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: Dr Julie Simmonds - Panmure Liberum Capital Ltd - Analyst
: Good afternoon. Congratulations on the progress over the last 12 months, most impressive. A couple of questions.
Firstly, with the sort of selection of the patients for the registration trial, I mean, it seems to make a lot of sense to recruit those who are most likely
to respond. Is the HLA typing done as a standard test, or would that be something that would be done specifically for use of iSCIB1+?
Question: Dr Julie Simmonds - Panmure Liberum Capital Ltd - Analyst
: Brilliant. That sounds very good news. And then on the manufacturing side of things, good to hear that that process has gone to plan. In terms of
any -- is there any sort of lead-in period that's required in terms of the manufacturer for doing a clinical trial? Is that going to cause any delay in
process once you've obviously got it signed off, and anything to get the active product necessary?
Question: Dr Julie Simmonds - Panmure Liberum Capital Ltd - Analyst
: Lovely, thanks very much.
Question: Edward Sham - Singer Capital Markets Securities Ltd - Analyst
: Hi there. Congratulations on your results. I think it's clear to see that you guys are on a journey to becoming a late-stage biotech. I've got a few
questions, if I just start with the first one.
So you say you're having accelerated discussions with the FDA, EMA, and MHRA. I just want to kind of understand how aligned are those agencies
in terms of trial design, endpoints, and data expectations?
Question: Edward Sham - Singer Capital Markets Securities Ltd - Analyst
: That's really helpful. Thank you. And then maybe just on the timeline you've indicated, you've suggested you expect to initiate randomized studies
in 2026. So is it safe to assume that you're confident in either a partnership or financing before that trial starts or the randomized study starts?
Question: Edward Sham - Singer Capital Markets Securities Ltd - Analyst
: Great. That's really encouraging. And then just my last one is just on the Genmab licensing deal. So you've mentioned that you're now on track for
near-term milestone payments. Is that a positive surprise? Is that something that's moved faster than expected, or is that simply the timing you've
always expected?
Question: Edward Sham - Singer Capital Markets Securities Ltd - Analyst
: Really helpful. Thank you.
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