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Operator
trial activity in the U.S. We believe Danielza will continue to grow in future periods, and this will not have a material impact on our cash flow guidance. We believe that Danielza will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that potentially could lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that all of our programs will be advancing at our own expense. No new programs other than the ones that are planned and in studies and trials are assumed at this point for the purposes of this analysis. With a strong balance sheet and a focused strategy, we believe BiMABS is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones as we move ahead.
Mike Rossi
This concludes the financial update, and now I will turn the call back over to Mike. Thank you for that overview, Pete. Now let's open the line for questions. Operator?
Pete
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. We ask that analysts limit yourself to one question and a follow-up so that others may have an opportunity to ask questions. You may re-queue if you have additional questions. For participants using speaker equipment, it may be necessary to pick up your handsets before pressing the star key. One moment, please, while we poll for questions. Our first question comes from with BMO Capital Markets. Please proceed with your question.
Mike
Great. Thanks for taking the questions. First one I had was on sort of the frontline BCC study. Just wondered if you could talk about how many patients maybe you anticipate enrolling in the randomized portion of that study. And I had a follow-up on FADA.
spk06
Great, thank you, Ezra. As far as the BCC study, I'll pass that off to Vinesh, so Vinesh can inform you a little bit more on the study. Vinesh?
Ezra
Yes, thank you, Mike. Yes, so the current study, ongoing single arm study, as Mike mentioned, enrolled 10 patients so far, and we're anticipating transitioning to a randomized study where the design is still being evaluated at the moment, I don't, I can't give you an exact figure of how many patients that is expected to be. But as soon as we get further details later this year, we will share that.
Mike
Great. Thank you. And then for the part A of the SADA study, just wondered if you could learn enough about GD2 expression and the various tumor types you're exploring. to start maybe thinking about expansions into specific tumors in Part B or C, or are you still sort of too early kind of in the process to get to sort of tumor-specific evaluation, if you will, in sort of the subsequent cohorts that you'll be enrolling on Part B, C, and beyond?
spk06
That's a good question. As we look at this, we opted to go with a wide basket. looking at different tumor expressions, and we'll collect that data. I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one, but we will take all that into account as we move into Part B. Great.
Nicole Germino
Thank you. Thank you.
Pete
Our next question comes from Nicole Germino with Truist Securities. Please proceed with your question.
Nicole Germino
Nicole?
Nicole
Hi. Sorry about that. I was on mute. Thanks for taking the question. For GD2-SATA, can you walk us through the cadence of data milestones and roughly when we could get some efficacy data from potentially Part B?
Pete
I have a quick follow-up.
spk06
Yes, Nicole. As we look at the drug study itself, we're not designed for efficacy in Part A. So what we're looking for is really the safety of the protein and making sure that we can continue to move on to Part B where we do a dose escalation. Secondary to that, we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope. So from our Part A, as we conclude it later this year, is really focused on the safety of the protein with the additional data coming in from the interval as well as the overall protein load that we'll use to move forward in Part B. Okay, got it.
Nicole
And then just more broadly on SADA, so the SADA administration has a cold protein infusion that can be administered by the treating oncologist before the isotope infusion. While this may be a bit early, can you help us understand how reimbursement would work out for both the med-onc and for the radonc?
spk06
Yes. Again, that's a good question. This is a novel approach in better utilizing the overall infrastructure in both oncologist offices as well as in nuclear medicine. We know there's challenges today with having enough theranostic suites to do long isotope infusions. as well as enough nuclear medicine physicians authorized users to be able to take the time to do that. So as we move forward going into our registration trials, we're looking at different opportunities for reimbursement and what that may look like, but that overall is not driving our strategy. Our strategy is to be able to more effectively dose patients, to better utilize those resources from both infusion centers as well as nuclear medicine departments, and ultimately be able to treat more patients in an effective manner.
Nicole Germino
Great, thank you. Thank you, Nicole.
Pete
Our next question comes from Justin Walsh with Jones Trading. Please proceed with your question.
Justin Walsh
Hi, thanks for taking the question. Can you provide any color on your timeline expectations for GD2 SADA going forward? Do we have a sense of how long Part B and C might take relative to Part A?
spk06
As we have it laid out today, we expect to conclude Part A later this year and move right into Part B. Now, we've been increasing the speed of our recruitment and our trials So we've been able to recruit rather quickly in Part A as we've progressed this trial. So looking at Part B, as we take the information from Part A, my expectation would be that we would be able to start treating patients in 25, early 25, with the potential to close that out in 25 or early 26. Vinesh, anything additional on your side?
Ezra
Nothing to add on that. I think that is a reasonable timeframe based on what we've seen so far. Obviously, it's very, very independent on what results in the symmetry we see along the way, but I think that's about as best estimation we can make at this stage.
Justin Walsh
Great. Thanks for taking my question.
Nicole Germino
Thank you.
Pete
Our next question comes from Alec Stranahan with Bank of America. Please proceed with your question.
spk02
Hey, guys. Thanks for taking our questions. Maybe a quick follow-up on the last question that was asked. Maybe walk us through how recruitment has gone versus your expectations for the GD2 SADA studies so far and any other unique logistical considerations you'd flagged to getting these studies either for GD2 or for CD38 off the ground, especially thinking as you move to parts B and C. Thanks.
spk06
Thank you, Alex. As far as recruitment goes, it was slow at first as we're getting the sites up. Now we've seen an increase in speed in recruitment in our 1001 trial for GD2. I'd expect to see that continue. As far as our 1201, we've recently initiated the first site with the second one right behind it. So we're actively seeking the first patient for our 1201. But as we look at this, I would expect As you dose proteins in patients for the first time, for physicians to really be judicious in who they select and how. But once you start seeing the safety data rolling in and the lack of DLTs, we see an increase overall in the speed of the trial. So I'm happy with the speed of recruitment. But again, first in humans, you do see some lag time. Ganesh, anything additional?
Ezra
Yeah, just to add, as you know, as Mike mentioned earlier on, this is a complex part of the phase one strategy where we set out to test different SADA dose levels all the way from 0.3 up to much higher doses, up to 5, 10 milligrams was the original protocol, including testing dosing intervals of two to five days. So we're still in that process at the moment. So it's too soon to determine the optimal combination or permutation. But this is kind of the step-by-step process we're taking to actually determine the optimal dose before we get going to Part B. Great.
Nicole Germino
Makes sense. Thank you. Next question operator.
Pete
As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question comes from Mike Holtz with Morgan Stanley. Please proceed with your question.
Mike Holtz
Hey, guys. Thanks for taking the question. Maybe just a follow-up on GD2 SADA. Can you remind us for cohort 5 in part A just, you know, what dose you're at, if you can? And then are there any plans to go to a cohort 6, for example, or dose higher? Thanks.
spk06
Oh, my good question. Vinesh, address the cohort five?
Ezra
Yes, we're currently in cohort five, where we are testing one milligram per kilo at a four-day interval. Whether or not what cohort five patients look like will determine how we proceed based on whether a cohort six is required will really depend on the dosimetry. So at the moment, we don't have any immediate thoughts on what that will look like. We'll wait to see what the results show in this cohort five. So at the moment, it's one milligram and four-day interval.
Nicole Germino
Got it. Thank you. Thank you, Mike.
Pete
Our next question comes from John Newman with Canaccord Genuity. Please proceed with your question.
John Newman
Hi, guys. Good morning. Thanks a lot for taking my question. I'm just curious, with the ongoing Danielsa launch, obviously you're seeing some expansions internationally, but I'm wondering if you could comment on whether you're continuing to see the duration of therapy mature in the United States and whether going forward that could make a meaningful contribution to growth. Thank you.
Mike Rossi
Thank you, John. For Danielle's specific growth, I'll pass this to Sue.
Sue
Great. Thank you. Yeah, we have seen some duration increase actually with some older patients that are added. And in general, we're actually seeing more continued use as our new campaign has data showing efficacy if someone has been on a prior GD2 therapy and has not progressed well on that. When switching over to our product, we have data showing now that patients with bone or bone marrow involvement actually can get a disease response if they've been on a prior GD2 therapy. So we're seeing an increase in uptake among physicians in that setting as well.
Nicole Germino
Great, thank you. Sure.
Pete
Our next question comes from Justin Walsh with Jones Trading. Please proceed with your question.
Justin Walsh
Hi, thanks for taking the follow-up. I'm wondering if you can remind us how you view the relative market opportunity for Danielza in frontline induction and high-risk neuroblastoma and osteosarcoma versus the currently approved relapsed refractory indication.
Mike Rossi
Thank you, Justin. Again, Sue? Sure.
Sue
Currently, the bulk of our use is in the relapse setting in the US and the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting. And actually, the data that is in our new campaign does a nice job of separating this out and actually showing that a patient with an incomplete response after any treatment who has residual disease in the bone or bone marrow, this is precisely where we were studied. So, we're starting to see and we've heard from physicians with the new campaign that they intend to increase their use in both of those settings based on the new data.
Nicole Germino
Great, thanks.
Pete
There are no further questions at this time. I would now like to turn the floor back over to Mike Rossi for closing comments.
Mike Rossi
Thank you all for joining us today to discuss the progress made during the second quarter of this year.
spk06
YMABS is supported by a strong financial foundation driven by the growing commercial success and geographic expansion of Daniaza. We believe we are uniquely positioned to continue growth while advancing the clinical development of our differentiated radioimmune therapy platform, SADA-PRIT, to potentially deliver better and safer therapeutic options in the treatment of a variety of cancers. We look forward to seeing many of you at upcoming investor and medical meetings throughout the fall.
Mike Rossi
Have a great day.
Pete
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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