Athira Pharma Inc at Jefferies CNS & Neuro Summit Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Andrew Tsai - Jefferies - Analyst : So maybe, we'll spend a brief couple of minutes talking about the Athira story. So for those in the audience who are less familiar, maybe talk about what you're working on, what your lead asset is, and what kind of milestones can we look forward to in the next couple of months?

Question: Andrew Tsai - Jefferies - Analyst : Very good. Thanks. And maybe let's talk about Fosgo Phase 2/3 data. Second half 2024 is going to be a big event for you guys. So taking one step back, talk to us about your prior clinical data in Phase 2, what did you learn to give you the confidence this could have worked? Phase 2/3?

Question: Andrew Tsai - Jefferies - Analyst : Got it. And what would be the real-world application of a monotherapy like this? We do have the A-beta drugs out there. How does this work if Fosgo is approved, ultimately?

Question: Andrew Tsai - Jefferies - Analyst : Got it.

Question: Andrew Tsai - Jefferies - Analyst : Makes sense. Okay. And so you've reported this Phase 2 data I believe, 2022 -- mid 2022 -- since then, LIFT-AD, which is the ongoing Phase 2/3, had been enrolling all along. But you did make some tweaks along the way. What are those tweaks and why should those tweaks make our conference unchanged, if not feel even better about the outcome of the study?

Question: Andrew Tsai - Jefferies - Analyst : And you mentioned no more semi high-dose. And now it's all about 40 migs mono for the Phase 3.

Question: Andrew Tsai - Jefferies - Analyst : So why should we feel fine that 40 milligrams works just as well as 70 milligrams?

Question: Andrew Tsai - Jefferies - Analyst : Okay. That's good to hear.

Question: Andrew Tsai - Jefferies - Analyst : And speaking of LIFT -- again, data second half 2024 -- this is a six-month study presumably you will complete enrollment first half 2024. Maybe just give us any tidbits. Where are you exactly in this enrollment?

Question: Andrew Tsai - Jefferies - Analyst : Okay, very good. And one more thing that recently -- a recent development is you went to the FDA talk to them about, perhaps, LIFT-AD. So what exactly did you ask them or discuss? What did you get alignment on when we talk about that meeting? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 12, 2023 / 12:30PM, ATHA.OQ - Athira Pharma Inc at Jefferies CNS & Neuro Summit

Question: Andrew Tsai - Jefferies - Analyst : Got it. So the FDA does care about you showing an effect on cognition function?

Question: Andrew Tsai - Jefferies - Analyst : Okay. And so what would be all the potential registrational pathways, then for Fosgo? Do you leverage a biomarker finding, seek accelerated approval? But then I think you mentioned FDA really wants cognition function. So how does this all work? What are all the scenarios?

Question: Andrew Tsai - Jefferies - Analyst : Okay. As we wait for the data, your open-label extension is actually ongoing and it's open-label. Could it make sense to do a data cut of the patients and give us some longer-term data to show? Yes, maybe the 40 -- or indeed the 40 mig -- works just as well as 70 mig would, just give us another proof point that Fosgo is active.

Question: Andrew Tsai - Jefferies - Analyst : Makes sense. And for LIFT to be considered centered a pivotal study, did the FDA say here's what you need to show here to be considered?

Question: Andrew Tsai - Jefferies - Analyst : Okay. In the primary endpoint you mentioned is a composite of cognition and function -- the GST endpoint. So for that to be stat sig, what --

Question: Andrew Tsai - Jefferies - Analyst : Can GST be stat sig if ADAS-Cog or both endpoints show a trend? Or do both need to hit stat sig for GST to give you -- .

Question: Andrew Tsai - Jefferies - Analyst : Right. And as a precedent, have there been other Alzheimer's companies pursuing some type of a composite endpoint to -- for the group?

Question: Andrew Tsai - Jefferies - Analyst : And you did mention you're also looking at biomarkers. So NfL in particular, what kind of reduction versus placebo do you want to see?

Question: Andrew Tsai - Jefferies - Analyst : Got it. And I know you want to see that wait for the data, but should the base case for investors be that even if that LIFT-AD succeeds you run another Phase 3? Or is there really a possibility you can file after LIFT-AD?

Question: Andrew Tsai - Jefferies - Analyst : Okay. And what are you seeing on a blinded basis in LIFT-AD in terms of dropouts and so forth, and as well as potentially efficacy?

Question: Andrew Tsai - Jefferies - Analyst : By half?

Question: Andrew Tsai - Jefferies - Analyst : Okay. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 12, 2023 / 12:30PM, ATHA.OQ - Athira Pharma Inc at Jefferies CNS & Neuro Summit

Question: Andrew Tsai - Jefferies - Analyst : What's ISR, again?

Question: Andrew Tsai - Jefferies - Analyst : And that's a good sign, then. Then, maybe we can talk -- we'll just wait for the data. So maybe let's talk about your ALS asset. I think you mentioned you're pursuing Parkinson's disease dementia. So let's talk about --

Question: Andrew Tsai - Jefferies - Analyst : I see. And the ALS program is a different asset?

Question: Andrew Tsai - Jefferies - Analyst : Maybe some data, 2024?

Question: Andrew Tsai - Jefferies - Analyst : Okay. And then as these three programs are running -- cash position. Last question, do you guys have enough cash to see this all through?

Question: Andrew Tsai - Jefferies - Analyst : Fantastic. Okay. Very good. I think that's all the time we had. But thanks for the updates and good luck on the progress, as well as the readout, of course.

Question: Andrew Tsai - Jefferies - Analyst : Nice chatting. Take care.