SHELTON, CONNECTICUT -- January 25, 2016 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a leading nanomedicine company developing anti-viral drugs, reported that its 2015 Annual Shareholders Meeting was held on January 23, 2016, at 10am ET at the Sheraton Hotel in Stamford, CT.
All of the members of our Board of Directors attended the meeting in person. Due to the snow storm, there was limited investors attendance, and several investors let the Company know that they had planned to attend but were unable to do so due to the severe weather. Shareholder votes were received by proxies as is customary, and in-person attendance was not required for voting.
The Business Meeting began at about 10am. Anil Diwan, PhD, Dr. Milton Boniuk and Professor Mukund Kulkarni were all re-elected as Class I Directors, each for a two-year term expiring at the 2017 annual meeting of stockholders and until each of their respective successors are duly elected and qualified or until each of their respective earlier resignation or removal. Also, the appointment of Eisner Amper LLP as the Company's independent registered public accounting firm for the fiscal year ending June 30, 2016, was ratified. There being no further business, the Business Meeting was adjourned.
Thereafter, Dr. Eugene Seymour, CEO, and Anil Diwan, PhD, President, each gave presentations discussing the Company's accomplishments and future goals.
Emphasis was placed on the Company's upcoming transition from an R&D and "pre-clinical proof of concept" stage company to a true clinical-stage pharmaceutical company which could market its drugs on its own, thus maximizing potential value.
"We are now a completely different Company than we were two years ago," said Dr. Diwan, President of the Company, adding, "Our recently completed c-GMP Manufacturing capability enables rapid translation of our drug candidates into the clinic, and should save us millions of dollars in cash and years of time for each drug candidate that we will be moving into human clinical trials."
Dr. Seymour also explained that although the Company has been in existence for over 10 years, it is only in the past two years, with the advent of the uplisting to the NYSE-MKT, the raising of over $43M in that process, and the extensive hiring of skilled scientists, that the Company is now poised to progress towards its goal of drug commercialization.
"Our new facility should enable early revenues estimated to be as high as $50M to $500M when our first drug candidate is marketable," said Dr. Seymour, CEO, adding, "This opens up the possibility that we could build a stand-alone pharmaceutical company, without dependence on big pharma collaborations. We would retain all of the income and maximize shareholder value if we become an independent pharma company."
The Company also detailed that it has chosen to focus on its HerpeCide™ program drug candidates, following successful animal studies that exhibited 85% to 100% survival of lethally infected animals with the severe HSV-1 H129 neurotropic strain.
The Company believes that it will pursue four different drug indications against various herpesvirus diseases that can benefit from topical treatments. These indications include (a) Ocular Herpes Keratitis (primarily HSV-1), (b) Herpes "Cold Sores" (HSV-1) (c) Herpes Genital Lesions (HSV-2), and (d) Shingles (HHV-3, aka VZV or the chickenpox virus, a related herpes virus). This expands the Company's drug pipeline significantly.
Studies for the identification of clinical lead drug candidates against these four indications are now being pursued. Additional collaborations as needed for performing the IND-enabling studies in these indications are being set up with renowned institutions, and will be disclosed as they are finalized, reported the Company.
The Company believes that these topical drug programs would move more rapidly towards the clinical stage than the systemic Injectable FluCide™ for hospitalized patients. IND-enabling work on the latter (i.e. FluCide) will continue in parallel.
The Company estimates that about 200g to 500g batch production scale should be sufficient for the pre-clinical studies, safety/toxicology or "tox package" studies, and also for the initial human clinical trials, of each of the topical herpes drug candidates.
The presentations were followed by discussions with investors. There was discussion that adding high level executives skilled in drug commercialization and large pharma relations would become necessary as the Company progresses into human clinical trials. The annual meeting of shareholders was adjourned around 1:30pm. A Board of Directors meeting followed the annual meeting of shareholders.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.