NanoViricides, Inc. (NYSE American: NNVC) announced positive results from a juvenile mouse study evaluating the safety, tolerability and toxicity of its broad-spectrum antiviral drug NV-387, supporting its potential advancement into pediatric clinical trials. The 12-day repeated-dose study found NV-387 Oral Gummies were well tolerated at all tested dose levels, with no mortality, systemic toxicity or treatment-related adverse effects. The highest tested dose of 3,690 mg/kg/day was established as the “No Observed Adverse Effect Level” (NOAEL), with no maximum tolerated dose identified. The company believes the findings could support pediatric enrollment in future clinical trials for Ebola, Mpox and measles, subject to further clinical development and regulatory requirements.
NV-387 is currently being evaluated in Phase II clinical trials for Ebola and Mpox in the Democratic Republic of Congo. The drug has also received U.S. Food and Drug Administration orphan drug and rare pediatric disease designations for measles. Separately, NanoViricides disclosed that its fiscal 2026 annual report included an auditor statement expressing substantial doubt about its ability to continue as a going concern. The company is pursuing potential nondilutive funding for clinical development while maintaining access to equity-based financing, including an at-the-market share offering facility.
To view the full press release, visit https://ibn.fm/5QClt
About NanoViricides
NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide(TM) class of drug candidates and the nanoviricide(TM) technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections, and even Measles. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
NOTE TO INVESTORS: The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC
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