Mirati Therapeutics, Inc. (NASDAQ:MRTX) Q4 2022 Earnings Call Transcript

Ben Hickey: Yes, I’ll take the first one. Again, it’s a little bit early to be sharing the information around what we’re seeing in regards to, is it market growth or share. We do have internal metrics and goals around both of those we think that critical. We do think that the market in general is still very nascent and has a long way to grow. So, we do think that will be a substantial part of the growth moving forward. But we also want to measure our competitiveness by our market share and we have a team that is out there are super energized and looking to take share as well. So, more of that to come in the future, but just too early at this stage.

David Meek: Yes, hi. I’ll take the second question there with the update on what are we going to be looking for. So, the bar is evolving initially with the all comer in 189 or 42. There is now emerging evidence perhaps that the G12C mutants may perform less well that the all comer. I think a way to look at it is as this evolves and shows what we going to be seeing this information in peer-reviewed journals coming up, we would anticipate a significant improvement over what we’ve seen historically so that we have confidence moving forward in the first-line studies in order to initiate Phase 3 trials.

Operator: The next question comes from Michael Schmidt at Guggenheim. Please go ahead.

Michael Schmidt: Hi guys, thanks for taking my question. I had one on your strategy for adagrasib in colorectal cancer. It sounds like you did have the FDA meeting recently. Could you just let us in a bit more on the feedback that you have received there and how we should think about the scope of the filing and also what needs to be accomplished before a submission later this year, as you mentioned? Thanks.

James Christensen: Michael, I’ll start. As we said that we going to go ahead, we will file for accelerated approval by the end of this year. We had a very good conversation with the agency based on the data that you’ve seen that was presented at ESMO last year. So, understanding what the requirements are for the accelerated approval pathway, we got all that laid out. Now, we just need to execute on it throughout the year put together the dossier and so on. You also saw that we received Breakthrough Therapy designation at the end of last year, which I think also speaks to the robustness of the data that we have in that third line plus setting in colorectal cancer adagrasib combined was to rituximab. Alan, anything you’ll say there?

Alan Sandler: No, I think you summarized it quite well. We going to be working hard to get that stand and we enthusiastic about the opportunity.

David Meek: We will just say that’s just the beginning with colorectal cancer. We also have a KRYSTAL-12 trial underway for second-line colorectal cancer as well and as Alan mentioned, that trial’s enrolling well and KRYSTAL-10 so that we’ll have that data 2024.

Operator: The next question comes from Benjamin Burnett with Stifel. Please go ahead.

Neil Carnahan: Yes, good afternoon. This Neil Carnahan on for Ben. When can we expect an update of more CNS data and how important do you think that is to defining the drug profile in second-line lung cancer patients? And then as a follow-up to that, are you evaluating adagrasib pembro combo in any frontline lung cancer patients with active brain mets? Thank you.