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: Faisal Khurshid - Leerink Partners - Analyst
: Hi, guys. Good to literally see you and congrats on the updates. Just a quick one for us. What supports your view that the 28 dosing in the atopic
derm Phase Ib is enough time to show robust biomarker activity? And then could you also comment a little bit on how you've kind of thought
about the inclusion/exclusion criteria for that Phase Ib?
Question: Faisal Khurshid - Leerink Partners - Analyst
: Yes. And then, just to kind of clarify on the choice to not have a placebo arm in the Phase 1b, especially given kind of like what's been seen in other
atopic derm studies?
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Question: Faisal Khurshid - Leerink Partners - Analyst
: Got it. Super helpful. Thank you, guys, so much.
Question: Andy Chen - Wolfe Research - Analyst
: Hi. Nice to see you in person. So the Phase 1b is designed to be single arm. So we won't be able to see dose response on biomarkers. Do you think
the Th2 biomarker data is going to be so clean that we won't need to see dose response across different doses to be comfortable with the data?
Just curious if we're going to have enough data to answer additional questions about efficacy by Q4? Thank you.
Question: Andy Chen - Wolfe Research - Analyst
: Thank you, Nello. Thank you, Jared.
Question: Ron Feiner - JPMorgan Chase & Co - Analyst
: It's Ron on for Eric. I just wanted to ask again on the dose selection maybe you will be evaluating only one dose in this Phase 1b for AD? And how
does the SAD/MAD data so far from the healthy volunteers trial kind of give you information on the effective range at least from a PD perspective?
Question: Ron Feiner - JPMorgan Chase & Co - Analyst
: Thanks. And then just maybe if I can try on the new program are you guys geared more towards staying in the Th2 space or anything additive or
orthogonal to current programs or is it going to be completely new?
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Question: Ron Feiner - JPMorgan Chase & Co - Analyst
: Thanks.
Question: Jeffrey Jones - Oppenheimer & Co. Inc. - Analyst
: Good morning, guys. Thanks for taking question. I think we've asked a lot on STAT6. Curious to get your view on the TYK2 program from a similar
perspective as we think about biomarkers and tissue penetration, how we should think about looking at that data which -- at the healthy volunteer
data which is, obviously, some way out. So can you share how you're going to be looking at not only safety, but efficacy signals there from a
perspective of TYK2 and biomarkers?
Question: Jeffrey Jones - Oppenheimer & Co. Inc. - Analyst
: Great. Appreciate that. And just one quick follow-up. As you mentioned the possibilities in Phase 2, how do you think about in terms of patient
selection patients who prior exposure to say deucrav or one of the biologics impacting the IL-23 pathway?
Question: Jeffrey Jones - Oppenheimer & Co. Inc. - Analyst
: Thank you guys.
Question: Brad Canino - Stifel - Analyst
: Great. Good morning. So, look, I think you've done a really good job previewing the STAT6 healthy volunteer data. And I can see how the target
profile will allow you to move into patients with conviction. You can marry that to the preclinical outcomes. It's the outstanding question and you
started to touch on this in some of the prior responses is how you see the Phase 1b building on that conviction, 20 patient study short four-week
treatment. How do you really see that being a useful tool to shape the view of the profile potential even though it's not designed to be a definitive
assessment of the drug in patients?
Question: Brad Canino - Stifel - Analyst
: Thank you.
Question: Marc Frahm - TD Cowen. - Analyst
: Yes. Thanks for taking my question. Maybe just start off, with one clarifying question on some of the enrollment criteria, you mentioned earlier for
the Phase 1b. Just take that obviously, no concomitant meds, but will you be requiring people to be biologic and JAK therapy naive? Or could there
be a patient or two that end up in this trial, that at some point seen some of these more modern agents? And then, I'll have a follow-up after that.
Question: Marc Frahm - TD Cowen. - Analyst
: Okay. Thanks. And then just on the Phase 2bs that you're planning in AD and asthma, I mean DUPIXENT has kind of a range of -- a handful of different
kind of dosing paradigms, depending upon the indication. Do you think those trials give you enough -- will ultimately give you enough information
about dosing to go to Phase 3 for kind of across the board of the IL-4 STAT6 pathway? Or are you expecting that you'll ultimately need more Phase
2bs, in some of these other indications as well to help select dose for the different indications? And if so, should we see -- expect to see those trials
done in parallel to AD and asthma, or you're going to really wait for AD asthma data until you would open up anymore?
Question: Marc Frahm - TD Cowen. - Analyst
: Okay. And then lastly, as we get that more robust efficacy readout from these Phase 2bs obviously, the goal is to every bit match DUPIXENT maybe
even potentially exceed it a little bit. But if that isn't the case and you end up being a bit lower on efficacy, is that acceptable? And how close do
you think you need to be to justify kind of the expense of late-stage trials?
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Question: Marc Frahm - TD Cowen. - Analyst
: Okay, super helpful. Thank you.
Question: Eliana Merle - UBS Investment Bank - Analyst
: Hey guys. Congrats on all the progress. Maybe just in terms of dose selection how are you thinking about how the doses you plan to study in Phase
IIb will compare between atopic derm and asthma? I guess do you expect to study the same doses in each indication?
And then kind of a broader question about STAT6 as it relates to dose selection. How does STAT6 expression potentially differ across indications
or maybe between patients? Thanks.
Question: Eliana Merle - UBS Investment Bank - Analyst
: Great. Thanks guys.
Question: Parth Patel - Morgan Stanley - Analyst
: Hi guys. Can you hear me?
Question: Parth Patel - Morgan Stanley - Analyst
: My video is not working. This is Parth on for Vikram. So just a question on 621. So, following the Phase 2 studies in AD and asthma how expansive
of a Phase 3 development program would you expect to initiate for KT-621? And how would you prioritize indications given the broad potential
you've laid out for the molecule?
Question: Parth Patel - Morgan Stanley - Analyst
: Okay. Thank you.
Question: Srikripa Devarakonda - Truist Securities, Inc. - Analyst
: Hey guys. Thank you so much for taking my question. This is a really interesting format. So you've mentioned this before, but in terms of degradation
levels, do you expect to see similar to what you've seen in the preclinical studies?
Degradation levels similar in different tissues skin and plasma, I know you're measuring it in healthy volunteers. And do you expect that to be -- to
follow through into patients as well? Like, what you see in healthy volunteers would you expect similar degradation levels in patients as well?
Question: Eric Wong - Goldman Sachs - Analyst
: Hi. This is Eric Wong on for Chris Shibutani. Thank you for taking the question. Just a quick one for me. So just thinking beyond the Sanofi collaboration,
how are you thinking about strategic partnerships to accelerate development or derisking programs? I guess particularly in oncology, can you
elaborate on the criteria you'll be using to select partners and how you intend to maximize the value of those assets and potential deals?
Question: Sudan Loganathan - Stephens Inc. - Analyst
: Yes. Thank you for taking the questions and being on video today. So mine is going to be just on the R&D spend. Just kind of curious on as you're
ramping up 2025 in those two trials for 295 and 621, how do you expect that to be -- the R&D expenses to be allocated between the two programs?
And then could we anticipate any expense profile changes as depending on the progress of those two trials over the next one to two years?
Question: Sudan Loganathan - Stephens Inc. - Analyst
: That's it. Thank you.
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