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: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Let's start off with a softball. And these are soft and often soft -- softballs are often not so soft -- and that is, when you think about neurodegenerative
diseases, and let's talk about Alzheimer's specifically, what has happened? And what do you think will happen for the therapeutic landscape in the
near term?
Cuong, why don't you start?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: You had a great, great perspective biller. Mark, your perspective.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: You know, I remember covering stocks as a younger, much younger analyst and having coverage on immune -- immune modulating companies
including one that's somewhat famous called Dendreon. And I would go to ASCO and I'd be walking up the hall to the immune modulating session,
and everyone else would be walking the other way. And they'd be like, where are you going, Charles? What am I doing, right?
And it turned out to be true. It was the case that those early observations eventually resulted in a transformation of the industry, frankly. And I
agree with you. I think that we're on the precipice of seeing that happen.
You know, Cuong mentioned 30% reduction in the progression of cognitive decline. But that kind of overplays that. That's after 18 months of
antibody therapy that requires fairly frequent injections. And it is not free, not only in terms of financial cost, but not free in terms of safety. But it
certainly is a step forward. So help us understand why you believe there's an opportunity to move beyond that step forward.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: So you make an interesting observation that the drug started its life in diabetes. And some people have suggested that Alzheimer's is the diabetes
of the brain, right? And I guess that makes some sense, but I'm wondering if Mark can add to the concept that inflammation is a key driver of
continued progression of neurodegenerative diseases. Mark?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Yes, we are going to go into the mechanism. Why don't we go into the mechanism of an HGF modulator in fosgonimeton? Let's proceed.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: But sticking with mechanism and bringing in the concept of inflammation -- because inflammation causes the pathology, often, of these things,
and where you need a repair mechanism. How is that connection made?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Interesting. I wonder if that plays a role in the observation Mark made with the mice and the rats and neuron life. So we heard earlier in a panel,
about little bit more of an earlier species of A-beta, which are referred to as the oligomers. Not the monomers, but the oligomers, which will result
in the plaque formation and accumulation. And that ultimately is the key biomarker for keeping track of whether or not a person has Alzheimer's
or may have Alzheimer's, may get Alzheimer's. And then secondly, whether or not there's clinical benefit, obviously, measuring clinical outcomes
as well.
But Mark, if you could help us understand how modulating HGF/MET with fosgonimeton can actually play a role in that cascade of plaque formation.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: We'll get -- we'll get into that.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay. And in both cases, you have an interesting differentiation of the paradigm relative to how and when the efficacy of monoclonal antibodies
is measured, which is generally 18 months. Maybe you see biomarker changes at six months that have predictive value, but really you need to go
out 18 months to see that kind of clinical benefit.
However, you two have drugs that are very different. Not monoclonal antibodies -- in one case, certainly oral; in another case, may be future oral
-- that may work quickly. And so, six months. Help us understand that therapeutic paradigm and why six months could be useful to a patient -- six
month clinical benefit.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: So we'll get into the clinical trials into detail. But before we do, just conceptually, why is six months useful?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: But it seems like the mechanism is perhaps amenable to creating value in even earlier stage patients as well.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: So it sounds like perhaps your clinical strategy is, first of all, a signal-to-noise and as well unmet need. Why don't we get into some of the clinical
development? So we'll reverse order. For fosgonimeton, you have an ongoing Phase 2. LIFT-AD, very interesting study. If you could provide us a
little perspective what that is.
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SEPTEMBER 26, 2023 / 2:30PM, ATHA.OQ - Athira Pharma Inc at Cantor Fitzgerald Global Healthcare
Conference
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay. You made an interesting observation in that trial with regard to your past results from ACT-AD, in that the drug seems to work better in
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Interesting. And the agency likes that? It's okay with that? I thought most Alzheimer's patients take Aricept.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay, interesting. So there is huge need and people don't necessarily want to take -- or do take -- Aricept over time. So my perception is wrong
that that is an impediment. Should you show activity or efficacy to actual adoption?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: And you mentioned the slippery slope of MMSE 19, what does that mean to people? For people in the audience -- we're talking about -- that starts
to accelerate progression in about a year.
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SEPTEMBER 26, 2023 / 2:30PM, ATHA.OQ - Athira Pharma Inc at Cantor Fitzgerald Global Healthcare
Conference
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: You become agitated, you become perhaps a burden to --
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Yeah. Okay. So interesting. When is LIFT going to read out?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: How do you know you're enrolling Alzheimer's patients?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Not vascular dementia? Not --
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay. But it doesn't depend necessarily on imaging of plaque?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Good. Okay. Makes sense. Any questions on Athira at this point? Because I was going to move over to BioVie. BioVie, very interesting time. Thank
you for coming at this time because you're about to read a Phase 3, right? Help us understand 3107 and the Phase 3 that you're conducting because
like Mark's team, you're also conducting a mild to moderate, which is a little bit later stage than where the monoclonal antibodies have shown
activity.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Yes, congrats.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: So you alluded to this, I'd like to say that every good clinical experiment has three possible outcomes: either it works, or it doesn't work, or it works,
maybe, right? And the works maybe, it sounds like that could be an interesting result as well for you and in fact, could be used to inform the next
step.
Now the next step, as I understand it, is a study in a little-bit-earlier patient population. Can you tell us about that?
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SEPTEMBER 26, 2023 / 2:30PM, ATHA.OQ - Athira Pharma Inc at Cantor Fitzgerald Global Healthcare
Conference
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: I'm a scientist. Back off, man. I'm a scientist. It works, maybe. Go do it again.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: I see. So no imaging required.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: So I want to ask you a question about something you just said but perhaps we'll open it up to a broader question, which is, if we are sitting here in
a year, what will you be most proud of having achieved? What will you look forward to talking to? And perhaps I'll start with you, Cuong, because
you just said starting a MCI study and then reading out next year, which is a pretty aggressive timeline. You think you can get that done?
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Okay. So I imagine that will be a proud moment, if you can read that out. I think that will be number one or number two.
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SEPTEMBER 26, 2023 / 2:30PM, ATHA.OQ - Athira Pharma Inc at Cantor Fitzgerald Global Healthcare
Conference
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: And so going back to the works maybe, every good experiment suggests two others. So I'm just looking for clear interpretable data. Mark, tell us
the next year. What is top of mind for you in Athira?
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