SHELTON, Conn., Feb. 21, 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 second quarter of financial year 2018 in a timely manner with the Securities and Exchange Commission on Tuesday, February 20, 2018. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000114420418009768/0001144204-18-009768-index.htm.
This press release should be read in conjunction with the Form 10-Q filed on February 20, 2018.
The Company reported that it had approximately $12.0 Million (M) of current assets (cash, cash equivalents, and prepaid expenses) as of December 31, 2017, the end of the reporting period. The net cash used in operating activities during the six months (two quarters) was approximately $2.96 M, compared to $4.84M in the six months ending December 31, 2016. The difference from prior period is primarily due to accounts payable, which were approximately $1.55M in current period compared to $0.48M in the prior period, and reduction in operating expenditures in current period. The Company's research and development (R&D) expenditure of approximately $1.4M in the current quarter was in line with our budgeted estimates. Shareholder equity stood at approximately $15.9M for the quarter (unaudited figures). The Company had no revenues.
The Company has no long term debt.
The Company estimates that it has sufficient cash in hand to last more than one year of operations at the current rate of expenditure. 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.
The Company has begun an initial safety and toxicology evaluation of its optimized nanoviricides® drug candidates developed against varicella-zoster virus (VZV), the shingles virus, as reported previously. This preliminary safety/toxicology study in the rat animal model is an important step in the drug development pathway for a treatment for shingles, a debilitating infection of human skin by VZV. The results of this study are expected to help us finalize the clinical lead. In addition, these results are expected to lead to refining and commissioning the GLP safety and toxicology study ("Tox Package" study) as required for filing an IND.
We believe, additionally, that the results of this preliminary rat safety/tox study will also be applicable to the dermal topical treatments we are developing for the treatment of HSV-1 cold sores, and HSV-2 genital ulcers.
Subsequent to this reporting period, the animal experiment portion of this study has been completed as of the end of January 2018. We have received initial verbal communications that indicate that our drug candidates were non-toxic in terms of behavioral and other observable signs during the study. We are awaiting a final report from the CRO, which is due shortly.
We have already begun to scale up production of these tested candidates to the larger amounts as estimated to be required for the ensuing Tox Package studies. We have estimated that approximately 500g of the candidate will be needed for such a study, based on discussions with BASi, Inc., IN, the service provider, and Biologics Consulting Group, VA, our regulatory consultants.
We have previously reported excellent results on efficacy of the shingles topical treatment in our HerpeCidetm program. Certain shingles drug candidates were found to be about five times more effective than acyclovir, the standard of treatment, in cell culture studies. These data were presented at the 2017 Annual American Society of Virology meeting in Madison, WI.
The same drug candidates also showed very high effectiveness in controlling VZV (varicella zoster virus, the causative agent) in human skin patch model for shingles in Professor Moffat's lab at the SUNY Upstate Medical Center, Syracuse, NY. On the basis of these results, these candidates were advanced into preliminary animal safety/toxicology studies, as described above. The shingles drug candidate is now moving towards identification of a clinical candidate for further IND-enabling studies.
The market size for anti-shingles drugs is currently estimated to be in the range of several billions of dollars, even after a new shingles vaccine, Shingrix® (GlaxoSmithKline) has become available, based on a recent report by Dr. Myers of BioEnsemble, LLC, pharma industry consultants, commissioned by the Company.
The Company believes that the anti-VZV drug candidates are very likely to be effective for dermal topical treatment of HSV-1 cold sores, as well genital ulcers caused by HSV-2, in addition to shingles. If the same anti-VZV/shingles drug candidates also demonstrate efficacy against the HSV-1 and HSV-2 animal models, then we will be ready to go into IND applications and clinical stage for these indications as well in relatively short time frames of six months to a year, after the first IND filing, depending upon the availability of funding. We had previously demonstrated significant efficacy of an anti-HSV-1 nanoviricide in animal models using nanoviricides based on closely related ligands and polymer that were not yet optimized.
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 is continuing the process for licensing of the shingles indication from TheraCour Pharma, Inc.. To this end, the Company has reviewed the initial valuation report submitted by Dr. Myers of BioEnsemble, LLC. Thereafter, we have asked that further modeling and analysis be performed incorporating additional assumptions that reflect our situation more closely than in the model that was presented. Thereafter, we anticipate license agreements will be drafted and the terms and conditions will be negotiated. 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. 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 essentially the same or closely related dermal topical drug candidates as in development under the VZV banner at present in the HerpeCidetm program. The Company already has licenses from TheraCour for these indications.
Additionally, the Company reported that Dr. Eugene Seymour, MD, MPH, the Company's co-founder and CEO, has resigned from his position as CEO as well as a Director of the Company to allow a successor with a pharmaceutical background in shepherding drugs through the process to FDA approval, to be appointed to serve in this capacity. Upon entry into severance agreement Dr. Seymour will assume the role of Chief Executive Officer Emeritus. The Board of Directors commenced a search for a permanent replacement for Dr. Seymour, which is ongoing. Pending the appointment of a permanent Chief Executive Officer, the Board of Directors appointed Dr. Anil Diwan, the Company's President, as Interim Chief Executive Officer.
Dr. Seymour, a co-founder of the Company, has been a driving force in building NanoViricides from a nanomedicines concept to a Company with a broad pipeline of drug candidates as it is today.
The Company's progress is expected to continue unaffected by the resignation of Dr. Seymour. Dr. Diwan, who has served as the Company's President since 2005, has assumed the additional duties as interim CEO. Dr. Diwan has been performing several of the CEO duties increasingly since the Company's 2013 uplisting from the OTC Markets to NYSE-American. Further, Dr. Diwan has led several of the Company's financing efforts with Dr. Seymour including two registered direct offerings conducted in September 2013 and January 2014 respectively, that raised approximately $30 million.
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.
SOURCE NanoViricides, Inc.
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