OYE Therapeutics | Brett Dines, CEO

Brett Dines  0:00  
My name is Brett Dines, Founder CEO of OYE therapeutics OYE stands for Open your eyes. We are a clinical stage pharma company, we have three opportunities in our pipeline and looking to have a $30 billion total available market for that pipeline. Our lead candidate addresses delayed emergence from anesthesia. And that looks to be a $2.2 billion service obtainable market in the United States. We're looking to bring that product to market as a repurposed drug product. In doing so we save roughly between six to eight years in product and preclinical development. A couple of disclosure slides. So management team very deep, I'm only going to touch on two people at this present time, which is the first is our interim chief medical officer used to be the global chief medical officer over at sharing notably materially developed Bridion, which was the last blockbuster drug product in the anesthesia space. And in doing so Merck launched that product worldwide, and achieves over several billion dollars a year in sales. Myself been a part of a couple of different drug product development programs, and notably, took the US 340B program for Walgreens from $10 million to $9.2 billion. Our pipeline is a series we go back one go back is slide. Okay, our pipeline is a series of label expansions to reduce overall investor risk and development risk for the opportunity. Notably, I'll talk to OYE 101 and 311. Later on, but OYE 201 was brought to our attention by the Department of Defense. And we address a gap in care for military medicine. And in doing so we believe that there will be significant civilian label use after the products approval for the military. Delayed emergence from anesthesia most understand that anesthesia is safe and effective in today's day and age. But I'm here to tell you that delayed emergency leads to roughly 2.4 million days of extra hospitalization, roughly 35,000 additional hospital acquired conditions and over 32,000 deaths annually. Dr. Schippert had demonstrated by reducing the time from the last stitch to exit of the operating room, hospitals could save roughly about $100,000 per surgery suite. What we're doing is targeting patient populations that have a high incidence rate for complications specifically related to delayed emergence being overweight. Persons with obstructive sleep apnea, in addition to the elderly, and then persons undergoing robotic surgical cases. We ultimately target roughly about 21 out of the 100 million surgical procedures annually in the US, and why can't that be ignored? It can't be ignored because the surgical enterprise at hospitals and surgery centers across the country drive revenue, their largest source of revenue, largest source of contribution margin, largest source of expense, and also largest source of risk for these hospitals and surgery centers across the US are, OYE 301 addresses opioid induced respiratory depression and addresses the opioid epidemic. And if you're not familiar with the fact that ages 18 to 45, has now become the leading cause of death in opioid overdose has become the leading cause of death in that patient population going forward. Premier estimates that that's costing US hospitals roughly $11 billion annually. And what we're doing is bringing a non opioid receptor, CNS stimulant and respiratory stimulant to address this problem to be used to jump to fully with naloxone.

So again, this is a prior proof small molecule the previous product was not conducive for use in the new indication it was approved for apnea in premature infants. We significantly made some enhancements to the formulation and proved the shelf life that attracted the attention for OYE 201 and the Department of Defense and development of that product. We significantly improved solubility, which now makes it conducive to dosing and adults subject for the indication of delayed anesthesia, and we reformulated so it would not recrystallize out in the operating room at lower temperatures. We have four different IP or patent families around formulation alone that are should be all orange book listed. The proof of concept was completed at the University of Chicago, Chicago where we addressed delayed emergence from anesthesia developed a suitable dose for the new indication also demonstrates proof of concept no adverse events or side effects associated with the product. And what caught my attention got me out of retirement was this healthy human subjects were woken up 6.9 minutes faster than placebo in a crossover design a healthy human subject undergoing a knee or something else, a simple procedure almost walked themselves off the OR table into recovery. And what they did was they found 6.9 minutes that the anesthesiology groups and researchers did not believe existed at that point. From my professional experience on the outpatient services side, that crease created a safer environment in terms of achieving a can we go back when again, sure, I'm waving my hand or what, but achieved the ability to achieve a safe airway 50% faster, your ability to reduce the time or episode of care and recovery by almost 50%. And the patients were waking at a cognitive state that was significantly improved, compared to standard of care. And from that point in time, you have the ability to have a safer, better and more effective product in the marketplace and help the prospective patient populations where you have products that are overweight, obese, obstructive sleep apnea and address those populations effectively. So we had a pre IND meeting with the FDA, align with the FDA thoughts regarding guidance for the approval process for clinical development, regulatory development that resulted in a retooling of our clinical development protocol. And doing so we believe that there's a higher likelihood of success. And most importantly, the FDA shorten our timeline to market by completing a single pivotal study to achieve NDA most recently presented at JP Morgan had the ability to couple weeks after that received our first term sheet, and that was for our Series A the series A completes all clinical and regulatory development to achieve our new drug application. So thank you, and look forward to talking to anybody afterwards.