Operator: And thank you. And one moment for our next question. And our next question comes from Brandon Folkes from Cantor. Your line is now open.
Brandon Folkes: Hi. Thanks for taking my question and congratulations on all the progress. I just want to come back to that first question around narsoplimab and the TA-TMA meeting with the FDA. Is there a way to contextualize sort of the level of work you have done ahead of this meeting? And what I mean for that is, if you do have a meeting of the minds on the approach to sort of addressing the CRL, is this something we should expect a submission relatively shortly thereafter or is it more just going to agree on an approach and then it could be a couple of months or quarters of work behind it?
Dr. Greg Demopulos: Yeah. Let me first say that, in the prepared comments, I think, I made it clear that we have identified and now can access the sources of information that we need or we believe we need to address FDA’s concerns. So I think it would be premature though on the front end of that FDA meeting to talk about how long it will take us to satisfy FDA. Let’s get through the meeting first and then I think we can speak more definitively about that, otherwise it’s pure speculation. But I think part of your question is what have we been doing, and certainly, in the meantime, since our last public statement around this, there’s been a tremendous amount of work being done; one, in identifying those sources of information; two, obtaining access to those.
Certainly, we aren’t running analysis upfront, because we want to make sure that we with FDA agree one analysis we are going to run. But then, I think, running them, if we are all in agreement on what we are doing, should not be a lengthy process. But let me see, again, I will ask Cathy and/or Steve, if you have any other comments on this.
Cathy Melfi: Thanks, Greg. Yeah. We have been working quite a bit since the last update. And also, as Greg mentioned earlier, we are working with our regulatory consultants and working closely with them to make sure that we are providing the best information that we can and trying to set ourselves up for success.
Brandon Folkes: Great. Thank you very much. That’s very helpful. One more if I may. You have done a tremendous job shoring up the balance sheet and I think the commentary in the press release was sort of funded through at least 2025. Can you just give us a sense of which programs you include in that runway? Is that your sort of the whole breadth of the pipeline or just how you are thinking about kind of maybe focusing on some? Anything you can do to speed up these trials just given your strong balance sheet? Thank you.
Dr. Greg Demopulos: Yeah. Sure. Thanks again, Brandon. Well, certainly, our focus on narsoplimab is a high priority, similarly, our focus on 906. I think as we made clear we began enrolling last December, we began dosing in January. We are pushing hard on that program. We think that that’s going to be a very important program not only for us, but for patients with alternative pathway disorder. So that’s a priority. When we kind of march down, you look at OMS1029, which is our backup to narsoplimab, that program is sailing through, everything looks good there. Similarly, the small molecule program, let’s see if we select, if we select a development candidate next quarter, we will be looking at advancing that. But as you know, that’s really a lot of pre-IND work and that’s pretty contained with respect to cost.
527, we are looking for external funding, and once we have that, assuming we get it, we expect that to fund clinical work and further development. If we turn over a positive card the levodopa-induced dyskinesias. That’s another area that we would consider a clinical trial. But again, that would be limited in size first. It would be proof-of-concept, so cost would be pretty contained. Then when you look at our immuno-oncology programs, those are preclinical, but we hope to, over the coming months, be able to start to move one or more of them into IND-enabling work, which again, those costs are pretty contained. So I think I have answered your question, but let me be very specific about it. All of the programs I have just mentioned are laid out there for the budget and fall within what we are doing all the way well into 2025.
Brandon Folkes: Okay.
Dr. Greg Demopulos: Again, based
Brandon Folkes: Great. Thank you very much.
Dr. Greg Demopulos: Yeah. Based on where we see success, we can always push the hammer down even more on those specific programs. But we are looking for additional revenue beyond OMIDRIA coming in and continuing to drive further development of the pipeline.
Operator: And
Brandon Folkes: Thank you very much.
Operator: And thank you. And one moment for our next question. And our next question comes from Serge Belanger from Needham & Company. Your line is now open.
Serge Belanger: Hi. Good afternoon. A couple of questions for us, the first one on the ARTEMIS Phase 3 trial that I think is expected to read out in the third quarter of this year. Greg, I think, you mentioned that, you expect this trial to support the BLA filing. Just curious when you would expect that the BLA filing, assuming that we get positive results in the third quarter. What kind of other data would you need to complete that filing?
