The Company's successful fundraising and inclusion in the Russell Microcap(R) Index comes after a series of promising test results for its COVID-19 drug candidates
Shelton, Connecticut--(Newsfile Corp. - July 23, 2020) - NanoViricides, Inc. (NYSE American: NNVC) (the "Company") is a development stage, nano-biopharmaceutical Company, with proprietary research focused on countering viral diseases. The Company's lead drug candidate, a topical cream for shingles, has been at the cusp of the IND (Investigational New Drug) application before heading for Phase 1 of human trials. Its research team has also been working on the development of a drug to treat the SARS-CoV-2 virus since the beginning of 2020 and has shown visible progress with positive results in the animal model.
The NanoViricides management announced the completion of a capital raise to the tune of $11.5 million through an underwritten public offering. The Company issued 1,369,863 shares and a fully exercised underwriters' over-allotment option of 205,479 additional shares of NanoViricides' common stock at the public offering price of $7.30 per share. This issue took place at an approximate discount of 17% over the stock's closing price in the previous trading session and was underwritten by Kingswood Capital Markets, a division of Benchmark Investments, Inc. Kingswood Capital acted as sole bookrunner for the public offering. The overall net proceeds with the Company after the pay out of commission and other transaction fees is approximately $10.53 million, before deducting the Company's legal and accounting expenses related to the offering. It is worth highlighting that prior to this offering, the management reported cash and cash equivalents worth $6.11 million in its most recent quarterly result. Currently, the Company has over $15 million in cash available for funding its research and meeting its working capital requirements. Notably, the Company had been added to the Russell Microcap® Index as of June 29, 2020.
Prior to the public offering, NanoViricides featured in the news for significant progress made on its COVID-19 drug candidate. The Company's proprietary nanoviricide® technology, which works by trapping virus particles the same way as a Venus-fly-trap captures and consumes insects, has wide-ranging antiviral applications and is being used in drug development against many different viruses including COVID-19, shingles, herpes, HIV, and others. With respect to COVID-19, the Company has developed broad-spectrum anti-coronavirus drug candidates and carried out initial tests using cell culture assays as well as through an animal model. In its tests using cell culture assays of two different coronaviruses, namely hCoV-229E, and hCoV-NL63, the Company's drug candidates have proven to be far more effective than favipiravir, a commonly used antiviral medication used for treating SARS-CoV-2. While the coronavirus samples used in the cell culture studies were not the SARS-CoV-2, they have related cellular receptors, namely APN which provides a rational basis to the research team. These tests were followed by the use of an animal model of the human coronavirus disease. The results were compared with remdesivir, the popular broad-spectrum antiviral medication developed by Gilead Sciences that has been approved as a treatment for COVID-19 patients. NanoViricides' candidates showed superior results to remdesivir in the animal model. For the animal study, the researchers employed the hCoV-NL63, the same coronavirus used in the cell culture assays which uses the same cell receptor, ACE2, as does the SARS-CoV-2. While the hCoV-NL3 is a milder strain of the coronavirus, it acts as a suitable surrogate for the study that can be done in the Company's BSL-2 lab. The Company would require BSL-3 or BSL-4 labs for carrying out similar studies using the actual SARS-CoV-2 strain for which the management is on the lookout for potential collaborations. The results of these tests were encouraging and prompted the Company to move ahead with safety and tolerability studies on its COVID-19 drug candidates.
As a part of its safety and tolerability tests, the Company's research team tested three different drug candidates at three different dosage levels and vehicle control through separate groups of mice intravenously. Sixteen mice in each group, eight males and eight females, were administered one of the three drug candidates at one of the three dose levels, and additionally, one group was administered vehicle control, for seven days by daily tail-vein intravenous infusion in this blinded study with additional evaluations on the eighth day. This non-GLP safety and tolerability study was conducted under GLP-like conditions by AR BioSystems in Tampa, Florida. The results indicated that tested drug candidates were safe and well-tolerated with no clinical signs of immune or allergic reactions. The results showed no observable changes in any organs, including the large intestine or colon, on post mortem in gross histology. The only reportable changes were, in the high dosage groups of two of the three drug candidates tested, associated with the non-absorption of water, in the colon. This is consistent with the clinical observation of very loosened stools in the same groups. The positive result is expected to enable the Company to move forward with further development of its candidates and advancing to human trials.
Prior to advancing with human clinical trials, the Company's management plans to conduct studies to carry out clinical candidate selection and possibly request a pre-IND meeting with the FDA for regulatory guidance. The management looks to engage in strong collaborations in the future and can also expect cash flows expected through licensing once its candidates for shingles as well as the SARS-CoV-2 start clearing the initial phases of human trials.
About NanoViricides
NanoViricides, Inc. (AMEX: NNVC) 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. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, shingles and chickenpox, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. 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. For more details on the Company, please visit http://www.nanoviricides.com/.
Forward-Looking 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. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".
