Xortx CEO Dr. Allen Davidoff took time to update investors on the company’s accomplishments over the last several months. XRX just announced a partnership with Mount Sinai’s Icahn school of medicine for a US based COVID-19 clinical trial for acute kidney injury associated with the virus. Dr. Davidoff also talked about their other key programs and the major milestones Xortx hopes to accomplish this year.
WSA: Good day from Wall Street. This is Juan Costello Senior Analyst with the Wall Street Analyzer. Joining us today, is Dr. Allen Davidoff, CEO for XORTX Therapeutics. The company trades on the Canadian Security Exchange ticker symbol XRX and on the OTCQB, XRTXF. Thanks for joining us today there, Allen.
Dr. Allen Davidoff: My pleasure. And thank you for the invitation to speak to your subscriber base.
WSA: Sure. So it’s been about a year since our previous interview, for some of our listeners here that didn’t catch that, can you start off with an intro and overview of the company?
Dr. Allen Davidoff: Yeah. You bet. The company itself was founded in 2012 and as you mentioned listed on several stock exchange. That happened within a reverse takeover undertaking in January of 2018. So we’ve been publicly listed for about three years now. The company itself has focused on developing therapies to slow and or reverse chronic kidney disease in diseases that really represent the largest portion of causative diseases for progressive kidney disease, like type two diabetic nephropathy and autosomal dominant polycystic kidney disease or ADPKD, it’s a mouthful to say. These are areas where there are a few therapeutic options that exist for physicians, and for patients and where our technology provides a first in class opportunity to deliver these therapies to patients in the next few years.
So we’re pretty excited about that. We aggregated over the course of our life patents in an area as broadly as claiming the use of any Xanthine oxidase inhibitor to treat obesity, hypertension, pre-diabetes, diabetes, and the health consequences of diabetes. And so that foundation of patents really is where our company began. We have built on that foundation of patents with strong patents, new patent filings in the area of polycystic kidney disease and more recently in the area of COVID-19 infection.
And what we’re seeing with COVID-19 is that many individuals who have the infection wind up with long-term kidney issues, if not complete loss of their kidneys. And so there’s an acute kidney injury happening there that we’ve filed a prophetic patent on and continue to expand on that patent portfolio as more new information comes in. We also have the benefit of an experienced management team that’s worked on most aspects of drug development and more importantly on this class of Xanthine oxidase inhibitors and specifically for this purpose. So we have a lot of agility on our management team and great advisors on our board of directors.
WSA: Sure. So, can you bring us up to speed there on some of that recent news, as you just announced the partnership with Mount Sinai’s Icahn School of Medicine for your COVID-19 US-based clinical trial?
Dr. Allen Davidoff: I’d be happy to. What we saw early in March was a number of reports on COVID-19 infection that came from China that suggested that a large number of individuals were facing acute kidney injury. So about 20% of individuals who have a COVID infection wind up being hospitalized, many of those have the involvement of their kidneys. Some unfortunate few wind up being on dialysis for the rest of their life and about the same number wind up having long-term injuries to their kidneys. The pattern that’s emerged with COVID-19 infection is that COVID is more an infection that starts with the lungs, but it’s more an infection of the cardiovascular system; the vascular lining, the endothelium. And as the infection progresses and gets worse, this is a scenario that leads to the death of cells, cell debris within the cardiovascular system and increasing levels of uric acid.
And we know once you reach a threshold of uric acid that that uric acid concentration can crystallize out in the blood and go and harm the kidneys. And so what we’re seeing is evidence that continues to build, to suggest that this is the case. And in fact, there are good animal studies to suggest that if you inhibit Xanthine oxidase, the enzyme that produces uric acid, you can have a benefit in terms of protecting kidneys and in terms of protecting potentially other organs that are injured during the course of this viral infection.
So there is a very promising opportunity here to grow our relationship with the folks at Mount Sinai’s Icahn School of Medicine with this initial clinical study. But also in the future as we start to ramp up and accelerate our proof of concept studies that will potentially help millions of people around the world. And in this scenario where we see this accelerating COVID-19 pandemic the need is ever increasing for therapies that will suppress not only the harm that’s coming to individuals because of the virus infection, but potentially decrease the number of folks who die.
WSA: Certainly. Can you talk about your other key program there, XRXOO8, and key updates there?
Dr. Allen Davidoff: You bet. So this is a program in autosomal dominant polycystic kidney disease, ADPKD. This is a disease where an underlying genetic mutation sets the stage for not only the formation of cysts, but for the growth and expansion of those cysts. Over the course of 20 or 30 years, individuals see that their kidneys go from what should be a fist size organ to an organ that could be the size of a cantaloupe or a football. As those cysts and as that kidney expands, we see that there’s destruction in the local areas of the tissue around these cysts. And there’s growing evidence to suggest that the enzymes inoxidase is expressed in that tissue and that is accelerating and causing harm.
But the other thing that happens is many of these individuals; more than 60% have been shown to have high uric acid levels. And again, it sets up the scenario for not only the accelerated growth and seeding of these cysts, but potentially the scenario where crystal injury can happen to the kidneys again, and this in turn accelerates disease progression. So we have the tool that we can suppress this uric acid effect with. There are very nice human studies suggest that we can in fact, in polycystic kidney disease, patients decrease and stabilize their kidney function and potentially slow and reverse their injuries so that they don’t wind up on dialysis. Their kidneys are preserved for longer periods of time. And of course this goes directly to quality of health.
Our ultimate goal is really to keep patients off of dialysis. And so there’s good evidence that suggests that that’s the case. Our current activities right now are focused on manufacturing drug for that program on our regulatory filings, including the final form of an IND and orphan drug designation. And that will then lead us into a phase three clinical trial in patients with polycystic kidney disease. So we have a late stage program that can move very quickly into the clinic and show meaningful results.
WSA: So what are the other key accomplishments from this year that investors should be aware of?
Dr. Allen Davidoff: Well, as we all know COVID has interrupted a lot of activities, but it’s also provided opportunities to help a huge number of patients that need help. So while we advance our clinical program in ADPKD, autosomal dominant polycystic kidney disease, with the manufacturing of drug and regulatory activities that lead us to that phase three, we’re also focusing now on obstructing that injury to kidneys and other organs in COVID-19 infection, with the idea that we can potentially provide a lot of protection and possibly effect mortality. So we’re quickly moving into partnerships with groups like Mount Sinai. There are others around the globe who have expressed interests from academic centers. And so we’re trying to act as the catalyst to bring that group of excellence together as a COVID fighting team. And then finally, we’re working diligently to put our regulatory documents in place that would then permit us to move into the clinic and tests our approach on individuals with COVID.
WSA: Surely. And so what are the key goals and milestones that you’re hoping to accomplish over the course of the next six months?
Dr. Allen Davidoff: With regards to the polycystic kidney disease program, our orphan drug designation and our IND filing as well as manufacturing clinical supply of drug for that phase three clinical trial is our focus. With regards to the COVID program, our focus again is on manufacturing this new proprietary formulation of Oxypurinol for COVID patients, meeting with the FDA, submitting our regulatory documents in order to permit us to move forward, working with individuals around the globe on possible clinical studies and launching a phase three clinical study in this area.
WSA: And can you discuss the recent management and advisory appointments from recently and what they bring to the table?
Dr. Allen Davidoff: Yeah, you bet. Our recent appointments in the last six to eight months are Dr.Anjay Rastogi. He’s an academic nephrologist who is at the University of Los Angeles and runs the core kidney program, which is a specialized polycystic kidney disease program in the Los Angeles area. He’s a thought leader and a kidney specialist who is a great addition to our team and advisor who can help us both with the design and development programs for the polycystic kidney disease program. And so we’re extremely pleased that he’s joined our clinical advisory group and joins other nephrologists who are in their own right thought leaders like Dr. Richard Johnson, Dr. Petter Bjornstad, Dr. Jamie Rivarie and Dr. Steven Coca. All of which make up a substantial group of well-known and well considered physician nephrologists.
Our recent appointment last week of Dr. David Sans brings into our management team an individual who’s worked with major pharma in drug development programs, but also has worked in the capital markets. And his experience really lends itself well to a couple of areas that includes future licensing discussions, a variety of capital markets activities, and also in the drug development space. So we’ve been fortunate to find very strong individuals to join our team and further help validate what we’re doing and bring it to patients as soon as possible.
WSA: Certainly. So once again, we’re speaking with XORTX CEO Dr. Allen Davidoff about recent news developments. The company trades on the Canadian Securities Exchange, XRX, and on the OTCQB, XRTXF, currently trading at 16 cents a share US. Market cap is about 12 million US. So before we conclude here, to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Dr. Allen Davidoff: I think the company represents a good investment opportunity because it really is a company with late stage clinical trial programs in three areas that have few therapeutic options. We have a growing strong intellectual property patent portfolio. In the near term, we have the opportunity to launch three clinical stage studies in polycystic kidney disease, in COVID programs, and a phase two study in diabetic nephropathy. As you pointed to with market capitalizations around 15 million and large value creation steps ahead, when one looks at comparable companies in this area, you see that the market caps are considerably larger. And as we continue to add value with our development steps, we think that the conditions are aligning well for moving towards the mean on those valuations.
WSA: Well, we certainly look forward to continuing to track the company’s growth and report on your upcoming progress. And we’d like to thank you for taking the time to join us today, Allen and update our investor audience on XORTX. It’s great having you on.
Dr. Allen Davidoff: My pleasure Juan. Thank you for the opportunity to speak to your investors.