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

Avanish Vellanki : Thanks, Yigal. I’ll take the first one around the potential combos. I hand the rest of the two question over to Bob and then have Richard address the frequency of checking the MANTRA events. So for the first part, for MANTRA-2, the path C, it doesn’t necessarily just need to be atezolizumab for additional combinations. I think, we will refer you to some of the recent discussed data and combination with other non-IO combination partners such as MEK inhibitors. So we will certainly look to other combinations that are far more broad reaching than just atezolizumab and just other IO strategies. But we’re not ready to comment specifically on what we’re planning to do there without knowing which path we’re going to go down. For RAD52, I’ll turn that over to Bob.

Robert Doebele: Yes, so Yigel in terms of RAD52 program, just to give a little bit more clarity. The goal of our screening was to identify biochemical assays that would predict potency in BRCA-deficient, but not BRCA expressing cell lines. So again, potency and selectivity. Unfortunately, none of the existing assays that we used we’re able to give that, and so we weren’t able to meaningfully progress candidate chemical compounds further based on that lack of valuable screen. Obviously, we think it’s an important target still perhaps given more time and not a need to prioritize. Other programs, we might have continued, but we believe that it would take a significant amount of time to get to a meaningful drug in that space.

Avanish Vellanki : Time and money. And the third question with regards to frequency of MANTRA checking the number events, Richard?

Richard Bryce : Sure, thanks, Yigel. So, currently, we have the data transfers from the central readers, the blinded independent review committee every two weeks. The events are relatively infrequent at the tail end as you would expect. And so the second part of your question was could we potentially analyze the data said greater than 105 events? Absolutely, it will depend on how many North, if you like, of 105, which is the minimum will be in that data transfer.

Operator: Our next question is from the line of Sam Slutsky with Lifesci. Please go ahead.

Sam Slutsky: Good evening, everyone. Thanks for the questions. Got two from my end. I guess first for the control arm assumption of three months in the ongoing MANTRA study, I realized that there’s literature showing about a two month PFS with trabectedin in DDLPS, which you referenced. Could you just remind us if there’s other data that have been published with trabectedin and DDLPS specifically? If so, what have there’s shown? And then, is there any notable difference on inclusion exclusion between MANTRA and prior studies?

Avanish Vellanki : Sure, thanks for the question Sam. I’ll turn that one over to Bob.

Robert Doebele: Yes, so, obviously, the literature that we’re referring to in the 2.2 months is the prospective registrational trial of trabectedin. We believe that’s the most useful dataset. All other data that has been published has either been small single institutional studies or retrospective data, which is never as rigorous or unbiased as a Phase 3 registrational trial. So there may be some variations there, but we believe the largest study and the most meaningful is that in the prospective study of trabectedin and that led to its administration.

Sam Slutsky: Got it. Okay. And then, assuming that milademetan ultimately gets approved for DDLPS, just remind us how big of a sales force you think you’ll need in the U.S. and then how you thinking about ex U.S. strategy?

Avanish Vellanki : Sure, Sam, happy to take that one. So again, it’s a smaller patient opportunity. We think in the range of 25 to 35 sales reps in the U.S. would be sufficient. And the strategy currently entails pursuing commercialization effort in the U.S. from Rain but partnering ex U.S.