NanoViricides Files Annual Report, Highlights Progress on Broad-Spectrum Antiviral NV-387

NanoViricides has filed its Annual Report for fiscal year 2025, highlighting the broad-spectrum antiviral NV-387 at Phase II clinical trial stage. The company aims to make NV-387 a revolutionary antiviral for respiratory viral infections, potentially dominating a $20 billion market. NanoViricides is also working on a Phase II clinical trial for NV-387 as a treatment for MPox disease in Africa and plans to leverage this towards approval for Smallpox treatment under the US FDA's "Animal Rule". A potential acquisition of NV-387 for Smallpox could be worth over $1 billion.

NanoViricides, Inc. (NYSE American:NNVC) has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2025, with the Securities and Exchange Commission (SEC). The report, accessible at the SEC website NanoViricides, Inc. Has Filed its Annual Report^[1], outlines significant achievements and future plans for the company's broad-spectrum antiviral NV-387.

In 2025, NanoViricides focused on evaluating NV-387's broad-spectrum antiviral activity, aiming to position it as a revolutionary therapy for respiratory viral infections. The company believes NV-387 could become a dominant player in the market, with a potential market size of over $20 billion if approved for empirical therapy of viral Acute/Severe Acute Respiratory Infections (V-ARI, V-SARI). To advance this goal, NanoViricides proposed a novel adaptive Phase II clinical trial for NV-387 as a treatment for V-ARI and V-SARI.

Additionally, NanoViricides is engaged in completing a Clinical Trial Application (CTA) for a Phase II clinical trial of NV-387 for the treatment of MPox disease in Africa. MPox continues to surge in African countries, and the African CDC has declared a Public Health Emergency of Continental Security (PHECS). The company has already obtained preliminary approval for its clinical trial protocol from the regulatory agency ACOREP in the Democratic Republic of Congo (DRC).

NanoViricides plans to leverage the MPox studies towards approval of NV-387 as a treatment for Smallpox under the US FDA's "Animal Rule". The US Strategic National Stockpile (US-SNS) could potentially acquire NV-387 for Smallpox, worth over $1 billion over five years if approved. The company also aims to seek Orphan Drug Designation (ODD) for NV-387 treatments for MPox, Smallpox, and Measles, which could provide market exclusivity and other benefits.

As of June 30, 2025, NanoViricides reported approximately $1.67 million in cash and cash equivalents, $6.83 million in Net Property and Equipment (P&E) assets, and $1.31 million in total current liabilities. The company's net cash utilized for operating activities was approximately $8.48 million, with expenditures for clinical trials and R&D. NanoViricides also raised $5.3 million in net cash from financing activities and has a line of credit (LOC) of $3 million from its founder, Dr. Anil Diwan. However, the company does not have sufficient funding to continue operations through September 30, 2026, and substantial doubt exists about its ability to continue as a going concern.

NanoViricides has several important milestones planned for 2026, including the completion of Phase I clinical studies, filing of Phase II clinical trial applications, and seeking Orphan Drug Designation. The company believes these milestones will enable it to raise financing for further regulatory activities.

NanoViricides' Phase II clinical stage drug NV-387 has completed Phase I clinical trials with successful results, indicating excellent safety and tolerability. The company also has developed a pan-Herpesvirus drug, NV-HHV-1, for treating Shingles rash, Chickenpox, HSV-1 Cold Sores, and HSV-2 Genital Ulcers, and an anti-HIV drug, NV-HHV-1, demonstrating strong effectiveness in a humanized animal model of HIV infection.