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
: Well, let's actually talk about the Royalty deal since that was announced this morning. It's new information. So just tell us a little bit more about
how that came about, and the strategic thinking there, and then I've got a few more detailed questions about it.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And it seems like both of you wanted to focus on the later stages of programs because this -- it didn't include, unless I missed it, it didn't include
MS. It included IgG4.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so it would capture MS up in the future. Okay, so let's -- thanks for clarifying that. Let's talk about IgG4-related disease. I think people are
becoming more familiar with it, but especially with the, obviously, Amgen having launched their drug, so tell us a little bit more about the design
of your study, what can be expected in terms of the profile. And of course, the key question is, what do you need to show, what do you believe you
need to show to be a competitive product.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And that would you manifest that to some of the other endpoints, presumably, complete remission rate.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And you expect you could see something higher than what you cited, the 30% to 50%? Yeah.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And will that data emerge with the top-line readout towards the end of the year as well?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. Are there other efficacy measures that you want to highlight beyond those that seem to be the key?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And then on the other side of the equation with any therapy is the safety. What can you say in terms of competitive differentiation there?
Or is it essentially similar to Uplizna in terms of what you expect?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: We'll talk more about that in terms of the rebound of the B cells. If you were to withdraw obexelimab versus withdraw with Uplizna, which is every
six months, so how quickly are the B cells coming back if you were to pause?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so quickly.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. So that's coming up. What's the exact guidance on that as far as the timing? You said towards the end of this year for the Phase 3?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Around the end of the year. Okay.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Sure. And of course, you talked about the royalty deal. I just wanted to ask another question. In that press release this morning, they specifically
said or you specifically said define success criteria in terms of hitting that milestone. Is that essentially meeting the primary endpoint, or do other
things need to happen to --?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Fair enough. Okay. So that's obviously a key milestone coming up. But let's also talk about the earlier readout for multiple sclerosis, which is obviously
a higher-risk, earlier-stage program. That's coming in early fourth quarter. So talk about the premise there. You've had some nice preclinical data
supporting that thesis, but as far as I know, not clinical data.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So you mentioned sort of some of the comps in the CD20 and the BTKs. I mean, are you suggesting you could potentially get as low as zero lesions
with these patients, or that's maybe too high a bar?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 02, 2025 / 5:00PM, ZBIO.OQ - Zenas Biopharma Inc at Citi Biopharma Back to School Conference
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Right. Well, have you talked at all about the baseline demographics in these patients? What they have at baseline or what you aim to roll?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, so at the 12 weeks, which is coming in early 4Q, we'll get what we just talked about, this lesion data. And then at 24 weeks, we'll get a follow
--
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And then how are you approaching the future? Obviously, assuming it goes to the finish line that you benefit from, you'd have the royalty.
With royalty, but would you be partnering this program? It's a big space. It's a big market, obviously.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And then as far as the different subtypes, like the primary progression -- progressing, the secondary progressing?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And then, you mentioned this novel endpoint, the progression independent of relapse activity. So are there benchmarks for that or will you be a
pioneer in demonstrating this -- the feasibility to this endpoint?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. At the beginning you mentioned the third program, which I guess is sort of intermediate in terms of the development progress to the lupus
program. So can you just review what happened with the Zencor trial? You talked about it a little bit and some of the possible flaws that you
uncovered there and how you've rectified those.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So when you mentioned some of these screenings where you're screening people out that, even the investigators are okay with. Is that -- are you
referencing the biomarkers, the deep seeks, or something else?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: So the sort of effective enrollment is, I guess, somewhat lower than 90, 95 or that's the net effect after you do the further screenings?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: You'll still have the 95 (multiple speakers)
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay, got it. And then -- so the timing for that data is, you said --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Middle of next year, okay. And then --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And as far as the next steps for that, would you -- you'd go into a Phase 3 potentially in this biomarker population or you'll have to see what
it looks like?
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: And we didn't talk about this, but across the three programs, what is the -- is it the same dose, different doses and the administration and the
interval.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. And you mentioned the cash at the beginning. And now, of course, you just got the 75-plus potential for another 150, I guess and then
another 75 with lupus potentially. So that takes you to when -- and you're comfortable with the --
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 02, 2025 / 5:00PM, ZBIO.OQ - Zenas Biopharma Inc at Citi Biopharma Back to School Conference
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Okay. Very good. And then as far as other plans, you said you're starting the -- you're already starting the BLA process for the IgG4. I was asking all
the companies whether you're leveraging any of the AI engines to facilitate the processing of that on the back end or --
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: Fair enough. Okay. All right, good. Yes, there's no questions in the room, but Lonnie, thank you.
Question: Yigal Nochomovitz - Citibank Cameroon SA - Analyst
: (multiple speakers) data very soon.
|