Morning. My name is David Appell. I'm the CEO of Yada Media, and I'll be the emcee for today's fireside chat with XORTX Therapeutics. This is the first of a planned series of events where we will hear directly from the company's management on the state of affairs of the company, including updates on the upcoming launch of phase III clinical trials and what that means for the company's outlook. With us today we have Allen Davidoff, XORTX's CEO, who will lead the presentation. We'll also hear from Amar Keshri, this company's CFO. After the presentation, we will open up for questions from the audience. Unfortunately, we do not expect to be able to answer all questions, but our team will work to sort through and pick out questions that represent the consensus of those we receive. Before we start, I just need to cover the safe harbor statement, and then Allen will take over. This company presentation may include forward-looking statements. All forward-looking statements are subject to a number of risks, uncertainties, and assumptions, and you should not rely upon forward-looking statements as predictions of future events. You can identify forward-looking statements by words such as anticipate, believe, could, estimate, expect, intend, may, will, plan, potential, predict, project, should, would, or negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Examples of forward-looking statements contained in this presentation include, among other things, statements regarding our ability to commercialize XRx-008, our ability to develop other products in our pipeline, status, timing, and results of preclinical studies and clinical trials, the potential benefits of XRx-008, the timing of seeking regulatory approval of XRx-008, our ability to obtain and maintain regulatory approval, our estimates regarding capital requirements, our plans to develop and market XRx-008, and the timing of development programs. Our estimates and the size of potential markets for XRx-008, sources of cash, the issuance contributions from other sources, the rate and degree of market acceptance of XRx-008, our intellectual property position, our ability to maintain and protect our intellectual property rights, the results of operations, financial conditions, liquidity, prospects, and growth strategies. The industry in which we operate and the trends that may affect that industry or us. This presentation discusses product candidates that are under preclinical studies and clinical trials and have not yet been approved for marketing by the Food and Drug Administration. No representations made to the safety or efficacy of these product candidates for the therapeutics use which they're being studied. Forward-looking statements are based on current estimates and expectations about future events, financial and other trends. There's no guarantee that future results, performance, or events reflected in forward-looking statements will be occur. Except as required by law, we have no obligation to update forward-looking statements whether as a result of any new information, future events, change in circumstances, or otherwise. With that, Allen, please take it away. Great. Thank you very much, David, and thank you to the folks at Yada Media for providing this opportunity to speak with investors. Good morning, everyone. Welcome. It's a pleasure to be able to speak with you today and introduce to you the exciting things that are happening with XORTX Therapeutics and how we are implementing our plan to build a high-value therapeutics company as we go forward and address unique injuries that are occurring within individuals with progressive kidney disease. It's my pleasure to present to you our focus on how we'll be deploying our treasury staff and time in order to bring this unique class of therapies, the xanthine oxidase inhibitor class, to individuals with kidney disease for the first time. Our focus and our key program, as mentioned in the forward-looking statement, is in autosomal dominant polycystic kidney disease. We also have substantial interest, and we believe that there is substantial evidence to suggest the type 2 diabetic nephropathy and acute kidney injury due to associated with COVID may be influenced by high uric acid levels by the xanthine oxidase enzyme. This enzyme plays a very key role in health, helping us rid our body of high circulating levels of RNA and DNA through the purine excretion pathway and breaking purines down into uric acid. In the setting of disease, though, this can become pathological and tend to accelerate or drive disease, I'll talk about that as we go forward. We're focused on developing late-stage kidney programs to slow the progression of kidney disease. We think we have an excellent opportunity to do that as we move into registration trials for polycystic kidney disease. The focus of the talk today will largely be on our key critical steps for that ADPKD program and how we think that will drive our enterprise value. Next slide, please. In the environment of progressive kidney disease and kidney disease in general, there are very few therapeutic options, very few options for physicians to treat progressive kidney disease other than treating high blood pressure that's often associated with kidney disease. When one estimates the size of today's kidney market and where that market might be growing, the best indicators suggest that over the course of the next 20 years, 16-20 years, this area will quadruple. Our best estimate today is really the dialysis market that exists in the U.S. at approximately $74 billion per year. Our focus as a therapeutics company is to continue to develop our patent portfolio, which we see as strong and growing stronger, and to build on a set of xanthine oxidase inhibitor molecules such as oxypurinol for our XRx-008 program, and address the many individuals, nearly 150,000 individuals in the U.S. who have progressive kidney disease due to this disease, and we see as the addressable market. Our XRx-101 program is focused on the treatment of high uric acid levels in individuals who are hospitalized with coronavirus infection and secondarily cardiac injury and potentially increased susceptibility to sepsis. Our early-stage XRx-225 program is looking to develop therapies for the nearly 12 million individuals in the U.S. today who have progressive kidney disease and slow the progression of that disease. We have the benefit of working with a very experienced clinical development team who has worked on the xanthine oxidase inhibitor class of molecules in the past, and the addition of key opinion leaders, including Dr. Richard J. Johnson, Dr. Charles Edelstein, Dr. Anjay Rastogi, all nephrologists who work in this area and know the pathological injury that can be associated with uric acid. Next slide, please. Our focus on developing XRx-008 for polycystic kidney disease is to follow the FDA 505(b)(2) path. That allows us to build upon the extensive work that has been done over the last decade or so with oxypurinol, but also to reference about a dozen or so excellent investigator-led phase II studies in polycystic kidney disease and chronic kidney disease that show when one lowers uric acid, there is a benefit to slowing the progression. We think as we develop this largely developed molecule oxypurinol in our new proprietary formulations, this provides the ideal scenario for a de-risk program that can enter a single registration trial based on discussions with the FDA and advance to marketing approval. Next slide, please. We have developed a highly bioavailable tablet for oral administration once daily to individuals with progressing kidney disease, in this case, polycystic kidney disease, that is based on an active pharmaceutical ingredient, oxypurinol. This is well known to be safe and effective, yet never approved anywhere in the world. We see it as an ideal molecule to begin our development and inhibit that xanthine oxidase mechanism of injury, associated mechanism of injury in individuals with progressing kidney disease, and more specifically polycystic kidney disease, where we have new evidence, and I'll talk about this new evidence, suggesting that one needs to optimally treat this disease by treating the circulating levels of xanthine oxidase and uric acid, but also specifically treat xanthine oxidase expression in the kidneys of individuals. This provides us with a drug product that we can go to that registration trial with by the end of this year. Next slide, please. We think there are three key mechanisms of injury occurring in autosomal dominant polycystic kidney disease patients. The first is associated with saturating levels of uric acid. We know if you look at the progression of the disease by mid-age, by 35- 40, individuals, approximately 63% of individuals have high uric acid levels that can contribute to deposition of crystals within the aorta or the coronary arteries, also can lead to the development of kidney stones that are either based on uric acid or seeded by uric acid in the form of oxalate crystals, and this can mechanically tear apart the kidney over time. That can be a singular cause of losing kidneys, we know in the polycystic kidney disease population, the propensity to form stones is manyfold higher than the healthy population. We think we can impair this process by lowering uric acid in these individuals and inhibiting xanthine oxidase. Next slide, please. However, more recently, there is a more insidious mechanism of injury that has been identified, reported that suggests that uric acid is an independent risk factor for larger kidneys and for end-stage renal disease, a higher frequency of end-stage renal disease. Accompanying this is a very nice non-clinical study in animal models that suggests that microcrystals of oxalate or possibly uric acid can act as a generator of new cysts, but also can increase the rate at which those cysts grow. As those cysts are growing, we believe that that squeezes the tissue around the cysts, depletes oxygen access, nutrient exchange, and decreases metabolite exchange, all of which can be toxic in this setting. We also note that between the time individuals become hyperuricemic and middle-aged, and by time half of individuals have lost their kidneys by age 55. There is a substantial dropout of filtering units, the glomeruli, the nephrons of the kidney, and we think that this progression is accelerated by uric acid. Dealing with it head-on with our tool, XRx-008, provides the opportunity to slow the progression. Next slide, please. There's additional new evidence that has emerged in this space that suggests that the tissue, the kidney tissue, may be specifically injured in polycystic kidney disease in a way that wasn't previously recognized. In this case, in the rat model of polycystic kidney disease, we have observed through our independent researchers that xanthine oxidase, that enzyme that can play a role in pathology, is increasingly expressed in polycystic kidney disease. These are 12-week-old rats, they show that uric acid, or pardon me, xanthine oxidase expression and xanthine oxidase activity is statistically increased in tubules that are largely unaffected, but also along the lining of cysts that are well-developed. This is an important region that has been reported in the past to be associated with hypoxia, with increased erythropoietin expression, with markers of kidney injury, with inflammation. The fact that xanthine oxidase occurs in this region suggests it's playing a role in the progression of disease. Next slide, please. We've also asked the very fundamental question, if the kidney tissue is actively being attacked in polycystic kidney disease, can we also show that in the system, in the circulation, that uric acid can play a role in harming the kidney? In this case, a mouse model of polycystic kidney disease, the gold standard, if you will, Pkd1RC/RC mouse model, shows that when one increases uric acid, there's a commensurate increase in two kidney, total kidney per body ratio that is statistically increased, and there's an increase in creatinine. Creatinine rises. This is a metabolite that rises in the circulation when kidney function decreases. Excellent evidence to suggest that treating circulating levels of uric acid, and most more specifically, the xanthine oxidase inhibitor, is critical to improving, optimally treating patients with polycystic kidney disease. Next slide, please. When one accounts for what's been published in human studies, one would like to see a body of evidence that suggests that uric acid may be a culprit in the progression of this disease. There are a number of key studies that are worth it, worth noting. When one looks at autosomal dominant polycystic kidney disease individuals and individuals with the same level of chronic kidney disease or CKD, it's been reported that individuals with ADPKD have higher levels of circulating uric acid, suggesting that this population might be specifically in need of a therapy that can act in the way that XRx-008 does. Higher serum uric acid has been associated with increased kidney volumes. Much like the mouse data, the human scenario shows a similar result. Serum uric acid has been associated with endothelial dysfunction in many disease states. That points to increased risk of cardiovascular injury because endothelial dysfunction is one of the harbingers of cardiovascular injury. That is a major symptom of polycystic kidney disease. Finally, serum uric acid has been associated in younger individuals with a more rapid rate of disease progression. This study on the right-hand side is one that is reminiscent of about a dozen studies in chronic kidney disease and in diabetic nephropathy and shows a very parallel result. That is if you identify individuals who are progressing, in this case, mild to moderate individuals losing 4.5 milliliters per minute per year of filtering capacity. This is an accelerating disease, that number tends to rise, year-over-year. If you treat these individuals for a year, lower their uric acid, there's an associated reversal of glomerular filtration rate that is about threefold that dashed red line, which is the level at which the FDA has indicated this is approvable. This is very promising for our late-stage clinical study program, and we certainly are encouraged by this result and parallel results in chronic kidney disease that show the same benefit. Next slide, please. It looks as though for every year that you treat a patient with this approach, you can buy a year off of dialysis, which means we may have at hand a therapy that can maintain improved quality of kidney life, improved quality of health for individuals, and that has the potential to redefine how kidney disease is treated in the future. If you or I lost our kidneys today, the real driving reason to stay off of dialysis is the cumulative survival diminishes rapidly after a year or 2 years or 3 years. Every year, a new therapy can buy an individual time off of dialysis. That's an enormous socioeconomic benefit. Next slide, please. We're beginning with a xanthine oxidase inhibitor, oxypurinol, that we think is ideally suited for this purpose. It's arguably the best-tolerated xanthine oxidase inhibitor available, yet never approved anywhere in the world. It has, in the past, been developed extensively as a replacement for allopurinol and received an approvable letter. The discussions to date with the FDA have suggested that they see this drug as eminently safe and effective. We know it's ideally suited in the orphan drug space and eligible for orphan drug designation for those 150,000 patients with ADPKD that we think we can address. We're undergoing a de-risking exercise, which means extensive conversations with the FDA under a special protocol assessment negotiation in the near future, so that we can establish precisely what's needed to approve this drug for marketing. There are other key differentiators for oxypurinol that are quite important, including the fact that it is absorbed and excreted unchanged, which means it involves the liver in metabolism less. It has a better side effect profile, which has been observed over time. We know this drug is ideal if you believe the evidence because it can act extracellularly in the circulation as you need to lower uric acid, but also intracellularly in the kidney tissue. If that evidence that xanthine oxidase expression is increased in the majority of individuals with polycystic kidney disease, then treating that tissue-related injury is key to success. It is worth noting that in the course of developing this drug, over 700 patients have successfully taken oxypurinol with a minimal set of side effects and adverse events. Next slide, please. There is a single drug approved in this space in 2018. It has had its challenges, including a black box warning and a side effect profile that makes it difficult to tolerate. Nevertheless, the drug right now, as of 2021, has been reported to treat approximately 7,500 individuals or 5% of the entire addressable market and earn, excuse me, approximately CAD 1 billion in revenue. We think there is 95% of the market that can be addressed. We're working diligently to bring that to individuals with a progressing polycystic kidney disease. Next slide, please. The world competitive landscape is changing rapidly. Tolvaptan is the approved drug. It has an orphan designation which expires in 2025. Mirdaxalone and venglustat have had their developmental concerns, and we're watching those two drugs carefully. We don't know that they'll be advancing. It is also notable that lixivaptan this week was abandoned by Centessa Pharma for this space. That largely leaves XRx-008, our xanthine oxidase inhibitor, in an ideal scenario to be developed through a single registration trial and then advance to treat the many individuals with those with polycystic kidney disease. Next slide, please. As a team, as an experienced team, we are actively working on characterizing this new proprietary formulation of XRx-008 oxypurinol. We have near term reporting of part one, part two, three, and a new part four over the course of the next months that will characterize and inform us on the dose that we'll advance into our phase III registration trials that we're slating for beginning at the end of this year. We're in the process of opening discussions with a meeting request to the FDA, but also preparing the final phase III protocol for discussion under a special protocol assessment, not only with the U.S. FDA, but the European Medicines Agency. We are also waiting on a small amount of data to be able to file the orphan drug application and have that orphan drug designation in place in the next two quarters. Next slide, please. At this point, I'll hand over the description of the capitalization table to our CFO, Amar Keshri. Thank you, Allen. The company as of now has about 12.9 million shares issued and outstanding in the market, with about 5 million warrants outstanding and about 1 million options, with a fully diluted of 19 million shares. The company is listed on NASDAQ, and our current cash flow is about CAD 13 million in bank. Thank you, Amar. To wrap things up, we're working in a area, environment where chronic kidney disease numbers are expanding rapidly. There are very few therapeutic options to address advancing polycystic kidney disease. We think we're ideally situated to deliver XRx-008, a xanthine oxidase inhibitor, to decrease or diminish the pathological effects of this enzyme in polycystic kidney disease. This should, along with our key regulatory and clinical milestones, support the evolution of XORTX from today into a high-value pharmaceutical company. We think, based on our discussions with the FDA, that a single registration trial will provide all of the information that's necessary for registration and marketing approval of this program, and we look forward to advancing those key steps over the course of the next year. Next slide, please. Thank you very much for your attention. These are our contact details. Please reach out to us if you have additional questions or a need for further discussion. You're on mute, David. Sorry about that. We're going to open this up for additional questions from the audience. Please submit your questions online, and we will sort through them and get some of these addressed as quickly as possible. Allen, I have the first question here. XORTX seems to have a lot of near-term milestones. What effect do you think these will have on the value of the company? Thanks, David. You know, during the past year, we've accomplished a lot. We've raised sufficient funds for developing our therapeutic approach in several areas over time. Those include the recent launch of our pharmacokinetic study and the grant of an IND and patent grants over the past recent six months. As we move forward, we're looking forward to a number of things that we think will be drivers of value for the company. Those include the reporting of the pharmacokinetic study that has been recruiting well and is well underway. We think that de-risking our ADPKD registration trial with a special protocol negotiations that we're undertaking with the FDA will be a key step. Also validating the science and qualifying the XRx program for orphan drug status is important. It's important for additional layers of protection and exclusivity and premium pricing for that program. Finally, you know, the key to all of this is really initiating that single registration trial that's necessary for clinical development, but ultimately getting to a result that would permit registration, marketing registration for this drug program and what we calculate, speculate to be substantial revenue. Thank you. Next question. XORTX has recently listed on NASDAQ and TSX. A quick review of companies with phase III clinical trials with treatments for kidney disease shows that Chinook Therapeutics and Reata Pharmaceuticals have market caps ranging from CAD 1.18 billion to CAD 1.24 billion. What key milestones should expect over the next six months that will influence the value of the company? Thanks, David. Yeah, I mean, we expect those key drivers really to be the clinical progress that we're undertaking, including the reporting of this pharmacokinetic study results. The orphan drug designation, again, is substantial in supporting that. We have additional patent filings that I didn't mention that will be coming over the course of this next year. Because of our late stage of progress, we have many discussions with Royalty Pharma, with investment banking, and with licensing partners, all of which can contribute substantially to the value of the company. We think as, you know, as things settle down within the overall biotech index, we're ideally situated to report a number of milestones that are key, and those should be drivers of our enterprise value. Great. Next question. You mentioned that oxypurinol received an approval letter in the past but has never been approved for marketing anywhere in the world. What does that mean? This drug was developed extensively over the course of the last 20 years or so. It was developed initially as a replacement for allopurinol, for those individuals who can't tolerate allopurinol. About 70% of those individuals can well tolerate oxypurinol and receive relief for their gout symptoms. Generally speaking, an approvable letter means that the FDA has approved the evidence, animal evidence, clinical evidence, and developmental evidence with respect to the drug product that one would like to deliver and considers it to be safe and effective. Usually there's a caveat with that letter often requires additional work. We're working diligently to provide the information, the outstanding information that was noted in that approvable letter and be able to advance this therapeutic in a well-informed and thorough way into polycystic kidney disease. Our innovations and technical advancements really have been aimed at providing solutions to permit this drug to be introduced and for marketing approval in the future. The approvable letter is a key saying that the drug is eminently safe and effective. We think that's an ideal entity to then introduce into rare diseases such as autosomal dominant polycystic kidney disease. Great. Next question. To file a new drug application, many subjects must have received the drug. How many individuals have received oxypurinol to date, and how does that influence your ADPKD program? Right. We know historically, because of the NDA filing and because of the number of individuals who have received drug, that the bulk of those individuals could not tolerate allopurinol. They had failed reintroduction of the drug twice. They were suffering substantially from gout and tophi and the other ravages associated with high uric acid. 70% of those individuals can tolerate oxypurinol just fine, get relief for their symptoms. It's effective at lowering uric acid and eminently safe. As we look to that NDA filing and historically what's been done, we can use the 505(b)(2) pathway that the FDA has established and begin to work on developing this drug, which is arguably the best tolerated xanthine oxidase inhibitor available that's never been approved anywhere, and focus our efforts on bringing that drug into patients with polycystic kidney disease within the therapeutic range where we think we can turn off the xanthine oxidase enzyme by over 90% and really make a difference for these individuals. That's great. I think we have time for one more question here. What are the key steps that XORTX needs to complete prior to starting the phase III clinical trial in ADPKD? The key steps that we are undertaking right now in order to be able to launch that phase III clinical style study, that registration study that we've discussed with the FDA, really are to complete our pharmacokinetic characterization of this unique proprietary tablet that we have, understand the oral dose that's necessary to reach the therapeutic, not only circulating levels of oxypurinol and tissue levels of oxypurinol, but to discuss with the FDA the special protocol assessment, to meet with the European Medicines Agency to bring that discussion forward. We move forward into that phase III trial, we're really looking at enrolling in Europe and in North America, so the U.S. and European Medicines Agency discussions are fundamental to moving that forward. Of course, there are the very important steps of manufacturing a sufficient supply and producing the tablets sufficient to supply that phase III trial as we go forward. Those are the key steps. The orphan drug designation is an enormous bonus, as would be a partnership and/or additional patent coverage for this space. I think that we've reached the end of our allotted time here. We appreciate you coming on today, and I look forward to future follow-ups with you and the audience. My pleasure, David. Thank you all for your time. We look forward to building XORTX into a substantial company as time passes. Great. Have a great day. Thank you. Thank you, everyone.