NanoViricides, Inc. reported that its broad-spectrum antiviral drug candidate, NV-387 was highly effective in an animal model that is used in drug development for MPox and Smallpox virus infections in humans. NV-387 is currently in Phase 1a/1b human clinical trials for COVID-19 indication in India, under sponsorship by company licensee and collaborator, Karveer Meditech, Pvt. Ltd. In addition to broad-spectrum activity against Seasonal Coronaviruses and SARS-CoV-2, NV-387 was previously found to have strong activity against the Respiratory Syncytial Virus (RSV) that was comparable to the last-resort toxic drug Ribavirin.

There is significant interest in the development of a smallpox therapeutic drug that works well by itself, as well as in combination with the known drug, Tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development. Since human clinical trials are not feasible for the deadly Variola virus, infection of the related animal viruses in their native species is used for evaluation of drug effectiveness under the FDA " Animal Rule".

Variola (Humans), Mpox (Monkeys), Ectromelia (Mice), and Rabbitpox (Rabbits) are some of the closely related pathogenic viruses belonging to the Orthopoxvirus genus (with their native hosts listed in parentheses). The animal-rule based efficacy studies conducted under GLP conditions substitute for the usual Phase 2/3 human clinical efficacy trials for regulatory approval under the Animal Rule. Additional human safety clinical studies are expected to be required.

Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI). NV-CoV-2 is in Phase 1a/1ss clinical trial sponsored by company and collaborator, KarveerMeditech, Pvt. Ltd., India.

NV-CoV-2-R is 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, drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead.

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 in this time that successful results against coronavirus in lab will lead to successful clinical trials or a successful pharmaceutical product. This release contains forward-looking statements that reflect the Company's current expectation regarding future events.

Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical clinical trials, and proof of principle in preclinical clinical trials.