NanoViricides President completes stock sales program

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced that its President, Dr. Anil Diwan, has completed the programmed sale of the NanoViricides stock that he had obtained as a founder. The Company had agreed to this stock sale in order to help partially offset the costs for the acquisition of a facility and of architectural and engineering design of its renovation.

The Company has reported that an 18,000 square foot facility in Shelton, CT has been acquired by Inno-Haven, LLC, a special purpose entity formed for the project. When completely renovated, the new facility is anticipated to house administrative, R&D and cGMP or "current Good Manufacturing Practice" manufacturing functions for the Company.

NanoViricides, Inc. did not incur any capital costs, as Inno-Haven, LLC financed the acquisition of the building. The financing was derived from Dr. Diwan's personal funds and from private mortgage loans that were personally guaranteed by him. Dr. Diwan is a controlling Member of Inno-Haven, LLC.

In order to ensure sufficient funding for the next phase of the project, with the Company's approval, Dr. Diwan engaged into a programmed sale under Rule 10b5-1 of a portion of his NanoViricides founder's stock. Dr. Diwan has determined that sufficient funding is now available for the next steps which include architectural and engineering design for the necessary modifications. This available funding includes the proceeds from his sale of stock and additional commitments from other investors that he has been able to obtain. The remaining funding for the engineering and construction phase is anticipated to be achieved using commercial programs available for such purpose, which may include SBA-guaranteed bank loan programs and other private institutions. As such, Dr. Diwan has determined that the sale of his NanoViricides shares is no longer necessary.

"Conserving capital is very important for NanoViricides," said Dr. Eugene Seymour, MD,MPH, CEO of the Company, adding, "Dr. Diwan's commitment and personal risk-taking has allowed us to minimize capital expenditures even as we endeavor to enable cGMP manufacturing capability for our drug candidates. We are further pleased that he has agreed to end the programmed sale, as soon as there was sufficient funding available."

The Company will be required to have cGMP manufactured drug products available for clinical trials when it files an Investigational New Drug application to the FDA. cGMP is a set of guidelines that address the manufacturing processes, equipment, and facility, among other aspects, that must be adhered to when producing drugs for human use.

The need for a cGMP drug manufacturing capability has become critical for the Company in order to advance its drug candidates into the FDA regulatory process. The Company has been working diligently over the last five years to address this issue. After evaluating various available options including leasing external existing cGMP facility, contract manufacturing, etc., the Company determined that building a pilot scale cGMP facility was the most cost-effective option available. The Company believes that Inno-Haven can be expected to obtain the financing necessary for this project with very limited capital requirements on the Company.

The Company has recently announced that it has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCide™) to develop for FDA submission. NV-INF-1 is expected to be a highly effective anti-influenza drug, based on the extremely high efficacy observed in animal studies.

The Company has also recently announced significant successes in its anti-HIV drug program, viz. HIVCide™. In a recent standard humanized mouse model study, the best HIVCide candidate showed effectiveness against HIV-1 that was similar to a three drug HAART (highly active anti-retroviral therapy) cocktail even though HIVCide was administered at a much lower total dosage. What is more significant, this nanoviricide drug candidate continued to work to suppress HIV viral load for at least 28 days beyond last drug administration. These data along with previous similar successes in anti-HIV drug development indicate that HIVCide may provide a "functional cure" of HIV/AIDS either alone or in combination with other drugs.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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