WEST HAVEN, CONNECTICUT – November 15th, 2011 -- NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), has filed its quarterly report with the Securities and Exchange Commission yesterday, November 14th, in a timely fashion.
The Company reported that it had approximately $10.879M in cash and cash equivalents, and approximately $321,900 in prepaid expenses as of September 30, 2011, the end of the reporting quarter. The shareholder equity stood at approximately $11.386M. In comparison, the Company had approximately $9.224M in cash and cash equivalents, approximately $332,300 in prepaid expenses and other cash equivalent assets, and $10.171M in shareholder equity as of the financial year ended June 30, 2011. The Company spent approximately $692,000 in Research and Development expenses (R&D) and approximately $448,700 in General and Administrative expenses (G&A) in the reported quarter. The Company’s rate of cash expenditure was in line with the Company’s budgeted targets.
The Company estimates that it currently has sufficient cash in hand to achieve the budgeted objectives through more than two years of operations from reported period. The Company has neither any long term debt, nor any short term debt, other than small working capital accounts payables.
Subsequent to the reported period, the Company received additional financing from a single investor, as reported previously. The Company and Seaside 88, LP, a Florida limited partnership (“Seaside”), have entered into a new agreement for Seaside to purchase up to a total of $5M of the Company’s Series B Convertible Preferred Stock. On November 2, 2011 Seaside purchased an initial 250,000 shares of the Company’s Series B Preferred Stock at the purchase price of $10.00 per share for an aggregate purchase price of $2,500,000. The Company received $2.5M upon closing, with a net of approximately $2.32M after deducting brokerage commission and expenses. The Series B Preferred Stock is convertible into a number of shares of the Company’s common stock every two weeks. The conversion price will be based on the same terms and conditions as the previous financing the Company concluded with Seaside, as described previously.
The Company reports that all of its drug development programs are progressing satisfactorily.
The Company has previously announced that it has chosen a clinical candidate for influenza, namely NV-INF-1, under its FluCide™ anti-influenza nanoviricides program. The Company reports that it is working on the pre-IND application with advice from the consultant firm, Biologics Consulting Group, that the Company has engaged for this purpose.
The Company is in the process of making arrangements to enable the cGMP manufacture of kilogram quantities of its clinical drug candidates without capital costs to the Company.
With the recent $5M raise subsequent to this reported period, the Company believes that it currently has sufficient funding available to perform Toxicology Package studies, and additional animal efficacy studies, to move at least one of our drug candidates into an Investigational New Drug Application (“IND”) with the US FDA. In order to file an IND application, we also need to enable manufacturing of the drug under US FDA guidelines called cGMP. The Company estimates that a small, less than 1kg/batch, production facility would be sufficient to satisfy the Company’s near future needs for supporting the FluCide clinical studies, at least through Phase II. This small batch size requirement is based on the extremely high effectiveness of the influenza clinical candidate observed in animal studies. The Company intends to enter into lease negotiations with Inno-Haven, LLC (“Inno-Haven”) to enable cGMP manufacture of our drug products. Inno-Haven is managed by its member Dr. Anil R. Diwan, who is the Company’s President and Chairman. Inno-Haven raised financing from Dr. Diwan and others, including some earlier investors of NanoViricides, Inc., and has purchased an 18,000 square foot building in Shelton, CT, on a 4 acre lot, enabling future expansion of operations. Dr. Diwan raised additional financing through the sale of his NanoViricides stock that he had obtained as a founder under a 10b5-1 plan that was recently concluded. Inno-Haven plans to raise the balance of financing through applicable and available loan programs such as the SBA-guaranteed bank loans and mortgages, and additional investors. No lease agreement has been drawn up and terms of lease have not been negotiated yet.
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.