NanoViricides Raises $6M from Equity Investors - Reports Having Sufficient Funds for the Initial Human Clinical Trials of its Broad-spectrum anti-Influenza Drug
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB: NNVC) (the "Company"), announced today that it has raised $6M from four equity investors. The investors included three prior investors (family offices) and a charitable foundation. The raise, involving convertible debentures, was completed on February 1, 2013. The Company reports having approximately $19M of cash in hand with this raise. The Company estimates that its current funding is sufficient for the first human clinical trials for its broad-spectrum anti-influenza drug candidate, FluCide™. FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models, exemplified by 100X to 1,000X greater viral load reduction than oseltamivir (Tamiflu®), the current standard of care.
"These family funds are sophisticated equity investors that have always shown a strong faith in both the nanoviricides® platform technology and our unique vision," said Eugene Seymour, MD, MPH, CEO of the Company, adding, "With these new investments, they continue to be long term investors in NanoViricides, Inc. We are extremely pleased with their continued support."
The investors purchased unsecured convertible debentures with a 4-year term from the Company. The debentures bear an annual coupon interest rate of 8%, and additional interest payable in restricted common stock and warrants (see below). The investors can convert the principal and any accrued interest into common stock at a fixed price of $1 per share. There were no fees or commissions associated with the transactions, and the Company realized a total of $6M.
NanoViricides is developing broad-spectrum anti-influenza drugs as part of its rich drug pipeline. The Company believes that its FluCide™ drug candidates will be effective against most if not all influenza viruses, including H3N2 or H1N1 epidemic viruses, seasonal influenzas, H5N1 bird flu, as well as novel influenza viruses. This is because FluCide is based on the Company's biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. In addition, earlier candidates were shown to be effective against two different strains of H5N1 viruses in cell cultures. In a highly lethal animal model, the injectable FluCide drug candidates have shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care. The small animal serves only as a "test tube" because FluCide is designed to attack the influenza virus directly and does not depend upon the host or its defenses. Thus the Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version is also dramatically more effective than TamiFlu in the animals given a lethal dose of influenza. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
The investors purchased unsecured convertible debentures with a 4-year term. The debentures bear an interest rate of 8% p.a., an additional interest payable in restricted common stock of 0.33, 0.33, and 0.34 shares in year 1, 2, and 3 respectively, and an additional interest of 0.33 warrants to be issued in the fourth year, per $1 of principal. The warrants are priced at $1 and will be valid for 3 years after issuance. The investors can convert the principal and any accrued interest into common stock at a fixed price of $1 per share. The Company can prepay the debentures, in which case the base interest rate shall increase by a 7% prepayment penalty. The Company agreed to use its best efforts to register the interest shares and the shares issuable from the interest warrants under a "shelf" registration statement provided same is available, in accordance with the provisions of the Securities Act. The Offering was conducted directly by the Company without the use of a placement agent. Accordingly, no placement agent fees or other commissions were paid by the Company in connection with the Offering. A current report "Form 8-K" has been filed with the SEC.
The Company has conducted a pre-IND meeting with the US FDA for its clinical candidate for influenza, namely NV-INF-1, under its FluCide™ anti-influenza nanoviricides program in March, 2012. The Company is currently working on the studies needed for an IND submission for this drug candidate. The injectable anti-influenza drug is designed for critically ill hospitalized patients with influenza-like-illness (ILI), including immunocompromised patients. This drug is also expected to be usable in a doctor's office for the treatment of less serious influenza cases.
The oral anti-influenza nanoviricide® is designed for use by less seriously ill out-patients and is anticipated to have the ability to prevent clinical illness in healthy individuals who have taken FluCide as prophylaxis. In addition, the Company is developing drug candidates against HIV, eye viral diseases, Herpes viruses, and Dengue viruses.
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 (HSV), 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 Massachusetts
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