SHELTON, CONNECTICUT -- May 11, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") filed its quarterly report in a timely manner with the Securities and Exchange Commission on Tuesday, May 10th. The submission can be downloaded from the SEC website at www.sec.gov.
NanoViricides reported that it had approximately $25.9 Million (M) of current assets (cash, cash equivalents, and prepaid expenses) as of March 31, 2016, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $2.4M. The Company's research and development (R&D) expenditure has increased as we advance towards human clinical trials. The increase in cash expenditures in this quarter as compared to the previous one was primarily due to the receipt and payment of certain invoices in this quarter corresponding to R&D accomplished in the prior quarter. The Company estimates the current quarterly cash expenditure rate to be about $1.9M per quarter. Shareholder equity stood at approximately $24M 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 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). However, we now have our own capabilities to perform initial cell culture based drug candidate screening for BSL2 viruses. We believe that this will speed up our drug development programs against such viruses significantly by removing the latencies of external testing in the earlier drug screening and the later drug optimization stages.
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 has achieved animal studies efficacy proof of concept for treating HSV-1 skin infection using its topical HerpeCide treatment. The Company believes that the broad-spectrum nature of these drug candidates should allow effectiveness against related herpesvirus types such as HSV-2 as well as the more distantly related HHV-3 aka VZV or chickenpox/shingles virus.
The Company has established additional collaborations towards IND-enabling development of drug candidates against the four indications listed above. We now have collaboration agreements with the CORL at the University of Wisconsin, the Campbell Lab at the University of Pittsburgh, and the Pflugfelder Lab at the Baylor College of Medicine, for the evaluation of its nanoviricides® drug candidates in models of ocular herpesvirus and adenovirus infections. TransPharm Preclinical Solutions, a CRO, will continue to perform testing of our anti-herpes drug candidates in dermal infection models.
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.
In the United States, approximately 1 million cases of shingles (i.e. zoster) occur annually. The risk of zoster increases with age, and with decreased immune system function. Zoster is characterized by pain and rash. One in four patients experience zoster-related pain that lasts more than 30 days, with several developing post-herpetic neuralgia (PHN) that persists for years. Severe shingles, especially in the elderly, and the follow-on PHN, are a major cost burden to the society. The Company believes that our topical HerpeCide therapy would enable control of the viral outbreak, and this control would lead to a significant reduction in PHN cases. With the aging population, the Company expects Zoster and PHN treatment to become very large markets if an efficacious drug is developed.
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 FluCide™ for out-patients with influenza. The development of Oral FluCide is expected to follow behind Injectable FluCide.
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-Herpesvirus 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," 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.