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: Jason Gerberry - Bank of America - Analyst
: Hey, guys. Good morning and thanks for taking my questions. First one from me is just -- and congrats on the data -- the primary endpoint, the
collarette cure, 43%, just wondering how you would kind of frame that rate of cure versus the roughly 79% achieved in the prior EUROPA trial Phase
I think you've got something like 10X more patients in your drug arm, probably more heterogeneous patients, 15 trial sites. I imagine you had that
many trial sites at EUROPA but maybe you can comment there. And any differences in just the composite collarette score baseline, that'd be helpful.
Question: Jason Gerberry - Bank of America - Analyst
: And can you just maybe elaborate on the primary endpoint though, that difference, is there any theory to what maybe drove that delta?
Question: Jason Gerberry - Bank of America - Analyst
: Okay, and if I could just squeeze a follow up in, so on the installation thing, really, the only adverse event where there is greater proportion in the
drug arm, albeit it mild, how transient was that adverse event, if you can just sort of put some context around that. I know it was mild and probably
not a big issue, but any kind of clarity would be appreciated. Thanks.
Question: Jason Gerberry - Bank of America - Analyst
: Got it, great. Thank you.
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Question: Briana Warschun - Jefferies - Analyst
: Yes, hi, this is Briana Warschun on for Anthony. Congratulations on the positive data. This is a follow-up to the collarette cure as 43%. I know we've
also spoken about a retreatment rate because this is a chronic condition. So given the 43% collarette cure rate which I understand is completely
different than a clinically meaningful collarette cure rate, are you see interest in patients willing to continue TP-O3 use or do you expect them to
take a break and then follow-up with use when symptoms return?
Question: Briana Warschun - Jefferies - Analyst
: That's really helpful. Thank you. And I have one quick follow-up. So regarding the LianBio partnership will the positive data out of SATURN-1 trigger
an additional clinical milestone payment, and if so how much will that be?
Question: Briana Warschun - Jefferies - Analyst
: Okay, great. Thank you so much.
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Question: Dane Leone - Raymond James - Analyst
: Hi, thank you. Congratulations on the data and outcomes to SATURN-1. Maybe two for me. I will start with when you think about the commercial
strategy with TP-O3, you have the payers, you have the clinicians, you have the consumers, your team's stated the goal to kind of tackle all three.
And when we've done our due diligence, obviously it breaks down a little differently of what the payers might focus on which would probably be
more on mite eradication rate versus what consumers might focus which is actually the collarette cure rate.
Just from your team's perspective, obviously the site hit across all the different primary and secondary endpoints, but how do you think about
what data are important to which end user of the product?
Question: Dane Leone - Raymond James - Analyst
: Great. And then the follow-up question for me, in terms of measuring some of the anatomical impacts of the drops, one to focus and that gets
asked to us by investors is on endothelial cell counts and potential impact on the cornea. I'm just wondering did you generate any data on that
within the Phase 2 studies, and then which studies out of the Phase 3 studies will that be measured in?
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Question: Dane Leone - Raymond James - Analyst
: Excellent. Thank you. Congrats again on the data.
Question: Patrick Dolezal - LifeSci Capital - Analyst
: Hi. Congrats on the data and thanks for taking the questions, just a couple for me. So I know it's obviously early days of this initial bit of pivotal data
in hand, but from a labeling perspective could you give us a feel for what might be possible surrounding any of the secondary endpoints that have
been assessed?
Question: Patrick Dolezal - LifeSci Capital - Analyst
: And then I guess just one as it relates to drop comfort, if you could just give a little more granularity when this was assessed. I am kind of curious
temporally if and how drop comfort changes over time, kind of thinking about when patients initiate treatment versus the end of the treatment
period?
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Question: Patrick Dolezal - LifeSci Capital - Analyst
: Great, thank you.
Question: Matt Kaplan - Ladenburg Thalmann - Analyst
: Hi, good morning, guys. And let me add my congratulations to the SATURN-1 results, impressive. A couple of questions, I guess maybe for Dr. Yeu
and Aziz, I guess.
Given the results of the TITAN study and some of the other independent studies, the ATLAS, where you are showing high rates of the prevalence
of Demodex and collarettes across a wide range of patients, how do you think TP-O3 could be incorporated into the care of patients going forward?
Question: Matt Kaplan - Ladenburg Thalmann - Analyst
: Thanks. Thanks for the detail. And one more follow-up I guess. How does the clinically meaningful cure results that you showed of 81% or the
primary endpoint, the complete collarette cure of 43% correlate with the resolution of blepharitis?
Question: Matt Kaplan - Ladenburg Thalmann - Analyst
: Thanks for taking the questions.
Question: Francois Brisebois - Oppenheimer - Analyst
: Hi, thanks for taking the questions and congrats on the data. Just quickly here, I was wondering from all the research, maybe, Aziz, with the TITAN
studies how aware maybe quantitatively are physicians of Demodex? Obviously they are very aware of blepharitis, although it's easy to look at
during a normal eye exam I was wondering anything about the awareness of physicians on Demodex in particular?
Question: Francois Brisebois - Oppenheimer - Analyst
: That's great. Thank you very much.
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