SHELTON, CONNECTICUT -- Tuesday, April, 16, 2017 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), filed the quarterly report for its third quarter of financial year 2017 in a timely manner with the Securities and Exchange Commission on Monday, May 15th. The submission can be downloaded from the SEC website at https://www.sec.gov/Archives/edgar/data/1379006/000114420417027501/v466096_10q.htm.
NanoViricides reported that it had approximately $16.74 Million (M) of current assets (cash, cash equivalents, and prepaid expenses) as of March 31, 2017, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $2.7M, consistent with previous quarter. Shareholder equity stood at approximately $22.4M for the quarter (unaudited figures). The increase in shareholder equity was the net effect of the conversion of Series B convertible debentures that matured on January 31, 2017, as previously reported. Briefly, holders of $5,000,000 principal value Series B Convertible Debentures, namely, an entity controlled by Dr. Milton Boniuk, a director of the Company, and The Boniuk Charitable Foundation, converted $5,000,000 of Series B debentures into equity, and the remaining $1,000,000 principal, with accrued interest as of the maturity date, was repaid to the holders thereof in cash. The Company believes that its offer to the debenture holders to convert at a rate based on the Company's recent stock price performance was in the best interests of its shareholders, as it bolsters the Company's available capital for executing on its current business plan.
The Company estimates that it has sufficient cash in hand to last more than one year of operations at the current rate of expenditure. 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. The Company's expenditures during the reported period were on track with this expectation.
The Company said its lead drug development program, namely topical skin cream for the treatment of shingles, is progressing satisfactorily, under its HerpeCide™ project. The drug candidates being advanced in the shingles program are variations of the drug candidates that were found to be highly effective against HSV-1 H129 in a lethal animal study with 80-100% of treated animals surviving fully as opposed to untreated animals showing 0% survival, as previously reported.
The Company is pursuing at least four different indications with these drug candidates in its HerpeCide™ program, namely, (1) skin cream for the treatment of shingles caused by reactivation of the chickenpox virus (VZV, aka HHV-3), (2) skin cream for the treatment of cold sores (herpes labials) caused by the herpes simplex virus-1 (HSV-1), (3) skin cream for the treatment of genital ulcers caused by HSV-2, and (4) topical eye drops for the treatment of herpes keratitis (mostly caused by HSV-1).
The Company recently reported that it has completed certain preliminary ex vivo human skin patch based efficacy studies for its initial drug candidates against shingles, and repeat studies to confirm the results are in progress. These studies were conducted in the laboratory of Professor Moffat at the State University of New York Upstate Medical Center in Syracuse, NY. The Company expects to report on these studies upon approval of the study investigators and their Institute. Further studies towards declaration of the final clinical drug candidate for shingles are continuing. We believe that these human skin patch studies should be highly predictive of human clinical trials success.
The Company said its work on the scale-up of manufacturing of the drug candidates in the HerpeCide project is advancing successfully. We are currently working on production at approximately 200g to 500g scales. The Company has recently estimated, with its service providers and industry expert consultants, that a quantity of approximately 1kg of drug candidate will be sufficient for its proposed Safety/toxicology studies for the shingles drug candidate. The Company is on course to have the ability to produce such quantities in its own manufacturing facility once a clinical drug candidate is declared.
The Company has continued to focus its work on studies needed for moving the shingles topical treatment towards human clinical trials stage as rapidly as it can. The Company is performing the Chemistry, Manufacture and Controls (CMC) studies needed for filing an Investigational Drug Application (IND) with the US FDA or equivalent application(s) in other countries including Australia, for the shingles drug candidate. In parallel, the Company is performing studies needed to finalize a clinical drug candidate out of several that have shown strong success in cell culture studies. There is no standard animal model for shingles.
The Company has eight different drugs in development, including the four indications in the HerpeCide program described above. This deep and wide pipeline demonstrates the robustness of the nanoviricide® platform technology.
NanoViricides, Inc. is one of a few bio-pharma companies that has all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. Our new campus at 1 Controls Drive, Shelton, CT, has 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 current topical drug candidates in our HerpeCide™ program are variants of the shingles drug further optimized for the specific herpesvirus and topical delivery constraints. These topical treatments are expected to provide a significantly faster path to human clinical stage than the other injectable and oral drugs in our pipeline.
Topical treatments for the herpesvirus indications are important. Although the herpesviruses stay latent in a nerve ganglion, the pathology of an outbreak in a patient begins with reinfection in the skin layer from the reactivated virus, followed by further expansion of the virus in the skin layer. The newly produced virus then causes additional spread of the virus to more nerve cells, and would become latent there. Topical nanoviricide® treatment would stop further expansion of the virus at the site and therefore should also potentially decrease further recurrences. Also, topical treatment allows exposure of the virus to much higher concentrations of the drug locally, and thereby should produce greater effectiveness with less overall drug use, as compared to systemic treatments.
There is no effective treatment for shingles and the shingles related PHN (post-herpetic neuralgia). The shingles associated debilitating pain usually lasts during the infection outbreak in most patients, but in some patients, PHN can develop, which can last 90 days to even a year in some cases after the skin has healed. Approved treatments for shingles and PHN include acyclovir related nucleoside analogs that are given in very high doses systemically for a week but with limited effect. A new nucleoside analog called FV-100 is in Phase 3 clinical trials. FV-100 development was previously abandoned by Bristol-Myers-Squibb and is now undertaken by a small pharma.
There is also a vaccine for shingles that may reduce occurrence of shingles as a preventive, but not as a treatment after a breakout occurs. Another vaccine is in development. The chickenpox vaccine is now standard for children. However, the incidence of shingles in adolescents and young adults is rising, although shingles generally occurs in older people due age related decrease in immune function, and in patients with immune function compromising conditions from stress to organ transplant to other infections and HIV/AIDS.
Although in most patients shingles is debilitating during the outbreak but not life-threatening, in a small percentage of patients, it can cause eye infections that can lead to blindness.
There is no topical treatment for shingles. We believe this is an unmet medical need. The market size for a successful topical treatment for shingles could be in the billion dollar range.
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, which includes herpesviruses. We believe that this is speeding 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.
The Company has established additional collaborations towards IND-enabling development of drug candidates against the four HerpeCide program indications listed above. We now have collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at the University of Pittsburgh, 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. In addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug candidates against shingles.
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.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.