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. These designations are significant because they could expedite development and provide financial incentives for a pediatric indication. The positive juvenile safety data are particularly important for advancing NV-387 into pediatric populations, where safety is a primary concern. If successful, NV-387 could become a much-needed broad-spectrum antiviral for several high-consequence infectious diseases. For more details on NanoViricides, visit NanoViricides, Inc. (NYSE American: NNVC).
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. This raises questions about the company's financial health and its ability to fund ongoing trials. Investors can view the full press release at https://ibn.fm/5QClt and access the company's website at www.nanoviricides.com. The latest news and updates relating to NNVC are available in the company's newsroom at https://ibn.fm/NNVC.
The announcement comes as NanoViricides continues to develop its nanoviricide platform, which is based on technology licensed from TheraCour Pharma. The company's 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 positive juvenile safety results could bolster the case for further investment in NV-387's clinical development. However, the going concern warning underscores the financial risks facing the company. As with any drug development effort, there can be no assurance that NV-387 will show sufficient effectiveness and safety for human clinical development.
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