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.
WSA: Good day from Wall Street, this is Juan Costello, Senior Analyst with the Wall Street Analyzer. Joining us today is Dr. Allen Davidoff, the CEO at XORTX Therapeutics. The company trades on the Canadian Securities Exchange XRX and now in Nasdaq XRTF. Thanks for joining us today there, Al.
Dr. Allen Davidoff: Thank you, Juan. And it’s a pleasure to be here and speak to your folks. I can say that the Nasdaq ticker for XORTX Therapeutics is XRTX, and we’re very pleased to have taken this most recent step in the last few months and certainly we’ve been working at it for the last couple of years.
WSA: Yeah, certainly. And it’s great and can you start off with an intro of the company, who you are, what you do here for people that are new to the story?
Dr. Allen Davidoff: Yeah, you bet. We’re a company that’s focused on developing kidney disease therapies. There are our two lead programs and a secondary program. Our lead programs are in late stage, late clinical stage testing. We’re working towards the initiation of those clinical trials, both in autosomal dominant polycystic kidney disease, where we see there’s a very large, unmet medical need. These individuals need therapies to be introduced into the market, and we’re working diligently to start our registration trial that would lead to marketing approval.
With respect to our second program, which is making great strides, because of a partnership we initiated with Mount Sinai Hospital Group in New York, is addressing the large number of individuals with acute kidney injury, and what we see is an emerging chronic kidney injury as a result, when COVID infection occurs. We’re seeing that there is excellent evidence emerging and being presented at the present time that shows that uric acid and high xanthine oxidase expression is a driver of acute kidney injury in patients who are hospitalized with COVID and that seems to be the indication for long COVID as well. And we’re moving quickly into a registration trial where we believe that emergency use approval would occur with a positive result from that late-stage clinical trial. And then our last trial is in diabetic nephropathy — our last work is in diabetic nephropathy, where we have early-stage candidate molecules under development.
WSA: Can you bring us up to speed on some of the most recent news, as you just closed an offering, and as you mentioned, you had the results from the trial?
Dr. Allen Davidoff: Yeah. So it’s been an exciting year for the company. We’ve raised sufficient funds through simultaneous Nasdaq up list and financing. Before that, we concluded a pipe financing in March of 2020. Those two financings together are largely institutional in nature, with very little retail funding, and we’re quite pleased to see some of the major life science funds participating in that financing. So we have the capital to move forward. Those programs will allow us to advance our partnership with Mount Sinai, looking at acute kidney injury in individuals with COVID, and open a phase three clinical trial sometime in the next year. The funds are also driving our research and development for an orphan drug designation in polycystic kidney disease and then the start of phase three clinical trials as we go forward as well.
So our news flow has been primarily related to the science and partnerships we’ve studied, but also as we come out of the quiet period that’s associated with the Nasdaq up listing and the SEC review, we look to start to speak more openly to the US and European markets about our story about where we are in late stage clinical development and push things forward from value creation standpoint.
WSA: So our previous interview was in January. Time flies, any other important markers and milestones since that time?
Dr. Allen Davidoff: Well, we’ve focused much of our work on building both our clinical advisory board and our Board of Directors. We’ve almost doubled our engaged, experienced drug development professionals since that time, and we see further growth going forward. We’ve made many of those announcements in the course of the last six to seven months, and we see now with treasury in place, that we can start a succession of regulatory filings both for the start of clinical trials, but also for orphan drug designation. There are a number of folks associated with a number of analysts looking at our programs and writing research reports as we go forward. And I think it bodes well for both news flow and for analyst coverage across the US and Canada and Europe as well.
WSA: What are the key goals that you’re looking at here over the course of the next three to six months that investors should keep an eye out for?
Dr. Allen Davidoff: Right. Well, I think the key goals that we’re working on are with respect to the polycystic kidney disease program, filings for a bridging clinical study and then moving into a full phase three clinical study in the mid-term of next year; for polycystic kidney disease pretty much the same path, regulatory filings with US and European regulatory agencies, filing of protocols for both of those registration trials, so they’re late stage phase three trials. And then other regulatory filings towards the end of next year, as we conclude one of those clinical studies and move that forward. So a succession of ridging clinical studies as well as full loan phase three clinical studies over the course of the next 15 months.
WSA: Good. And what do you feel makes XORTX unique from some of the other players in the sector and able to grab market share?
Dr. Allen Davidoff: Well, I think the state we’re in right now in terms of market cap is somewhere around $40 million. Our comparable companies have market caps that are substantially different than ours. Our Nasdaq up listing exercise really was for the same reason that everybody up lists on Nasdaq, and that is the liquidity, the exposure to the global markets and certainly recognition for the late-stage trials we have. We hope to augment over the course of this year by getting out and telling the story and marketing the company heavily. We see that that’s a big driver of recognition for where we are and what we’re poised to accomplish.
WSA: Yeah, sure. And perhaps you can talk about your background and who some of the key management team is there, as you mentioned, some additions and, you know, shifts.
Dr. Allen Davidoff: Yeah, you bet. So we have worked very diligently on bringing in key people. Most recently our Chief Medical Officer, Stephen Haworth, who has extensive regulatory and clinical experience as we move forward with the clinical path. He’s a key member of the C Suite team. We’ve also brought on a half a dozen or so members of my former team at Cardiome Pharma, who worked with this class of drug and filing of late stage regulatory filings and drug development for this molecule that we’re now innovating and enhancing in terms of its pharmaceutical qualities. Our Board of Directors continues to expand. We have an upcoming AGM in late December, and we expect to add at least two high level board members to the team as well. So there is growth on the management and the governance side of the company as well as we go forward.
WSA: Yeah, great. So as far as investors in the financial community, is there anything that you wish, perhaps they better understood about you guys, which would result in a possible higher valuation?
Dr. Allen Davidoff: I think the take home message is that we’re new to the Nasdaq. We expect that there will be recognition for the company and our late-stage programs in the course of the next year, two years. And many of the milestones that we have ahead of us are really key milestones for the development of these drugs and getting them to marketing and revenue. So there is a well laid out critical path ahead that includes a lot of markers that investors tend to cherish.
WSA: That’s great. And so once again, we’re speaking with Dr. Allen Davidoff, the CEO at XORTX Therapeutics, which as mentioned, now trades on Nasdaq XRTX and of course, on the Canadian Securities Exchange XRX. Current US share price $2.67 a share, market cap is slightly north of $30 million. So before we conclude here, why do you believe investors should consider the company as a good investment opportunity today?
Dr. Allen Davidoff: Well, I think where we are today and where the Nasdaq up listing permits us to go with the things that we are working on in terms of the direct development programs, both for polycystic kidney disease, which is largely unmet and with regards to the new opportunity that is growing very rapidly for acute kidney injury and chronic kidney injury in individuals with COVID infection, represents a fairly bright future for the company. I think if you do a comparable chart of kidney disease companies and companies at this late stage of development, we expect that there are many opportunities for value creation over the course of the next 24 months.
WSA: Well, we certainly look forward to continuing to track the company’s growth and report there on your upcoming progress. And we’d like to thank you for taking the time to join us today Al and to get an update here to our investor audience on XORTX. It’s always good having you on.
Dr. Allen Davidoff: My thank you to you and the folks at Wall Street Analyzer, Juan, appreciate the time.