MacroGenics, Inc. (NASDAQ:MGNX) Q4 2023 Earnings Call Transcript

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Operator: Thank you. One moment for our next question. Our next question comes from Courtney Kowalsky with Barclays. Your line is now open.

Pete Lawson: This is Pete Lawson from Barclays. So just a couple of questions. Firstly, in the abstract, where we see safety that’s broken out by discontinuation rates and/or side effects such as [indiscernible] And then I’ve got a follow-up.

Scott Koenig: Peter, you will have the discontinuation rates as of that cut of January data. With regard in the abstract itself, I don’t recall specifically how deep in terms of the breakdown of the AEs were? I have to get back to you on that.

Pete Lawson: Got you. Thank you.

Scott Koenig: And then in the TAMARACK study, patients been exposed to radiopharmaceuticals such as Pluvicto.

Pete Lawson: And will you be able to break that out eventually?

Scott Koenig: Yes. Unfortunately, they are allowed in the study, but given the timing of the study, and as I pointed out, the majority of these patients came from Europe, the actual availability of vobra duo [ph] and the timing didn’t work out to get those Pluvicto progressors and experienced patients there. We expect a few of them from the U.S., but very small numbers there.

Pete Lawson: Okay. And then just a quick question for Jim on the puts and takes around the cash guidance just with the expansion of the B7-H3 clinical trials kind of I guess that’s a negative for cash, but what are the puts and takes we can be thinking about for you to maintain that cash guidance?

Jim Karrels: Yes. Thanks, Peter. Thanks for the question. So our guidance of cash runway into 2026 reflects the additional cohorts under the TAMARACK umbrella, the digital vobra duo cohorts. So everything we’re talking about, all of these studies that we’re currently running. And talking about running are included as part of our guidance.

Pete Lawson: Got you. And are there any additional inflows of cash you’re thinking through to kind of counterbalance that? Was that always in the cash guidance?

Jim Karrels: Peter, I’m sorry, could you repeat the question, please?

Pete Lawson: Or is there any additional cash inflows that you’re thinking through? Or were those cohorts always in the cash guidance?

Jim Karrels: Those cohorts are new to the guidance. There have been some savings. There’s always a possibility of additional business development activities. And of course, with $1 billion milestones hanging out there related to both TZIELD and ZYNYZ, which we’ve handicapped significantly, we would anticipate recognition of some of those over the next couple of years.

Scott Koenig: And there were some additional revenues coming in that weren’t anticipated originally that are part of this guidance. So…

Pete Lawson: Great, okay. Thank you so much. Thanks for the clarity.

Operator: Thank you. One moment for our next question. Our next question comes from Silvan Tuerkcan with Citizens JMP. Your line is now open.

Silvan Tuerkcan: Thank you. Thanks for taking my question and congrats on the progress. Maybe piggybacking a little bit on the previous question. What’s the bar for the safety profile in the abstract or also at the ASCO presentation versus the safety profile that we’ve seen on the older doses? And I’m asking, in particular, maybe on the grade 3 or higher issues that we’ve seen with the [indiscernible] Can you just comment on what you’re trying to improve? And is there any bar that makes you confident in the future here? And I have a follow-up.

Scott Koenig: Sure, Silvan, I just want to correct you. Our concern was not Grade 3 hand foot. Obviously, we want to avoid that at all though the incidence of that was quite low. The issue was that patients would either with Grade 2 where they have experiencing pain would be electing to come off treatment despite the fact that they were having antitumor effects. And so number one is the most important is that we can decrease the incidence totally. And then for those that have — with a reduced incidents converting or preventing them from going from Grade 1 to Grade 2 would be what our goal is there. With regard to the neutropenia, clearly, that is something most likely due to free toxin getting to the bone marrow. But again, this is a situation where it was largely a laboratory value.

It did not result in increased infections or federal neutropenia. And so this is mostly handled by holding the drug or stopping the drug. And again, if we can reduce that both in terms of incidents and grade, I think that will be better. But that wasn’t as concerning to the treating physicians in managing these patients.

Silvan Tuerkcan: Thank you. And maybe about the LORIKEET study, will we get data from that study this year? And maybe how does that relate to your late-stage monotherapy plans if you get data from the combo of what we do in lorigerlimab?

Scott Koenig: With regard to the timing of this, we’ll provide, as I said earlier, a update on the study. It ultimately will depend on the speed in which we can enroll these patients clearly over the next 2 months, we — will we exceed the plan? Or will it take longer, meaning later in the year to get full enrollment of the study. If it’s the latter, it’s more likely that we’ll have a more fulsome update in early ’25. But again, we’ll be able to give you a little bit more guidance later in the year based on enrollment rates. With regard to the success in this trial, clearly, we’re testing this in the chemo-naive population in combination with docetaxel. I think that if that trial is successful, it’s a great problem to have if the vobra duo pans out also in that same line of therapy.

I should also say that we are not eliminating the possibility that we’re going to look at LORIKEET and Lorigerlimab in late-line prostate cancer that is certainly a possibility to consider. But as I have said before, we are also going to look at Lorigerlimab outside of prostate cancer going forward. So it’s just too early to make a decision on registration studies until we have the data.

Operator: Thank you. [Operator Instructions] Our next question comes from Yigal Nochomovitz with Citigroup. Your line is now open.

Yigal Nochomovitz: Thank you so much for taking the follow up. Scott, I just had a quick follow-up on TAMARACK, it’s unusual that you see a trial that’s 77% over enrolled relative to the target and enrolled very quickly. Could you just comment on some of the factors that resulted in the heavy over-enrollment and as well as the speed to which it was overenrolled. Thanks.

Scott Koenig: Yes. So go with regard to our decision on letting so many more patients into the study as we felt it was not ethical for us to not allow these patients into the study if they had already been in screening and passed the screening requirements. And so we felt that we should do this because the patients made a — and the investigators made great efforts to find patients in the study. As I was commenting on earlier, the surge of enrollment once we had the go ahead from the amended protocol in Europe, there was tremendous enthusiasm to join the study. And I’m sure there are a lot of different reasons as I was pointing out, some of the amendments included the fact that we didn’t require 12 months of treatment on an ARAD and so patients who were progressing quickly were able to join the study, and they probably did not have much in terms of other alternatives.

There also, it turns out to be a large number of patients for varying reasons, whether they’re not qualified to go on docetaxel or chemotherapeutic or they choose not to, I think we attracted a large number of those patients into the study that allowed us to have a very sizable subpopulation of chemo-naive patients.

Operator: Thank you. I’m showing no further questions at this time. I would now like to turn it back to Scott Koenig for closing remarks.

Scott Koenig: Well, thank you very much for participating in the call today. We look forward to obviously updating you at ASCO in the near term and talk to you at future times at on earnings calls and in other venues. Thank you very much.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.+

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