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NanoViricides' Revolutionary Broad-Spectrum Drug Candidate NV-387 Has Successfully Demonstrated Excellent Indications for Safety and Toxicology in a Juvenile Mouse Pups Animal Study, Paving the Way for Pediatric Use in Clinical Trials
NanoViricides' Revolutionary Broad-Spectrum Drug Candidate NV-387 Has Successfully Demonstrated Excellent Indications for Safety and Toxicology in a Juvenile Mouse Pups Animal Study, Paving the Way for Pediatric Use in Clinical Trials
The Spreading Ebola Epidemic as well as Mpox Endemic in Africa Disproportionately Impact Children; The Measles Outbreaks Primarily Impact Children
SHELTON, CT / ACCESS Newswire / October 20, 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, announces that its broad-spectrum antiviral drug NV-387 has successfully demonstrated strong safety, tolerability, and toxicological parameters in an animal model study involving juvenile mouse pups.
This study is expected to pave the way for pediatric use of NV-387 in clinical trials in children possibly as young as 1 year old.
Pediatric drugs for Ebola, Mpox, and Measles, as well as RSV - to name a few of the Company's current or contemplated clinical trial programs - are unmet medical needs.
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.
The Impact of the Juvenile Animal Model Study of NV-387 Treatment
NV-387 Oral Gummies formulation is currently in a Phase II clinical trial for the treatment of Ebola in the Democratic Republic of Congo (DRC). The novel Ebola Bundibugyo virus is known to disproportionately affect children i. NanoViricides anticipates being able to add a pediatric cohort in a Phase III registrational clinical trial, assuming the drug is found to be effective in the current Phase II clinical trial. If successful, NV-387 will likely be the first and only treatment for Ebola virus infection in children. There is no approved treatment nor an approved vaccine for the Ebola Bundibugyo virus.
NV-387 is also currently in another Phase II clinical trial for the treatment of Mpox in the Democratic Republic of Congo (DRC). Mpox Clade I, which is the currently most prevalent version of this virus, is known to disproportionately affect children. There is no approved treatment for Mpox. If Phase II is successful, we intend to add a pediatric cohort in the following Phase III registrational clinical trial.
NV-387 as a Treatment for Measles was granted an Orphan Drug Designation as well as a Rare Pediatric Disease Drug Designation by the US FDA. Measles primarily affects children. There is no approved treatment for Measles. The Company intends to perform a Phase II and, if successful, a Phase III clinical trial for NV-387 as a Treatment for Measles, towards a US FDA Marketing Authorization Application. If the program is successful and MAA is granted, then the Company will be eligible for a Priority Review Voucher (PRV). A PRV can fetch around $200 million if sold to another Pharma company ii, enabling substantial revenues even prior to achieving significant commercial sales.
The Juvenile Animal Model Study of NV-387 Oral Gummies Treatment and Results
Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was determined to be 1,230 mg/kg per dose administered three times daily, or 3,690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. This was actually the highest dose level tested. Therefore, a Maximum Tolerable Dose (MTD) could not be estimated iii.
These numbers are indicative of extremely strong safety and will enable a wide range for dosing of NV-387 in pediatric clinical trials for the treatment of various viral diseases.
A 12 Day Repeated-Dose Safety/Tolerability, Toxicity and Toxicokinetic Study with a 14-Day Recovery Period in Juvenile Balb/c Mouse Pups, was conducted to evaluate the safety/tolerability, toxicity and toxicokinetic profile of NV-387 Oral Gummies, containing the active pharmaceutical ingredient (API) NV-387. The Juvenile Balb/c mouse pups received NV-387 Oral Gummies formulation doses three times daily for up to 12 consecutive days, followed by recovery period to assess persistence, reversibility, or delayed occurrence of any treatment-related effects.
NV-387 Oral Gummies were well tolerated at all dose levels, including the highest dose of 1,230 mg/kg per dose amounting to drug exposure of 3690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. There was no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, alterations in cardiovascular parameters, changes in clinical pathology, or treatment-related gross or microscopic pathological findings observed in either sex.
Most Recent Annual Report
The "Company" has previously reported that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 with the Securities and Exchange Commission (SEC) on Monday, September 28, 2026. The report can be accessed at the SEC website (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000110465926111390/nnvc-20260630x10k.htm). The Company's Financial Statements included in its Annual Report on Form 10-K for the fiscal year ended June 30, 2026, contained an audit report from its Independent Registered Public Accounting Firm with an explanatory paragraph emphasizing that the audit opinion expressed substantial doubt about its ability to continue as a going concern. Release of this information is required by Section 610(b) of the NYSE American Company Guide and does not reflect any change or amendment to any of the Company's filings for the fiscal year ended June 30, 2026.
Management's Plan of Financing Activities, in Particular, Financing Clinical Trials
Management believes that the Company is working on diseases of global importance with a potential for a high positive impact. In particular, the Phase II Clinical Trial of NV-387 Oral Gummies for the Treatment of Ebola Virus Disease in DRC, is addressing a global high priority concern.
The USA has been, laudably, and proudly, the largest provider of humanitarian and relief assistance in this Ebola outbreak, with almost $1.4 Billion in contributions. The USA has already provided $887 Million, and has pledged another $500 Million, of which $267 million has been released, according to the US Department of State iv. This includes support for various public health measures, on site personnel, as well as funding for clinical trials of drugs and vaccines that were already under the auspices of US Government agencies. All of these supported drugs require infusions, a procedure that is not scalable for response in such a rapidly growing outbreak that the current Ebola Bundibugyo virus outbreak has turned out to be.
We believe that NV-387 being the only oral treatment in clinical trial for Ebola, there is a strong potential for non-dilutive funding for this regulatory development of NV-387 towards licensure. Management is continuing to work on obtaining non-dilutive funding for NV-387 as a unique and novel broad-spectrum antiviral, that we believe is revolutionary in the field of treatment of viral diseases, and now, in particular, for Ebola.
Additionally, we plan on continuing our efforts at financing the Company, when opportune, through different equity-based funding routes. In particular, the Company has an "At-the-Market" facility with an investment brokerage house, for issuing and selling common shares directly to investors.
Additional details can be found in the annual report filing.
Forward Looking Statements
Certain matters discussed in this press release are 'forward-looking statements' intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company's statements regarding trends in the marketplace, future revenues, earnings and Adjusted EBITDA, the ability to realize firm backlog and projected backlog, cost cutting measures, potential future results and acquisitions, are examples of such forward-looking statements. The forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of projects due to variability in size, scope and duration, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company's control. The factors discussed herein and expressed from time to time in the Company's filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.
Contact:
NanoViricides, Inc.
[email protected]
Public Relations Contact:
[email protected]
Source: NanoViricides, Inc.
i https://www.wbur.org/hereandnow/2026/10/15/children-ebola-patients
iii NOAEL is the highest amount of drug exposure at which there are no significant increases in adverse effects compared to a control group. MTD is the highest amount of drug exposure that does not cause unacceptable side effects or overt toxicity.
iv https://www.state.gov/releases/office-of-the-spokesman/2026/09/united-states-pledges-additional-life-saving-health-assistance-in-response-to-ebola-outbreak/. September 23, 2026.
SOURCE: NanoViricides
View the original press release on ACCESS Newswire
A.Jackson--SMC
