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: Akash Tewari - Jefferies LLC - Analyst
: Hey. Thanks so much and great results here. A few questions on my end. On the exposure response you saw in your trial, roughly what were the
weight cutoffs for the quartiles and how surprised were you to see that kind of jump in IGA for quartile four? Was there something unique about
its baseline characteristics, perhaps severity that could have driven that benefit?
Maybe stepping back also, can you comment on baseline severity and geographic variability for the trial overall? It did look like placebo came out
a bit higher than I think what we had internally expected. And then finally, when we're thinking about that Phase 2 head-to-head against DUPIXENT
for next year, do you think OX40 will be additive on the more stringent endpoints like EASI-90 and the IGA 0/1 when combined with IL-13? Thanks
so much.
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JULY 07, 2025 / 12:00PM, APGE.OQ - Apogee Therapeutics Inc APEX Phase 2 Part A Readout
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Great, thanks. Good morning, guys. Congratulations on the tremendous data package. I have a couple for you. So given the data, is there a hypothesis
as to why APG777 might be significantly better on itch than Dupi and lebri? And the second one is the similar rate of conjunctivitis to Dupi at week
16 is encouraging. But how would you expect the incidence of that adverse event in particular to evolve with much higher exposures in Part B?
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JULY 07, 2025 / 12:00PM, APGE.OQ - Apogee Therapeutics Inc APEX Phase 2 Part A Readout
Question: Julian Harrison - BTIG LLC - Analyst
: Good morning. Congratulations on these results and thank you for taking my questions. First, I'm wondering if you could talk about how much
market share in atopic dermatitis you expect 777 to command if these initial results from APEX are replicated in Phase 3?
And then beyond efficacy, what do you expect payers to be most receptive to in [payers'] therapeutic profile? Finally, can you talk more about the
rescue criteria in APEX and the differences across key trials that are worth highlighting there?
Question: Julian Harrison - BTIG LLC - Analyst
: Correct.
Question: Julian Harrison - BTIG LLC - Analyst
: Thanks. Very helpful. Thank you and congrats again.
Question: David Nierengarten - Wedbush Securities Inc - Analyst
: Hey. Thanks for taking the question. Maybe it's too early, maybe it's not too early to think about commercial slotting of both 777 and the combo.
And I was just curious, how you see that evolving over time, if you planning on maybe having a higher dose format, lower dose format plus the
combo to treat maybe bioexperienced non-responders, kind of how do you see that matrix evolving and what to look for in the clinical trials to
help you decide on those potential commercial products? Thanks.
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JULY 07, 2025 / 12:00PM, APGE.OQ - Apogee Therapeutics Inc APEX Phase 2 Part A Readout
Question: David Nierengarten - Wedbush Securities Inc - Analyst
: And maybe just to cut to the chase, is the kind of the commercial goal here to own every single spot, frontline, high-dose and non-responders,
bioexperienced? Or is it to really push forward just the best product possible and over time, maybe other companies or other candidates come
into play on experienced or refractory patients? Kind of is that -- you see what I'm saying, like are you going for breadth in terms of multiple products
approved here or the kind of depth in getting the best absolute number out in a single product?
Question: David Nierengarten - Wedbush Securities Inc - Analyst
: Got it. Thank you.
Question: Timothy Anderson - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Thanks so much for the question. Can you talk about baseline characteristics for patients in the trial? There's obviously different ways of reporting
this. So just looking for something that would help us compare this data to competitor data sets. And if you can't disclose it now, will that be
published at some point or not until we have the 52-week data? And then another question, I think you may have made a comment on this.
Is there any potential for a narrowing of clinical effect when going from Phase 2 to Phase 3? I think you said it might have actually been the opposite
when you look at competitor data sets where strength is in Phase 3. But if you could just confirm. And then last question is you'll be starting Phase
3 in 2026, presumably that's back half '26, does that imply a potential regulatory filing in something like early '29?
Question: Timothy Anderson - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Thank you.
Question: Geoffrey Meacham - Citibank Cameroon SA - Analyst
: Hey, guys. Thanks for the question and congrats on the great data. On the higher exposure, what do you think the upper end of the EASI-75 can
be on induction? Is that something that you guys are focused on? And Michael, I know you talked about the risk of conjunctivitis, RTIs being sort
of lower and with higher doses. But is there any special consideration as you look to future trials to have to mitigate any or monitor any -- the risk
of any of these AEs? Thank you very much.
Question: Geoffrey Meacham - Citibank Cameroon SA - Analyst
: Great. Thank you.
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JULY 07, 2025 / 12:00PM, APGE.OQ - Apogee Therapeutics Inc APEX Phase 2 Part A Readout
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