NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it is presenting today, January 29, at 11am at the MicroCap Conference 2025 in Atlantic City, NJ.
Event Information:
Event
NanoViricides Presentation at the MicroCap Conference, Atlantic City
Day & Date
Wednesday, January 29, 2025
Time
11:00 am to 11:30 am
Location
The Borgata Hotel, Atlantic City, NJ
Admission
Open Admission Policy, Everyone is Welcome
NanoViricides is rapidly moving towards Phase II Safety, Tolerability and Efficacy Evaluation of its Lead Drug candidate, NV-387, for the Treatment of MPOX disease. The Company has announced that it has engaged a CRO for conducting the Phase II clinical trials in the African Region.
There is currently no treatment for hMPXV infection that causes the MPOX disease. Tecovirimat, (TPOXX®, SIGA) approved under "Animal Rule" by the US FDA, failed in a clinical trial to demonstrate effectiveness for treating MPOX infection in a clinical trial.
MPox Clade 1 and 1b infections have caused a continuing pandemic in the Africa that led to WHO declaring a Public Health Emergency of International Concern (PHEIC) in August 2024.
Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline and Technologies available for licensing.
The Phase II-ready drug NV-387 has demonstrated extremely broad antiviral spectrum of activity in animal models, which could prove to be as revolutionary for viral infections as penicillin was for bacterial infections. This broad spectrum is because NV-387 is designed to mimic a host-side feature that is used by over 90-95% of human pathogenic viruses when they cause infection.
In light of the concerns regarding H5N1 Bird Flu and its potential spread, NV-387 is one of the most promising candidates that can respond to an Influenza pandemic. The Influenza virus would be unable to escape the NV-387 drug treatment because this drug mimics the feature on the host-side that all Influenza viruses continue to use for causing an infection, even as they evolve rapidly in the field.
NV-387 has demonstrated activity substantially superior to each of oseltamivir (Tamiflu®), peramivir (Rapivab®), and baloxavir (Xofluza®) in lethal animal models of Influenza A lung viral infection. These approved drugs as well as vaccines and antibodies are readily escaped by the virus as it evolves in the field.
NV-387 has also shown strong activity in lethal animal model studies for MPox and Smallpox treatment developments. There is no drug for the treatment of MPox infection at present.
NV-387 has demonstrated cure of lethal RSV infection in animal model studies. There is no drug for the treatment of RSV infection at present, except for the last resort toxic drug ribavirin.
NV-387 has demonstrated strong activity against coronavirus lethal animal models for SARS-CoV-2 infection (COVID-19).
In addition, the Company has developed a platform that enables important non-oral drugs to be delivered as active oral drugs, which we believe is a sought after technology by Pharma companies.
The overall market size of NV-387 indications is estimated to be well in excess of $10 billion.
This year, registered attendees can view NanoViricides' presentation live, and also access a recorded version after the event. With 24x7 on-demand access, attendees can view recorded presentations at their convenience when scheduling does not allow viewing during the main event week.
Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year in San Francisco during the course of one of the industry's largest gatherings and busiest weeks.
The Microcap Conference is the largest independent microcap event in the U.S., featuring three days of one-on-one investor meetings, company presentations, expert discussions, and nonstop networking - all set against the vibrant backdrop of the Borgata in Atlantic City.
Focused on high-quality companies, the conference provides unmatched access to our investor network, with participation fees and an event format that reflects our commitment to excellence.
With an open admission policy, everyone is welcome. Plus, attendees can bring a guest to enjoy the entertainment and social activities alongside the conference experience.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.
