WEST HAVEN, CONNECTICUT -- May 21st, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") has filed its quarterly report with the Securities and Exchange Commission today, May 21st, in a timely fashion.
The Company reported that it had approximately $12.984M in cash and cash equivalents, and approximately $295,749 in prepaid expenses as of March 31, 2012, the end of the reporting quarter. The shareholder equity stood at approximately $13.572M. In comparison, the Company had approximately $12.099M in cash and cash equivalents, approximately $322,880 in prepaid expenses and other cash equivalent assets, and $12.388M in shareholder equity as of December 31, 2011. The Company spent approximately $1.582M in Research and Development expenses (R&D) and approximately $494,080 in General and Administrative expenses (G&A) in the reported quarter. The Company’s rate of expenditure was in line with the Company’s budgeted targets.
In this quarter, the Company raised an additional $2.5M from Seaside 88, LP, a Florida limited partnership (“Seaside”), upon Seaside’s exercise of their option to purchase the Company’s Series B Preferred Stock, as previously disclosed on February 9, 2012. The final conversion of the preferred shares of stock purchased by Seaside took place on May 2nd, 2012.
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. The Company has neither any long term debt, nor any short term debt, other than small working capital accounts payables
The Company reports that all of its drug development programs are progressing satisfactorily.
The Company 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 and is progressing NV-INF-1 development further towards an IND submission. On May 7, 2012, the Company announced that a fundamental patent, on which the nanoviricides® technology is based, was due to be issued in the USA on May 8, 2012. The US Patent (No. 8,173,764) is granted for "Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers." The patent term is expected to last through October 1, 2026, including an anticipated extension, with the possibility of further extensions in compensation for time spent in clinical trials.
This US Patent has been allowed with a very broad range of claims to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and uses of the same. The disclosed structures enable self-assembling, biomimetic nanomedicines. NanoViricides, Inc. holds exclusive, perpetual, worldwide licenses to these technologies for a broad range of antiviral applications and diseases.
Based on international PCT application number WO 2007/1084126, which was filed in 2006, corresponding patents have also been issued in Mexico, New Zealand, South Africa, and as a regional (OAPI) patent valid in sixteen other African states. Additional issuances are expected in Europe, and in several other countries around the world.
The Company is in the process of making arrangements to enable the cGMP manufacture of its multiple clinical drug candidates to support their human clinical trials. On May 14, 2012 the Company announced that it has retained the services of Mr. Andrew Hahn to help with the overall design and construction of its laboratory and cGMP pilot production facility. This facility will be built by renovating an existing 18,000 sqft light manufacturing plant on a 4.2 acre lot in Shelton, CT, as previously announced. Mr. Hahn will help the Company in the overall design, architecture, engineering, and construction of the whole facility that includes the cGMP facility, laboratories, and office spaces.
Mr. Hahn recently retired as the Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company.
With the current strong cash position, the Company believes that it has sufficient funds available to perform the necessary IND enabling studies for NV-INF-1 and to file an Investigational New Drug Application (“IND”) with the US FDA.
The Company currently has five commercially important drug candidates in its pipeline. These include FluCide™, 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. 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.