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: Jonathan Chang - Leerink Partners LLC - Analyst
: Hi guys, thanks for taking my questions and congrats on the positive Phase 3 EPCORE FL-1 results. What is your latest thinking on the positioning
of EPCORE versus other C20 bispecific in the competitive landscape, both in terms of clinical development and your commercial experience. Thank
you.
Question: Jonathan Chang - Leerink Partners LLC - Analyst
: Got it. Thanks for taking the question.
Question: Asthika Goonewardene - Truist Securities - Analyst
: Hi guys, thanks for taking my question. So there is a lot of chaos at the FDA right now or calamity, what do you want to fall it? As we think about
some of the regulatory filings you have coming up, I want to -- so I have a two part question on that.
One, how confident do you feel that you can file RAINFOL-01 Part C, which is a single-arm cohort. How confident you intimate accelerator approval?
And then secondly, is there any risk of pushback from the FDA on EPCORE FL-1 to wait until OS is more mature? Thanks.
Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst
: Hi, thanks for taking the question. Firstly, on EPKINLY, so assuming you get the approval in November. Could you just outline your initial launch
strategy? Is there a specific patient group that you might be targeting? Or -- and how should we think about revenue contribution in '25 and '26?
And then just on the label there, do you expect that there will be no requirement for hospitalization.
And then second question was just on the pipeline. I noticed that the HexaBody-OX40 or GEN1055 has been discontinued in solid tumors. Could
you just talk to the rationale here? And I think that's the second HexaBody asset now that's not being progressed this year. So it would be great to
just hear your confidence in that platform. And could that OX40 asset be used in immunology potentially? Thank you.
Question: Michael Schmidt - Guggenheim Securities LLC - Analyst
: Oh, hey, thanks for taking my questions. I had another one on Rina-S and specifically around your plans for development outside ovarian cancer.
You did talk about this new Phase 2 study in non-small cell lung cancer. And just wondering if you could expand upon that opportunity. Do you
have any data in how Phase 1 is and how is the supporting this? And what do we know about the full of the alpha expression in lung cancer? Thanks
so much.
Question: Matt Phipps - William Blair - Analyst
: Thanks for taking my question. Congrats on the strong, of course, all one data. Maybe a question -- you mentioned the broad development plan
with epcoritamab being a strength. I was wondering what you think about ADC combinations. And do you see a role for those longer term in
lymphoma? Maybe how you will continue to explore those? And then quickly, acasunlimab and melanoma. will that use the same Q6 dosing or
do you need to explore additional dosing regimens in melanoma? Thank you.
Question: Qize Ding - Redburn Atlantic - Analyst
: Oh, hi. Thanks for taking my question. I just have one follow-up question on the Rina-S in non-small-lung cancer. Is the Phase 2 trial going to test
Rina-S patients in the first line or second line setting of the non-small cell lung cancer or all come. And just a quick follow-up. Is the arena as going
to be taxed as a monotherapy or in combination with other checkpoint inhibitor. Thank you.
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