NanoViricides Files Quarterly Report for Period Ending September 30, 2018
SHELTON, Conn., Nov. 26, 2018
SHELTON, Conn., Nov. 26, 2018 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), filed its quarterly report for its first quarter of financial year 2019 in a timely manner with the Securities and Exchange Commission. This press release should be read in conjunction with the Form 10-Q filed on November 14th, 2018. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000114420418059983/tv506169_10q.htm.
The Company reported that it had approximately $6.28 Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $1.39M, as of September 30, 2018, the end of the reporting period.
The net cash used in operating activities during the last three months (first quarter) was approximately $0.96 M, compared to approximately $1.56M in the three months ending September 30, 2017. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $17.37M for the quarter (unaudited figures). The Company had no revenues.
The Company has no long term debt.
The Company has reported earlier that its new CEO, Dr. Irach B. Taraporewala has joined as of September 1, 2018. In addition, the Company has reported that Mr. James Sapirstein has joined the Company's Board as an independent director, and has become a member of the Audit Committee, Nomination and Governance Committee, and Compensation Committee of the Board, as of November 1, 2018. Dr. Taraporewala was also appointed to the Board on November 1, 2018. Both of these Board appointments are to be ratified by a shareholder vote at the Annual Meeting of Shareholders to be held on Friday, November 30, 2018.
The Company is now in compliance with the NYSE-American listing requirements of an Audit Committee composed of a minimum of three independent directors.
Management has continued and increased its investor outreach programs. The Company has previously appointed TheMoneyChannel-NYC for investor outreach. Subsequent to the reporting period, the Company has engaged Zacks Investment Research for the purpose of developing and disseminating investment research analysis reports on the Company.
The Company reports that its development of the dermal topical treatment for shingles rash is progressing into IND-enabling preclinical studies. The Company has engaged BASi, IN to perform the non-GLP and GLP Safety/Toxicology studies. The Company is in the final steps of producing the large quantities of materials required for these studies. In addition, we are now working on final formulation of the "drug product" as well, using known excipients as necessary.
The Company has previously reported that the shingles drug candidates have successfully shown strong safety in a preliminary rat toxicology study. This has cleared the path for taking the shingles drug candidates into formal GLP safety/toxicology studies that are required for filing an IND. The Company believes that, additionally, the results of this previously completed preliminary rat safety/toxicology study also give us confidence that the dermal topical treatments we are developing for the treatment of HSV-1 cold sores, and HSV-2 genital ulcers also should exhibit similar strong safety characteristics.
The Company's drug candidates against shingles have shown excellent effectiveness in the human skin organ culture VZV infection model ("SOC model") in Professor Jennifer Moffat's Lab at the Upstate Medical Center, SUNY Syracuse, NY.
In addition to VZV, we are also developing dermal topical drugs against HSV-1 cold sores and HSV-2 genital ulcers. The Company intends to advance these drug candidates towards human clinical trials as soon as possible. The Company has a strong pipeline of drug candidates in the HerpeCide™ program which is at top priority level at present.
The Company develops its class of drugs, that we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
The anti-VZV drug development program has moved rapidly towards clinical candidate declaration stage because of several factors, namely (a) that it was simply the existing HSV-1 drug program in which the existing candidates were re-tested for effectiveness against VZV, (b) that we have had a highly successful collaboration with Dr. Moffat Lab at SUNY Syracuse with rapid turnaround times, and (c) the drug candidates were found to be highly effective against VZV in these studies.
NanoViricides currently has existing licenses from TheraCour Pharma, Inc., (TheraCour), our development partner and where the intellectual property has originated, for HSV-1 and HSV-2, but not for the remaining herpesviruses. NanoViricides has disclosed our intention to obtain licenses for VZV as well as other remaining unlicensed herpesvirus indications from TheraCour Pharma. We anticipate license agreements will be drafted and the terms and conditions will be negotiated soon. TheraCour has in the past not denied any licenses for any virus programs that we initiated. We have retained counsel to prepare and negotiate the new license agreement on our behalf. The Company intends to complete these new license negotiations soon. Due to the departure of our former Chief Executive Officer, we were unable to negotiate such terms until the vacancy was just recently filled by Dr. Taraporewala. If we cannot come to an agreement with TheraCour for the shingles license, we will continue and accelerate our work on the HSV-1 (cold sores) and HSV-2 (genital ulcers) indications, which we believe will be using closely related dermal topical drug candidates as in development under the VZV banner at present in the HerpeCide™ program.
Thus we have made significant and substantial progress in the reporting quarter towards the goal of filing our first IND application, and we continue to build on this progress.
The Company has stated that it will be required to raise additional capital in the near future to fund our drug candidates as they advance towards IND stage and into human clinical trials, as is the case with most if not all non-revenue innovative pharmaceutical companies.
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. The Company is 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. 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.
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SOURCE NanoViricides, Inc.