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 Butler - JMP Securities, LLC - Analyst
: Hi, thanks for taking the question. I know you've just got the data, but anything you can speak to about the patient population that could maybe
address the placebo change or why you didn't see more of a decline in the placebo patients.
And then second question for me, can you talk about the magnitude of change on the NfL biomarker and what we know about how that may or
may not translate to the program in ALS? Thanks.
Question: Jason Butler - JMP Securities, LLC - Analyst
: Great. Thanks for taking the questions.
Question: Graig Suvannavejh - Mizuho Securities USA, LLC - Analyst
: Thank you very much. Thanks for taking my questions. Sorry to see the news on the data. Two questions for me, if I could. Just first, as you think
about the results that you ended up getting in LIFT-AD, in hindsight, is there anything else that perhaps you might have done differently, whether
it was the dose or the patient population, the trial design? Any aspect of the trial in hindsight that perhaps might have given you more confidence
knowing what you know now about perhaps the chance of seeing more positive data?
And then maybe just to clarify, I'm not quite sure if I missed it, but in terms of next steps with this particular program, is it fair to assume that perhaps
there's not a path forward in Alzheimer's disease and what's next for the company is really pivoting away from fosgo and AD and focusing on 1105
and ALS? Thank you.
Question: Graig Suvannavejh - Mizuho Securities USA, LLC - Analyst
: Okay. Thank you for taking my questions.
Question: Andrew Tsai - Jefferies LLC - Analyst
: Hi. Thanks for taking my questions. Appreciate the update. Should you move forward with 1017 in a subsequent trial, what kind of design or
population you think would be most suitable to get the benefit that you want? And then secondly, does it still make sense for you to talk to the
FDA about the study result? Thank you.
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Question: Andrew Tsai - Jefferies LLC - Analyst
: Thanks.
Question: Corinne Johnson - Goldman Sachs - Analyst
: Yeah. Hi. Good afternoon, everyone. I guess following up on some of the prior questions, following this outcome here, how are you thinking about
key priorities for the company as you look at the cash you have on hand and what you can execute against with the current balance sheet?
And then kind of along the same lines with the cash that you have on hand, can you support operations through proof-of-concept data with 1105
towards the end of next year? Thanks.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Yes. Good afternoon, Mark and team. Thanks for taking the question. Provocative, although certainly not compelling results when you look at the
daylight between the curves on slides 10, 11, and 12. But the question that I have is really around slide 13 and the lack of details in terms of -- that
you're providing with regard to the treatment of emergent adverse events.
Is there a difference between the moderate and mild patient population with regard to the safety or tolerability of the drug? In any way, could that
have been functionally unblinding? Thanks.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay. And then my second question is do you have any mechanistic rationale for the much more moderate patient responding differently than
the less moderate? So if you look at CDR 2 versus 1 on slide 12, there is clearly a difference. And that said, it may just be sample size and error bars,
et cetera, that really eliminate that if you had more patients.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Moving into the realm of ALS, it has been said that rapid progressors versus non-rapid progressors provide different signal to noise. Are you thinking
about these results in that context? And with that, I'll jump back in the queue. Thanks.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Thank you.
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