SHELTON, CONNECTICUT — Monday, April 6, 2020 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a leader in the development of highly effective antiviral drugs based on a novel, patented, nanomedicines platform, reports that U.S. Senator Richard Blumenthal visited the Company’s facility in Shelton, Connecticut, on Tuesday, March 31, 2020.
The Honorable Senator Blumenthal visited the Company to receive an update regarding the coronavirus drug development program and to tour the cGMP-capable manufacturing facility. The Senator, his staff, and members of the Press participated in a tour of the Company’s lab and manufacturing facility.
Following the tour, the Senator held a press conference in front of the building.
“NanoViricides, Inc. must be given full and fair consideration for CARES funding because every approach that has strong potential for developing a treatment for COVID-19 must be supported immediately – it will save American lives. I am going to ask my staff in Washington, DC to do whatever we can to enable the Company to access such funding and I will do everything in my power to help NanoViricides get the attention and review they merit from BARDA, the FDA and other federal agencies,” assured Senator Blumenthal.
Anil R. Diwan, PhD, President and Executive Chairman of the Company, welcomed the Senator and gave a brief overview of the Company’s approach to coronavirus drug development to the Press. “We are developing what is effectively a ‘Venus-Fly-Trap’ for the virus particle. Just as a fly is attracted to a Venus-Fly-Trap flower, and then the flower closes onto it, our material attracts the virus particle, and then wraps around the virus particle thereby rendering the virus particle incapable of infecting cells,” said Dr. Diwan, adding, “Our material, i.e., a nanoviricide, mimics the human cell surface receptors to attract the virus.”
“The beauty of this technology is that, a virus would not be able to escape a nanoviricide by mutations or genomic changes, because no matter how much it changes, the mutated virus still lands on the same cellular receptor in the same fashion as its earlier version,” elaborated Ms. Meeta R. Vyas, SB, MBA, the Chief Financial Officer of the Company.
“I co-authored the $8.3 Billion CARES act to support the development of drugs, diagnostics, vaccines, and other measures to combat COVID-19,” said Senator Blumenthal, adding, “The drug development by NanoViricides deserves to be supported.”
In response to questions from reporters, Dr. Diwan explained that the Company had already identified some drug candidates that had strong activity against at least two coronaviruses that use different cellular receptors. One of these viruses uses the same receptor, namely ACE2 (angiotensin-converting enzyme 2), as SARS-CoV-2, the coronavirus that causes COVID-19 disease.
This broad-spectrum activity provides confidence that these candidates would be effective against SARS-CoV-2, he emphasized. Testing against SARS-CoV-2 itself is expected to be performed very soon. The Company is in the process of setting up collaborations with external BSL3/BSL4 labs that have developed assays for such testing, he added. Dr. Diwan also stated that the Company intends to publish its results once the verification experiments are completed. In parallel, the Company has already begun certain animal studies to help identify clinical drug candidates against SARS-CoV-2, in order to expedite the program.
When asked to comment on other drugs being considered to treat the virus, Dr. Diwan explained that the nanoviricides technology was complementary to other drugs because nanoviricides attack the virus outside the cell to prevent it from infecting the cell, while other drugs (except antibodies) work inside the cell to reduce virus replication. “A nanoviricide drug for attacking the virus particle and stopping the re-infection cycle taken together with another drug for limiting viral replication inside cells would make an even more effective treatment for COVID-19 than either one by itself,” he explained.
“We can produce sufficient quantities of a drug to treat as many as a thousand patients in a single batch in our cGMP-compliant manufacturing facility,” said Dr. Diwan, in response to a question from a reporter regarding manufacturing capacity of the Company adding, “The manufacturing capacity can be substantially increased with additional resources.”
“We have been working on this project with limited internal resources while continuing our work on our lead drug against Shingles which is close to an IND,” said Dr. Diwan. He added, “At this stage, we need help from government agencies, laboratories, and collaborators to quickly deliver our promising potential treatment to patients suffering from COVID-19. It is an honor to have Senator Blumenthal visit our facility. We are grateful for his commitment to assist us in accessing potential federal funding and agency support, from the likes of the Biomedical Advanced Research and Development Authority (BARDA), the FDA and the NIH, in our effort to save American lives in the fierce battle our country faces to defeat SARS-CoV-2.”About NanoViricides
NanoViricides, Inc. (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-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. 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. The Company has previously worked on developing drug candidates against the MERS coronavirus. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc.
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this press release are forward-looking statements, including, but not limited to, the company’s proposed follow-on offering. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the company believes may affect its financial condition, results of operations, business strategy and financial needs, including the expectation that the offering will be successfully completed. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. The company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the company cautions investors that actual results may differ materially from the anticipated results. 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.
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