SHELTON, CONNECTICUT -- Friday, September, 29, 2017 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), reports that it has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) on Thursday, September 28, 2017 in a timely manner. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000114420417050412/v474679_10k.htm)
NanoViricides, Inc. is a global leader in the application of nanomedicine technologies to the complex issues of 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 call "nanoviricides®" are designed to 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. The Company presented these studies in a poster entitled "Novel Nanoviricides® Highly Effective Against Varicella Zoster Virus in Cell Culture" at the 36th Annual Meeting of the American Society of Virology (ASV) on June 26th, 2017. The ASV Meeting was hosted and held at the University of Wisconsin- Madison, from June 24th to 28th, 2017 (https://extensionconferencecenters.uwex.edu/asv2017/).
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 Moffat at the SUNY Upstate Medical Center. The Company is now conducting additional studies for declaration of a clinical candidate for the treatment of shingles.
The Company is also performing chemistry, manufacturing and controls (CMC) related studies that are necessary for producing large scale drug API (active pharmaceutical ingredient) batches under the US FDA cGMP and ICH guidelines. These studies are being performed at our campus in Shelton, CT. We have successfully scaled up several synthetic and processing steps to 200g~500g scales, and some steps to even kg-scale. We believe that ~500g batch would be sufficient for the safety/toxicology studies of our shingles drug candidate. We also believe that the Phase I human clinical trials would require similar quantities. We are therefore focused on producing the shingles drug candidates at ~500g batch scale at present.
The Company reported that, as of June 30, 2017, we had cash and cash equivalent balance of $15,099,461 that is expected to be sufficient to fund our currently budgeted operations for more than one year. Property, plant and equipment stood at $13,776,561 (net of accumulated depreciation of $2,505,501). Long term Liabilities were approximately $2M, as the derivative value of outstanding warrants. Current liabilities stood at $4,665,518, which include the debenture C held by one of our directors, Professor Milton Boniuk, MD. Shareholder equity stood at $20,321,942.
In comparison, as of June 30, 2016, we had cash in hand of approximately $24.38M; Property, plant and equipment stood at approximately $11.76M (net of accumulated depreciation of approximately $1.85M); while Long term Liabilities were approximately $6.94M and the Shareholder Equity stood at about $23.05M.
During the reporting period we spent $7,897,746 in cash toward operating activities. In contrast, we spent ~$7.3M in cash toward operating activities in the previous year.
On February 8, 2017 two Holders of the Company's Series B Debentures elected to convert $5,000,000 of the principal into restricted common stock of the Company. One of the holders is an entity controlled by Dr. Milton Boniuk, the Company's Director, and another holder is a charitable foundation established by him. A third holder elected to redeem the principal balance of $1M in cash. With this transaction the Company effectively raised cash financing of $5M in exchange for restricted stock.
We do not anticipate any major capital costs going forward in the near future. Based on the current rate of expenditures (excluding capital costs), we believe that we have sufficient funds in hand to last more than one year. In addition, in order to conserve cash expenditures, we also pay compensation in stock and stock instruments to various parties.
Thus, the Company has ended the year on a strong financial footing. We project, based on various estimates that we have obtained, that our current available financing is sufficient for accomplishing the goal of filing at least one IND or equivalent regulatory application for at least one of our drug candidates. We believe that we will need to raise additional financing for conducting the clinical trials to get our first drug licensed by the US FDA or another regulatory authority so that we can enter commercial revenue-producing stage of our business plan. We believe that clinical trials for our lead candidate (shingles treatment) would be relatively less expensive being a topical treatment, as opposed to our injectable drugs in development.
The Company re-prioritizes its programs based on its available funding and input from experts with a view towards near term opportunities for revenue generation. The Company believes that the topical treatments in the HerpeCide program would be both faster and easier for pre-IND package development, and thus for entering into human clinical drug development phase.
This year, the Company has focused on advancing its pre-clinical drug candidates in the HerpeCide™ program into clinical trials in the most expeditious manner. The Company believes it will continue to expand the number of indications in this program as opportunities arise, to take advantage of the synergies arising due to its broad-spectrum anti-herpes drug development candidates. Currently, we are targeting four different indications, namely, (1) skin cream for the treatment of shingles, (2) skin cream for the treatment of HSV-1 "cold sores", (3) skin cream for the treatment of HSV-2 genital ulcers, and (4) eye drops for the treatment of herpes keratitis (HK), an ocular infection. Expansion to additional indications such as viral acute retinal necrosis (vARN) are likely. vARN is caused primarily by HSV-2 and VZV, and may be neonatally acquired. It leads to extreme decrease in visual acuity and may lead to blindness. Treatment of vARN is an unmet medical need, although some clinical approaches exist.
In addition, the Company continues to work on its preclinical candidates in the FluCide™ broad-spectrum anti-influenza program, namely (5) Injectable FluCide™ for hospitalized patients with severe influenza, and (6) Oral FluCide for our-patients with influenza. The Company has several other drug candidates in its pipeline, such as anti-HIV nanoviricide (HIVCIde™), broad-spectrum anti-dengue nanoviricide (DengueCide™). All of these programs are at a low priority, based on their drug development costs, length of drug development programs, and the Company's available resources.All of these drug candidates have previously shown strong effectiveness as well as very high safety in preclinical studies which include cell culture based studies as well as animal studies. The Company's platform technology enables rapid drug development against many other viruses as well. Further, we believe NanoViricides may be the first company to have shown very high bioavailability of its nanomedicines when given orally.
Our new 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 new facility makes NanoViricides unique in development stage pharma companies in that we now possess fully integrated drug development capability from design/discovery, synthesis, characterization, scaling up for clinical drug development, and c-GMP-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 addition to attacking the virus itself, 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. We believe that we will continue to develop substantially improved drugs against the viruses we target by utilizing these additional features of the technology after we have advanced our current drugs into licensure.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.