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: Mark Breidenbach - Oppenheimer & Co. Inc. - Analyst
: Hey, guys. Congrats on the progress. And just a couple of quick questions from me. First of all, I guess since we're expecting data later this year
from the [CANOPY-A] study of Nadunolimab in the non-small cell cancer adjuvant setting, do you see any potential for (inaudible) to impact your
development plans in lung cancer? For instance, if CANOPY-A is a success, would you consider running a trial in an adjuvant setting perhaps in
collaboration with a partner?
And the second question is just with regard to the PanCAN Precision Promise trial, would you expect this study population to differ much from the
PDAC cohort that you enrolled in CANFOUR? Or are you expecting these two study populations to be more or less the same given their treatment
histories? Thanks for taking the questions.
Question: Mark Breidenbach - Oppenheimer & Co. Inc. - Analyst
: Thanks for taking the questions.
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: Okay. Thanks for taking my questions. So, my first question is on the European development pathway for Nadunolimab in pancreatic cancer,
obviously Precision Promise only includes US centers, so are you planning for an additional registration-directed study conducted at European
centers? That's my first question.
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: Right. So, how likely do you view it that EMA will accept registration based on purely US data? That seems -- there's not too many examples of that,
I suppose, with the main scenario that you will have to perform some sort of study in Europe.
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: Fair enough. Okay. And then I was just wondering if you can give us any indication on what to expect in terms of R&D and SG&A expenses going
into 2022, at least directionally compared to 2021?
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FEBRUARY 24, 2022 / 2:00PM, CANTA.ST - Q4 2021 Cantargia AB Earnings Call
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: So, my question was if you could give us any indication of what to expect when it comes to the development for R&D expenses and SG&A expenses
as well going into 2022, at least on a directional level compared to 2021?
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: Okay. Thanks. That's very helpful. And then just the last question for me. So, we're obviously waiting for the biomarker analysis from CANFOUR
with great anticipation. So, could you give us any update on when we can expect results from this?
Question: Arvid Necander - Carnegie Investment Bank - Analyst
: Okay. Great. Yes, that's it for me. Thanks.
Question: Richard Ramanius - Redeye AB - Analyst
: Hi. I had -- to start I had two questions about the Precision Promise trial. Can you tell us something more about the timeline? Do you expect any
[green dot] before 2027? And what do you expect would be the [approvable] endpoint for the overall survival?
Question: Richard Ramanius - Redeye AB - Analyst
: Okay, G÷ran. You have two other ongoing trials in pancreatic cancer. How do you intend to go forward with this Precision Promise? Or how could
you use them in some -- and for example, like if you would like to make a licensing deal, could you use those data from those other trials?
Question: Richard Ramanius - Redeye AB - Analyst
: Okay. And then last question. You have, as I understood it, previously been mainly focused on second-line treatments in breast cancer in new
combination trials with Keytruda, would be for the first-line, so are you open for -- but how do you see the most important way forward, second-
or first-line, in metastatic breast cancers?
Question: Richard Ramanius - Redeye AB - Analyst
: Sorry, I meant, lung cancer.
Question: Richard Ramanius - Redeye AB - Analyst
: Of course, got it. Those were my questions.
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