Rain Therapeutics Inc. (NASDAQ:RAIN) Q4 2022 Earnings Call Transcript

Operator: Our next question is from the line of Graig Suvannavejh with Mizuho Securities. Please go ahead.

Graig Suvannavejh: Hey, good afternoon. Thanks for taking my questions. I had a couple, but one, if you could just remind us with the MANTRA study, the powering assumptions in what you need to show in order for the trial to be considered a win. Is it simply just stat sig? Are there some other elements of whatever you need to see that would make it a clear win? That would be helpful. And then my second question just has to do with the timing of when you’ll get the readout. I know that the guidance is second quarter, but just want to do get your thoughts again on how confident you feel that second quarter is the appropriate timeline, and that it won’t potentially slip further? Thanks.

Avanish Vellanki: Thanks, Graig. I’ll start — I’ll take the second one first. I’ll throw it over to Richard for the first part of your question. But starting with the second question first. We’re not going to provide any additional granularity beyond the second quarter timeline. And currently we are highly confident that it’ll be in that in that quarter. So hopefully that addresses the second part of your question. Richard, if you want to review the powering assumptions for MANTRA?

Richard Bryce: Sure. So, as we’ve previously disclosed, Graig, the study is powered at 94% to show a hazard rate 0.50. So we are estimating within the study three months versus six months’ difference. But it’s 94%, and then the standard 5% Type 1 error, two-sided Type 1 error.

Graig Suvannavejh : Great. Thanks so much. And maybe just a quick follow up. I was curious as to the comments from the financial side of things. So I guess this is for Nelson. Just the comments around, I guess the withdrawing of cash runway guidance versus the prior guidance from the third quarter that you had runway to 2025. It’s something I haven’t really seen before. And I know you had some prepared comments, but I’m just curious as to why you decided to change the language per se, especially in light of the recent equity raise? Thanks.

Nelson Cabatuan : Thanks, Graig. So that really is predicated on the proximity of the top line results from MANTRA. Knowing the extent of the activities that we need to do after that, the prior guidance issue may be irrelevant anymore. So as I’ve said in the prepared comments, we will continue to evaluate this in the light staff line data and we’ll provide further guidance after that if appropriate.

Robert Doebele : And just to follow up on that, Graig, there’s been no meaningful change in terms of our expected cash burn rate. So, we don’t want to convey that we are withdrawing guidance because of some meaningful change in the business. It’s just that given a very near-term large catalyst which will influence the path forward.

Graig Suvannavejh: Okay, understood. Thanks so much.

Operator: Our next question is from the line of Mitchell Kapoor with H.C. Wainwright. Please go ahead.

Mitchell Kapoor: Hi, everyone. Thanks for taking the questions. Wanted to start off with MANTRA-2 and just talk about those patients. So you’d shown efficacy in patients with a medium of four prior lines of therapy, but I wanted to kind of relate that to the population that you continue to enroll and trying to understand are they more or less healthy and does a higher copy number have anything to do with this disease severity?

Avanish Vellanki: Thanks, Mitchell. I’ll turn that question over to Bob in terms of the profile of the patients on MANTRA-2. But just as a broad comment, we’re not providing any meaningful detail around what we’re seeing in terms of the patients being enrolled just yet. So we can’t give you a lot of color, but I’ll throw over to Bob, any additional color you can add.