Jay Olson: Great. Thanks so much for taking the questions. Congrats again on the progress.
Operator: Our next question comes from Mayank Mamtani from B. Riley Securities. Your line is now open.
Mayank Mamtani: Good morning team. Thanks for taking our questions and appreciate the comprehensive update. Maybe just quickly on the Phase 2 SHINE study, could you comment on your expectation for rate of ARIA? And if you do have any understanding on how the split of mild and moderate patients are going to be in the SHINE study, obviously with your earlier 24-patient cohort, breaking out mild and moderate was not possible, but in this larger cohort, that could be a possibility. And then I have a couple of follow-ups.
Lisa Ricciardi: Good morning, Maya. I’m going to let Tony take your question.
Tony Caggiano: Yes, so taking the second part first, we will be doing analysis of how folks, their scores entering, breaking down between mild and moderate or more severe and less severe, and how that impacts their change on our outcome measures. And then remind me of the first question – rate of ARIA. Yes. So, we don’t expect that based on our mechanism of action that ARIA will be an issue. With antibody therapies pulling amyloid from brain and blood vessels and the rest of the vasculature, you would expect to see those findings. We do not – however, obviously the full safety picture of our drug will come out as we do complete studies.
Mayank Mamtani: Understood. And then in regards to your recent EEG proteomics and even brain volume data, that has been helpful to understand sigma-2 receptor biology. Any specific biomarker data you’d have in the topline for both readouts that is worth paying attention to? If you could point to that, Tony, that would be great.
Tony Caggiano: Yes, sure. So, we’ll be reporting out basically the same biomarkers that we did from the preliminary read, and those are the canonical biomarkers that you would expect to see, changes in monomer, synapse proteins, GFAP, NFL, et cetera. And then as we did previously, we’ll be doing complete proteomic analysis from the cerebral spinal fluid and plasma of these individuals to look at more refined measures of target engagement and disease modification. So, we’ll be doing pretty much the same thing we did in the preliminary read, as well as expanded based on what we’ve learned in the intervening time.
Mayank Mamtani: Great. And then on the Phase 2 MAGNIFY study, how has the initial investigator feedback been? I know you’re doing well with site activation, but just if you are able to comment on study enrollment. And then lastly, on financials, how much of expected grant funding is baked into your runway guidance so we could have aptly model the next four to five quarters of cash flow. Thanks again for taking our questions.
Lisa Ricciardi: You’re welcome, Maya. With regard to MAGNIFY, there is tremendous enthusiasm in the clinical research community for the trial, as well as from patients. So, there is positive momentum in that study. And like our other studies, we don’t provide guidance on enrollment. They are a very enthusiastic group of PIs and patients, so we can tell you that much. And on the grants, John?
John Doyle: With respect to the grant funding, Mayank, so we expect to complete the SHIMMER grant fund this year as we wrap up that trial. And then the remaining balance of that will be dedicated to START trial as we progress through 2024 and 2025.
Lisa Ricciardi: So, Maya, your question was about the $67 million in the press release we identify. Is that right? And how much of that is baked into the runway?
Mayank Mamtani: Yes, that’s correct.
Lisa Ricciardi: As you know, Maya, the grants are drawn down as the studies are completed. So, it’s really a function of the progress we make in those studies, how quickly that grant funding is absorbed.
Mayank Mamtani: Got it. That helpful. Thanks again for taking our questions and looking forward to an exciting next few months for you guys.
Lisa Ricciardi: Yes, thank you. We are as well. Thank you.
Operator: As of right now, we don’t have any raised hands. So, I’d now like to hand back over to the management for their final remarks.
Lisa Ricciardi: Terrific. To conclude, we’re looking forward to our continued progress and important Phase 2 data readouts in 2024. We believe our science is sound and we continue to build evidence supporting CT1812’s potential for patients. We’re positioned to achieve and deliver on multiple clinical milestones, and we’re focused on creating long-term value for our shareholders. Thank you for joining us today.
Operator: That will end today’s conference call. You may now all disconnect. Have a good day.
