WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), announced today that its “Injectable FluCide™” drug candidate for severe influenza has been chosen as one of the “Top Ten Infectious Diseases Projects to Watch” by a panel of industry experts assembled by Informa and the publishers of In Vivo, Startup and The Pink Sheet. As a result of this selection, Anil R. Diwan, PhD, President and Chairman of the Company, will give a company presentation at the Therapeutic Area Partnerships Meeting taking place on November 19-21, 2014, at the Hyatt Regency Boston (www.tapartnerships.com). The presentation is scheduled for 4:20pm Eastern time, today, November 20, 2014.
"Selected companies have been screened using a strict set of judging criteria for the Top 10 award and represent what our committees consider among the most attractive opportunities the industry has to offer," said Marc Wortman, Editorial Director, Therapeutic Area Partnerships. "Winners have met rigorous criteria, including: unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability. As the industry leader in strategic analysis and transaction tracking, our main goal is to give these companies exposure to potential investors, partners, and acquirers.”
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 synthesis of anti-Ebola drug candidates is progressing satisfactorily. The Company has recently 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 these candidates. The Company is working expeditiously on its anti-Ebola program at present, in order to develop an effective drug candidate that may be available in response to the current Ebola epidemic crisis. The Company has the ability to produce sufficient quantities of a successful drug candidate for potential field use.
The Company has developed a state-of-the-art nanomedicines manufacturing facility that 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’s Board of Directors has authorized acquisition of this facility from Inno-Haven, LLC, rather than leasing it. The acquisition process is in the due diligence phase at present, and is expected to be concluded soon.
Initial large animal safety/toxicology studies in the Company’s FluCide™ drug development program have begun at BASi, as previously reported. In addition, the Company is performing process development and scale up studies on its FluCide™ drug candidate in its existing facilities. The extremely high safety of FluCide has resulted in a very large quantity requirement for the GLP Safety/Toxicology studies, necessitating scale-up studies at this early stage.
The Company estimates that it now has approximately $42.6 Million (M) of current assets plus restricted cash in hand. 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. 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.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.