Sean Lee: Great. Thanks for the clarification. And as a follow-up on that, for the potential future pivotal study that’s coming next year, do you see CNS side serving as a primary endpoint for that study? Or will it be more used alongside more standard measures, such as the OS and response rate?
Marc Hedrick: Yes, good question. I’m going to let Dr. LaFrance take the brunt of that question. But I – think most likely this will be used as an exploratory endpoint in our LM pivotal, Phase 2/3 pivotal trial. We just don’t have enough data yet, to know how we might incorporate that as a primary endpoint. But I think long-term, it could be in LM. Another reason why we think it’s a valuable test for these patients. But Dr. LaFrance, would you like to talk a little bit about primary endpoint selection in LM?
Norman LaFrance: Sure, Marc. Thanks. And Sean, great question. And for LM, I think it’s important to look at what our options are. So mentioning on the CN side, given the study and where FDA typically feels about surrogate endpoints, probably the most realistic, as Mark mentioned, is a secondary, or exploratory endpoint. And we’ll be positioning that and getting some of those data as we progress the current Phase 1 monotherapy. And as Marc mentioned in his remarks, there are several additional LM programs that, will be starting later this year, or early next year. We would expect all of those to have the CN side assay in some regard, as a secondary or exploratory endpoint. Those data will really drive what makes sense in terms of generating the best pivotal database.
But I think it’s important to underline how the investigators feel about this test. And they’ve been using it, before the current – the prior company’s difficulties in a lot of standard of care applications, and very successfully. In terms of trial endpoints, although we have reported OS, and of course, we know the agency likes an OS primary endpoint, I think we all need to remember LM is a very tragic, and difficult to treat complication, of a primary tumor. We would anticipate focusing on breast cancer with the leptomeningeal complications for several reasons. First of all, that’s one of the main contributors to a leptomeningeal complication. And as we all know, FDA is very specific on wanting disease specific indications. And we’ve already accomplished their preliminary agreement by having orphan drug designation for that indication.
In terms of endpoint, OS would certainly be one of the endpoints. I would anticipate that likely to be a secondary endpoint, despite some of our very provocative and promising preliminary information only, because we know that what drives these patients survival, is their primary tumor. In our current database, we have seen that the patients that although have gotten some benefit, both some clinical benefit. And certainly the benefits of CSF tumor reduction that Marc mentioned in his remarks, the patients that unfortunately have expired have all expired from the primary tumor. So the important thing with this indication will be the control of the leptomeningeal complications. So their medical oncologist can focus on the treatment of the primary tumor, giving them more runway for that.
All of this needs to be reviewed with FDA and that’s the plan. I’ll stop here and see if that satisfied your question and happy to give you more feedback, if you’d like.
Sean Lee: Thank you, Norman. That’s very helpful. And my last question is for Andrew. Could you provide us with an overview of how much of the CPRIT grants are still left? And what’s the – how much do you expect to recognize over the next year?
Andrew Sims: Hi Sean, thanks for the question. So at this point, we have additional funding expected from CPRIT of just over $10 million through kind of as I look at it from now, through August 2025, which would be the end of the three-year period. So how that – how we expect and how we forecast that to breakdown is really into three additional payments to be received. The first payment is – should be received kind of late in the first half of this year, and it will be about $3.3 million approximately. We then expect the next incremental advance in CPRIT to be $3.6 million, to be received on, or about the end of this year. And then the final piece and the balance will be received in probably early to mid-2025. If that answer your question.
Sean Lee: Great. Thank you for that. That’s all the questions I have.
Andrew Sims: Yes. Thanks, Sean.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Edward Woo from Ascendiant Capital. Your line is open.
Edward Woo: Yes. Congratulations on all the progress. You mentioned that you guys were going to look for $10 million of grant proposals this year on top of $7 million last year. What are you seeing in terms of the landscape for grant opportunities out there? Is the pot getting bigger, the pot getting smaller, pot about the same? And what about the competitive landscape of competing with other people looking for grants? How is that impacting your ability to get these grants?
Marc Hedrick: Hi Ed, thank you. I don’t see a big change over the last few years. Grants are hard to get. And the yield is low, which means you need to put a lot of them out there to get one or two. So, we are in an advantage not only, because we have unmet medical needs, but also we’re a Texas-based company. And that opens up, what is still the second largest funder of cancer research in the world, which is the state of Texas and CPRIT. And we’ve had success. In fact, we have one of the biggest CPRIT grants ever given, which is for LM. So, I think we have a pretty good – we have a great – working relationship with CPRIT. We have a very good understanding of how to get those grants. We know that there are companies that have up to three of those grants, and we know the process for that.
