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: Sam Slutsky - LifeSci Capital LLC - Analyst
: Hey, good morning, everyone. Thanks for taking the questions. Just kind of two quick ones you mentioned that you're entering the hockey
stick phase of enrollment.
Any expectations you can provide though for how many patients we might get in the 2026 updates? And then just on the potential second
line plus registrational study, what's that look like as you think about the control arm and then when are you hoping that might start? Thanks.
Question: Jeffrey La Rosa - Leerink Partners LLC - Analyst
: Yeah, great, thanks for taking my question. Also on the dosing and safety data, it seems that the it is striking how much better the tolerability
is of the combination than the monotherapy, and you implicated, the lower dosing is maybe a big driver of that.
Are you considering, also testing, going back and testing the 4.4 mgs per kg maybe, as a monotherapy, would that have a similar effect to
using the adjusted ideal body weight strategy?
And I guess another follow-up specific question on the example that you gave on the adjusted body weight dosing on the neuropathy
patients. Were these patients that had, were those that did have the prior taxane treatment, or were these taxane naive?
Thank you.
Question: Jeffrey La Rosa - Leerink Partners LLC - Analyst
: Thank you. Just a quick follow-up. Does the FDA weighed in on the adjusted body weight? Do they share your perspective that this is
probably something that all ADCs would benefit from, and in addition to the investigators?
Question: Jeffrey La Rosa - Leerink Partners LLC - Analyst
: That's all my questions you get just that prior taxane, then that's good for me. Thanks for taking my questions.
Question: Swayampakula Ramakanth - H C Wainwright & Co LLC (Pre-Merger) - Analyst
: Thank you. This is RK from HC Wainwright. Congratulations on all the data sets that you've talked about this morning, Lara. A lot of my
questions have been answered, but just a couple of quick questions. So the combination cohort, showed in 70%, 71% of our, of course, it's
seven patients. Just trying to think through, the next stages for this, for the combination.
Do you think you're not, I mean, initiated any conversation with the FDA because you still need to get some additional data into this, study?
If so, at what point or how many more patients do you need to initiate a conversation with the FDA regarding a pivotal trial?
And also, a second quick question is, obviously, the mechanism of action for MCIVO is quite different from what other drugs in the clinic
are at this point. Does that allow you to use as a combination with either the Merus drug or the Bicarra drug? Is that a possibility at all?
And also, does this also allow you to look at beyond head and neck cancer, especially in the EGFR negative tumors?
Question: Swayampakula Ramakanth - H C Wainwright & Co LLC (Pre-Merger) - Analyst
: Perfect. If there is a possibility for me to ask a quick follow-up, when I look at your slide 16 and look at, the baseline tumor size, as you said,
even it, you had a varied sizes within your cohorts, going into the next stage of studies? Are you planning to have any criteria around the
tumor size, the baseline tumor size, when the inclusion, exclusion criteria?
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