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THIS INNOVATIVE BIOTECH COMPANY IS TAKING A NOVEL, GAME-CHANGING APPROACH TO
ERADICATING MANY RESPIRATORY VIRUSES ONCE AND FOR ALL INCLUDING THE TRIPLEDEMIC
THREAT OF COVID, RSV, AND THE FLU!



NANOVIRICIDES, INC. (NYSE AMERICAN: NNVC) IS A GLOBAL LEADER IN BROAD-SPECTRUM
ANTIVIRAL NANOMEDICINES DEVELOPING DRUGS THAT WORK SAFELY AND EFFECTIVELY EVEN
AGAINST VARIANTS.



THESE DRUGS DO NOT RELY ON IMMUNE SYSTEMS MAKING THEM GREAT FOR SENIORS AND
CHILDREN!



DOWNLOAD THE CORPORATE PRESENTATION


Learn More about Nanoviricides, Inc. by gaining access to the latest corporate
presentation







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NV-387 - A NOVEL BROAD-SPECTRUM ANTIVIRAL WITH ACTIVITY AGAINST RSV.


NanoViricides, Inc. (NYSE American: NNVC)’s lead drug candidate is NV-387 (drug
product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza,
Bird Flu H5N1, and other respiratory viral infections. 

NV-387 has completed a Phase 1a/1b human clinical trial in healthy subjects with
no reported adverse events even at the highest and repeated dosages. 

The Company is currently focused on advancing NV-387 into Phase II human
clinical trials for the treatment of RSV infection.

NNVC has reported that the antiviral activity of NV-387 against RSV/A2 is strong
enough to have resulted in the full survival of lethally infected animals!

In this study, extended dosing of NV-387 given orally was compared with a high
dose of ribavirin given orally for the same duration. Two doses were given on
first day of dosing followed by one daily dose for next 9 days (for a total of
11 doses). NV-387 given by this dosing regimen led to complete survival of the
mice beyond the 21 days study period, with no signs of pathology (disease)
apparent on the last day of observation. In contrast, ribavirin led to death of
all animals by 14 days!

Ribavirin is the only currently approved drug for RSV infection, that can be
used only as a last resort because of its extensive toxicity that limits its
effectiveness.


NANOVIRICIDES, INC. (NYSE AMERICAN: NNVC) BELIEVES NV-387 ORAL TREATMENT COULD
POTENTIALLY CURE RSV INFECTION!


RSV is an important disease in infants and children less than 5 years old, as
well as in older persons over 65 years old. According to the CDC, each year in
the United States, RSV leads to approximately:

 * 58,000-80,000 hospitalizations among children younger than 5 years old;
 * 60,000-160,000 hospitalizations among adults 65 years and older;
 * 6,000-10,000 deaths among adults 65 years and older; and
 * 100-300 deaths in children younger than 5 years old.

Two vaccines have recently been approved for protection of persons 60+ years old
from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer).

Abrysvo was recently approved for use in pregnant women for protection of
infants. Synagis (palivizumab), an antibody, as well as a new antibody,
nirsevimab (Beyfortus®) have been approved by the US FDA for protection of
newborn children at risk of RSV disease.




NANOVIRICIDES, INC. (NYSE AMERICAN: NNVC) BELIEVES NV-387 ORAL TREATMENT COULD
POTENTIALLY CURE RSV INFECTION!


No approved treatment currently exists for RSV other than ribavirin. This means
a safe and effective treatment remains an unmet medical need and offers NNVC an
incredible market opportunity.

"This is an extremely significant result. To date, in our lethal infection
animal models, we have not observed uniform survival with any of the treatments,
including approved drugs, against viruses that include Influenza A,
Smallpox/Mpox, and Coronaviruses. Our studies are designed to be so lethal that
the survival lifetime itself can be used as the ranking parameter to evaluate
the effectiveness of a treatment. Complete survival is not expected in such
studies, unless the drug is extremely effective."

Anil R. Diwan, PhD, President and Chairman of the Company


NV-387 POSSESSES STRONG ANTI-INFLUENZA-A VIRUS ACTIVITY, AND MAY ALSO HAVE
ACTIVITY AGAINST H5N1 BIRD FLU VIRUS!

NNVC reported that in a lethal animal model of lung infection by Influenza A
/H3N2 virus, NV-387 was found to have substantially superior antiviral effects
compared to three approved anti-influenza drugs.

The company performed a lethal lung infection study of mice infected with
Influenza A/H3N2 that were treated with NV-387 or one of the three approved
drugs for direct comparison: Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®,
Biocryst), and Baloxivir (Xofluza®, Shionogi, Roche). 

In this study, NV-387 Oral treatment led to a survival lifespan of 15 days,
compared to 10 days with Oseltamivir Oral treatment, 11 days with Peramivir I.V.
treatment, and 11 days with Baloxivir Oral treatment, while the vehicle-treated
and untreated (infected) animals survived only 8 days!

Thus the anti-Influenza activity of NV-387 given orally was substantially
superior to all three of the approved anti-influenza drugs, namely Tamiflu,
Rapivab, and Xofluza.

GIVEN THE BROAD SPECTRUM OF ANTIVIRAL ACTIVITY OF NV-387 AGAINST VIRUSES IN MANY
DIFFERENT VIRUS FAMILIES, NNVC BELIEVES THAT ITS EFFECTIVENESS AGAINST INFLUENZA
A/H3N2 IS INDICATIVE OF POTENTIAL ANTIVIRAL ACTIVITY AGAINST MOST IF NOT ALL
INFLUENZA A VIRUSES.



A NOVEL BROAD-SPECTRUM ANTIVIRAL WITH ACTIVITY AGAINST SMALLPOX/MPOX.


The ultra-broad antiviral activity spectrum of NV-387 includes activity against
orthopoxvirus family (Smallpox/Mpox), with both inhalation and skin abrasion
(sexual) modes of infection acquisition. 

Ectromelia virus infection of mice is a model for Smallpox infection in humans,
and also serves as a surrogate for MPox infection in humans. All three viruses
belong to the orthopoxvirus family.

NNVC completed a lethality animal study wherein animals were infected with
ectromelia virus into the lungs directly. In this study, the company found that
NV-387 alone treated animals survived 15 days, tecovirimat alone treated animals
survived 16 days, and NV-387 plus tecovirimat treated animals survived 19 days,
whereas vehicle-treated animals died in 8 days.

This lung-infection study emulates infection from aerosolized dispersion of the
virus, as may be expected in a bioterrorism scenario.

Previously, on November 14, 2023, we have reported that in a lethal intradigital
footpad infection of mice with ectromelia virus, oral NV-387 treatment led to
lifespan improvement comparable to oral tecovirimat treatment, with both
treatments resulting in 14 days survival, whereas vehicle treated animals died
in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat
resulted in a significantly improved survival of 17 days in this study.



Tecovirimat is the drug approved for smallpox under "animal rule" and is
stockpiled by the Biomedical Advanced Research and Development Authority
(BARDA). It was mobilized from the stockpile during the recent MPox Clade 2
pandemic. 

BARDA is interested in development of additional poxvirus therapeutics as per a
recent Broad-Agency Announcement (BAA). There is significant interest in the
development of a smallpox therapeutic that works well by itself, as well as in
combination with the known drug, tecovirimat. Tecovirimat has a low barrier of
escape; a single mutation in one protein can enable the virus to escape this
drug, adding to the significance of additional smallpox drug development.

NNVC believes that NV-387 is a viable clinical candidate to be developed by
itself for the treatment of poxvirus infections under the US FDA "Animal Rule".
In addition, the company believes that the combination of NV-387 and tecovirimat
could reduce the potential for escape resistant generation against tecovirimat,
as is known with other drug combination studies against viruses.

A safe and effective antiviral drug that the virus would not escape by simple
mutations or field evolution is the holy grail of antiviral drug development!




NANOVIRICIDES, INC. IS CLOSE TO HAVING A SINGLE DRUG NV-387 FOR THE TREATMENT OF
ALL OF THE TRIPLEDEMIC RESPIRATORY VIRUSES - CORONAVIRUSES, RSV, AND INFLUENZA
A, WHICH WOULD BE A REVOLUTIONARY ACHIEVEMENT!



LEARN MORE ABOUT NANOVIRICIDES, INC. BY GAINING ACCESS TO THE LATEST CORPORATE
PRESENTATION


Download Research Report





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:


 * 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)

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.

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.


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!

As biotech stages a big comeback, one NYSE-traded company looks well-positioned
to be a market disruptor with nontoxic, effective antiviral therapies based on
patented nanomedicine technology. 

This global leader in broad-spectrum antiviral nanomedicines had remarkable news
recently, revealing that the antiviral activity of its NV-387 oral treatment
against RSV/A2 is strong enough to have resulted in full survival of lethally
infected animals. The company believes the NV-387 oral treatment is capable of
curing RSV infection. Why is this important? Because there is currently no
approved treatment for RSV other than ribavirin. A safe and effective treatment
remains an unmet medical need!

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.

This year the company has a focus on advancing NV-387 through further clinical
trials, expanding its treatment capabilities to address unmet medical needs.
This includes RSV, the flu, and other viruses.

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!

START YOUR RESEARCH NOW




LEARN MORE ABOUT NANOVIRICIDES, INC. BY GAINING ACCESS TO THE LATEST CORPORATE
PRESENTATION


Download PRESENTATION


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