SHELTON, CONNECTICUT — Monday, October 16, 2023 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2023 with the Securities and Exchange Commission (SEC) on Friday, October 13, 2023. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057823002146/nnvc-20230630x10k.htm).
We reported that, as of June 30, 2023, we had cash and cash equivalent current assets balance of approximately $8.15 Million. In addition, we reported approximately $8.1 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.53 Million. In comparison, as of June 30, 2022, we had cash and cash equivalent balance of approximately $14.4 Million, P&E assets of approximately $8.7 Million (after depreciation), and total current liabilities of approximately $0.41 Million.
We estimate that we have sufficient funds to complete the on-going human clinical trials for our lead drug candidate NV-CoV-2 which is the drug product based on our “nanoviricide” active pharmaceutical ingredient (“API”), NV-387.
We believe that the successes of NV-387 as a broad-spectrum antiviral (see below) bode well for validating the multiple modalities in which our Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.
We believe that NV-387 works by a novel mechanism of action, that of blocking the re-infection cycle of the viral disease. We believe that NV-387 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (for example, the S protein, and its products S1 and S2 proteins from coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of covering the virus, generally incompletely, and require immune system assistance for clearing the resulting complex.
We believe that NV-387 mimics the “Sulfated Proteoglycans” (“S-PG”) family of virus attachment receptors. This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (KSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV – Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. Therefore, NV-387 may be anticipated to exhibit strong antiviral activity against at least some, if not many, of these viruses.
We have found that NV-387 is highly active against tested coronaviruses including SARS-CoV-2 in pre-clinical studies. We are expanding our pre-clinical studies to evaluate the antiviral activity of NV-387 against other viruses. We believe that this work would expand the range of indications for NV-387. Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).
We have already found that NV-387 is highly effective against a lethal lung infection by RSV in an animal study, a result which is expected to add significantly to the commercial potential of NV-387 if the drug proves out further in clinical studies. We believe that we will be able to take RSV into Phase 2 clinical studies once the current Phase 1 studies are completed.
We believe that NV-387 has a broad spectrum of antiviral activity that is reminiscent of the antibacterial activity of antibiotics. We believe that the Nanoviricides Platform Technology is poised to revolutionize the fight against viruses just as antibiotics revolutionized the fight against bacterial infections. Antibiotics attack a bacteriological common feature, the peptidoglycan wall, of bacteria. Analogously, NV-387 is designed to attack a virological common feature, the binding of viruses to S-PG family attachment receptors.
RSV is an important pathogenic virus that can cause lethal infection in infants as well as seniors and immunocompromised persons. Two different vaccines against RSV have been recently approved by the US FDA, but none are for pediatric use at present. Two different antibodies have been approved as prophylactic (i.e. to prevent RSV infection) for babies, but are not approved as therapeutics (i.e. after disease occurs). There is no safe and effective therapeutic available for RSV. Ribavirin, a highly toxic drug that attacks red blood cells and can cause multi-organ failures is reserved for use as a last resort only in extremely severe hospitalized cases of RSV. NV-387 was almost as active as ribavirin. Additionally, NV-387 has been found to be extremely safe in pre-clinical studies. Thus, we believe NV-387 could be a clinical quality drug candidate for the treatment of RSV infections.
GrowthPlus Reports, in June 2023, said the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
NV-387 is in Phase 1 human clinical trial as two oral formulations: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies in India. The drug sponsor, Karveer Meditech Pvt. Ltd., is our licensee and collaborator and has the rights to develop and commercialize the drugs in India. As of now, 26 out of a target of 36 healthy human subjects have completed the clinical trial. There were no reports of adverse events or serious adverse events, indicating both of these formulations and the API NV-387 are extremely safe in humans. These results are consistent with our pre-clinical safety/toxicology animal studies.
In addition to the S-PG family, another important attachment receptor family is “Sialylated Glycoproteins”. Influenza viruses, some pathogenic Adenoviruses that cause epidemic kerato-conjunctivitis (EKC), as well as a large number of other viruses bind to sialic acid which is the terminal part of these receptors. We are making headways in developing nanoviricides that mimic this class of receptors.
We call the broad-spectrum nanoviricides based on such general features as the S-PG and the Sialic based receptors that are widely used by viruses for attachment as “Modality #1” of the application of nanoviricide platform technology. This modality is expected to result in very broad spectrum antiviral agents, as evidenced by NV-387.
In another methodology, that we call “Modality #2”, we have developed nanoviricides that specifically bind to a specific type of virus, mimicking the cell-surface receptor to which the virus binds in order to gain entry into cells (called the “cognate” receptor). We have developed NV-HHV-1 as an antiviral that is active against certain herpesviruses. NV-HHV-1 has completed IND-enabling studies. Its first indication, formulated as a skin cream, is for the treatment of Shingles rash. It has been found to be active against HSV-1 (“cold sores”), HSV-2 (“genital herpes”) and VZV (Chickenpox and Shingles) in pre-clinical studies. We have also developed an anti-HIV drug candidate that mimics CD4 which is used by HIV.
No matter how much a virus mutates, changes, or generates new variants, it continues to utilize the same attachment receptor(s) and the same cognate receptor(s) and, further, binds to the receptor(s) at the same locations. Thus, the virus is expected to be unlikely to escape a nanoviricide drug if our nanoviricide properly mimics the location on the cellular receptor that the virus uses.
This very much sought-after feature sets apart our Nanoviricides Platform Technology from other antiviral approaches. The virus learns to escape readily the battery of conventional approaches, which is comprised of antibodies, vaccines, and small chemical drugs, as has been amply evidenced in the COVID-19 pandemic, the recurring Influenza pandemics and epidemics, the on-going HIV pandemic, and other instances.
We are particularly excited about our “Modality #3” of applying the Nanoviricide Platform Technology that we believe will enable true cures for a large number of viral infections. In this modality, we have been able to create a nanoviricide that (i) blocks the virus particle from infecting a new cell in the first place, and (ii) holds in its belly another API that blocks the virus that has infected a cell from making and releasing its copies. We believe such a nanoviricide would be a true cure for infections of viruses that do not generate latent infections in the body. This modality goes beyond the conventional approach of treating a patient with multiple drugs simultaneously, in at least two ways: (i) as an infrequent single drug treatment that improves patient compliance, and (ii) by virtue of the improvement in the pharmacokinetics of the guest API due to the nanoviricide encapsulant. We have already demonstrated that NV-387-g-R, which is remdesivir as guest encapsulated within the polymeric micelle of NV-387, protects remdesivir from bodily metabolism.
In a fourth modality, we are conducting preliminary research to harness the power of the Nanoviricide Platform Technology to cure latent virus infections as well.
We have not only established a broad and expanding antiviral drug pipeline, led by NV-387 for coronavirus infections (clinical), NV-387 for RSV infections (advanced pre-clinical), and NV-HHV-1 for treatment of Shingles rash (IND-enabling), and many other pre-clinical drug candidates, but have also developed the Nanoviricide Platform Technology to the level that cures against many virus infections can now be envisaged.
We have made significant progress despite limited resources in our endeavor of curing viral infections using the power of the Nanoviricide Platform Technology, and this year, we have been able to take the first nanoviricide drug into human clinical trials. We believe this opens a new era in the development of NanoViricides, Inc. We plan on seeking non-dilutive as well as equity-based funding as we go forward in this quest.
What is a “nanoviricide”?
A “nanoviricide” is a uniform polymer that self-assembles into nanoscale droplets called “micelles”, that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus “looks like” a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called “lipid-lipid mixing.” We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.
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-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of factors including external collaborators and consultants. NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.
NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including RSV, 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, Ebola/Marburg viruses, and human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, if the initial research is successful. 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.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
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. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. “Prodrug” means a chemical that is readily converted into the referenced drug in the body.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides, Inc.