Vicore Pharma Holding AB (publ) (VICO) Earnings Call Transcript & Summary

Welcome, everyone. It's my pleasure to have Carl-Johan Dalsgaard, the CEO of Vicore Pharma with us today.

The key question we often get is on the IPF data that has been quite unique so far. What would you highlight about the last readout in November last year?

I think what is clear is that we're stabilizing the disease now over 36 weeks. So the data that we had in November actually is stronger than the data that we had in February. We have more patients, stronger data and a clear stabilization, and that is really unprecedented. So that means that if we diagnose early and medicate, we may even stop this deadly disease.

Great. And now looking forward to the expected final readout of that study. When can we expect it? And how many patients can we expect that 24 weeks and 36 weeks if you can give a bit of a ...

I can say that we have 25-plus patients now for 24 weeks, and we expect to have, of course, then moving ahead. So we will have a substantial data set already by summer with patients going into a 36 weeks end of trial. So we still have patients now recruited and we will -- we expect the final data by the end of the year. But by summer, we will know pretty well what it looks like. And again, it is a substantial data set that is emerging now.

So we can expect around double as many patients, around 36 ...

And even more, yes.

Great. And also one question that came up a lot was about the dropouts that you had previously. Can you say now that these dropouts have decreased since November now going forward?

Yes. I mean what we can see is that the dropout frequency is going down. That is primarily because of COVID because COVID was a real issue for us because patients were either afraid of COVID. With this deadly disease, you don't want to go to hospitals for visit every second week, and that is, I think, understandable. So that is not a problem for us right now. So we see less drop-outs there. There are always a frequency of about 20% dropout in these types of studies.

Okay. And the geographic distribution, could you elaborate a bit how the patients have distributed? And also one question we sometimes got, is there a difference in the Indian side? And if you could walk us through a bit how Indian patients are assessed if there is a difference or not.

Yes. There is no difference actually. We have about 75% -- 73% of patients now from India. And then we have the rest of them from U.K., Ukraine, Russia. Obviously, we're not having any patients in Russia, Ukraine now, but that's the balance we have. And the patients are all clinically diagnosed according to the guidelines, whether they're in India, U.K. or Russia or Ukraine, then we have a high resolution computer tomography that is then sent for a central reader in U.K. Professor [indiscernible] at Royal Brompton in London. So he does all the readings and he's a world expert in doing these readings for diagnosis. And of course, you have to be very key -- very thorough in that analysis. So we've also seen a lot of screen phases because we were not 100% sure that we had IPF disease. But when we have IPF disease, when we know that we have the traction bronchi disease that they can see, we know that these patients will lose about 250 Ms per year. And that's what we've seen in all the published studies on placebo groups plus/minus, of course, but around that level. So that's important to be sure that the diagnosis is right. Number two then is that we have a standardized way of measuring FVC. So that's a gold standard, the ERT system, and they overread and they work with us so that they control that the measurements make sense and that they've done the utmost for doing this. And they actually also train the sites to do these measurements. And in addition, we have been there ourselves in the 2 highest recruiting sites and visited even a few more to do with proper audits and making sure that when we see them do these analyses that they know how to do it and that they're doing it properly and that everything is under control. So I would say that the Indian population in this trial is as much IPF as any other population in any other trial.

Thank you for that elaborate answer. And here, you're not alone in the space of IPF. You might be valuation-wise a bit alone. But Pliant Therapeutics has recently released some IPF data first in summer last year and again now in February. How would you assess that data?

Well, I think -- I mean, Pliant have showed some encouraging maybe 12-week data, but it's a small study and a short time period, and it's very difficult to interpret data with small and short time periods. So it will, of course, be interesting to see they will come with 24-week data on the high dose group [ assuming ] holds up. But the difference there is that their slope is going downwards. And our trajectory, our stabilization is actually trending upwards over time. So I think that's a big difference. And again, I mean, they don't have long-term data either.

One last question maybe, and that is on the next stage and then maybe a bit time lines. What can we expect for the Phase IIb trial in terms of size and implications? Is it potentially pivotal? Is that a stretch? And how could that be pivotal and when can we expect it to start?

Well, as you can imagine, I mean, IPF is our top priority with C21 now, and it's really our focus. And we've been working both with an advisory group of key opinion leaders from different countries in the world, U.S., Japan, Europe and making sure that we make a very solid Phase IIb trial. And we also interacted with the FDA in so-called pre-IND meetings to make sure that we know what they want to see in the next step. And we will do a Phase IIb trial with 2 doses. It will be powered enough to really pick up the differences that we see. It will be a double-blind and placebo-controlled trial, and we will also take old comers. So not only patients who are not on any other standard of care, so to speak. So it will be all comers. So that will, of course, have a big impact on recruitment pace and also the possibility to use the data in an early access because I believe that if these data repeat itself in a solid Phase IIb trial, we should definitely have the courage to go and see if we can get an early access with the drug, meaning that we also then need to do more trials. But at least in the situation when there is nothing, but what we have today is the standard of care, I think there's a huge medical need and that should be possible. The trial since we believe will or we expect to start early next year. It's a lot of planning, but we're -- I think it's important that we do a solid trial as the next trial for the reasons that we just elaborated on.

Thank you very much. Thank you for coming out, Jeff.

Thank you.