SHELTON, CT / ACCESSWIRE / October 12, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), announces that the Company's President, Dr. Anil Diwan, will be presenting a talk in person at the Partnership Opportunities in Drug Delivery (PODD) Conference in Boston, MA, on October 16, 2023 at 6:07pm ET in Track 2B.

Dr. Diwan will present a talk entitled "Revolutionizing Antiviral Treatments - Orally Available Nanomedicines that Can Also Deliver Difficult APIs and Improve Their PK." His talk will focus on the following topics:

• NanoViricides Flexible, Site-Targeting, Platform Technology is in Phase I
• Orally Available, Broad-Spectrum Antivirals Platform Goes Beyond Immunotherapeutics
• Escape of Virus is Not Likely
• Curing Viral Infections is Within Reach

The NanoViricides technology platform has produced a highly effective, broad-spectrum antiviral drug candidate for the treatment of RSV, COVID-19, MERS, SARS, and many other viral infections. This drug, NV-387, is formulated into three different drug products, called (i) NV-CoV-2 Oral Gummies, (ii) NV-CoV-2 Oral Syrup, and (iii) NV-CoV-2 Solution for Injection, Infusion, and Inhalation.

The two oral formulations of NV-CoV-2 are in Phase 1a/1b clinical trial in India, sponsored by the Company's licensee and collaborator, Karveer Meditech Pvt. Ltd. The clinical trial includes single-ascending-dose (1a) and multiple-ascending dose (1b) arms in healthy subjects to evaluate the safety and pharmacokinetics in humans. In addition, the clinical trial also includes COVID-19 patient treatment arms in the multiple-ascending dose part (1b-COVID) that is designed to evaluate safety in COVID patients and to obtain efficacy parameters for dose regimen selection for Phase II/III clinical trials.

To date, 26 of 36 subjects have completed the study in the healthy subjects portion. No adverse events or severe adverse events were found and the drug was well tolerated even at the highest dosage tested. These results are consistent with the strong safety observed in pre-clinical studies.

In addition to its strong effectiveness in pre-clinical studies against multiple coronaviruses,
NV-387 was also found to be highly effective as a treatment of RSV infection in a Lethal Lung Infection (ARDS/Pneumonia) Animal Model of the disease as previously reported. In this study, animals treated with oral NV-387 survived 15 days, almost matching the 16 days survival when treated with the highly toxic drug ribavirin. There is no treatment for RSV infection, other than ribavirin which is conditionally approved only for patients with high risk of progressively severe RSV disease, due to its significant side effects including hemolytic anemia and kidney failure.

We anticipate that NV-387 for treatment of RSV infection can enter into Phase II/III human clinical trials upon completion of its on-going Phase I human clinical trial.

The strong effectiveness as well as excellent safety of NV-387 observed in pre-clinical studies for multiple indications bodes well for the entire NanoViricides Technology Platform.

The Nanoviricides Platform also enables delivery of difficult active pharmaceutical ingredients (APIs) and improves their pharmacokinetic properties as demonstrated by the pre-clinical studies of NV-387-g-R (Remdesivir as a guest encapsulated within NV-387 polymeric micelles), and NV-387-g-Ribvp (a Ribavirin prodrug as a guest encapsulated within NV-387 polymeric micelles).

Viral infections can be cured by drugs utilizing power of the NanoViricides Platform that enables (a) "Re-Infection Inhibition", and (b) "Replication Inhibition" in a single drug, thereby blocking the virus lifecycle completely. The NanoViricides Platform also enables additional approaches towards potentially curing latent viral infections such as those caused by herpes family viruses (HSV-1, HSV-2, VZV, EBV, CMV, HHV-6A/B, HHV-7, KSHV), HIV and others.

Further applications of the Nanoviricides Technology Platform would be evident to researchers in their own unique fields to tackle other diseases.

In addition to the conference presentation, Dr. Diwan has scheduled several meetings at the Conference.

Dr. Diwan will present the Company's Assets and current development stage:

• NV-CoV-2 (API NV-387): Clinical Stage. Treatment of COVID and certain cases of long COVID. Broad-Spectrum, Pan-coronavirus Drug "(viral) Resistance is Futile". Highly Effective and Extremely Safe in pre-clinical models. Excellent PK in monkey and rodent animal models.
• NV-CoV-2-R: Encapsulates remdesivir within NV-CoV-2 substantially improving its PK profile and enabling synergistic drug action. Expect complete cure of coronaviruses by blocking both the re-infection cycle and replication cycle.
• NV-HHV-1: Skin cream for treatment of Shingles rash. IND-enabling studies completed.
• NanoViricides Technology Platform for Drug Encapsulation: The nanoviricides technology platform is proven to be capable of encapsulating and thus protecting a number of APIs improving their PK/PD and bioactivity. Enables long acting acute timeframe (~ 24 - 72 hours). Has enabled Oral, Transdermal, I.V. Injection, I.V. Infusion, and Lung Inhalation routes for drug delivery. Rescue drug candidates.
• NanoViricides Technology Platform for Drug Development: Specific site-directed ligands for bind to viral surface glycoproteins enable blocking of re-infection and engulfment of the virus particle within the nanoviricide™ micelle. Expected to deliver encapsulated APIs to virally infected cells projecting viral glycoproteins, sparing normal cells from toxic antiviral APIs.

About PODD (from their website, https://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/)

Pharma, biotech and the drug delivery industries gather annually at PODD to assess delivery needs, latest trends and information on deals and learn about a wide range of innovative drug delivery technologies that could improve the delivery of various types of drugs. This can include proteins, peptides, oligonucleotides, biologics, and small molecules and more. PODD provides business development opportunities through organized networking and a partnering tool for new, emerging and established collaborations.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced 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 factors including external collaborators and consultants. The NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India.

NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-CoV-2 does not contain 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 RSV, 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 human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.

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.

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". "Prodrug" means a chemical that is readily converted into the referenced drug in the body.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com

SOURCE: NanoViricides, Inc.