NanoViricides Files Quarterly Report for Period Ending December 31, 2018 - HerpeCide Drug Candidate Progressing in IND-Enabling Studies Towards Clinical Trials
SHELTON, Conn., Feb. 19, 2019 /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 second 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 February 14th, 2019. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000114420419008138/tv511808_10q.htm.
The Company reported that it had approximately $4.07 Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $1.16M, as of December 31, 2018, the end of the reporting period.
The net cash used in operating activities during the last six months (first and second quarters) was approximately $3.12 M, compared to approximately $2.96M in the six months ending December 31, 2017. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $13.84M for the quarter (unaudited figures). The Company had no revenues.
The Company has no long term debt.
NanoViricides is pioneering a unique platform for developing anti-viral drugs based on the "bind-encapsulate-destroy" principles. Viruses would not be able to escape a properly designed nanoviricide® drug by mutations because in doing so they would lose the ability to bind their cognate cellular receptor(s) and thus fail to infect productively, becoming incompetent.
NanoViricides is a unique pre-clinical pharma company in that it fully owns its own lab and cGMP-capable flexible custom manufacturing facility where any of our drug candidates can be produced in multi-kilogram quantities to support corresponding IND-enabling tox package studies as well as initial human clinical trials. This enables rapid translation of our drug candidates to the clinic, saving years of manufacturing translation and set-up activities, as well as saving several millions of dollars of external costs, while ensuring requisite quality assurance, as compared to using a contract manufacturing organization ("CMO") for our complex nanomedicine drugs.
Management has continued and increased its investor outreach programs. The Company has engaged TheMoneyChannel-NYC for investor outreach. Additionally, the Company has engaged Zacks Investment Research for the purpose of developing and disseminating investment research analysis reports on the Company.
Subsequent to the reporting period, the Company reported on February 4, 2019, that its lead drug candidate has entered IND-enabling Safety/Toxicology studies at the end of December, 2018. This candidate, which is under the broad-spectrum anti-herpes drug program "HerpeCide™", is designated as "NV-HHV-101". The Company is developing it for the first indication as a dermal topical treatment for shingles rash. 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 the GLP portion of these studies.
The Company also reported that it has completed the development of the final formulation of the "drug product" in a short period of about six weeks. This rapid formulation development was enabled by the very design characteristics of the TheraCour® polymeric micelles that form the backbone of the nanoviricides® drugs.
The Company has previously reported that two shingles drug candidates have successfully shown strong safety in a preliminary rat toxicology study. This study 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. We are anticipating results from the initial safety/toxicology studies soon.
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's 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 VZV. The terms for the VZV license are being finalized as of this report. Thereafter, we anticipate final license agreements to be drawn by the legal representatives of the parties for signatures and consummation. TheraCour has in the past not denied any licenses for any virus programs that we initiated.
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 previously 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.