As of December 31, 2023 NNVC had cash and cash equivalent current assets balance of approximately $5.31 Million

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…

ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We have a new profile that we want you to put back on your radar for Wednesday’s session.

This is a company that we profiled a few weeks back when it was sitting at lower levels.

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.

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.

NNVC 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 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 (previously referred to as NV-HHV-101). 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-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 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 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 poxviruses and/or enteroviruses 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.

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)

A New Era in Targeted Anti-Viral Therapeutics

NanoViricides, Inc. is a globally leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.

Our anti-viral therapeutics, that we call “nanoviricides®” are designed to appear to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. Viruses would not be able to escape the nanoviricide by viral mutations since they continue to bind to the same cellular receptor and thus would be captured by the nanoviricide. Virus escape by mutations is a major problem in the treatment of viral diseases using conventional drugs.

Versatile Platform Technology

A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates

Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone “nanomicelle”, separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry.

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 developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg. This is similar to antibiotics such as penicillin against bacteria that exploit a feature common to all bacteria.

A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design

A single nanoviricide micelle may be capable of completely engulfing a Virus Particle. Nanoviricide micelles self-assemble from multiple chains. A single chain micelle shown for convenience. Illustration not to scale.

Each nanoviricide drug is designed as an antiviral agent specifically targeted for a particular type of virus or group of viruses. Most existing anti-viral agents are known to have non-specific effects against both host cells and viral machinery at the same time often leading to side effects. Most current anti-viral agents act inside human cells. It is believed that this intracellular mechanism leads to significant opportunities for unwanted side effects against host cells. Nanoviricides, on the other hand, are designed to work directly against virus particles in bodily fluids. The Company believes that this approach may make nanoviricides inherently safer than existing approaches.

A nanoviricide is designed to seek and attach to a specific virus particle, engulfing the virus particle in the process, thereby rendering it incapable of infecting new cells, and disabling it completely. This suggested mechanism of action encompasses much more than what the current entry and fusion inhibitors are expected to do. The fusion and entry inhibitors do not completely cover the virus particle, likely blocking only a few sites on the virus particle. This means the virus particle may still be capable of infecting cells using its unblocked attachment sites. In contrast, a nanoviricide, because of its larger size and flexible nature, is expected to engulf the virus particle completely, thus disabling the virus particle. The action of a nanoviricide, if it works as designed, may be expected to be superior to antibody agents that attack viruses. Antibodies, being large, are expected to block relatively greater portions of the virus particle surface compared to small molecule entry inhibitors. However, antibodies depend upon the human immune system responses for clearing the virus particle. In contrast, nanoviricides are thought to be capable of acting as completely programmed chemical robots that finish their task of destroying the virus particle on their own.

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 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.

A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricides

SHELTON, CONNECTICUT – Wednesday, May 8, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that 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.

NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.

This lung infection study substantiates the results of the previously reported intradigital footpad infection study that: (i) NV-387 has comparable antiviral activity as tecovirimat, and
(ii) NV-387 plus tecovirimat has much stronger antiviral activity than either drug alone.

We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly. In this study, we 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.

Survival Lifespan of Lethally Infected Mice – Lung Infection with Ectromelia Virus

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.

Survival Lifespan of Lethally Infected Mice – Intradigital Footpad Infection with Ectromelia Virus

This intradigital footpad infection study emulates the skin-to-skin transfer of the virus as in sexual transmission, such as that in the case of current Clade 1 MPox virus epidemic in the DR Congo; Clade 1 MPox is more deadly than the Clade 2 MPox; the latter had caused a small pandemic recently with sexual mode of transmission (https://www.sciencefocus.com/news/monkey-pox-new-strain , May 5, 2024).

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.

Therefore we believe 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, we believe 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. We believe that the NanoViricides Platform technology meets this challenge.

A Novel Broad-Spectrum Antiviral with Activity Against RSV -Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral Treatment

SHELTON, CONNECTICUT – Tuesday, May 14, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that antiviral activity of NV-387 against RSV/A2 is strong enough to have resulted in full survival of lethally infected animals was achieved.

In this study, extended dosing of NV-387 given orally was compared with a high dose of ribavirin given orally. Two doses were given on first day of dosing followed by one daily dose for next 9 days (total 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 apparent on the last day of observation. In contrast, ribavirin led to death of all animals by 14 days.

Survival Lifespan of Lethally Infected Mice – Lung Infection with RSV A2

TreatmentSurvival, DaysIncrease in
Survival, DaysIncrease in
Survival, %NV-387, Oral22+ (Complete)> 14> 175%Ribavirin, Oral14675%Vehicle800%

Thus we believe NV-387 oral treatment is capable of curing RSV infection. There is currently no approved treatment for RSV other than ribavirin. A safe and effective treatment remains an unmet medical need.

“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 most viruses including Influenza A, Smallpox/Mpox, and Coronaviruses,” said Anil R. Diwan, PhD, adding, “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.”

Previously, in July 2023, we reported that NV-387 treatment led to survival in lethally RSV infected animals equal to that observed with ribavirin treatment. In this study, we extended the dosing regimens of both ribavirin and NV-387, to determine if that improves survival.

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.

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, but not for treatment of RSV infection and disease.
About NanoViricides

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. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.

Our 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 successfully 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 treatment of RSV infection.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 “cold sores” and HSV-2 “genital ulcers”. 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 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 poxviruses and/or enteroviruses 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.

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”. API means active pharmaceutical ingredient.

The Sustained, Slow Declining, Blood Concentration Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect -A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More

SHELTON, CONNECTICUT – Tuesday, June 4, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a nonhuman primate (NHP) animal model.
The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidateNV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau ofblood concentration of the drug with very slow decline over a 24 hour period in a cynomolgusmonkey model.
The maximum concentration as well as the plateau concentration increased in a dose-dependentmanner, as expected.
This sustained drug level in the blood stream for a relatively long period of time enablesinfrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a”chemical nanomachine”. It is made up of polymer with its size chosen to minimize loss by renalfiltration.
The observed pharmacokinetic profile of NV-387 supports a once-daily or less frequent dosingregimen.
The Company has already developed an injectable formulation of NV-387, namely NV-387Solution for Injection, Infusion, and Inhalation.
An injection of NV-387 would be useful for moderate to severe illness, especially because of thesustained blood profile that requires infrequent dosing.
An infusion would be suitable for severely ill hospitalized patients.
Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patientusing a simple handheld nebulizer over a period of a few minutes. Such delivery can enable directattack on the virus where such attack is most needed in the cases of severe lung infection.
The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics.
We have found that NV-387 could cure lethal lung infection in RSV infected animals even withan oral dose. There is no approved drug for RSV treatment other than the toxic, last resort drugribavirin, which was not very effective in this lethal study compared to NV-387.
We have also found that NV-387 IV administration as well as PO (oral) administration wassubstantially superior to each of the approved drugs Tamiflu, Rapivab and Xofluza in anInfluenza A/H3N2 lethal lung infection model.
We believe that NV-387 is expected to possess similar strong antiviral activity against InfluenzaA/H5N1 “Bird Flu” viruses as well. Our belief is based on the putative mechanism of NV-387.
NV-387 is a host-mimetic, direct acting antiviral designed as decoy, to look like a cell decoratedwith sulfated proteoglycans, to which over 90% of human pathogenic viruses, including H5N1,are known to bind.
We have found that NV-387 has strong antiviral activity against all tested coronaviruses,including SARS-CoV-2 pseudovirions. NV-387 was substantially more effective than remdesivirin a lethal coronavirus infection animal study. We believe that NV-387 has a strong potential forthe treatment of COVID as well as “Long COVID”.
COVID continues to cause substantially more fatalities annually than Influenza viruses. LongCOVID has substantial personal as well as societal costs. Available drug, Paxlovid (Pfizer) hassignificant limitations for patient suitability. Thus a new drug against COVID and Long COVIDis sorely needed.
About NanoViricidesNanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a development stage companythat is creating special purpose nanomaterials for antiviral therapy. The Company’s novelnanoviricide® class of drug candidates are designed to specifically attack enveloped virusparticles and to dismantle them. Additionally, nanoviricides mimick the host-side features that theviruses continue to require in spite of mutations, and therefore the viruses would be highlyunlikely to escape the nanvoricide drugs.
Our 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 successfully completed a Phase 1a/1b human clinical trial in healthy subjects with noreported adverse events even at the highest and repeated dosages. This trial was conducted by thedrug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.
The Company is currently focused on advancing NV-387 into Phase II human clinical trials fortreatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 “coldsores” and HSV-2 “genital ulcers”. The Company cannot project an exact date for filing an INDfor any of its drugs because of dependence on a number of external collaborators and consultants.
The Company is also developing drugs against a number of viral diseases including oral andgenital 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. NanoViricidesholds a worldwide exclusive perpetual license to this technology for several drugs with specifictargeting 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 forpoxviruses and/or enteroviruses if the initial research is successful. The Company’s technology isbased on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas fromTheraCour Pharma, Inc. The Company’s business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specific viruses, as established at itsfoundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug developmentof any pharmaceutical product is extremely lengthy and requires substantial capital. As with anydrug development efforts by any company, there can be no assurance at this time that any of theCompany’s pharmaceutical candidates would show sufficient effectiveness and safety for humanclinical development. Further, there can be no assurance at this time that successful results againstcoronavirus in our lab will lead to successful clinical trials or a successful pharmaceuticalproduct.
This press release contains forward-looking statements that reflect the Company’s currentexpectation regarding future events. Actual events could differ materially and substantially fromthose projected herein and depend on a number of factors. Certain statements in this release, andother 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 SecuritiesExchange Act of 1934. You should not place undue reliance on forward-looking statements sincethey 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 publiclyupdate or revise these forward-looking statements for any reason, or to update the reasons actualresults could differ materially from those anticipated in these forward-looking statements, even ifnew information becomes available in the future. Important factors that could cause actual resultsto differ materially from the company’s expectations include, but are not limited to, those factorsthat are disclosed under the heading “Risk Factors” and elsewhere in documents filed by thecompany from time to time with the United States Securities and Exchange Commission andother regulatory authorities. Although it is not possible to predict or identify all such factors, theymay include the following: demonstration and proof of principle in preclinical trials that ananoviricide is safe and effective; successful development of our product candidates; our abilityto 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 ourproducts.
The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer toresearch findings including clinical trials as the customary research usage and do not indicateevaluation of safety or effectiveness by the US FDA.
“NOAEL” means “No-Observed-Adevrese-Event-Level”, which is the maximum dosageemployed at which there were no adverse events found in animal studies.
“MTD” means “Maximum Tolerated Dose”, which is the maximum dosage employed that doesnot compromise survival of the animals.
FDA refers to US Food and Drug Administration. IND application refers to “Investigational NewDrug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to”Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Productsfor Human Use, which is the European Medicines Agency’s (EMA) committee responsible forhuman medicines. API stands for “Active Pharmaceutical Ingredient”. API means activepharmaceutical ingredient.

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NEWS

June 4, 2024 – This is NHP PK profile of NV-387 which showed desirable unusually slow declineMay 29, 2024 – A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More – Novel Host-Mimetic, Virus Killing Technology PlatformMay 23, 2024 – NanoViricides Bolsters Partnership Efforts – Engages Aagami IncMay 20, 2024 – The RSV animal study lung histopathology results are astounding. They indicate complete cure ofRSV by NV-387 treatment. Only partial protection for some time by ribavirin treatment.May 15, 2024 – NanoViricides Has Filed its Quarterly Report – NV-387 Advancing to Phase II Clinical Trial for the Treatment of RSV InfectionMay 14, 2024 – A Novel Broad-Spectrum Antiviral with Activity Against RSV – Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral TreatmentMay 10, 2024 – NanoViricides to Participate in the 2024 EF Hutton Annual Global Conference On May 15 in New York CityMay 8, 2024 – A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricidesMay 6, 2024 – NA Novel Broad-Spectrum Antiviral with Activity Against Influenza A – NV-387 Possesses Strong Anti-Influenza-A Virus Activity, and May Have Activity Against H5N1 Bird Flu Virus, Says NanoViricidesApril 30, 2024 – NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected SoonFebruary 15, 2024 – NanoViricides Has Filed its Quarterly Report – NV-387 Clinical Trial Healthy Subjects Part Successfully Completed, COVID Patient Treatment on the HorizonFebruary 1, 2024 – Clinical Trial Demonstration of Safety and Tolerability of NV-CoV-2 Has Implications Beyond COVID Treatment, Explains NanoViricides – NV-387 Could be As Revolutionary as AntibioticsJanuary 29, 2024 – Safety in Multiple-Ascending-Dose Healthy Subjects Clinical Trial Part Successfully Established for the NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2 with No Adverse Events FoundJanuary 4, 2024 – NanoViricides to Present at the Biotech Showcase in San Fransisco

MANAGEMENT

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Anil R. Diwan, PhDExecutive Chairman, President

Dr. Diwan has been President and Chairman of the Board of the Company since its founding in 2005 Dr. Diwan spearheaded the efforts for the Company’s 2013 uplisting from the OTC Markets to NYSE-American. Dr. Diwan has led several of the Company’s financing efforts since 2010.

Dr. Diwan invented novel polymeric micelle-based nanomedicine technologies as early as 1991. Dr. Diwan is a prolific inventor and a serial entrepreneur. Prior to co-founding NanoViricides, Inc., he has founded TheraCour Pharma, Inc., a privately held company focused in nanomedicines and cell-targeted drug delivery, and AllExcel, Inc., a company with diverse portfolios including nanomedicines, small chemicals, device technologies, as well as informatics. He has won several NIH SBIR (small business innovation research) grant awards. Anil holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India, and has consistently held high scholastic ranks and honors. Dr. Diwan has over 25 years of Bio-Pharmaceutical R&D experience with over 20 years as an entrepreneur.

He has several patents issued internationally resulting from three fundamental international patent applications. Under Dr. Diwan’s leadership, NanoViricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while robustly expanding the drug pipeline every year. Dr. Anil R. Diwan was recognized as “Researcher of the Year” by BusinessNewHaven, a Connecticut Area Business Journal, in 2014.

Ms. Meeta R. Vyas, MBA (Fin.), BS (Chem. Eng.)

interim Chief Financial Officer

Ms. Vyas is known as a strong leader with board level experience and successful achievements as a Senior Executive in a broad range of entities including publicly listed corporations, non-revenue generating entities, and medium to large size companies. Meeta has over twenty-five years of experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, in areas ranging from Finance and Operations to Strategy and Management. Meeta holds the distinction of being the first Indian woman to be named CEO of a publicly listed US corporation, Signature Brands, Inc., best known for “Mr. Coffee” and “Health-O-Meter” brand products. As CEO, acting COO and Vice Chairman of the Board of Signature Brands, Inc., she was responsible for the development and implementation of a turnaround plan, resulting in a return to profitability and growth within a short period of time. Later, as the CEO of the World-Wide Fund for Nature – India (WWF-India) and then as a Vice President of the National Audubon Society (USA), both non-revenue generating entities, Meeta successfully raised unrestricted funding that significantly exceeded annual requirements and also instituted financial processes to measure a variety of performance metrics. Earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the highly successful information technology outsourcing program at General Electric (GE). Also at GE, Ms. Vyas ran GE Appliances’ Range Products business unit having revenues exceeding $1 Billion where her team doubled operating income in less than two years. Prior to that, as a management consultant with McKinsey and Company, she served publicly listed companies in chemicals, industrial, and technology markets, primarily focusing on growth strategies, valuations, post-merger integrations, and logistics operations. Meeta is married to NanoViricides, Inc. President and Chairman Anil R. Diwan.

Ms. Vyas holds a MBA in Finance from Columbia University’s Graduate School of Business, and a BS in Chemical Engineering from the Massachusetts Institute of Technology.

NanoViricides won the IAIR AWARD as Best North American Company for Leadership in the Nanomedicine Sector.

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Randall W. Barton, PhD.Chief Scientific Officer – Consulting

Dr. Barton has experience in drug discovery and development of both small molecule and biological drug candidates in virology, immunology, inflammation, and cardiovascular diseases in the pharmaceutical and biotech industry as well as academic research and teaching experience. Most recently, he was Vice-President of Drug Discovery at A&G Pharmaceuticals, a biologics and diagnostics company. He retired at the Director level after 20 years at Boehringer Ingelheim Pharmaceuticals. During his time at Boehringer Ingelheim he performed drug development pre-clinical studies on nevirapine (Viramune), a non-nucleoside inhibitor of HIV reverse transcriptase and an important HIV drug.

Prior to joining Boehringer Ingelheim, he was on the faculty at the University of Connecticut Medical School where he was the recipient of an NIH Career Development Award conducting research and teaching in immunology. Dr. Barton has authored over 80 scientific publications, and has been the principal investigator leading to 5 patents. He has a Ph.D. in biochemistry from the University of Tennessee at Oak Ridge National Laboratory and a B.A. from Indiana University.  

Jayant Tatake, PhD.

Vice President, R&D

Jay Tatake is an organic chemist with over 25 years of experience in Research and Process Development of fine chemicals. His experience encompasses production scale-up, and large scale manufacture of raw materials for pharmaceuticals. Before joining NanoViricides, Inc., he was Assistant Director of Analytical R&D at Interpharm, Inc. Prior to that, he was Director of Analytical Services at Pharmax Group, Inc. Dr. Tatake has several years experience in Analytical methods development and Quality Control in cGMP environment. His experience includes bio-analytical methods development. Prior to Pharmax Group, he was in the Pharmacology Department, University of Connecticut Health Center, where he synthesized and developed novel bio-conjugates for bio-diagnostics applications.

Jay has a Ph.D. from Department of Chemical Technology, University of Bombay. He is a member of American Chemical Society (ACS). He has published several papers in leading journals and is a co-inventor of several patents.

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