MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2023 Earnings Call Transcript

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Richard Ghalie: Right, you’re absolutely right about this report, the Phage 3 study in fact that was reported, ASCO GI came in when we were just launching the study. So just let me explain where the 20% threshold came, but then also what it means for us going forward. The 20% threshold was driven by the monotherapy kinase inhibitor, say the regorafenib phase we studied. And Our Advisors, which is, as you may know, is the academic GI cancer consortium who was running the trial, said that they would like to see something upward of maybe double of what was seen with regorafenib alone in this patient population. So that’s where the 20% came. This is not our ceiling, this is the floor. We need to see at least something better than to go to Phase 2 — to the cohort 2.

A separate question that you’re asking is, if we just get 20% only, is this enough? Would we get excited knowing that Lonsurf bev has a 40% PFS at month four to six, and you’re right. I think the answer to that is going to be, it depends who we enroll. If we enroll a patient who had failed Lonsurf or Lonsurf bev or another TPI, then what would get us excited would be very different than if we have patients who really fail prior chemotherapy with bev, and then they come on that study. So I’m not trying to dodge the answer, I’m trying to say it will be determined by the kind of patient we enroll. Not unlike what David mentioned about voruciclib. If we see response in voruciclib, a patient will progress on voruciclib, there will be — the excitement level will be very different if we see response on patient who respond to venetoclax and then progressed and went back on the combination response.

So it’s primarily driven by the patients we enroll, as is often the case in Phase 1 studies. Once enrolled, we look at the data we analyze, then we make conclusions based on what we see.

Stephen Willey: Okay, that’s helpful. And then just lastly, I guess when you look at the 4Q R&D number implied from what you reported year end, it looks to be demonstrably down sequentially, I think sub $3 million. How should we think about that number just going forward and is that somehow impacted by the Kyowa transaction, some true up there or is that just a true number per the quarterly report and that’s just going to accelerate as you guys do more clinical development here? Thanks.

Jay File: Yeah, it’s Jay. I’ll take that. So yeah, you’re correct in your assessment. We’re not giving specific guidance as to R&D into the next fiscal year, but I will tell you, of that about $52.5 million of R&D, about $26 million of that was specifically related to zandelisib. We do know that that trial continues to wind down. We do expect that to run out right about October timeframe and probably not incur expenses any more than a million, less than that most likely. The Q4 activity is just seeing the continued wind down of COASTAL and TIDAL in Q4. And like I said, we expect that to go ahead and wind down. Then, in addition to some of the other cost reductions that we’ve made throughout the second half of the year, overall R&D, yeah, you’re right, it’ll be down significantly from the prior year.

Stephen Willey: Okay, thanks for taking the questions.

Jay File: Sure.

David Urso: Thank you.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to David Urso for any closing remarks.

David Urso: Thank you for joining the call today, and we appreciate your participation.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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