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Oragenics, Inc. (ONI) |
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CEOCFO
Interview Index |
This is a printer friendly page! Oragenics is working on products that
could eliminate tooth decay and promote better overall oral health BIO: Mutacin 1140 CEOCFOinterviews: Mr. Soponis, how has Oragenics changed under your leadership? Mr. Soponis: “I was the first employee and we have fifteen employees now, so that is one change. We had no capital and we now have just under two years worth of operating capital. With the infusion of this capital, we have made significant progress in moving the technology forward.” CEOCFOinterviews: How have you done that and how have you driven the organization to where it is today? Mr. Soponis: “The most important thing was getting capital and we were able to raise about 360 thousand dollars from a pharmaceutical company, in order to allow us to do some of the animal studies that we needed to do for the FDA –IND (Investigational New Drug) submission. We were then able to get a private placement for a half-million dollars among individuals. Since venture capital was very difficult in Florida for the past several years, for a start-up biotech company, I decided to take the company public in Canada and was able to complete an IPO and attach warrants to it that allowed us to obtain eight million dollars from the IPO.” CEOCFOinterviews: Where are you with your products at this point? Mr. Soponis: “We
are looking at one of the most exciting products that I have seen in recent memory. We
have three products; the first product is a replacement therapy that has been developed
over the past 25 years. There has been 16 million dollars in grant funding that supported
this along the way, so there has been a significant investment in the development of it.
It is a product that we call replacement therapy and it is going to revolutionize dental
care; it has the potential to eliminate most cavities and that is very remarkable. CEOCFOinterviews: Hasn’t fluoride reduced much of the cavity problem? Mr. Soponis: “Fluoride has reduced cavities probably by about 50%. The reason that number comes up all the time in the industry is that Japan doesn’t allow fluoride in the water at all and their rate of cavities is about twice that of what it is in the United States. What fluoride does is remineralizes the etching that is done by the acids but it can’t keep up with the sugar diet that people have, particularly with people up to twenty years old.. Fluoride is sixty years old and there is still a 40 billion dollar dental expense annually in this country in dealing with tooth decay and repairing things that happen because of tooth decay. Worldwide it is a significant problem; the World Health Organization just came out with a report saying that five billion people in the world experience tooth decay, so fluoride hasn’t eliminated tooth decay, but only reduced it.” CEOCFOinterviews: You mentioned that one treatment is all that is necessary; is that at any age? Mr. Soponis: “The treatment would be at any age. Our first studies will be in adults to establish safety. The ideal would be when the child first gets teeth; they don’t have any bacteria in their mouth because these bacteria grow only on the hard surfaces of the tooth, so until you have teeth, the bacteria doesn’t survive. It works at any age.” CEOCFOinterviews: You are talking about clinical studies, will you tell us about the timeline? Mr. Soponis: “We have an IND filed with the FDA that is on clinical hold and subject to approval from the FDA;, we expect tobegin our Phase I clinical study this year. There are two requirements that one has to have in order to move forward in these studies with the genetically modified organism; one of them is the FDA, the other one is the National Institute of Health; DNA Recombinant Advisory Committee and by law you are required to appear before them in a public hearing to explain the science and the protocol and determine if it is safe to put into humans. We received the unanimous recommendation from the advisory committee to move forward in clinical trials. So we are now looking to get FDA approval to begin human studies later this year.” CEOCFOinterviews: Is this something dentists will welcome or will they perceive it as something that will hurt their business? Mr. Soponis: “Dentists clearly try to reduce the incidence of cavities in their patients. They provide sealants which for a short time stop cavities from forming because it doesn’t allow acid to erode enamel and they give fluoride treatments and those are all designed to stop cavities. We are offering dentists what one may consider the ultimate procedure to reduce cavities. What is different is that this is a one-time procedure. Companies we have been talking with have done some focus groups on that because they were concerned at the consumer level and the dentist office whether or not it would be supported. Of the consumers, 95% said that they would welcome and use it because they would love to avoid the pain of going to the dentist and having cavities and it would be wonderful for their children to have even though they knew it was clinically modified, so that was a positive response in our opinion. In the focus groups with dentists, and I think there were two of those, more than half of the dentists said they would use it when it became available; if it is FDA approved and they are satisfied that it is safe and the if the FDA would give them that satisfaction, they would use it. However, 45% of the dentists said they would not use it until they were convinced it was safe. A portion of the dental community is very conservative and it would be some time until they would become involved. There is economic consideration involved with that; a dentist is going to charge for cleaning teeth and if he elects not to do this and the patient really wants to get this done, he may lose a patient to another dentist, so there is an economic incentive for them to do it as well. “ CEOCFOinterviews: I would imagine public opinion would welcome something like that! Mr. Soponis: “We had a small report on the BBC that ran for most of the day about a year ago. It did not give the name of the company; it gave the name of Oragenics’ Chairman, Chief Scientific Officer and Co-founder, Jeffrey Hillman, DMD, PhD and the name of the University of Florida, but no contact information. Within 48 hours, we had over 500 volunteers wanting to participate in clinical studies. I think this kind of product will generate a tremendous amount of interest in the consumer public.” CEOCFOinterviews: Do you have sufficient funding to do the testing? Mr. Soponis: “We have sufficient funding to go through with Phase I clinical studies. These are shorter in duration and are particularly designed to establish safety. When you get to the Phase II and Phase III study, you are talking about a study of about two or three years until you show efficacy and a rather large patient population that you follow for two years. You do quarterly testing on them, and constant monitoring to make sure their health is fine and that gets expensive. At that point, we are either going to have to raise additional capital or engage a partner to undertake those studies.” CEOCFOinterviews: Will you tell us about your other products and ideas? Mr. Soponis: “We
have a second oral-care product, which is a probiotic. Dr. Hillman had identified that
there was a strain closely related to Streptococcus mutans, that was found in the
mouth; it processed sugar but it didn’t produce very much acid, and it actually
competes with the Streptococcus mutans for the sugars. When you introduce it into
the patient, it reduces the total amount of acid in the mouth, so if you take that on a
daily basis, you are going to reduce the amount of acid and limit the incidence of
cavities, and until people take our replacement therapy, this would be very helpful. CEOCFOinterviews: I can see that people can relate to what you have to offer very easily and I think that makes a difference! Mr. Soponis: “Yes, I think that is one of the attractions of the company; people can understand what we have and what it is going to do. We do have a more esoteric opportunity with something else Dr. Hillman invented called In vivoinduced antigen technology. That technology is looking at genes that are activated during human infection. There is no other screening technology looking for those targets; we are really the first one. That is the case where we would spend time identifying these targets and then finding pharmaceutical companies to develop the products because that is not something we have the resources to do ourselves. We received a $100,000.00 grant from NIH to look at targets for tuberculosis. For our antibiotic we have received an NIH grant as well. Scientists in the federal government apparently see that our technology has promise.” CEOCFOinterviews: Will you tell us more about your recent move to AMEX? Mr. Soponis: “Initially we were listed on the Toronto Stock Exchange and we were planning to stay there for a longer period without moving forward into an American exchange. What is happening is our stock was trading on thepink sheets and while the stock was trading at $3.50 on TSX, on the pink sheets people were buying it at $4.20, which is a tremendous mark-up and of course I am getting phone calls from people asking why they are losing money buying our stock, so Public Securities out of the West Coast, filed an application to be able to trade our stock on the bulletin board. Then it just made more sense to us to gain the visibility of being on the American Stock Exchange. Because of the support we had in the stock and our cash position, we were able to do so; we qualified. It makes more sense; it is going to give us greater visibility. I think one of the major reasons there is no volume in our stock right now is that we don’t have much visibility; that is going to be changing as we move forward. When we decide we need additional capital, being on the AMEX provides us with potential for a more liquid opportunity for investors.” CEOCFOinterviews: What would you like to say to potential investors, and why should they be interested? Mr. Soponis: “We have one of the great minds in science in Dr. Hillman. He is not a dentist; he is a molecular geneticist and a biochemist. We have added Eric Chojnicki, Ph.D., Vice President, Product Development with big Pharma experience that will help us with product development. We have product opportunities of tremendous magnitude and if you are talking about something that is going to eliminate tooth decay, you could just imagine yourself with the potential of that market, even using it just one time, it is a very large market. Having an antibiotic for which there is no resistance, provides you another tremendous opportunity. The probiotics market worldwide is approximately four billion dollars. It is largest in Asia and Europe, but not very large presently in the U.S, but it is something that is beginning to grow in the United States. Johnson & Johnson became the first major company to put a probiotic product on the market; and for a large company to do this is an indication that there is a market that is going to develop. We have tremendous product opportunities and market potential. In addition, we intend to keep adding to our pipeline; as products get into development, we will bring other technologies that are in pre-clinical development, taking them through Phase I and perhaps Phase II, before we find partners. We have very good relationships with the University of Florida, and other technology transfer offices. There are many University-developed technologies that died because of a lack of funding. We are in a position where we are going to have sufficient capital and we can fill that need, so that we can be the technology transfer company and take a technology that needs pre-clinical development and taking it through the FDA into Phase I studies. That is where value is added and we think we are going to be very well situated to do that.” CEOCFOinterviews: If the testing goes the way you plan, what challenges do you see on the horizon, and how are you ready for them? Mr. Soponis: “In my experience, it has always been having enough money to get the job done, and that will always be a challenge. I think the AMEX will help us resolve any problems that we will encounter. We don’t have any immediate problems with that. The other challenges are selecting the right partners for our technology, and negotiating a fair agreement. Along with that, once technologies are out-licensed, selecting the right technology to in-license and develop is a major challenge. We are actually now recruiting a senior regulatory person and we will begin recruiting some very experienced business people. With those people, adding to what we have internally, I think we are addressing what I consider to be are our major challenges.” CEOCFOinterviews: As CEO, what are the functions that you undertake throughout the day? Mr. Soponis: “I just got back from eight days in Japan, introducing Oragenics to potential partners. I will be presenting at BIO’s Annual Convention and we will have a series of partner meetings at BIO. I will be talking to fund managers; I do that at least once a month. I recently returned from Europe, where I met with eighteen fund managers to introduce Oragenics. We are also building a new building; we will be leasing it. I will be working with the builder and the architect to make sure it is done properly. Unfortunately, I haven’t even had time to go out and play golf in the afternoon; I am a passionate golfer but I am too busy!” CEOCFOinterviews: In closing, what would you like readers to remember about Oragenics? Mr. Soponis: “We have a wonderful culture here; we have terrific employees; very hardworking, very compatible, and all very excited about what we are doing and what we have. We are making progress in moving our technologies forward.Our future has great promise” disclaimers |
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