Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q1 2024 Earnings Call Transcript

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Michael Rossi: No. Thank you for the question on that. I think as we look at this, there may be some data that we release early, just to show kind of where we are. But at the end of the day, I think it’s more meaningful to look at a significant number of patients, collect that data and come back with the learning. As far as the timing of the cadence, the hope is now that we’ve had GD2 in patients in our 1001 study that 1201 will recruit a little bit more quickly. And we could potentially get some of this use the learnings from our 1001 and one to expedite our 1201. But that being said, my goal would be to put as much meaningful data together and look at it all in one consistent data release.

Nick Unan: Okay. Thanks. Appreciate it.

Operator: And our next question comes from David Nierengarten from Wedbush Securities. Please go ahead, David.

David Nierengarten: Hey, thanks for taking the question. I have one on SADA and that is, do you have any patients yet in that have entered into the Part C and kind of where are you on dosing dose escalation for the 1001 study? Thanks.

Michael Rossi: Yes. Thank you, David. Now, we’re still in Part A and we have not moved to Part B yet. So, where we are, we’ve done the first 14 patients. We dose escalated up to three milligrams per kilogram and we’ll be moving on to our fifth cohort shortly. However, until we complete Part A, the goal in Part A is to eliminate the two variables of protein load and the dose time to the radioisotope. Once those two variables are narrowed down, then we’ll move into Part A, where we escalate the activity in the isotope and then move to Part C, which is repeat up to five cycles.

David Nierengarten: Maybe, a quick follow-up if I could on the SADA protein dose escalation. Do you expect the targeting SADA molecules to have different dosing levels, depending on the tumor type in the future or do you think you’ll kind of be able to saturate the target and then figure out the appropriate radiation dose?

Michael Rossi: Yes. I think that’s part of our learnings moving forward. And so, I want the data to take us to the right conclusion. So, at this point, we’re really trying to determine what the optimal protein load is. And once we determine that, there may be variations from SADA molecule to SADA molecule. There may be some variations patient to patient. But at the end of the day, we want to make this as simple for healthcare practitioners as possible. They give both the practitioner and the patient the best opportunity for an effective therapy. So, we’re taking in all of the data that we can, we’ll collect that and then take a qualified step backwards, to let the data dictate, where we go and what that looks like from both the protein loading and dosimetry perspective.

David Nierengarten: Okay. Thanks.

Michael Rossi: Thanks, David.

Operator: And our next question comes from Mike O from Morgan Stanley. Please go ahead, Mike.

Unidentified Analyst: Hi, good morning. This is Rowan on for Mike. Thanks for taking our questions. Just on the DANYELZA trends for the remainder of the year, are you expecting consistency from quarter to quarter? Or do you expect to see more volatility? Thanks.

Sue Smith: Thanks, Mike.

Michael Rossi: Thank you, Rowan. All right. Go ahead, Sue.

Sue Smith: I’m sorry. Yes. I think in terms of quarter to quarter, there is some seasonality. But again, we reiterate that overall. We anticipate there will be a strong attainment of the of the global — I’m sorry, the forecast number for this year. So, the consistent trend is there. And with the new programs in place, we’re starting to see those kick in. So, I think that we’ll have a steady growth, perhaps some seasonality in the summer, which we’ve seen every year since launch.

Unidentified Analyst: Thank you.

Michael Rossi: Thank you, Rowan.

Operator: And at this time, there are no further questions. I would like to turn the call back over to Michael Rossi for closing remarks.

Michael Rossi: Well, thank you all for joining us today to discuss the progress made during the first quarter of this year. With strong financial foundation from DANYELZA’s commercial success and our responsible capital allocation strategy, we’re uniquely positioned to continue top-line growth, while advancing the clinical development of our differentiated radio-immune therapy platform, SADA PRIT, and potentially deliver better and safer therapeutic options in the treatment of a variety of cancers. We look forward to seeing many of you at upcoming investor and medical meetings, in particular, ASCO and SNMMI. Thank you and have a great day.

Operator: This concludes today’s conference call. Thank you for attending.

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