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: Cory Jubinville - LifeSci Capital LLC - Analyst
: Congrats on the news. The NDCs in CRN09682 is pretty exciting. Anything more you could tell us about this program and kind of where you see it
best fitting within the existing paradigm? And I guess what else are some of the key challenges that needed to be overcome to develop an NDC?
And what are some of the specific advantages you could point to of an NDC approach over, say, ADCs or radiotherapies?
Question: Jessica Fye - JPMorgan - Analyst
: So with several products entering the clinic next year, what's the soonest that we can expect Phase 1 data from any of those? And which will it be
from? And then if I could sneak a couple in on 9682. Can you talk about how you chose the MMAE toxin for that product and how different or
similar the ligand is to paltusotine?
Question: Jeff Hung - Morgan Stanley - Analyst
: From your early stage pipeline, how are you thinking about the obesity indications for candidate selection in 2025? What would you need to see
with your GLP-1 or GIP programs in order to have confidence advancing those given the increasingly competitive landscape?
Question: Joe Schwartz - Leerink Partners LLC - Analyst
: It's great to see you select the TSH antagonist development candidate. So I was wondering if you could talk about what your criteria has been for
the characteristics you need to reach in order to be satisfied that the candidate meets your criteria. And how high is the hurdle here compared to
what you needed to clear for other programs such as paltusotine and atumelnant? And then from a biological standpoint, how should we think
about the relative degree of efficacy which an IGF-1 or a TSH antagonist can inherently offer, all else equal, based on crosstalk or any other factors?
So just the chemistry and the biology, if you could address those, that would be great.
Question: Joe Schwartz - Leerink Partners LLC - Analyst
: It just seems like your TSH antagonist has a different approach than IGF --
Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst
: Congrats on the progress. I guess, Scott, maybe as a follow-up to that, I mean, historically, you as a company have been very innovative in terms
of using sort of Phase 1 study to provide very compelling proof of mechanism data that has really sort of given confidence in derisked programs
as they enter Phase 2 and ultimately Phase 3. When you think about the TSH program and Graves' as well as TED, from your sort of initial sense,
will you be able to accomplish that in sort of a Phase 1, Phase 1b study? And will that necessarily inform the initial direction you take with that
program in terms of the sort of time at which you sort of intervene with Graves' and if patients are already starting to show manifestations of eye
disease?
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: Thanks for unveiling this new program in NDC. Scott, I just wanted to ask sort of a forward-looking question with respect to the opportunities here
with this new approach as we think about ways in which you can tune ligands to successfully cause the internalization of GPCRs versus not having
them be internalized, i.e., with paltusotine. Are you able to identify others that you could approach following the first compound for perhaps other
tumor types with GPCRs?
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: Got it. And then just a question on the TSH antagonist. Good to see that be nominated. So will you be planning to study that in Graves' and TED
as separate kind of campaigns? Or will you be looking at kind of an overarching Graves' development program with TED as constituting a sort of
a subset of those patients?
Question: Catherine Novack - JonesTrading - Analyst
: Just one on CAH, given that this is an area that has not really seen any new approvals in recent years, I guess what learnings were you able to take
from Neurocrine's pivotal programs when you go to design your own, maybe you can learn from anything or have better designs? And then what
do you anticipate the standard of care would be following potential crinecerfont approval next year?
Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst
: Thank you so much for the really nice surprise. I -- definitely caught many of us for this really wonderful update. And I'm sure a ton of work went
into this. So I guess the question to ask is, in terms of development for NETs, like what would a path look like? I mean, I think many of us may think
of these tumors more slow growing, takes a long time to show a separation. Could you maybe educate us what a path would look like in NETs if
you decided to pursue that? That would be really important. And how big that market would be if you've done any work in that regard?
Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst
: Congrats again. A great surprise.
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