NanoViricides, Inc. issued the following announcement on Sept. 30.
NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), announced today that it has filed a Form S-1 Registration Statement with the Securities and Exchange Commission ("SEC"). This Form S-1 will enable the Company to raise the necessary capital once it is declared effective by the SEC. Maxim Group LLC will serve as the Company's underwriter for the offering under this Form S-1
The Company does not understand the drop in its share price since the reverse split of its common stock became effective on September 24, 2019. The Company's balance sheet is relatively unchanged, with a fully owned state-of-the-art cGMP-capable nanomedicines manufacturing facility and equipment, valued on the balance sheet at $10.5 million dollars. The Company has no debt. The fundamentals of the Company's business remain strong, and the Company is preparing to raise the funds necessary for the anticipated human clinical trials.
The Company is moving forward towards filing an IND application with the US FDA, for starting human clinical trials with its advanced, next generation antiviral nanomedicines assets. We anticipate starting Phase I human clinical trials of NV-HHV-101, our lead candidate, against the shingles rash indication soon after the IND is approved. This drug candidate is a dermal topical cream formulation for direct application on the rash where the underlying VZV viral load is the highest. This enables achieving strong effectiveness.
The market size for shingles treatment is estimated to be in the range of a billion dollars and that for shingles+PHN (post-herpetic neuralgia) treatment, the market size is estimated to be significantly larger. These estimates take into account the effect of the introduction of the new Shingrix® (GSK) vaccine for shingles, and of existing vaccines. The additional HerpeCide indications that we are working on represent a market size opportunity of over $3B.
The effectiveness of this drug candidate, NV-HHV-101, has been demonstrated in human skin organ culture model ("human SOC model") in studies performed by Professor Jennifer Moffat at the SUNY Syracuse Upstate Medical Center.
Almost 1 out of 3 people in the United States will develop shingles in their lifetime, according to the CDC. The risk of getting shingles increases as you get older. The most common complication of shingles is post-herpetic neuralgia, which is severe pain in the areas where the shingles rash occurred lasting beyond six months. About 10 to 18% of people who get shingles will experience PHN. Approximately 1 to 4% of people who get shingles are hospitalized for complications. (https://www.cdc.gov/shingles/surveillance.html).
There is no effective treatment for shingles at present. Several antiviral medicines in the acyclovir family are available to treat shingles and shorten the length and severity of the illness if you start taking them as soon as possible after the rash appears (https://www.cdc.gov/shingles/about/treatment.html). However, unlike HSV-1 and HSV-2, the shingles virus, namely VZV, is highly resistant to these acyclovir family of medications because of a defective viral enzyme called vTK that is required for these drugs to become activated in the body.
Our shingles drug candidate NV-HHV-101, with some modification, is expected to be our lead candidate for dermal topical treatment of (B) "cold sores" caused by HSV-1, and (C) "genital ulcers" caused by HSV-2. We believe that these two additional indications will be ready for entering IND-enabling Safety/Toxicology studies as the human clinical trials of NV-HHV-101 for VZV shingles rash indication are going on. At present, we are planning to develop one drug candidate against both HSV-1 cold sores and HSV-2 genital ulcers indications, in order to achieve cost and time savings in pre-clinical development. This strategy of going after multiple diverse indications with the same drug candidate or its derivatives enables the Company to maximize shareholder value and return on investments.
Additionally, the Company has a large number of further developments including drugs against HIV/AIDS and Influenzas in the pipeline. Thus, the Company believes it has a bright future.
The Company's drug development business model is based on licensing the patents and intellectual property held by TheraCour Pharma, Inc. that enabled creation of drugs engineered specifically to combat viral diseases in humans. The Company has a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of a number of human viral diseases including HSV-1 and HSV-2. The Company does not currently have a license for the VZV field from TheraCour. While the Company has signed a Memorandum of Understanding on the economic terms of a license for VZV, we must disclose as a risk that there can be no assurance that a license agreement will be entered into. The Company is in late stages of negotiations with TheraCour to finalize the license agreement for VZV.
NanoViricides is one of the few bio-pharma companies that owns a highly customizable, cGMP-capable drug manufacturing facility, with no mortgage. The Company intends to produce its drugs for clinical trials at this facility, saving time and money in its advance towards regulatory approvals. This facility, with its multi-kilogram production scale, is expected to provide the drug product for initial market entry, enabling substantial revenue generation once a drug is approved.
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