OUR NEW PROFILE IS: (NYSE AMERICAN: NNVC)
NV-387 IS HIGHLY ACTIVE AGAINST TESTED CORONAVIRUSES INCLUDING SARS-COV-2 IN PRE-CLINICAL STUDIES
THE ENTIRE FLOAT ON NNVC IS JUST 11.2 MILL ACCORDING TO FINVIZ!!!!
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
We have another new profile that we want you to research right away. This is one you should research immediately.
This is a company that we have never profiled on this newsletter before.
NNVC has several promising catalysts that we want you to take a look at right away.
This one has a small float and a history of volatility like several of our latest profiles.
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.
FINVIZ HAS THE ENTIRE FLOAT AT JUST 11.2 MILLION. THAT WOULD EXPLAIN THE VOLATILITY ON THE CHART. YOU WILL NOTICE THAT THIS ONE HAS BOUNCED OFF OF THE LOWS SEVERAL TIMES IN THE PAST YEAR.
NOTEWORTHY CATALYSTS
- Broad-Spectrum, Pan-Coronavirus Drug NV-CoV-2 (API NV-387) for COVID, certain cases of long COVID, Seasonal Coronaviruses, MERS is in Clinical Trials. Two formulaJons are in clinical trials at present: Oral Syrup which can be titrated for body weight and is therefore preferable in pediatric seeng, and Oral Gummies, a fixed strength dosage form generally preferable for adults. We believe they would be highly effecJve for mild-to-moderate (non-hospitalized) cases of COVID. AddiJonally, NV-CoV-2 Solu=on for Injec=on, Infusion, and Inhala=on is developed for hospitalized COVID patients with severe disease; direct lung inhalaJon should provide significantly superior benefits by providing high pulmonary local concentraJon of the drug. NV-CoV-2 (NV-387) was found to have strong effecJveness in mulJple coronaviruses in vitro, and also strong effecJveness even when compared to remdesivir in animal studies of lethal lung infecJon. We believe the human clinical trial results should be consistent with these pre-clinical studies, and if so, would establish NV-CoV-2 as perhaps the most effecJve COVID treatment. There is no safe and effecJve COVID drug that covers all the paJent populaJons and disease severiJes at present, indicaJng significant unmet medical needs.
- NV-387 Expanded Indications Program. We are elucidating the breadth of the anJviral spectrum of NV-387 at present. NV-387 is based on mimicking sulfated proteoglycans to a_ack the virus parJcle. A large number of viruses bind to such structures before gaining cell entry, including RSV, human MetaPneumoVirus (hMPV), certain Adenoviruses, other respiratory pathogens, as well as a number of systemic viruses such as Dengue viruses, Chickengunya, among others. Successful addiJonal indicaJons against any such viruses, if any, would significantly improve the return on investment, while fulfilling unmet medical needs.
- Such additional indications would be eligible for Phase II/III studies with NV-387 having completed Phase I studies already.
- Additonally, NV-387-R Could Result in Potential Cure Against a Number of Non-Latency Viruses.
- HerpeCideTM Program. Variants of NV-HHV-101 are expected to become clinical drug candidates for topical treatment of HSV-2 “genital ulcers”, and HSV-1 “cold sores” soon aqer NV-HHV-101 goes into clinical studies. NV-HHV-101 is anJcipated to further expand into additional indications against chickenpox – a possibly orphan drug in the USA – and PHN (a morbidity of shingles persistent pain that may last for six months or longer, aqer the rash resolves).
- We are also developing drugs against HIV.
NanoViricides, Inc. is possibly the first in the world to have developed an orally effecJve nanomedicine.
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.
NANOVIRICIDES BROAD SPECTRUM ANTIVIRAL COULD CHANGE HOW WE TREAT VIRAL INFECTIONS
So far, NanoViricides has built a robust foundation of promising preclinical research that demonstrates the unique antiviral platform’s potential to treat not just COVID-19 but a wide range of other common and hard-to-treat viral diseases like other coronaviruses, RSV, shingles, herpes, rabies and the flu.
The reason it could have such broad applicability is because the NanoViricides platform was specifically designed to target a particular binding site that’s common across many viruses and doesn’t change even as a virus mutates. Essentially, the nanoviricide platform mimics the binding site on a human cell that a virus would normally target in order to infect that cell. Then it seeks out the virus and when the virus binds to the nanoviricide instead, the drug candidate immediately engulfs the virus, where it’s unable to infect the patient’s cells or reproduce.
THE FIRST OF THESE DRUGS IS NOW IN HUMAN PHASE 1A AND 1B CLINICAL TRIALS
The Phase 1a/1b clinical trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) safety and tolerability studies in healthy subjects. NanoViricides reported that 26 of the 36 volunteers in the SAD study and 17 of the 36 volunteers in the MAD study have already completed the program. And so far, the early data looks promising. Neither adverse events nor serious adverse events have been found to date in either study.
“The excellent safety and tolerability of NV-CoV-2 in both formulations in the clinical trials is consistent with the results of pre-clinical animal studies, giving us confidence that our preclinical animal studies can be expected to be predictive of human clinical trials,” said NanoViricides Executive Chairman and President, Anil R. Diwan, Ph.D.
ONGOING PHASE 1A AND 1B CLINICAL TRIALS WILL GIVE FIRST INDICATION OF NANOVIRICIDES EFFICACY IN HUMANS
With that baseline of safety and tolerability, the next part of the trial is to enroll COVID patients in the trial and start evaluating whether the positive preclinical effectiveness results for the drug will translate to human trials. Once this trial is finished, NanoViricides plans to seek permission to move into phase 2 clinical trials from multiple regulatory agencies worldwide.
Of note, the same drug was found to be effective in pre-clinical studies against another important respiratory virus, RSV. Such a broad spectrum antiviral effectiveness is reminiscent of the development of antibiotics against bacteria. This could be a game-changing development in antiviral therapeutics.
This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.
NANOVIRICIDES TREATMENT FOR RSV
NanoViricides (NYSE American: NNVC), a leading developer of antiviral treatments through its nanomedicines platform, is developing a safe and effective alternative therapeutic for RSV. Its drug candidate, NV-387, has already been shown to not have the toxicity or side effects associated with Ribavirin, according to the company. It reports that in the recent pre-clinical animal study, NV-387 almost matched the efficacy of Ribavirin with no toxicity. This animal study was designed to mimic the lethal lung pneumonia in infants caused by RSV infection.
Importantly, NV-387 is already in phase 1 human clinical trials as the active ingredient in the company’s COVID drug candidate NV-CoV-2. The company has just reported that it was found to be completely safe, with no side effects found to date, in this continuing phase 1 Study. For this reason, the company anticipates soon being able to advance NV-387 to a phase 2 human clinical trial against RSV.
If the results of animal studies are replicated in humans, this nanoviricides drug could become truly a game-changer in the treatment of RSV infections.
CGMP PRODUC=ON IN MUL=-KILOGRAM SCALE IN OUR OWN FACILITY
We have completed producJon of the drug in mulJ-Kg quanJJes for the GLP porJon of the IND enabling Safety/Toxicology studies. This producJon was performed under cGMP-compliant condiJons in our State of the Art cGMP-capaead on, by building our own capability. We believe we have thus minimized the manufacturing risk for our en=re pla4orm technology.
ble Manufacturing Facility for Clinical Drug Produc=on in Shelton, CT. We have engaged in the producJon of the cGMP manufactured drug product for the upcoming human clinical trials at this plant. cGMP Manufacturing capability is a major risk for new pharma companies, especially in nanomedicines. We are happy to report that we are tackling this risk hThe NanoViricides facility in Shelton, CT, contains customizable mulJ-product cGMP manufacturing
capability, as well as advanced nanomedicines characterizaJon and R&D laboratory, to support clinical drug
manufacture of any of our drug candidates, enabling cost-effecJve, speedy entry to clinic. Moreover, its
Manufacturing Scale is more than sufficient to support ini=al marke=ng needs, enabling early revenues upon drug approval.
GLOBAL, STRONG, PIONEERING, INTELLECTUAL PROPERTY WITH RUNWAY BEYOND 2040
Strong Global Intellectual Property Posi=on with Drug Patents to Expire Beyond 2040
All of our drug candidates are based on broad & exclusive world-wide licenses in perpetuity from TheraCour Pharma, Inc. The licensed fields include human diseases of COVID, VZV, HSV-1, HSV-2, all Influenza viruses including H5N1 and pandemic H1N1, HIV, Dengue, Ebola, Marburg, Rabies, etc. These licenses are extremely broad and cover development of drugs a_acking the stated virus in pathological indicaJon benefieng from viral load reducJon. NanoViricides intends to own the regulatory drug licensure (use of enJty for indicaJon), and may commercialize the same on its own or further sublicense to other Pharma companies.
NanoViricides has exclusive worldwide licenses from TheraCour Pharma, Inc., to field-defining, pioneering, proprietary intellectual property and global patent applicaJons, that have already issued into 61 patents in countries including the U.S., Australia, Japan, China, Canada, and all of Africa. Issued patents are “first-in-class” with no prior art, showcasing the Company’s leadership posiJon in this field. The patents cover broad composiJons of ma_er, methods of making, and uses. The first of the fundamental patents has expiraJon date in 2026. We have begun to patent IP estate around each of our drug candidates separately. Two internaJonal PCT patent applicaJons have been made for the COVID space; resulJng patents would expire in 2040. AddiJonal applicaJons are expected soon. This provides substanJal runway for commercial realizaJon.
UNIQUE, NOVEL, POST-IMMUNOTHERAPEU=C “BIND-ENCAPSULATE-DESTROY” MECHANISM ENABLES FIRST-IN-CLASS PRODUCTS
Beyond An=bodies and Vaccines: AnJbodies have been developed as drugs against viruses. However, each anJbody only binds by two points to the virus, and destrucJon of the complex requires effecJve immune funcJon, which is not the case in sickness. Vaccines only train the body into producing anJbodies against the virus in the vaccine. AnJbodies and vaccines are easily overcome by viruses by mutaJng in the field as is now well known from COVID.
A Nanoviricide is A Nanomachine that Completes the Task of Destroying Virus without Help from the Pa=ent’s Immune System Key Issue of Drug Resistance from Viral Muta=ons is Unlikely with Nanoviricides Drugs due to Unique Biomime=c Technology
In contrast, a nanoviricide should work against all strains of the virus because they sJll bind the same way to the same host cell receptor. The nanoviricide® technology plalorm mimics the host cell. We design and develop a virus-binding ligand that mimics the site on the host cell receptor to which the virus binds. This ligand is then chemically a_ached to a special polymer to make a nanoviricide®. The virus is expected to be fooled into binding to the nanoviricide, like a venus-fly-trap. The nanoviricide is then expected to engulf the virus and possibly destroy it. A nanoviricide a_acks the virus with hundreds of virus-binding sites on its surface. The nanoviricide is capable of dismantling the virus, and the resulJng complexes are fully biodegradable in the body.
Not shown here, is a nanoviricide’s ability to encapsulate drugs inside it, protect them from bodily environments, and deliver them as per design. This ability can be harnessed to develop cures for many viruses.
NANOVIRICIDES, INC. HAS FILED ITS ANNUAL REPORT: BROAD-SPECTRUM ANTIVIRAL NV-387 (NV-COV-2) IN PHASE 1A/1B CLINICAL TRIAL IS HIGHLY ACTIVE AGAINST CORONAVIRUSES AS WELL AS RSV
SHELTON, CONNECTICUT — Monday, October 16, 2023 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2023 with the Securities and Exchange Commission (SEC) on Friday, October 13, 2023. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057823002146/nnvc-20230630x10k.htm ).
We reported that, as of June 30, 2023, we had cash and cash equivalent current assets balance of approximately $8.15 Million. In addition, we reported approximately $8.1 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.53 Million. In comparison, as of June 30, 2022, we had cash and cash equivalent balance of approximately $14.4 Million, P&E assets of approximately $8.7 Million (after depreciation), and total current liabilities of approximately $0.41 Million.
We estimate that we have sufficient funds to complete the on-going human clinical trials for our lead drug candidate NV-CoV-2 which is the drug product based on our “nanoviricide” active pharmaceutical ingredient (“API”), NV-387.
We believe that the successes of NV-387 as a broad-spectrum antiviral (see below) bode well for validating the multiple modalities in which our Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response.
We believe that NV-387 works by a novel mechanism of action, that of blocking the re-infection cycle of the viral disease. We believe 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.
We believe that NV-387 mimics the “Sulfated Proteoglycans” (“S-PG”) family of virus attachment receptors. This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (KSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV – Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. Therefore, NV-387 may be anticipated to exhibit strong antiviral activity against at least some, if not many, of these viruses.
We have found that NV-387 is highly active against tested coronaviruses including SARS-CoV-2 in pre-clinical studies. We are expanding our pre-clinical studies to evaluate the antiviral activity of NV-387 against other viruses. We believe that this work would expand the range of indications for NV-387. Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).
We have already found that NV-387 is highly effective against a lethal lung infection by RSV in an animal study, a result which is expected to add significantly to the commercial potential of NV-387 if the drug proves out further in clinical studies. We believe that we will be able to take RSV into Phase 2 clinical studies once the current Phase 1 studies are completed.
We believe that NV-387 has a broad spectrum of antiviral activity that is reminiscent of the antibacterial activity of antibiotics. We believe that the Nanoviricides Platform Technology is poised to revolutionize the fight against viruses just as antibiotics revolutionized the fight against bacterial infections. Antibiotics attack a bacteriological common feature, the peptidoglycan wall, of bacteria. Analogously, NV-387 is designed to attack a virological common feature, the binding of viruses to S-PG family attachment receptors.
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. 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. 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.
GrowthPlus Reports, in June 2023, said the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.
NV-387 is in Phase 1 human clinical trial as two oral formulations: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies in India. The drug sponsor, Karveer Meditech Pvt. Ltd., is our licensee and collaborator and has the rights to develop and commercialize the drugs in India. As of now, 26 out of a target of 36 healthy human subjects have completed the clinical trial. There were no reports of adverse events or serious adverse events, indicating both of these formulations and the API NV-387 are extremely safe in humans. These results are consistent with our pre-clinical safety/toxicology animal studies.
In addition to the S-PG family, another important attachment receptor family is “Sialylated Glycoproteins”. Influenza viruses, some pathogenic Adenoviruses that cause epidemic kerato-conjunctivitis (EKC), as well as a large number of other viruses bind to sialic acid which is the terminal part of these receptors. We are making headways in developing nanoviricides that mimic this class of receptors.
We call the broad-spectrum nanoviricides based on such general features as the S-PG and the Sialic based receptors that are widely used by viruses for attachment as “Modality #1” of the application of nanoviricide platform technology. This modality is expected to result in very broad spectrum antiviral agents, as evidenced by NV-387.
In another methodology, that we call “Modality #2”, we have developed nanoviricides that specifically bind to a specific type of virus, mimicking the cell-surface receptor to which the virus binds in order to gain entry into cells (called the “cognate” receptor). We have developed NV-HHV-1 as an antiviral that is active against certain herpesviruses. NV-HHV-1 has completed IND-enabling studies. Its first indication, formulated as a skin cream, is for the treatment of Shingles rash. It has been found to be active against HSV-1 (“cold sores”), HSV-2 (“genital herpes”) and VZV (Chickenpox and Shingles) in pre-clinical studies. We have also developed an anti-HIV drug candidate that mimics CD4 which is used by HIV.
No matter how much a virus mutates, changes, or generates new variants, it continues to utilize the same attachment receptor(s) and the same cognate receptor(s) and, further, binds to the receptor(s) at the same locations. Thus, the virus is expected to be unlikely to escape a nanoviricide drug if our nanoviricide properly mimics the location on the cellular receptor that the virus uses.
This very much sought-after feature sets apart our Nanoviricides Platform Technology from other antiviral approaches. The virus learns to escape readily the battery of conventional approaches, which is comprised of antibodies, vaccines, and small chemical drugs, as has been amply evidenced in the COVID-19 pandemic, the recurring Influenza pandemics and epidemics, the on-going HIV pandemic, and other instances.
We are particularly excited about our “Modality #3” of applying the Nanoviricide Platform Technology that we believe will enable true cures for a large number of viral infections. In this modality, we have been able to create a nanoviricide that (i) blocks the virus particle from infecting a new cell in the first place, and (ii) holds in its belly another API that blocks the virus that has infected a cell from making and releasing its copies. We believe such a nanoviricide would be a true cure for infections of viruses that do not generate latent infections in the body. This modality goes beyond the conventional approach of treating a patient with multiple drugs simultaneously, in at least two ways: (i) as an infrequent single drug treatment that improves patient compliance, and (ii) by virtue of the improvement in the pharmacokinetics of the guest API due to the nanoviricide encapsulant. We have already demonstrated that NV-387-g-R, which is remdesivir as guest encapsulated within the polymeric micelle of NV-387, protects remdesivir from bodily metabolism.
In a fourth modality, we are conducting preliminary research to harness the power of the Nanoviricide Platform Technology to cure latent virus infections as well.
We have not only established a broad and expanding antiviral drug pipeline, led by NV-387 for coronavirus infections (clinical), NV-387 for RSV infections (advanced pre-clinical), and NV-HHV-1 for treatment of Shingles rash (IND-enabling), and many other pre-clinical drug candidates, but have also developed the Nanoviricide Platform Technology to the level that cures against many virus infections can now be envisaged.
We have made significant progress despite limited resources in our endeavor of curing viral infections using the power of the Nanoviricide Platform Technology, and this year, we have been able to take the first nanoviricide drug into human clinical trials. We believe this opens a new era in the development of NanoViricides, Inc. We plan on seeking non-dilutive as well as equity-based funding as we go forward in this quest.
What is a “nanoviricide”?
A “nanoviricide” is a uniform polymer that self-assembles into nanoscale droplets called “micelles”, that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus “looks like” a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called “lipid-lipid mixing.” We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.
About NanoViricides, Inc.
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. Our lead drug candidate is NV-CoV-2 (API NV-387) 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. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of factors including external collaborators and consultants. NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.
NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 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 RSV, 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 human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, 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.
NEWS
PUBLISHED
OCT 16, 2023
NANOVIRICIDES, INC. HAS FILED ITS ANNUAL REPORT: BROAD-SPECTRUM ANTIVIRAL NV-387 (NV-COV-2) IN PHASE 1A/1B CLINICAL TRIAL IS HIGHLY ACTIVE AGAINST CORONAVIRUSES AS WELL AS RSV
PUBLISHED
OCT 12, 2023
NANOVIRICIDES, INC. TO PRESENT AT THE PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY CONFERENCE IN BOSTON ON OCTOBER 16, 2023 AT 6:07PM ET
PUBLISHED
OCT 3, 2023
MULTI-BILLION DOLLAR TREATMENT MARKET FOR LUNG INFECTION THAT CAUSES OVER 200,000 HOSPITALIZATIONS ANNUALLY WITH ELDERLY, YOUNG AT MOST RISK HAS GAME-CHANGING NEW ENTRANT
PUBLISHED
SEP 27, 2023
MULTI-BILLION DOLLAR TREATMENT MARKET FOR LUNG INFECTION THAT CAUSES OVER 200,000 HOSPITALIZATIONS ANNUALLY WITH ELDERLY, YOUNG AT MOST RISK HAS GAME-CHANGING NEW ENTRANT
PUBLISHED
SEP 19, 2023
FIRST HUMAN CLINICAL TRIALS OF A POTENTIALLY “GAME-CHANGING BROAD SPECTRUM ANTIVIRAL” ARE PROGRESSING SUCCESSFULLY – DRUG COULD TREAT COVID, RSV AND MANY OTHER RESPIRATORY VIRUSES
PUBLISHED
AUG 31, 2023
NANOVIRICIDES PROGRESSING WELL WITH NEW COVID STUDY
PUBLISHED
AUG 21, 2023
THE PHASE 1A/1B HUMAN CLINICAL TRIAL OF NV-COV-2, THE COMPANY’S BROAD-SPECTRUM ANTIVIRAL DRUG, IS PROGRESSING SUCCESSFULLY, REPORTS NANOVIRICIDES
PUBLISHED
JUL 19, 2023
SARS-COV-2 IS NOT DONE YET — COULD THIS NEW DRUG IN CLINICAL TRIALS BE THE SAFEST OPTION FOR TREATING COVID-19?
PUBLISHED
JUL 13, 2023
NANOVIRICIDES TESTING ORAL GUMMY AND SYRUP COVID-19 TREATMENT – PROACTIVE RESEARCH ANALYST
PUBLISHED
JUL 11, 2023
NOVEL NANOMEDICINE PLATFORM WITH PIPELINE OF ANTIVIRALS GOES TO HUMAN TRIALS – WHAT OTHER VIRUSES COULD THIS COVID TREATMENT TARGET?
PUBLISHED
JUL 11, 2023
COMPANY’S BROAD-SPECTRUM ANTIVIRAL NV-387 HAS DEMONSTRATED EXCELLENT EFFECTIVENESS IN RSV IN A LETHAL LUNG DISEASE ANIMAL MODEL, REPORTS NANOVIRICIDES
PUBLISHED
JUL 6, 2023
NANOVIRICIDES INC. (NYSE AMERICAN: NNVC) BEGINS LONG-AWAITED CLINICAL TRIALS FOR ITS ANTI-VIRAL NANOMEDICINE NV-COV-2, ORAL, AMID CONTINUING NEED FOR COVID TREATMENT
PUBLISHED
JUL 6, 2023
CLINICAL TRIAL OF BROAD-SPECTRUM ANTIVIRAL DRUG NV-COV-2 IS PROGRESSING WELL, SAYS NANOVIRICIDES – NV-COV-2 IS POSITIONED TO FULFILL MANY UNMET MEDICAL NEEDS
PUBLISHED
JUN 29, 2023
NANOVIRICIDES TAKE BIG STEP FORWARD BEGINNING TRIALS ON ITS ANTIVIRAL DRUG NV-COV-2
PUBLISHED
JUN 29, 2023
NANOVIRICIDES ANNOUNCES THAT CLINICAL TRIALS OF ITS BROAD-SPECTRUM ANTIVIRAL DRUG NV-COV-2 HAVE BEGUN
PUBLISHED
MAY 31, 2023
NANOVIRICIDES, INC. TO PRESENT AT THE BIO INTERNATIONAL CONVENTION IN BOSTON ON JUNE 5TH, 2023 AT 3:15PM ET
MANAGEMENT TEAM
Anil R. Diwan, PhD
Executive 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.
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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