SHELTON, CT / ACCESSWIRE / October 15, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2020 with the Securities and Exchange Commission (SEC) on Tuesday, October 12, 2020. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000110465920114577/tm2024737-1_10k.htm).
The Company reported that, as of June 30, 2020, it had cash and cash equivalent current assets balance of approximately $14 Million. In addition, the Company reported $9.54 Million in Property and Equipment (P&E) assets. The strong P&E assets comprise the Company's cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were $2.15 Million. In comparison, as of June 30, 2019, we had cash and cash equivalent balance of approximately $2.8 Million, P&E assets of approximately $10.2 Million, and no debt. Subsequent to the reporting period, the Company raised approximately $10.5 Million net proceeds from an equity offering on or about July 20, 2020, further increasing its cash assets.
The Company believes it has sufficient funds to move at least one and possibly two drug candidates into initial human clinical trials with available funds.
The Company has completed preclinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-101. The Company was in the process of human clinical trial design and site selection for this drug candidate when the COVID-19 pandemic struck the world. The viral pandemic had an adverse impact on the clinical trial design and the Company chose to set aside this project until the pandemic situation resolves, and re-engage with filing an IND and performing clinical trials for NV-HHV-101 regulatory approvals thereafter.
Since January 2020, the Company has been engaged in novel drug development to treat human infection by SARS-Cov-2, the coronavirus that has caused the global pandemic of the COVID-19 spectrum of diseases. In a short period of time, the Company has met several milestones in this new drug development program.
The nanoviricide platform technology is a leading nanomedicine technology that uniquely enables attack on both (a) the virus particles outside cells and (b) the replication of virus inside cells. If both of these factors can be controlled effectively, then the resulting drug could be a cure for the viral disease. In contrast, antibodies only bind to the virus particles outside cells, and tag them for the immune system for further processing, whereas antiviral small chemical drugs affect only the replication cycle of the virus inside cells.
The Company is currently advancing "second generation" coronavirus drug candidates that are capable of simultaneously attacking the external virus particles and the intracellular viral replication, in addition to our "first generation" nanoviricide drug candidates that are designed to attack and potentially dismantle the external virus particles.
The Company is continuing to work on multiple drug candidates simultaneously in its fast-paced coronavirus program to minimize the risks of possible failures associated with the many stages of drug development. The Company has declared a clinical drug candidate recently, with additional drug candidates as back-up candidates. These drug candidates have already shown effectiveness against multiple coronaviruses in cell culture studies. These drug candidates have further shown strong effectiveness in animal model studies of a coronavirus, namely hCoV-NL63, related to SARS-CoV-2, with both viruses utilizing the same human ACE2 receptor for binding and entry into cells. There is no validated animal model for SARS-Cov-2 infection as yet. If and when such a validated animal model becomes available, it will only be available in BSL3/4 bio-containment facilities.
The Company has already produced several hundred grams of these drug candidates in cGMP-like conditions in its own cGMP-capable drug manufacturing facility. The Company plans to advance one or more of its coronavirus drug candidates into core pre-clinical safety/toxicology studies soon. The Company plans on filing a pre-IND application with the US FDA for a selected clinical candidate to seek further guidance towards an Investigational New Drug application (IND) and human clinical trials. The Company cannot provide definitive timelines for entry into clinical trials because of extensive dependence on external labs, regulatory consultants, and contract service providers. However, the Company is aggressively and rapidly advancing these drug candidates further with the goal of making a significant impact in terms of curing the coronavirus infection.
Research and development expenses for the year ended June 30, 2020 were approximately $4.69 Million, less than the prior year ending June 30, 2019, of about $5.92 Million. The reduction was primarily due to reduction in R&D staff. General and administrative expenses (G&A) were at about $3.3 Million, compared to $2.7 Million in the prior year. The increase in G&A is primarily due to increase in legal, professional, and consulting costs, most of which were related to the expenses related to the equity financings.
For the year ended June 30, 2020, the Company had a net loss of about $13.45 Million, or a basic loss per share of $2.39 compared to a net loss of about $8.42 Million, or a basic loss per share of $2.35 (adjusted) for the year ended June 30, 2019.
During the fiscal year, the Company performed a uniform reverse stock split of all of its equity instruments at a 20:1 ratio in September 2019. The Company arranged an Open End Mortgage Note of up to $2 Million with its founder and President, Dr. Anil R. Diwan, Ph.D., and borrowed $1.1 million of this note in December 2019. In addition, the Company was able to convert $250,000 of accounts payable to TheraCour Pharma into restricted preferred Series A shares in Decembe, 2019. These two transactions together provided a much needed cash infusion of up to $2.3 million to the Company at a critical time. Subsequently, the Company raised equity-based financing in a registered direct offering (RDO) of its common stock in January, 2020, with net proceeds of about $7.45 Million, and another RDO in May, 2020, with net proceeds of about $9.22 Million, for a total of $16.67 Million. In addition, subsequent to the reporting period, in July 2020, the Company raised equity-based financing in another RDO with net proceeds of about $10.53 Million. There were no warrants issued in any of these transactions. Further details of these transactions are reported in the Annual Report.
During the fiscal year, the Company has continued to strengthen its management team and its Board of Directors with two key additions and a view towards further growth. Dr. Makarand Jawadekar, an ex-Pfizer executive with 30+ years of big pharma experience in drug development and business development joined the Board of Directors as an independent director in February, 2020. In addition, Honorable Mr. Theodore ("Todd") Rokita, a former Congressman from Indiana joined the Board of Directors as an independent director in May, 2020.
The market potential for a drug against SARS-Cov-2 is expected to be significant, based on various deals reported in industry news articles that have reached into several hundreds of millions of dollars. In addition, the market size for our immediate target drugs in the HerpeCide program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials, after the coronavirus program drug candidate. The Company believes that additional topical treatment candidates in the HerpeCide program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
The Company's drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. 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 VZV (shingles), HSV-1 and HSV-2. Additionally, the Company and TheraCour have signed a Memorandum of Understanding for the field of human coronavirus infections, which has provided a limited development license to the Company at no additional cost. A definitive agreement is currently being negotiated between the parties.
The Company intends to perform the regulatory filings and own all the regulatory licenses for the drug candidates it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
In general, as a pharmaceutical company achieves drug development milestones, its risk-profile with investors improves as reflected in the market capitalization. Management believes that as the Company achieves these milestones, it could significantly improve the Company's ability to raise funds in the public markets. However, there can be no assurance that the Company will achieve any of these milestones or that such achievements will reflect favorably in the Company's share price and market capitalization metrics.
NanoViricides is a global leader in the application of nanomedicine technologies to the complex issues of treatments for viral diseases. 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.
Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. We believe that our drug candidates would be difficult for a virus to escape because these binding sites for a given virus do not change despite mutations and other changes in the virus. Further, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
The nanoviricide platform is designed to additionally hold small molecule active pharmaceutical ingredients (API's) of different types in its "belly". This allows targeted delivery of the encapsulated API to infected cells, and is also expected to improve the pharmacokinetic and pharmacodynamic properties of the API, such as rapid metabolism. Rapid metabolism is known to be an effectiveness-limiting factor for many drugs, including remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been approved under emergency use regulations in the USA as well as in many other countries.
NanoViricides, Inc. (the "Company") (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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we have declared a clinical development candidate, namely NV-CoV-1-R, which encapsulates remdesivir inside NV-CoV-1, for the treatment of COVID-19. The Company cannot project an exact date for filing an IND for NV-CoV-1-R because of its dependence on a number of external collaborators and consultants. The Company is now working on performing required safety pharmacology studies and completing an IND application for NV-CoV-1-R. The Company believes that since remdesivir already has an emergency use approval, NV-CoV-1-R is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed NV-CoV-1-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
The Company is also 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. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Forward Looking Statements
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. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".
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