WEST HAVEN, CONNECTICUT -- Wednesday, February 25, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") filed its quarterly report with the Securities and Exchange Commission on Tuesday, February 24th. The submission can be downloaded from the SEC website at http://www.sec.gov/Archives/edgar/data/1379006/000114420415011553/v402511_10q.htm.
The Company estimates that it now has approximately $36.4 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2014, the end of the reporting quarter. The Company's operating expenditure during this quarter was approximately $1.9M. Shareholder equity stood at approximately $30.5M for the quarter.
The Company reports that all of its drug development programs are progressing satisfactorily and that it will continue to provide updates as appropriate.
In particular, the Company has reported that its anti-Ebola nanoviricide® drug candidates have been sent for testing at a prestigious BSL4 facility in the United States, subsequent to the end of the reporting period. These candidates were designed and synthesized in less than four months utilizing our rapid drug development platform. The Company has previously reported that it has signed a "Cooperative Research and Development Agreement - Materials Transfer Agreement (CRADA-MTA)" with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) for biological testing of its anti-Ebola drug candidates. The Company has the ability to produce sufficient quantities of a successful drug candidate for potential field use.
The Company has previously reported that it completed the acquisition of the state-of-the-art nanomedicines manufacturing facility at 1 Controls Drive, Shelton, CT, from Inno-Haven, LLC, by reimbursing Inno-Haven for the costs incurred. This facility will be capable of producing any of the Company's drug candidates in a cGMP-compliant manner in multi-kilogram quantities. 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).
The Company has previously reported that the initial safety and toxicology studies of FluCide™ in a rat model were completed at BASi, Inc., subsequent to the reporting period. These studies have continued to demonstrate an excellent safety profile for our injectable FluCide drug candidate, at doses up to 300mg/kg given for 14 days (total 4,200mg/kg).
In addition, the Company is performing process development and scale up studies on its FluCide drug candidate. FluCide is designed as a treatment for influenza in seriously ill hospitalized patients, a potentially fatal disease for which no satisfactory treatment exists. FluCide's excellent safety profile resulted in the need for a very large quantity of the drug for the GLP Safety/Toxicology studies required for an Investigational New Drug ("IND") filing. The multi-kilogram quantities of FluCide needed for these safety and toxicology studies will be produced in the new Shelton facility.
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. As previously reported, our strong cash position has enabled us to restart our anti-Ebola drug development program in response to the current epidemic. 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 it has successfully transitioned to Eisner-Amper LLP as our new external auditing firm with this quarterly report. During this transition, it was discovered that the Company had inadvertently treated certain warrants issued in relation to the registered direct offerings in September 2013 and in January 2014, and a certain Debenture issued in July 2014, without considering potential derivative effects related to the terms of these instruments. Upon finding this omission, and determining that this required restatement of certain previously filed reports, the Company filed a current report on Form 8-K that the previously issued Annual Report for the period ending June 30, 2014, and the recently issued quarterly report for the period ending September, 30, 2014, could not be relied upon.
The corresponding restated annual report and the restated quarterly report were filed on February 23, 2015. The restatements only affected the derivative treatment of certain warrants and certain terms of the debenture referenced above. The Company has taken steps to improve its internal controls to avoid such issues in the future. However, the excessive workload associated with these restatements and the transition from the previous audit firm to the new external audit firm led to late filing by one day of the Company's filing of the quarterly report for the period ending December 31, 2014.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.