Star Metro - NanoViricides Discusses the Multi-Billion-Dollar Potential of Its Broad-Spectrum Drug NV-387; Its Effectiveness Against Influenza, Coronaviruses, RSV, MPox and Now Measles Expected to Drive Value

As additional indications of NV-387 have been validated in animal studies, approvals against the multiple indications of NV-387 are expected to drive increase in overall market share that the Company can achieve once the drug is approved. The costs leading up to Phase II clinical trial would be substantially common across all indications of this same drug, improving return on investment significantly.

Additionally, NV-387 should become the drug of choice to develop and stockpile for strategic pandemic preparedness and response because of its activity against most of the viruses of concern at present: Influenza, Coronaviruses, Orthopoxviruses (Smallpox and Mpox), and Measles. The Company believes that NV-387 is likely to be effective against Ebola/Marburg viruses, Hendra/Nipah viruses, and other lethal viruses as well, based on known binding of these viruses to HSPG. In addition to the USA, UK, Europe and India have established agencies to enable pandemic preparedness and response.

Approval of NV-387 against any of the currently established indications would drive its value as a strategic tool for pandemic preparedness against a multiplicity of potential threats. Pandemic preparedness is already a multi-billlion dollar market globally, and growing, as additional countries and regions seek to fortify their public health defenses against unknown viral threats. (see further below).

To this end, the Company is moving forward to open a Phase II clinical trial to evaluate effectiveness of NV-387 to treat MPox virus infections. If the trial is successful, NV-387 will be the first ever drug to be approved for MPox ^[1] . There is no effective drug for MPox at present.

Such approval will also translate to NV-387 as a currently best available option for potential smallpox therapeutics as well, based on human infection data of the smallpoxvirus-related virus MPXV , rather than animal orthopoxvirus data that FDA has currently relied upon ^[1] .

Additionally, the Company intends to file for orphan drug status for several indications of NV-387, including MPox, Smallpox, and Measles. Each orphan drug indication in itself would result in several economic benefits, in addition to increased interactions with the FDA.

We believe some of the indications of NV-387 will be eligible for Fast-Track designation, as well as for awards of Priority Review Vouchers (PRV). A PRV is a tradable instrument that has been traded at about $150 million to $250 million dollars each because the buying pharma company can apply the PRV for any one drug to expedite its own drugs in development. Thus PRVs could enable an early revenue source for the Company if awarded.

The speed with which a first indication of NV-387 can be approved is estimated to be the fastest for Mpox, Smallpox, and Measles. This is because of the specific orphan drug characteristics of these diseases in the USA. This is why the Company has prioritized these indications.

The Company is continuing its work on planning of clinical trials for what are generally considered as commercially lucrative indications that include Influenza, RSV, other respiratory viruses, as well as coronaviruses.

Viruses crossing over newly into humans from other species do so only upon acquiring significant ability to bind to HSPG, the cell-side molecule that NV-387 mimics as a decoy for the viruses ^[2] . It is highly unlikely that bioterrorism agents would be created that can drastically infect humans and yet do not bind to HSPG.

To date, pandemic preparedness has been dominated by one-drug-one-bug philosophy. With hundreds of potential biothreats, such a strategy is too expensive and would not realize a highly effective protective shield against potential pandemics.

Besides, the medical countermeasures pursued to-date for pandemic preparedness are severely lacking in that every one of them would be readily defeated by the virus as it mutates or evolves in the field. This is one lesson that has become starkly clear after the COVID-19 pandemic.

NV-387 is expected to provide a low cost option for pandemic preparedness against a multiplicity of threats, and could become an effective first response drug for practically any viral pandemic. Over 90% of viruses that can cause disease in humans are known to bind to HSPG. Our development of NV-387 suggests that most of these viruses would be susceptible to NV-387. Moreover, escape from NV-387 is highly unlikely because even as viruses mutate or evolve, they continue to bind well to HSPG as long as they are pathogenic in humans.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") ( www.nanoviricides.com ) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug 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 external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

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". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

^[1] Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox therapeutics based on animal model data generated in animal infections by animal native orthpoxviruses. Tecovirimat failed in clinical trials of MPox. Brincidofovir caused sever drug-induced liver injury (DILI) in there of three patients given the drug in case studies, not in clinical trial.

^[2] It has been reported that highly pathogenic duck influenza viruses that lack or substantially lack HSPG binding ability do not cause significant pathology in other birds, nor in humans. They appear to use exclusively sialic acid-related receptors and yet have failed to infect other species. We believe these results require further investigation.

SOURCE: NanoViricides

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A.Harris--SMC