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: Ry Forseth - Guggenheim Securities LLC - Analyst
: Setting this up. I really appreciate it, and I'm here representing Debjit today. A question for Dr. Krishnamurthy. Could you comment on the baseline
characteristics of the sunRIZE study, and how we should think about the likelihood of spontaneous improvement in hypoglycemia event rates for
subjects that have an inadequate blood sugar control on standard of care? And two, could you help define what it means to have an inadequate
blood sugar control on standard of care in your practice?
Question: Pete Stavropoulos - Cantor Fitzgerald & Co - Analyst
: Congratulations on your new position, Sunil. So first question is for Dr. Krishnamurthy. In your clinical experience, in what proportion of your
patients is diazoxide effective, defined by complete control or high control? And knowing the side effect profile of diazoxide versus ersodetug to
date as well as the efficacy differences where patients either partially or do not respond to diazoxide or, say, somatostatin analogs, would you
consider using erso as a frontline treatment?
And knowing the outcomes of young patients, including irreversible neurological outcomes, can you speculate if payers will give you a significant
pushback if you chose to go first line with Rezolute?
Question: Pete Stavropoulos - Cantor Fitzgerald & Co - Analyst
: Okay. And just one question for Dr. Farooki. Can you just give a little bit of detail on diagnosis process? And is it really -- is it easy or difficult to sort
of diagnose NICT patients with hypoglycemia? How easy is to identify those patients? And the company is initially focused, or at least I believe
they're initially focused on hepatocellular carcinoma. Are there other tumor types that drive hypoglycemia and that could possibly be addressed
by Rezo's mechanism of action? And if so, how often do you see those tumor types?
Question: Pete Stavropoulos - Cantor Fitzgerald & Co - Analyst
: How difficult is it to identify?
Question: Pete Stavropoulos - Cantor Fitzgerald & Co - Analyst
: And just one last question for Rezolute. How exactly are you thinking about pricing? Like what benchmarks should we be using? And as you
mentioned through the presentation, as you go from child-based -- or child-based basically pricing on a kilogram basis or a unit basis, you're going
three times higher for adults. So by our calculations, pricing starts to sort of balloon up. And do you expect to cap the price or somehow have a
mechanism in there for pricing for adults?
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Question: Maurice Raycroft - Jefferies LLC - Analyst
: Maybe one for Dr. Farooki. Should we think about ersodetug as potential frontline treatment in NICTH and as a second-line plus treatment option
for ICT, given that steroids and SSAs are not that effective in NICTH? And maybe you or the company can talk about just the proportion of these
patients that you think would get erso in frontline or second line?
Question: Maurice Raycroft - Jefferies LLC - Analyst
: Got it. So probably high proportion of your patients, and are all your patients -- you kind of assume that?
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Question: Maurice Raycroft - Jefferies LLC - Analyst
: And then maybe one other question, too, just with what you're looking for in the upLIFT pivotal trial that could support widespread adoption,
would you want to see a 50% reduction in glucose infusion rate from baseline? Would that be sufficient? Or would you want to see near or complete
weaning off of IV glucose? And then for other endpoints, how important are time to discharge from the hospital and CGM? How important are
those for adoption?
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: My first question is for Dr. Krishnamurthy. So when you discuss the treatment duration for CHI. Can you help us understand why patients grow --
why there are no adult patients that you're treating? Are they growing out of the disease? Or is there something else that's happening that's
changing the course of the disease as these patients grow up?
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Got it. And then switching gears to talk about tumor hyperinsulinism. You mentioned that you still have less than 50% of Tumor HI patients
responding to diazoxide. And we've seen, I guess, with the sunRIZE trial, how even so-called diazoxide respondent patients are experiencing
hypoglycemia. But can you help us understand why so many Tumor HI patients are not responding to diazoxide?
Question: Julian Harrison - BTIG LLC - Analyst
: On diazoxide, I'm wondering if you could put the pulmonary hypertension and broader cardiovascular risks in more context for us? How often do
patients have to discontinue diazoxide due to these side effects? And is it typically reversible after patients stop? And then on a related note, I'm
wondering if there's a chance that erso could be used perhaps preferentially in CHI and maybe Tumor HI as well just based on diazoxide's
cardiovascular risks alone?
Question: Julian Harrison - BTIG LLC - Analyst
: Okay. Great. And then a follow-up, if I may, for management. Home infusion seems like a really nice proposition in CHI for patients who are old
enough. Curious if this setting requires a human factor study? And would you expect that setting of use to be available upon initial approval
potentially?
Question: Yun Zhong - Wedbush Securities Inc - Analyst
: So the first question on Tumor HI, streamlined design for the pivotal study is very encouraging. But I'm just curious, have you got any confirmation
or indication from the FDA that the type of patients enrolled in the study on continuous glucose infusion is not going to be affecting the label that
the approval or in some way limited to only those type of patients?
I know that in the market research that you presented, it looks like you have already taken account this type of patient in the NICTH market estimate,
but what about the insulinoma patients, please?
Question: Yun Zhong - Wedbush Securities Inc - Analyst
: Okay. And then a question on congenital HI and maybe for Dr. Krishnamurthy, please. So I saw that 13% of the patients in the Phase III study had
already undergone pancreatectomy how -- what's the percentage of patients still having hypoglycemia after the pancreatectomy? And I believe
that virtually all patients will eventually develop diabetes. So the erso treatment, would that further increase the risk of diabetes development?
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