Author: NanoViricides

SHELTON, CONNECTICUT / ACCESS Newswire / January 13, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, declares that the current severe influenza wave demonstrates the clear need for broad-spectrum antivirals that can work against all influenza viruses, as well as the seasonal respiratory viruses including RSV and Coronaviruses.

This year has been a “moderately severe” flu season according to CDC. The new subclade K variant of Influenza A/H3N2 is causing more than 80% of the cases. CDC estimates that there have been at least 15,000,000 illnesses, 180,000 hospitalizations, and 7,400 deaths from flu as of January 6 this season (https://www.cdc.gov/fluview/surveillance/2025-week-53.html).
The seasonal influenza vaccine, which always lags the actual field viruses, was mismatched, and contains an older subclade J of H3N2, making it substantially less effective. Every season, new influenza vaccines have to be created because the influenza virus changes rapidly. Despite that, Influenza vaccine mismatch occurs frequently. Influenza seasonal vaccine efficacy in unmatched years has been reported to be as low as 11-17% ^[1].

Two Influenza antivirals exist, namely Tamiflu (oseltamivir), and Xofluza (baloxavir). Any of these antivirals needs to be taken within 48 hours for it to be moderately effective. Importantly, Influenza viruses can rapidly become resistant to both of these antivirals.

In contrast, the broad-spectrum nanoviricide drug candidate NV-387 is highly unlikely to be defeated by viruses, because it copies the essential cell-side (host-side) feature that these viruses require, and do not mutate away from, called heparan sulfate.

Clearly, the current severe influenza epidemic demonstrates how valuable NV-387 will be as an antiviral. Additionally, NV-387 is active against Coronaviruses, RSV, and many other viruses that use heparan sulfate or related features for attacking human cells and causing an infection.

In fact, it is estimated that NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for emperic therapy of viral ARI/SARI (Acute or Severe Acute respiratory Infections).

NanoViricides’ Current Antiviral Drugs Pipeline: NV-387, A Revolutionary Broad-Spectrum Antiviral with Multiple Indications

The Phase II clinical stage revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections. Over 90% of human pathogenic viruses use heparan sulfate features, which NV-387 copies and presents to fool the virus.

NV-387 is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle using the same features that the virus uses to infect cells.

Viruses cannot escape NV-387 despite all the changes in the field because the virus still needs to bind to heparan-sulfate like features in order to cause productive pathogenic infection. NV-387 presents copious amounts of these binding sites to the virus, thereby engulfing the virus particle. Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans – the very characteristic that NV-387 emulates.

This solves the long-standing problem of antiviral medicines, that viruses escape them. Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field. This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.

NV-387 for Influenza and Bird Flu

NV-387 was found to be substantially superior to Tamiflu as well as Xofluza against Influenza virus A/H3N2 in animal model studies of Influenza A/H3N2 lethal lung infection ^[2].

Further, should Bird Flu H5N1 turn into a human outbreak, variants resistance to Tamiflu and Xofluza can be expected to generate rapidly ^[3]. NV-387 would be the ideal drug to combat the resulting outbreak, epidemic or pandemic. The causative influenza virus would not be able to escape NV-387 ^[4].

NV-387 for All Respiratory Viral Infections

A Phase II clinical trial for the evaluation of NV-387 as a first line therapy of any respiratory viral infection (NV-387 for the treatment of Viral Acute or Severe Acute respiratory Infections, Viral ARI/SARI) is being planned. Success in this clinical trial would enable NV-387 to become the first ever antiviral drug that can be prescribed by a physician based on symptoms, as an emperic therapy for respiratory viral infections, without having to test for which virus is causing the disease.

NV-387 was found to be highly effective against the “tripledemic” respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study. These studies prompted evaluation of NV-387 as a first line therapy of respiratory viral infections.

There is no treatment approved for RSV, an important disease for infants and children in early life, as well as for geriatric subjects.

ABOUT NANOVIRICIDES

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.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

^[1] Yegorov S et al., Effectiveness of influenza vaccination to prevent severe disease: a systematic review and meta- analysis of test-negative design studies, Clinical Microbiology and Infection, https://doi.org/10.1016/j.cmi.2025.09.023

^[2] Tamiflu (Oseltamivir) – Roche. Xofluza (Baloxavir) – Shionogi, Roche. H5N1 bird flu viruses resistant to Oseltamivir have already occurred. Resistance to Xofluza occurred at a high frequency in its clinical trial.

^[3] Influenza viruses generate variants by more mechanisms than most viruses: (a) by mutations, typically few and small changes in viral proteins; (b) by recombinations, wherein portions of its genomic strands are swapped between the strands derived from two different Influenza A viruses infecting the same cell; (c) by re-assortments, wherein entire genomic segment from one Influenza A virus is packaged into a different Influenza A virus in the same cell. Each complete Influenza A virus contains eight separate genomic RNA strands, giving it tremendous flexibility for “swapping” these segments and generating new variants. It is thought that all influenza A viruses causing outbreaks or pandemics among humans since the 1900s originated from strains circulating in wild aquatic birds through reassortment with other influenza strains (wikipedia, https://en.wikipedia.org/wiki/Influenza_A_virus).

^[4] All Influenza viruses bind to HSPG (heparan sulfate proteoglycan) as the first “attachment receptor”, and thus are targeted by the drug NV-387. The viruses then gain proximity to cells, and latch onto the Sialylated glycoproteins on the cell surface which is called the “cognate receptor” that enables the virus to be taken inside the cell. The cognate receptor for Influenza viruses that remain infectious to birds is slightly different from the one that the virus would need to use for efficiently infecting human cells. However, just one or a few mutations would be required in the currently circulating H5N1 bird flu viruses to become efficient in human-to-human transmission. Two different clades of H5N1 are circulating, one in wild birds, infecting into poultry, and another in dairy cattle, infecting pets and animals that drink raw milk, bringing the threat closer to a potential pandemic than it has ever been since the late 1990s.

SOURCE: NanoViricides

View the original press release on ACCESS Newswire

SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has signed a Master Services Agreement (MSA) with Only Orphans Cote, LLC, (“OOC”) a regulatory consultant firm founded by Dr. Timothy Cote. Dr. Cote and OOC will help the Company formulate its orphan drug strategy for NV-387, as well as develop relevant orphan drug designation applications and prosecute these applications at the US FDA Office of Orphan Products.

“In earlier discussions with Dr. Cote, it became apparent that the broad-spectrum antiviral drug NV-387 could harness several benefits from an orphan drug regulatory strategy,” said Anil R. Diwan, PhD, President & Executive Chairman of the Company.

NV-387 has demonstrated excellent activity against lethal animal models of orthopoxvirus ectromelia infections in mice. This opens up the regulatory pathway for licensure of NV-387 for the treatment of Smallpox. NV-387 for the treatment of Smallpox is expected to be eligible for an “Orphan drug” designation by the US FDA. Smallpox, eradicated globally in 1980, is considered an important bioterrorism threat.

Additionally, MPox disease caused by the Monkeypox virus, MPXV, a related orthopoxvirus, is considered an “orphan disease” in the USA. Therefore, we believe that NV-387 for the treatment for MPox will be eligible for orphan drug designation.

Further, NV-387 is the only drug candidate to our knowledge that has demonstrated in vivo activity against the Measles virus in a humanized animal model study. Measles infection in the USA is considered an “orphan disease” due to the small number of cases. Therefore, we believe that NV-387 for the treatment for Measles will be eligible for orphan drug designation.

Orphan drug designation qualifies sponsors for incentives including:

• Tax credits for qualified clinical trials;

• Exemption from user fees;

• Potential seven years of market exclusivity after approval;

according to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products).

Measles cases are rising across the Western world. The USA is likely to lose its Measles elimination status in 2026, if the current outbreak that began in Texas in January 2025 continues through the whole year. Canada has already lost its Measles elimination status. This means Measles is now considered endemic in Canada, and will likely be considered to be endemic in the USA as well. As of November 25, 2025, a total of 1,798 confirmed measles cases were reported in the United States, in 46 outbreaks, across 42 states, according to the CDC (https://www.cdc.gov/measles/data-research/index.html).

NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.

Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.

Viruses crossing over newly into humans from other species do so only upon acquiring significant ability to bind to HSPG, the cell-side molecule that NV-387 mimics as a decoy for the viruses ^[1] . It is highly unlikely that bioterrorism agents would be created that can drastically infect humans and yet do not bind to HSPG.

To date, pandemic preparedness has been dominated by one-drug-one-bug philosophy. With hundreds of potential biothreats, such a strategy is too expensive and would not realize a highly effective protective shield against potential pandemics.

Besides, the medical countermeasures pursued to-date for pandemic preparedness are severely lacking in that every one of them would be readily defeated by the virus as it mutates or evolves in the field. This is one lesson that has become starkly clear after the COVID-19 pandemic.

NV-387 is expected to provide a low cost option for pandemic preparedness against a multiplicity of threats, and could become an effective first response drug for practically any viral pandemic. Over 90% of viruses that can cause disease in humans are known to bind to HSPG. Our development of NV-387 suggests that most of these viruses would be susceptible to NV-387. Moreover, escape from NV-387 is highly unlikely because even as viruses mutate or evolve, they continue to bind well to HSPG as long as they are pathogenic in humans.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.

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.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.co

---

^[1] It has been reported that highly pathogenic duck influenza viruses that lack or substantially lack HSPG binding ability do not cause significant pathology in other birds, nor in humans. They appear to use exclusively sialic acid-related receptors and yet have failed to infect other species. We believe these results require further investigation.

SOURCE: NanoViricides

View the original press release on ACCESS Newswire

SHELTON, CONNECTICUT / ACCESS Newswire / November 17, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the “Company”), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2025 with the Securities and Exchange Commission (SEC) on Friday, November 14, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000110465925112608/nnvc-20250930x10q.htm).

Clinical Stage NV-387, a Single Drug, Meets Many Unmet Medical Needs in Viral Diseases
NV-387, based on a novel mechanism of action, and a novel nanomedicine technology that defines a new class of drugs, is a first-in-class broad-spectrum antiviral drug.

Viruses cannot escape NV-387 because no matter how much a virus changes, it continues to bind to the sulfated proteoglycan attachment receptor(s) of the host which the virus needs to cause infection as well as for human-to-human transmission. NV-387 mimics the critical features of the conserved attachment receptors on the host-side that over 90% of viruses are known to use.

This escape-resistant drug feature of NV-387 solves the biggest problem in antiviral medical countermeasures: Viruses readily evolve to escape the countermeasures in the field, whether vaccines, antibodies, or traditional small chemical drugs.

At present:

• There is no approved drug for Influenza that can be reliably predicted to be not escaped by the next potential epidemic or pandemic Influenza virus, including H5N1. All approved influenza drugs are known to be readily escaped by Influenza variants.

• Additionally, in the current season, the mutated clade K of the A/H3N2 subtype is dominant in the Northern hemisphere, and the seasonal Influenza vaccine is “mismatched” (i.e. it contains the older variant, clade J, of A/H3N2). When the vaccine is mismatched, the overall vaccine efficacy as determined post-season has been as low as 11-17% ^[1] .

• There is no approved drug for RSV, although three different antibodies have been approved for pre-exposure protection of infants from potential risk of RSV infection, and some vaccines have been approved for use in geriatric patients and adults at risk, as well as for pregnant women. While the market size is projected to be exceeding $8 billion or so, the regulatory development timelines are long for RSV pediatric drug development.

• There is no approved drug for Measles.

• There is no approved drug for MPox.

• The Smallpox approved drugs (under FDA Animal Rule) have significant shortcomings, leaving the US practically unprepared for this bioterrorism scenario despite several billions of dollars in development and acquisitions.

• The approved drugs for Influenza are unlikely to meet the challenge of an H5N1 or highly pathogenic influenza virus epidemic.

NV-387, based on relevant animal model studies, and based on safety and tolerability observed in a Phase I human clinical trial, can fulfill these glaring gaps in pandemic preparedness for current and emerging threats, as well as for potential bioterrorism threats.
Thus, NV-387, as a single drug, is responding to several unmet medical needs in viral infectious diseases at once.

Current Quarter Developments

During the current quarter, we have diligently continued our progress towards initiating a Phase II human safety and effectiveness clinical trial for the evaluation of NV-387 as a treatment of Monkeypox in the Democratic Republic of Congo.

The local regulatory agency, ACOREP, has already approved this Phase II clinical trial, subject to completion of certain requirements.

Africa continues to suffer from the Monkeypox epidemic, which has resulted in the Africa CDC declaring in August 2024 a “Public Health Emergency of Continental Security” (PHECS), a status that continues because this epidemic has continued to expand across national boundaries. This Mpox epidemic is driven by the more morbid and more virulent versions, Clade 1a and 1b, as compared to the 2022 outbreak that was driven by the less virulent Clade 2. The latter has become endemic in the USA and the Western World, but remains limited to sexual transmission primarily in the men-having-sex-with-men (MSM) population. The case fatality rate of Clade 1 has been between 9% to 1.5%, whereas that of Clade 2 is less than 0.3%.

Our objective is to bring the data from the clinical trials external to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA. NV-387 has certain orphan disease as well as bioterrorism related indications.

Therefore, we first plan to file the appropriate Orphan Drug Designations (ODD) for NV-387 as a treatment for MPOx, Smallpox, and also for Measles. The ODD if approved provides several benefits that would accelerate the NV-387 program towards regulatory licensure. These include frequent FDA meetings and rapid decision-making. Additionally, the economic benefits include certain tax credits for R&D costs, waiver of certain PDUFA fees, and a seven year exclusivity for marketing the drug for the licensed indication.

Company Financials

We reported that, as of September 30, 2025, we had cash and cash equivalent current assets balance of approximately $1.25 Million. In addition, we reported approximately $8.36 Million in total Assets including $6.78 Million of 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 $1.18 Million.

The net cash utilized during the three months ended September 30, 2025 was approximately $1.59 Million. This included certain non-recurring expenditures including R&D expenditures in preparation for a Phase II clinical trial application. We raised approximately $1.25 Million net of commission and certain expenses in an At-the-Market offering (“ATM”) during the three months ended September 30, 2025.

Additionally, subsequent to the reporting period, we raised approximately $0.68 million in the said ATM offering from October 1 through November 4, 2025.

Further, on November 10, 2025, we raised approximately $5.5 Million in cash after expenses and commissions, in a Registered Direct Offering (“RDO”) and a concurrent private placement offering (both together, the “Offering”) from a single institutional healthcare-focused investor. The overall Offering consisted of (i) 1,970,000 shares of common stock, par value $0.00001 per share (the “Common Stock”), at an offering price of $1.68 per share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 1,601,429 shares of Common Stock, at an offering price of $1.67999 per Pre-Funded Warrant, in the RDO, and in the concurrent private placement with the same investor, the Company has issued and sold Series A warrants to purchase up to 3,571,429 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to 3,571,429 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Warrants”). The Series A Warrants will have an exercise price of $1.75 per share, will be exercisable after 6 months from date of issuance, and will expire 2 years following the issuance date. The Series B Warrants will have an exercise price of $2.00 per share, will be exercisable after 6 months from date of issuance, and will expire 5.5 years following the issuance date.

These financings have added cash amounts of approximately $6.1 million to the Company’s cash balance as of November 12, 2025. Additionally, we continue to have access to an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan. Based on budgeting considerations, 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 infection 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 note that an additional gross cash financing of $6.25 Million would result into the Company if and when the Series A warrants are exercised. We also note that we continue to have access to the aforementioned ATM Equity Offering. Additionally, we believe we will have access to the equity markets to raise the funds necessary for our current objectives, as we meet various milestones in the ensuing year. We continue to re-prioritize our programs in line with available resources.

Thus we believe that our recent financings have substantially fortified the Company’s fiscal position, and we further believe that we have the ability to continue on our regulatory development plan for NV-387 including the Phase II MPox clinical trial, as well as various planned US FDA engagements for different indications.

We believe our regulatory developments for the orphan diseases and for bioterrorism agents response, provide for a rapid regulatory pathway for US FDA licensure of NV-387, with potential for non-dilutive grant and contracts funding, as well as possible direct US Government acquisition contracts worth hundreds of millions of dollars per year if NV-387 is approved for one of the agents that the US Government stockpiles drugs for. We believe that these early stage revenue opportunities would help us fuel the commercial drug development of NV-387 towards the tens of billions of dollars markets in RSV, Influenza, and other viral infections; as well as to further advance our NV-HHV-1 pan-herpesvirus drug candidate, among others.

About NanoViricides

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, and even Measles. 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.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

^[1] Yegorov S et al., Effectiveness of influenza vaccination to prevent severe disease: a systematic review and meta- analysis of test-negative design studies, Clinical Microbiology and Infection, https://doi.org/10.1016/j.cmi.2025.09.023.

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

SHELTON, CONNECTICUT / ACCESS Newswire / November 14, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it will be presenting today, Friday, November 14th, at 11:25am ET at the Pharma Partnering Summit 2025 held at the Hilton Boston Logan Airport in Boston, MA.

Event Information:

Event	NanoViricides Presentation at the Pharma Partnering Summit 2025 in Boston, MA
Time & Date	11:25 am to 11:45 am ET on Friday, November 14, 2025
Location	Hilton Boston Logan Airport, Boston, MA

Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline and Platform Technologies available for licensing.

NanoViricides’ Current Antiviral Drugs Pipeline: NV-387, A Revolutionary Broad-Spectrum Antiviral with Multiple Indications

The Phase II clinical stage revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections. Over 90% of human pathogenic viruses use heparan sulfate features, which NV-387 copies and presents to fool the virus.

NV-387 is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle using the same features that the virus uses to infect cells.

Viruses cannot escape NV-387 despite all the changes in the field because the virus still needs to bind to heparan-sulfate like features in order to cause productive pathogenic infection. NV-387 presents copious amounts of these binding sites to the virus, thereby engulfing the virus particle. Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans – the very characteristic that NV-387 emulates.

This solves the long-standing problem of antiviral medicines, that viruses escape them. Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field. This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.

NV-387 stands to combat viral infections where there is no current medical treatment available, including RSV for pediatrics, Measles, MPox, and others.

NanoViricides lead clinical stage drug candidate NV-387 is rapidly moving into Phase II clinical trial for the treatment of MPox in the Democratic Republic of Congo.

NV-387 for Influenza and Bird Flu

Additionally, NV-387 was found to be substantially superior to Tamiflu as well as Xofluza against Influenza virus in animal model studies of Influenza A/H3N2 lethal lung infection ¹.

The H3N2 Influenza A virus, subclade K, currently circulating in the Northern Hemisphere already has several mutations that distinguish it from the subclade J strain included in this year’s Influenza vaccine. The mismatched vaccine is therefore expected to be less effective than if the circulating strain was the same as the vaccine strain. The circulating H3N2 strain is also thought to cause a more severe pathology ². Efficacy of seasonal influenza vaccines against H3N2 strain, even when well matched, has been about half that for H1N1 subtype, in terms of protection against severe disease leading to hospitalization. Influenza seasonal vaccine efficacy in unmatched years has been reported to be as low as 11-17% ³.

Further, should Bird Flu H5N1 turn into a human outbreak, variants resistance to Tamiflu and Xofluza can be expected to generate rapidly ⁴. NV-387 would be the ideal drug to combat the resulting outbreak, epidemic or pandemic. The causative influenza virus would not be able to escape NV-387 ⁵.

NV-387 for All Respiratory Viral Infections

A separate Phase II clinical trial for the evaluation of NV-387 as a first line therapy of any respiratory viral infection (NV-387 for the treatment of Viral Acute or Severe Acute respiratory Infections, Viral ARI/SARI) is being planned. Success in this clinical trial would enable NV-387 to become the first ever antiviral drug that can be prescribed by a physician based on symptoms, as an emperic therapy for respiratory viral infections, without having to test for which virus is causing the disease.

NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such emperic therapy of viral ARI/SARI.

NV-387 was found to be highly effective against the “tripledemic” respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study. These studies prompted evaluation of NV-387 as a first line therapy of respiratory viral infections.

There is no treatment approved for RSV, an important disease for infants and children in early life, as well as for geriatric subjects.

NV-387 has shown excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses.

There is no treatment approved for MPox; tecovirimat (TPOXX) has failed clinical trials, and no results are available from the brincidofovir (TEMBEXA) clinical trial “MOSA”.

“For Smallpox bio-threat readiness, the USA remains without an effective drug because of deficiencies in the two drugs approved under animal rule ⁶,” asserted Anil Diwan, PhD, President of the Company, adding, “NV-387 is ready to fill this gap.”

US government acquisitions for smallpox drugs have been in the range of hundreds of millions of dollars.

Additionally, NV-387 has shown excellent effectiveness against Measles virus lethal lung infection in a humanized (hCD150+ knock-in) mouse model.

There is no treatment approved for Measles. Cases of Measles have been rapidly rising in the developing world including USA, Canada, UK and European countries. Measles is an important health threat because the disease can lead to “immune amnesia”, wiping out pre-developed immunity against other diseases, because it attacks the immune system itself.

NanoViricides’ Robust Technology Platform Has Enabled a Broad Drugs Pipeline: HerpesViruses, HIV, Others

The nanoviricides™ platform technology is yielding novel antiviral drug candidates against a number of challenging viral targets at a rapid pace.

In addition to NV-387, the Company has developed a clinical-ready pan-herpesvirus drug candidate, NV-HHV-1 that has shown activity against HSV-1, HSV-2 and VZV, and is expected to have activity against CMV, HHV-6, and HHV-8 as well.

The Company has also developed an anti-HIV drug candidate, NV-HIV-1, that has shown strong efficacy in SCID-hu-Thy-Liv animal model of HIV infection. NV-HHV-1 mimics the landing site on cellular CD4 that is required for all HIV viruses to cause cellular infection. Thus, HIV, despite constant changes, will be unable to escape NV-HHV-1.

NanoViricide Platform Enables Drug Rescue, Oral Drug Delivery, and Zip-Code Specific Delivery

Oral drug delivery of small chemicals, peptides (such as the GLP-a obesity drugs), and proteins is feasible by encapsulation of the guest drug into the nanoviricide polymeric micelle. The encapsulation protects the guest from metabolism thereby enabling effective drug delivery.

Encapsulation of a difficult or failed drug within the nanoviricide polymeric micelle can enable rescue of the drug candidate turning it into a clinically viable drug candidate, saving hundreds of millions of dollars of development work.

Going another step further, the nanoviricide platform technology can be customized to enable zip-code-like specific delivery of encapsulated drugs to specific tissues (e.g. non-liver targeted delivery),, cells (e.g. cancer-cell specific delivery sparing normal cells), bacteria, or viruses (e.g. NV-HHV-1, NV-HIV-1) in a fully synthetic chemistry based, scalable technology stack.

ABOUT THE PHARMA PARTNERING SUMMIT 2025

A Premier Conference for Pharma Business Development and Licensing Professionals.

ABOUT NANOVIRICIDES

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.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

¹ Tamiflu (Oseltamivir) – Roche. Xofluza (Baloxavir) – Shionogi, Roche. H5N1 bird flu viruses resistant to Oseltamivir have already occurred. Resistance to Xofluza occurred at a high frequency in its clinical trial.

² https://ici.radio-canada.ca/rci/en/news/2206627/canada-could-face-worst-kind-of-flu-season-as-experts-warn-evolving-strain-may-be-mismatch-for-vaccine

³ Yegorov S et al., Effectiveness of influenza vaccination to prevent severe disease: a systematic review and meta- analysis of test-negative design studies, Clinical Microbiology and Infection, https://doi.org/10.1016/j.cmi.2025.09.023

⁴ Influenza viruses generate variants by more mechanisms than most viruses: (a) by mutations, typically few and small changes in viral proteins; (b) by recombinations, wherein portions of its genomic strands are swapped between the strands derived from two different Influenza A viruses infecting the same cell; (c) by re-assortments, wherein entire genomic segment from one Influenza A virus is packaged into a different Influenza A virus in the same cell. Each complete Influenza A virus contains eight separate genomic RNA strands, giving it tremendous flexibility for “swapping” these segments and generating new variants. It is thought that all influenza A viruses causing outbreaks or pandemics among humans since the 1900s originated from strains circulating in wild aquatic birds through reassortment with other influenza strains (wikipedia, https://en.wikipedia.org/wiki/Influenza_A_virus ).

⁵ All Influenza viruses bind to HSPG (heparan sulfate proteoglycan) as the first “attachment receptor”, and thus are targeted by the drug NV-387. The viruses then gain proximity to cells, and latch onto the Sialylated glycoproteins on the cell surface which is called the “cognate receptor” that enables the virus to be taken inside the cell. The cognate receptor for Influenza viruses that remain infectious to birds is slightly different from the one that the virus would need to use for efficiently infecting human cells. However, just one or a few mutations would be required in the currently circulating H5N1 bird flu viruses to become efficient in human-to-human transmission. Two different clades of H5N1 are circulating, one in wild birds, infecting into poultry, and another in dairy cattle, infecting pets and animals that drink raw milk, bringing the threat closer to a potential pandemic than it has ever been since the late 1990s.

⁶ Tecovirimat (TPOXX) was approved under the US FDA Animal Rule, and is stockpiled by the US Government Strategic National Stockpile (SNS). However, Tecovirimat-resistant viruses develop with a single point mutation in the viral VP37 protein. It is illogical to believe that any terrorist attack would be from a non-resistant smallpox strain. Brincidofovir (Tembexa) was approved under the US FDA Animal Rule, and is stockpiled in SNS. Brincidofovir carries a black box warning due to increased mortality rates in another indication, causes elevation of liver damage-related markers, is a carcinogen, may cause embryonic or fetal harm, and may irreversibly impair fertility, according to its prescribing information, limiting its applicability as a drug to be used across all population in the case of a smallpox bio-terrorism event ( https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf .).

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

SHELTON, CONNECTICUT / ACCESS Newswire / November 10, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”) today reported that it has received approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).

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 now cleared to proceed subject to filing of certain documents.

“This is an important milestone in regulatory development of NV-387,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company.

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. Another drug, brincidofovir (TEMBEXA ®, EBS) entered into a clinical trial called “MOSA” with fanfare in January, 2025, with early topline results expected by the end of the quarter. The status of this clinical trial is not publicly known as of now.

MPox Clade II has become endemic in the USA but it affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.

Most recently, three new cases of MPox Clade I have been found in California in unconnected persons, with no travel to Africa; yet the MPXV viral genomes were found to be in the same cluster, suggesting that community spread of the MPXV Clade I is likely already occurring, according to the CDC (https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case).

“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.”

The Company previously announced in May, 2025 that it has received an approval from the Ethics Committee CNES of the national regulatory agency in DRC that NV-387 can be considered for a Phase II clinical trial for the treatment of MPox. This approval was based on a summary package of information regarding NV-387 regulatory development until then. This Ethics Committee approval cleared the path for us to engage with the regulatory agency ACOREP and prepare the documentation required for their evaluation and approval as instructed by them.

We have now completed submission of substantial required documentation in the draft forms as requested. We are now in the process of compiling all of this documentation together into the final form Clinical Trial Application, along with associated certifications and disclosures. These documents will be translated into French as required by the DRC. Both French and English sets of documents, certified to be accurately translated, will then be submitted to the ACOREP regulatory agency. The approval to start recruiting patients will then become effective.

MPox disease, caused by the human MPox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the WHO African Region that includes the Democratic Republic of Congo (DRC), Uganda, and other countries. It led to the WHO declaring a Public Health Emergency of International Concern (“PHEIC”) on August 14, 2024 that was closed in September, 2025. However, 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. Therefore, the Africa CDC has maintained the status of the MPox pandemic as Public Health Emergency of Continental Security (“PHECS”).

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 also found to be highly effective against lethal lung infection by Measles virus in a humanized (hCD150+knock-in/IfnR-/-) mouse model.

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.

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.

About NanoViricides

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.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

SHELTON, CONNECTICUT / ACCESS Newswire / November 12, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), today announced the closing of its previously announced securities purchase agreement with a single healthcare institutional investor for the purchase and sale of 3,571,429 shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.68 per share in a registered direct offering (the “Offering”). The gross proceeds from the Offering are approximately $6 million, before deducting placement agent commissions and other offering expenses. In addition, in a concurrent private placement, the Company has issued and sold Series A warrants to purchase up to 3,571,429 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to 3,571,429 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Warrants”). The Series A Warrants have an exercise price of $1.75 per share, are exercisable after 6 months from date of issuance, and expire 2 years following the issuance date. The Series B Warrants have an exercise price of $2.00 per share, are exercisable after 6 months from date of issuance, and expire 5.5 years following the issuance date. The exercise price of the Series B Warrants represents approximately a 20% premium to the closing price for the Company’s common stock on November 10, 2025.

The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

A.G.P./Alliance Global Partners acted as the sole placement agent in connection with the offering.

The common stock (and common stock equivalents in lieu thereof) offered to the institutional investor described above were offered pursuant to a registration statement on Form S-3 (File No. 333-271706) which was declared effective by the Securities and Exchange Commission (the “SEC”) on May 22, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus which are a part of the effective registration statement. The Warrants were issued in a concurrent private placement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering were filed with the SEC and is available on the SEC’s website at www.sec.gov. Additionally, electronic copies of the prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.

The private placement of the Warrants and the shares underlying the warrants offered to the institutional investor were made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, (the “Securities Act”) and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About NanoViricides

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.

Forward Looking Statements

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the SEC and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:

NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

SOURCE: NanoViricides

View the original press release on ACCESS Newswire