NanoViricides Files Quarterly Report for Period Ending March 31, 2018; Company Has Over A Year's Worth of Cash in Hand, and It Is Scaling Up Production of Certain Herpecide Program Drug Candidates
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 third quarter of financial year 2018 in a timely manner with the Securities and Exchange Commission yesterday. This press release should be read in conjunction with the Form 10-Q filed on May 21, 2018. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000114420418030083/tv492966_10q.htm.
The Company reported that it had approximately $10.95 Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of 2.29M, as of March 31, 2018, the end of the reporting period.
The net cash used in operating activities during the last nine months (three quarters) was approximately $4.26 M, compared to $6.89M in the nine months ending March 31, 2017. The difference from prior period is primarily due to accounts payable and reduction in operating expenditures in current period. The Company's research and development (R&D) expenditure of approximately $1.03M in the current quarter was in line with our budgeted estimates. Shareholder equity stood at approximately $19.1M 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 reports that its HerpeCide™ program is advancing satisfactorily towards our first IND filing in the near future. The Company has reported that a preliminary rat toxicology study of two of its lead candidates in this program that are developed against the shingles indication was completed recently. Both of the tested candidates were found to be extremely safe in this study.
Success in this study has paved the way for taking a clinical candidate towards the GLP Safety/Toxicology study required for filing an IND application.
No clinically observable adverse safety and toxicology effects were seen in this study of the Company's optimized topical dermal drug candidates. There were no adverse effects on the skin at the treatment sites. Equally importantly, the results of the non-GLP safety and toxicology study showed that there were no overall observable systemic effects either. There were no observable direct effects on the primary organ function whether the drug was administered to the skin or administered systemically. This includes liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity.
These results are consistent with the positive findings in a model of VZV (the shingles virus) infection of human skin in which no safety or toxicology concerns have been observed, further demonstrating the safety of these drug candidates.
These drug candidates have shown strong effectiveness in shingles virus infection studies in human skin organ culture model as well, as previously reported. Further, these candidates have demonstrated strong anti-viral activities against HSV-1, HSV-2, and VZV in cell culture studies using multiple cell lines.
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 re-estimated that approximately 750g 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 the capabilities for producing such large quantities of the drug substance in our current cGMP-capable production facilities.
The Company is developing drugs against several indications in the HerpeCide program, that are based on the tested drug candidates. These indications include: (1) skin cream for the topical treatment of shingles (VZV or chickenpox virus); (2) skin cream for the treatment of "cold sores" (HSV-1); (3) skin cream/ointment for the treatment of genital ulcers (HSV-2); (4) eye drops/gel for the treatment of external eye viral infections, primarily herpes keratitis (mainly HSV-1); (5) intraocular injection for the treatment of retinal diseases caused by viral infection (primarily VZV and HSV-2), such as ocular herpes and viral Acute Retinal Necrosis (v-ARN). Of these, the shingles program is currently the most advanced towards an IND filing, with HSV-1 and HSV-2 skin cream/ointment programs following on its heels. All of our animal studies and skin studies are done externally. The timelines of our programs thus inherently depend upon the external collaborations.
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 overall market size for the indications in development in our HerpeCide program may be estimated in the several tens of billions of dollars.
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 believes that it will complete negotiations of a license for the shingles field from TheraCour after our new CEO is appointed. TheraCour has in the past not denied any licenses for any virus programs that we initiated. Nevertheless, we will accelerate our work on the HSV-1 (cold sores) and HSV-2 (genital ulcers) indications, if we cannot come to an agreement with TheraCour for the shingles license. The Company already has licenses from TheraCour for these indications. The topical drug candidates in development for HSV-1 and HSV-2 programs are very closely related to the ones in development for the shingles program at present.
The Company's search for a new CEO with strong pharmaceutical industry background was begun prior to Dr. Seymour's retirement. It has been accelerated and the Executive Search Committee reports that it is now in due diligence phase, to be completed soon. In the interim, the Board has appointed Anil R. Diwan, PhD, President and Chairman, as the acting CEO in January, following retirement of Dr. Eugene Seymour.
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.
The Company has a continuity of leadership in place after Dr. Seymour's retirement, with the temporary appointment of Dr. Diwan as the interim CEO. Dr. Diwan and Dr. Seymour together previously constituted the Executive Committee, and thus, Dr. Diwan has been involved in strategic decision-making, as well as fund-raising activities since the founding of the Company. The company's executive committee works with the senior leadership and additional consultants to develop and execute the Company's business strategy and activities.
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.
CONTACT: Anil Diwan, firstname.lastname@example.org, (203)-606-9180
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SOURCE NanoViricides, Inc.