NanoViricides (NNVC) Files Form 10-K; Offers Update on Operations, Cash Position
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NanoViricides, Inc. (NYSE: NNVC) has filed its financial year end annual report (Form 10-K) with the Securities and Exchange Commission (SEC) on Friday, September 16, 2016 in a timely manner. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000114420416124276/v447590_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. 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.
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.
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 be pursuing four different indications in this program, 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. 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 also continues work on its (7) DengueCide™ broad-spectrum anti- dengue virus therapeutic, and (8) HIVCide™ broad-spectrum anti-HIV therapeutic.
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 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.
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, we have moved our operations to the new campus in Shelton, CT. This new 18,000+ soft facility in Shelton, CT houses a production scale-up laboratory, a large chemistry synthesis lab, and more than 180 linear feet of advanced, state of the art analytical instrumentation lab for nanomedicines characterization. The facility also has a virology laboratory for cell culture based characterization of anti-viral effects of our drug candidates.
Our new facility also contains a kg-scale c-GMP-capable manufacturing facility that is capable of producing any of our nanoviricides, whether oral, skin cream or injectables.
This year our new virology laboratory has received Biological Safety Level 2 certification from the State of Connecticut. Our in-vitro virology lab became fully operational circa March, 2016. This enables preliminary screening of a much larger number of drug candidates in-house, enabling more rapid identification and optimization of viable drug candidates than what has been feasible with our contract relationships in the past. The Company does not have any animal studies facilities, and depends upon external contracts and collaborations for the same.
This year, we have engaged several additional collaborators to help us advance our HerpeCide and FluCide programs towards IND filings. These include the CORL at the University of Wisconsin, Madison, WI, the Campbell Lab at the University of Pittsburgh, Pittsburgh, PA, and the St. Jude Children's Research Hospital, Memphis, TN, among others.
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.
The Company reported that, as of June 30, 2016, we had $24,162,185 in hand, and additional assets of $219,458 in the form of prepaid expenses, other assets and security deposits. Property, plant and equipment stood at $11,760,767 (net of accumulated depreciation of $1,850,816) and with additional equipment purchases. Long term Liabilities were at $6,841,190 and the Shareholder Equity stood at $23,048,214 as of June 30, 2016. In comparison, as of June 30, 2015, we had cash in hand of approximately $31,467,748 and additional assets of approximately $214,425. As of June 30, 2015, Property, plant and equipment stood at $11,962,648 (net of accumulated depreciation of $1,534,203) and with additional equipment purchases, while Long term Liabilities were at $11,800,327 and the Shareholder Equity stood at $31,785,867.
During the reporting period we spent $7,300,530 in cash toward operating activities and approximately $476,368 in capital investment. In contrast, we spent $6,212,332 in cash toward operating activities and approximately $5,760,109 in capital investment during the previous year. 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 two years. 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 have not engaged in any additional raises after the old warrant conversion that closed in September 2014. We believe that we will not need to raise additional capital in the very near future. We project, based on various estimates that we have obtained, that our current available financing is sufficient for accomplishing the goal of filing one or possibly two IND or equivalent regulatory applications, and initial human clinical trials in at least one of our drug programs.
"We have made substantial progress in this financial year, with our new state of the art, c-GMP manufacturing capable campus, and further progress in our HerpeCide program which is now at advanced pre-clinical stage," said Eugene Seymour, MD, MPH, adding, "The topical HerpeCide program is developing in parallel with our injectable FluCide. The HerpeCide program is currently moving faster towards clinical trials, because of the inherent advantages in the nature of topical drug development."
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