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: Ritu Baral - Cowen and Company LLC - Analyst
: Good afternoon, guys. Thanks for laying everything out so clearly today for expectations. A couple of questions for me. Amy, can you just go over
exactly how many patients that we should expect six-month MMR from at a value -- essentially six months of valuable MMR from the 320-milligram
and the 500-milligram dose?
Question: Ritu Baral - Cowen and Company LLC - Analyst
: Understood. And then a quick follow-up on that one patient that had the inadequate response to asciminib but a good response to 701. Was there
something about that patient's mutation profile or, I guess, the lesson learned about mutation profiles in general that may set up patients that
wouldn't respond to asci, but would respond to 701?
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Thanks for providing this update. Since you had no DLTs in dose escalation, does that suggest that you could go to even higher doses with 701
than 500 milligrams?
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Okay. Understood. And then when you consider some of the safety advantages for 701 compared to asciminib, what are the most clinically significant
safety differentiators that you'll be looking for?
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Great. That's super helpful. And then maybe one big picture question. How would you define a next-generation allosteric TKI? And what would
you like to see from 701 to position it as a next-gen allosteric TKI?
Question: Silvan Tuerkcan - Citizens JMP Securities LLC - Analyst
: And thank you for putting up this clarifying event. My question is also a little bit bigger picture, maybe about the patient population you're looking
more near term in the second-line plus setting. What's the principal reason for progression here? Is it tolerability issues? Or is it disease progression?
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Question: Silvan Tuerkcan - Citizens JMP Securities LLC - Analyst
: Just within the profile that you have, you -- and thanks for the data, you have some better target coverage, and at the same time, you have higher
selectivity here versus other compounds out there. Just what is more important in the clinical setting?
Question: Silvan Tuerkcan - Citizens JMP Securities LLC - Analyst
: And maybe just one follow-up for the upcoming data set. I think all eyes will be on the shift table. Do you think in what category is it harder to
make headway, so the MMR maintaining or the putting people into MMR achieve population? What will be, let's say, the bigger surprise or better
success for you for this first data set?
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Question: Eliana Merle - UBS AG - Analyst
: At this upcoming data cut, what proportion of the patients enrolled entered the study not in MMR? And then in terms of the time frame for the
pivotal trial, I guess if you could elaborate on when you think you'll be able to begin the Phase 3 second line study and whether 2026 is a possibility
for that trial start? And just any more color on when you plan to speak to the FDA about the pivotal trial design and when we could get an update
on that?
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