Yeah, please. Allen, hey, it's Craig. Can you hear me? Yeah. Do you know how to get on? Nick is on. Do you know how to get on? Okay. We will send you, I will send you a link right this minute. Okay. My colleague, Rob, just sent you the link that you need to get in. Registration link. You'll register as a regular attendee, then I will promote you to panelist, okay? Let's just wait until you get it in your inbox. Yes, this is the XORTX Therapeutics webinar. We'll be getting started shortly. Allen is just about ready to join us. Thank you. Allen, great to see you. Yes, I do see you now. Thank you very much for all the trouble we had to put you through there. Sorry about that. Okay. Could we do what we did yesterday? Show your screen, your presentation, make sure that's working. I can't hear you yet either. Testing, testing. Okay, I can hear you. Good. Perfect. Are you able to see the presentation? Okay. Allen, what I'm going to do in a moment here is press record. I'll introduce you briefly, read the safe harbor, and then you can get started. We will then take the questions after your presentations, like we talked about yesterday. Everything looks great. If you're ready, then so am I. Hello, everyone. This is Craig with RedChip. Thank you for joining today's event with XORTX Therapeutics, which trades on the NASDAQ under the ticker XRTX. With us today, we have Allen Davidoff, who is the CEO of XORTX. We will begin with a brief presentation in a moment, and then we'll open the event to your questions. I will keep everyone's lines muted throughout the presentation. Users may reach us at any time by clicking the Q&A button at the bottom of the Zoom window and typing in their question. Before we begin, please allow me to read the safe harbor statement. This call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical facts should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. Let me now turn this webinar over to Allen. Please go ahead. To everyone who's joined for this presentation of XORTX Therapeutics. Our company is focused on developing therapies for two areas. First, gout. That is our primary focus. And for progressive kidney disease, more specifically a rare kidney disease called polycystic kidney disease. I hope for the course of the presentation, you'll realize the lucrative opportunity that we have, i.e., the risk opportunity, and certainly the opportunity to create a high-value entity as we move through the final steps that the company needs to take prior to filing a New Drug Application for the gout indication. Today, we look at a schedule of activities that we need to undertake in order to prepare and file a New Drug Application with the FDA to begin to market the oxypurinol formulation for the gout indication. As announced previously, we are actively preparing an IND, an Investigational New Drug application. We intend to have that filed in the next quarter. We also have, through our communications that occurred in the spring of this year, direction from the FDA that they would like to see a small medical study with our commercial tablet. We also need to advance the New Drug Application by creating a year and a half of commercial supply of tablets that would serve the U.S. market once that approval is in place. To do that, we need a year of stability. That is a key activity for the company over the next 12 -1 8 months. We believe there is an opportunity for a conservatively estimated market for allopurinol-intolerant gout patients for XORTX. Conservative estimates is that it is a CAD 700 million opportunity. We are trying to fill a gap that was left by a drug called febuxostat that has diminished in the market. The drug we're developing has a longstanding safe and effective clinical record. That effective clinical record has been established in over 800 patients. We use the number 700 patients here. The number today is even more than that. That gives us an opportunity to conduct a few steps and file a New Drug Application within the next 12-1 4 months. We have a second program in autosomal dominant polycystic kidney disease, or ADPKD. The discussions with the FDA have indicated that a single small registration trial would be sufficient to show the benefit of our drug in that disease and slowing that disease. That is a market where we estimate our independent commercial assessors estimate that there is a CAD 1 billion-CAD 1.5 billion opportunity. Underpinning what our activities is a strong developmental team, both on the board level but on the management level as well, with many senior experienced leaders in big and small pharma. Today, we see predictions that high uric acid that leads to gout is increasing and is projected to double in the course of the next 20 years. In these individuals who have gout attacks because of their high uric acid, the active inflammatory environment with which they live leads to a number of symptoms. The ones we recognize most are the sore big toe. There are other health consequences of high uric acid, chronically high uric acid that include accumulation of kidney stones that can mechanically injure the kidney, pain in not only the big toe but in ankles, knees, wrist joints, toe deposition. Those bumps under individual skin, due to their uric acid can also accumulate. More recently, clinical studies have shown that if you have chronically high uric acid, the crystals that form within your blood can impale your major vessels, your aorta that feeds your body from your heart, and the arteries that feed your heart in a way that accelerates the formation of atherosclerosis, which means you have a higher propensity to stroke and heart attack. We seek to address, with our New Drug Application, the 3%- 5% of individuals who can't tolerate allopurinol. When one looks at the demographics and tries to estimate the addressable market, it is reported today that there are 50 million individuals who have uric acid levels in their blood that are higher than normal. Of those, about 7 million- 9 million individuals have had at least one diagnosis of gout. Of those, about 3.5 million individuals have a once-daily allopurinol regimen. In many of those individuals who start on allopurinol, 3%- 5%, they can't tolerate the drug. If it's introduced and they're withdrawn because of side effects, generally rash or liver enzyme issues, and it's tried again and they fail, they have very few therapeutic options. We have the opportunity with our XORLO product or tertiary formulation of oxypurinol to serve that market in a way that has already been shown to be effective in clinical trials. We project that the launch price for this drug in this space would be somewhere between CAD 6,000 and CAD 8,000 per patient per year. That projects out to a peak addressable market, peak net sales of around CAD 700 million per year at its most conservative. I'll talk about that a little bit in the study. The opportunity that has arisen over the course of the last four or five years is an opportunity that was being filled by a drug called febuxostat. Typically, when you're diagnosed with gout, the guidance is that you start on allopurinol. If you're not getting relief of your gout symptoms or sufficient uric acid lowering, then a drug like febuxostat was prescribed. Febuxostat at its peak, which was peak net sales of around CAD 180 million, was being prescribed to about 70,000 individuals. That's a key number to pay attention to. Our estimates are that we can fill that gap that resulted from the black box warning that was placed on the febuxostat monograph and its diminishment, its decrease in the market to CAD 25 million-CAD 30 million in peak net sales today, by advancing our XORLO product. No drug currently fills this gap. All individuals who can't tolerate allopurinol, oxypurinol has been tested in a number of individuals in phase one and phase two trials and also in a compassionate use trial. For individuals who failed allopurinol introduction twice and so had no therapeutic options, the use of oxypurinol would provide therapeutic relief to about two-thirds, about 70% of allopurinol-intolerant individuals. We believe that bodes well for the market we wish to address. It is notable that at its peak, febuxostat addressed really only 70,000 individuals. We believe that patient population is between 280,000 and 300,000 individuals. We believe with that tolerability, 70% getting therapeutic relief, it is much greater than the CAD 450 million that febuxostat reached with peak net sales. Currently, in the competitive landscape today, allopurinol is the drug of first choice. If you fail that, febuxostat is still available, but with a black box warning. That black box warning arose because of reports that individuals on drugs had increased levels of sudden cardiac death if they had a heart attack. We believe the opportunity is right now. We are about a year to a year and a half away from filing that NDA. The review period is estimated to be 9 months-1 2 months. We aren't very far from getting to that marketing approval. Steps we need to undertake to bring this exciting opportunity forward are an IND filing. The team is currently working on that IND filing now. We are designing a pharmacokinetic study to provide the last questions to the FDA, the last answers to the FDA regarding how our commercial tablet is absorbed when an individual takes the tablet in a fasted state, so open, and when an individual takes the tablet with a heavy meal, a heavy meal, if you will. The difference in absorption for our commercial tablet is something that the FDA uses to judge how effective that will be and the range of effectiveness. It is also a check to understand that we're not seeing so much drug accumulated in the system that you would anticipate the emergence of side effects. The last step that we need to undertake before we file a New Drug Application, the NDA, is to produce a phase three standard cure drug tablets in the formulation, the XORLO formulation, and the tablets in packaging and put them on stability. One year of stability is necessary for the FDA to approve. We see manufacturing drug and moving it forward as a parallel operation to preparing the NDA and filing it. We've taken a drug with an excellent safety record, oxypurinol. We have formulated it in a way that makes it much more druggable, so much more available to individuals. That allows us to administer the drug with ease across the full therapeutic range. The pharmacokinetic studies that we've done previously show that we can reach the levels that are necessary for 90% inhibition of this enzyme that is key in reducing uric acid levels and reaching that optimal therapeutic range. That wasn't possible without the reformulation of oxypurinol. Our second program, which is equally lucrative, but not our priority at this point, is the ADPKD program. This is a disease that begins with a mutation, and that mutation leads to the increased formation of cysts within blood vessels, within the kidney, within the liver. That can lead to a number of symptoms. Those individuals with the disease, typically by age 20 or so, have kidneys that have gone from this size to one liter size or so. By their 30s, those individuals have kidneys that are now two times that. Typically, in this population, by age 55 or so, mid-50s, half of individuals have lost their kidneys. They also suffer from a wide variety of symptoms, such as reduced kidney function, high blood pressure, high uric acid, increased kidney stones. One of the major issues for these individuals is cardiovascular disease. They have a higher incidence of stroke or heart attack. There is a desperate need for therapies in this space. The one drug that's approved is tolvaptan. Its average price is CAD 156,000 per patient per year. It earns, by treating only 5% of the individuals with the disease, almost CAD 1 billion a year. There is a desperate need to treat the other remaining 95% of individuals. As we estimate the addressable market for autosomal dominant polycystic kidney disease, we have reached out to independent commercial assessors. Their feedback after speaking with 30 nephrologists and payers who represent more than two-thirds of all insured individuals in the U.S. is, as an orphan drug, designated drug, they would adopt this drug if it was approved by the FDA. As we estimate what that market looks like, what peak net sales could we reach, we know that individuals with stage two, three, and four, allopurinol-assisted kidney disease, those who most need therapeutic intervention to manage, to maintain their disease rate as today, we estimate that almost half, 55% of those individuals with stage two, three, and four ADPKD are hyperuricemic. They have high levels of uric acid. We know from several animal models, not just one, that when uric acid is high in this disease, it accelerates the total kidney volume expansion. That is closely correlated to declining kidney function. If we use the precedent set by the pricing of tolvaptan at CAD 156,000 per patient per year in this rare disease, and we are designated, we come up with an estimate, not treating 5,000 individuals, but probably treating 18,000 individuals or so, 50% penetration, with peak net sales estimates that are well in excess of CAD 1 billion. We are there today, and we are preparing an IND submission. We think that will be creative in terms of building company value. The PK study that we are preparing to launch will also be very important to facilitate and support the NDA filing. The manufacturer of drug product and the tablets' stability is essential for the NDA filing. As we prepare the New Drug Application in parallel with these steps, we believe within 12-1 4 months, we can be filing the NDA. It is notable that both in the gout space and the polycystic kidney disease space, there are large partnership deals that have been set in recent times. We believe these two programs are poised for those kinds of conversations. We have an experienced team of drug developers that have skills across the various disciplines necessary to bring this drug product to its final stage and commercialization. Our priority is to find a partner to advance forward on a global scale. However, we are also open to those partnership deals that would be more than a jurisdictional basis. Other individuals with experience in developing drugs, clinical and regulatory, Dr. Stephen Howardth, Dr. Terry Moybihan, with chemistry and manufacturing leadership experience. Michael Bumby, who is Chief Financial Officer and who has experience with companies such as Zion Aluminy, as well as a handful of other small Canadian biotech startups. Stacy Evans, who has experience in business development with Pfizer. Our board of directors, similarly, has experience across many of the varying disciplines of developing a drug from start through commercialization. Giovinazzo had a lucrative exit in 2015 with a drug and the company Synapsis. That exit was CAD 841 million. Paul Van Damme has had experience on the financial side with large and small pharma companies. William Farley experienced with business development and partnering activities in large and small companies. Abigail Jenkins and Patrick Traynor both experienced in commercializing drugs and valuation. Dr. Raymond Pratt is a nephrologist by training who has decades of experience in drug development and in advancing drugs through marketing approval. Today, we have a very tight cap table with 9.6 million shares fully diluted, about 5.1 million common shares issued, 5.2 million warrants outstanding of 4.3 million shares, and a 10% rolling option plan. In summary, we're very close to advancing a number of key steps. Those key steps, in our mind, we believe are low risk. That puts us in great stead to be able to prepare and file the New Drug Application in the near term, leading to the very exciting transition from a research and drug development company to one that is revenue positive and reaching for that CAD 700 million a year peak net sales for the gout program, then secondarily the ADPKD program. XORTX Therapeutics, located in Calgary, Alberta, with a team spread across North America. Thank you for your attention. Thank you very much, Allen. Allen, we are hearing you, but it's a little bit rough and murky. If it's easy for you, if you completely understand what may be the problem, fine. Otherwise, let's not get into a big investigation about it. We can accept the way you're sounding now. If you just have some quick fix that you know of, something that you may have forgotten to turn on or something, then by all means, do it because you're a little murky today. Now we're moving to questions. If you have a question for Dr. Allen Davidoff, please indicate that you have one by using the raise hand button at the bottom of your Zoom window. I can then enable you to speak. You can also type in your question using the Q&A button at the bottom of your Zoom window near the raise hand button. We will give everyone a moment for questions for Dr. Davidoff. Allen, what de-risking steps have been completed for the gout program, such as the patient tolerability study, and how do they position XRx-026 for accelerated approval pathways? Several levels where that question can be answered. This is a drug that was advanced through an NDA filing in the early 2000s. It's a drug that received an approval letter, which in the FDA's interpretation means it's largely safe and effective, but there are several questions to be answered. As I mentioned previously, the dosing of oxypurinol and the absorption of oxypurinol in the unformulated state doesn't allow you to hit the therapeutic range, the therapeutic sweet spot. For the company, there was an opportunity to innovate, the drug, how it was delivered, and produce it in a tablet form that was convenient for individuals. We've tested that in pharmacokinetic studies. It has been previously tested in gout patients, in patients who are intolerant to allopurinol, and in patients with renal insufficiency. We believe the safety record that has been accumulated because of those clinical trials substantially de-risks the program. Our conversations with the FDA in the past, both with regard to the ADPKD program and with regard to this program, have indicated that that is the case. Thank you very much. With the recent EU patent grant for XRx-026, what is the status of U.S. patent protections, and how do they provide exclusivity against competitors in the xanthine oxidase inhibitor space? Recent patent grant, the European Patent Office side, covers the major countries within Europe: Great Britain, Spain, Germany, France, Italy, and a handful of others. The design of the patent portfolio began with a general patent that covers the use of all xanthine oxidase inhibitors. That means that those enzymes are free acids by nature, so any of them can benefit by reformulation in combination with basic molecules and primarily basic organic molecules. Those patents were granted in the U.S. and in Europe. They have a life that extends from 2014 when they were first submitted through 2034. The clinical work that we're doing with the molecule now and this formulation specifically, we believe we can pursue extensions of those patents. In addition, we bring patents that cover the use of this drug specifically in cystic diseases. In diseases where the formation of cysts can have health consequences, and that is wide-ranging, polycystic kidney disease being the focus, but cystic fibrosis and other diseases have an element of cystic formation that affects health. Finally, more recently with the pharmacokinetic studies, the clinical studies that we've done to date, we've also written a new layer of formulation patents and use patents specifically in the gout space and in progressive kidney disease. That creates its own additional layer. Those two families of patents have life through 2041 and 2043. Those are the patents that cover the gout as well as have utility in the ADPKD program. Thank you, Allen. Looking ahead to potential approval and launch, what is your commercialization strategy for XORLO, including pricing and distribution? We're working on that as we speak. We still have key activities with regards to the development of the drug. We anticipate putting in place manufacturing, distribution, and selling group contracts in the near term, within the next year or so, in preparation for launch of the XORLO product for gout. Our strategy is to begin in the U.S. and then expand quickly to the various other jurisdictions around the world where we know we've had increased respect to the availability of this drug, that there is a need for alternatives to allopurinol. That's the status today. Just a simple question here. What happened to XRx-008? This is a program for autosomal dominant polycystic kidney disease. Because of the very near-term opportunity with gout, the priority is on the gout program. Once revenue is generated and starts to come in, the ADPKD program will be restarted. Thank you very much, Allen. Give everyone a moment here for any questions they may have for Dr. Allen Davidoff, the CEO of XORTX Therapeutics Inc. Allen, now that I'm not seeing any more questions in the queue here, could you give us the essential value proposition before we wrap up? Why should investors take an interest in XORTX Therapeutics right now? It's a simple question. In concept, today, we have a market capitalization of around $4 million -$ 5 million. Over the course of the next 12- 24 months, with the activities that we have planned, we believe those are low risk, so achievable, and will be accretive. By accretive, typically what we see with other companies within this space, as you submit your NDA and reach for that approval, typically you see that the value creation steps you've undertaken start to approach your peak net sales projections and even up to multiples of 2x-3x that. We think this is an important transitional time and a very exciting transitional time for the company. As we work towards achieving these things, we think there is an opportunity to create a high-value entity in XORTX Therapeutics. Thank you very much, Allen. Thank you. All right. As we wrap up, let me give some ways that users today can learn more about your company. You can write us at XORTX info, oh, sorry, xortx@redchip.com. That's xortx@redchip.com. Of course, you can always call us at 1-800-REDCHIP. We also have an information page for XORTX Therapeutics. It's xortxinfo.com. There, you can view and download the investor presentation and fact sheet and sign up for news alerts on XORTX. Please watch Small Stocks, Big Money, RedChip's program featuring exciting small-cap companies on Bloomberg USA every Saturday night at 7:00 P.M. U.S. Eastern. Join RedChip's next webinar with 60 Degrees Pharmaceuticals on Tuesday, September 16th, 2025, at 4:15 P.M. ET Register for all RedChip webinars at redchip.com events, where you can also view an archived version of today's webinar. Also, if you want to see an archived version of this webinar, you can go to youtube.com/redchip. You can subscribe or look down under the investor webinars and find today's webinar in about 12 hours from now. It takes us a little bit of time to process it. Thanks again to our many participants today. Thank you very much, Allen. Thank you for the opportunity.