All right, welcome back inside our proactive newsroom. And joining me now is Roger Dublin-White. He is the CEO of Feralase Technologies. And Roger, good to have you back again. How are you? - I'm great, Steve. Great to be on the show. - Yeah, so here to provide a bit of an update for everyone on Rufadar, which is your lead drug as far as cancer is concerned, blood cancer. And so you're in a phase two registration study. So maybe you update everyone about Rufadar and where you're at right now. - Well, I think we're at the final stages. We're just wrapping up that study. So we've enrolled 75 patients to date, 68 of them we've evaluated at 90 days. And then the numbers get smaller as we go out to three years. We're still waiting for that data. But I think the data is very, very strong. You're showing a complete response rate for patients of 60% at any point in time. So three out of five patients who walk into the clinic on the morning, walk in at seven o'clock in the morning, leave at 12 noon. Three out of five are walking out cancer-free, which for bladder cancer is incredible. But what's really interesting is the duration of that response. We're showing around 26%, 26 and a half, I think, at 15 months, so 12 months duration of response. And when we look at the Kaplan-Miers curve, we're seeing about 35, 36% at three years on their estimation. So for these patients, three out of five are getting cancer-free right off the bat. According to the data analysis, a third of those are keeping their bladders and obviously their quality of life for three years or more. It's great for them. - Yeah, and obviously this data is very encouraging moving forward, as you said, and just about how long out it is. Can you sort of talk about the generality of where it is right now in the market, as far as what people would see normally? Like, are you seeing these improvements in what's available for people now? - Well, you're seeing a BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, which is a high-grade disease. There really hasn't been anything available for that disease for really four years. So the first drug was approved of Val Rubisson which was about 40 years ago. Fairly low response. Merck came out with Catruda, which they've used for a lot of different conditions. They got approved January, 2020. They were showing at 15 months, around 19%. Then you had Immutative Bio, was another drug that came out using their drug in combination with BCG. There was also faring that came out with the oncolytic virus. But all these numbers are in the teens to be the low 20s, as far as performance. Fairlays is showing a little higher than that, 46 and a half percent. But what's really interesting is really only giving the patient one or two treatments. For these other therapies, the patient has to come in weekly or monthly or quarterly for up to two years of treatments. So I think that's kind of a significant difference. Those are the FDA approved drugs. As far as guys coming down the pipe, Johnson and Johnson has a chemotherapy, Jim Cinnabine, not approved yet. Starts off pretty high, but it drops pretty quickly as you get further on the data. There's a couple of other companies, CG Oncology. Again, starts out strong. It's a gene therapy, drops pretty quickly. Time progresses. Another company on gene starts out high, but again, drops pretty quickly. What you're seeing with Fairlays is a duration of response, or an ability to keep that response. So for these patients to maintain their bladder function, keep their bladders, their quality of life, and go on their daily business and not have to worry about their disease. - Yeah. So Roger, the company has really emphasized in the news release that the data is still interim data. And so will there be more data coming out interim-wise or until the study is completed? As you mentioned, there's obviously a longevity of this particular study. So what's sort of the next stages of this? - Well, we have 75 patients. According to our statistical analysis plan, we're looking to do 75 to 100 patients. So we're at the low end, but we have enough data for statistical significance. So we'd like to collect some more data, you know, over the next three to six months to make sure we have enough patients into the study. You always have certain patients that could be removed from the study for various reasons. And then we need to follow those patients to at least mid-2026. So between now and then you'll see a number of updates. As the data set fills in, and you see more of the assessment points for these patients and look at the duration of that response. Once we have completed the primary and the secondary, objectives and the tertiary for safety would be above mid-2026. We'd be compiling the data for health Canada and the FDA. So you'll see a number of updates come, you know, probably another one, end of 2024, maybe a couple more in 2025. - It's exciting times for sure. And it's a very encouraging data. And we look forward to seeing the next results as well. Roger, thanks so much. Really appreciate the update. Thanks, Steve, always a pleasure. - All right, Roger, Dumel and White. He is the CEO of Theraleis Technologies.
