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Nathan Bryan, Bryan Therapeutics - Restoring Nitric Oxide to the Body | LSI USA '24

Bryan Therapeutic's mission is to transform lives through research and natural products that generate and restore nitric oxide in the human body.
Speakers
Nathan Bryan
Nathan Bryan
, Bryan Therapeutics

Nathan Bryan  0:04  
Imagine if you will a single molecule that could address the root cause of all age related disease. And if that molecule exists, would you want to be part of its commercialization and help to change the world? And so the reason I'm here is that opportunity exists today. My name is Dr. Nathan Bryan, I've been an academic medicine for the past 25 years have a number of patents with press professor of medicine at UT Medical School in Houston. We've sold over a billion dollars in product through my portfolio of companies over the past 15 years. And the revenue from my patents from UTA account for about 33% of their annual revenue. So we've been very successful out of 81 portfolio companies. So Brian therapeutics as a Texas based C Corp. Were cashflow positive, no debt revenue generating. My drug company acquired my consumer products good company several months ago, strong margin seven 80% growth margins. I've got a history of growing successful businesses, as I mentioned over $1 billion in global revenue from these companies. So get a private placement memorandum for $20 million raise the use of funds, we've got three drugs going into advanced clinical trials to finish our registration badge for the drug through pantheons. About a million complete our ischemic heart disease drug which is in phase three is about a $4 million price tag. We've got ut milestone payments as we enter certain stages of these clinical trials. And then we've got drugs going into Alzheimer's and topical drugs for diabetic ulcers. But we're going to focus on first getting the ischemic heart disease drug approved. We've assembled a very strong team, founder chairman and CEO Susan Shaffers, built my other companies from ground up to several 100 million in revenue to date. David Perlmutter is leading leading our Alzheimer's and neurodegenerative program and Susan treadgold holds up mine heads up my investor relations, but we've got a strong team of clinicians, John Sonnenberg has performed about 45 clinical studies for the FDA and getting 40 drugs approved. So nitric oxide is a it's a gas that's produced in the lining of the body and a Nobel Prize was awarded in 1998 to these three US scientists for discoveries of nitric oxide as a signaling molecule in the cardiovascular system. And I've studied and worked under Fred Murad, who recruited me to join the faculty of UT Medical School in Houston, back in 2005. But although we're in biotech, we're really in the longevity space. And this is an emerging field. And once we figured out how to capture the biological activity of a fleeting gas in an in product, we're really we're leading the forefront of this longevity field. So we're very focused in our clinical indications. But if you look at every single chronic disease, whether it's autoimmune disease, diabetes, cardiovascular disease, there's hallmarks there's common denominators, there's ischemia, and hypoxia, which means there's insufficient blood supply to that organ or tissue. There's inflammation, immune dysfunction, and oxidative stress. And nitric oxide corrects all four. In fact, many of my patterns are method of reducing inflammation. The older we get, the less nitric oxide we make. And then we call this in the theory of dysfunction. So when the endothelial loses the ability to produce nitric oxide, there's compromised blood flow, you lose the regulation of blood flow to these organs. And if you lose the ability to make nitric oxide, these are the clinical presentations, you develop high blood pressure, you develop insulin resistance, basically all the global phenotypes of Alzheimer's disease, advanced vascular disease, diabetes, and this is a short list of clinical symptoms. And the functional loss of nitric oxide in the vasculature precedes the structural changes we see in advanced coronary disease by many years, sometimes decades. So if you can maintain normal nitric oxide production, you can prevent the onset and progression of vascular disease we need to get data showing we can regress plaque, so patients with stable plaque in six months we can regress this plaque about about 11%. This is some in vitro or in vivo ex vivo study. So you can see here we can induce vascular inflammation in a vascular bed you see the monocytes and neutrophils and upregulation of the adhesion molecules. Obviously, this is a heightened state of vascular inflammation. If we induce that same vascular inflammation, but we get our nitric oxide, you can see that same vascular bed is more dilated, the monocytes and neutrophils home along the endothelial but they don't stick and they don't migrate, she completely suppress the microvascular inflammatory response simply by restoring the production of nitric oxide, cardiovascular disease, as most of you know, it's still the number one killer of men and women worldwide. For me that's unacceptable. We know what causes cardiovascular disease, we know it had diagnosis and we know how to treat it. So it's not a lack of information. It's the translation of that new science into clinical practice. So the amount of people dying from cardiovascular disease is equivalent to four jets crashing and killing everyone on board every hour, every day every year. That should be the headlines. We're going after a very small segment of Cardiovascular Disease wouldn't call ischemic heart disease. It's a growing market. It's not getting better the cornerstone therapy for ischemic heart disease organic nitrates, such as isosorbide, or nitroglycerin. We know that long term outcome studies on people taking organic nitrates patients get worse, develop tacky flags. So you get to wean patients off of these drugs. And so there has to be a better way. So we developed an orally disintegrating tablet, we made a solid dose form of nitric oxide gas. It's never been done before. Everybody can make nitric oxide and we do it for you through this oral delivered bucal delivery, it's vasoactive, we can see dilation of the crowds within about 12 seconds, we see dilation of the coronary arteries. It's very cost effective. And it's vasoactive. There's no tolerance formation, and we can see dilation of the coronary arteries within a couple of seconds of placing the lozenge in your mouth. The proforma we built out the ischemic heart disease market is very well defined, there's 33 million Americans living with it today 250 million around the world. If we do a very poor job of marketing, and we capture 2% of the market, we'll have about 25 million in earnings, we capture 20% of the market, the first year will be about a quarter of a billion. If we kept or 50% of the market in the first year, we'll have earnings of about 1.7 billion. And this will be a very easy adoption because all cardiologists are looking for alternatives to isosorbide for treating their ancient patients. We had a drug and phase three clinical trials for COVID. We were making COVID patients better, but obviously the goalposts kept moving with COVID. So we aborted the study that we establish safety, we treated over 600 really sick highly susceptible patients with no safety signal. So now the FDA has allowed us to go straight into phase three trials without oral drug. And so most of you know that saves us probably four to six years and anywhere from 20 to 70 million in development cost. We've had pre ind meetings with the FDA, the FDA has indicated that if we can demonstrate in 100 patients in a 30 day study that we can prolong exercise induced engineer with no tolerance formation, then they'll approve the drug can a single study. So the 400 100 patients, a 30 day study is a $4 million. And then obviously once we get that drug approved it on the market, then we'll have sufficient revenue to fund all the other programs. I developed a commercial a direct to consumer line of products that's now fueling this part of our revenue. We developed an OTC form of our earliest integrating tablet we make a fermented beet powder for performance and energy pre workout. And then I developed a topical line of products for skincare that generates nitric oxide and eliminates fine lines and wrinkles. This is based on our our last quarter exit out of 2023. This is our five year revenue projections we'll do 2020 and 30 million this year, we're growing 40 to 50% every 30 days on this. So we're cashflow positive. At the 84% gross margins. We've got an oral drug for Alzheimer's, we get to the root cause of Alzheimer's reduced blood flow insulin resistance, we improve glucose uptake and insulin signaling and basically improve cerebral blood flow. We can demonstrate this through SPECT scans and functional MRIs. And then we got a topical drug for diabetic ulcers, non healing wounds, these are multibillion dollar total addressable markets. We've achieved key milestones we've got commercial drug manufacturer, we get to your safety or to your stability data. We completed our COVID study in August of 2020. To develop safe safety, we have full regulatory guidance from the FDA. So our strategic plan is to focus on our scheming heart disease drug, get that approved on the market, and then use the revenue from that we're very lean machine and then move our other drugs into advanced clinical trials. Our strategy is kind of changed. You know, our strategy now is to build a global company, because we really lightyears ahead of the competition and position the company for an IPO in fourth quarter of this year, probably third quarter. So thank you very much. There's my contact information. I'll be around for the rest of the afternoon. So if you have any questions, feel free to approach me. Thank you

 

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