Gil Blum: That’s very helpful. Maybe another detail on the enrollment here, so it sounds like the wild-type cohort is enrolling well, any thoughts on the mutant cohort? Thank you.
Brian Sullivan: Well, they enroll in tandem. Essentially we’re enrolling screening patients who have had prior CDK4/6. If they meet criteria, screening criteria, that includes assessment of their PIK3CA status, they then get randomized. So, essentially, the enrollment of wild-type and mutant are occurring concurrently. And so, if our wild-type is on track, then our mutant population is on track, just because of the way the trial enrollment is designed.
Gil Blum: Thank you. That’s a very helpful clarification. Thanks for taking our questions.
Brian Sullivan: You’re welcome.
Operator: Thank you. Your next question is from Brad Canino from Stifel. Please ask your question.
Bradley Canino: Hi. Good afternoon. I want to ask is there any way you’ve been able to track adherence with the prophylactic mouthwash for stomatitis mitigation in VIKTORIA-1?
Brian Sullivan: Well, we do. One of the primary advantages we have in managing that and monitoring compliance is when the patients come in for their three-week on, one-week off infusion. And so, the treating physicians or the associated nurses are evaluating and including compliance with that prophylactic and standard questionnaire. And so, we have a high degree of confidence based on that, that if patients aren’t compliant, we’ll find out, but also we reinforce the value of that prophylaxis. And just as a reminder, that prophylaxis is only used and prescribed for the first two cycles of treatment. The data is fairly clear that for patients who may be prone to development of mucositis, it’s in almost all cases likely to occur in the first two cycles of treatment.
And so, that if you are able to provide that prophylaxis for that first two cycles, that the manifestation of mucositis is much, much lower after that period. So, it’s not a requirement then for patients to remain on that prophylaxis beyond those first two cycles.
Bradley Canino: Okay. And then, I’ll try to ask another enrollment question, maybe in a slightly different way. Because I think the continued reiteration of top-line guidance for VIKTORIA-1 is going to be important for investors. I think based on the enrollment pace you see, is there anything you can share about a time point that could be passed this year where you would reach that sufficient enrollment to fully secure the second-half guidance for the wild-type using the rate assumption you got for events?
Brian Sullivan: I think, again, we provided the guidance for the second-half of this year. Obviously, as we get closer to that, we can get more granular. And I think we’ll update that each quarter. And so, the closer we get, I think, the more descriptive we can be. But so far, again, we’re monitoring enrollment, we’re monitoring the event rate, and you make certain assumptions about the event rate, and we’re tracking to what our assumptions are so far.
Bradley Canino: Thanks for the question.
Brian Sullivan: You’re welcome.
Operator: Thank you. Your next question is from Swayampakula Ramakanth from H.C. Wainwright. Please ask your question.
Swayampakula Ramakanth: Thank you. This is RK from H.C. Wainwright. Good afternoon, Brad.
Brian Sullivan: Good afternoon.
Swayampakula Ramakanth: Most of my questions have been answered. So, when the data — when you are ready to publish the data from the wild-type in the second-half. I’m just trying to figure out how would you disseminate that information? Would that be a medical meeting or do a press release and then follow up with a medical meeting at the appropriate time?
Brian Sullivan: It’s somewhat situational depending on the timing of meetings and when the data will be cleaned and able to be released publicly. And so, when the event threshold is triggered, we’ll understand whether what the gross or not gross, but what the data is telling us. And we would finish up data cleaning at that point. Obviously that’s going on an ongoing basis. But it would be our expectation that we would announce the top-line results, meaning whether or not we met statistical significance, whether the trial was positive, and probably characterize how clinically relevant those results are. But I think it’s typical that you present these results of a Phase 3 study at a medical meeting. That would be our current desire, but again, depending on the timing of when the data’s available, we may reconsider.
But we’ll follow, I think, practice that’s been used with other drugs, but I think it’s fairly typical that if a major meeting isn’t scheduled coincident with the availability of data that people will provide that top line and then wait until a medical meeting to provide the more fulsome description of the results.
Swayampakula Ramakanth: Thank you. Thanks for taking my question.
Brian Sullivan: You’re welcome.
Operator: Thank you. [Operator Instructions] Your next question is from Alex Nowak from Craig-Hallum Capital. Please ask your question.
Alex Nowak: Hey, great. Good afternoon, everyone. As we’re getting close to the first VIKTORIA readout here, you brought on your Chief Commercial Officer. That’s great. Just what other additional investment in the commercial talent, commercial resources do you need to plan for here over this year?
Brian Sullivan: Sure. You start to build out the team underneath Eldon, which I think typically includes a person who would head up your market access, a person who would head up your marketing, and a person who would head up commercial operations. And with that team, you can do the planning that’s necessary to lay the groundwork for obviously a lot more significant efforts once the data reads out and you’re really marching towards a specific date for launch. And so, we factored that into the assumptions in our budget for this year. We’ve incorporated that in our forecast of cash requirements and they’re not extraordinary, they are appropriate relative to what needs to be done and when.
Alex Nowak: Okay. No, it makes sense. And then, can you remind us the IEP position of Geda within breast cancer and then the potential to expand that length within breast or potentially other cancer indications?
