About: XORTX Therapeutics Inc (XORTX) is a drug development company primarily focused on orphan disease indications which have a uric acid imbalance as well as metabolic syndrome, diabetes and diabetic nephropathy. XORTX possesses patents and patent applications that include US and Worldwide rights for the development of uric acid lowering agents for the treatment of Hypertension, Insulin Resistance, Diabetes, Metabolic Syndrome and Kidney Injury – large market opportunities.
Dr. Alen Davidoff provided an update on his previous interview from August 2020. Xortx just announced a recent grant on their European patent as well as other activity in the market. The company is hoping to start on their phase III trial on their autosomal dominant polycystic kidney disease program in the next quarter as well as up-list to a higher-tiered US exchange.
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 at XORTX Therapeutics. The company trades on the Canadian Securities Exchange XRX and on the OTCQB XRTXF. Thanks for joining us, hey there, Allen.
Allen Davidoff: My pleasure. Thank you for the invitation to chat to you and to your listeners.
WSA: Great to have you back on. And for some of our listeners that didn’t catch our previous interview, can you provide us there with an overview of the company?
Allen Davidoff: Yeah, my pleasure. XORTX is the company that for the last four or five years has been focused on developing therapeutics for chronic kidney disease, specifically autosomal dominant polycystic kidney disease, which is a rare disease, an orphan disease, and for diabetic nephropathy. This is an area — both areas actually where there is a large unmet need and substantial market opportunities around the globe for products to help individuals. More recently, with the advent of COVID, we found ourselves in a unique position with a tool that is well suited to lower uric acid, a partnership with Mount Sinai Research in New York and the opportunity to gather evidence, which we’ve presented most recently, showing that there is concerningly high uric acid levels in hospitalized COVID patients and not sufficiently high to cause concern regarding acute kidney injury, but also acute other organ injury – cardiovascular, neurological, et cetera.
WSA: Sure. So can you talk about some of the most recent news there? You just announced, you know a recent grant of the European patent and perhaps some of the relevant news here over the last few months since we spoke?
Allen Davidoff: Yeah. So with the turn of 2020, we’re working diligently on the autosomal dominant polycystic kidney disease program and saw very early in March, the emergence of acute kidney injury and started with the team to do research that suggested we could write a provisional patent in this area covering our class of drugs, which are those xanthine oxidase inhibitor class of drugs because there is a clear signal that high uric acid in this setting might be playing a role as an accelerant, but also worsening the outcome for patients. A couple of months after that we agreed with Mount Sinai Icahn School of Medical Research to a partnership that would allow us to look at the existing database of patients’ records at that hospital group and really gleaned out some key pieces of information: is there high uric acid in these hospitalized patients; when does that happen; and what does that tell us about the way we need to treat these patients in order to help them?
And so we’ve announced the topline result as early as a couple of months ago. We continue to analyze data and see new data emerging that suggests we’re on the right track. And as you alluded to more recently over the late part of December, we received news from the European Patent Office that our patent for new formulations, new compositions of xanthine oxidase inhibitors was granted, and that specifically is a patent that we wrote for the autosomal dominant polycystic kidney disease program, those individuals who have advancing polycystic kidney disease lose their kidneys typically in the early 50s or 60s of age and that puts them on a path to dialysis. And we think that there’s an opportunity under this granted patent and under an orphan drug designation for protecting this patent through 2023, 2024. We’re also waiting for the US grant of that patent and hope to have that soon.
WSA: Yeah, sure. I was just going to ask you, what are the main goals and milestones that you’re hoping to accomplish over the first half of the year?
Allen Davidoff: We see the opportunity here to move quickly on several fronts on the Covid front where we’re looking to tee up a phase III trial in the near future in the next quarter or so, possibly as an investigator led trial. We think that there is an opportunity and we’ve had inquiries regarding potential up-listing to an American exchange which opens the door to exposing our story more broadly and certainly because we have late stage programs in both the COVID space and in polycystic kidney disease, there is substantial interest in these unmet medical needs around the globe and there are tens of pharma companies based on our experience, who are looking for late stage programs to fill that unmet needs. So there are opportunities to join into development agreements this year that should be substantial and important inflection points, key catalysts for the company.
WSA: And what are some of the key drivers that investors should look out for as far as what makes you guys unique in the space?
Allen Davidoff: Well, we anticipate seeing additional results from Mount Sinai Research Partnership and possibly a published paper that will really help to characterize what’s happening in COVID patients with regard to substantially increased uric acid levels. It also leads us to steps such as manufacturing of drugs for these clinical trials to regulatory filings in both the Covid and the polycystic kidney disease programs and other orphan drug designations if you will. We anticipate later in the spring or summer to be initiating short bioavailability studies for these new formulations of drugs and then moving into phase three trials in both autosomal dominant polycystic kidney disease and in COVID sometime in the next three quarters. Those should all be inflection points and a pretty steady flow of news as we go forward.
WSA: Yeah, and perhaps you can walk us through your background experience Allen and the key management?
Allen Davidoff: Yeah, you bet. The key management is composed of myself and a number of others who have a lot of industry experience. My background is a Ph.D. in Cardiovascular Physiology. I’ve been in the drug development industry for almost 20 years now. My experience ranges from cardiovascular to neurological and now more recently to developing drugs in the renal space, in the kidney space. Much of the team I have worked with over the last 20 years and that includes individuals within the manufacturing, medicinal chemistry, clinical trial development and regulatory development sides of the business. And so we’ve got a well-rounded team, and recently added individuals like Dr. David Sans who has considerable experience both in business development and in finance.
WSA: Right. And I’m not sure we discussed it, but yeah, I know last time we discussed, you have another play there, XRX008, any other updates in that space?
Allen Davidoff: We are working to manufacture drug. We launched the manufacture of drug in the late summer last year that should be moving along to completion. That will provide us with clinic ready material – drug material in order to move towards both the bioavailability study in this XRX008 program but the phase III study, which is key and is a driver for discussions with other industry partners and moving to the approval stage.
WSA: Certainly. So once again, we’re speaking with Dr. Allen Davidoff, CEO at XORTX Therapeutics, which trades on the Canadian Securities Exchange XRX and in the OTCQB XRTXF, currently US price on the OTCQB price is $0.21 a share US, market cap is about 17 million US. So before we conclude here, Allen, to get a brief and quick recap of some of your key points here, why do you believe investors should consider the company as a good investment opportunity today?
Allen Davidoff: The company is poised with a number of inflection points, including an up listing to the US and certainly the opportunity for partnering drivers to change both where we are in terms of our status, provide cash flow, and also our focus on exposing the story now to a much broader global audience should be drivers of interest and certainly awareness of what we’re doing. And that usually equates to movement towards the main—where we’re on the Canadian Exchange right now and on the OTC board—but have considerable interest to move up to the larger, more broadly focused on boards for life science companies, and in that movement should be a driver towards the market cap mean that we see for companies at our late stage of development.
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 there, Allen, and update our investor audience on XORTX. It was great having you on again.
Allen Davidoff: My pleasure. Thank you for the invitation Juan.