skin cream/lotion for the topical treatment of "cold sores" (typically caused by HSV-1); (b) eye drops/gel for the treatment of ocular herpes keratitis (mostly caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c) skin cream/lotion for the treatment of "genital lesions" caused by herpesvirus (typically HSV-2); and (d) skin cream/lotion for the treatment of shingles (caused by HHV-3 also known as VZV i.e the chickenpox virus).
The Company is in the process of establishing additional collaborations towards IND-enabling development of drug candidates for these indications. Of these, the Company has announced on February 1, 2016, that it has entered into an agreement with the University of Wisconsin for the evaluation of its nanoviricides® drug candidates in models of ocular herpes virus infections. The studies will be performed in the laboratory of Dr. Curtis Brandt, an expert in herpes simplex virus infections and in evaluating anti-viral agents. The Company has previously reported the successes of its nanoviricides drug candidates in pre-clinical studies of dermal herpes virus infections in mouse models. The goal of these studies will be to identify a drug development candidate as a treatment for ocular keratitis in humans caused by herpes simplex virus infections.
Ocular infections with HSV-1 have been reported to be the leading cause of infectious blindness in the developed world. Corneal transplants to replace the damaged cornea cost about $15,000-25,000. The Company believes that the market for an effective ocular herpes keratitis drug could explode to several hundred millions of dollars. The Company believes that it has sufficient production capacity at its current site to supply the US requirement of the drug for treatment of (ocular) herpes keratitis upon drug licensure.
The Company continues to work on its anti-influenza drug candidates in parallel to its HerpeCide program. We are currently developing Injectable FluCide™ for hospitalized patients with severe influenza as our first, broad-spectrum anti-influenza drug candidate. We have demonstrated the very first effective orally available nanomedicine, namely oral FluCideT™ for out-patients with influenza. The development of Oral FluCide is expected to follow behind Injectable FluCide.
Because of our limited resources, we have assigned lower development priorities to other drug candidates in our pipeline such as DengueCide™ (a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS)) and HIVCide™ (a potential "Functional Cure" for HIV/AIDS).
NanoViricides believes that it would be able to rapidly develop a drug candidate against the recent epidemic Zika virus by leveraging its Dengue drug efforts. Zika belongs to the same class of viruses as dengue viruses, called flaviviruses. Therefore, we believe that our broad-spectrum anti-dengue drug candidates would provide good leads for Zika drug development, should resources for engaging in this activity become available.
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.
"We continue to make steady progress towards our goal of initiating human clinical trials of our first drug candidate in the near future," said Eugene Seymour, MD, MPH, CEO of the Company, adding, "And we believe we will be able to perform clinical trials of at least one drug candidate with our available cash resources."
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.