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Ishan Majumdar
Ishan Majumdar
Articles (158)  | Author's Website |

NanoViricides: Ready for the IND Application for a Novel Covid-19 Drug

The biopharma player has completed the Chemistry, Manufacture and Controls studies and seems ready for its Investigational New Drug application

September 03, 2020 | About:

NanoViricides Inc. (NNVC) has consistently been in the news over the past few months owing to its efforts to develop a novel drug to counter the novel coronavirus, SARS-CoV-2. The company is a promising researcher in the antiviral space and has drug candidates in the pipeline for many other viral diseases such as shingles, herpes, HIV and cold sores. While its process has been slower than most pharma giants, the company's unique platform technology has been highly effective in the testing process done to date, and it may soon be able to develop its first approved antiviral treatment.

A note on NanoViricides technology

The company is named after its proprietary platform technology called nanoviricides®, which has certain unique characteristics. A nanoviricide is defined as a biomimetic – a substance that is designed to appear like the cell surface to the virus and attracting it towards the same. Its mechanism of destroying a virus is similar to the functioning of a Venus flytrap and its technology looks to attack the incoming virus particles at multiple points. In theory, this is a far more effective approach than antibodies that can attack viruses at a maximum of two attach points.

The company is still in the development phase and has yet to produce a treatment for sale. All of the company's drug candidates, such as the Covid-19 drug and even its topical cream to fight shingles. are based on its proprietary technology.

With respect to the Covid-19 drug, the reason for its process of gaining approval being relatively slower than the other popular drugs in the market is the fact that the company's drug candidate is a novel type of drug. Most popular drugs available in the market to counter Covid-19, such as favipiravir or even Gilead's (NASDAQ:GILD) remdesivir for that matter, are repurposed drugs, i.e. existing drugs that have been identified to have a new therapeutic application.

Despite the slow process, the company has managed to complete the CMC ("Chemistry, Manufacture and Control") studies which are the key requirement for the IND (Investigational New Drug) application with the U.S. FDA in order to enter Phase 1 clinical trials.

Covid-19 drug progress

NanoViricides developed a broad spectrum of drug candidates to counter SARS-CoV-2 and carried out initial tests using cell culture assays as well as through an animal model. In fact, the company measured the effectiveness of its candidates against favipiravir in its tests using cell culture assays and against remdesivir in its animal model. The testing process yielded highly satisfactory results for multiple drug candidates and the company moved on to carry out the safety and toxicology studies required for the IND application, prior to the CMC studies.

Given the fact that its drug candidates are novel drugs, these tests were a requirement, but so far, multiple drug candidates of the company have given satisfactory results. Now, NanoViricides has to zero in on a candidate for which it can proceed with the IND application and push into Phase 1 of clinical trials.

It is worth noting that all of the company's drug candidates have given phenomenal results in its BSL2 virology lab against coronavirus strains that cause a milder version of SARS-CoV-2. It remains to be seen how their lead candidate will perform against the actual SARS-CoV-2 strain in a BSL3 or BSL4 lab. Assuming that NanoViricides is able to have a successful Phase 1/2, the company could possibly start earning some licensing revenues as well, which would be a big relief for the investors. The company had reported a loss of $8.08 million, or $1.24 per share, in the most recent result.

Final thoughts

As we can see in the chart above, NanoViricides has witnessed a spike in the stock price of over 42% in the previous trading session after a gradual fall over the past three months. This spike is largely a function of the fact that the company's CEO, Dr. Anil Diwan, will be presenting the findings of the CMC studies in the LD 500 investor conference, and investor expectations are high.

It is worth highlighting that the NanoViricides management is not relying on the FDA alone for progressing with its Covid-19 drug candidate. The company is in talks with contract research organizations (CROs) and Government authorities of other countries and evaluating their requirements so that it can enter its candidates for a speedy clinical trial.

The other key candidate in the pipeline which is also on the verge of the IND application is the NV-HHV-101, NanoViricides' topical cream for shingles. The progress of this drug candidate was put on hold due to perceived difficulties in conducting the shingles clinical trials during the Covid-19 pandemic. However, this is immediately next in line after the IND filing of the Covid-19 drug candidate.

To sum up, I believe that if the company continues to deliver promising results for its drug candidates in the various tests, the stock could certainly build well on its existing momentum.

Disclosure: No positions.

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About the author:

Ishan Majumdar
I am a qualified Chartered Accountant with a Masters in Management (Grande Ecole) from HEC Paris. I run a proprietary boutique financial advisory firm called Baptista Research (www.baptistaresearch.com) specializing in M&A, corporate advisory, equity research and valuation of listed companies.

I have nearly a decade of experience spread across investment banks, financial advisory firms, investment funds and other corporates in many different geographies, such as France, Spain, India and others. I was a part of the LBO Financing team at BNP Paribas where I worked on deals with a combined enterprise value of over $1 billion. I have also worked in mergers and acquisitions with Credit Agricole CIB and corporate strategy with Groupe Danone SA. Over the years, I have developed a strong specialization in corporate valuations, strategy and financial analysis.

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