SHELTON, CONNECTICUT -- Monday, May 18, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") filed its quarterly report in a timely manner with the Securities and Exchange Commission on Friday, May 15th. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420415031364/v410164_10q.htm.
The Company estimates that it now has approximately $34.3 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of March 31, 2015, the end of the reporting quarter. The Company's operating expenditure during this quarter was approximately $1.12M. Shareholder equity stood at approximately $31.86M for the quarter.
The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of our injectable FluCide™ drug candidate, as well as possibly to advance another drug candidate towards initial human clinical trials.
The Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analytics Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility. We implemented a phased program for commissioning the new facility. This has enabled us to continue to progress in all of our existing programs, without interruptions.
The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.
Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
In April 2015, subsequent to the reporting period, the Company reported that its anti-Herpes nanoviricides drug candidates demonstrated dramatic effectiveness in a lethal mouse model of dermal herpes infection. The reported studies were performed in Professor Ken Rosenthal's laboratory at the NorthEast Ohio Medical University ("NEOMED").
The Company reported that topical dermal treatment with two of its anti-herpes nanoviricides formulations led to almost complete (>85%) survival of the lethally infected mice in this animal model. In contrast, animals treated with an acyclovir formulation exhibited significantly lower survival rates
The Company believes that the drug approval process for a topical herpes treatment could be relatively rapid, based on the strong effectiveness results. The Company intends to meet with its FDA advisory consulting group, namely, Biologics Consulting Group, Inc., to chart out the path towards approval. In addition, the Company intends to engage a Contract Research Organization (CRO) for further development of a topical anti-herpes drug into the regulatory approval pathway for US FDA as well as internationally. The Company intends to study various indications including HSV-1 cold sores, HSV-2 genital lesions, Herpes keratitis (an eye disease), and Shingles, among other possibilities.
The market size for herpes virus treatments is in excess of $2 billion annually. The Company believes that a drug that is superior to existing therapies could result in significantly expanded market size, as has been demonstrated in the case of HIV, Hepatitis C and other diseases. An estimate of over $40 billion for an effective anti-herpes drug may not be excessive, considering the near-complete penetration of the various herpesviruses in human population, and the repetitive and debilitating nature of illnesses that they can cause.
In just four cycles of further improvements the Company has now reached its goal of substantially complete survival in the highly lethal animal model of dermal herpesvirus infection (HSV-1 H129c strain), wherein no current drugs have shown substantial survival effect. Our anti-herpes program began in 2009, and we immediately observed dramatic viral load reduction (>99.9%) in cell cultures. Nevertheless, due to financial constraints, this program continued to be on the back burner. This and many of our other programs were accelerated following up-listing in 2013 to the NYSE-MKT exchange which enabled us to raise significant funding.
The recent anti-HSV small animal studies employed the HSV-1 H129c strain. This highly neurotropic strain is derived from a patient. It is known to be far more virulent than other HSV-1 strains that have been used in drug and vaccine development against herpes viruses. The Company had previously reported that its earlier anti-HSV drug candidates had exhibited greater than 99.9% viral load reduction in cell culture studies employing the HSV-1 McCrae strain, indicating that these nanoviricides are broad-spectrum anti-herpes agents.
Professor Rosenthal retired last year and continued as Professor Emeritus at NEOMED. Even after his retirement, he continued his research, and was personally involved in on-going studies of nanoviricides drug candidates in his laboratory. Professor Rosenthal has now joined Roseman University of Health Sciences, Las Vegas, Nevada, as a Professor of Biomedical Sciences. He will continue as a consultant to NanoViricides for our anti-herpes drug development program. He is a leading researcher in herpes virus anti-viral agents and vaccines.
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.
Initial cell culture testing of our drug new candidates against Ebola virus that was completed recently at a BSL-4 facility in the USA indicated that a further improvement in the effectiveness of these drug candidates in cell cultures is needed in view of current guidelines for advancing into animal studies. From previous experience with many of our programs, we are aware that our nanoviricide® drug candidates, which are based on a whole systems-biology-based approach, do not fare well in the cell culture assays that are optimized for testing of small molecules, even as they have demonstrated extremely high effectiveness and safety in animal models. It is also likely that the NPC1-binding site on Ebolavirus glycoprotein, which is thought to be buried, may have been substantially inaccessible to our drug candidates. We believe that we can substantially improve the effectiveness and thereby produce a highly effective, broad-spectrum, drug candidate against Ebola/Marburg in a few cycles of optimization. We believe USAMRIID will continue to be our collaborator for testing the new drug candidates for such optimization. We are looking for potential funding for this program from non-dilutive sources.
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.