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: Tyler Van Buren - Cowen and Company LLC - Analyst
: Since we have 20-plus minutes and a lot to discuss, we're going to get straight into it. You guys, ever since you went public, have done a really
great job of accelerating your timelines. I feel like every earnings report, I look forward to moving something up in our milestones table. b+But a
lot going on over the course of the first half. of next year, and then even in the second half. So maybe we'll just knock off each catalyst one by one.
And wanted to start with the APG777 asthma data in Q1, right? So lebri did not succeed in asthma. So maybe you guys could start by discussing
why lebri did not succeed, why you guys might succeed, and what do you need to show with that Phase 1 readout to have confidence that you
are doing something much different than lebri and perhaps similar to dupi?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Okay, great. Thanks for that. And have you guys disclosed the dose that you're exploring in that Phase 1 trial and how that relates to what you've
disclosed with Part A and atopic disease?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Okay. And just maybe remind everyone how that exposure compares to the labeled lebri dose.
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Okay, great. and if you all achieve that goal or exceed that bar that you all just discussed, what are the future plans in asthma, and how soon can
the next study start?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: That's a good point. Yes, the overlaps and comorbidities with these types of drugs is obviously pretty unique relative to other therapeutic areas.
So let's get into the atopic dermatitis Phase 2 program. Obviously, you guys reported great Part A results over the course of the summer.
During the first quarter of next year, we will also receive the 52-week maintenance data that you guys pulled forward from prior timelines. Based
upon that Part A 16-week data that we received, how clearly should that translate to 52-week maintenance data? And ultimately, what is the bar
for what we should hope to see on the various endpoints at 52 weeks?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Yes, and I understand that last point is obviously pure upside. I have no idea if that will happen or not, but I mean, mechanistically, I think historically
we've spoken about the lebri data and the higher order response rates going out to a year, right? When you compare that to dupi, it looks like there
might be some improvement. When you think about IL-13 relative to IL-4, that could be leading to better durability over time or better maintenance
of response over time? Or is this just something you'll have to see with the data?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Wonderful. Thanks so much for that, Carl. All right, maybe we'll move to Part B, that data also now coming a little bit earlier in Q2. which is going
to be a very interesting follow up to the Part A results. Maybe you could start by just explaining some of the key differences of the Part B study
relative to Part A in terms of patients, how the dosing compares, and ultimately what you hope to see.
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Right. And we'll definitely get to Jeff here shortly. But so, obviously, even if you maintain the impressive data that you saw in Part A, the part A, you
had a historically high placebo response rate, right? So when you adjust, you were using a very high placebo rate. So can you talk -- and obviously
there's more patients here, so you might see a more normalized placebo rate in Part B. But can you talk about the difference in enrollment in
patients between US, ex-US, and what you saw in Part A with respect to placebo and how that might impact the placebo rate?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Right. And you saw -- just to be clear, you saw lower placebo rates in Europe, right?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Great. And on conjunctivitis, you guys trended similarly to dupi over time. KOLs could not be less concerned about it. But in terms of these much
higher exposures being tested in Part B, how do you think that might impact conjunctivitis?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Okay, great. Maybe to wrap it up before we get to the 279 or OX40 ligand combo data, what is the approximate timeline for the pivotal trial and
when do you believe that you could get to market with APG777?
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NOVEMBER 13, 2025 / 5:30PM, APGE.OQ - Apogee Therapeutics Inc at TD Cowen Immunology & Inflammation
Summit (Virtual)
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Perfect. As well as the other Phase 1 and 2 programs that you have disclosed, right?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Great. So again, as we just discussed with Part B, there's reason to be excited about that data, and especially the arm of higher exposures. And then
you go into the second half where you've got a bold study with APG777 combined with 990, the OX40 ligand, with the superiority head-to-head
versus dupi trial.
You guys, OX40 ligand drugs, as we have seen, are clearly quite effective. Some people thought that they would compete directly with dupi and
lebri, although you guys have been remarkably consistent for a long time now that you think it's best used as a combination partner. So if you just
add the response rates from the two together, obviously you're seeing numbers that are way higher than dupi. But what gives you confidence that
efficacy between these two will actually be additive? what delta on top of dupi do you think you need to show to be successful here versus your
PRD?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: And that is coming out in the second half, 16-week data. And then you'll -- similar to Part A and Part B, you guys are going to look for -- are you
doing maintenance or what would the pathway for it be for the combination?
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Great. So maybe getting to Jeff, can you tell us the latest on the market research based upon the initial profile we've observed so far with APG777?
Also, how do you think about having both a three- and a six-month dose, potentially even an OX40 ligand combo? A number of potential presentations
here for patients and physicians, and it'd be helpful if you could put it together for us.
Question: Tyler Van Buren - Cowen and Company LLC - Analyst
: Perfect. We're way over time, and the next session's starting in four minutes, but I have to ask about 333. You guys just had great Phase 1 results,
right, with the TSLP. And so maybe you could just briefly talk about the plans for that agent and potentially even in combination with 777 and
when we could see the next study start.
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consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 13, 2025 / 5:30PM, APGE.OQ - Apogee Therapeutics Inc at TD Cowen Immunology & Inflammation
Summit (Virtual)
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