NanoViricides, Inc. Announces that Renovation for its cGMP Clinical Drug Facility has Begun; also Addresses Shareholder Concern - Knows No Reason for the Price Drop Yesterday
The Company reports today that its project for enabling clinical scale drug product cGMP capability has reached a new milestone with the commencement of renovation of the facility at 1 Controls Drive in Shelton, CT. The design of this facility allows a very high degree of customization of the production process. This facility is thus expected to enable cGMP production of all of the Company's several nanoviricide® drug candidates, in various delivery forms ranging from injectables, oral, eye drops, to skin creams.
The Company has previously reported that it has approximately $20M cash in hand (including prepaid expenses) after the recent $6M raise. This raise involved only three family offices and a charitable foundation, all of who have been long term investors in and supporters of the Company. In addition, the Company has developed an innovative strategy to minimize its capital costs burden in the construction of its clinical drug product scale cGMP production facility, as previously described.
The Company is moving forward on all of its initiatives at a steady pace. NanoViricides technology continues to pioneer highly effective novel antiviral drugs, including the recently demonstrated oral anti-influenza drug in the FluCide™ program. The Company's drug candidates continue to demonstrate significant superiority to standard of care drugs for every virus that they have been developed against.
On February 25, an unusual pattern in the trading of the Company's common stock was brought to its attention by concerned shareholders. This highly unusual pattern involved selling of very large amounts of the Company's common stock shares in a short time prior to the close of trading, leading to a large drop in the share price. The Company does not have any knowledge of who the sellers were.
The Company advises that it is unaware of any fundamental basis for such an unusual trading pattern or the associated share price drop. The Company has no knowledge of any business related events or of any fundamental changes in its business, programs or technology developments, that would constitute an adverse business event. All of the Company's programs are on track, and the Company has sufficient cash in hand to execute on its current plans.
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 candidates and to begin human clinical studies in a reasonable timeframe.
The Company is developing its injectable anti-influenza drug, NV-INF-1, towards IND-enabling studies. This drug is intended for use in hospitalized patients with influenza. The Company believes it will be useable in immuno-compromised populations, and may receive an orphan drug classification for this indication.
The Company is also advancing its oral broad-spectrum anti-influenza drug candidate, NV-INF-2. This may be the first ever nanomedicine drug of any kind that is active when administered orally. This drug is being developed for out-patient influenza cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers. Both of these drugs in the anti-influenza FluCide™ program have demonstrated very high effectiveness in a lethal influenza animal model, routinely showing substantial superiority to oseltamivir (Tamiflu®), the current standard of care.
Including the Flucide program, the Company currently has six commercially important drug candidates in its pipeline that together address a market size greater than $40 Billion. These drugs include the aforementioned 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 broad-spectrum nanoviricides against a number of Neglected Tropical Diseases, and 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.
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.
Amanda Schuon, 310-550-7200
KEYWORDS: United States North America Connecticut
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