NanoViricides Inc (NNVC)

I can't wait to see if the bot that you just thanked says "You're welcome".

https://investorshub.advfn.com/boards/profilea.aspx?user=878289

Well - at least we know NOW that the trial might actually start. Thanks for posting this.

NanoViricides Has Shipped NV-387 Oral Gummies Drug Product for Phase II Clinical Trial to DR CongoJune 22, 2026 9:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / June 22, 2026 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company") today announced that it has shipped the NV-387 Oral Gummies Drug Product for a Phase II Clinical Trial of Monkeypox Treatment to the Democratic Republic of Congo (DRC), in preparation for enrollment of patients.Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel have visited the site several times, despite travel restrictions, and changing flight schedules and cancellations, as required for the preparations. Enrollment and dosing of patients is expected to begin after the staff training is completed in a few weeks.This Phase II clinical trial was previously delayed because of change in the clinical trial site away from Kinshasa. An on-site examination of the new site by our CRO found that the new site required substantial amount of preparation in readiness for conducting the clinical trial. Our preparations experienced additional delays after the travel restrictions within DRC and internationally were imposed subsequent to the May 17 declaration of a Public Health Emergency of International Concern (PHEIC) due to an Ebola outbreak in DRC.NanoViricides believes that NV-387 could be a useful and effective treatment for the current Ebola Bundibugyo Virus (BDBV) outbreak. This outbreak is rapidly spreading within Eastern DRC and in Uganda, threatening several neighboring countries.There is no approved drug or vaccine for the Bundibugyo Ebola virus at present. Vaccines are highly specific to virus strains, and therefore, a new vaccine would need to be developed and tested in clinical trials. Antibodies also are highly specific to virus strains.Antibody drugs as well as Remdesivir, a broad-spectrum nucleotide analog drug, require multiple infusions. Implementing such intensive care units in a resource-strained, emergency response set up of isolation tents is logistically extremely difficult and expensive.NV-387 is the only oral broad-spectrum antiviral at present.The shipment of NV-387 Oral Gummies has made it locally available to repurpose it towards Ebola containment if so desired.NanoViricides has recently proposed to perform a clinical trial of NV-387 Oral Gummies for the treatment of Ebola viruses, and this proposal was accepted by the Pillar Committee of DRC for Ebola Response, as previously reported. The Company will provide updates regarding this Ebola Phase II clinical trial related developments as they take place.The Company has previously reported that it has received approval to start said 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 scheduled Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection.MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.There is no drug available for the treatment of hMPXV infection that causes the MPox disease.NV-387 would be the "go to" pandemic response candidate if it is successful in the Phase II MPox clinical trial. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.MPox Clade I cases in the USA have been slowly increasing. As of March 23, 2026, there have been 15 cases of MPox Clade I in the USA since November, '25, with 4 of them in March, '26, according to CDC[1].Community spread of the MPXV Clade I is likely already occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC[2].Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study[3]. The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II[4]The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.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 that quarter. The status of this clinical trial is not publicly known as of now. Previously, three MPox cases treated with TEMBEXA developed liver dysfunction. TEMBEXA carries a black-box warning, due to severe liver toxicity, entero-gastric toxicity, and requires clinical monitoring, making it unsuitable as a drug for pandemic response.Thus both of the Smallpox drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads, representing an opportunity for NV-387."NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."NV-387 was found to 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 NanoViricidesNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.cdc.gov/monkeypox/situation-summary/index.html[2] https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case[3] https://www.cidrap.umn.edu/mpox/amid-new-mpox-outbreak-study-suggests-waning-protection-jynneos-vaccine[4] From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43.SOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: NanoViricides Has Shipped NV-387 Oral Gummies Drug Product for Phase II Clinical Trial to DR Congo

But can it core a apple?

So,...NNVC is now claiming to have gotten permission to try out NV-387 from some DRC authorities. It appears the next steps are to file the necessary paperwork for another trial, however they seem to think that shouldn't be too difficult as it will be the same types of paperwork that they already have used for the Monkey Pox trial.

https://www.benzinga.com/pressreleases/26/06/ac53191825/as-the-ebola-epidemic-spreads-nv-387-oral-gummies-can-enter-a-phase-ii-clinical-trial-for-treatme

June 15, 2026 8:30 AM13 min read
As the Ebola Epidemic Spreads, NV-387 Oral Gummies Can Enter a Phase II Clinical Trial for Treatment of Ebola - NanoViricides Proposal is Approved by the Pillar Committee in DR Congo
by ACCESS Newswire

SHELTON, CT / ACCESS Newswire / June 15, 2026 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, NanoViricides announces that its proposal to perform a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus has been approved by the Pillar Committee in Charge in the Democratic Republic of Congo (DRC).

There is no approved treatment or vaccine for the new variant of the Bundibugyo Ebolavirus (BDBV) that is causing the current rapidly expanding outbreak of the Ebolavirus Disease (EVD) in DR Congo and Uganda. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[1], such as fruit bats.

NV-387 is a broad-spectrum antiviral that mimics the host-side features that the virus requires, and is likely to be effective against Ebola viruses because they use the same feature mimicked by NV-387.

NV-387 is the only orally active agent under consideration for clinical trial as a treatment of Ebola to the best of our knowledge. In an epidemic scenario in resource limited settings such as in DRC, oral drug is a highly advantageous feature.

Other treatments require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario if this Ebola virus outbreak continues to grow, as has been widely expected.

"We believe NV-387 could be effective against Ebola viruses," said Anil R. Diwan, PhD, adding, "It is an oral drug, in contrast to other infusions, which makes for easy scalability of NV-387 treatment in this lethal disease theater to treat the most number of patients while requiring the least amount of healthcare resources. Thus evaluating if NV-387 treatment works is of paramount importance to combat this outbreak."

NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for the Phase II Mpox clinical trial in DRC previously. Om Sai CRO has been instrumental in the successful submission, in a rapid timeframe, of our proposal to the Pillar Committee for the Phase II Clinical Trial for Evaluation of NV-387 Oral Gummies as a Treatment of Ebola Viruses in DRC.

The next steps for NanoViricides will be to perform appropriate submissions to the National Ethics Committee of DRC, and upon their approval, to submit a clinical trial application to the regulatory agency, ACOREP for approval to begin the clinical trial. Most of these documents are ready because the same drug NV-387 Oral Gummies has been approved by ACOREP for a Phase II clinical trial as a Treatment for Mpox in DRC.

The Bundibugyo Ebola Viral Disease (BVD) outbreak has already expanded to 782 confirmed cases, with 181 deaths reported as of June 14 in DR Congo. It has expanded to two additional health zones, covering 20 of the 36 zones, in the Ituru province where it started, with 10 of 34 zones in North Kivu and 1 health zone in South Kivu provinces reporting increasing numbers of cases[2].

While there is currently minimal risk of Ebola in the USA, the CDC's mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths in the next three months alone, rivaling the largest outbreak to date in 2014-2016[3].

The outbreak which was declared a Public Health Emergency of International Concern ("PHEIC") by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk[4].

Infusions with a new antibody cocktail, MBP134 (ZMapp), or a monoclonal antibody, Maftivimab (Regeneron), or a nucleotide analog Remdesivir are being considered for treatment and are likely to advance into clinical trials.

All of these potential treatments require I.V. infusions with most requiring multiple infusions. This is very difficult to implement in the low resource environment, complicated with the lethal disease scenario of extreme isolation suites, and healthcare workers covered with PPE. Further, monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.

Further, viruses readily escape antibodies after exposure to the drugs.

In contrast, NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.

This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.

Additionally, NV-387 was previously found to be superior to remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is very likely to extend to the current novel Bundibugyo ebolavirus strain.

Further, it is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.

NV-387 Oral Gummies drug product is ready to be shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.

These factors presented a compelling case making NV-387 a strong contender for conducting Phase II clinical trials as a treatment of the Bundibugyo Virus (BDBV) infection and the resulting Bundibugyo Virus Disease (BVD).

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.

All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.

Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[5]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.

The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the USA. To this end, travel from DRC has been restricted, and suspect travelers are directed to screening at specific airports and may be quarantined.

The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. So far, BDBV has demonstrated variable CFR ranging from under 5% (in Uganda, 2026), to around 15% (in DRC), to over 35% (some specific parts of DRC). Therefore, BDBV is particularly of greater concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols, and require extensive contact with bodily fluids of an infected person. Currently there is no apparent threat of a global pandemic.

With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. 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 combat viruses and 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 such potential that is in clinical development today, to the best of our knowledge.",...

Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.

NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.

If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.

New SEC filing - they are setting up a shelf offering. We all had to kind of figure that some sort of capital raise/dilution was going to have to happen. Clinical trials are generally not free.

This bit on page 5 of the SEC filing is a bit concerning IMO - "Presently, our focus is on the two separate Phase II clinical trials for NV-387 for the treatment of (i) MPox Virus Infection, and (ii) Viral Acute and Severe-Acute Respiratory Infections (Viral ARI and SARI). We are preparing the clinical trial application for the Phase II MPox trial and we have already obtained preliminary approval from the regulatory ethics committee for the clinical protocol in the Democratic Republic of Congo (DRC). In addition, we have already developed a draft clinical protocol for the Phase II Viral ARI and SARI clinical trial that is now in planning stage."

They are "preparing" for the Monkey Pox Phase II trial?

Is there no end to the grift and greed of this crook?

As the Ebola Emergency Outbreak Grows Rapidly, NanoViricides Has Proposed a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment - with Superior Oral Administration and Escape Resistance Features Over AntibodiesJune 8, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / June 8, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, NanoViricides announces that it has proposed a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus to the Committee in Charge in the Democratic Republic of Congo (DRC).The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[1], such as fruit bats.The outbreak which was declared a Public Health Emergency of International Concern ("PHEIC") by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The WHO has revised the number of confirmed cases to 452 and deaths to 82 in DRC plus 19 confirmed cases and 2 deaths in neighboring Uganda[2]. These are the latest numbers after the WHO had previously reported 906 suspected cases and 220 suspected deaths in DRC; the latter numbers have been revised after expanded testing. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk[3].While there is currently minimal risk of Ebola in the USA, the CDC's mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths in the next three months alone, rivaling the largest update to date in 2014-2016[4].There are no approved vaccines or treatments against the Bundibugyo virus."We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is spreading rapidly in Africa," said Anil R. Diwan, PhD, adding, "It is an oral drug, in contrast to other infusions, which makes for easy scalability of NV-387 treatment in this lethal disease theater to treat the most number of patients while requiring the least amount of healthcare resources. Thus evaluating if NV-387 treatment works is of paramount importance to combat this outbreak."A new antibody cocktail, MBP134 (ZMapp), a monoclonal antibody, Maftivimab (Regeneron), and a nucleotide analog Remdesivir are being considered for treatment.All of these potential treatments require I.V. infusions with most requiring multiple infusions. This is very difficult to implement in the low resource environment, complicated with the lethal disease scenario of extreme isolation suites, and healthcare workers covered with PPE. Further, monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.Infusions are certainly not scalable in a large outbreak scenario if this Ebola virus outbreak continues to grow, as has been widely expected.Further, viruses readily escape antibodies after exposure to the drugs.In contrast, NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.Additionally, NV-387 was previously found to be superior to remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is very likely to extend to the current novel Bundibugyo ebolavirus strain.Further, it is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.Additionally, NV-387 Oral Gummies drug product is ready to be shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.These factors should make NV-387 a strong contender for conducting Phase II clinical trials as a treatment of the Bundibugyo Virus (BDBV) infection and the resulting Bundibugyo Virus Disease (BVD).NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[5]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.The WHO declared a Public Health Emergency of International Concern (PHEIC) for the Bundibugyo outbreak in Eastern DRC, with two cases in Uganda in travelers from Congo, on May 17, 2026[6]. The outbreak itself was declared on May 15, although the initial or "patient zero" case likely occurred in April, 2026. This delay was primarily because of the cases occurring in clusters in multiple remote locations that had limited reporting capabilities.Three American Doctors working at hospitals in the Ebola affected area were exposed to the BDBV. One of them was moved to Germany and treated in hospitalized setting. He has recovered after approximately 15 days and has been released. His wife (another doctor) did not develop symptoms, and she and their children have been united in Germany. The third doctor was moved to the Czech republic. It is believed that he did not develop symptoms.The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the USA. To this end, travel from DRC has been restricted, and suspect travelers are directed to screening at specific airports and may be quarantined.The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. So far, BDBV has demonstrated variable CFR ranging from under 5% (in Uganda, 2026), to around 15% (in DRC), to over 35% (some specific parts of DRC). Therefore, BDBV is particularly of greater concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols, and require extensive contact with bodily fluids of an infected person. Currently there is no apparent threat of a pandemic.With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. 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 combat viruses and 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 such potential that is in clinical development today, to the best of our knowledge."ABOUT NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.comSource: NanoViricides, Inc.[1]https://virological.org/t/initial-genomes-from-may-2026-bundibugyo-virus-disease-outbreak-in-the-democratic-republic-of-the-congo-and-uganda/1032[2]https://www.thehindu.com/news/international/nearly-500-confirmed-cases-in-central-africa-ebola-outbreak-who/article71070867.ece[3]https://www.forbes.com/sites/maryroeloffs/2026/05/25/african-health-officials-on-ebola-this-is-too-much-live-updates/[4]https://www.cdc.gov/media/releases/2026/update-on-ebola-outbreak-in-the-democratic-republic-of-the-congo-and-uganda-6-5-2026.html[5]Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.[6]https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concernSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: As the Ebola Emergency Outbreak Grows Rapidly, NanoViricides Has Proposed a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment - with Superior Oral Administration and Escape Resistance Features Over Antibodies

Solid volume today. I'm working under the assumption that this rise, and this volume, will be short-lived unless we start to hear some results from the Monkey Pox Phase 2. The "Ebola" hype will fade fast once the outbreak is under control again.

NNVC..............................p/m

So - volunteering to send an unproven drug, one that has not even successfully completed a Phase 2 trial against any actual disease causing virus in humans - let alone any of the Ebola-type viruses in a sick person - is just grasping and desperate.

Then again - consider the source - Diwan.

Disgusting. Attempting to profit by selling shares while dancing on the graves of Ebola victims.

There’s a special place for scum like Diwan.

In the Ebola Emergency, NV-387 is Ready to be Shipped to DRC, and It Compares Favorably as a Treatment for Ebola Versus Possible Options, Says NanoViricidesMay 26, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 26, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, compares potential treatment options for Ebola Bundibugyo virus strain and finds that the Company's broad-spectrum antiviral drug candidate NV-387 is worthy of evaluation in this scenario.The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[1], such as fruit bats.The outbreak which was declared a public health emergency of international concern by the WHO on May 16, 2026, is rapidly expanding, outpacing containment efforts, with over 900 suspected cases and over 220 deaths, in a high traffic region bordering the Democratic Republic of Congo (DRC), Uganda, and South Sudan and with 11 more nations in Africa at risk[2].There are no approved vaccines or treatments against the Bundibugyo virus.As such, the possible treatment options during the current expanding outbreak scenario must look at either other approved therapies that may not work, or look at new therapies that are at clinical stage.There were four drug candidates tested in a clinical trial in an Ebola Zaire outbreak, namely an antibody cocktail called ZMapp, another antibody cocktail called REGN-EB3, a monoclonal antibody developed from a survivor patient called mAb114, and a broad-spectrum nucleotide analog drug called Remdesivir. Of these, the more effective mAb114 (Ebanga) and REGN-EB3 (Inmazeb) were approved as treatments for Ebola Zaire infection, and the effect of ZMapp and Remdesivir against standard of care was not evaluated in the PALM clinical trial[3].All of these four drugs require infusions, which is very difficult in a deadly disease such as Ebola that requires strong patient isolation protocols, and wherein protection of health care workers is of utmost important. Further, monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.Recently, a drug candidate, obeldesivir, was developed related to remdesivir[4]. Oral obeldesivir failed as a treatment for COVID-19 in a Phase III clinical trial[5].This clinical failure raises substantial doubts that obeldesivir would be of any benefit in Ebola Bundibugyo infection, since the clinical activity of obeldesivir indeed appears to be less than that of remdesivir, Remdesivir was approved for COVID-19, but not for Ebola Zaire.NV-387 was previously evaluated by the Company in animal models wherein a separate group of infected animals was treated with remdesivir to serve as a positive control. The increase in survival over untreated animals was 8.5 days (170%) for NV-387 IV, 4.4 days (88%) for NV-387 Oral, but only 2 days (40%) for Remdesivir IV in this uniformly lethal infection model for COVID-19[6]. This indicates that NV-387 IV as well as NV-387 PO were substantially superior to Remdesivir.We believe these results of NV-387 being superior to Remdesivir as a treatment would hold for other viruses as well, including Ebola viruses.NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments."We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is spreading rapidly in Africa," said Anil R. Diwan, PhD, adding, "All filoviruses including all Ebola strains utilize the sulfated proteoglycans for initial cell attachment; which is the feature that NV-387 presents to the viruses to destroy them."NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.NV-387 Oral Gummies drug product is ready to be shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[7]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.The WHO declared a Public Health Emergency of International Concern (PHEIC) for the Bundibugyo outbreak in Eastern DRC, with two cases in Uganda in travelers from Congo, on May 17, 2026[8]. The outbreak itself was declared on May 15, although the initial or "patient zero" case likely occurred in April, 2026. This delay was primarily because of the cases occurring in clusters in multiple remote locations that had limited reporting capabilities.Some Americans currently in DRC have been affected. It is not clear if they have been traced as contacts, or have acquired infection awaiting diagnosis. The US CDC with other US departments is active in extracting Americans exposed to ebolavirus and moving them into an isolated area for treatment, as necessary[9].The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. Currently there is no apparent threat of a pandemic.With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. 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 combat viruses and 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 such potential that is in clinical development today, to the best of our knowledge."ABOUT NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] https://virological.org/t/initial-genomes-from-may-2026-bundibugyo-virus-disease-outbreak-in-the-democratic-republic-of-the-congo-and-uganda/1032[2] https://www.forbes.com/sites/maryroeloffs/2026/05/25/african-health-officials-on-ebola-this-is-too-much-live-updates/[3] Prasad, AN, Woolsey, C., Borisevich, V., Agans, KN, Deer, DJ, Geisbert, JB, Harrison, MB, Dobias, NS, Karla A. Fenton, KA, Robert W. Cross, RW & Geisbert, TW. "Remdesivir, mAb114, REGN-EB3, and ZMapp partially rescue nonhuman primates infected with a low passage Kikwit variant of
Ebola virus." Nature Communications (2025)16:3824.[4] Obeldesivir is an oral prodrug of a metabolite of remdesivir called GS-441524, i.e. Obeldesivir converts to GS-441524, which then converts to its phosphate form that is the same active moiety as formed from remdesivir itself. However, GS-441524 was known to be substantially less active compared to remdesivir.[5] Lancet Infect Dis 2025; 25: 1282-92, https://doi.org/10.1016/S1473-3099(25)00238-5.[6] We developed a BSL-2 uniformly lethal animal model (rat) for COVID-19 by using hCoV-NL63 infection. NL63 uses the same receptor ACE2 as SARS-CoV-2. Additionally, all coronaviruses use HSPG as the initial attachment receptor. Untreated and Vehicle treated animals in this study died uniformly on day 5.[7] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.[8] https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern[9] https://www.statnews.com/2026/05/17/ebola-outbreak-congo-americans-exposure-suspected-cases/SOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: In the Ebola Emergency, NV-387 is Ready to be Shipped to DRC, and It Compares Favorably as a Treatment for Ebola Versus Possible Options, Says NanoViricides

A historically accurate statement sunspotter. It's been their pattern since at least 2010, when I started paying attention to them.

NanoViricides Announces Closing of ~$2 Million Registered Direct OfferingMay 18, 2026 11:55 PM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 18, 2026 / NanoViricides, Inc. (NYSE American:NNVC) ("NanoViricides" or the "Company"), 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, today announced the closing of its previously announced registered direct offering (the "Offering") of 1,333,334 million shares of common stock (or pre-funded warrants in lieu thereof), together with accompanying warrants to purchase 1,333,334 common shares (the "Offering"). The Offering was made to a single, fundamental institutional investor and priced at-the-market price of US$1.50 for each common share and accompanying whole warrant to purchase one common share. Each whole warrant has an exercise price of US$1.75 per share and will be exercisable six months from issuance and will expire in three years. The Company received aggregate gross proceeds of $2,000,001 from the Offering, before deducting placement agent fees and other related expenses.D. Boral Capital LLC acted as the exclusive placement agent for the Offering.The ordinary shares (or pre-funded warrants in lieu thereof) were 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 was filed with the SEC and is available on the SEC's website at https://www.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 NanoViricidesNanoViricides, 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 StatementsStatements 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.ContactsFor Inquiries, Contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:
ir@nanoviricides.comSource: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: NanoViricides Announces Closing of ~$2 Million Registered Direct Offering

NNVC has a template where they insert the disease du jour into the opening paragraph of a PR, then scrape some stuff from AI about that disease and finally finish with a paragraph saying that NV-387 is the only known cure.

If only Diwan could devote a tiny bit of effort into actually trying to progress NV-387 through a clinical trial program - any clinical trial program - it might not be so obvious that NNVC is a stone cold scam designed for the sole purpose of enriching Diwan.

Ebola Global Health Emergency Needs a Broad-Spectrum Drug - NV-387 is a Strong Potential Candidate, Says NanoViricidesMay 18, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 18, 2026 / 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 as another severe Ebolavirus outbreak has occurred in the Eastern part of DR Congo (DRC), with spillage across the border into Uganda."We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is ravaging DRC," said Anil R. Diwan, PhD, adding, "All filoviruses including all Ebola strains utilize the sulfated proteoglycans for initial cell attachment; which is the feature that NV-387 presents to the viruses to destroy them."Viruses are unlikely to escape NV-387 because no matter how much the viruses change, they still depend upon their interaction with sulfated proteoglycans for initial attachment to cells, which NV-387 mimics.In contrast, antibodies and vaccines are highly specific, and are readily escaped by viruses. Further, antibodies require a cold chain and must be given as infusions in patients. The equipment and facilities for the cold chain and for infusion itself in a high isolation setting are generally not available in remote areas.NV-387 is an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[1]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.The WHO declared a Public Health Emergency of International Concern (PHEIC) for the Bundibugyo outbreak in Eastern DRC, with two cases in Uganda in travelers from Congo, on May 17, 2026[2]. The outbreak itself was declared on May 15, although the initial or "patient zero" case likely occurred in April, 2026. This delay was primarily because of the cases occurring in clusters in multiple remote locations that had limited reporting capabilities. The outbreak had already resulted in 88 deaths and at least 336 suspected cases[3]. WHO estimates there could be potentially a much larger outbreak with many unreported or undiagnosed cases.Some Americans currently in DRC have been affected. It is not clear if they have been traced as contacts, or have acquired infection awaiting diagnosis. The US CDC with other US departments is active in extracting these subjects exposed to ebolavirus and moving them into an isolated area for treatment, if necessary.[4]The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-20%, the potential threat of global pandemic from such an outbreak would increase substantially. Currently there is no apparent threat of a pandemic.With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. 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 combat viruses and 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 such potential that is in clinical development today, to the best of our knowledge."ABOUT NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.[2] https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern[3] https://www.forbes.com/sites/omerawan/2026/05/16/why-the-current-ebola-outbreak-in-congo-matters-to-the-entire-world/[4] https://www.statnews.com/2026/05/17/ebola-outbreak-congo-americans-exposure-suspected-cases/SOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: Ebola Global Health Emergency Needs a Broad-Spectrum Drug - NV-387 is a Strong Potential Candidate, Says NanoViricides

NanoViricides Announces Pricing of ~$2 Million Registered Direct OfferingMay 15, 2026 8:35 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 15, 2026 / NanoViricides, Inc. (NYSE American:NNVC) ("NanoViricides" or the "Company"), 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, today announced it has entered into a securities purchase agreement with a single fundamental institutional investor for the purchase and sale of 1,333,334 million common shares (or pre-funded warrants in lieu thereof), together with accompanying warrants to purchase 1,333,334 common shares for gross proceeds of approximately US$2 million in a registered direct offering (the "Offering"). The common shares are being sold in combination with an accompanying full warrant (with each whole warrant being exercisable into one common share of the Company). Each whole warrant has an exercise price of US$1.75 per share and will expire three years from the date of issuance.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 https://www.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 NanoViricidesNanoViricides, 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 StatementsStatements 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.ContactsFor inquiries, contact:
NanoViricides, Inc.
info@nanoviricides.comPublic Relations Contact:ir@nanoviricides.comSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: NanoViricides Announces Pricing of ~$2 Million Registered Direct Offering

Agreed - it's been way too long and way too many 'flavors of the month' for a lot of years.

The Monkey Pox trial "should" be running through its Phase 2a patient set in the DRC by now assuming that they actually got started during Mid April. If so - hopefully we should have some data on that cohort by the end of May. If what I read about the trial structure and timing was accurate, they were going to follow the patient treatment course for 28 days post-treatment.

How many years has Diwan been living off of our money spouting his drug can/could cure this and that disease with no completed results?
https://investorshub.advfn.com/stock-market/AMEX/nanoviricides-NNVC/stock-news/98491386/recent-hantavirus-on-a-cruise-ship-highlights-the

NanoViricides, Inc. Announces Participation in the D. Boral Capital Global ConferenceMay 6, 2026 3:37 PM
NewsfileShelton, Connecticut--(Newsfile Corp. - May 6, 2026) - NanoViricides, Inc. (NYSE American: 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.Anil R. Diwan, PhD, President & Exec. Chairman will be hosting one-on-one meetings on May 7th from 9:45 A.M. to 2:45 P.M. (ET).To register for one-on-one meetings with management at The Plaza Hotel in New York City, interested parties should contact the DBC Conference Team at dbcconferenceteam@dboralcapital.com.About NanoViricides, Inc.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. About D. Boral CapitalD. 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 clients across diverse sectors worldwide, leveraging access to capital from key markets, including the United States, Asia, Europe, the Middle East, and Latin America. A recognized leader on Wall Street, D. Boral Capital has successfully aggregated approximately $35 billion in capital since its inception in 2020, executing ~400 transactions across a broad range of investment banking products. For further information:
Meeta R Vyas
CFO
?+1 (203) 937-6137?
info@nanoviricides.com 
www.nanoviricides.comSource NanoViricides, Inc. Original: NanoViricides, Inc. Announces Participation in the D. Boral Capital Global Conference

So - it looks like share prices are at their high for 2026. It would be nice to see this stock edge back up over $2 and hold above there for a while while we watch how the monkey pox trial goes.

OK Diwan - you are finally starting to make some progress. In theory, there should be some dosed monkey pox patients in the DRC by now. Once that first cohort of patients has passed their monitoring period, hopefully there will be some sort of PR about it. Even if they can't share specifics, we should at least get an announcement about 2b starting up.

The Measles Orphan Drug designation is also a good step forward. However, it's only a benefit once a clinical trial is set to go for measles.

NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDAMay 4, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / May 4, 2026 / NanoViricides, Inc., 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 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 FDA[1]."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 deaths[2].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 years[3].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 data[4]).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.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 NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[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[4] https://www.cdc.gov/measles/data-research/index.htmlSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA

DDMAC/FDA would have been down on him like a ton of bricks a few years ago.

Of course he’s claiming efficacy, and comparative efficacy at that:

"Our drug NV-387 is currently the only medical countermeasure that can help these patients and save lives.

He’s also making safety claims based on cell
models and Phase I studies, both of which are huge no-nos (and scientifically absurd):

“ NV-387, we believe, is the only drug candidate that has been shown to be effective and safe in specially humanized animal model studies…………

NV-387 has completed a Phase I clinical trial with no reported adverse events, indicating excellent safety and tolerability in humans.”

"He's not directly claiming efficacy."
Sounds to me like he is.
How does your use of the word "directly" change the meaning of "claiming efficacy"?

How does he get away with that?He's not directly claiming efficacy or that the drug has been approved for anything. He's just on the edge of making that claim though. It's almost, but not quite, enough to raise the ire of the FDA.

Just get the Monkey Pox data generated already,... Demonstrate that the drug actually works on 'something' outside of an animal model system and get on with it.

"Our drug NV-387 is currently the only medical countermeasure that can help these patients and save lives."

How does he get away with that?

"NV-387 is Here to Help Patients and Control Spread"

Except it's not "here", of course. It hasn't even completed Phase II.

Given that the raison d'être for NNVC is to sell shares, this should not surprise anyone who has taken even a brief look at this long running festering sore of a scam.

FDA should haul them up over this crap. DDMAC would have crucified them in an instant for this blatant promotion of an unapproved, untested drug candidate, and rightly so.

Deadly Measles Cases Accentuate the Need for a Treatment - NV-387 is Here to Help Patients and Control Spread, Says NanoViricidesApril 21, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 21, 2026 / NanoViricides, Inc., 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 cannot escape, comments that its drug candidate NV-387 is the weapon necessary for combatting growing cases of deadly measles worldwide.Bangladesh recently reported 18,219 suspected measles cases, including 2,897 confirmed cases, and 164 suspected case deaths, with transmission in 58 of 64 districts, in the single month of March 15 to April 14, 2026[1]. Over 80% of the cases are in children under the age of 5 years, and most of the deaths are in unvaccinated cases. The nation has rolled out a vaccination campaign which is expected to reach 1.2 million children in 18 of the 64 districts in the first phase."This response clearly leaves out treating patients which is the immediate need," said Anil R. Diwan, PhD, adding, "Our drug NV-387 is currently the only medical countermeasure that can help these patients and save lives."A treatment such as NV-387 would help curtail the transmission chain as well, which would help stall the epidemic sooner. This is because a patient recovering in a shorter timeframe due to receiving treatment compared to without treatment means less days of further transmission from the patient.Additionally, contacts including health care workers can be treated with the same drug in smaller doses to prevent infection and transmission immediately.In contrast to the immediate effect of drug treatment, a vaccinated individual becomes protected only after 2-3 weeks post vaccination; so they continue to remain at risk while immersed in the epidemic. Also worth noting is the fact that measles vaccination requires two doses separated over several weeks in order to reach maximum effectiveness.NV-387, we believe, is the only drug candidate that has been shown to be effective and safe in specially humanized animal model studies of lethal Measles virus infection (humanized h-CD150+ knock-in, IfnAR-/- genotyped mice), as reported previously by NanoViricides. NV-387 has completed a Phase I clinical trial with no reported adverse events, indicating excellent safety and tolerability in humans.As of April 16, there were 1,738 confirmed measles cases reported by 33 jurisdictions in the USA according to CDC[2]. Since then, at least two additional states have reported cases.Measles 2-dose vaccine is considered to be highly effective, with only a 10-11% breakthrough rate (i.e. infection in vaccinees). This is in spite of the fact that the vaccine was developed 60 years ago, by attenuating genotype A measles virus, whereas current circulating viruses are genotype D8 and B3, among others. Although the virus has continued to mutate, the receptor binding sites on the viral glycoprotein H are not hidden from the immune system, and also these sites are functionally conserved despite mutations. This is why infection with any measles virus (vaccine strain or circulating "wild-type") protects against substantially all genotypes.Nevertheless, infants under the vaccination age (especially after 3 months when the maternal antibodies in the infant wane), immune-compromised persons including HIV, persons with morbidities such as diabetes, auto-immune diseases, etc. cannot generate sufficiently high levels of protection from vaccines. These groups, as well as health care workers (the latter due to high exposure risk) remain susceptible despite vaccination. As such, even if these groups catch asymptomatic or mild infection, they would potentially transmit the virus to others.This is why having a treatment as a complement to the vaccine is essential for containment towards elimination and eventually potentially eradication of measles virus. At present, NV-387 is the only drug candidate that we know of that fulfills this unmet medical need.Measles is considered a rare orphan disease in the USA. It is also a rare pediatric disease. As such, NV-387 for the treatment of Measles would qualify for an Orphan Drug Designation (ODD) together with a Rare Pediatric Disease Drug (RPDD) designation. These designations provide sponsors with incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval[3]. Additionally, RPDD would qualify NV-387 for issuance of a Priority Review Voucher (PRV) upon drug approval. NanoViricides has applied for NV-387 as a treatment for measles for ODD as well as RPDD to the US FDA.A PRV is a tradable instrument and can fetch cash value of $150 million to $200 million. A PRV, if granted, would thus significantly improve the business case for the regulatory development of NV-387 as a measles treatment.ABOUT NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.who.int/southeastasia/news/detail/15-04-2026-response-measlesBN[2] https://www.cdc.gov/measles/data-research/index.html[3] https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-productsSOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: Deadly Measles Cases Accentuate the Need for a Treatment - NV-387 is Here to Help Patients and Control Spread, Says NanoViricides

So - assuming that the CRO training and set-up for on site medical staff does get done this week or next in the DRC and the dosing schedule proceeds as described as below (linked PDF) it's supposed to include a total of 80 patients.

Phase 2a: 10 patients with SOC and 10 patients with SOC + NV-387 for total of 6 days of doses and then evaluated for whether dosing should continue for a longer period of time. Not particular dosing strength is described.

Phase 2b: 60 more patients - apparently if I read the document correctly - 20 of SOC and 40 of SOC + NV-387 at the same dosage as determined in the 2a portion.

Outcomes to be included: Complete lesion recovery, elimination of new rash formation, viral load, and 28-day outcome. They estimated at the time that the trial should take between 3-6 months depending on the patient recruitment rates. So if they actually do get the trial rolling this month, they could have the Phase 2 data by sometime between July & October. So Phase 2a could be completed by as early as late May depending on recruitment.

https://www.nanoviricides.com/files/News%20PDFs/Zacks_SCR_Research_11062025_NNVC_Bautz.pdf

It's good to see that some actual progress is being made of late. It's been long overdue to get this drug into testing.

We have to be prepared for some sort of capital raise in the near future, but here's hoping it's not too bad of a dilution and enough to get the Monkey Pox data collected and analyzed.

Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricidesApril 7, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 7, 2026 / NanoViricides, Inc., 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 cannot escape, announced today that it has filed an application for "Rare Pediatric Disease Drug" Designation (RPDD) for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development (OOPD). This RPDD application is expected to be joined together with the Orphan Drug Designation application for NV-387 as a Treatment for Measles that the Company has filed in February, 2026.NanoViricides will be eligible for a Priority Review Voucher (PRV) upon approval of the drug if NV-387 is designated as a Rare Pediatric Disease Drug. A PRV carries immediate economic value. It is a tradable instrument, and recently has generally fetched around $160 million upon sale of the PRV to another company [1]. A PRV carries the benefit of accelerated approval of the drug for which it is used by the purchaser, which brings this value to the PRV."NV-387 as an effective drug is expected to be an important tool to fight Measles resurgence in the USA and worldwide, when approved," said Anil R. Diwan, PhD, adding, "Treating a Measles patient with NV-387 would help with rapid recovery and eliminate the high morbidity and the rare post-Measles ‘Immune Amnesia' effects." "A Rare Pediatric Disease Drug Designation for NV-387 would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles, by substantially boosting the potential economic benefits and the business case for this indication," said Meeta R. Vyas, CFO of the Company.There is no drug for the treatment of Measles at present.The Rare Pediatric Disease Priority Review Voucher program was re-authorized by the US Congress and signed into Law by President Trump on February 3, 2026, as part of the Consolidated Appropriations Act of 2026 [2].Measles cases have been rising in the USA, with 1,661 laboratory confirmed cases already reported, with occurrences across 33 states, with 17 new outbreaks, as of April 2, 2026, according to the CDC [3]. An additional 10 cases were reported to have occurred in international travelers visiting the USA. A total of 2,286 confirmed cases in 48 outbreaks were reported in 2025. The rate of hospitalization in 2026 has decreased to about 5% from the 11% rate in 2025. This decrease is presumably due to a better understanding of case handling guidelines, and the strong efforts of the CDC including updated information and toolkits for Public Health and Healthcare professionals [4].Measles is a rare disease in the USA, with annual incidence rates well below 200,000 cases. About 70% of the cases have been in pediatric subjects (0-18 years of age), which qualifies NV-387 for Measles Treatment as a Rare Pediatric Disease Drug.At least 8% of cases in 2026 to date, and at least 7% of cases in 2025 occurred in vaccinated individuals. The CDC reports the vaccine breakthrough rate at about 10%.Infants below 9 months of age are not eligible for routine vaccination. Recently, at least 100 child deaths due to Measles were reported in Bangladesh during 2026, with a large portion of them in infants, leading to a vaccination campaign relaxing this lower age limit [5].NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the RPDD application. 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.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 for contacts 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.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 would eliminate the need for quarantining, with a significant positive impact for children as well as economically.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 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 in the developing and less developed nations.Thus, a drug for Measles is sorely needed for combating Measles worldwide.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.Over 90% of human pathogenic viruses are expected to be susceptible to NV-387, based on its design as a sulfated proteoglycan mimetic.ABOUT NANOVIRICIDESNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.fiercepharma.com/pharma/bavarian-nordic-sells-priority-review-voucher-chikungunya-vaccine-approval-160m .[2] https://www.fiercepharma.com/pharma/fdas-rare-pediatric-disease-voucher-program-revived-2026-government-funding-bill .[3] https://www.cdc.gov/measles/data-research/index.html[4] https://www.cdc.gov/measles/php/toolkit/index.html[5] https://www.foxnews.com/health/least-46-children-dead-amid-measles-outbreak-virus-spreads-globally ; https://www.bbc.com/news/articles/cevkz2z7dm8oSOURCE: NanoViricidesView the original press release on ACCESS NewswireOriginal: Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricides

An informative flier - upcoming events: summary and valuation estimates.

https://www.nanoviricides.com/files/News%20PDFs/Zacks_SCR_Research_11062025_NNVC_Bautz.pdf

So - at last - an actual clinical trial with actual sick people. Let get it done (for a change) Diwan.

Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricidesApril 1, 2026 8:30 AM
ACCESS NewswireSHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC).Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel are expected to visit the Site for final preparations and for staff training in the first week of April, 2026. Enrollment and dosing of patients is expected to begin after the staff training is completed.The Company previously reported that it has received approval to start said 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 Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection.MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I."This is an important milestone in regulatory development of NV-387," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.There is no drug available for the treatment of hMPXV infection that causes the MPox disease.NV-387 would be the "go to" pandemic response candidate if it is successful in the Phase II MPox clinical trial. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387.MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity.MPox Clade I cases in the USA have been slowly increasing. As of March 23, 2026, there have been 15 cases of MPox Clade I in the USA since November, '25, with 4 of them in March, '26, according to CDC[1].Community spread of the MPXV Clade I is likely already occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC[2].Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study[3]. The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II[4].The vaccine effectiveness is likely to be much less against the more severe MPox Clade I.Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic.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 that quarter. The status of this clinical trial is not publicly known as of now. Previously, three MPox cases treated with TEMBEXA developed liver dysfunction. TEMBEXA carries a black-box warning, due to severe liver toxicity, entero-gastric toxicity, and requires clinical monitoring, making it unsuitable as a drug for pandemic response.Thus both of the Smallpox drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads, representing an opportunity for NV-387."NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."NV-387 was found to 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 NanoViricidesNanoViricides, 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.comPublic Relations Contact:
ir@nanoviricides.com[1] https://www.cdc.gov/monkeypox/situation-summary/index.html[2] https://www.aha.org/news/headline/2025-10-29-cdc-says-3-cases-severe-mpox-california-may-be-linked-august-case[3] https://www.cidrap.umn.edu/mpox/amid-new-mpox-outbreak-study-suggests-waning-protection-jynneos-vaccine[4] From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43.SOURCE: NanoViricides, Inc.View the original press release on ACCESS NewswireOriginal: Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides

Agreed - in order to have 'sufficient' quantities on hand - they would have to have a really good idea what size the patient pool is intended to be.

Some information on the study structure is going to be would also be useful. For example - are they going to specifically have a placebo control group, or is the trial intended to be a comparison to an equal sized pool of patients that just receive whatever the standard of care would be in the DRC?

Or - what is their dosing plan going to look like - for example do they have multiple dosing concentrations or frequencies of use planned? What are they going to use as their criteria to evaluate patient response or the lack of response to NV-387?

But expecting details out of Diwan is probably something we shouldn't expect - it's kind of his MO.

It sure would be interesting to know what the expected recruitment is for this trial and if they know this---"Manufacture of Phase II Clinical Product NV-387 Oral Gummies is Complete"---they know that.

NNVC.........................https://stockcharts.com/sc3/ui/?s=NNVC&p=w&b=5&g=0&id=p86431144783

NanoViricides Presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, FL March 12, 2026 - Announces Manufacture of Phase II Clinical Product NV-387 Oral Gummies is Complete.

https://finviz.com/news/336418/nanoviricides-presenting-at-nibas-152nd-investment-conference-in-fort-lauderdale-fl-march-12-2026-announces-manufacture-of-phase-ii-clinical-product-nv-387-oral-gummies-is-complete

By ACCESSWIRE | March 11, 2026, 8:30 AM

SHELTON, CT / ACCESS Newswire / March 11, 2026 / NanoViricides, Inc. (AMEX:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, is pleased to announce that it will be presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, Florida.

NanoViricides announces herewith that the manufacture of the drug product for this clinical trial, "NV-387 Oral Gummies" is now complete, in anticipation of starting dosing in patients as soon as site readiness is established.

Anil R. Diwan, PhD, President and Executive Chairman of the Company will deliver a company presentation on Thursday, March 12th at 11:50 am ET, and will be available for one-on-one investor meetings throughout the event.

NV-387, NanoViricides' lead clinical stage drug, is an extremely broad-spectrum antiviral drug that is poised to revolutionize the treatment of respiratory antiviral infections just as antibiotics have revolutionized the treatment of bacterial infections. NV-387 has multiple indications in development, including, RSV, Influenza, Coronaviruses (including COVID), Monkeypox, Smallpox, Measles, as well as Viral Acute Respiratory Infections (V-ARI), and Severe ARIs (V-SARI).

NV-387, as an oral drug, has successfully completed a Phase I clinical trial and healthy human subjects with no dropouts and no reported adverse events, indicating excellent safety and tolerability.

NV-387 has been approved to enter a Phase II clinical trial for the treatment of Monkeypox (MPox) by the regulatory agency ACOREP of the Democratic Republic of Congo (DRC).

NanoViricides is developing first-in-class antiviral drugs that act by a novel mechanism of action, enabling unparalleled broad-spectrum antiviral activity as well as safety. The Nanoviricides technology defines a novel antiviral mode of action that we call "Re-Infection Inhibition". A "nanoviricide™" is designed to look like a cell to the virus, presenting a high concentration of virus-binding ligands on its surface. Upon binding of the virus, the nanoviricide is further designed to change shape and engulf the virus particle, rendering it incapable of infecting cells.

Viruses are unlikely to escape the nanoviricide platform drugs, because the nanoviricide platform drugs mimic the essential feature on the hist cell that the viruses require, and continue to use, even as they go through a multitude of changes in their genomes and their protein makeup, via mutations, recombinations and in some cases, re-assortments.

About National Investment Banking Association (NIBA)

The National Investment Banking Association (NIBA) is a non-profit organization that has been serving the micro-cap and small-cap investment community for over 40 years. NIBA's 152nd Investment Conference website is available here:
https://nibas-152nd-investment-conference.events.accessnewswire.com/.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy.

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. NV-387 is a unique broad-spectrum antiviral that is also effective in animal models for Monkeypox (MPox), Smallpox, as well as Measles.

Our other advanced drug candidate is NV-HHV-1 for the treatment of all Herpesvirus infections including HSV-1 "cold sores", HSV-2 "genital ulcers, VZV Shingles and Chickenpox. 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.

NV-387 has successfully completed a Phase I human clinical trial in healthy volunteers with no reported adverse events. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

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 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.

Media Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

SOURCE: NanoViricides

If AI had used the study that I linked for you earlier it may have concluded that a study to find out if compound x is a safe and effective drug to treat monkeypox (mpox) could very well enroll 597 patients with the disease.

I'm generally wary of AI generated information as well - but since this links to an FDA source - it's probably a realistic source for the AI to grab and cite.

Not a big AI fan.

https://clinicaltrials.gov/study/NCT05559099?intr=tpoxx&rank=4&tab=study

One way or the other - we will find out.

According to Google's AI - When I asked the question "Approximately how many patients are enrolled in a phase II clinical trial for a new medical drug?"

It came back with the answer as follows:
"Phase II clinical trials for a new medical drug typically enroll between 100 and 300 volunteers who have the disease or condition the drug is intended to treat. These studies are designed to evaluate effectiveness and assess safety, usually involving a few hundred patients, though in some cases, such as specific cancer studies, this number may be fewer than 100." Citation traces back to the FDA website.

So I would guess that Diwan falls back on a smaller size group. The 'good news' here is that the treatment should either work, or not work, quickly.

Proactive is a paid promoter***.....they say what he tells them to say. So when they write "Management stated that current funding is sufficient to execute and complete the planned Phase II study in the DRC according to its projections" you would think that one could confirm that in a publication made by management itself.
UPDATE to the above:
I just endured as much of the clip at your link that I could stand and Diwan does in fact say "So based on that we have sufficient money to complete this clinical trial".
I haven't read EVERYTHING, but I'm left to wonder how many patients the trial will require.


***"In exchange for publishing services rendered by the Company on behalf of any issuer named on the Site, including the promotion by the Company of the issuer in any Content on the Site, the Company receives from said issuer annual aggregate cash compensation in an amount equal to Twenty Five Thousand dollars ($25,000)."
https://www.proactiveinvestors.com/pages/terms

That confusingly worded sentence had also not escaped my notice.  
Either Diwan thinks he's going to pull off the trail within 12 months, or he thinks he's going to do another raise, or he's just full of sh*t again.  

"Management stated that current funding is sufficient to execute and complete the planned Phase II study in the DRC according to its projections."

Contrast that with this from last weeks 10Q filing:
"The Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern."

Does this company really have a Director who goes by the name of Zucker Brian?
https://www.sec.gov/Archives/edgar/data/1379006/000110465926019284/xslFormDX01/primary_doc.xml

When they're not busy being vague they are focused sharply on being sloppy.

From a recent Proactive article on NNVC dated 2/19/2026 linked on NNVC's corporate website:

https://www.proactiveinvestors.com/companies/news/1087630/nanoviricides-advances-toward-fully-funded-phase-ii-mpox-trial-in-drc.html

"Dr. Diwan said the company is advancing NV-387—a novel broad-spectrum antiviral that represents a new class of antiviral drugs—toward a Phase II clinical trial. NanoViricides is preparing to initiate a Phase II human study to evaluate the safety and effectiveness of NV-387 as a treatment for MPox in the Democratic Republic of Congo (DRC).

The local regulatory authority, ACOREP, has already approved the Phase II clinical trial, subject to the completion of certain remaining requirements. The company reported that most of these conditions have been satisfied and is now focused on final site readiness and documentation necessary to formally launch the trial. Management stated that current funding is sufficient to execute and complete the planned Phase II study in the DRC according to its projections."

Maybe it will actually 'happen" for once and they will test NV-387 on an actual set of sick patients? Maybe some actual human efficacy data will be generated?

I don't have any to sell...never did.
😁