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: Karin Johnson - Goldman Sachs Group Inc - Analyst
: Morning, guys. Maybe a couple from us. First, could you provide some more detail on the nature of the patents that exist around this asset? And
maybe second, could you just talk to us about the dose selection of 90 [mix]. I think there's a couple of different doses study that -- I'd be curious
how you are thinking about that dose selection? Thanks.
Question: Karin Johnson - Goldman Sachs Group Inc - Analyst
: Okay. Thank you.
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JULY 10, 2024 / 12:00PM, AMLX.OQ - Amylyx Pharmaceuticals Inc To Discuss the Acquisition of Avexitide
Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst
: Hey, guys, thanks for taking my question. And again, congrats on this transaction. My first question is any initial assuming that this does get approved
and come to market and initial thoughts on pricing and treatment duration? And my follow-up is that, big picture wise, this is a clear divergence
away from ambulances initial focus on neurodegeneration. Could this be considered a one-off opportunistic play or does this mark a bona fide
change in focus for the company in terms of disease state? Thank you.
Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst
: Thanks so much.
Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst
: Hey, good morning. Thanks for taking my question, congratulations on closing the deal. PBH is probably not known to many of us, including myself.
So I was wondering if -- while there's excitement around the potential of the program in PBH, could you give us maybe a sense of the competitive
landscape? Are there other mid or late-stage clinical programs that are in the clinic right now? Thanks.
Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst
: Thanks. And if I could ask a follow-up, just on how should we be thinking about the commercialization model? I know it's a rare disease, but any
kind of broad comments on how you think this is going to be commercialized?
Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst
: Thanks, Justin.
Question: Charlie Yang - BofA Securities, Inc. - Analyst
: Great. Thanks for taking the question. My first question is just can you provide more details in terms of the background therapies that in the from
the Phase 2 trial? I guess specifically, I'm just wondering, I think your prior reports about potential efficacy in with GLP-1 Agonist. As well as was
GLP-2 wondering whether those were used in the Phase 2 studies and then whether you think that could be potential count comparison down
the road?
And then my second question is regarding the financial cost to build out the infrastructure. I guess if the trial would just be successful in terms of
cost to build out for commercialization?
Thank you.
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affiliated companies.
JULY 10, 2024 / 12:00PM, AMLX.OQ - Amylyx Pharmaceuticals Inc To Discuss the Acquisition of Avexitide
Question: Ananda Ghosh - H.C. Wainwright & Co., LLC - Analyst
: I have two questions. You know, given the variability one sees with the GLP-1 antagonist, I was just curious to understand how common are
hypoglycemic events with GLP-1 agonists and in also those people who are who have both undergone bariatric surgery and on these agonists.
That's the first question.
The second question is what is the rationale behind using the composite score for the Phase 3 trial design?
Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst
: Thanks so much for taking my follow-up questions. A few for me. The first one is why not just use Intranasal glucagon or subcutaneous glucagon
shots to treat? Is it safe to assume that these options are more considered as a one-time on-demand agents and \that's a tied offers kind of a more
predictable or basal coverage.
And then the second question is Amylyx is currently available as a weekly injection. So why couldn't Avexitide be formulated as such? And I have
two more follow-ups after that.
Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst
: That's very helpful. And just two final questions for me. One is kind of a nitpick. -- Previous slides say the US prevalence is 180k, why does that differ
from your quota prevalence of 160k prevalence in the US? And my final question is just thoughts on the increasing use of more effective GLP-1
and how it may erode in the long term that the number of bariatric surgeries performed annually.
I mean, we hear with these next-gen incretin therapies that categorization and triple G kind of approaching bariatric surgery like weight loss. Do
you foresee the numbers of bariatric surgery procedures in the long term are diminishing? And if so, how may that impact your outlook for this
product?
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