The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. Yeah, let's do that. So let's start with the lymphoma, which is the CB-010. So what -- yeah, tell us what about -- what studies are going to be
reading out later in the year, and what's that going to teach you about the next steps for a pivotal study?
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Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. So you covered a lot of territory there, so that was good. Of course, so what -- so when you say on par with the auto CAR-Ts, I mean, you're
not doing -- obviously this is not a head-to-head situation. That'll be later potentially if that's what you do. But -- so what -- how are you going to
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make that assessment? Is it just going to be -- because what you did before was sort of an overlay which was good just graphically. Is it that kind
of thing where you're going to show median PFS, the curves kind of look the same? Is there more to it than that or that's kind of the exercise?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: And I guess technically speaking, you do -- I mean, people say you will capture safety in PFS obviously cause you --
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: The quick -- stopping the drug if it's not well tolerated. So with the HLA matches, so the idea there is -- is the idea to also another avenue for
preventing exhaustion or is it different?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: So it's about being more self-like, and that's what's keeping the PK better or there's something else going on?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. I mean, of course, when you embarked on this program at the beginning many years ago before you even -- to the end of the trial, I mean,
you and your scientists knew about HLA and matching. But I guess at that point, it just -- it wasn't apparent enough that that should be elevated
to kind of an inclusion-exclusion criteria, even though you obviously knew this.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And so for whatever reason, I guess four was sort of the threshold number, above which it didn't really matter anymore, and below which it
did matter a lot?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: (inaudible) Yeah.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. So that's coming. And the timing for that is what? Is it -- you have you said -- is it going to be a medical meeting or is it going to be something
else?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: All right. And then at that point, you'll be able to take that data to the FDA or will you have already spoken to the FDA at the point where you tell
us the data?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay, and so you're -- I mean, essentially you're following this data as a -- as in real time, essentially, so you're aware of it. You just have to keep it
under wraps for now.
What are the different possibilities for the Phase 3 trial? What do you want to see? What do you think FDA wants to see? Where will the meaning
of the minds be?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay, so you, I guess you don't want to get into the super weeds on that. (multiple speakers) But we're going to learn what the design is by the
end of the year?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And I guess, I mean, the advantage of going up against the auto CAR-T would be if you achieve equivalence with a much faster delivery
turnaround time for patients, then that's a win. On the other hand, it's a higher bar. And then I don't have to answer this.
And then on the other hand, if you do the chemo immunotherapy, then I guess, lower bar, but maybe you can claim a little less, so I guess it depends
how you do it. Okay. All right. And so that will be at an investor -- you said an investor event in the fourth quarter or you didn't say that?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Before the end of the year. Okay, got it. All right. And then any other -- I wanted to ask about -- you talked about accessibility and having it in two
days and it's in the freezer. So -- and I remember you were saying it's 12 -- it's 12 different lines that covers like 90% of the population. So that -- so
if someone needs it, they just find the one that has at least the four for that person and you're going to -- you did the math on that and you cover
everybody?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: And how would it work? Would you -- if you have it's -- if it's in all the different community hospitals, then you have to kind of airlift it to the -- you
leave certain supply at each place. How does it work?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And how much more scale-up is -- I mean, how much more scale up is needed to get to supply the market? Are you there yet or --?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: And where do you -- where is this all happening in the SF area? Where's your facility?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay, well that's kind of what I was trying to get for obvious reasons. Okay, so that's kind of the update on ANTLER. Anything else you wanted to
come in there with regard to that? So that, just to clarify, that's -- so you -- it's prospective in the sense that you're picking the greater than four.
And then sort of implicitly, you're comparing to what was done without picking. I mean, because you're not doing the prospect of less than four?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And so the data coming up will be -- it'll be very clear, essentially what the situation is. And then, I mean, more of like a nerdy scientific
question is if you -- you mentioned there's some that even have up to eight. Would they be performing even better? I mean, that's something to
look at, I suppose, not that it --
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay, all right. Well, let's talk about the myeloma program as well. So that's one where -- correct me if I'm wrong, but I don't think you've quite
qualitatively made some comments, but you've never said anything very concrete and numerically about data yet.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Right? So when is -- that's also happening this this half?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And tell us a little bit more about what to expect?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. So sorry, which -- this is at which dose for the 25?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Right. That's what I was asking. Yeah. So how many? Which ones is it because it was quite a latter, right?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: And so out of that update will be a clear conclusion as to which of those would make the most sense with the 500 Cy to take forward.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And obviously having the -- this -- what is this, 66% increase in this cytarabine dose, this gives you better lymphodepletion. Now you saw a
step change there.
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Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay, okay. And then the comment about the -- on par with bispecifics, which that, of course, makes sense and you want to be on par for all sorts
of reasons for clinically as well as how investors think about the story. But also, I mean, you made the point that the treatment burden with the
bispecific, so I imagine there must be some KOLs out there with -- let's say, well, look, I mean, if you're not to say it's going to be this, but if you were
like 55% or 60% and you're the one and done and versus a 65% and it's -- keep going every -- however, often bispecifics are -- what's the regimen?
Every two weeks? I don't know what that is. Something like that.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Like there's an argument that there's a -- there's some tolerance, there's some wiggle room there, right? I don't know how the KOLs think about
that.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. But you didn't mention specifically FDA discussions on myeloma, or is that also happening? Just discuss --
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: But sometimes in these FDA meetings, you say you're talking about one thing. But since it's the platform, sometimes other -- you can kind of get
advice on some of the other programs too, right? I mean, does that -- is that conceivable or not really? You have a very -- you're very mission focused
on the ANTLER stuff.
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Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. So those are the two clinical programs. You had some other programs, was it ROR1? What was it called?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: CLL. Yes. So that one you put on the side for now. Is that something that would -- could come back with more capital or are you just going to leave
it for now?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. Now both of these indications are sort of in relapsed/refractory disease. You going to get to that goal first obviously and get the approval,
but is there -- could these types of allo approaches go into earlier lines of therapy?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: So if you get these two into late stage studies and approved -- I remember I asked you once why you didn't do the PL-1 and the HLA-E at the
beginning -- but if you get validation of those independently, and then you also said about the HLA-E is like having six missing, so it's like you're
kind of by default matching six, then you could -- that could be the next thing. I mean, you probably have the cells in the lab somewhere.
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Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: So speaking about, pivotal trials and other things that's obviously going to cost money, what's the -- you did some spend rationalization very
recently, extended the runway. So do you have the funds at the moment to -- sometimes people say, well, you shouldn't start a Phase 3. It's not
ethical to start unless you have the money cause you can't stop in the middle. So, well, how do you stand from that perspective?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. And you also had a -- I know you had a strategic investment from Pfizer, but that was a myeloma specific, if I recall. Do they have interest in
further allocations?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. Well, in the last few minutes, let's think about even further into the future. So you do the studies, you raise the money, you do the studies
work, and now you have to commercialize. So you've already talked about some of the operational aspects of that with the cryopreservation, and
then the shipping. What else are you doing to do market research or to get everybody lined up so that when it -- when the products available that
you can -- you hit the ground running?
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Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: I mean, another obviously big picture question, and there's plenty to do in the United States, but people get sadly blood cancers all over the world.
So are you thinking about -- is there work being done with -- do you have sort of a field office in Europe or I just think you're not at that point yet?
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: You do, okay.
Question: Yigal Nochomovitz - Citi Investment Research (US) - Analyst
: Okay. Well, very good. Thank you so much. We look forward to the update.
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