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Nanoviricides: Dual track clinical development during 2026

Published: 08:46 14 Oct 2025 EDT

Nanoviricides (NV), a US company, targets the unmet medical need for an effective, broad-spectrum acute oral antiviral therapy with NV-387. NV’s nano-polymer, micelle technology directly binds and destroys virus particles in the blood preventing them entering and infecting cells; in effect a highly selective, ruthless (but safe) nanomachine.

NV is now pursuing a dual track strategy for clinical development. The first trial will be against MPox virus, a relative of smallpox. The second is in respiratory viral diseases. NV’s lead molecule NV-387 has already completed a Phase 1 study in 2023 showing safety and tolerability.

The immediate study, which could start by late CY25 or early in CY26, is for MPox. MPox is an endemic virus related to smallpox so has biodefense applications. Ethics approval for an NV-387 Phase 2 trial in Congo has already been gained; the next stage is a formal Phase 2 Clinical Trial Application (CTA). A successful African trial could lead to possible development funding from the US biodefense agency (BARDA).

The second planned study uses mostly the same CTA as the MPox study but will target respiratory viral diseases. An adaptive “basket-type” trial in India will gather data on NV-387 efficacy against flu, RSV and coronaviruses.  This might start in winter 2026 but a later start is possible. This could lead to focused US trials, perhaps from 2027. Management notes independent estimates of a US$2.6 bln opportunity in RSV and US$4.6 bln in influenza.

NVs FY25 financial report showed Y/E US$1.6 mln in cash A further US$1.25 mln net was received through an “at the market” facility by 24 Sept 2025. We estimate a probable need for about $8 mln of FY26 funding at constant burn rates so NV may require a further US$6.75 mln as of October 2025. NV also has a US$3 mln loan facility from management. Non-dilutive funding for clinical development is being explored.

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