Release Date: February 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Hi, this is Sarah on for Jill Tanginis. I had a question regarding the Ascend trial. I know you can't exactly speak to timing, but regarding the data cut that's expected from cohort B, can you do you have any insight into what kind of data we could expect? Would it be, along the similar lines of what we saw earlier this year from cohort A? Thanks. A: Hi Sarah, thanks very much for the question and giving me the opportunity to clarify. For the cohort B data, we expect something that would be akin to what was reported for cohort A. That is an analysis of both the progression-free survival, and at least the preliminary, if not final, overall survival of all patients in that cohort. So we're looking forward to that because those data will be indicative of final trial results and also will give us a good head start into planning for phase 3, assuming that they'll be supportive.
Q: Hi. Hello, everybody. Thank you. So just following up on that with regard to the cohort B, you said, In the coming months, can you be a little more specific? Is that you hope by the end of the year or in the 3rd quarter, 4th quarter, what does that look like? A: So the best I can do, Pete, because, as I think we've explained, at least in writing in the past, and I can take a moment here to repeat it, we, under contract with AGITG and the CTC of the University of Sydney do not have any control over the release of the data. This is an investigator-initiated set of trials and so they control the data release. As best as we know right now, the plans are to attempt to have all of the analysis done in time to submit an abstract so that the data could be presented at the American Society of Clinical Oncology or ASCO meeting, which is the last few days of May 1st few days of June this year. If they get their analysis done on time and submit that abstract, then that would be the date of the public disclosure most likely. If they missed the deadline for the submission of the abstract, the next relevant major International scientific meeting is ESMO, the European Society of Medical Oncology, and that would be I think actually October. So to narrow it down, it's most likely going to be sometime, from 2nd through 3rd quarter of this year that the data will become available, although we're working with them being the AGITG and CTC to see if they can get the analysis done faster and allow for release of the information under other circumstances. So you know that's the best we can say right now.
Q: And that is, will the Cova deal lead to, let's say, future diagnostics that will enable better analysis in clinical trials, say, a phase 3 clinical trial that would look at tumor sizes and all that sort of stuff, or is it not really directly related to that? A: Well, once again, I will give you my interpretation and conclusions based on the transaction with Cova and discussions with their head, but I can't speak for Cova, so I want to make that very clear. Cova speaks for itself, but I believe that the intention with Cova is to do exactly what you just described, not only for clinical trials, but actually as a personalized medicine for treatment of actual patients once certepatide is approved. So the goal is to identify those patients and those tumors that are particularly susceptible to increased permeability in the presence of certepatide and therefore demonstrate or identify those patients who would respond better with certepatide in their anti-cancer treatment regime. So I think that's exactly what they intend to do, and I think we'll be doing it collectively, both clinically and hopefully eventually commercially.
Q: Hey guys, thanks for taking the questions. I do have a question, and it's not about timing or outcomes per se in terms of when the data comes out, but, what are some of the expectations, not from yourselves, but what you've been talking to a number of pharmaceutical partners. What are they looking for in data that would have appealed to them? Obviously, pancreatic cancer is a critical disease and it's always found late and you obviously are looking at improving outcomes clinically in a significant fashion. What can you tell us in any granularity without talking about timing that you would be looking that pharmaceutical partners have told you that they're looking for and I will hop back in the queue. Thank you. A: Hey, Steve, thanks very much for joining and for the question. So, in general, what I'll say is not particularly profound because it would apply almost to any oncology program at which a large pharma company would be looking and considering. But in our particular case, what they're looking for are the complete trial results from the Ascend trial for the reasons I just explained to the prior caller, the complete trial is what counts. And also a consistency of both therapeutic effects and safety. And so, they want to know that the drug works consistently, that we have a good handle on the relative magnitude of that effect so that we can appropriately size and power and optimize phase 3 registration protocol and that there have been no untoward safety signals that have come out of exposure to larger populations and so up until, well, let's just say to date we've been able to do that and we'll be expecting, to be able to do that hopefully with the results from cohort B when we get them and of course this is all done in the context of in comparison. With standard of care, right, the whole point of the matter is that the addition of certepatide is designed to improve standard of care. So I'm talking about therapeutic effect. I'm talking about the combination of the cytotoxics, gem cytabine and nab-paclitaxel with certepatide and seeing that they have an improved effect over treatment without certepatide.
Q: Alright thank you. Most everything's pretty straightforward here, but you have an interesting comment about the fortified trial. And alternative approaches to achieving the study objective. Yeah, are you in a position to elaborate on any of that? A: Ken, thanks for joining and I appreciate your question. Thank you. I can say, what we're thinking, originally the fortified trial was designed to elicit or elicit further information around the pharmacodynamics of certepatide in humans and the original concept was that it would have to have its conclusions based upon both progression-free survival and overall survival data in patients. And as we know, they take a long time to get to and it's sort of a perverse situation, but the better the drug works, the longer it takes to get that information. And so we've been considering other ways, and now that we have a strategic partnership with Cova, it prompted the thought process around a possible means of eliciting the same information using imaging techniques and imaging endpoints for these purposes. Now we haven't yet refined that we're certainly not in a position to discuss
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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