Nanoviricides Stock Price, News & Analysis

NanoViricides (NYSE:NNVC) has nearly completed the design of an adaptive clinical trial protocol for testing NV-387, their novel broad-spectrum antiviral drug, for treating MPox Virus Clade Ia and Ib infections. The trial will involve approximately 80 patients across two phases (IIa and IIb) in the Democratic Republic of Congo.

The Phase IIa will include 20 patients (10 in treatment arm, 10 in control), while Phase IIb will involve 60 patients in a 2:1 randomization (40 treatment, 20 control). The study will use "NV-387 Oral Gummies," designed specifically for MPox patients who have difficulty swallowing due to mucosal lesions.

If successful, NV-387 would be the first effective drug for MPox treatment in human clinical trials. The company plans to pursue regulatory approvals in Africa, USA, and EU, with potential for Orphan Drug Designation in the USA. The market opportunity is significant, as demonstrated by competitor SIGA's Tecovirimat generating over $600 million in US government sales through December 2024.

NanoViricides (NYSE Amer.:NNVC) has announced plans to advance its lead drug candidate NV-387 into Phase II clinical trials, initially focusing on MPox treatment. The company has already secured a Clinical Trial Site in the Democratic Republic of Congo (DRC) and is finalizing the trial protocol.

The strategic decision to prioritize MPox is driven by several factors: the ongoing epidemic in Africa enabling timely patient recruitment, lower clinical trial costs compared to US/Europe trials, and potential inclusion in the US Strategic National Stockpile (SNS). The company notes that current approved drugs for smallpox treatment, tecovirimat (Tpoxx) and brincidofovir (Tembexa), have shown limitations in MPox treatment.

NanoViricides has developed "NV-387 Oral Gummies" as the drug delivery format, specifically designed for MPox patients who may have difficulty swallowing due to mucosal lesions. The drug substance manufacture is substantially completed at the company's facility, with drug product manufacturing in progress.

NanoViricides (NYSE: NNVC) announces that its broad-spectrum antiviral drug NV-387 could be crucial for pandemic preparedness amid rising COVID and bird flu variants. The drug has shown superior effectiveness against both COVID-19 and influenza compared to existing treatments like Remdesivir and Tamiflu. NV-387 has completed Phase I trials with no adverse events and is formulated as oral gummies. The drug targets invariant viral features, making it difficult for viruses to develop resistance. The company highlights NV-387's advantages including US-based manufacturing capabilities, room temperature storage, and potential rapid deployment for pandemic response. The drug's development comes as new COVID variant Nimbus (NB1.8.1) emerges with increased transmission and vaccine resistance, while H5N1 bird flu cases show concerning developments in Michigan and Cambodia.

NanoViricides (NYSE:NNVC) announces advancement in its Measles drug development program with an imminent animal trial using their clinical-stage drug NV-387. The study will use specially modified mice bearing human CD150/SLAM protein to evaluate drug candidates in a lethal infection model. NV-387, which previously demonstrated success in curing lethal RSV infection in animals, is designed to act as a cell decoy that destroys virus particles. This development comes amid rising measles cases, with 1,088 confirmed cases across 33 US jurisdictions in early 2025 and a ten-fold increase in European cases in 2024. The company aims to address an unmet medical need, as there are currently no approved drugs for measles treatment, while vaccination rates have declined below the 95% herd immunity threshold and vaccine failure cases are increasing due to new virus genotypes.

NanoViricides (NYSE:NNVC) will present at the BIO International Convention 2025 in Boston on June 16th at 2:30pm. The company's President, Dr. Anil R. Diwan, will provide updates on their drug pipeline and platform technologies. Their lead drug candidate, NV-387, is advancing towards Phase II trials for MPOX treatment and shows effectiveness against RSV, Influenza A, and Coronaviruses. The drug's unique mechanism mimics host-side features that 90-95% of human pathogens use, making it difficult for viruses to develop resistance. The company is also developing NV-HHV-1 for herpesvirus infections and NV-HIV-1 for HIV treatment. NanoViricides' platform enables oral drug delivery, drug rescue, and targeted delivery capabilities. The estimated market size for NV-387 indications exceeds $10 billion.

NanoViricides (NYSE:NNVC) has filed its Q1 2025 quarterly report, highlighting significant progress with its broad-spectrum antiviral drug NV-387. The company is advancing towards Phase II clinical trials for treating MPox in the Democratic Republic of Congo, following successful completion of Phase I trials with no adverse events. NV-387 has shown promising results against multiple viruses including MPox, Measles, and Bird Flu (H5N1). The company reported $2.73M in cash and $6.98M in property assets, with current liabilities of $1.20M. However, NanoViricides needs additional funding to continue operations through February 2026 for planned clinical trials. The company has access to a $3M credit line from its founder and is exploring ATM equity offerings for funding.

NV-387's unique host-mimetic mechanism makes it potentially effective against various viruses while being difficult for viruses to develop resistance, positioning it as a potentially revolutionary treatment comparable to penicillin's impact on bacterial infections.

NanoViricides (NYSE:NNVC) is advancing its broad-spectrum antiviral drug NV-387 to combat multiple viral threats. The company is targeting two major opportunities: Measles, where cases have increased 10-fold in Europe with concerning vaccine failure rates, and MPox, which remains a Public Health Emergency of International Concern according to WHO.

The company has initiated an animal efficacy study for Measles and received clearance from DRC's National Ethics Committee to proceed with Phase II Clinical Trial for MPox treatment. NV-387 will be available to licensed physicians for treating Measles cases under FDA's Individual Patient Expanded Access protocol.

Additionally, NanoViricides is developing NV-387 as an "emperic" treatment for respiratory viral infections through a "basket-type" clinical trial targeting All Influenzas, All Coronaviruses, and RSV. The company is also developing NV-HHV-1, a pan-herpesvirus drug targeting infections linked to neurological damage and Alzheimer's disease.

NanoViricides (NYSE:NNVC) has received approval from the Democratic Republic of Congo's National Ethics Committee for Health to proceed with a Phase II clinical trial for NV-387, their broad-spectrum antiviral drug targeting MPox disease. The company is now preparing a detailed Clinical Trial Application for submission to DRC's Ministry of Public Health. NV-387 is designed to mimic human cells to trap and destroy viruses, potentially targeting 90-95% of human pathogenic viruses. The drug has shown promising results in animal studies against multiple viruses including influenza, RSV, coronavirus, and orthopoxvirus. Unlike existing treatments such as tecovirimat (which failed in clinical trials), NV-387's unique host-mimetic mechanism makes viral escape highly unlikely. This development is particularly significant as MPox continues to spread in the WHO African Region, maintaining its Public Health Emergency of International Concern status since August 2024.

NanoViricides (NYSE: NNVC), a clinical-stage company focused on developing broad-spectrum antivirals using host-mimetic nanomedicine technology, has announced its participation in the D. Boral Capital Inaugural Global Conference. The event will take place on May 14, 2025, at The Plaza Hotel in New York City. Company President & Executive Chairman Anil R. Diwan will be available for one-on-one meetings from 9:00 A.M. to 3:00 P.M. (ET). Interested parties can schedule meetings by contacting John Perez at jperez@dboralcapital.com.