SHELTON, CONNECTICUT — Wednesday, April 29, 2020 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that the Company’s presentation with an update of its drug development programs for the treatment of Shingles and for COVID-19 made at the Planet MicroCap Showcase 2020 on April 22nd is now available for viewing. Anil R. Diwan, PhD, President and Executive Chairman of the Company, presented this Corporate Update.
The archived presentation is now available for on-demand playback by accessing the following link: https://www.webcaster4.com/Webcast/Page/2059/34392
The archived presentation has the full audio track linked to the slides. There was a technical error whereby the slides were not changing during the live presentation. Therefore, the Company encourages people to visit the archived presentation.
Key takeaways from the presentation are as follows.
• The Company has drug candidates that were highly successful in cell culture studies against multiple coronaviruses.
• The observed broad-spectrum anti-coronavirus activity of these drug candidates provides confidence that even as the virus mutates, the selected nanoviricide drug would continue to be effective against it.
• The Company’s technology goes well beyond antibodies in attacking the virus particle. Whereas an antibody binds to the virus only at two points, a nanoviricide is designed to bind to the virus at several points, like a nano-scale “Velcro” tape, and further to encapsulate the virus, thereby disabling it from infecting a cell.
• Viruses can escape antibodies due to genomic changes including mutations. However, a virus continues to bind to the same cellular receptor with the same “footprint”. A nanoviricide is designed by attempting to mimic this footprint, and therefore, it is expected that it would continue to be effective in spite of changes in the virus.
• A nanoviricide is designed to act like a “Venus-fly-Trap” for viruses.
• The Company is anticipating a collaboration to enable testing against SARS-CoV-2, the virus that causes the COVID-19 disease.
• The Company has worked on developing an animal model to test anti-coronavirus effectiveness in vivo using a model coronavirus that binds to the same ACE2 (“angiotensin convertase enzyme 2”) receptor as SARS-CoV-2, namely human coronavirus NL-63 (hCoV-NL63). The Company anticipates using this animal model to obtain indications of effectiveness of the nanoviricide test drug candidates against the model coronavirus in vivo.
Shingles Candidate IND Update:
• The Company’s first IND application for the use of NV-HHV-101 Skin Cream for Shingles Rash treatment is being prepared by us and is being reviewed by the Company’s regulatory consultants.
• The Company is currently working on establishing collaborations with clinical regulatory consultants and is evaluating clinical site selections.
• The Company has developed a preliminary clinical plan and is preparing the more detailed clinical plan to be included in the IND application.
The Company is developing broad-spectrum drugs against coronaviruses by developing mimics of the ACE2 receptor to which SARS-CoV-2, SARS-CoV-1, hCoV-NL-63 and possibly some other coronaviruses bind. The Company has previously developed a broad-spectrum anti-herpesvirus drug candidate. This candidate, originally developed to be active against HSV-1, the virus that causes cold sores, was found to be effective against HSV-2, the virus that causes genital ulcers, and also against VZV, the virus that causes chickenpox and shingles. Of these, HSV-1 and HSV-2 are known to bind to the HVEM (“herpesvirus entry mediator”) cellular receptor, which the Company mimicked to produce the drug candidates against herpesviruses. It is not definitively known whether VZV binds to HVEM. NV-HHV-101 is the Company’s lead drug candidate that has completed IND-enabling studies, and is ready for human clinical trials, once the IND process is completed.
NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drug for about 1,000 patients in a single batch of production, depending upon dosage. This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic, as well as for the anticipated clinical trials of NV-HHV-101.About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also developing drugs against SARS-CoV-2 virus for the treatment of COVID-19 disease, and a number of other 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. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack virus particles by mimicking the same receptor sites that viruses use to bind to cells, enveloping and then dismantling them, thereby blocking the reinfection cycle. This goes beyond what antibodies and immunotherapeutics can do. Our unique biomimetic approach enables creation of drugs that a virus would be highly unlikely to escape due to mutations. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses from TheraCour Pharma, Inc. While the Company does not currently have a license to the coronavirus field, TheraCour has not denied any licenses to the Company. The Company typically begins the licensing process only after demonstrating effectiveness of some candidates in optimization stage.
Safe Harbor Statement
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.
As with any drug development efforts, there can be no assurance that any of these candidates would show sufficient effectiveness and safety for human clinical development at this time. There can be no assurance that the Company will be successful in establishing the necessary collaborations, although the Company has been successful at establishing necessary collaborations for its drug programs in the past.
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