WEST HAVEN, Conn.--(BUSINESS WIRE)--
NanoViricides, Inc. (OTC: NNVC) (the "Company"), announced that the renovation of the facility for its new clinical scale cGMP production plant has begun.
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 Companys 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 Companys 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 Companys common stock was brought to its attention by concerned shareholders. This highly unusual pattern involved selling of very large amounts of the Companys 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 Companys 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.
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NanoViricides, Inc. Announces that Renovation for its cGMP Clinical Drug Facility has Begun; also Addresses ...