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: Charlie Yang - Bank of America - Analyst
: Great. Thanks for taking the questions. I wanted to just touch on PBH as well. You know, just given what we know about the IGO on previous
agreement with the FDA on this, you know, trial design. What are the other factors that how you are contemplating with, you know, in terms of
design? And is there a potential to have read out earlier in 2026? Thank you.
Question: Charlie Yang - Bank of America - Analyst
: Thank you.
Question: Michael DiFiore - Evercore - Analyst
: Hey guys, thanks so much for taking my questions. Two for me. The first one is on an avexitide. Just kind of curious on how you think about the
risk of hyperglycemia since the GOP one antagonist don't address this this happening. It could lead to lots of undesirable, sequently. So just kind
of wanted to see how you're thinking about that. And then separately with regard to AMX0014, any color on why the FDA deems a 12.5 mg dose
to be too high. Like assuming the trial just runs in Canada and, and safety seems fine. Do you think the FDA will be amenable to allowing future
trials to be run in the US? Just thinking on whether this, asset could even be commercialized in the US? If the FDA still deems that, that, that starting
dose too high? Thank you.
Question: Michael DiFiore - Evercore - Analyst
: Very helpful. Thank you.
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 07, 2024 / 1:00PM, AMLX.OQ - Q3 2024 Amylyx Pharmaceuticals Inc Earnings Call
Question: Graig Suvannavejh - Mizuho Securities - Analyst
: Okay. Thank you very much. Thanks for taking my question and congrats on the continued progress. I did want to go back to the proposed phase
|| trial design for avexitide and PBH I think Camille and the team you are proposing that you go with a primary end point that is the composite of
level || and level |||. And I just want to get thoughts around maybe a clarification as to why in PBH you've chosen to include level ||, I believe had
previously proposed focusing just on level || and there was, concurrence around that. So just trying to maybe get a sense of, of whether including
level || hypoglycemia. What that does around giving increased confidence on trial success? Thanks.
Question: Graig Suvannavejh - Mizuho Securities - Analyst
: Great, thank you. And then maybe just my follow up, with respect to your PSP trial and the interim readout, I apologize if I may have asked this in
the past, but, with regards to a go no go decision in PSP, could you just remind us what you're looking for and what would be considered to be
good enough to feel comfortable with moving forward with the phase ||| portion? Thank you.
Question: Graig Suvannavejh - Mizuho Securities - Analyst
: Thank you.
Question: Ananda Ghosh - HC Wainwright - Analyst
: Hey, hi guys. Good morning. I just have one question on avexitide. Can you briefly talk about the pharmacokinetic profile for the 90mg dose of
aide with respect to the hypoglycemic events that is how fast those symptoms occur, post events and how fast a counter them based on their PK.
Question: Ananda Ghosh - HC Wainwright - Analyst
: All right, great.
| 
