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: Yatin Suneja - Guggenheim Securities LLC - Analyst
: Hey guys, can you hear me?
Question: Yatin Suneja - Guggenheim Securities LLC - Analyst
: Hi, thank you so much for taking my questions. Some very exciting news about the two new assets, the disclosure that you've made today. So I
have two questions. One is more on the funding front? And then I have a question about the the Plant City. So the first question I have is you are
about to have the minutes from the FDA. You're about to start studies for Fiber One, and then you have these two exciting assets. So how are you
thinking about funding the development of these three assets? And what is the funding situation now?
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And then the second question I have is that are there specific studies that you need to do in order to file an IND for 502 and when can we expect
that?
Question: Yatin Suneja - Guggenheim Securities LLC - Analyst
: I'd have one more question, if I may. So is it clear -- this is for the broader team, is it clear in the literature, whether the overreaction or what activation
or hyperactivity of 5-HT7 receptor, of course, in agitation? And do we know if there are other possible targets for the Company?
Question: Yatin Suneja - Guggenheim Securities LLC - Analyst
: All right. Thank you so much.
Question: Sumant Kulkarni - Canaccord Genuity - Analyst
: Good afternoon. Thanks for taking my questions. My question is for Dr. Cummings. So what ways electroplating mechanism of action potentially
better suited to tackle chronic agitation and how would you compare it to other agents in the space are candidates in development?
And separately, in your experience with patients, how would you conceptualize what constitutes acute versus chronic agitation in the Alzheimer's
context?
Question: Sumant Kulkarni - Canaccord Genuity - Analyst
: Right. Thanks.
Question: Elliot Bosco - UBS Equities - Analyst
: Hi, all. Ellie Bosco on for Colin Bristow, UBS. Could you -- a few questions for me. Could you just outline some of the expectations for milestones for
both the TRANQUILITY and SERENITY at-home studies this year? And then on Dermabond, I think the there were elevated rates of depression and
some of the prior studies.
And so can you frame how you think about that in terms of chronic dosing and then on And then sorry, lastly, can you just qualify why we should
be treating clinically the neuropsychiatric symptoms along with agitation?Thank you.
Question: Graig Suvannavejh - Mizuho Securities USA - Analyst
: Thanks, good afternoon. I got two quick questions. One and just on maybe I'm looking at slide 48 in your deck, and I'm just trying to ask about dose
response with respect to what you're seeing in opioids in the opioid setting and perhaps a lack of dose response. So if you could comment on that.
And then maybe second question is just stepping back very big picture, just stuff and by ourselves always position the technology as kind of AI
based. And I'm wondering if you could just remind us simply how you consider your AI. similar or different to other companies, AI. based approaches
that be well, thanks so much.
Question: Graig Suvannavejh - Mizuho Securities USA - Analyst
: Yeah, thanks so much.
Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst
: Thanks for taking my questions. These are for Dr. Comer. I was wondering if you could shed some light on the following two aspects of the opioid
withdrawal program with potentially 501. Firstly, you talked a little bit about how the advent of and fentanyl and Sentinel plus Vyleesi is complicating
the overall opioid withdrawal landscape because patients typically on these medications don't appear to behave the same way as, for example,
people addicted to herald and then of particular, I was wondering if you could talk a little bit about what challenges, if any, this may pose to the
patient enrollment and also the patient dropout rate that you expect to see in the ongoing proof of concept study with 501?
And then secondly, if you could also give us a sense of you talked about fees, three potential pools of patients who could benefit from 501 has an
approved therapy for opioid withdrawal and give us a sense of whether that would contrast in any meaningful way with the manner in which you
see the effects the Deen currently being? Thank you.
Question: Ram Selvaraju - H.C. Wainwright & Co., LLC - Analyst
: Thank you very much.
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