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: Peter Stavropoulos - DBRS Ltd - Analyst
: Nevan and Brian, sorry for these outcomes. Can you help us understand the response over time on the weekly -- average weekly hypoglycemia
events? Was there a treatment effect initially that waned over time? Or was the response consistent, say, from the first dose through the
end of the study?
Question: Peter Stavropoulos - DBRS Ltd - Analyst
: I know that you touched on it, but again, can you just sort of try to help us understand the placebo response and reduction in hypoglycemia
events? What sort of drove that higher-than-expected response? And how did you actually calculate the expected placebo response?.
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DECEMBER 11, 2025 / 1:30PM, RZLT.OQ - Rezolute Inc To Host sunRIZE Topline Data
Question: Peter Stavropoulos - DBRS Ltd - Analyst
: Okay. Just one last question. Was there any changes in therapy during the treatment period, especially in placebo?
Question: Peter Stavropoulos - DBRS Ltd - Analyst
: No. Okay.
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Just want to express my condolences to you and the patients for this outcome. I wanted to ask, was the drug lot between Phase II and --
Phase IIb and III the same? Were there any changes in the manufacturing process that might have impacted the results?
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DECEMBER 11, 2025 / 1:30PM, RZLT.OQ - Rezolute Inc To Host sunRIZE Topline Data
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Okay. And then thinking about the standard error and the 10 mg per kg, how did that look? Do you think there would have been any different
outcomes if this study were run, let's say, in a 2:1 randomization of just looking at 10 mg per kg versus placebo?
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Got it. Yeah, and on CGM, can you just confirm when you say that miss significance, was it nominally significant or was multiplicity control
plan allow for this to be significant even if the primary endpoint failed?
Question: Julian Harrison - BTIG LLC - Analyst
: Sorry about this outcome. On upLIFT, has the FDA communicated an expectation in regards to response rate on the primary endpoint?
Also, are you able to comment on or indicate the target number of enrollment sites for that study? And how much cash runway you're
expecting after top line data next year?
Question: Albert Lowe - Craig-Hallum Holdings LLC - Analyst
: I was wondering for the hypertrichosis, that was noted that like an unexpected effect of ersodetug or could that perhaps be reflective of
maybe some of these changes on background diazoxide where that's more common.
Question: Albert Lowe - Craig-Hallum Holdings LLC - Analyst
: Okay. And maybe just to clarify something that you were saying before, for these patients that did have scheduled tube feeding for any
changes there, is that data that was collected in the study?
Question: Yun Zhong - Wedbush Securities Inc - Analyst
: Very sorry to hear the negative outcomes. The first question, a follow-up question on upLIFT, and apologies if you already commented on
this, if I missed it, but would you consider adding some type of interim analysis into the study to, well, kind of increase the likelihood of
success?
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DECEMBER 11, 2025 / 1:30PM, RZLT.OQ - Rezolute Inc To Host sunRIZE Topline Data
And were there any discussions when you reached that alignment with the FDA back in September that you will need to do certain steps
or potentially could do certain steps in the case of sunRIZE fails to confirm the efficacy of the treatment, please?
Question: Yun Zhong - Wedbush Securities Inc - Analyst
: Okay. And just to confirm because I believe you have breakthrough therapy designation for both indications. So when you seek a meeting
with the FDA to talk about congenital HI, are you going to also confirm the FDA's approach or attitude towards the tumor HI indication? Or
will that be strictly limited to discussion about the congenital HI indication?
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