SHELTON, CT / ACCESSWIRE / November 19, 2019 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), has filed its quarterly report for its first quarter of financial year 2020 in a timely manner with the Securities and Exchange Commission. This press release should be read in conjunction with the Form 10-Q filed on November 15th, 2019. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465919064800/tm1919560d1_10q.htm.
The Company reported that it had approximately $1.34Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $1.43M, as of September 30, 2019, the end of the reporting period. The net cash used in operating activities during this quarter was approximately $1.43M. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $9.13M for the quarter (unaudited figures), primarily due to the asset value of its cGMP-capable manufacturing facility, R&D labs, and equipment, that it owns fully. The Company had no revenues.
The Company has no long term debt.
The Company's founder and President, Anil R. Diwan, PhD., has provided a commitment of up to $2 million as a secured non-convertible loan to help with taking our first drug program through IND filing as a bridge to additional financing. The Company anticipates obtaining a mortgage on the facility, and is in the process of obtaining equity-based financing. On September 24, the Company effected a uniform reverse stock split of its outstanding shares of common stock and shares of preferred stock at a ratio of one-for-twenty in order to remain compliant with NYSE American share price requirements. On September 27, the Company filed a Form S-1 public offering with the SEC, that it withdrew on November 5, after the Board of Directors determined that the proposed terms of equity-plus-warrants based offering were not in the best interests of the shareholders. The Company anticipates filing a Form S-1 for public offering of common stock only.
The Company is pleased to note that it has been executing on all milestones towards the IND filing for its first clinical candidate along a reasonable projected timeline, and is doing so with highly conservative expenditures.
The IND-enabling Safety/Toxicology studies as well as other required non-clinical studies of its first clinical lead candidate, namely NV-HHV-101, are mostly complete as of the filing date. The Company anticipates receiving draft reports soon, and final cGLP reports for inclusion in our IND filing are expected shortly thereafter.
The Company has undertaken cGMP manufacture of the drug product, NV-HHV-101 skin cream for the topical treatment of shingles rash, at its own facility, for supplying anticipated Phase I human clinical trials. The Company has industry-leading internal expertise in the cGMP manufacture of complex nanomedicines drugs, right from simple starting materials to formulated drug products.
In a human skin patch organ culture model ex vivo, the Company has previously demonstrated the effectiveness and safety of topical NV-HHV-101 against VZV, the cause of shingles and chickenpox. These studies were conducted by Professor Jennifer Moffat at the Upstate Medical Center, SUNY Syracuse, NY. Professor Moffat has developed this model for pre-clinical evaluation of therapeutics against VZV, and is a well known expert in the field.
It is anticipated that the high effectiveness of our clinical drug candidate observed in this human skin model should be predictive of effectiveness in human clinical trials for topical dermal treatment of shingles.
Following shingles drug development, the Company anticipates developing drugs for HSV-1 cold sores and HSV-2 genital ulcers treatments using NV-HHV-101. The total market for our HerpeCide™ program drugs is estimated at several tens of billions of dollars because neither cures nor very effective treatments are available. The Company also has drug candidates in development at different pre-clinical stages in its Influenza and HIV drug programs. In addition, the Company has drug candidates against Dengue viruses, and was developing drugs against Ebola/Marburg viruses among others. The Company anticipates re-engaging these programs upon appropriate financing becoming available. Thus the Company has a rich and expanding pipeline of highly effective and safe drug candidates against a number of viral diseases.
NanoViricides is pioneering a unique platform for developing anti-viral drugs based on the "bind-encapsulate-destroy" principles. Viruses would not be able to escape a properly designed nanoviricide® drug by mutations because in doing so they would lose the ability to bind their cognate cellular receptor(s) and thus fail to infect productively, becoming incompetent.
The Company believes that enabling cGMP manufacture at large scale de-risks all of its drug programs to a substantial degree in terms of manufacturing risk. cGMP Manufacture of nanomedicines is known to be complex. Additionally, the Company expects to reduce the costs of its drug programs substantially because of being able to manufacture the drug products for human clinical trials.
NanoViricides is one of very few pre-clinical pharma companies in that it fully owns its own lab and cGMP-capable flexible custom manufacturing facility where any of our drug candidates can be produced in multi-kilogram quantities to support corresponding IND-enabling tox package studies as well as initial human clinical trials. This enables rapid translation of our drug candidates to the clinic, saving years of manufacturing translation and set-up activities, as well as saving several millions of dollars of external costs, while ensuring requisite quality assurance, as compared to using a contract manufacturing organization ("CMO") for our complex nanomedicine drugs.
There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy for shingles has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy for shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine, assuming scaling up of their production in the 2024 time-frame, and the impact of the existing Zostavax® vaccine. Of note, the Shingrix vaccine has been found to cause significant, debilitating, side effects in as many as 15%-20% of the persons receiving it. Given that shingles is not a life-threatening disease (except under certain conditions), the uptake of such a vaccine with high incidence of adverse effects may be limited. Shingrix is not yet widely available, and GSK has recently announced that additional capacity is not expected until after 2024 (https://www.reuters.com/article/gsk-vaccines/gsk-eyes-step-change-in-shingles-vaccine-output-in-2024-idUSL8N27V2AM).
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.
NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour Pharma, Inc. NanoViricides holds licenses for developing drugs against several different viruses from TheraCour, including HSV-1 and HSV-2. On November 1, 2019, the Company entered into a licensing agreement with TheraCour for an exclusive license for the Company to use, promote, offer for sale, import, export, sell and distribute products for the treatment of VZV derived indications, as previously described in our press release (www.nanoviricides.com). TheraCour is owned substantially by the Company's President and Executive Chairman of the Board, Anil R. Diwan, Ph.D.
Thus we have made significant and substantial progress in the reporting quarter towards the goal of filing our first IND application, and we continue to build on this progress.
The Company has previously stated that it will be required to raise additional capital in the near future to fund our drug candidates as they advance towards IND stage and into human clinical trials, as is the case with most if not all non-revenue innovative pharmaceutical companies.
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 Shingles and other diseases caused by VZV, 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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SOURCE: NanoViricides, Inc.