NanoViricides has provided an update on the development of its investigational antiviral NV-387, alongside the filing of its quarterly report for the fiscal quarter ending December 31, 2025.
NanoViricides said it is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox (MPox) in the Democratic Republic of Congo. The trial has received regulatory approval from ACOREP, subject to completion of certain requirements, most of which have been met. NanoViricides is now finalizing clinical site readiness and related documentation.
Preclinical studies cited by the company indicate that NV-387 has activity against a range of viruses, including RSV, Influenza A (H3N2), MPox, Smallpox, and Measles. NanoViricides said that in animal models, NV-387 demonstrated efficacy that was superior to existing treatments for certain viral infections and may reduce the risk of viral resistance by targeting conserved viral attachment receptors.
The company has filed for Orphan Drug Designation with the US Food and Drug Administration (FDA) for NV-387 in Measles, MPox, and Smallpox, which could provide regulatory incentives, including market exclusivity, tax benefits, and certain fee waivers.
As of December 31, 2025, NanoViricides reported cash and cash equivalents of approximately $5.29 million and total assets of $12.27 million, with current liabilities of $1.20 million.
During the six months ended December 31, 2025, the company used roughly $4 million in cash, including R&D expenditures in preparation for Phase II trials.
Recent financing included a $5.5 million registered direct offering and private placement in November 2025, along with a $0.68 million ATM offering in October-November 2025. The company also maintains access to a $3 million line of credit from its founder.
NanoViricides stated that current funding is sufficient to complete the planned Phase II MPox trial, while additional financing would be needed for broader development programs.
“We believe that our recent financings have substantially fortified the company’s fiscal position, and we further believe that we have the ability to continue on our regulatory development plan for NV-387, including the Phase II MPox clinical trial, as well as various planned US FDA engagements for different indications,” the company said in a statement.