WEST HAVEN, CONNECTICUT -- Monday, January 27th, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) reported today that construction of the modern R&D Lab and cGMP Clinical Production facility in Shelton, CT, is nearing completion on schedule. The Company reports that the R&D lab section of the facility is nearing completion, slightly ahead of schedule. In addition, construction of the cGMP Clean Room Production Suite is expected to be completed in March, 2014, on schedule, and shortly thereafter, the project will enter facility testing and validation phase. The Company and the project staff, including Mr. Phil Mader and Mr. Andrew Hahn have been working diligently to keep this complex project on time.
"Our urgency to bring this facility online has increased with the new wave of H7N9 Influenza A infections in China this year," said Eugene Seymour, MD, MPH, explaining, "It is now thought that H7N9 bird flu has at least sporadically transmitted from humans to humans. This is the first step before the H7N9 virus gains ability to cause an epidemic, which could become a pandemic if a drug-resistant mutant strain of the virus takes over. Drug resistant H7N9 has already been found in China."
"We believe that the broad-spectrum FluCide™ should be an excellent treatment for H7N9," added Anil R. Diwan, PhD, President and Chairman of the Company, explaining, "This FluCide drug candidate was designed to mimic both the bird and human variants of the sialic acid receptors on cells to which the influenza virus binds. FluCide has shown extremely strong activity in animal studies against both Group I and Group II Influenza A viruses. Thus we fully expect it to work against H7N9."
In late March 2013, investigators confirmed that 3 patient deaths in China were due to a novel avian-origin influenza virus, H7N9. Approximately 32% case fatality rate is reported from H7N9 by the European Center for Disease Prevention and Control (ECDC; http://ecdc.europa.eu/en/press/news/_layouts/forms/News_DispForm.aspx?List=8db7286c%2Dfe2d%2D476c%2D9133%2D18ff4cb1b568&ID=930&Web=86661a14%2Dfb61%2D43e0%2D9663%2D0d514841605d).
The Company reports that its project for enabling clinical scale drug product cGMP capability at the Shelton facility is now nearing completion of construction. After construction is complete, the facility, and particularly the cGMP Clean Room Suites will undergo facility testing and validation to ascertain that the facility satisfies the requirements. After validation, the Company plans to occupy the new facility while keeping the current facility active to minimize impact on the multiple nanoviricides® drug development projects. The Company intends to first start production of FluCide in the cGMP section, set up appropriate cGMP operation for this production, produce multiple batches of FluCide under cGMP conditions, and demonstrate equivalence of the batches produced, in preparation for human clinical trials.
Certain countries including Australia allow early human clinical trials to be conducted using cGMP-compliant material. The Company intends to begin human clinical trials at the earliest after completing the Tox Package studies, and is evaluating all available options.
Safety and toxicology studies of our injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from our preliminary safety study, as well as our in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies ("Tox Package") studies of our injectable FluCide drug when the requisite large amount of drug substance is produced at our current facility.
In another news, the Company reports that its recently announced registered direct offering ("Offering") has been completed successfully on Friday, January 24th, 2014. The Company sold 3,815,285 units and raised gross proceeds of $20,030,246.25 before estimated expenses of approximately $1,200,000, which includes placement agent fees but does not include and attorneys' fees and other expenses. The price per Unit was $5.25, equal to a four percent (4%) discount to the 20-day VWAP of the NNVC stock price on Friday, January 17, 2014. The exercise price of the Warrant was equal to the closing price of NNVC stock on Friday, January 17, 2014. Each Unit consisted of one share of the Company's common stock, par value $0.001 per share, and 0.65 of a warrant to purchase one share of common stock, issuable upon exercise of the Warrant at the exercise price of $6.05 per share. The Warrants are exercisable immediately and expire five years after issuance. The Offering was made pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-184626), which was declared effective by the Securities and Exchange Commission on December 21, 2012 and Form S-3MEF (File No. 333-193439). The Company, pursuant to Rule 424(b) under the Securities Act of 1933, has filed with the Securities and Exchange Commission a prospectus supplement relating to the Offering.
The Company intends to use the proceeds for general business purposes and expects that it will be able to accelerate the development of its drug candidate pipeline with this additional funding. With this raise, the Company now has approximately $40 Million cash in hand (including non-current cash-based assets), which the Company believes is sufficient for its planned activities for the next three years and beyond. With these funds, in addition to certain clinical trials for FluCide and DengueCide, the Company anticipates that it will also be able to expedite development of its four other drug candidates, namely, Oral FluCide, HerpeCide™, HIVCide™, and EKCCide™ into the FDA approval process.
The injectable and oral FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. This indicates that our FluCide drug candidates are "broad-spectrum", i.e., they should work against most, if not all, influenza viruses. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The oral FluCide is also dramatically more effective than TamiFlu in these animal studies. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth. The Company believes that these animal model results of both injectable and oral FluCide drug candidates should translate readily into humans.
The Company has recently signed confidentiality agreements with both Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI). Both of these institutions have the ability to perform further testing of our FluCide drug candidates against additional influenza viruses including H7N9. The Company intends to perform our remaining IND-enabling studies of FluCide at these institutions.
In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models. The US FDA as well as the European Medical Agency (EMA) has recently designated DengueCide®, our drug for dengue and dengue hemorrhagic fever as an "orphan drug" in their respective territories.
The Company has previously reported that it has engaged Inno-Haven, LLC, to renovate the Shelton facility as per NanoViricides' requirements for expanded R&D facility and a cGMP pilot scale (kg scale) production facility including clean room suites suitable for injectables active pharmaceutical ingredient (API) manufacture. Inno-Haven, LLC, a private company, is controlled by Anil R Diwan, PhD, who is also the President of NanoViricides, Inc. Dr. Diwan sold certain amount of his NNVC stock to finance purchase of the building that was completed in August, 2011. Further, Inno-Haven has raised substantial amounts of additional capital for this project independently. NanoViricides has signed a Memorandum of Understanding with Inno-Haven to lease the facility. No lease has been signed at present.
NanoViricides, Inc. has assembled a marquee team of experienced personnel to help us with the design, architecture, and engineering of this facility. Mr. Andrew Hahn continues to provide overall stewardship for this project. He was formerly Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his firm, MPH Engineering, LLC ("MPH"), continue to help with the overall project management and design engineering of the laboratory and cGMP pilot production facility. Prior to founding MPH, from 2000 to 2007, Phil Mader served as the Senior Capital Project Manager at Bristol-Myers Squibb Company in Wallingford, CT ("BMS"). He was involved in the design, implementation, and commissioning of various biology and chemistry laboratory projects within budget and in a timely manner. Ms. Kathyann Cowles of ID3A, LLC, serves as the Principal Architect. Ms. Cowles, co-founder of Id3A, has over thirty years of experience as a licensed Architect and Senior Project Manager for diverse and complex design and construction projects in the academic, science, technology, corporate and research sectors.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.