NanoViricides, Inc. Has Filed its Quarterly Report - NV-387 Advancing for Phase II

SHELTON, CT / ACCESS Newswire / May 15, 2026 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2026 with the Securities and Exchange Commission (SEC) on Thursday, May 14, 2026. The report can be accessed at the SEC website by searching for the Company (https://www.sec.gov/edgar/browse/?CIK=1379006&owner=exclude) .

Clinical Stage NV-387, a Single Drug, Meets Many Unmet Medical Needs in Viral Diseases

We continue to advance NV-387, a novel broad-spectrum antiviral that defines a new class of antiviral drugs, towards a Phase II clinical trial. We are working on initiating a Phase II human clinical trial for the evaluation of the safety and effectiveness of NV-387 as a treatment of Monkeypox in the Democratic Republic of Congo. The local regulatory agency, ACOREP, has already approved this Phase II clinical trial.

We are now working on clinical trial site readiness.

We have chosen an "Orphan-first" development strategy for regulatory advancement of NV-387. To this end, we have filed "Orphan Drug Designation" (ODD) applications with the US FDA for three different scenarios, namely:

1. NV-387 for the treatment of Measles,

2. NV-387 for the treatment of MPox, and

3. NV-387 for the treatment of Smallpox.

Orphan drug designation, if approved, will provide us with several incentives. These include frequent communication with the FDA, an additional 7 years of market exclusivity, certain R&D tax benefits, and waiver of certain FDA PDUFA fees. These incentives are expected to result in a shorter timeline of the regulatory process as compared to NV-387 development for Influenza or RSV.

An ODD was granted for NV-387 for the treatment of Measles by the US FDA on or about April 27, 2026, subsequent to the reporting period.

We have also applied for a "Rare Pediatric Disease Drug" (RPDD) designation for NV-387 for the treatment of Measles. If granted, the RRPD will enable us to obtain a Priority Review Voucher (PRV) upon drug approval from the FDA, which is a tradable instrument. Recently, a PRV was sold for $180 million. This would represent a revenue-generation opportunity even prior to commercial market sales of the drug.

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