SHELTON, CONNECTICUT -- Monday, October 22, 2018 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") reports that its new CEO, Dr. Irach Taraporewala, has presented a letter to the shareholders of the Company. The letter provides a Corporate Update along with his assessment of where the Company stands today. Dr. Taraporewala also explains his expertise in taking a novel drug from pre-clinical development through human clinical trials in the letter.
The CEO letter is available on the Company's website at www.nanoviricides.com.
The text of the CEO letter is provided below:
Letter to Shareholders from CEO Irach B. Taraporewala, Ph.D., with Company Updates
It is a real pleasure for me to have come aboard as the new CEO of NanoViricides, Inc. at the beginning of September, 2018. The annual report, and charting the Company's course, became the top priorities since I joined, and I am now happy to be able to present to you where we are.
I was attracted to the novel nanomedicines platform technology that NanoViricides is bringing to fruition. This technology which holds great promise. Not only that, but the Company is currently at a very exciting new phase of its evolution – almost ready to enter the clinical development phase for its first drug candidate, having successfully established efficacy and safety in pre-clinical studies.
Previously I have successfully led a novel drug through FDA regulatory stages, through Phase II clinical trials. Before joining NanoViricides, I conducted substantial due diligence on the Company, and after joining, I have been busy diving into the intricacies of the technology and laboratory data on the drug candidates, especially as it relates to Chemistry, Manufacture, and Controls (CMC) and Safety/Toxicology studies that become part of an Investigational New Drug (IND) Application filing. I am happy to report that we are in a great shape and the Company is moving rapidly towards filing its first Investigational New Drug (IND) application with the FDA.
The FDA looks for indicators of both efficacy and safety in its assessment of drug products. NanoViricides has obtained evidence that the shingles virus (VZV) is cleared effectively when virus-infected human skin is treated with the nanoviricides drug formulations targeting VZV. Importantly, this validation came from the laboratory of Dr. Jennifer Moffat at the SUNY Upstate Medical Center, an international expert. The nanoviricides drug formulations were also shown to be non-toxic in these ex-vivo human skin patch studies, using histological assessments. The drug candidates were also shown to be effective and non-cytotoxic in cell-culture studies. Preliminary animal toxicology studies conducted by the company have shown that its nanomedicine products are safe. All of these studies have paved the way for us to now conduct the Good Laboratory Practice (GLP)-certified IND-enabling safety/toxicology studies required to be filed with the IND application that we will be submitting to the FDA.
I am knowledgeable about current Good Manufacturing Practices (cGMP) required for drug product manufacture. The company has built a state-of-the-art cGMP compatible manufacturing plant at its Shelton, CT headquarters location, capable of scaled-up manufacture of clinical trial materials. The facility is currently gearing up to full cGMP compliance and capability. In examining the facility, reviewing manufacturing procedures, and interviewing the staff, based on my own extensive cGMP manufacturing experience, I am confident that the company has the full capability for manufacturing high quality materials suitable for the IND-enabling safety/toxicology ("Tox Package") studies as well as for early human clinical trials.
Therefore NanoViricides is now set for moving rapidly into the regulatory clinical trials stage of drug development. The Company's broad and deep pipeline will enable us to bring several drugs into the clinical stage, one after another, once the first drug goes forward.
With this steady progress, I believe that the Company has a number of important milestones that it can be expected to achieve relatively rapidly.
We have started reaching out to the investment community with a refined message. The company has recently engaged a media relations firm, The MoneyChannel-NYC to assist with the company's extended investor outreach. In addition, we recently presented at various investor conferences including the Rodman and Renshaw Conference, the LD MicroCap event in New York City and the MicroCap Conference, and we will continue to perform investor outreach and get the word about the company through such events.
I am now a new member of the NanoViricides team (I certainly do view a CEO 's role first and foremost as an active "hands-on" team member as well as company leader). I believe my past experience in running both the business/fundraising and technical/regulatory realms in a small pharmaceutical company setting will prove invaluable.
Having taken drug molecules from the lab bench through the FDA regulatory process and into successful clinical trials has provided me with the means to advance the goals of NanoViricides, Inc. to drive up shareholder value. In my previous role as CEO of a NASDAQ-listed start-up pharmaceutical company, I achieved progressive rounds of corporate financing, each at a higher valuation. I was involved in business development, licensing, and M&A activities as well. That experience, the corporate contacts, and knowledge base I have progressively built up will serve NanoViricides well.
I look forward to getting to meet the shareholders of the Company and keep open lines of communication with all of you. The path of drug development seems long at times. But NanoViricides has built up its highly promising technology and infrastructure properly from the ground up through a staged, pragmatic approach. The elements of success have now all been put in place.
I anticipate your continued support of our Company to help us in achieving success. NanoViricides' technologies hold real promise to benefit humanity with innovative new therapies for viral diseases. That has been the unwavering mission of NanoViricides all along. I am very glad to now be a part of the c\Company's team that strives tirelessly to make that a reality.
Sincerely,
Irach Taraporewala, PhD
Chief Executive Officer.
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.