WEST HAVEN, CONNECTICUT -- Monday, November 18th, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), has filed its quarterly report with the Securities and Exchange Commission on Thursday, November 15th, in a timely fashion. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420413061915/v360486_10q.htm.
The Company reported that it had approximately $22.0M in current assets (cash, cash equivalents, collateral advance, and prepaid expenses) as of September 30, 2013, the end of the reporting quarter. The shareholder equity stood at approximately $11.75M. In comparison, the Company had approximately $15.5M in current assets plus collateral advances, and approximately $8M in shareholder equity as of June 30, 2013, the end of its financial year.
The Company spent approximately $1.175M in Research and Development expenses (R&D) and approximately $714,561 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 reported that it had raised approximately $10.33M in a registered direct offering on September 10, 2013, immediately following a reverse split of its common stock at the rate of 1 new share for 3.5 old shares effected the same day. The Company received approximately $9.690 Million in proceeds after deducting approximately $640K for broker commissions and attorney fees. Midtown Capital Partners LLC and Chardan Capital Markets LLC jointly served as placement agents for this raise.
The Company’s long term and trusted supporters (family funds) including our Director, Professor Milton Boniuk, MD, have invested a majority of the total funds in this raise. The Company had undertaken the reverse split in order to enable it to be listed on a national stock exchange.
On September 25, 2013, the Company’s (new) common stock began trading on NYSE MKT exchange under the symbol “NNVC”. This is a significant milestone for the Company, resulting as a culmination of a year long effort spearheaded by its founder and chairman, Dr. Anil R. Diwan.
The Company estimates that it currently has sufficient cash in hand to support operations for at least two years from reported period at the current rate of cash expenditure. NanoViricides, Inc. also estimates that it has sufficient cash in hand to support initial human clinical trials of its first drug candidate, a broad-spectrum anti-influenza drug in its FluCide™ program. 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 reports that all of its drug development programs are progressing satisfactorily.
Of these, our Injectable FluCide™ is the most advanced. This drug candidate has shown extremely high effectiveness in a lethal influenza infection mouse model against two different types of influenza A virus, namely H1N1 and H3N2. The Company believes that this drug should be effective against most if not all influenza A subtypes, and strains, including the novel H7N9 strain. The Company held a pre-IND Meeting with the US FDA for its clinical drug candidate NV-INF-1 (i.e. Injectable FluCide) in the FluCide program in March 2012. The Company obtained valuable advice and is developing this candidate towards an investigational drug application (“IND”) to the US FDA as well as for similar applications to other international regulatory agencies. The Company recently performed a short preliminary non-GLP study designed to guide the planned GLP Safety and Toxicology studies (“Tox Package”) that are required for an IND filing.
On October 7, 2013, the Company announced that in this small animal non-GLP safety/toxicology study of NV-INF-1 drug candidate, even at maximum feasible dosage, the drug was well tolerated and that no adverse events were found at study completion. The Company is awaiting a full report on the chemistry and histology data from this study. These results are consistent with our findings during efficacy studies of this drug candidate in lethally infected mouse models.
The Company is currently performing scale up studies on its FluCide drug candidate in its existing facilities. Upon scale-up, we will be able to produce the quantities of materials we need for the GLP Safety/Toxicology study of the injectable FluCide drug. 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.
On August 12, 2013, the Company announced that this anti-dengue drug candidate has been awarded an orphan drug designation by the US FDA. Subsequent to this quarterly report, on November 11, 2013, we announced that this anti-dengue drug candidate was also awarded an orphan drug designation by the European Medicines Agency (EMA). These orphan drug designations provide the Company with several financial and other benefits that have now enabled the Company to give a high priority to the development of this drug.
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 its future human clinical studies. (“c-GMP”= current Good Manufacturing Practices, a set of guidelines developed by the US FDA that the manufacture of a drug must adhere to for human clinical trials and future sales. Internationally, there are similar guidelines promoted by local regulatory agencies, and ICH harmonization guidelines promoted by the WHO). A group of private financiers that includes our founder Dr. Anil Diwan has acquired an 18,000 sq.ft. 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 now 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.The Company reported that the renovation of the facilities at 1 Controls Drive, Shelton, CT is now in Construction phase, and is expected to be completed in the first calendar quarter of 2014.
The Company previously held a pre-IND meeting with the US FDA for its anti-influenza drug candidate, NV-INF-1, in the FluCide program on March 29, 2012. The Company believes it has received valuable input from the US FDA, applicable to the development of its anti-influenza drug candidates.
With the current strong cash position, the Company believes that it has sufficient funds available to perform the necessary IND enabling studies for its anti-influenza drug programs, to file an Investigational New Drug Application (“IND”) with the US FDA, and to conduct initial human clinical trials of its first anti-influenza drug. The Company’s estimates are based on information it has obtained from reliable sources, confidential cost estimates from consultants and service providers, and other sources. There is no guarantee that this information is accurate. The Company will continue to refine its estimates as the development programs progress further.
Including the Flucide program, the Company currently has six commercially important drug candidates in its pipeline. These include the Injectable and Oral drugs against all Influenzas, HIVCide™, HerpiCide™, DengiCide™, and a broad-spectrum nanoviricide eye drop formulation against viral infections of the eye. These programs are based on the Company’s platform technology that enables specifically targeting a particular type of virus with a novel mechanism of action. In addition, the Company continues its other research and development programs. These include (a) broad-spectrum nanoviricides against a number of Neglected Tropical Diseases, and (b) its novel ADIF™ (“Accurate Drug In Field”™) technologies which promise a way to attack novel viruses, whether man-made (bioterrorism) or natural (such as SARS), before they cause a pandemic.
On November 15, 2013, the Company has filed its Quarterly Report on Form 10-Q for the period ended September 30, 2013. However, the Registrant was unable to complete the financial statements in interactive data format in eXtensible Business Reporting Language (“XBRL”) without unreasonable effort or expense. We will amend our Form 10-Q to provide financial statements in XBRL format within the time prescribed for the filing.
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.