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NV-387’s Extremely Broad Antiviral is a Host Mimetic That Acts As a Decoy To Attract And Trap Many Diverse Viruses, Preventing the Virus from Replication and Reinfection of Other Cells
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!
ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate
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Hello Everyone,
Hopefully you kept your feet moving as soon as you saw the news on today’s profile.
We think this next one has real potential both long and near term.
We have a fan favorite back int the crosshairs for tomorrow’s session. We have looked at this one a few times. We profiled this back in mid may at 1.40. Six sessions later it hit 10 month highs breaking through 1.90.
You might remember this one from January when it was sitting around the 1.10 level.
If you have been a member for a little while then you should go back and look at this one when we profiled it back last July when it doubled in just a few sessions.
Now that we have established that this one has the potential to move let’s dive into the meat and potatoes of what we want to look at for Fridays session.
Pull up NNVC and urgently get it on your screen.
NNVC looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.
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.
NV-387 – A novel broad-spectrum antiviral
- Since it is a potential cure for RSV infection, and since there is no non-toxic drug for general treatment of RSV infection at present; NV-387 meets an unmet need.
- A therapeutic for treating measles is a completely missing link in the response the the current measles virus outbreak; NV-387 could meet this unmet need too.
- The anti-Influenza activity of NV-387 given orally was substantially superior to all three of the approved anti-influenza drugs (Tamiflu, Rapivab, and Xofluza).
- Bird flu is rampant in poultry in the USA leading to hen culling and soaring egg prices, resulting in a race to find a treatment that works; NV-387 can address it.
- Long COVID also remains a problem for an estimated 17 million adults; an effective antiviral such as NV-387 has already delivered successful Phase 1 results.
- While smallpox is eradicated in the USA, contagious monkeypox has appeared but there is no effective drug treatment for it and competitors clinical trials have failed; NV-387 is entering Phase 2 clinical trials for it.
NanoViricides, Inc. (NYSE American: NNVC)’s lead drug candidate NV-387 (drug product NV-CoV-2), a drug that treats RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections as well as Monkey-pox, has successfully completed Phase 1 clinical trials in healthy subjects with no reported adverse events, even at the highest and repeated dosages. Remarkably, NNVC has been able to develop NV-387 for oral administration already, as well as for injectable and inhalation formulations to enable many modes of use. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for the treatment of RSV infection.
Susceptible viruses CANNOT escape NV-387, even as they continue to evolve in the field into variants. Why? Because no matter how much the virus changes, it continues to use the same host-side signature to bind to and cause infection in the hosts, and thus the nanoviricide would be anticipated to continue to be effective even as the virus mutates to generate variants.
Thus NV-387 and other antiviral drugs designed on the nanoviricides platform can be expected to have decades of effective usability against the target viruses similar to the life of current antibiotics against bacterial infections but in stark contrast to current antiviral approaches.
A broad-spectrum antiviral drug such as NV-387 would be a highly desirable drug globally because it would enable treatment by physicians of patients as soon as they present symptoms of a viral disease without waiting for a test to identify a specific type of viral infection. This is reminiscent of how antibiotics are prescribed, without specific infectious agent identification, relying on the ultra-broad-spectrum of the drug.
NV-387’s Extremely Broad Antiviral is a Host Mimetic That Acts As a Decoy To Attract And Trap Many Diverse Viruses, Preventing the Virus from Replication and Reinfection of Other Cells
Over 90% of human pathogenic viruses are known to use one or more “landing sites” that are in the Sulfated Proteoglycans (“SPG”) family. A successful host-mimetic nanoviricide drug using SPG as the key feature to attract viruses could theoretically be able to attack most if not all such viruses.
NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. We have accumulated substantial evidence that in lethal viral infection animal studies, NV-387 demonstrated strong antiviral activity against a range of different virus families, exceeding or matching the activity of known approved drug agents.
Superior to Other Treatments???????????
NV-387 was substantially superior to remdesivir in coronavirus infections, using a model for SARS-CoV-2 (COVID) virus, as reported earlier. We believe that NV-387 continues to be one of the most active antiviral drugs against multiple coronaviruses, and that it is a viable clinical candidate for drug development to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections.
In treating Influenza, NV-387 was substantially superior to the three approved drugs, namely Tamiflu®, Rapivab® , and Xofluza® against an Influenza H3N2 lethal lung viral infection study, as previously reported. We believe that NV-387 is expected to possess strong antiviral activity against H5N1 “Bird Flu” as well, given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and based on the observed broad-spectrum activity of NV-387.
NNVC has also found that NV-387 is capable of completely curing a lethal RSV lung virus infection in animals, leading to indefinite survival of the animals, as reported recently. There is no cure for RSV, and no approved drug for treatment of RSV infection other than the toxic last-resort drug ribavirin.
Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ SPG for gaining access to human cells to infect and cause disease. Thus, NV-387 could be highly valuable for preparedness against novel viral epidemics and pandemics.
NV-387 could thus be a single drug to treat all of the “tripledemic” viruses (COVID, RSV, FLU ), and more, when so approved!
Finally, NV-387 was at least 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.
NanoViricides, Inc. Has Filed its Quarterly Report: Broad-Spectrum Antiviral NV-387 To Combat MPox Pandemic in Africa – Phase II Clinical Trial Update, Also Readying to Combat Measles Outbreaks, and to Tackle Bird Flu
SHELTON, CT / ACCESS Newswire / May 16, 2025 / NanoViricides, Inc.(NYSE Amer.:NNVC) (the “Company”), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending March 31, 2025with the Securities and Exchange Commission (SEC) on Thursday, May 15, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057825001336/nnvc-20250331x10q.htm) .
NV-387 – Phase II Clinical Trial to Treat MPox Infection – Unmet Medical Need
We reported that we submitted requisite due diligence information to the National Ethics Committee of the Democratic Republic of Congo (DRC) including a draft report from the Phase I clinical trial for the safety and tolerability of oral formulations of NV-387, the summary information from our studies for treatment of lethal MPox infections in animal models, as well as summary information on the manufacturing.
The National Ethics Committee found that the provided information was sufficient to justify a Phase II clinical trial, and has cleared us to file a Phase II Clinical Trial Application for the Use of Oral NV-387 for the Treatment of MPox Disease Caused by the hMPXV virus, subsequent to the reporting period.
We also reported that we have commissioned manufacture of clinical trial quantities of NV-387 drug substance and the corresponding NV-387 oral gummies formulations drug products at our own cGMP compliant facility in Shelton, CT.
We are now preparing the Phase II Clinical Trial Application for NV-387 to combat MPOX for submission to the DRC regulatory agency.
There is no drug available for the treatment of MPox disease. The MPox Clade 1a/1b viruses have a substantially greater fatality rate than COVID, at 3-4%, and Clade 1b has been disproportionately affecting pediatric populations.
The MPox Disease which is caused by hMPXV Clade 1a/1b virus infection was initially declared a Public Health Emergency of International Concern (PHEIC) by the WHO in August 2024, a designation that has been continued to stay in effect in April 2025, due to the severity of the pandemic in WHO African Region.
Spillover cases of MPox Clade 1a/1b have occurred in several Eastern and Western countries already, raising the probability that the epidemic may spread more widely, although the current MPox virus is not as communicable as Coronaviruses or Measles virus.
MPox Clade 2 spilled over from Africa into the Western World in a small pandemic during 2022, and has become endemic with several cases occurring every year in many countries, driven primarily by sexual contact. MPox Clade 2 causes much less severe disease than the Clade 1a and 1b viruses.
MPox/Smallpox drug represents a billion dollar market globally, should an effective drug be developed, because of potential biosecurity implications.
NV-387 as Treatment for Measles Virus Infection – Unmet Medical Need
Upon finding significant rationale that NV-387 would be potentially highly effective against the Measles virus, we have initiated a program to evaluate NV-387 in a humanized animal model of Measles lethal infection.
The Measles outbreaks in the USA have continued to grow since January, 2025, and have crossed 1,000 confirmed cases as well as 3 deaths. Measles cases have been increasing year over year in the USA, especially after the COVID pandemic substantially resolved with the SARS-CoV-2 becoming an endemic virus. In Europe, over 35,000 cases of Measles have been reported in 2024 according to the European CDC.
A 95% vaccination coverage is required to eliminate Measles virus. This has become a practically impossible goal because of several factors, among them: (i) Vaccine Hesitancy as a rebound public response because of compulsion of COVID vaccine shots multiple times; (ii) Religious Vaccine Prohibitions in certain communities, including certain Jewish religious communities, Mennonites, and other conservative religious communities; (iii) Increasing immune function disability in the general population due to chronic diseases such as Diabetes, Obesity, Cardiac Issues, Autoimmune Diseases, Allergies, etc. wherein the person upon vaccination would not develop strong enough immunity and would become a carrier if infected; (iv) Vaccine Failure caused primarily by a variety of immune function disabilities.
The Measles vaccination rates across the world, and particularly in European countries and the USA have dipped well below 95% on average, and much lower in specific areas, and vaccine breakout cases i.e. Measles disease in vaccinated persons, have also increased substantially, as seen from the ECDC statistics [1] , [2] .
It is therefore essential to develop a drug to treat Measles in order to combat these outbreaks and achieve full control over the public health situation. There is no drug available for treatment of Measles.
We strongly expect that NV-387 would be effective against Measles. This is because NV-387 cured lethal RSV infection in an animal model. RSV and Measles both are paramyxoviruses, and both use HSPG as the Attachment Receptor, and then transfer to their respective Cognate Receptor that is needed for cell fusion. NV-387 was designed to present to the virus like a cell that displays HSPG-mimetic small chemical ligands on its surface, thereby providing the attachment-receptor-mimetic landing sites for the virus, capturing, engulfing, and destroying it. (HSPG = Heparan Sulfated Proteoglycans).
NV-387 as Treatment for Bird Flu, H5N1, H7N9 – Unmet Medical Need
We have previously found that NV-387 was substantially more effective than the existing stockpiled influenza virus treatments including Tamiflu (oseltamivir) and Xofluza (baloxavir) in lethal animal models of Influenza virus lung infection.
Given the extremely broad antiviral activity spectrum of NV-387, and knowing that the Highly Pathogenic Avian Influenza (HPAI) viruses such as H5N1 and H7N9 have polybasic sequences in their H-protein that bind to HSPG, we believe NV-387 would be effective against Bird Flu viruses.
Influenza viruses mutate rapidly, and also exchange their full genomic RNA segments with other co-infecting viruses (“Re-assortment”), or copy portions of a different genomic sequence into their own RNA (“Re-combination”). Thereby an Influenza virus can acquire new traits such as (i) rapid communicability from person-to-person, and (ii) readily escaping vaccines, antibodies, and the small chemical drugs such as oseltamivir and baloxavir.
NV-387, we believe, fulfills the unmet medical need for a pan-Influenza drug that the Influenza virus would not be able to escape, because the virus does not lose its ability bind to HSPG as Attachment Receptor and then to Sialic Acid Receptors leading to cell fusion and infection.
A severe version of H5N1 is widely circulating in the wild birds, and has caused sporadic losses of entire poultry farm houses. This, and a mild version of H5N1 have infected thousands of dairy herds in the USA. The H5N1 virus is only a few mutations away from becoming highly communicable from person to person, and if that comes to bear, we would be facing a pandemic possibly worse than COVID-19.
It is well established now that vaccines, antibodies, and small chemical drugs do not provide the ability to stall an outbreak let alone a pandemic caused by a highly variable virus such as a Coronavirus or an Influenza virus.
We believe NV-387 will be ready to fight any human outbreaks of H5N1 under emergency use protocols for investigational drugs.
Company Financials
We reported that, as of March 31, 2025, we had cash and cash equivalent current assets balance of approximately $2.73 Million. In addition, we reported approximately $6.98 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 $1.20 Million.
The net cash utilized during the nine months ended March 31, 2025 was approximately $6.78 million. This included certain non-recurring expenditures including R&D expenditures in preparation for a Phase IIclinical trial application. We raised approximately $4.57 million net of commission and certain expenses in an At-the-Market offering (“ATM”) during the nine months ended March 31, 2025.
We have approximately $5.7 million (approximately $4.5 million net of current liabilities) available for cash operational expenses going forward including an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan. As such, we reported that we do not have sufficient funding in hand to continue operations through February 14, 2026, for our planned objectives that include (i) a Phase II clinical trial of NV-387 for MPOX in Central Africa, (ii) a Phase II clinical trial of NV-387 for Viral Acute and Severe Acute Respiratory Infections (V-ARI and V-SARI), and (iii) Preparation and pre-IND filing for a Phase II clinical trial of NV-387 for RSV indication in the USA. We have access to the aforementioned ATM Equity Offering, and we believe we will have access to the equity markets to raise the funds necessary for our current objectives. We continue to re-prioritize our programs in line with available resources.
NV-387 – Phase I Clinical Trial Completed Successfully with No Reported Adverse Events
NV-387 has successfully completed a Phase Ia/Ib clinical trial in healthy subjects with all subjects discharged as of end of December, 2023. There were no adverse events reported. We are now awaiting a final report of this Phase I clinical trial.
NV-387 A Potentially Revolutionary Antiviral Drug that the Viruses are Unlikely to Escape
Our host-mimetic, direct-acting, broad-spectrum, antiviral agent. NV-387 was found to have activity that surpassed the activity of known agents in lethal virus infection animal model trials for COVID, RSV, Influenza, and Mpox/Smallpox.
In fact, we found that NV-387 treatment possibly completely cured the lethal RSV infection in mice, based on indefinite survival of the animals with no lung pathology. There is currently no treatment for RSV infection. In particular, pediatric RSV infection treatment is an unmet medical need that we believe is of critical importance. Pediatric RSV treatment itself is expected to be a multi-billion-dollar market in the USA alone.
NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs, namely, oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, Biocryst), and baloxavir (Xofluza®, Shionogi/Roche).
Additionally, NV-387 also demonstrated activity against lethal poxvirus infection animal models that was on par with or superior to the approved drug tecovirimat (TPOXX®, SIGA).
NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for COVID, Influenza and Poxviruses.
This demonstrated broad-spectrum activity of NV-387 against widely varying viruses is because NV-387 is designed to attack the virus particle by mimicking sulfated proteoglycan (S-PG) feature, and all of these viruses are known to utilize heparan sulfate proteoglycans for gaining cell entry.
Further, for all of these tested viruses, even as the virus genome changes in the field, NV-387 is expected to continue to be effective, and the virus would be highly unlikely to escape NV-387. This is because despite all of the genomic changes, the virus continues to use HSPG, as is well known. Thus NV-387 solves the greatest problem in antiviral countermeasures; the problem of virus escape. Viruses are known to escape all of the current antiviral tools that include vaccines, antibodies, and small chemical drugs.
Thus we anticipate that NV-387 would revolutionize the treatment of viral infections reminiscent of how penicillin revolutionized the treatment of bacterial infections.
NV-387 Regulatory Strategy
In the ensuing year, we plan on advancing NV-387 into Phase II clinical trials. In addition to the Phase II clinical trial to assess effectiveness of NV-387 in treating MPox infections, we are also planning to advance NV-387 into a Phase II clinical trial for treatment of Viral Acute Respiratory Infections (V-ARI), and Viral Severe Acute Respiratory Infections (V-SARI). This clinical trial is expected to provide information on NV-387 effectiveness in treating Influenza viruses, Coronaviruses (including SARS-CoV-2/COVID) as well as RSV.
Thereafter we are planning a regulatory program for advancing NV-387 as the treatment of pediatric RSV infection.
We plan on advancing the regulatory processes for NV-387 registration for other indications including Influenza and COVID via partnerships and non-dilutive funding.
As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity
With Rising Variants of COVID and Bird Flu, the Single Broad-Spectrum Antiviral NV-387 Would be the Best Partner for Preparedness, Says NanoViricides’ Dr. Diwan
PUBLISHED
JUN 18, 2025 6:30AM EDT
SHELTON, CT / ACCESS Newswire / June 18, 2025 / Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE Amer.: NNVC ) (the “Company”), asserts that with new rising variants of COVID and Bird Flu, the single broad-spectrum antiviral drug NV-387 is well-positioned to support preparedness efforts and to combat potential pandemics.
Nimbus, a new COVID variant, officially NB1.8.1, is displacing the LP8.1 variant that was dominant until a few weeks ago in the USA(https://www.today.com/health/coronavirus/new-covid-variant-nb181-nimbus-symptoms-rcna212304).
Nimbus has been rising globally since Spring according to WHO(https://cdn.who.int/media/docs/default-source/documents/epp/tracking-sars-cov-2/23052025_nb.1.8.1_ire.pdf).
Nimbus causes “razor-sharp” sore throat in some individuals, which is extremely painful and lingering for some time, in addition to the usual COVID symptoms.
Nimbus is more resistant to antibodies generated from previous vaccines, although prior vaccination or natural COVID infection is expected to still be protective in terms reduced severity compared to without such immunity according to CDC.
Nimbus is likely to be more transmissible than the previous variants. It belongs to the JN.1 subfamily of the Omicron family of SARS-CoV-2 virus.
Recently, the Influenza A H5N1 virus from a dairy worker in Michiganwas found to be capable of airborne transmission in a ferret animal model [1] (https://www.freep.com/story/news/health/2025/06/05/h5n1-bird-flu-michigan-dairy-farm-airborne-spread-cdc-study/84046550007/). This genotype B3.13 (clade clade 2.3.4.4b) virus in dairy cattle causes moderate severity disease in humans. In contrast, a highly pathogenic genotype D1.1 that is circulating in birds birds has led to one critical month-long illness in Canada and one death in the US signifying the potential for high morbidity and mortality from this genotype if it spreads in humans.
Additionally, a new genotype of H5N1 in Cambodia has caused four fatalities and fifth severe infection as of today (https://www.cidrap.umn.edu/avian-influenza-bird-flu/h5n1-avian-flu-infects-fifth-patient-cambodia).
NV-387, the broad-spectrum antiviral drug is expected to be effective against all of these bird flu viruses. NV-387 was found to be substantially superior to Tamiflu® (Roche, Oseltamivir), Rapivab® (Biocryst, Peramivir), as well as Xofluza (Shionogi/Roche, baloxavir) in lethal lung infection animal model of Influenza infection. All three of these existing anti-influenza drugs are known to be escaped by Influenza viruses by single point mutations in H or PB2 genes.
NV-387 was found to be substantially superior to the approved drug Remdesivir in a lethal coronavirus lung infection animal model for SARS-CoV-2.
Thus the single drug NV-387 alone can combat H5N1, Influenza as well as COVID infections.
NV-387 has completed Phase I clinical trial in healthy human subjects with no reported adverse events.
COVID as well as Influenza viruses readily escape vaccines, antibodies as they change in the field during an epidemic wave. They are also likely to escape small molecule drugs by such changes.
NV-387 takes advantage of the invariant features that these viruses use for causing infection, by mimicking heparan sulfate-like structures. No matter how much these viruses change in the field, they continue to use the heparan sulfate attachment receptors in order to cause infection. Thus it is practically impossible that the viruses may be able escape NV-387 without losing their ability infect and transmit across humans, the Company believes.
NV-387 is orally available, formulated as oral gummies that dissolve in the mouth, thus avoiding issues of inability to swallow which occurs related to sore throat, old age, as well as in young children.
NV-387, as a treatment, is designed to help actually patients with disease recover rapidly, thus limiting the viral spread as well as providing for natural infection-based immunity in the recovered patient.
“NV-387 is thus the best current choice available for a highly cost-effective pandemic preparedness development,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “We have US-based cGMP manufacturing capabilities already set up as well.”
Of note, natural immunity, as induced by recovery from infection, is known to be superior to immunity from subunit and mRNA vaccines. One of the important reasons is that in natural infection, the immune system is subjected to all possible antigens from the entire virus, unlike just the selected antigens or antigen fragments that are present in subunit or mRNA vaccines.
Also, NV-387 can be manufactured in the USA and stockpiled readily at room temperature or refrigeration (for longer periods of time).
Unlike NV-387, vaccines or antibodies would require to be created after the virus takes hold, and they would suffer substantial loss of effectiveness within months after deployment due to changes in the virus. Additionally, vaccines require a cold chain handling. Vaccines also need to be administered to a large proportion of healthy population. There are significant logistical problems with vaccines. There is also the issue of vaccine reluctance, which is a personal choice, as it should be in a free country like the USA.
The broad-spectrum antiviral drug NV-387 was developed specifically to overcome all of these problems. In case of further spread of a severe COVID variant and also a Bird Flu variant in human populations, it will be possible to move NV-387 rapidly into Phase II clinical trial for these diseases, and then prepare for deployment early in the potential pandemic, curtailing its spread.
NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug 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 external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) 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-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 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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.
Broad-Spectrum Antiviral Drug NV-387 Cleared for Phase II Clinical Trial Application by the National Ethics Committee of the Democratic Republic of Congo
SHELTON, CT / ACCESS Newswire / May 8, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the “Company”) today reported that it has received approval from the National Ethics Committee for Health (CNES) of the Ministry of Public Health (MSP), of the Democratic Republic of Congo (DRC). With this CNES approval, the proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection is cleared for further regulatory filing of a complete Clinical Trial Application (“CTA”).
“We are now fully engaged in completing the detailed CTA for the Phase II human clinical trial of NV-387 for the treatment of MPOX disease (hMPXV infection) for submission to the DRC Regulatory Agency, namely MSP,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company.
The Company previously announced in January, 2025 that it has engaged a CRO for conducting a Phase II clinical trial to evaluate the safety and effectiveness of NV-387 for the treatment of MPox in the African Region.
Subsequently, the CRO has engaged the Medical Hospital at the University of Kinshasa as the clinical trial site (the “Site”) for the Phase II clinical trial.
Thereafter, the Company, the CRO, and the Principal Investigator at the Site have developed a package of information comprising synopses of the clinical trial protocol, and required background information on the novel drug NV-387, including a draft summary report of the Phase I human clinical trial, prior non-clinical data, as well as summary of the animal model effectiveness and safety of NV-387 for the treatment of lethal MPox infection providing rationale for the use of the novel broad-spectrum antiviral drug NV-387 for the treatment of hMPXV viral infection and the MPox disease caused by the infection.
This summary package was submitted to the National Regulatory Agency’s Ethics Committee CNES for a first review towards approval to proceed to the preparation and submission of the detailed CTA to the National Regulatory Agency, namely MSP of DRC.
The approval that we have now received from CNES clears the path for the perfected CTA filing to the MSP for approval and start of the clinical trial.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.
“NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases,” said Anil R. Diwan, Ph.D., adding “NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria.”
NV-387 was found to be highly effective in increasing survival in lethal animal models of influenza virus, surpassing existing drugs Tamiflu®, Rapivab® and Xofluza® by a large margin.
NV-387 led to a complete cure of lethal RSV lung infection in an animal model study. There is no approved drug for RSV treatment.
NV-387 was found to be highly effective in increasing survival in lethal animal models of Coronavirus infection (a stand-in model for SARS-CoV-2 infection), surpassing existing drug remdesivir by a large margin.
NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.
In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.
Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37.
Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field.
In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as “attachment receptor” in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.
MPox disease, caused by the human MPox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the WHO African Region that includs the Democratic Republic of Congo (DRC), Uganda, and other countries. It led to the WHOdeclaring a Public Health Emergency of International Concern (“PHEIC”) on August 14, 2024. Since then, the PHEIC status declaration has been extended twice, most recently in March, 2025. The Mpox epidemic has continued to spread in the DRC, Uganda, and neighboring countries and the number of new weekly cases is still increasing in the WHO African Region.
NV-387 is a host-mimetic drug that “looks like a cell” to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.
Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic.
NEWS
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NanoViricides President Dr. Diwan to Present at the PODD Conference
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MANAGEMENT
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.
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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