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ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We have had the good fortune of being able to throw some real explosive profiles in front of you as of late.

We have been seeing some of these small cap companies take off without notice, mirroring a fraction of the volatility that we have been seeing on the crypto markets.

It is highly unusual to profile a 180% winner and a 350% winner back to back.

Don’t say I never got you anything for Christmas.

We have a new profile that we want you to research for Thursday’s session.

You are definitely going to remember this one if you have been a member since the beginning of the year.

This is a company we showed you back in May when it was all the way down at 1.80 the session we asked you to research them. We also brought it to your attention back in mid-June when it was around 2.50.

By mid June NNVC went on a major run, closing green 6 session in a row and exploding all the way to 3.59 for a pure DOUBLE from our first emails in May and 45% in just 3 sessions from our emails in early June.

NNVC certainly had incredible run in early 2024 and has been building a lot of support around it’s current levels.

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.

NV-387 – A novel broad-spectrum antiviral

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.

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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.

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NanoViricides, Inc. Has Filed its Quarterly Report: Broad-spectrum Antiviral NV-387 Progressing to Phase II Clinical Trial – Multiple Indications of NV-387 Include MPOX/Smallpox, RSV, Influenza, COVID

PUBLISHED

NOV 15, 2024 6:30AM EST

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SHELTON, CT / ACCESSWIRE / November 15, 2024 / SHELTON, CT / ACCESSWIRE / November 15, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending September 30, 2024 with the Securities and Exchange Commission (SEC) on Thursday, November 14, 2024. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057824001991/nnvc-20240930x10q.htm).

We reported that, as of September 30, 2024, we had cash and cash equivalent current assets balance of approximately $3.87 Million. In addition, we reported approximately $7.36 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 $1.63 Million. In comparison, as of June 30, 2024, we had cash and cash equivalent balance of approximately $4.8 Million, P&E assets of approximately $7.51 Million (after depreciation), and total current liabilities of approximately $1.36 Million.

The net cash utilized in the reported period for operating activities was approximately $2.6 million that included certain non-recurring expenditures including R&D expenditures in preparation for a Phase II clinical trial application of approximately $1 million. We raised approximately $1.71 million net of commission and certain expenses in an At-the-Market offering (“ATM”) in the reported period.

Subsequent to the reporting period, we raised approximately $0.63 million net of commission and certain expenses in an At-the-Market offering (“ATM”). With this raise and an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan, we have approximately $7.6 million (approximately $6 million net of current liabilities) available for cash operational expenses going forward. As such, we reported that we do not have sufficient funding in hand to continue operations through November 14, 2025, for our planned objectives that include (i) a Phase II clinical trial of NV-387 for MPOX infection in Central Africa and (ii) a Phase II clinical trial of NV-387 for RSV indication in the USA.

NV-387 – Progressing Towards Phase II Clinical Trial

We have made significant progress in the regulatory advancement of NV-387. A Phase Ia/Ib clinical trial in healthy subjects was completed 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.

Additionally, we have made significant progress towards initiating Phase II clinical trial of NV-387 for the treatment of MPox infection in Central Africa. The MPox Clade 1/1b infection has been declared a Public Health Emergency of International Concern (PHEIC) by the WHO. Spillover cases 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. The MPox Clade 1/1b has a substantially greater fatality rate than COVID, at 3-4%, and it has been disproportionately affecting pediatric populations.

There is currently no drug available for the treatment of MPox infection. A drug approved for Smallpox/Mpox and stockpiled by the US Strategic National Stockpile, namely tecovirimat (TPOXX®, SIGA), was found to be ineffective for the treatment of the MPox infection in a clinical trial co-sponsored by NIH/NIAID. A vaccine developed for Smallpox, Jynneos (Bavarian Nordic) is being deployed but is in short supply. Its clinical utility for MPox Clade 1/1b is not known.

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 RSV infection in adults as part of the regulatory process required for registration of the drug for 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-based funding.

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NanoViricides Executes an Agreement Encompassing All Antiviral Drug Treatments With Theracour, Including “Trojan Horse” Drugs

SHELTON, CT / ACCESSWIRE / September 26, 2024 / NanoViricides, Inc. (NYSE American.:NNVC) (the “Company”), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it has now obtained a right of first refusal (ROFR) for all antiviral drug developments from the R&D firm TheraCour Pharma, Inc.(“TheraCour”).

NanoViricides has signed a broad Memorandum of Understanding Agreement (MoU) with TheraCour encompassing all antiviral drugs developments on September 23, 2024, an important step that provides the Company certain intellectual property rights for developing treatments against any viral infections.

NV-387, the Company’s lead drug, is proving to be a revolutionary drug that has demonstrated strong effectiveness, surpassing existing drugs, against a number of distinctly different types of viruses in animal studies. With this MoU in place, the increasing number of antiviral indications of a broad-spectrum drug such as NV-387 can be quickly and easily discovered and added by the Company to its portfolio of drugs in its development pipeline.

In addition to NV-387, certain “Trojan Horse” drugs that can completely cure most viral infections by attacking the virus lifecycle in multiple ways have been developed by the Company. This MoU expands NanoViricides Inc’s abilities to opportunistically and rapidly develop such drugs to treat viral infections of public health importance, even for those viruses that don’t exist today and cannot be predicted.

The new MoU provides NanoViricides with the ability to rapidly progress in such new endeavors and provides the important intellectual property rights to further develop multiple drug candidates towards a multitude of antiviral applications, many of which may have been previously considered to be intractable.

The MoU also codifies the process by which the two parties negotiate licenses to specific antiviral fields. As in the past, a license would not be restricted to a single drug, but rather would encompass all drugs that can be conceivably applicable with the R&D performed against the licensed field of antiviral application.

The revolutionary nanoviricide technology resulting in host-mimetic, direct-acting antiviral drugs is opening up a new era of treating viral infections just as penicillin opened up a new era and revolutionized the treatment of bacterial infections, enabling “one drug – many bugs” model instead of the current “one bug – one drug” model. NV-387, an example of the capabilities of nanoviricide technology, was developed in 2020 in response to the COVID pandemic and has completed a Phase I human clinical trial successfully. The Company is now planning for NV-387 to enter into Phase II clinical trials for evaluation of its efficacy against several viral diseases that include RSV, Influenza, Bird Flu, COVID, as well as MPOX/Smallpox infections.

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.

What are “Trojan Horse” nanoviricide drugs?

A nanoviricide can hide in its “belly” (i.e. encapsulates) one or more drugs that can attack the virus in other ways. The nanoviricide holding the drugs is expected to attack the virus particle itself and thus block the virus from infecting cells. We call this “Re-Infection Inhibition”. The encapsulated drug can be protected from host’s metabolism and delivered into infected cells to block the virus from replicating inside the cell. If both of these parts of the virus lifecycle are blocked, the viral infection would be cured, except in the case of viruses that create latency. A different encapsulated drug can also be delivered to attack the virus in its latent or dormant phase, although this has been a topic of scientific research rather than drug development as of now. Thus the “Trojan Horse” capability of a naoviricide enables developing drug that can cure most virus infections, and can be developed in the future to cure even viruses that cause latency such as herpesviruses and HIV/AIDS that are non-curable at present.

TheraCour is founded by and substantially owned by Dr. Anil R. Diwan, who is also the Company’s co-founder. Dr. Diwan recused himself from the MoU discussions that were led by the Company’s Board of Directors in conjunction with legal advice from the Company’s counsel.

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NEWS

• DealFlow Events Unveils First Wave of Companies for The Microcap Conference in January 2025
• Nov 27, 2024
• NanoViricides, Inc. Has Filed its Quarterly Report: Broad-spectrum Antiviral NV-387 Progressing to Phase II Clinical Trial – Multiple Indications of NV-387 Include MPOX/Smallpox, RSV, Influenza, COVID
• Nov 15, 2024
• NanoViricides to Provide Corporate Update at the Spartan Capital Investors Conference 2024, Today at 9:45am
• Nov 4, 2024
• NanoViricides President Dr. Diwan to Present at the PODD Conference
• Oct 22, 2024
• NanoViricides President Dr. Diwan Interviwed in PODD Podcast; He Explains the Revolutionary Clinical Stage Broad-Spectrum Antiviral NV-387, and the Potential of the Platform to Revolutionize Fields Beyond Virology
• Oct 15, 2024
• NanoViricides, Inc. Has Filed its Annual Report: Broad-spectrum Antiviral NV-387 Progressing to Phase II Clinical Trial – Multiple Indications of NV-387 Include RSV, Influenza, MPOX/Smallpox, COVID
• Sep 30, 2024
• NanoViricides Executes an Agreement Encompassing All Antiviral Drug Treatments With Theracour, Including “Trojan Horse” Drugs
• Sep 26, 2024
• MPOX is Emerging as a Global Threat – NanoViricides Investigating MEURI Protocol for Using NV-387 to Treat MPOX
• Aug 26, 2024
• NanoViricides Continues Its March Towards a Phase II Clinical Trial of NV-387 -
A Potentially Revolutionary First Line Antiviral Therapy for RSV, COVID, and Other Viral Infections
• Aug 19, 2024
• NanoViricides Provides an Update on Its Clinical Program and Strategy – NV-387 Could be As Revolutionary as Antibiotics
• Aug 8, 2024

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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.

SINCERELY,

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