NanoViricides, Inc. reports that it has filed its annual report (Form 10-K) for the financial year ending June 30, 2018, with the Securities and Exchange Commission (SEC) on Friday, October 12, 2018.
SHELTON, Conn., Oct. 15, 2018 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), reports that it has filed its annual report (Form 10-K) for the financial year ending June 30, 2018, with the Securities and Exchange Commission (SEC) on Friday, October 12, 2018. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000114420418053665/tv501564_10k.htm) .
The Company reported that, as of June 30, 2018, we had cash and cash equivalent balance of approximately $7.08 Million. In comparison, as of June 30, 2017, we had cash in hand of approximately $15.10Million. Research and development expenses for the year ended June 30, 2018 decreased about $700K to $4.83 Million from $5.53 Million for the year ended June 30, 2017, primarily due to reduction in payroll and consultant costs, and related reduction in lab supplies and chemicals. General and administrative expenses increased about $429K to $4.50 Million for the year ended June 30, 2018 from $4.07 Million for the year ended June 30, 2017. The increase in general and administrative expenses is generally attributable to recognition of stock and cash compensation paid to Dr. Seymour upon his resignation and an increase in legal, professional and consultant costs.
For the year ended June 30, 2018, the Company had a net loss of about $8.56 Million, or a basic loss per share of $0.13 and fully diluted loss per share of $0.13 compared to a net loss of about $10.3 Million, or a basic loss per share of $0.17 and a fully diluted loss per share of $0.17 for the year ended June 30, 2017. This decrease in the Company‘s net loss is generally attributable to the gain resulting from the change in fair value of derivatives, discount on convertible debenture expense, and interest expense, which were partially offset by a loss on extinguishment of debt from the conversion of convertible debentures to equity in November, 2017.
During the financial year, the Company has taken steps to strengthen its management team and its board to increase depth in pharmaceutical industry expertise. Dr. Eugene Seymour resigned at the end of January, 2018, and his severance was formalized in May 2018. In addition, Dr. Milton Boniuk resigned as a Director of the Company in July, 2018 due to differences with Management and Board of the Company.
Dr. Irach Taraporewala, a 25+ years pharma industry veteran joined the Company as its Chief Executive Officer (“CEO”) officially on September 1, 2018. Dr. Taraporewala has demonstrated expertise in QA/QC, CMC, c-GMP production, and regulatory strategy, having taken a novel drug through successful Phase 2 human clinical trials.
The Company has restructured its business plan to focus on taking its first drug candidate into human clinical trials at the earliest possible date. The Company has redeveloped its budgets and believes that it has sufficient funds in hand to accomplish this. The Company anticipates raising additional capital for conducting human clinical trials in the future. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company’s process of negotiation with TheraCour Pharma, Inc. for licensing of the VZV and potentially all remaining herpesvirus areas has begun in earnest after the new CEO joined. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 “cold sores” treatment, and HSV-2 “genital ulcers” treatment are expected to follow the shingles candidate into IND-enabling development and subsequently into human clinical trials.
The Company anticipates achieving several important milestones in the ensuing year. In brief, these include the declaration of a final clinical candidate for its lead drug indication, achieving successful cGMP-like production of the drug as required for the ensuing “Tox Package” studies, initiation and completion of the Tox Package studies, a “Pre-IND” meeting with the FDA, filing of an IND, and the beginning of initial human clinical trials. In general, as a pharmaceutical company achieves these milestones, its risk-profile with investors improves as reflected in the market capitalization. Management believes that as the Company achieves these milestones, it would significantly improve the Company‘s ability to raise funds on the public markets. However, there can be no assurance that the Company will achieve any of these milestones or that such achievements will reflect favorably in the share price and market cap metrics.
NanoViricides, Inc. is a global leader in the application of nanomedicine technologies to the complex issues of treatments for viral diseases. 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.
Our anti-viral therapeutics, that we refer to as “nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
The Company’s most advanced pre-clinical drug candidate is our anti-VZV nanoviricide for the topical treatment of shingles, being developed as a skin cream. In cell culture studies, it was as much as five times more effective than acyclovir, the current standard of care. These anti-VZV drug candidates have also shown strong effectiveness in studies involving VZV infection of human skin patches ex vivo. These studies were conducted by Professor Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized expert on varicella-zoster virus (VZV) infection, pathogenesis, and anti-viral agent discovery. The work was presented at the 31st International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.
The Company is currently performing chemistry, manufacturing and controls (CMC) related tasks that are necessary for producing large-scale drug API (active pharmaceutical ingredient) batches under the US FDA cGMP and ICH guidelines. These activities are being carried out at our campus in Shelton, CT. We have successfully scaled up various synthetic and processing steps up to kilogram scales. We are currently producing kilogram-level materials for the pre-IND enabling safety/toxicology studies of our shingles drug candidate. We also believe that the Phase I human clinical trials would require similar manufactured quantities. Our Shelton, CT facility contains a kg-scale c-GMP-capable manufacturing facility that is capable of producing any of our nanoviricides, whether oral, skin cream or injectables.
We believe that our facility makes NanoViricides unique in development stage pharma companies in that we possess fully integrated drug development capability from design/discovery, synthesis, characterization, scaling up for clinical drug development, and cGMP-capable manufacturing to support initial market entry, when licensed, for any of our nanoviricides drug candidates.
Our drug programs address a market size in the range of $40 Billion to $70 Billion by various estimates. We are thus poised for strong growth with a number of drug candidates in a number of disease indications in our broad and deep pipeline enabled by our platform technology.
About NanoViricides
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 H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, shingles and chickenpox, viral diseases of the eye including EKC and herpes keratitis, 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. (FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medicines Agency.)
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SOURCE NanoViricides, Inc.
Company Codes: AMEX:NNVC
