Rezolute Inc RZ358 Phase 3 Planning Update Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jason Butler - JMP Securities LLC - Analyst : Hi. Thanks for taking the questions and congrats on all the progress. Nevan, can I just ask you to start with maybe giving us some more color on why FDA is taking a different view here, including the reversing the dose restriction? And I guess more importantly, what pre-clinical data could enable expansion of the trial to the US and how those timelines fit into the enrollment timelines you've set out today? And then I have a follow-up. Thanks.

Question: Jason Butler - JMP Securities LLC - Analyst : Okay, great. And then, it's probably too early to speculate on the potential to explore a label in the US for patients just over 12, but can you maybe just give us some color on what you learned from the RIZE Phase 2 trial in terms of efficacy in different age groups under and over 12? And then just lastly, can you clarify what drove the dose selection for 5 and 10 milligrams versus the 5 to 9 you used in RIZE? Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2023 / 8:30PM, RZLT.OQ - Rezolute Inc RZ358 Phase 3 Planning Update Call

Question: Jason Butler - JMP Securities LLC - Analyst : Okay, really helpful. Thanks for taking the questions. And again, congrats on the progress.

Question: Maury Raycroft - Jefferies & Company, Inc. - Analyst : Hi, thanks for taking my questions. You said after the May 24 meeting -- you discussed additional studies to potentially address FDA's concerns. Can you clarify if there was any alignment with FDA on what the additional studies would be? And you said there would be short-term studies. Are there any more specifics on how long you think the studies could take and maybe bookend timing for when you could expand the Phase 3 to the US?

Question: Maury Raycroft - Jefferies & Company, Inc. - Analyst : Got it. That's helpful. And maybe one other follow-up question. Was it discussed with FDA and potentially getting some clinical data from the ex-US study on a blinded basis or maybe even something specific that FDA wanted to see and bringing that clinical data back to FDA to discuss that with them?

Question: Maury Raycroft - Jefferies & Company, Inc. - Analyst : Got it. Understood. Thanks for taking my questions.

Question: Pete Stavropoulos - Cantor Fitzgerald, L.P. - Analyst : Hi, Nevan and Brian. Thank you for the update, and I look forward to the study's start. Just continuing on, I guess, the rodent finding. So taking into consideration the mechanism of action of 358, is there any mechanistic rationale that can actually explain the tox finding in rodents? Or do you believe it's an off-target effect restricted to rats?

Question: Pete Stavropoulos - Cantor Fitzgerald, L.P. - Analyst : All right. And just moving on to the Phase 3 sunRIZE study, are you going to focus on patients who have known genetic mutations, or are you going to go more broadly? And will there be any restrictions of patients based on genetics or any phenotypic characteristics?

Question: Pete Stavropoulos - Cantor Fitzgerald, L.P. - Analyst : Okay, thank you. And if you don't mind one question for Dr. Thornton. Dr. Thornton, seeing the effects of 358 as an investigator in the RIZE study, can you just sort of (technical difficulty) REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2023 / 8:30PM, RZLT.OQ - Rezolute Inc RZ358 Phase 3 Planning Update Call

Question: Pete Stavropoulos - Cantor Fitzgerald, L.P. - Analyst : Yes. So seeing the effect of 358 as an investigator on the RIZE study, can you discuss what also improves besides hypoglycemia and the other type of clinical benefit? I recall seeing a poster to discussing seizure frequency.

Question: Pete Stavropoulos - Cantor Fitzgerald, L.P. - Analyst : Okay. Thank you very much. And, Brian, thank you for taking my questions.

Question: Jorge King - H.C. Wainwright & Co., LLC - Analyst : Hello. This is Jorge King on behalf of Douglas Tsao. Thanks for taking my question. I'm just curious. I think this was briefly mentioned during the call, but because this indication is also prevalent in neonatal population, I'm just curious if you want to [avoid] this antibody in patients that are younger than three months old. Thank you.