NanoViricides Reports Positive Juvenile Safety Data for NV-387, But Going Concern Risk Persists

NanoViricides, Inc. (NYSE American: NNVC) on Tuesday reported positive results from a juvenile mouse study of its broad-spectrum antiviral drug NV-387, a finding that could support the drug’s advancement into pediatric clinical trials. The 12-day repeated-dose study found that 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, and no maximum tolerated dose was identified.

The company believes these 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. For investors, the juvenile safety data represent a potential milestone toward expanding NV-387’s label into pediatric populations, a move that could significantly broaden its market if the drug succeeds in later-stage trials.

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. The going concern warning highlights the financial risk facing the clinical-stage company as it funds expensive Phase II trials without a marketed product.

NanoViricides is a clinical-stage company creating special-purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed as a treatment for RSV, COVID, Long COVID, influenza, and other respiratory viral infections, as well as MPOX/smallpox and measles. The company’s platform technology is based on the TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. For a full press release, visit https://ibn.fm/5QClt. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC. More information about the company is available at www.nanoviricides.com.

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