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NanoViricides Reaches an Agreement on Terms of License for Shingles Virus Drug Development

SHELTON, Conn., Feb. 26, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), reported today that it has reached an agreement on the terms of the license for the drug development against VZV, the virus that causes chickenpox in children and shingles in adults.

Targeted Virus-Killing Nanomedicines (PRNewsFoto/NanoViricides, Inc.)

NanoViricides previously tested the nanoviricide®  drug candidates being developed for HSV-1 against VZV in cell cultures and found them to be highly effective, in early 2017. The Company continued further development of these drug candidates against VZV while it was continuing to develop new collaborations for animal testing of its HSV-1 and HSV-2 drug candidates. The Company and TheraCour Pharma, Inc., the  licensor, have been in negotiation regarding the terms of TheraCour's license of VZV to the Company. TheraCour agreed in principle to license VZV upon completion of due diligence and an independent valuation. In the past, TheraCour has never denied any licenses for any virus programs that we initiated, and therefore the Company continued its development of the VZV skin cream drug candidate. Several factors, including the rapidity with which we were able to conduct the pre-clinical candidate optimization studies in the ex vivo human skin organ culture model developed by Professor Moffat at the Upstate Medical Center, SUNY, Syracuse, NY, led to the anti-VZV drug candidate to be our first drug candidate to move into IND-enabling regulatory studies.

The Company and TheraCour have agreed, subject to a definitive agreement between the Company and TheraCour, that TheraCour will not receive any payment upon signing of a License Agreement and that TheraCour will receive no cash but 500,000 shares of the Company's Series A Preferred Stock as a milestone payment when an IND ("investigational New Drug Application") becomes effective. Additionally, if the Company completes Phase I human clinical trials, then, upon completion, TheraCour will receive a milestone payment of $1.5 million in cash. Further, if the Company completes Phase II human clinical trials, then, upon completion, TheraCour will receive a milestone payment of $2.5 million in cash. Other compensation terms will be consistent with the Company's existing license agreements with TheraCour, including a 15% royalty on sales (net of costs) and 15% of sub-licensing revenues.

Recently, on February 4, 2019, the Company has announced that it has selected a clinical candidate for further development under the HerpeCide™ broad-spectrum drug program. The candidate, called "NV-HHV-101" is now in IND-enabling cGLP Safety/Toxicology studies in the regulatory pathway. Its first indication is for the treatment of shingles rash as a dermal topical cream.

The Company has substantially de-risked this program towards clinical success. We have already performed successful safety assessments in a non-GLP preliminary safety/toxicology study against two precursor candidates that led to NV-HHV-101 in a standard rat animal model. In these studies, the candidates were found to be extremely safe, with no evidence of dermal topical or systemic adverse events.

We scaled up production after achieving these strong safety signals, to get ready for the IND-enabling cGLP Safety/Toxicology studies and the Phase I human clinical trials, at our own facility. This enabled rapid translation to regulatory development, minimized cost outlays, saved time, and improved quality assurance, as compared to going to an external contract manufacturing organization ("CMO"). Also, this strategy has de-risked the manufacture by keeping it in the hands of experts who developed the scalable chemistries and performed the scale-up operations.

Additionally, in a human skin model, we have found that the development candidates during optimization phase have continued to show robust effectiveness in controlling the shingles virus. This ex vivo human skin organ culture model has been developed by Professor Jennifer Moffat, the Upstate Medical Center, SUNY Syracuse, NY. Dr. Moffat is an international expert on the shingles virus.

We therefore have several reasons to be highly optimistic about the human clinical success of this drug program. The actual success of any drug can only be determined in human clinical trials, and the Company is advancing rapidly towards beginning this phase of drug development.

In addition to VZV, we are also developing dermal topical drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company intends to advance these drug candidates towards human clinical trials as soon as possible. The Company has a strong pipeline of drug candidates in the HerpeCide™ program which is at top priority level at present. 

The Company develops its class of drugs, that we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.

About NanoViricides 
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 oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, 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 preclinical 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.

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