May 28th- NNVC Fundamental Update-Visited May 27th
Posted by Dave Banister on May 28th, 2010 at 11:34 AM
NNVC- This is a speculative biotech-nanomedicine company with a laboratory and offices near Yale University in West Haven, CT. I visited in person on May 27th taking a 2 hour drive there from my office in Rhode Island. I spent about 2 hours with the team and below is my summary:
Present were Dr. Anil Diwan, CEO and Co-Founder of NNVC. Dr. Randall Barton, Chief Scientific Officer, and Dr. Jay Tatake, Head of Chemistry.
This group of men has an astoundingly strong background both academically and professionally. Jay and Randy both have extensive experience working for and with Big Pharma. Dr. Diwan is a brilliant scientist who has extensive research and development work to his credit going back to 1991. From 1991-1999 he was working under a research grant at a large science park near Yale University. He worked on top secret development of Drug agents for major pharmaceuticals. He has also studied and taught at Rice University, as well as completed studies and research of particle mapping and blood clotting research at The University of Wisconsin-Madison. This is where he was the first ever to use nanomicelles.
The fledgling young company was founded in 2005 officially as Dr. Diwan was introduced to Dr. Eugene Seymour in 2003 and one thing led to another. As Dr. Seymour finished up contract work for a larger pharmaceutical firm that was being sold to Teva, he was then free to join with Dr. Diwan to begin this venture. The decision was made to list the company publicly so as to best raise funds rather than staying private. To wit, they are currently working on paperwork and filing requirements for an up-listing to the AMEX exchange, which would certainly help with credibility and potentially additional larger shareholders and with raising future funds.
Per Dr. Barton, the company has had good success at “in vivo and in vitro” analysis and results, and they now need to focus on one main area to take to the FDA level for pre-IND initiation discussions. The newer Nano technology is a learning curve for the FDA, so it will take some time to educate the FDA, get feedback, get buy-in from them, and then proceed forward with further pre-clinical work and later trials. The easiest path to accomplish this will be using the path of least resistance. This may be Dengue Fever, or perhaps Herpes.
NNVC is testing 8 different areas for Viral Therapeutics, with the highlights currently being Dengue Fever, Ebola, HIV, Herpes, and Rabies. I toured the new laboratory facilities which are really clean and filled with brand new high end equipment. The company currently has 10 employees total and is looking to staff up to help with the juggling of 8 balls at various stages of scientific work. There were many brand new pieces of equipment still in boxes and being unwrapped and set up in various rooms. They have also taken additional space for more expansion and future production as they get into phase 1 trials down the road and hire more staff.
Data is currently coming in on Dengue Fever work, and is being cross checked and verified before results are released. This is the second set of studies, following the in vitro (petrie dish) type work, the In Vivo (Animal) studies are the ones I assume are being put together now (Mice). HIV “in vitro” results have come in and are also being cross checked and likely soon released. Ebola study findings will be shared in July at a major biological societal meeting using NNVC’s nanotechnology. Results can take awhile to process and then release due to negative control procedures, double blind studies on each end, and the layers of Project managers, lab staff, institutions, and attorney’s that must all sign off together before data can be released.
If the company was to layout the areas of the most interest and excitement for them in the next few years it would be roughly as follows:
1. HIV is the most exciting, but also has something like 20 different strains and can reside in the Human Body for a lengthy period of time. This makes trials very long and expensive; however the early results appear to be quite encouraging.
2. EKC- Herpes- NNVC is trying to work on how to best block the sleeping cells and have made strong progress.
3. Dengue Fever- There is no known therapeutic for it now, and Dr. Diwan estimates it at a 2 billion current market. A recent flare-up in Florida only highlights the problem. Unlike HIV where there are products and multiple trials ongoing, NNVC arguably is the first company to attack Dengue Fever in the laboratory and with studies. This is an area of potential first mover advantage for NNVC.
4. Rabies- Rabies is extremely difficult to attack. The NNVC team calls it “Nobel prize winning” type of work, which could take many years of study and still never be solved. However, it is an area of focus.
5. Influenza- The theory here is they could attack the strains each season and come up with solutions within a very short period of time.
Some other notes are that there are no currently issued patents, but they are pending. Also, the company takes the highest levels of care and safety in guarding their secret methodologies and formula’s as it were. The exciting part about the Nanomicelle being developed as the therapeutic agent or virus killer is the toxicity is not present. It would release through the body’s normal excretion paths much like absorbing and digesting food.
There is a long road ahead for NNVC and they have 4 trials ongoing now at various labs/institutions. We hope to see some HIV and Dengue results, along with Ebola in the next 60 days time window, and perhaps an AMEX listing. These could all be catalysts to move the shares higher.
The stock is speculative and should not be over weighted as I’ve mentioned before. I will continue to follow the story closely and monitor the technical action. I came away impressed with the buttoned down scientific attitude of the team. They were all very down to earth and enjoy the work they are doing, and also realize it is a long road. Dr. Diwan is extremely proud of his work and very excited by the potential for Nano Therapeutics using the Nanomicelle being developed as agents. In summary, I wanted to get a feel for the people and the scientific backgrounds, and the processes in place. Like many biotech firms, this is a heavy research and development stage based company and they will succeed or fail based on results from studies, financings, and sponsors/supporters. So far at an early stage, NNVC seems to be on a strong path.
David A. Banister
Chief Investment Strategist
www.ActiveTradingPartners.com
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