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: Evan Seigerman - BMO Capital Markets - Analyst
: I wanted to drill down a bit on some of the tolerability components, specifically the relatively high rate of nausea and vomiting. Maybe could you
expand as to what we saw kind of at weeks 10 and 12? And maybe taking a step back, you mentioned a lot on the PK properties of the asset. Maybe
walk us through what you can do from a PK and formulation perspective that could improve upon that?
Question: Evan Seigerman - BMO Capital Markets - Analyst
: And then just on the formulation. I know you were talking about the PK profile and kind of ability to reformulate or improve upon formulations.
What can you do there to maybe attenuate the side effect profile even more?
Question: Yasmeen Rahimi - Piper Sandler - Analyst
: I guess the first question, team, is you did a really nice job breaking down the rates of nausea vomiting at the end of 12 weeks or in total on Slide
16. That's for the capsule formulation. Could you maybe now talk about how this compares to the tablet?
And if you have the data on hand, that would be great. I think clients are just wondering what does the time curve look like around nausea? And
more importantly, what do the overall rates look like, just kind of relative to Slide 16?
And then the second question is, given the three cases of liver enzyme elevations, I guess, what evidence is there to conclude, especially the two
cases that was on the 120 mg dose group, that it was just not related to drug?
I know you guys went quite a bit in detail around the patients, how they have predisposition. But if you could just highlight a little bit more like
why weren't this screened out of the study initially and they had a propensity for liver enzyme elevations? And my apologies for asking two questions.
Question: Jonathan Wolleben - JMP Securities - Analyst
: You guys mentioned that you had two batches of patients and you gave us eight-week data, I believe, back in December from the first group. Can
you talk a little bit about any differences in weight loss or tolerability or baseline demographics between those two groups?
Question: David Risinger - Leerink Partners - Analyst
: Congrats on the results, and thanks for the detailed presentation. So I have two questions, please. First, the weight loss moderated significantly
between weeks eight and 12. We've gotten questions on that. I just was hoping that you could comment on that.
And then second, if you could just update us on your plans for potential partnering discussions. I believe that earlier this year, you mentioned that
you could have discussions following the release of this data set. So I'm just hoping for an update on that, please.
Question: Seamus Fernandez - Guggenheim Partners, LLC - Analyst
: Great. So just a couple of quick ones. First, can you comment on the 60 milligram dose? The performance of that product in the titration study or
of that dose seems actually quite good. I guess one of the dynamics that may be missing there is just tolerability by dose selection.
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Question: Prakhar Agrawal - Cantor Fitzgerald - Analyst
: Congrats on the update. So this trial had lower baseline BMI related to some of the other obesity trials. Could you talk about how movement into
higher baseline BMI will change the magnitude and the slope of the weight loss curve? And could that lower baseline BMI be influencing the weight
loss flattening that you're seeing from week eight to week 12?
And my second question is, could you talk about the tolerability profile of cohort three in the PK formulation trial that had slower titration? You
disclosed nausea and vomiting is lower at by week two, but what about the other time points?
Question: Roger Song - Jefferies LLC - Analyst
: Congrats for the data. I will limit my question to one. Maybe, team, if you can comment on your PK profile, this kind of mean plasma concentration
meeting this 10-nanogram, versus you wanted those a little bit higher than 120, how this will improve your overall weight loss over longer term,
and how high that those you're kind of planning to go based on your safety profile?
Question: Hardik Parikh - JPMorgan Chase & Co. - Analyst
: I was just wondering that have you guys seen any data as relating to your titration schedule that kind of gives you any insight of as you moderate
the titration, is it easier to potentially reduce the rates of nausea or vomiting, like one versus the other? Is there specific type of levers you can pull
that kind of maybe hit vomiting more than nausea?
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Question: Myriam Belghiti - LifeSci Capital - Analyst
: Congrats on the data. So just one question from me. So naturally, with the slower titration schedule, we will expect lower AEs, but also slower
weight loss. What in your mind is a limit to how well you can titrate GSBR-1290? And then is there a minimum weight loss threshold by some time
point that you think is important to hit?
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