Sulfagenix, Inc.

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July 7, 2014 Issue

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Improving the Safety, Bioavailability and Efficacy of Molecules

www.sulfagenixinc.com

Sulfagenix, Inc., and its wholly owned subsidiary, Sulfagenix Australia Pty. Ltd, is built on decades of research on modifying existing molecules to improve safety, bioavailability and efficacy for new uses. SG1002, the Company’s lead molecule, is a precursor to a natural-occurring molecule, hydrogen sulfide, for which deficits have been shown to exist in a number of serious diseases, including cardiovascular disease, type II diabetes, cancer, hypertension, Alzheimer’s Disease, asthma, & wound healing. In addition, sulfur deficiencies in the diet may be directly contributing to these diseases. Sulfagenix’s lead product, SG1002, is being developed in a Phase I clinical trial (http://www.clinicaltrials.gov/ct2/show/NCT01989208) in Australia by Sulfagenix Australia to treat problems associated with heart failure.

Tony Giordano

CEO

Dr. Giordano is a co-founder and President and CEO of Sulfagenix, Inc. and a Director of Sulfagenix Australia Pty Ltd. He has held senior management positions at six separate biotechnology companies, two of which were purchased by public companies, including Message, Nucleonics, Alteris, and TheraVasc. He has been involved in business planning, licensing, directing research and development efforts, fundraising, financial management and four clinical development programs. Dr. Giordano serves on numerous Boards and has served as a consultant/advisor to three venture funds, a consultant to the Biomedical Research Foundation, the Assistant Dean of Research and Business Development at LSU Health Sciences Center in Shreveport and was appointed by the Governor of Louisiana to the Innovation Council. Before beginning his career in biotech, Dr. Giordano was a senior scientist at Abbott Laboratories.

“I think this is a phenomenal product that is going to be safe, has utility in many diseases and has a very rapid path to the marketplace that will benefit many people and provide an excellent return on investment.” - Tony Giordano

Sulfagenix, Inc.

7515 Cedar Rd.
Chesterland, OH 44026

318-349-3851

www.sulfagenixinc.com


 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – July 7, 2014

CEOCFO: Mr. Giordano, what is the concept and foundation of Sulfagenix?

Mr. Giordano: We are based on work that was started in Mexico in the early 2000s with a father and son team, Dr. Gabriel Gojon, who is a PhD chemist, and his son, Gabriel, a business person. They started thinking about diseases and what was key to diseases. They hypothesized that hydrogen sulfide is very important in diseases way back in the early 2000s, so Dr. Gojon and his son started working on compounds, molecules and formulations that could improve hydrogen sulfide levels. They went through a number of reiterations before they came up with our product, SG1002, which through a single synthesis gives rise to a couple products that are all natural products, but by synthesizing them together, they dramatically increase the bioavailability of sulfur. They then contacted a very well known cardiovascular researcher in the United States, Dr. David Lefer, who was at Emory at the time. They sent him some of their product to test in his animal models of heart disease. The product worked beautifully, and David called me up. We were working together on another company called TheraVasc, and he called me and said I had to see this. He had tested many products for major drug companies and heart failure, and this is one of the best he had ever seen. David introduced us, and we started talking about how to develop this product. From there, we started Sulfagenix and started the development of SG1002.

CEOCFO: What specific condition is it addressing and what is the science?

Mr. Giordano: In many diseases, there is oxidative stress, so there are free radicals that are formed in the body that causes damage to cells. What this does is prevents oxidative stress, prevents inflammation and it stimulates endothelial cell function. These are the cells of the blood vessels and heart. So it is improving function and reducing stress on the blood vessels and heart. For these reasons we are developing this for heart failure.

CEOCFO: How does it do so? What is happening when this drug gets into the cell?

Mr. Giordano: It is doing two things predominantly. It is eliminating the free radicals, so it is eliminating all the damaging agents, and then the second thing it is doing is stimulating the production of nitric oxide. Nitric oxide is the molecule that has the profound effects on endothelial cell function.

CEOCFO: How and when would this be used?

Mr. Giordano: We believe it is going to be used on a daily basis. The product itself is very safe, and actually there is another really important aspect. All of us have circulating hydrogen sulfide in our bodies. In our blood, we have hydrogen sulfide, but with heart failure patients they have a lower level of hydrogen sulfide than non-heart failure patients. It is a normal substance that you could find in food, but unfortunately you do not get enough from food. Hydrogen sulfide sulfur is plentiful in garlic, but you would have to eat thousands of cloves of garlic to get what SG1002 provides. What we are doing is giving something that will boost your normal levels of hydrogen sulfide, and remember, in heart failure patients these are low. SG1002 boosts these levels back up to normal. It is going to help the function of the heart and reduce the damaging molecules that are there that could cause problems with the heart. We think that once a patient is diagnosed with heart failure, they should start taking SG1002 because of its safety profile and because all we are doing is providing what the patient does not have. We believe that they should stay on the product for the rest of their lives.

CEOCFO: Is the medical community in agreement?

Mr. Giordano: It is a very new field. I just returned from Japan where they had the third International Hydrogen Sulfide Conference. It is still very early. In fact, Sulfagenix gave the only presentation of clinical data at the conference. No other investigator is even in clinic yet. We believe that this is a really crucial pathway that is starting to gain recognition. The number of articles being published are going up significantly each year and I think you are starting to see more acceptance by the scientific community of the role of hydrogen sulfide in diseases.

CEOCFO: Where is Sulfagenix in the process?

Mr. Giordano: Right now we are in the middle of a double blind, placebo controlled phase one study in Australia. We are treating eight normal subjects and then following that with eight heart failure patients. We are doing a dose escalation study. The eight normal subjects have completed the trial. We see no real safety issues, and with the dose finding study, we see very nice increases of hydrogen sulfide levels in the normal patients’ blood. As I told you, hydrogen sulfide should stimulate nitric oxide. Nitric oxide itself is very unstable. When nitric oxide is made, it readily picks up another oxygen and becomes nitrite. What we also see in the blood is a significant rise in nitrite levels. We are very encouraged with the data from the normal subjects in that we see safety, increased hydrogen sulfide levels, and one of the outcomes of hydrogen sulfide should be production of nitric oxide, which we believe we have demonstrated by observing the increase in nitrite levels. We are now in the middle of eight heart failure patients in Australia. We have three enrolled to date. One of them has completed the three-week study, and two more are in the middle of testing. We are screening others to get the last five enrolled in the study. We hope to have that completed by the end of July.

CEOCFO: Is this a pill?

Mr. Giordano: This is a capsule.

CEOCFO: What other conditions down the road might benefit?

Mr. Giordano: In Mexico, before we got involved, a doctor friend of the Gojons, Dr. Arturo Morales, tested this. He runs an infertility clinic in Mexico and he did a great deal of reading and found that one of the big problems with infertility is oxidative stress and damage to the sperm due to oxidative stress. He started a double blind study where he looked at Resveratrol, which is one of the molecules from grapes that is supposed to be a very good antioxidant, a placebo, and SG1002. This was sort of an investigator initiated trial. He did 18 patients per group. What he found was that Resveratrol did nothing, but SG1002 had a significant increase in sperm concentration and a significant reduction in sperm abnormality. He strongly believes because of the effects on oxidative damage, that this would be very beneficial for male infertility. Along those same lines, we have been talking to a pharmacologist in Italy, Dr. Giuseppe Cirino, who is the director of the Institute on Sexual and Reproductive Medicine at University of Napoli, and he thinks that because of the nitric oxide stimulating activity, this would also be a very good drug for treating erectile dysfunction. We may be doing another trial in the future looking at this product’s effects on male infertility and sexual dysfunction. I think that is one that is way up there on the list. I was just at a conference in Cleveland on nitric oxide, which had some sessions on hydrogen sulfide, and one of the leaders in the nitric oxide field, Dr. Sol Snyder from Johns Hopkins, gave a talk. Dr. Snyder pointed out that one of the key enzymes in hydrogen sulfide production is missing in Huntington’s disease patients. These patients may not be producing enough hydrogen sulfide, so there is another opportunity that I think we should be exploring in the future.

CEOCFO: Are there any potential side effects to taking hydrogen sulfide?

Mr. Giordano: One of the things that we know nitric oxide does is that nitric oxide is a vessel dilator, so it opens up blood vessels. Since hydrogen sulfide will stimulate nitric oxide, you have the issue of opening up blood vessels. Vessel dilation can cause a drop in blood pressure, and it could cause headaches and dizziness. What we have found at least within our normal patients is that there was a very slow production of nitrite, which means there is a slow production of nitric oxide, and none of the patients complained of headaches or dizziness, which you typically see if you produce a lot of nitric oxide at once. Nor did we see any real drop in blood pressure. The hemodynamic effects that might be attributed to the nitric oxide piece of this were completely nonexistent, so that was the big thing that we were looking at. In Dr. Morales’ trial in Mexico and in our phase one trial, the only complaint of these subjects was at the highest dose some of them complained of feeling a little nauseous.

CEOCFO: What is your status as to funding?

Mr. Giordano: We are going to be looking for funding later this year. We raised three million dollars from investors in Mexico. We have some very good business people in Mexico who have invested in the company, and that is allowing us to go through the phase one study and allowing us to get the product ready and actually get started on the phase two study, which we hope to start later this year in Australia. We are developing this in a unique pathway as a medical food as opposed to a drug. What that is going to allow us to do is get into the marketplace very quickly. We expect that after the next study, we will have the information we need to move this into the marketplace. What we will be raising funds for later this year is to bring on a sales and marketing team. We have already identified two very key people who we are bringing on. Both of them are senior vice presidents with companies today, and one of them is big in the pre-commercialization area while the other is big in the implementation of sales and marketing. The Series B funding will allow us to bring those people on, complete the phase two study and gear up for market and product launch in 2016.

CEOCFO: Why market yourself? Why that decision as opposed to a third party?
Mr. Giordano: We believe that with the experience of these two individuals we will be able to do this. The other aspect is that with the medical food, we are going to be marketing direct to cardiologists and not necessarily to patients. We may use a contract sales organization for sales function, marketing direct to the cardiologist I think we will be able to generate and create enough of a market that we can support additional development.

CEOCFO: What have you learned from past experiences that has been most helpful and continues to be in this particular situation?
Mr. Giordano: It is kind of unfortunate but it makes more sense to keep your cost low and keep things virtual as long as you can. In some of my previous organizations, we built out facilities, we hired people and we built in many costs that were ongoing costs that we needed to support. We were therefore constantly raising money. In this operation, we have kept things very lean. We are outsourcing all of our activities, so we can either speed things up or slow things down without a big drain on our capital resources.

CEOCFO: Put it together for our readers. We reach many people in health care and we reach the investment community. Why Sulfagenix?

Mr. Giordano: I think this is a phenomenal product that is going to be safe, has utility in many diseases and has a very rapid path to the marketplace that will benefit many people and provide an excellent return on investment. We have a key patent on producing hydrogen sulfide in the body, so in our belief, once we completely validate hydrogen sulfide as a drug target in humans, people will need to come to us to practice in this area. I think we are sitting in a nice position both with our product and with our IP.

CEOCFO: Final thoughts?
Mr. Giordano: The one thing I would like to mention is that we are doing all of our clinical studies in Australia, and I think Australia is a phenomenal place right now to do business. Their regulatory path is very reasonable to get a product into clinical trials, and they have a great refundable tax credit available for doing research and early stage development in Australia. I encourage people to really look at Australia. They have very high quality clinical sites, CROs and manufacturing organizations. I am just really happy and excited about the work we are doing in Australia.

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