SHELTON, CT / ACCESSWIRE / January 6, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a global leader in nanomedicines against viruses, reports that it has received a cash infusion of $2.25 Million in two different transactions in December, 2019.
The Company consummated a debt facility of $2 Million provided by Dr. Anil R. Diwan, its co-founder, President and Chairman of the Board, on December 16, 2019. Of this commitment, the Company has drawn a total of $1.1 Million as of December 31, 2019, with an additional $0.9 Million remaining available to the Company.
In addition, the Company exchanged $250,000 of accounts payables for 100,000 shares of its preferred Series A stock with TheraCour Pharma, Inc., resulting in a decrease in current liabilities, on December 17, 2019.
Together, these two transactions have effectively provided $2.25 Million of cash infusion to the Company, significantly improving the Company’s cash position. The Company spent only approximately $1.43 Million in the quarter ended September 30, 2019. Thus, the current cash infusion provides an effective runway anticipated to enable the Company to file its first IND application and further continuing operations.
“This cash infusion comes at a critical time for the Company,” said Mr. Stanley Glick, Lead Independent Director, and Chair of the Audit Committee, adding, “It provides substantial valuable runway for the Company as it progresses its drug candidate towards filing the first IND application to the US FDA.”
The Company’s first drug candidate, NV-HHV-101, is a skin cream for the treatment of shingles rash, caused by reactivation of the Varicella-Zoster virus (VZV), with an estimated market size in billion dollar range. In a human skin patch organ culture model ex vivo, the Company has previously demonstrated the effectiveness and safety of topical NV-HHV-101 against VZV, the cause of shingles and chickenpox. These studies were conducted by Professor Jennifer Moffat at the Upstate Medical Center, SUNY Syracuse, NY. Professor Moffat has developed this model for pre-clinical evaluation of therapeutics against VZV, and is a well known expert in the field.
It is anticipated that the high effectiveness of our clinical drug candidate observed in this human skin model should be predictive of effectiveness in human clinical trials for topical dermal treatment of shingles.
The various non-clinical studies required for an IND have been mostly completed, with certain remaining analyses expected to be completed within the next few weeks. Thereafter, the Company anticipates receiving a GLP report for the required Safety/Toxicology studies conducted by BASi, IN, a specialized contract services organization in this field. In addition, the Company expects GLP and non-GLP reports on other required analyses performed by external laboratories soon. The Company anticipates finalizing clinical service provider(s) and engaging clinical consultants for preparing the definitive clinical plan shortly. Other sections of the IND application are in preparation. Once the clinical plan is complete, the Company intends to integrate it into the IND application and thereafter convert the IND application into the required eCTD (“electronic common technical document”) format and submit the same.
The Company has a broad pipeline of drug candidates with several drug candidates in the HerpeCide™ program following the shingles drug, as well as drug candidates in development for HIV, Influenza, Dengue and other viruses. The Company’s technology is licensed from TheraCour Pharma, Inc., in broad, exclusive licenses for application to specific virus types listed in the licenses. TheraCour is substantially owned and founded by Dr. Anil Diwan, the Company’s co-founder. The licenses are not limited to specific drugs or chemical entities as with typical pharmaceutical industry licenses, but broadly encompass any drug developed utilizing the TheraCour® nanomedicine technologies in the licensed fields.
The $2 Million loan from Dr. Diwan is secured by a mortgage interest in the Company’s fully-owned facility at 1 Controls Drive, Shelton, CT. The bridge loan carries a 12% per annum interest, payable only on the portion of monies actually drawn by the Company. A commitment fee in 10,000 shares of preferred Series A stock of the Company was paid for the loan. No payments are due on this bridge loan during its term, and the entire amount becomes due on December 15, 2020. The preferred shares have a voting preference of 9 votes per share. Only upon a change of control of the Company, a preferred series a share will convert into 3.5 shares of common stock. There is no market for these shares.
There were no agents or brokers in these transactions and no commissions or agency fees were paid other than legal and regulatory fees. Dr. Diwan, being a party with interest, recused himself from, and was not present at, the discussions and negotiations of the Company’s Board of Directors on both of these transactions.
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’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 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 means an Investigational New Drug application.
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SOURCE: NanoViricides, Inc.
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