This Innovative Biotech Company Is Taking A Novel, Game-Changing Approach To Eradicating Many Respiratory Viruses Once And For All Including Tripledemic Threat Of COVID, RSV, FLU…

NanoViricides, Inc. (NYSE American: NNVC) is developing drugs that work safely and effectively even against variants; drugs that don’t rely on immune systems…great for seniors and children!

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    What’s in store for biotech in 2024? Perhaps a lot of good!

    As biotech stages a big comeback, NanoViricides, Inc. (NYSE American: NNVC) looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.

    NanoViricides, Inc. (NYSE American: NNVC) is a global leader in the application of nanomedicine technologies to the safe and effective treatment of viruses and their variants INCLUDING drugs against Covid-19, RSV and other respiratory viruses!

    Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*. 

    *Source: Transparency Market Research

    The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**. 

    **Source: Growth+ Market Reports.

    Analysts have said that the 2023 year-end spurt of biopharma mergers and acquisitions bodes well for the sector this year. The SPDR S&P Biotech ETF, which tracks the sector, had a strong November and December.

    The recent AbbVie-ImmunoGen deal “may be the start of more consistent activity we will see in 2024,” RBC Capital Markets analyst Brian Abrahams wrote in a note published late recently. “We do believe we are likely past the XBI bottom and can look to somewhat improved enthusiasm for the group—in part driven by M&A—into 2024.”

    AbbVie spent about $18.8 billion on two large deals in a matter of seven days. 

    According to an RBC Capital, the cumulative value of biopharma deals in 2023 has been $128 billion, up from $61 billion in 2022. Major acquisitions announced  include Pfizer’s $43 billion deal for the cancer-focused biotech Seagen, and Merck’s $10.8 billion deal for the immunology-focused biotech Prometheus Biosciences.

    RECENT COMPANY HIGHLIGHTS:

        • NanoViricides, Inc’s lead drug, NV-387, is in Phase 1 clinical trials. 
        • Broad spectrum antiviral NV-387 showing promise against many virus families including and beyond Tripledemic (i.e. COVID-19, RSV, FLU) . 
        • No adverse events in Phase I SAD and MAD studies even at the highest dose 40mg/Kg
        • Found to be non-immunogenic, non-mutagenic, non-allergenic, and non-phototoxic.
        • Strong safety allows use in pediatrics, adults with co-morbidities, and immune-compromised patients unlike limitations of products currently in the market.  
        • Developed Oral Syrup and Oral Gummies (soft solids) - good for geriatric and pediatric patients 
        • Drugs expected to continue to be effective even as the virus generates variants - unique receptor site doesn’t change
        • Technology mimics unique receptor site used by virus; delivers to specific targets using receptor-recognition (no bulky antibodies)

    Led by the inventor of nanoviricides technology President, Dr. Anil Diwan, and managed by a highly effective team with decades of entrepreneurial, pharmaceutical, and nanomedicine experience, Nanoviricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while expanding the drug pipeline.

    ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate!!!

    NANOVIRICIDES are better because they destroy viruses and their variants without relying on the patient's immune system, thereby making them effective for populations that include geriatric and pediatric patients..

    Antibodies only bind by two points to the virus, and destruction of the complex requires effective immune function, which is not the case in sick patients.. 

    Vaccines only train the body into producing antibodies against the virus in the vaccine. Antibodies and vaccines are easily overcome by viruses by mutating in the field, hence the need for annual influenza vaccine updates.

    See Below for Nanoviricides' Unique, Novel, Post-Immunotherapeutic “Bind-Encapsulate-Destroy” Mechanism

    NV 387 IN CLINICAL TRIALS

    The drug, developed in response to the COVID-19 pandemic, demonstrated exceptional safety in clinical trials, even at the highest dose levels, with NO adverse events reported. The unique mechanism of action involves mimicking a cell membrane, encapsulating and blocking the virus.

    Beyond COVID-19, the drug also displayed promising results against respiratory syncytial virus (RSV), offering a potential solution for infants and seniors where existing treatments like ribavirin may be contraindicated due to side effects.

    The clinical trials involved both oral tablets and oral gummies, catering to various age groups, including pediatrics. NV 387 exhibited broad-spectrum activity against multiple strains of coronaviruses, showcasing effectiveness 10 times greater than remdesivir in preclinical studies.

    The ongoing clinical trial progress and positive results position NanoViricides at the forefront of antiviral drug development, marking a significant milestone in their journey from preclinical research since 2005 to clinical trials.

    The company believes 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!

    NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families:

    • NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.
      • There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity. 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.
      • 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. 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.
    • NV-387 was as effective as the approved drug tecovitrimat (TPOXX®, SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism.
      • Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic. 
      • It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.

    NV-387 Acts by a Novel Mechanism:

    NNVC developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell.

    The company calls this novel antiviral mechanism "Re-Infection Blocker".

    In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, the company anticipates that NV-387 may have effectiveness against many other viruses. 

    NNVC plans on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications.

    NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.

    NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats:

    There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.

    NNVC believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.

    NV-387 Addresses Large Market Sizes:

    Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*. 

    *Source: Transparency Market Research

    The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**. 

    **Source: Growth+ Market Reports.

    NANOVIRICIDES TECHNOLOGY WILL TRANSFORM THE WAY VIRUSES & THEIR VARIANTS ARE TREATED WORLDWIDE!

    NNVC’s novel approach has already enabled variant-proof drugs, blocking the complete viral life cycle without requiring help from the host’s defense systems! If both the viral re-infection cycle, and viral replication cycle arms of the viral lifecycle are blocked, a cure for many viral diseases is possible!!

     The Company’s virus-specific nanoviricides have been created against important viruses such as HIV, Influenza and Bird Flu by choosing highly virus-specific ligands. 

    Broad-spectrum nanoviricides have been created that can bind to possibly as many as 90-95% of known viruses. The Company is also developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg.


    With its ongoing expansion and development of their diverse and promising product pipeline, NanoViricides, Inc. is positioned to be a dominant and innovative leader in the nanomedicine and antiviral therapy space.

    LEADERSHIP

    Creator and developer of nanomedicine technologies, Dr. Anil R. Diwan co-founded NanoViricides and currently serves as the company’s President and Executive Chairman. Diwan has over 35+ years of experience in entrepreneurship and bio-pharmaceutical R&D, including the invention of novel polymeric micelle-based nanomedicine technologies in 1991, the birth of NanoViricides, Inc in 2005, the uplisting from OTC to NYSE-mkt in 2013, and now the first clinical trials of its COVID-19 drug in 2023. Along the way, Dr. Diwan has led several of the finance efforts and has raised over 60+ MM in equity financing and has over 60 patents issued internationally resulting from three fundamental international patent applications. 

    Before that, he has won several NIH SBIR (Small business innovation research) grant awards and holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India where he held high scholastic ranks.

    THE BOTTOM LINE

    NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria!

    There is no denying that the world is changing… viruses are becoming more rampant. NNVC, an exciting NYSE company that is ahead of the problem, could see unstoppable growth ahead!

    The company has sufficient funds to complete the on-going human clinical trials for its lead drug candidate NV-CoV-2 which is the drug product based on its "nanoviricide" active pharmaceutical ingredient ("API"), NV-387.

    The successes of NV-387 as a broad-spectrum antiviral bode well for validating the multiple modalities in which NNVC’s Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.

    NanoViricides, Inc.’s innovative platform technology, R&D agility, flexible cGMP compliant facility, highly effective management team, and extensive anti-viral experience should place this company at the top of your “invest” watchlist!

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