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: Richard Ramanius - Redeye - Analyst
: I have a few questions. Let's start with the financial ones. You reported liquidity of almost SEK200 million, and you stated that will fund this year's
activities. So that would imply a burn rate of around SEK50 million per quarter. Do you have -- that seems low compared to your expenditure last
year? Do you have any comments?
Question: Richard Ramanius - Redeye - Analyst
: Great. Makes sense. I'd also like to ask if you could discuss your funding options, if possible, for the pancreatic cancer trial.
Question: Richard Ramanius - Redeye - Analyst
: Yeah, I understand. And considering the readouts for this trial, when did you say the interim readout would be and the full readout from the 150
to 200 patients?
Question: Richard Ramanius - Redeye - Analyst
: And then continuing on this same trial, you have any idea about the possibility of obtaining accelerated approval? Will you power this study to
demonstrate a statistically significant overall survival?
Question: Richard Ramanius - Redeye - Analyst
: Okay. And my last question about the breast cancer study. I my assumption was that the ongoing Phase IIb or Phase II study will be Phase III enabling.
Is that correct? And as a follow-up to that, this makes it a late-stage asset. How does -- how would that affect partnering these discussions and
interest?
Question: Richard Ramanius - Redeye - Analyst
: Okay, thanks. So that's all for me for now.
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: I have a few. Maybe starting with PDAC indeed. Could you remind us how much is the PANFOUR study projected to cost? And in terms of operating
expenses for this year, can we expect a further decrease or now to maintain stable? Yes, if you could comment on that, please.
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: Okay. Very clear. And maybe could you elaborate a bit more in terms of PDAC. What is the FDA exactly looking? And in your view, what are the
most important endpoints. So does the FDA indeed only look at median overall survival? Or is PFS also, yes, quite important?
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: Okay. Very clear. And maybe just a last question on the triple-negative breast cancer trial. What is the benchmark here that you're trying to surpass
with the data that you're presenting at the end of this year?
Question: Luisa Morgado - Van Lanschot Kempen N.V. - Analyst
: Okay. Thank you very much. That's all.
Question: Arvid Necander - Carnegie Investment Bank AB - Analyst
: So first, on the PANFOUR studies, within terminal is being baked in and the sort of adaptive study design, do you see an opportunity for sequential
financing where you wouldn't need to raise the amount for the whole study upfront?
Question: Arvid Necander - Carnegie Investment Bank AB - Analyst
: Okay, thanks. And then secondly, on triple-negative breast cancer and the readout towards the end of the year. How should we think about
positioning here? And what are the most relevant comparisons. I guess, with TROP-2 targeted ADC combinations being investigated both in the
frontline and setting of the advanced setting and the new adjuvant setting, how do you expect nadunolimab to sort of fit into the paradigm here?
And what are the most relevant comparisons?
Question: Arvid Necander - Carnegie Investment Bank AB - Analyst
: Okay, thanks. And I guess just assuming that you go ahead, at least in the first step with the GMCAR combination. Is it fair to assume that the at
least immediate opportunity would likely to be the second- or third-line setting of advanced triple-negative breast cancer, that's a fair assumption?
Question: Arvid Necander - Carnegie Investment Bank AB - Analyst
: Okay, great. Thanks so much, guys.
Question: Richard Ramanius - Redeye - Analyst
: And I had another question about CAN10. Could you just remind us about how you're studying the IV versus the subcutaneous version and which
you intend to go forward with?
Question: Richard Ramanius - Redeye - Analyst
: It sounds reasonable, similar to the commercial version, how are you implementing this in your current Phase I study?
Question: Richard Ramanius - Redeye - Analyst
: Okay, perfect. Thanks.
Question: Sten Westerberg - Analysguiden - Analyst
: Just a clarification on the dosing. There is -- you show a flat dosing in your schedule for the 4 study. Just to understand, is this equivalent to the
dosing, which is used in TRIFOUR study 1 milligram per kilo, 2.5 milligram per kilo. That is my first question.
The second one is if the topline data that you expect to release from TRIFOUR by the end of this year will be based on the fully recruited population.
Thank you.
Question: Sten Westerberg - Analysguiden - Analyst
: Okay. That concludes my question. Thank you.
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