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Highlights:
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NV-387, a broad-spectrum antiviral, progresses to Phase II clinical trials targeting multiple viral infections.
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Demonstrated superior efficacy in preclinical studies compared to existing antivirals, including Tamiflu and Xofluza.
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Ongoing exploration of funding options to support further development and regulatory approvals.
NanoViricides {NYSE-NNVC} has announced significant progress with its antiviral candidate NV-387, which is advancing to Phase II clinical trials. This compound shows promise against various viral infections, including RSV (respiratory syncytial virus), influenza, MPOX/smallpox, and COVID-19.
The company highlighted NV-387's broad-spectrum efficacy demonstrated in preclinical trials, where it has outperformed existing antiviral medications in animal models. The completion of a Phase Ia/Ib trial in healthy subjects was achieved without any adverse events, paving the way for the upcoming Phase II trials. Notably, NV-387 could address the unmet medical need for pediatric RSV treatments in the United States and may qualify for use under the WHO’s Monitored Emergency Use protocol amid the MPOX outbreak in Central Africa.
NanoViricides emphasized NV-387’s unique mechanism, which mimics sulfated proteoglycans (S-PG) to prevent viral entry. This innovation potentially positions the drug as a resilient treatment option, capable of countering viral mutations. The company is actively pursuing partnerships and non-dilutive funding to facilitate further development and navigate regulatory pathways for NV-387.
As of June 30, 2024, NanoViricides reported cash and cash equivalents of approximately $4.97 million, a decline from $8.15 million in the prior year. The firm also holds $7.5 million in net property and equipment assets, mainly associated with its cGMP-capable manufacturing and research facility. Total liabilities increased to $1.36 million from $530,000 in 2023.
During the fiscal year, NanoViricides utilized $6.31 million for operational activities, including costs associated with the Phase Ia/Ib clinical trial. The company successfully raised approximately $3.12 million through an At-the-Market (ATM) offering and secured an additional $1.53 million post fiscal year-end.
Despite these financial maneuvers, NanoViricides expressed concerns regarding its operational sustainability through September 2025 without additional funding. The firm is exploring various avenues, including grants, partnerships, and financing options, to secure the necessary resources. The ATM agreement, active since April 2024, provides ongoing access to capital markets to support its initiatives.
