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: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Bobby, thank you for the detailed overview. That's very helpful. Really sets the stage for some of the questions I want to dig into a little bit here,
specifically on TP-03.
Congratulations on the very strong results for the first Demodex blepharitis Phase 3 study, Saturn-1. Can you provide us a little bit more color on
the efficacy results that you saw there, I guess, and observed both across the primary and all the secondary endpoints?
But specifically, what you saw with respect to reduction in the collarette cure rate in the study versus Europa, this is an area that -- your Phase 2
study, this is an area that we've gotten some questions with. You showed a cure rate of 43% versus 79% what you saw in Europa. Can you kind of
walk us through how you view that?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Okay, yes. Very helpful. Thank you. And then with respect to the endpoints that you looked there, what are the most important endpoints in the
study from a physician's and patient's perspective?
You have the cure rates of grade 0, where you had zero to two collarettes; grade 1, 3 to 10 collarettes; mite eradication and erythema; and you
showed strong results across all of those. But what is the most important from a patient perspective and a physician's perspective?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Okay, great. Perfect. And then from a safety perspective and tolerability perspective, you mentioned that there were I guess no discontinuations
-- very low discontinuations in the Saturn-1 from a tolerability perspective. But what do you know about right now about TP-03's impact on the
cornea? And I guess did you look at this in Saturn-1 or in Phase 2 studies? And what do we know so far?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
:
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Great. And how is Saturn-2 progressing so far? Are you seeing any impact or do you think the rise of the Delta variant will impact the conduct of
the study at this point?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: And any other significant differences in design of Saturn-2 compared to Saturn-1 besides some of the safety parameters that you are examining?
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Okay, great. Maybe in the time remaining, let's -- maybe we can shift gears a little bit and talk about your commercial strategy for 03 in the US and
what you are thinking about there.
Question: Matthew Kaplan - Ladenburg Thalmann & Co. Inc. - Analyst
: Great. Well, Bobby thank you for taking part in the conference today. Really looking forward to the read-out of the Saturn-2 results and also looking
forward to kind of the other formulations that you are working on, topical for rosacea and then oral for the prevention of Lyme's, and malaria for
lotilaner.
And congrats again on all the progress. I think we will have to wrap it up there as we are pushing against the clock here.
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