The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Lucy Codrington - Jefferies - Analyst
: So just a few. Just to confirm the 20 patients, were they all on 600 milligrams of varoglutamstat? Secondly, doesn't look like any of the patients on
Varo actually had Stage 3b or 4 kidney disease. So what is your level of confidence that you would be able to move straight into a Phase 2 within
this population? Any concerns there?
And then I guess related to that, have you saw any regulatory feedback on your development plan? And I guess, just generally, what's your -- I
appreciate the data look compelling, but we are talking very small patient numbers here. So I guess what's driving your level of confidence and
supporting, prioritizing this indication over potentially an orphan indication whereby, as you said, the timelines are quicker, the pricing is higher.
Is that not a potentially more sensible route, particularly given the increasing evidence supporting the benefits of GLP-1s within the diabetes
population? There's been kind of 10% patients on a GLP-1 and this is that reflective still of what we would expect to see in the clinical trial now?
And then just to confirm on that, the 10% on sema and the 10% on SGLT2 in the Vara group, what was that in the placebo group?
Question: Christian Ehmann - Warburg Research GmbH - Analyst
: Thanks for giving us the interesting update for your R&D efforts and results. I was looking at the standard deviation for the glomerular filtration
rate at the beginning, and we already see very high standard deviation in this area. And a little bit to go to my question goes into the same area I
heard by my colleagues. So given that we have highly pretreated patients here and we see the high standard deviation, what kind of patients are
you looking for when you try to design the trial? And what kind of pretreatment, would you say were eligible for inclusion in your trial?
Question: Christian Ehmann - Warburg Research GmbH - Analyst
: Yes.
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: Well, first of all, congrats on this data. And also thank you for the thorough analysis on it. I wanted to ask if you could first elaborate on the non-clinical
and mechanistic. If you already touched a bit upon it. If you could elaborate a bit on those studies that you mentioned could be conducted for
additional disorders.
And of course, once again, if you could just remind us. So I'm asking probably in what other disorders would be possibly the most obvious step.
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: Okay. Very clear. And in terms of the Phase 2 trial cost, do you have any estimation for that? And beyond that, in terms of scenarios from here
onwards in securing that funding, of course, what are the different scenarios that you are outlining?
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: More in terms of, of course, in terms of raising our partnerships, what are the different scenarios, well that you're trying to -- that you consider in
terms of being able to fund this trial and moving forward with the rest of the development plan.
Question: Joseph Hedden - Rx Securities - Analyst
: Congrats on this very interesting data. I just wanted to pick up again on the BD point there and the funding of the trial. So you've known for a while
that there's been a positive effect in kidney diseases, and you've informed us very well that you're kind of looking at target indications, you've come
out with that information. In the period of that time, did you have any kind of interesting discussions in business development with potential
partners? And has any seen these data already?
Is there anyone on the hook that this plan could now tip over the edge? Or is it a case of now you have the package that you can actually kind of
go out and present the plan to potential partners. And that's the first thing.
The second thing is just on as part of this kind of redirection of the development program for varoglutamstat and the emphasis on kidney disease,
so are all the cost savings that you could possibly make in other areas. But have they been implemented already at this point?
Question: Joseph Hedden - Rx Securities - Analyst
: Okay. So just on the runway, the runway remains, as you previously stated, I think into next year and obviously, this Phase 2 trial subject to additional
financing and development in other -- in orphan indications, those preclinical models? Is that subject to additional financing as well? Or is that
built into the plan.
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