ACADIA Pharmaceuticals Inc at TD Cowen Novel Mechanisms in Neuropsychiatry Summit Transcript

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

Question: Ritu Baral - TD Cowen - Analyst : Got it.

Question: Ritu Baral - TD Cowen - Analyst : Got it. Okay. I think that answers the client question certainly. And now we're going to move on to -204. That's your next-generation 5-HT2A antagonist that you will be developing for Alzheimer's disease psychosis, call it just ADP. Maybe we could just start with that difference between -204 and pimavanserin, both on a receptor activity level and maybe a differential safety level as well.

Question: Ritu Baral - TD Cowen - Analyst : Got it. Do you have preclinical data that suggests to you that that 30 is not at the top of the dose response curve in preclinical models and in a good preclinical model of psychosis or is this based off of receptor biology?

Question: Ritu Baral - TD Cowen - Analyst : Understood.

Question: Ritu Baral - TD Cowen - Analyst : Understood.

Question: Ritu Baral - TD Cowen - Analyst : Got it. And how are you leveraging and adapting your learnings from pimavanserin's development to -204? You didn't do a prospect -- well, you did it Phase 2 prospective ADP study, but most of the Phase 3 studies that you guys have conducted with pimavanserin were in alternate indications. What are those big learnings, either from that Phase 2 or from the Phase 3s that you ran?

Question: Ritu Baral - TD Cowen - Analyst : Can you walk us through the design of the seamless Phase 2/3 study that you have planned for -204 in ADP and how the different parts of that study, the Phase 2 and Phase 3 might differ?

Question: Ritu Baral - TD Cowen - Analyst : You mean the Phase 3, makes you want to change the Phase 3 design.

Question: Ritu Baral - TD Cowen - Analyst : Got it. How much, by the way, does the Phase 2 portion of the study resemble the lead-in portion of the HARMONY study. I mean, other than the fact that you were enrolling DRP patients, so not all ADP patients. But is that double-blind, placebo-controlled portion from a conduct perspective the same?

Question: Ritu Baral - TD Cowen - Analyst : Oh, that was open label. Okay, so there --

Question: Ritu Baral - TD Cowen - Analyst : Got it.

Question: Ritu Baral - TD Cowen - Analyst : Timelines to data. Have you commented publicly on what the enrollment could look like and when we might get that Phase 2 data at least?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Two years to topline data? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 20, 2023 / 9:00PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Novel Mechanisms in Neuropsychiatry Summit

Question: Ritu Baral - TD Cowen - Analyst : Got it. Are you able to enrich enrollment in any way?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And the primary endpoint again. Again, could you just go over that again? Do you have full FDA buy-in and also KOL buy-in from the clinical meaningfulness of that?

Question: Ritu Baral - TD Cowen - Analyst : Got it.

Question: Ritu Baral - TD Cowen - Analyst : Got it. Have you discussed the powering of either of those studies, at least the Phase 2 portion, understanding that the Phase two portion will inform the ultimate power of Phase 3? Have you said anything about that Phase 2?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Before we jump into negative symptoms, we've been getting a lot of inbounds just on the situation around the pimavanserin IP. Obviously, we're talking about -204 and the next generation you've got, new composition of matter. But before we get into the pimavanserin negative symptoms, can you review first where that IP stands right now? There's a few things going on, on that landscape. Steve?

Question: Ritu Baral - TD Cowen - Analyst : Got it. I do want to spend a few more minutes on negative symptoms. That data is expected in Q1 of 2024. Let's start with that unmet need. Percentage of schizophrenia patients that have negative symptoms, we started off the day with our schizophrenia panel. Obviously, that's a huge REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 20, 2023 / 9:00PM, ACAD.OQ - ACADIA Pharmaceuticals Inc at TD Cowen Novel Mechanisms in Neuropsychiatry Summit unmet need. But how are you thinking about the percentage of patients with negative symptoms that will require treatment? Is there a foreseeable

Question: Ritu Baral - TD Cowen - Analyst : Got it. What's a good effect size that you would look for in successful data right now, and are there subscales of the PANSS negative that are -- or portions of that subscale that are more important than others?

Question: Ritu Baral - TD Cowen - Analyst : Effect size. What's a good effect size [parts of the subscale] and maybe secondary endpoints, too.

Question: Ritu Baral - TD Cowen - Analyst : Got it. And secondary endpoints in the study of importance.

Question: Ritu Baral - TD Cowen - Analyst : How are you controlling for placebo? It has always been a problem in schizophrenia studies. Is that less of a problem in negative symptoms or how are you tightening up that protocol?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then payers. For our last question today, how do payers really understand the value proposition of treating negative symptoms? Do they see cost savings to themselves in their system?

Question: Ritu Baral - TD Cowen - Analyst : Got it. Very helpful, guys. We have run overtime. Thank you again, Doug. Thank you, Steve, for the updates today. And we look forward to, first of all, the negative symptom data in Q1 of next year, the updated DAYBUE launch, and getting closer to that -204 data.