Curis, Inc. (NASDAQ:CRIS) Q4 2022 Earnings Call Transcript

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Robert Martell : And Li, and just to give a little bit more detail on the specific data, one thing that the FDA really likes is what they call an efficacy response analysis — I’m sorry, exposure response analysis. So what they look at closely is the actual exposure of emavusertib in each patient. So as you know, we’re doing detailed pharmacokinetic analyses on all of these patients. So they’ll look at that. They’ll compare that to safety. They’ll compare it to efficacy and that will help give them and us a very granular understanding of the optimal dose. And so that’s really the fundamental aspect of what we’re going to be looking for.

Unidentified Analyst: Got it. And sorry, maybe just one quick follow-up. If you potentially have your hold lifted in 3Q or 4Q, how quickly do you think you could restart?

Robert Martell : Well, we’re already — the studies are actually already open and going. So it would essentially once we have that agreement, the studies are already open, and we continue with that dose level. So I don’t anticipate any significant delay once that happens.

James Dentzer : Yes, Rosemarie, let me add to that. So that was when I said it kind of quickly in the comments. But of course, when we went on hold, you have to effectively shut your sites down. The big change that we had at the end of last year was they allowed us to resume enrollment. So we went through the process already in Q4 of getting all our sites open and then recruiting new patients. So to Bob’s point, as far as the FDA is concerned, we are open. We needed to recruit those nine patients, but that’s not done. And we’re now in the process of wait for the data, give it to the FDA and see which dose they prefer. Do they prefer 200 or 300? Either way, our sites are open and we’re off to the races.

Unidentified Analyst: As soon as you get the dose, you can go?

Robert Martell : We can continue enrollment at that dose, which ultimately, we feel like we can accumulate data there. We’re interested in let’s step back and think about our overall potential registrational plan. So we’ve mentioned that there’s a couple of opportunities for very rapid registration and that would be single-arm studies in FLT3 mutated patients, with FLT3 mutated AML; and secondly, in patients with splicing factor mutated AML. And so those are single-arm studies. As soon as we have our dose, we can start expanding that. And really at that point, having much greater clarity on what our registrational plan will be.

End of Q&A:

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to the company’s President and Chief Executive Officer, James Dentzer, for any closing remarks.

James Dentzer : Thank you, operator, and thank you, everyone, for joining today’s call. And as always, thank you to the patients and the families participating in our clinical trials; to our team at Curis for their hard work and commitment; and to our partners at Aurigene, ImmuNext and the NCI for their ongoing help and support. We look forward to updating you again soon. Operator?

Operator: The conference has now concluded. Thank you again for your participation. And you may now disconnect.

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