NanoViricides Highlights Broad Antiviral Effectiveness Of NV-387; Expects Accelerated Development And Early Revenues From MPox, Smallpox, And Measles Indications

NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC ) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, explains that the strong effectiveness of its broad-spectrum antiviral drug against all viruses that the drug NV-387 was tested against to date will drive significant valuation for its portfolio. The Company further elucidates that the MPox, Smallpox, and Measles indications of NV-387 are expected to enable rapid regulatory development towards approval and realization of early revenues from multiple pathways.

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.