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: Seamus Fernandez - Guggenheim Partners - Analyst
: Congrats on the excellent profile of 990. Maybe the first question is really, if you can just help us understand it seems like the company has continually
executed their profile of recruitment and then study and then data presentation faster in most cases. And it seems like second half of 2026 might
be a little bit long.
Are you just kind of providing extra cushion for execution of that study versus Dupixent or are there specific workup dynamics that need to be
executed on before the official initiation of the 279 study? And then two just very quick additional questions in terms of controversies that investors
have been dealing with.
First, just hoping that you could provide -- I know you have done this in the past, but maybe to remind investors, all of the dynamics that you've
brought into play for the 777 -- Phase 777 induction Phase II to really manage the placebo response in that study and what your expectations are
along those lines?
And then just the second question on a similar topic. Maybe just to remind investors how challenging it is to actually generate assets with a profile
like what you are delivering in -- with 777, 990 and your anti-AX40 as well.
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MARCH 03, 2025 / 1:30PM, APGE.OQ - Apogee Therapeutics Inc To Discuss Interim Results from the Phase 1
Healthy Volunteer Trial
Question: Alexander Thompson - Stifel Financial Corp. - Analyst
: Congrats on the data. I guess maybe can you talk a little bit about your confidence in dose selection for the 279 proof of concept? What are the
key considerations there? And are the Phase IIa data for 777 important for sort of finalizing that dose? And then secondarily, I think it's pretty clear
what the pathway from other is an atopic down right now. But could you talk a little bit at a high level about what the path towards approval might
look like for co-formulated combination, particularly if 777 is approved first?
Question: Akash Tewari - Jefferies - Analyst
: Two on the upcoming data sets from Sanofi and then one on atopic derm for L3. So firstly, how is your team framing the upcoming OX40 data in
asthma from Sanofi we internally suspect that efficacy would look more modest than what we've seen with Dupi in a biomarker controlled population.
Would you consider moving forward with the common approach even if the Sanofi results aren't statistically significant?
Number two, if we look at the Sanofi IL-13 TSLP bispecific, it seems like there's strong reduction has been driven by population and baseline
differences. So how much utility is there from combining overlapping mechanisms like IL-13 and TSLP versus OX40 when you think about your
combination strategy?
And then finally, Michael, in the prepared remarks, you mentioned 777 will be hitting IL-13 more potently than lebri at the same time, I think your
team has been pretty reticent to predict an efficacy benefit as a monotherapy. So what are your latest thoughts on efficacy expectations for your
atopic derm data set that's coming up soon.
Question: Julian Harrison - BTIG - Analyst
: Congratulations on these early results and all the recent progress. I'm wondering if you could talk a little more about your enrichment strategy for
the Phase Ib 279. Any notable differences you would highlight compared to how you approach development for pure type 2 inhibitor?
Question: Julian Harrison - BTIG - Analyst
: Got it. That's helpful. And then another on that Phase Ib. I'm wondering what you expect to be the most informative data points? Is there a go/no-go
threshold associated with or IGA you're able to share now?
Question: Julian Harrison - BTIG - Analyst
: Okay. Excellent. That's helpful. And then a fiynal 1 for me. I'm just wondering, in light of prior trials of monotherapy, OX40 and OX40 ligand inhibitors.
Are there any learnings from those prior efforts you're applying to your plan to develop 279?
Question: David Nierengarten - Wedbush Securities - Analyst
: I have two maybe quick ones. First off, I assume since they weren't reported, but there weren't any ADA antibodies or anything like that? And then
second, is there -- when you think further ahead, is there a scenario where the combination goes ahead of the seven monotherapy where you you
prefer to develop one or the other? I'm just curious how you're planning for different outcomes with the mono versus combo therapy?
Question: Salveen Richter - Goldman Sachs - Analyst
: You mentioned the numerical win versus Dupixent. Could you just speak to what that might look like with regard to the profile that you're hoping
to see in the head-to-head versus Dupixent. And then secondly, with regard to the comparison to JAK here, just your thoughts on whether that
sets the efficacy ceiling or theoretically could be improved upon with one of your assets, assuming combinations and safety and tolerability holding
at higher doses?
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