Rezolute Inc RZ402 Phase 2 clinical program - Corporate Call Transcript

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

Question: Maury Raycroft - Jefferies - Analyst : Hi, everyone. Thanks for doing this event, and thanks for taking my questions. I was going to ask about the ongoing Phase 2. Given the early-stage patient characteristics that you're enrolling into the study, can you talk more about what you'd expect in the control arm during the 12-week treatment period? And then for any efficacy that you see during the 12 weeks, would you expect that to hold up during the four-weeks follow-up?

Question: Maury Raycroft - Jefferies - Analyst : Got it. That makes sense. And then also, I think Dr. Agrawal mentioned that stabilization could be an outcome, could be something that you're interested in seeing as well. If you do see stabilization and maybe not a lot of difference between the control arm and the treatment arm, could there be success on other exploratory outcomes like you mentioned the EGFR and microalbuminuria? Could you potentially win on some of those exploratory measures, and how do you think about that?

Question: Maury Raycroft - Jefferies - Analyst : Got it. That makes sense. I'll ask one more question, and then hop back in the queue. I think you mentioned that 402 could bathe the systemic vasculature wall, and you showed some data that it enriches in the vascular spaces. Can you talk a little bit more about whether this is a unique attribute of 402 relative to systemic kallikrein inhibitors approved for HAE, whether oral or injectable?

Question: Maury Raycroft - Jefferies - Analyst : That's great. Thanks.

Question: Maury Raycroft - Jefferies - Analyst : Got it. That's all very helpful. Thanks for taking my questions.

Question: Pete Stavropoulos - Cantor Fitzgerald - Analyst : Hi, and thank you for holding this call. Very informative. First question for Dr. Pete Bhisitkul. When you look at the diabetic retinopathy preferred practice pattern guidelines by the American Academy of Ophthalmology, and in particular, when you look at a table, which I'm sure you're familiar with, that provides initial management recommendations for patients with diabetes, you see that for non-center involved DME, anti-VEGF agents are not recommended for mild non-proliferative diabetic retinopathy, all the way to use -- sometimes use in progressive diabetic retinopathy. So my question is, just for those patients alone, the non-center involved DME, what drives the decision to not use anti-VEGF? And could an oral agent like 402 usher in a new paradigm treatment for that particular population? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Pete Stavropoulos - Cantor Fitzgerald - Analyst : Okay, can you possibly suggest a proportion of patients that have non-central that actually become central as time progresses, as disease progresses?

Question: Pete Stavropoulos - Cantor Fitzgerald - Analyst : Okay. Thank you. Very informative. A question for Brian or Raj. For the study, will you focus in on certain patient populations measured by some type of scale, like the diabetic retinopathy severity scale to sort of differentiate proliferative from non-proliferative? Because it's my understanding that DME, could occur at any stage of diabetic retinopathy. So will you focus in on a particular stage of disease?

Question: Pete Stavropoulos - Cantor Fitzgerald - Analyst : All right. Thank you. And the last question is, taking into consideration the mechanism of action of 402, can you see it being leveraged in other ophthalmological indications?

Question: Pete Stavropoulos - Cantor Fitzgerald - Analyst : All right. Thank you very much for taking my questions.

Question: Roy Buchanan - JMP Securities - Analyst : Okay. It's Roy in for Jason. Thanks for taking the questions. I guess to follow up on the patient population question, a couple for Dr. Bhisitkul. Just the lower severity patients that are going to be studied in this Phase 2, based on your gut, again, I guess, what proportion of the overall DME population do you expect that represents? What's the typical time from diagnosis of diabetes to develop DME in a patient that does? Do you think, maybe going a little bit out on a limb in the future, but does it make sense to use a drug like RZ402 potentially before any vision loss, and even just after they've been diagnosed with diabetes or something like that? I have a couple for the company. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Roy Buchanan - JMP Securities - Analyst : Yes, correct.

Question: Roy Buchanan - JMP Securities - Analyst : Okay, great. Thank you. And then, I probably -- REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Roy Buchanan - JMP Securities - Analyst : Okay, great. Thank you. And then I had a couple more, probably for the company. I just want to make sure I understand the fellow eye and the study eye. So, the fellow eye is standard of care as if it's not being treated with 402. Is that correct? And the rescue really only applies to the study eye. I guess, how likely do you think it's going to be that you get actually a potentially combo data with the VEGFs in the fellow eye and the study? And then I just want to be clear -- Okay, go ahead. I have one more.

Question: Roy Buchanan - JMP Securities - Analyst : Okay. That strikes me as a potentially second way to win. If you see amazing results in patients that are getting VEGF as well as 402, maybe something interesting there. Anyway --

Question: Roy Buchanan - JMP Securities - Analyst : Okay. And then just on the kind of patients that you're getting, it sounds like if you're getting these patients that are not on VEGF or limited VEGF, is it mostly patients that are afraid of injections, don't want to do the injections? It sounds like DME not central is another criteria. But what do you expect the breakdown of the patients that you're going to get in the trial to mostly be? Thanks.

Question: Roy Buchanan - JMP Securities - Analyst : Okay, great. Thanks for taking the call.