Unknown Analyst: Good afternoon. Hi, this is Dina on for Jason. Congrats on the progress this quarter and thank you guys for taking our question. So, our first question is on XEN1101IP. Some investors have expressed skepticism over 1101 later expiring 2039 to 40 patents covering polymorph in method of enhancing food effect. Can you explain why you think generics will need to copy the patented polymorph? And secondarily, the extent to which food effect patent claims may intertwine with desired product labeling. And then our second question is — have your thoughts on the competitiveness of Biohaven’s KV7 changed at all after seeing the Phase 1 data Biohaven presented? Does the safety data cast any doubt on Biohaven’s ability to differentiate on dialing out GABA-related AEs? Thank you.
Ian Mortimer: Thanks Dina. Sherry will tackle the IP question, and then I’m happy to provide some commentary on your last question around the competitiveness in KV.
Sherry Aulin: Sure. Thanks Dina. So maybe just by way of background, just to let everybody know on the call. So, yes, we had two important patents that were granted to us or issued in late 2021. The first one that you referenced is our polymorph patent. So, we discovered several novel polymorphs of XEN1101, which were successfully patented, and that patent expires in 2040. So, importantly, there a generic entrant would have to essentially discover a new novel polymorph that doesn’t have any trace of our patented polymorphs to be successful. In addition, the second patent that was issued or granted to us in late 2021 is the food effect, which you referenced. And there, the important point is that 1101 has — there’s a multifold increase in Cmax and AUC when the drug is taken with food.
So, there’s a positive food effect. And that 1101 has been taken or is taken with food, and we do expect that, that will be included within the label. Obviously, that’s pending label negotiations with the FDA. But given that we have been dosing the drug within our clinical studies with food, we do expect that, that will be on label and is an important part of the dosing for the drug to be both safe and effective. So, a generic entrant would need to work around both of those patents. And I think that’s a really important point. And for that reason, we feel very confident in our IP strategy. And maybe lastly, I’ll just mention the food effect patent expires in 2039.
Ian Mortimer: Thanks Sherry. And then just your question on the competitive space. So, we’re not surprised that the competitive space is heating up and it’s increasing given just the strength of our data in Phase 2b in our X-TOLE study. I mean as we’ve mentioned a number of times, I think we have a clear leadership position. Obviously, this is known pharmacology, but I think we also have a molecule that has properties that are performing extremely well clinically and we haven’t seen that from any other drug yet. So, there hasn’t been any efficacy generated with any of the competitive molecules. So, I think from just a leadership position and a time perspective, we feel very comfortable. Maybe another comment we do get some questions just around adverse events as we think about Phase 1 data for these types of molecules.
