Interview with: Dr. George Adams, President and CEO - featuring: their diagnosis and treatment of brain-wasting diseases, where aggregated misfolded proteins (AMPs) are prevalent, these include “prions”, the infectious agents of the Transmissible Spongiform Encephalopathies (TSE), such as BSE and variant CJD, as well as degenerative diseases such as Alzheimer’s disease, ALS and Parkinson’s disease.

Amorfix Life Sciences Ltd. (AMF-TSXV)

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Amorfix Life Sciences is doing something effective for brain wasting diseases and as a diagnostic company they will not have to go through the many years of clinical studies before they can start generating revenues

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Healthcare
Biotechnology
(AMF-TSXV)


Amorfix Life Sciences Ltd.

3080 Yonge St., Suite 6020
Toronto, Ontario M4N 3N1 Canada

Phone: 416-482-3813

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Dr. George Adams
President and CEO

Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published - January 18, 2007

BIO:
Dr. George Adams

Chief Executive Officer and Director
Dr. Adams is a scientist and serial entrepreneur providing leadership, senior management and strategic guidance to life sciences companies in roles including CEO or board participation. Dr. Adams was the President and CEO of the Innovations Foundation from 1999 until 2004, where he was involved in creating companies and commercializing technologies. Prior to this, he held research and executive positions with Boston Scientific Inc, Pfizer Inc., Corvita Canada Inc., University of Ottawa and Canadian Red Cross, Blood Transfusion Service. He has also been a founding angel investor in six start-up companies in Canada and the United States.  He has been instrumental in obtaining venture financing for 24 companies who have raised $85 million and has been a Director of 10 venture capital funds and 8 start-up companies. Dr. Adams has 124 publications including 9 invited reviews, 26 full papers and 3 patents. He is a past President of the Canadian Biomaterials Society. He has been a reviewer for numerous scientific journals, national granting agencies and several national and provincial centres of excellence. He has been a principal investigator for over $40 million in private and publicly-funded research and development.

Company Profile:

Amorfix is an emerging biotechnology public company in the field of diagnosis and treatment of brain-wasting diseases, where aggregated misfolded proteins (AMPs) are prevalent. These include “prions”, the infectious agents of the Transmissible Spongiform Encephalopathies (TSE), such as BSE and variant CJD, as well as degenerative diseases such as Alzheimer’s disease, ALS and Parkinson’s disease. Amorfix is focused on discovering and commercializing technologies to become the world leader on AMP diseases. The company will use this knowledge to develop diagnostic kits, treatments and vaccines for AMP diseases.

CEOCFO
: Dr. Adams, first, what was your vision when you started with Amorfix, and where are you today?
Dr. Adams: “We started the company with a technology coming out of the University of Toronto and Sunnybrook Hospital, which showed that we had the potential to detect something in blood from people who had the human form of mad cow disease called vCJD. We had a vision that if there was an impending epidemic of the human form of mad cow disease, like what happened with the cows, then we would need to diagnose it and stop it from being spread through the blood transfusion system. Therefore, we set out to show that approach worked, and we have done that now. At the same time, we realized that there are a number of other diseases where these protein aggregates accumulate in your brain, specifically Alzheimer’s disease, Parkinson’s disease and ALS, commonly known as Lou Gehrig’s disease. We reasoned that if we could detect infectious prion aggregates, we could probably detect all of the other aggregates too, so we built a diagnostics business around detecting early stages of brain wasting diseases. That has turned out to be true, as we have proof of concept in Alzheimer’s and there are several more diseases, which are thought to be aggregated misfolded proteins (AMP) diseases.

It seems like we could go on and on creating more and more diagnostics, but we also have a dream to create new treatments for these diseases as well. We were very fortunate to approach Biogen Idec (NASDAQ: BIIB) with an idea of a therapeutic approach and they loved it. We have since established an alliance with Biogen Idec, which is the 3rd largest biotech company in the world, to develop a therapy for ALS (Amyotrophic Lateral Sclerosis). Therefore, we started as a diagnostic company, and we are now moving towards therapeutic approaches as well.”

CEOCFO: Please explain the problem and tell us why you have succeeded in working with these aggregated misfolded proteins.
Dr. Adams: “The limitation was in trying to find a small number of these aggregates in the blood, which has a high abundance of normal, healthy, properly-folded proteins. Therefore, it is a needle in a haystack problem. Everyone who tried to detect these aggregates bumped into this huge background, and none of the conventional approaches worked. Some people worked on these for 5 to 7 years. Even our CSO, Dr. Neil Cashman, who consulted for many diagnostic companies, and built specific antibodies for these aggregates, found that when you looked at the blood, you still could not get past the background. Therefore, he went back to his lab and decided to do something completely different. He then came up with epitope protection (EP) technologies, which are a way to get rid of all of the background, so that all that is left are the aggregates. We chemically treat the blood sample in such a way that all of the normal proteins are modified, and so that the antibodies you would use in a conventional immunoassay no longer see the normal proteins. However, because the aggregates are clumped, the chemical does not get into the core. The molecules in the middle do not get modified, so we can then find them. Instead of searching through all of the hay in the haystack, we burn down the haystack down and then use a magnet to find the needle without a problem. This has turned out to work exceedingly well. It is a brand new approach, so we get some very nice patent applications.

There are 3 people who have now come down with vCJD as a result of blood transfusions. We are right back to where we were in the 1980’s with the development of HIV/AIDS, where we know that we are transmitting this disease in the blood system and have no test for it. We are pushing hard to get the test out next year, so that we can start testing. Unfortunately, for people with vCJD, it is a worst-case scenario, because you can actually be a carrier for 20 years and be infectious and giving blood, before you come down with symptoms. Further, unlike HIV/AIDS, you cannot really put a question on a questionnaire for a blood donor to screen for people at risk. In Western Europe, where most of these BSE (Bovine Spongiform Encephalopathy) cows arose and virtually everyone has consumed some type of BSE tainted beef over the last 10 years, they have seen more and more people coming down with the disease. Therefore, we know that we have people walking around with it.  In the U.K. alone, it is estimated about 20,000 to 25,000 people have the disease, and will present symptoms in the next 10 years. Hence, we are very keen to get our tests out and make the blood transfusion systems safe again.”

CEOCFO: Are you looking at more alliances and partnerships?
Dr. Adams: “We are quite happy to roll out the blood tests for vCJD ourselves, because there is really only one customer per country and we can easily supply the needs and run that business, even from a Canadian location. We are pushing ahead with a test for Alzheimer’s disease using the same approach, and we are trying to get the assay to a point where it is a commercially-viable platform. We would probably look to partner the AD test, because it is not one customer per country, that is, everybody over the age of 60 should be screened for Alzheimer’s disease every couple of years. This is about trying to get the test into every clinical laboratory in the world; it is not something that a small company like us could do effectively. We will look for a partner once we have validated the test, and shown that we can detect Alzheimer’s at a higher rate than the current interview test, which is at best 70 to 80% accurate. Therefore, if someone asks you if you can remember where you had lunch yesterday and you can’t, they may say that you have Alzheimer’s, but 25% of the time you don’t; you just can’t remember what you had for lunch yesterday. The first application for the Alzheimer’s test would be to screen people into therapeutic clinical trials. There are now 250 treatments under development by 100’s of companies around the world for Alzheimer’s disease, and they all have the same problem when they go to run a clinical trial. When they go to screen people for the trial, they end up with 25% of the people in the trial who do not actually have Alzheimer’s, this creates a huge background, and makes it more difficult to show that a treatment works. The sooner we get better treatments for Alzheimer’s, the more it would drive the need to screen people.”

CEOCFO: Development is costly; what is the financial picture like today?
Dr. Adams: “We are in very good shape; we’ve raised about $9 million in the first year of being a public company and we still have over $6 million in the bank, with a burn rate of about $250 thousand per month. We will launch our diagnostic product for CJD in the next year. Therefore, we have all the money we need to launch our first product.”

CEOCFO: There are many biotech companies out there; why should investors be looking at Amorfix Life Sciences?
Dr. Adams: “When I talk to my shareholders, they like the idea that we are going to do something effective for brain wasting diseases and that we will be a revenue generating company sooner rather than later. This is unlike traditional biotech companies that take 5 to 10 years to get to revenue because they have to go through Phase I, II and III clinical trials to confirm that their therapies will work. Fundamentally, we have a diagnostic company, which will generate significant revenues because there are 100 million donations of blood every year that are taken, separated and transfused into people, and they should all be checked for CJD. This creates a significant market opportunity for us. We will then take that cash flow, develop other diagnostics, and get into the therapeutics business. Therefore, we have a sustainable business model with an early revenue generating opportunity. We do have competition as others have been trying to develop a test for CJD and Alzheimer’s disease, but as far as we can see, we are at the front of the pack.”

CEOCFO: Could you touch on your strong background in biotech?
Dr. Adams: “This is my 5th time around creating a company, deriving value, and selling it or taking it public. I am an engineer with a doctorate in medical sciences and I have spent several years working for the blood transfusion service here in Canada. I understand how that system works. I started a company that turned into WorldHeart Corporation (Nasdaq: WHRT, TSX: WHT), which is a publicly traded company that makes artificial hearts. I also did a diagnostic project with a company called Hemostat, which ended up being part of DuPont (NYSE: DD), when it had a diagnostic business. DuPont sold the diagnostic business to Dade Behring Inc. (NASDAQ: DADE), which was ultimately sold to Hoffmann-La Roche Inc. (Roche). I also developed a drug eluding stent for coronary applications as a part of a company called Corvita Corporation. Corvita went public on NASDAQ in 1994 and Pfizer Inc. (NYSE: PFE) bought us out in 1996 when they had a hospital products division, and we were then rolled into their Schneider Division, which was eventually sold to Boston Scientific (NYSE: BSX) in 1998. Therefore, the Boston Scientific stent actually has the Corvita polymer as the drug delivery platform on the stent for Boston Scientific’s Taxus™ stent, and that technology has been implanted a million times, saving many lives. It has been a career of creating life saving technologies and I fully expect that as Amorfix we will save lives by making the blood system safe and we will also come up with therapies for these brain-wasting diseases, for which right now there are no effective therapies.”

CEOCFO: Please tell us about Amorfix Life Science being named a “Technology Pioneer” by the World Economic Forum in Davos, Switzerland in January 2007.
Dr. Adams: “The “Technology Pioneer” award is awarded annually by the Word Economic Forum to companies which have a sustainable, world changing, proven technology and in our case that refers to our Epitope Protection (EP) diagnostic technology. There are only 47 companies that received it this year and we are the only Canadian company to receive the award. For that I get an invitation to Davos, Switzerland and get to interact with world thought leaders and discuss some of these global-impacting issues that we work on such as Alzheimer’s, ALS and Parkinson’s, which are global diseases. As we get older, these diseases become more and more prevalent. We also have a full page article in Time Magazine worldwide; Time Asia, Time Europe, Time Canada, so that has given us great exposure in telling our story and reaching out to people to tell them that help is on the way.”

CEOCFO: In closing, what should people take away from this interview and remember about Amorfix?
Dr. Adams: “I would hope that people would remember that Amorfix Life Sciences is working on global diseases with a unique approach. I also hope that they would want to follow our story and watch us continue to execute on our plan.”


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“When I talk to my shareholders, they like the idea that we are going to do something effective for brain wasting diseases and that we will be a revenue generating company sooner rather than later. This is unlike traditional biotech companies that take 5 to 10 years to get to revenue because they have to go through Phase I, II and III clinical trials to confirm that their therapies will work. Fundamentally, we have a diagnostic company, which will generate significant revenues because there are 100 million donations of blood every year that are taken, separated and transfused into people, and they should all be checked for CJD. This creates a significant market opportunity for us. We will then take that cash flow, develop other diagnostics, and get into the therapeutics business. Therefore, we have a sustainable business model with an early revenue generating opportunity. We do have competition as others have been trying to develop a test for CJD and Alzheimer’s disease, but as far as we can see, we are at the front of the pack.” - Dr. George Adams

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