NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing broad-spectrum antiviral drugs, reported fiscal year 2026 results and provided updates on its lead candidate NV-387. The company received regulatory approval in the Democratic Republic of Congo to initiate Phase II trials evaluating NV-387 Oral Gummies for the treatment of Mpox and Ebola. Enrollment for both trials began at the end of September 2026. This approval represents a critical step forward for NanoViricides, as it transitions from preclinical research to human clinical testing in regions where these viral diseases pose significant public health threats.
In addition to the Phase II progress, the company received two key designations from the U.S. Food and Drug Administration for NV-387 as a treatment for measles: Orphan Drug Designation and Rare Pediatric Disease Drug designation. These designations could provide incentives such as market exclusivity and expedited review, enhancing the drug's commercial potential. The FDA's recognition underscores the unmet medical need for effective measles treatments and positions NanoViricides to potentially address a global health priority.
Financially, NanoViricides reported approximately $2.79 million in cash and cash equivalents as of June 30, 2026, up from approximately $1.67 million a year earlier. During fiscal 2026, the company raised approximately $9.01 million through registered direct and at-the-market equity offerings. In July, it raised an additional $3.8 million and is pursuing further funding through grants, contracts, partnerships, and debt or equity financing. This strengthened cash position is essential to support the ongoing clinical trials and regulatory activities.
The company's lead drug candidate, NV-387, is being developed as a treatment for a range of viral infections, including RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and measles. Another advanced candidate, NV-HHV-1, targets Shingles. NanoViricides' platform technology is based on the nanoviricide(TM) class of drug candidates, which are designed to attack viruses directly. For more details on the company, visit www.nanoviricides.com. The full press release can be accessed at https://ibn.fm/s000r, and the latest news and updates relating to NNVC are available at https://ibn.fm/NNVC.
The progress on NV-387 is significant because it could offer a broad-spectrum antiviral solution, potentially simplifying treatment regimens for multiple diseases. The Phase II trials in the DRC will test the oral gummy formulation, which may improve patient compliance, especially in low-resource settings. If successful, NV-387 could become a key tool in managing outbreaks of Mpox and Ebola, which have caused devastating epidemics in Africa. The FDA designations for measles further highlight the drug's versatility and potential to address rare pediatric diseases.
MissionIR, a communications platform, distributed the announcement. MissionIR is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions through InvestorWire, editorial syndication to 5,000+ outlets, and social media distribution. For more information about MissionIR, visit www.MissionIR.com. Investors should note the risks inherent in drug development, as outlined in the company's disclosures.
