NanoViricides (NYSE-A:NNVC) filed its annual report, announcing that its broad-spectrum antiviral NV-387 is progressing to Phase II clinical trials, with potential indications including RSV, influenza, MPOX/smallpox, and COVID-19.
NV-387 has demonstrated broad-spectrum efficacy in preclinical trials against viruses such as COVID-19, RSV, and influenza. A Phase Ia/Ib trial in healthy subjects was completed with no adverse events, and the company is now preparing for Phase II trials.
The drug has shown superior results compared to existing antiviral drugs, including Tamiflu, Rapivab, and Xofluza, in animal models, NanoViricides (NYSE-A:NNVC) said in a statement and has potential as a treatment for pediatric RSV, an unmet medical need in the US.
The drug also demonstrated effectiveness against poxvirus infections and may qualify for use under the WHO’s Monitored Emergency Use protocol for the ongoing MPOX epidemic in Central Africa.
NanoViricides said it believes NV-387’s unique mechanism of action—mimicking sulfated proteoglycans (S-PG) to block viral entry—makes it a revolutionary antiviral, potentially resistant to virus mutations. The company is actively seeking partnerships, non-dilutive grants, and other funding to support further development and regulatory approvals for NV-387 in treating multiple viral infections.
As of June 30, 2024, NanoViricides reported cash and cash equivalents totaling approximately $4.97 million, down from $8.15 million the previous year. The company also noted $7.5 million in net property and equipment assets, primarily related to its cGMP-capable manufacturing and research facility. Total liabilities were $1.36 million, up from $530,000 in 2023.
NanoViricides utilized $6.31 million for operating activities during the year, including expenditures for a Phase Ia/Ib clinical trial of NV-387. The company raised approximately $3.12 million through an At-the-Market (ATM) offering and an additional $1.53 million after the fiscal year-end.
Despite these efforts, the company expressed concerns about its ability to continue operations through September 2025 without further funding.
The firm is “actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan,” it said.
NanoViricides noted that it has on-going access to capital markets via its ATM agreement that became active in April 2024.
“We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so,” it said.