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 - Citibank Cameroon SA - Analyst
: Okay. Well, let's start with the latest stage then with the prostate cancer. So you're going into a very interesting slice of the prostate cancer market,
but it's a big slice and it could be a bigger slice depending on where you go. But explain what this is, this locally advanced market and how it's --
what the options are for patients, the radiotherapy and the prostatectomy? And how you've done the study to support this admittedly novel but
very interesting thesis which is gaining adoption.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. So can you just maybe walk through the -- just so everyone's clear on the data and what you showed in terms of the benefit. You showed it
on DFS for everything and then you showed prostate-specific as well. So can we go through that so we understand?
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Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. Very good summary. So now you mentioned that about 50% of the patients do the prostatectomy and then the others do the radiotherapy.
And I think you may have made the point in the past, but we'd love to hear it again, that this -- if with your data, there's the potential that could
shift or you could see more of a shift to the radiotherapy given your data. Is that a fair statement? Like how does that market dynamic work?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so you mentioned the market and the BLA. Can you talk about just the timelines and the strategy for filing the applications. I understand
there's some more work to do before you can file. And what's the strategy here in the US and of course, Europe's also a very important market. So
what's the strategy over there?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so you mentioned the three commercial runs. So that's with the old process --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: New process.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So are there differences in the two? You mentioned the comparability study. I mean the -- what was done in the Phase 3 trials was presumably the
older version, and now you're going to -- you've just said you just finished the runs for the new version.
So what you -- what do you need to show with comparability? Obviously you're not going to do another efficacy trial with 10 year. I mean, that's
not happening. So what exactly is the FDA need to see to --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And what are the benefits of this improved process? Are there specific benefits or is this just a more modern manufacturing with a different
--
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And this is -- is this the one at Merck Millipore, is that right? Or is that a different one?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And then as far as preparation for launch and so forth, what are you doing in terms of early commercial prep? I mean, I know you're not filing
the BLA until the end of next year, but still a lot to do to prepare.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. Well, let's talk about some of the other indications before we run out of time. So the lung cancer, you're about to embark or you're planning
to embark on a Phase 3. I think you've talked about that. Can you just discuss what that would look like and what the timelines would be and where
you are from a funding perspective in terms of potentially kicking off that trial?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So if I get it right, so that's all very interesting. So the idea is that you don't want to run a Phase 3 with pembro control because, well, they won't
respond. We've seen this many times where it's not a good second therapy to try to retreat.
So that's not -- so you want to do docetaxel, but you still want to have this contribution of components. So there's this smaller study where, yes,
you will treat a much smaller segment of people with pembro again, but not in a Phase 3, but it's enough data to satisfy the FDA's curiosity on this
question. Is that right?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so that sounds like a very good meeting of the minds or compromise or whatever the word is. Okay, so what about the -- and then as far as
the timelines that you've locked that down, but you're not quite ready to push go yet on that study. What needs to happen?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so when you say non-dilutive, you've talked about different types of partnerships, regional partnerships, other types of partnerships. Is that
what you mean when you say non-dilutive? And would that be something that intersects with the prostate market too? Or would it be a lung
cancer partnership or both, or how is it working?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. No worries. And now you mentioned pancreatic. So can we talk about that one too because that's the other indication for 2409. Where does
that stand?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Because in the -- I'm just looking at my notes in the -- I mean in the Phase 2, you had a very, very strong OS, that was -- I know it wasn't randomized,
right? But it was --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: This was randomized?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Oh, this was randomized. Okay. So you had a -- what was it about a 20-month difference or something like that?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. So that's a lot going on with those three solid tumors. But where would you go beyond that? I mean, in prostate cancer, you could go in
different directions, right? You could go north or south, meaning like to the adjuvant or you could go to the metastatic. So what would come --
would that be sort of the next thing to do? Or would you look into other solid tumors outside of the three already -- you've already studied?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And then at the beginning, you mentioned the other -- or the second of the three platforms. So for high-grade glioma, this is the one you
said that was replication-competent. So -- well, first of all, just explain to -- for those that are less familiar why for this particular situation, the
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replication competent is the one you want. And then what is the data shown in this setting. And I think you also are planning to have an update
later the year.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: I should bring Charles into the conversation before we run out of time. So Charles, just we've talked a little bit about financing, but if you could
summarize the financial situation of the company currently. What you've said as far as your cash outlook and opportunities where you could extend
it?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So in terms of different priorities, when you do have -- when you get additional capital, would it go first to the 2409 to some of these studies we
talked about? Or where does 3110 fit into the hierarchy in terms of the prioritization of the resources?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And then last question, you mentioned briefly the enLIGHTEN Platform, and I think you said you had three or maybe more pre-clinical programs.
Are those opportunities for partnering? Or you'd want to take those into your IND studies yourself?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. Well, great. Thank you both so much. Paul Peter, Charles, thank you so much for the time, and we look forward to further updates.
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