Cognition Therapeutics, Inc. (NASDAQ:CGTX) Q4 2022 Earnings Call Transcript

Tony Caggiano: Sure. So as we mentioned before, some of the impetus for us to move into GA was based on the genome wide association studies that are in the literature demonstrating that certain changes in the proteins that make up the σ-2 receptor confer either risk or protection against developing GA. So indeed there is some of that data out there. And then your next question was €“

Jay Olson: Do you have any of those patients in your Alzheimer’s study?

Tony Caggiano: Yes. So, yes, it’s an interesting question. We don’t screen those subjects for geographic atrophy. Obviously, these are complex studies in individuals with dementia. So that’s not really part of our operations.

Lisa Ricciardi: And last, Jay, with regard to the market, the great thing for us is that, you have drugs ahead of us that are building this market, right? (ph) other companies coming behind them. And as we’re going through development, we will see as the retinal community takes forward these products, we’ll look at what the reimbursement is. We’ll see how this landscape evolves. We believe for patients that an oral drug is a far simpler regimen to take for the long term than having intravitreal injections and we’ll see what the practice of the retinal specialist court. So we’re watching and waiting carefully. We think an oral drug has an enormous advantage. Could it be disruptive? Possibly. Could it work in combination? Possibly. Those are things we’ll be looking to study as we progress.

Jay Olson: Sounds great. Thanks for taking my questions.

Lisa Ricciardi: Thanks, Jay. Our next question comes from Mayank Mamtani from B. Riley Securities. Please go ahead. Your line is open.

Mayank Mamtani: Good morning, team. Thanks for taking our questions and appreciate the level of detail. So maybe I’ll go in reverse order. Staying on the GA Phase 2 trial design, sorry if I missed this. Could you touch on the treatment period for your primary efficacy endpoint, assuming it’s GA lesion reduction? And are you also, by any chance, looking at Visual Equity, maybe as a safety measure? And at what time point could we have an update for that? And then I have a follow-up on Alzheimer’s question.

Lisa Ricciardi: Good morning, Mayank. Thank you. Tony will take your questions.

Tony Caggiano: Sure. Yes. So Indeed, we are following the precedents of others who have recently filed for approval in this field. They’ve taught us a lot, particularly about the approvability of measuring change in GA. So we’re following very much what others have done. Our study is a two year trial. And this is largely because while the effects of changing GA are devastating, they are relatively slow progressing. So you need a significant period of time to measure change. Finally, to answer your next question. We are measuring visual acuity in various different ways. And indeed like others these will support our primary outcome, but they are not the primary.

Mayank Mamtani: If I may just ask a follow-up, that two year treatment period, was that your proposal to the agency or was that coming from Dr. Chambers?

Tony Caggiano: So, we did have discussions with FDA. And we landed on this number based on what we and they thought was the most likely chance of success.

Mayank Mamtani: Got it. And then on the Alzheimer’s program, I appreciate the level of detail on expectations for sequel. I was just curious, as you know, there’s a big focus on CSF biomarkers, right? Also, I believe in your — both your SEQUEL and SHINE studies. So could you just maybe elaborate on which markers are more relevant with oligomer displacement and you could expect to move acutely in a study like SEQUEL versus other markers where you may need sort of a six month to a 12 month time period, longer chronic dosing, that would be helpful, Tony.