Nanoviricides (NV), a US company, targets the unmet medical need for an effective, broad- spectrum acute antiviral therapy with NV-387. NV has now opted to pursue a clinical Phase 2 in Mpox, a virus infection related to smallpox. An African trial is being planned; management see this as the fastest and most cost-effective way to gain clinical proof of concept. Mpox cases have risen in Africa over 2024. Results are possible from mid-2025. If successful, this could lead to possible development funding from the US biodefense agency (BARDA), probably from CY2026 given government timescales. The potential RSV indication is on hold till resources are available to run the US Phase 2.
NV’s nano-polymer, micelle technology is designed directly to bind and destroy virus particles in the blood preventing them entering and infecting cells. NV’s focus is on acute treatment of diseases like Mpox, RSV, flu (including potentially “bird flu”) and COVID19. NV’s lead molecule NV-387 completed a volunteer first Phase 1 study in India in 2023 showing safety and tolerability.
NV needs its Mpox Phase 2 to provide data to gain BARDA development funding. A precedent is a 2025 US$375mln contract between BARDA and Shionogi to develop a COVID-19 product.
In the US, a smallpox vaccine, JYNNEOS, is stockpiled by BARDA plus some yearly private use. Vaccine sales were US$450mln in 2024. An acute anti-viral drug, Tecovirimat (Siga), has failed to show good efficacy against Mpox leaving an unmet need that might be filled by NV-387. Siga had 2023 Tecovirimat sales of US$131 mln, its only product. Siga has a market value of about US$400mln from ongoing BARDA stockpile contracts. This could indicate a future value benchmark for NV if NV-387 proves clinically efficacious.
Background
In 2023, NV-387 successfully completed a Phase 1 Indian study with various oral single and multiple doses using h e a l t h y participants. The full data is still being processed and the results to date show that oral NV-387 is safe and well tolerated with no adverse events.
NV has previously announced preclinical data on MPox using a mouse model. Mpox, is related to smallpox but with low mortality. Smallpox, although eradicated, is a major potential biosecurity risk hence the US government stockpiles drugs and vaccines. NV plans to file with regulators in March and start an African Mpox Phase 2 from April onwards. Results could be available from late summer CY2025. In the US, there are a few cases per week of Mpox. Outbreaks in the Western Hemisphere are triggered by the exotic pet trade and international travel (NIH); 31,000 US cases have been reported since 2022. In Africa, in 2024 to 1 Sept, about 5,732 cases were reported with 35 deaths (WHO).
We note the preclinical data on Influenza A with NV-387 compared to existing blockbuster therapies., Influenza can account for 1.5% of weekly deaths in January 2025 in the US: 200-300 per week according to CDC. Avian flu, present in US cattle, may become a hazard but the concern is transmission from infected birds (very rare) and mutation to allow human transmission, not seen.
RSV remains as an ongoing preclinical program. This will progress when funds allow with an IND application then a US Phase 2. There are vaccines and a good prophylactic antibody in infants.
The core NV-387 patents expire between 2026 and 2028. A 2020 application has limited designation. On an FDA approval, NV can rely on US exclusivity of five years plus six months for a pediatric indication or seven years if an orphan drug. Exclusivity is longer in Europe.
Financial – ATM providing cash; funding adequate for proposed MPox Phase 2
The operating cash burn over FY 24 (to 30 June 2024) was US$6.3mln. This was offset by US$3.1mln from the sale of common stock. The Q2FY25 10-Q report (14 February 2025) stated that cash resources are insufficient to fund a further 12 months. On December 31 2024, cash (including prepayments) was US$4.1mln. The ATM facility yielded US$4.0mln in H1FY25. We estimate that NV may require US$3.5mln more cash over the remainder of FY25. A US$3mln loan facility from the CEO is available; a previous US$1.5mln loan was converted to preferred stock in FY24.
As of February 14, 2025, there were 15.64 mln shares, a rise of 2.5 mln since 30 June.
Although smallpox, a major killer, has been eliminated, related but far less lethal related viruses are still circulating. One of these is “monkeypox”, now referred to as Mpox (UK Health agency). There are two varieties (clades) circulating: I and II with subtypes.
Clade I/1b is virulent and endemic in central Africa and occasional cases are brought into the US by travelers. African cases rose in 2024.
Clade II is milder. Clade IIa is in Africa; Clade IIb is present in the US at very low reported circulating levels, currently under 10 cases a week (CDC) after an outbreak in 2022.
Mpox transmission is through contact with infected individuals and Mpox transmits within households. However, most community transmission seems to be sexual, particularly male to male. After a symptom-free incubation of one to two weeks, a short fever ensures followed by pustules around the mouth and face. These spread, typically to the hands and feet, and gradually crust over. The infection resolves in 3-4 weeks. Mortality is low (about 1-4 %+) in adults in Africa infected by Clade I/Ib but it can be higher (about 11%) in younger children. The WHO reports a 2024 outbreak to 1 September in the Democratic Republic of Congo (5,147 cases) with 90 cases in other countries. Since 2022 in the US, there have been over 31,000 cases and 50 deaths due to Clade IIb. Up to 40% of cases required medical treatment, and 1-13% required hospital admission for treatment or isolation (Bavarian Nordic report).
There is an approved, effective vaccine, JYNNEOS (Bavarian Nordic); 2024 sales of US$450mln. The vaccine gives high antibody titers and in “real world” studies offered 66-89% Mpox protection. An acute therapy, tecovirimat is approved for smallpox (and by analogy Mpox) and is stockpiled for emergency use. Sales in 2024 (largely to the US stockpile) were US$130mln; tecovirimat has failed to show efficacy.
NV has mouse model data where lethal aerosolized doses of a murine pox virus (Ectromelia, so mimicking a possible bioterrorism incident) were given to mice. NV-387 either on its own or with Tecovirimatimprovedsurvivalfrom8days(untreated)tobetween15and19days(Figure1). Further work might be funded by BARDA (the US Biomedical Advanced Research and Development Authority).
Clinical development of NV-387 in Mpox
No trial plan is yet public for the African study. Results could be available from late summer CY2025.
An analogous study in the DRC at two sites was run by the National Institute of Allergy and Infectious Diseases (NIAD) (NCT05559099); called PALM 007. This recruited nearly 600 patients and tested Tecovirimat. It took about two years to run (Shabil et al (2024)). Mortality was reduced from 3.6% to 1.7% but the study did not meet the primary endpoint of reduced time to lesion clearance. However, patients who received Tecovirimat early and had more severe disease had less severe symptoms. A US NIAD Mpox study, STOMP (NCT05534984) enrolled over 700 patients in Phase 3 over about two years. The trial stopped early in December 2024 on futility grounds as it failed to show efficacy in reducing the time to clear lesions (NIH STOMP). The failure of these two trials means that there is an unmet need for an effective acute Mpox therapy that NV-387 might fill. BARDA continues to buy Tecovirimat for the US stockpile as no alternatives are available. BARDA might fund development work from CY2026. BARDA recently agreed pay Shionogi US$375mln to help develop a preclinical (Phase 1 due in 2025) product for COVID-19 prophylaxis.