Press Releases
D. Boral Capital LLC is acting as the exclusive placement agent for the Offering.
The closing of the Offering is expected to occur on or about May 18, 2026, subject to the satisfaction of customary closing conditions. The Company expects to receive aggregate gross proceeds of ~$2 million from the Offering, before deducting placement agent fees and other related expenses.
The common shares (or pre-funded warrants in lieu thereof) are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333- 271706), which was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on May 22, 2023.
A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC. Once filed, it will be available on the SEC’s website at http://ww.sec.gov. A copy of the prospectus supplement and accompanying base prospectus relating to the offering may be obtained, when available, from D. Boral Capital LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, or by telephone at (212) 404-7002, or by email at dbccapitalmarkets@dboralcapital.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About NanoViricides
NanoViricides, Inc., is a publicly traded company (NYSE American: 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 and their variants cannot escape. Its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an “Orphan Drug Designation” (ODD) by the US FDA Office of Orphan Products Development (OOPD). This could provide 7 years market exclusivity, tax credits for clinical trial costs, and fee exemptions upon approval. NV- 387 is a revolutionary antiviral that we believe will be the drug offered at “first visit” when the patient presents to a doctor with any respiratory viral illness. NV-387 was also found to be highly
effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles.
Forward-Looking Statements
Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the use of words such as “may,” “will,” “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends, and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. These risks include, but are not limited to, the ability to complete the offering on the terms described or at all, the ability to satisfy customary closing conditions, market conditions, regulatory developments affecting the digital asset and stablecoin industries, and other risks described in the Company’s filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Risk Factors” in the Company’s Annual Reports on Form 20-F, as may be supplemented or amended by the Company’s Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information, or otherwise.
Contacts
For inquiries, contact: NanoViricides, Inc. info@nanoviricides.com
Public Relations Contact: ir@nanoviricides.com
Source: NanoViricides, Inc.
Amer.: NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2026 with the Securities and Exchange Commission (SEC) on Thursday, May 14, 2026. The report can be accessed at the SEC website by searching for the Company ( https://www.sec.gov/edgar/browse/?CIK=1379006&owner=exclude ) .
Clinical Stage NV-387, a Single Drug, Meets Many Unmet Medical Needs in Viral Diseases
We continue to advance NV-387, a novel broad-spectrum antiviral that defines a new class of antiviral drugs, towards a Phase II clinical trial. We are working on initiating a Phase II human clinical trial for the evaluation of the safety and effectiveness 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.
We are now working on clinical trial site readiness.
We have chosen an ÒOrphan-firstÓ development strategy for regulatory advancement of NV-387. To this end, we have filed ÒOrphan Drug DesignationÓ (ODD) applications with the US FDA for three different scenarios, namely:
(i) NV-387 for the treatment of Measles,
(ii) NV-387 for the treatment of MPox, and
(iii) NV-387 for the treatment of Smallpox.
Orphan drug designation, if approved, will provide us with several incentives. These include frequent communication with the FDA, an additional 7 years of market exclusivity, certain R&D tax benefits, and waiver of certain FDA PDUFA fees. These incentives are expected to result in a shorter timeline of the regulatory process as compared to NV-387 development for Influenza or RSV.
An ODD was granted for NV-387 for the treatment of Measles by the US FDA on or about April 27, 2026, subsequent to the reporting period.
We have also applied for a ÒRare Pediatric Disease DrugÓ (RPDD) designation for NV-387 for the treatment of Measles. If granted, the RRPD will enable us to obtain a Priority Review Voucher (PRV) upon drug approval from the FDA, which is a tradable instrument.
Recently, a PRV was sold for $180 million. This would represent a revenue-generation opportunity even prior to commercial market sales of the drug.
We plan on advancing NV-387 for the treatment and prophylaxis of Measles in the USA. We intend to obtain non-dilutive funding such as US government grants for this development.
At present:
★ 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.
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.
We have chosen to first develop NV-387 for the treatment of MPox. Its more severe form, MPox Clade I, is endemic in African region, affecting entire population including children. The less severe form, MPox Clade II, has become endemic in the Western World, where it is primarily transmitted in Men-having-sex-with-men population.
There is no approved treatment for MPox viruses. Two drugs that were approved under the US FDA ÒAnimal RuleÓ, namely tecovirimat (TPOXX¨, SIGA) and brincidofovir (TEMBEXA¨, EBS) have been tried for MPox. Tecovirimat has failed in clinical trials to demonstrate efficacy over the standard of care. Brincidofovir has a black box warning and has known hepatotoxicity issues. Yet it was advanced into the MOSA clinical trial with first cohort dosed in January, 2025, It appears that further advancement beyond the initial cohort did not take place. A vaccine Jynneos, is FDA-approved for Smallpox and MPox. However, vaccine deployment logistics and costs are a major problem for developing countries such as DRC. Further, the effectiveness of 2-dose JYNNEOS vaccine against disease progression (not infection prevention) after 2-doses is only 66.6% in HIV negative subjects and 44.8% in HIV positive subjects, for MPox Clade II, based on US surveillance data (Lancet Infect Dis 2025; 25: 1106–15; https://doi.org/10.1016/ S1473-3099(25)00180- X). It is suggested that its efficacy against the more severe Clade I is likely even less.
We believe that the MPox clinical trial, if successful would help us advance NV-387 towards regulatory approval for Smallpox in the USA. Smallpox is considered an important bioterrorism agent. Two drugs have been stockpiled in the US Strategic National Stockpile for Smallpox preparedness, namely TPOXX and TEMBEXA, at the cost of billions of dollars.
However, the virus can readily escape TPOXX by a single point mutation. TEMBEXA requires physician care during treatment, making it unsuitable as a bioterrorism response agent. Thus there is a need for a better antiviral agent.
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.
NV-387 has an extremely broad spectrum of antiviral activity. To date, it has been found to be highly active against every virus that we have tested in animal models:
NV-387 treatment was found to be able to cure lethal RSV infection in mice.
NV-387 treatment was substantially superior to the existing treatments, namely Tamiflu (oseltamivir) and Xofluza (baloxavir) in a lethal infection with H3N2 Influenza A virus.
NV-387 treatment was highly effective in an animal model for MPox using dermal orthopoxvirus infection.
NV-387 treatment was highly effective in an animal model for Smallpox using lethal lung infection with orthopoxvirus.
In addition, NV-387 treatment was highly effective in a humanized animal model (hSLAM+k.i.,InfAR-/- mice) in lethal infection with Measles virus.
Thus, NV-387, as a single drug, is responding to several unmet medical needs in viral infectious diseases at once.
Company Financials
We reported that, as of March 31, 2026, we had cash and cash equivalent current assets balance of approximately $3.38 Million. In addition, we reported approximately $10.20 Million in total Assets including $6.53 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 $1.07 Million.
The net cash utilized during the nine months ended March 31, 2026 was approximately
$5.58 Million. This included certain non-recurring expenditures including R&D expenditures in preparation for a Phase II clinical trial application.
Based on budgeting considerations, we reported that we do not have sufficient funding in hand to continue operations through May 14, 2027, 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. As such, we have focused on the objective (i), the Phase II Mpox clinical trial.
We continue to have access to an ÒAt-The-MarketÓ common stock facility under a shelf registration, with D. Boral Capital, LLC, the sales agent. We also note that an additional gross cash financing of $6.25 Million would result into the Company if and when the Series A warrants from the November, 2025 financing are exercised.
Additionally, we continue to have access to an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan. No funds have been drawn on this facility as of now.
At present, we have sufficient funding to execute and complete the Phase II clinical trial of NV-387 for MPox infection in DRC according to our plans and projections.
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 "CompanyÓ) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricideª class of drug candidates and the nanoviricideª 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 ÒsafetyÓ, ÒeffectivenessÓ 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 ÒInvestigational New DrugÓ application. cGMP refers to current Good Manufacturing Practices. CMC refers to ÒChemistry, Manufacture, and ControlsÓ. 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 ÒActive Pharmaceutical IngredientÓ. 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.
NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, emphasizes the critical need for a revolutionary, broad-spectrum, antiviral drug like NV-387 in light of the recent Andes hantavirus incident on a cruise ship that has led to a flurry of worldwide activity to effectively quarantine the ship MV Hondius and trace passengers’ contacts in an effort to prevent a potential global epidemic.
“NV-387 could have possibly saved lives of the infected patients, given the preponderance of evidence on effectiveness of NV-387 in lethal lung infections in animal models,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “Physicians in charge could have sought it under emergency or expanded use procedures, given that there is no drug for the treatment of hantavirus infections. NV-387 has successfully completed Phase I clinical trial of safety and tolerability in healthy human volunteers.”
The Andes hantavirus infects directly into the lungs via fomites (droplets of cough or spit) from infected persons.
NanoViricides, Inc. has used exactly this route of infection in our lethal animal models of many distinctly different viruses for testing NV-387. We have found NV-387 to be highly effective in treating every one of the viruses that we have tried so far, including: Coronaviruses, RSV, Influenza, Monkeypox, and even Measles virus.
The ship has docked on May 10th for orderly release of persons on board in Tenerife, Canary Islands, Spain1. Disembakation and transfer of travelers on board under strict procedures designed to minimize spread are almost completed and the ship with minimal staff will proceed to the Netherlands. The travelers are being returned with special flights to their countries of residence. All of those on board will be isolated for observation once they reach their countries. Persons testing positive will be put in special hospital bio-containment units for care. Of the 18 persons returning to the USA, one has tested positive, and another one is showing symptoms. The US passengers will be brought to an isolation facility in Nebraska for observation 2.
The extreme care in handling this incidence is designed to eliminate the risk of any spread.
Persons that had left the ship before the deadly infection was confirmed on May 2nd are being traced and their contacts are also being traced. Constant observation can minimize the risk of spread by isolating anyone testing positive for the hantavirus. Seven Americans that returned from the ship to four states are being observed; none of them is positive for the hantavirus, suggesting minimum risk.
The economic cost of the global effort for this single incidence is tremendous, not to mention the inconveniences to all involved, including the passengers, their contacts, health care workers, and all persons who were brought in to control this situation so that it does not explode into a global outbreak.
Imagine if we had a broad-spectrum antiviral on hand, ready for use. The first infected cases could have been saved. Further, all suspected infections could be successfully treated with minimal potential for spread, and contacts could be prophylactically treated to block any possibility of spread. The result would be a highly effective, rapid and low cost response.
This is exactly what NanoViricides is aiming for, and NV-387 will likely address 90% of pathogenic viral infections, known and unknown, because of its unique design.
The Andes hantavirus that infected patients aboard the cruise-ship is capable of sustained person-
1 https://www.foxnews.com/video/6395149720112?msockid=265ec6d7e0276c1833cbd183e1a46d5e .
2 https://www.cbsnews.com/news/cruise-ship-stricken-by-hantavirus-reaches-canary-islands/ and other news sources.
to-person transmission, and has a very high case fatality rate (~35%, i.e. one in three infected people could die of the severe hantavirus pulmonary syndrome, called HPS). The “patient zero” and his wife, both of whom were infected before boarding, died, and so did another person on board. Several other suspected infected persons are under observation and some have recovered.
While Andes hantavirus is generally limited to South America, the potential for global spread is vividly brought out by the recent incidence.
Another lethal hantavirus, called “Sin Nombre” (SNV) is endemic in the western deer mouse population in North America west of the Mississippi, but the number of cases remains low. Since 1993 (the virus’ discovery) to 2023 it had caused 890 confirmed cases with 35% resulting in deaths in the USA, according to the CDC3; and over 100 cases have occurred in Canada4. In February, 2025, actor Gene Hackman’s wife Betsy Arakawa was found dead from hantavirus infection from suspected aerosolized rodent material contamination.
With ever-increasing global travel, local zoonotic infections such as hantavirus can quickly travel far and wide if not caught in time, potentially causing global pandemics, as was the case with COVID-19. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus; Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic.
“Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to defend the global population in the war against known and unknown nanoscopic enemies that are viruses,” commented Dr. Diwan, adding, “NV-387 is the only drug with this potential that is in clinical development today, to the best of our knowledge.”
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
3 https://www.cdc.gov/hantavirus/data-research/cases/index.html
4 https://en.wikipedia.org/wiki/Sin_Nombre_virus cites original reference.
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
Source: NanoViricides, Inc.
Shelton,CT--(NewsfileCorp.-May6,2026)-NanoViricides,Inc.(NYSEAmerican: NNVC), today announced its participation in the D. Boral Capital Global Conference, taking place May 7, 2026, at The Plaza Hotel in New York City.
AnilR.Diwan,PhD,President&Exec.Chairmanwillbehostingone-on-onemeetings on May 7th from 9:45 A.M. to 2:45 P.M. (ET).
Toregisterforone-on-onemeetingswithmanagementatThePlazaHotelinNewYork City, interested parties should contact the DBC Conference Team
atdbcconferenceteam@dboralcapital.com.
AboutNanoViricides, Inc.
Recently, NanoViricides, Inc., a publicly traded company (NYSE Amer.: NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrumantiviralsbasedonhost-mimeticnanomedicinetechnologythatvirusescannot escape, announced that its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an “Orphan Drug Designation” (ODD) by the US FDA Office of Orphan Products Development (OOPD). A "Rare Pediatric Disease Designation" is also sought, that would enable a "Priority Review Voucher" upon approval of NV-387 for Measlesthat the Company can sell to generate $100~200 million in quick revenues. NV-387 is a revolutionary antiviral thatwe believe will be the drug to be offered when the patientfirst presents to the doctor with any respiratory viral illness. This is as revolutionary as the development of broad-spectrum antibiotics. NV-387 is entering a Phase II humanclinical trials for the treatment of Mpox, for which there is no known drug. NV-387 was found to be highly effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles. We believe our animal study design is such that the animal studies are predictive of human clinical success. NV-387 was found to be very safe and well tolerated in healthy humans in a Phase I clinical trial in India. NV-387 is orally available, and formulated as a gummy that does not require swallowing or even water, since it dissolves in the mouth by itself as it is naturally taken in. This is valuable for older patients and infants and children alike. Viruses cannot escape NV-387, because NV-387 presents to them the very host cell features that they essentially require to be able to infect the human cell. NV-387 does not rely on human immune system, unlike vaccines, antibodies, and small chemical drugs, and would be effective in immunocompromised patients as well as otherwise healthy subjects.NV-387 is a complete chemical nanomachine "nanoviricide" that is designed to bind to the virus particle at multiple points, and then engulf the virus, thereby rendering it incapable of infection. The Company has also developed NV-HHV-1, a pan-herpesvirus drug candidate, and NV-HIV-1, a pan-HIV drug candidate, based on this host-cell-mimetic nanoviricidetechnology. Webelieve thecurrent targetmarket sizeof thesedrugs exceeds $25 Billion.
About D.Boral Capital
D. Boral Capital LLC is a premier, relationship-driven global investment bank headquartered in New York. The firm is dedicated to delivering exceptional strategic advisory and tailored financial solutions to middle-market and emerging growth companies. With a proven track record, D. Boral Capital provides expert guidance to clientsacrossdiversesectorsworldwide,leveragingaccesstocapitalfromkeymarkets, including the United States, Asia, Europe, the Middle East, and Latin America.
ArecognizedleaderonWallStreet,D.BoralCapitalhassuccessfullyaggregated approximately $35 billion in capital since its inception in 2020, executing ~400 transactions across a broad range of investment banking products.
For further information:
MeetaRVyas
+1(203)937-
info@nanoviricides.comwww.nanoviricides.com
SourceNanoViricides,
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 its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an “Orphan Drug Designation” (ODD) by the US FDA Office of Orphan Products Development (OOPD).
The orphan drug designation will qualify NanoViricides for incentives including:
•Tax credits for qualified clinical trials;
•Exemption from certain user fees;
•Potential seven years of market exclusivity after approval; according to the US FDA1.
“The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 for the Treatment of Measles,” said Anil R. Diwan, PhD., adding, “NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved.”
NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.
Measles cases have been rising globally. This year, a major epidemic has broken out in Bangladesh with over 227 children dead and over 35,000 cases, while Guatemala has an on- going Measles outbreak with over 5,300 cases and four deaths2.
Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks.
Measles is endemic globally. Many countries that had achieved an elimination status for Measles have by now lost this status, due to severe outbreaks over the last three years3.
1 https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-
orphan-product-drugs-and-biological-products
2 https://www.cidrap.umn.edu/measles/measles-case-counts-mount-utah-arizona-while-
bangladesh-guatemala-battle-deadly-outbreaks (May 1, 2026, CIDRAP news).
3 https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in- the-u-s-and-globally
Measles cases have been rising in the USA. As of April 30, 2026, already 1,803 confirmed measles cases (excluding 11 in international travelers) were reported in the United States in 2026. in the year 2025, 2,251 confirmed cases with 3 deaths were reported, increasing from 285 in 2024 and 59 in 2023 (no deaths in these prior years). Vaccine breakthrough accounted for
6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. (CDC data4).
Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which has qualified NV-387 for Measles Treatment as an Orphan Drug indication.
NanoViricides employed the expert services of Only Orphans Cote, LLC, (“OOC”) a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application as well as the RPDD application. Dr. 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.
In addition to the ODD, NanoViricides has also applied for a “Rare Pediatric Disease
Drug” (RPDD) designation for NV-387 as a Treatment of Measles to the OOPD. The RPDD, if granted would additionally enable the Company eligible for a “Priority Review Voucher” (PRV). A PRV cuts the FDA review time for the corresponding NDA significantly. A PRV is tradable, and it has fetched $150~200 million dollars to the holder when traded. A PRV would provide a significant early revenue source for the Company, and would make a strong business case for prioritizing the development of NV-387 for Measles.
There is no approved drug for the treatment of measles, although an effective vaccine exists and is generally given in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age providing lifelong immunity. Measles is a highly contagious disease. A population vaccination rate of more than 95% is thought to be needed for blocking spread of measles if a case occurs. Vaccination rates have been dropping worldwide primarily due to vaccine hesitancy.
Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.
In absence of a treatment, quarantining of all contacts of a case for at least 14 days is the public health approach at present to minimize spread. Vaccination is urged but any vaccine requires 2-3 weeks from administration to become effective. Also, Measles vaccine requires 2 doses spread apart in time for full effectiveness.
4 https://www.cdc.gov/measles/data-research/index.html
Quarantining causes significant disturbances in the society, in particular, causing significant loss of in-school days for children. A preventive NV-387 treatment of contacts could eliminate the need for quarantining, with a significant positive impact for children as well as economically.
Thus, a drug for Measles is sorely needed for combating Measles worldwide.
NV-387 is an extremely 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.
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.com
Source: NanoViricides, Inc.
NanoViricides Product Pipeline
COVID
RSV
VZV "SHINGLES
DERMAL TOPICAL
CREAM
HSV -1
"GENITAL LESIONS"
HSV-2
"COLD SORES"
HIVCIDE
Potentially
"Functional Cure"
RABIES
Company Fact Sheet
Meeta Vyas
Chief Financial Officer
Ms. Vyas was First Indian woman to be named CEO of a publicly listed US corporation
