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

David Meek: Sure. I, what we would be looking for these sort of started these early conversations is an ex-US partner for adagrasib. So, we have a US presence and what we do not have an ex-US presence at this point. The marketing authorization application is going well. We expect third quarter approval of adagrasib in Europe. So that’s an upcoming event that we have. The derisking event really which we wanted to wait until we have that event before we begin the partner conversations with the FDA approval. So, we now behind that. That’s behind us. So we having conversations about the right commercial and potentially development partner would be so we can maximize adagrasib sales globally. So, we are in this conversations now.

Operator: The next question comes from Ami Fadia at Needham. Please go ahead.

Ami Fadia: Hi, thanks for taking my question. I had a follow-up question on the first line part in the TPS greater than 50% by September versus pembro. You’ve indicated that you’ve had a preliminary discussion with the FDA. Is there anything additional that needs to be confirmed with the FDA? Or are you good to go with going ahead with the trial? And then that once you have the data, you – submission there? And then just a follow-up on KRAZATI, how do we think about sort of the cadence of the launch, particularly in the first quarter. Are there any sort of factors outside of some additional inventory stock about – in the first quarter in terms of perhaps any kind of broader dynamics in terms of coverage and pricing. Thank you.

James Christensen: I think I can take those. So regarding the TPS greater than 50% in the frontline setting, the comparator would be pembro because monotherapy pembrolizumab is the standard of care in that patient setting. So that would be the comparator. So, our plans would be assuming the data continues to mature, as we hope it does, it would be a combination of adagrasib plus pembrolizumab versus pembrolizumab in that trial as Alan mentioned and we had those preliminary conversations with the agency. So let’s wait for the data to mature and before we make the – we pull the trigger on moving forward with our Phase 3 program, greater than 50. But in the meantime, we doing the groundwork, as Alan mentioned, now to prepare for success.

Regarding the launch of KRAZATI, we will share this information and the very specifics of how the launch is going in Q1 at the Q2 earnings calls and will walk through those metrics of sales and share and access and so on. We were just approved in mid-December. So, it’s very early weeks at this point, but we’re excited to share that information in May.

Operator: The next question comes from Kalpit Patel B. Riley Securities. Please go ahead.

Andrew Fleszar: Good afternoon, This is Andy on for Kalpit Patel. Thank you for taking questions. Regarding your exploratory combination of chemo-plus adagrasib plus pembro in frontline NSCLC, can you give us some color on what doses of adagrasib you are starting with to try and limit toxicity from this triplet? And then, when should we expect initial data from this exploratory combination?

David Meek: Yes, thanks. So this is going to be, it’s a study that’s just getting started. And we going to be looking at adding as you mentioned, they have aggressive to 189, we’ll do it in a sequential fashion, adding to the maintenance portion first and then if tolerated, bringing it up forward to the concurrent. We anticipate being able to utilize the four hundred-milligram dose starting. That’s the combination with adagrasib and pembrolizumab so will add that to the chemotherapy at that point, we’ll be doing it, of course, the usual Phase 1 fashion.

Operator: The next question comes from Jay Olson with Oppenheimer. Please go ahead.