WEST HAVEN, CONNECTICUT --Monday, May 19th, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) has filed its quarterly report with the Securities and Exchange Commission on Thursday, May 15th, in a timely fashion. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420414031119/v378344_10q.htm.
The Company estimates that it now has approximately $36.6M of current assets plus restricted cash in hand as of the date of filing. The Company estimates that this funding is sufficient to enable us to perform initial human clinical trials of our injectable FluCide™ drug candidate, as well as possibly to advance our DengueCide™ orphan drug candidate towards initial human clinical trials. The Company's estimates are based on its current rate of expenditure and also on certain approximate estimates for clinical development of its drug candidate as gleaned from discussions with various contract research organizations.
The Company reported that it had approximately $36.6M in current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of March 31, 2014, the end of the reporting quarter. The shareholder equity stood at approximately $32.0M. In comparison, the Company had approximately $19.8M in current assets plus restricted cash, and approximately $10.2M in shareholder equity as of December 31, 2013, the end of previous quarter. The increase in shareholder equity and cash in hand resulted from the approximately $20M raised in January in a registered direct offering (see below).
The Company spent approximately $625K in Research and Development expenses (R&D) and approximately $605K in General and Administrative expenses (G&A), including stock-based expenses, in the reported quarter. The current rate of expenditure was in line with the Company's budgeted targets.
The Company proudly notes that its co-founder and inventor of the underlying technologies, Anil R. Diwan, PhD, was recognized as the "Researcher of the Year, 2014" by BusinessNewHaven and NewHavenRegister group of publications.
In addition, we happily report that NanoViricides, Inc. won the prestigious "IAIR Award 2014" for Leadership in Nanomedicines in the North American Sector. This award was given by the IAIR group which publishes the International Alternative Investments Review, among other publications (www.iairawards.com).
The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.
The Company is currently performing process development and scale up studies on its FluCide™ drug candidate in its existing facilities. The scale-up studies, were necessitated to be performed at this early stage of our drug development because of the extremely high safety of FluCide that resulted in a very large quantity requirement for the GLP Safety/Toxicology studies. The limitations of the current laboratory facilities impose that we produce these materials in multiple batches at present, resulting in extended production and characterization time periods. We have now begun production of the large quantities of the anti-influenza ligand needed for the GLP safety/toxicology study. We intend to begin the GLP Safety/Toxicology study as soon as feasible.
The Company has previously announced that its anti-dengue drug candidate in the DengueCide™ program achieved an unprecedented 50% survival rate in a special mouse model that mimics the most severe dengue disease in humans. This study was performed by Professor Eva Harris at the University of California, Berkeley. This drug candidate has been designated as an "orphan drug" by both the US FDA and the European Medicines Agency (EMA). As such, the Company has prioritized the development of this drug candidate.
The Company has disclosed that it has designed and synthesized drug candidates against the deadly MERS virus ("Middle East Respiratory Syndrome") virus in its R&D program. Three cases of MERS infection have been reported in the USA, and one of these was direct human to human transmission within the USA (http://www.usatoday.com/story/news/health/2014/05/17/mers-corona-virus-saudi-arabia-illinois-indiana-infection/9217731/).
In addition, the Company is developing a flexible, multi-product, pilot manufacturing facility capable of manufacturing any of its drug candidates in c-GMP compliant manner. This facility will be able to provide the cGMP clinical drug substances for the Company's future human clinical studies. ("c-GMP"= current Good Manufacturing Practices). A group of private financiers that includes our founder Dr. Anil Diwan has acquired an 18,000 sqft building on 4 acres with possibilities of expansion, in Shelton, CT, via Inno-Haven, LLC, a company formed specifically for that purpose. This building is undergoing a total renovation to facilitate setting up a modern cGMP drug substance manufacturing facility with injectable drugs capability, as well as supporting analytical and chemistry laboratory facilities.
A majority of the construction phase of this renovation project is now substantially complete. The project has remained substantially on schedule in spite of significant adverse weather and related delays.
We are currently evaluating the lease versus purchase option regarding this facility. We have commissioned an independent consultant report to assist the Company with this decision. Based on this report, the Board has requested the Executive Committee to perform additional detailed studies regarding the potential purchase of this facility. As such, the Company has not engaged into a lease as of the date of this report, with consent from Inno-Haven, LLC.
On January 21, 2014, the Company raised approximately $20M in a registered direct offering. This offering grossed approximately $20M before estimated expenses of approximately $1.2M, which includes placement agent fees but does not include any attorneys' fees and other expenses. The price per unit was $5.25, with 1 unit comprising 1 share of registered common stock and a 5-year warrant to purchase 0.65 shares at a price of $6.05. Chardan Capital Markets, LLC, acted as lead placement agent and Midtown Partners & Co., LLC was the co-placement agent in connection with the offering.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.