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
: Absolutely. Maybe we can stick with that neuroprotective theme for a second. And you mentioned that you're activating this repair system and
HGF/MET. Can you talk about, I guess, both sides of that equation why you think that you can be impactful across a range of diseases as well as
why you don't necessarily need to be as selective?
Question: Jason Butler - JMP Securities LLC - Analyst
: I think it's also important to recognize that this system is not working normally in these disease states, correct?
Question: Jason Butler - JMP Securities LLC - Analyst
: I want to kind of do this a little bit backwards and come back to the basic design of the LIFT study in a second. But we -- just a quick version of
history. You've got some really interesting initial clinical data, and then you started two trials, the Phase 2 ACT study and the Phase 2/3 LIFT study.
Question: Jason Butler - JMP Securities LLC - Analyst
: The ACT study was intended to be somewhat informative of the ongoing LIFT study, and the results from ACT were different to what you were
planning for, right? So you've learned a lot from that study, so maybe we can fast-forward and say, where are we today in terms of the changes
that you've made to the LIFT study? And what do the next six to nine months look like until we get data hopefully in early 2024?
Question: Jason Butler - JMP Securities LLC - Analyst
: Absolutely.
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MAY 15, 2023 / 2:30PM, ATHA.OQ - Athira Pharma Inc at JMP Securities Life Sciences Conference
Question: Jason Butler - JMP Securities LLC - Analyst
: Okay. So I guess, just one clarification point there. Does -- the information that you've got back from the interim does not differentiate between
the 30 milligram and the 70 milligram.
Question: Jason Butler - JMP Securities LLC - Analyst
: Right.
Question: Jason Butler - JMP Securities LLC - Analyst
: Got it. So can we come back into the interaction and the AKT piece of the story?
Question: Jason Butler - JMP Securities LLC - Analyst
: You presented some data at AAN a few weeks ago. Can you just walk us through now what you think is going on here and why there is a muted
response or effect when you add standard of care into the mix?
Question: Jason Butler - JMP Securities LLC - Analyst
: The other part of the update last week was that you're going to go back to the FDA in coming months to basically just make sure that you're still
on the same page, and I think this is important for a couple of reasons. One, let's talk about your primary endpoint, the global statistical test, and
why you chose that originally. It was different.
I think we've learned from FDA, when they're thinking about Alzheimer's, they're willing to have conversations and do things differently because
they recognize the way that we were doing. Things was not necessarily Perfect. So the primary endpoint, the trial design changes, obviously.
What are you looking to get out of this meeting with FDA? And how should we think about that when we think about the -- ultimately, when we
see the results in early --
Question: Jason Butler - JMP Securities LLC - Analyst
: Right.
Question: Jason Butler - JMP Securities LLC - Analyst
: Just an important context here. When the green zone analysis, the interim you did -- correct me if I'm saying this wrong, but you either had to see
a relatively profound effect on cognition or function or effects on both. So I guess when you think about the probability of scenarios, if you hit on
the GST, most likely, you're having a real effect on both cognition and function. Is that fair?
Question: Jason Butler - JMP Securities LLC - Analyst
: Okay. Last couple of minutes, I wanted to make sure we spend some time talking about ALS. Again, like you said, presented some really exciting
preclinical data at AAN. Just walk us through, number one, the novel compounds, plans there to move into the clinic, and just mechanistically, why
ALS is the right investment?
Question: Jason Butler - JMP Securities LLC - Analyst
: And so, I know it's early. But thinking about your target development program here, you're looking, like you said, at a broad array of ALS patients.
Are there things that you've learned in recent years? I get it. The most recent experience, tofersen, tells us that NfL is important. But other than
that, it is a very narrow patient population.
But just -- we have had a lot of failures, but we've also learned some things about endpoints and trial conduct, et cetera. So just set the stage for
us a little bit about how you think about an ALS development program.
Question: Jason Butler - JMP Securities LLC - Analyst
: I guess, just the last few seconds, Mark, could you just review for us? We talked about a lot of milestones that we're going to hit, and then --
Question: Jason Butler - JMP Securities LLC - Analyst
: Just recap for us.
Question: Jason Butler - JMP Securities LLC - Analyst
: And the AKT publication as well.
Question: Jason Butler - JMP Securities LLC - Analyst
: Fantastic. Well, Mark, Hans, I really appreciate you being here, and we're excited to keep watching for the next few months.
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