Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q4 2022 Earnings Call Transcript

Taylor Hanley : This is Taylor on for Tess. I did have some follow-ups on the SADA Phase I trial. I was wondering, given that we’ve kind of had the expectation that the first patient would be dosed soon and there seems to have been some challenges there, would you be able to give any more color on like why a patient hasn’t been dosed yet? And how many patients do you think you’ll need in order to give a clinical update? And then my last question would be, I guess, what gives you confidence that you can still show data from the SADA program later this year?

Thomas Gad : Yes. Thank you, Taylor. So I don’t think we have any unusual challenges. I think when you open up a first-in-class drug that has never been in humans, it takes some time also due to the fact that we are limiting patients and screening for patients. These are third-line patients that have been through a lot of treatments when they come for this option. And I do think we are confident that our timelines still hold, and we will come out and update you on the good news once we’ve actually dosed the two doses on the first patient. Regarding — what we are looking for is validating the mechanism of action. So tumor uptake of the protein and then we are — and then showing on spec scans that we can actually light up the protein and don’t see any off-target normal tissue noise.

We do believe that we will be through two cohorts by summer. And then we do believe that we will be into the third cohort by our R&D Day and hope to share some more exciting updates on this Phase I at that time, if that gives you some color.

Operator: Our next question comes from the line of Charles Zhu with Guggenheim.

Edouard Mullarky : Hi. This is Edouard on for Charles Zhu. Can you hear me?

Thomas Gad : Yes. Yes, Edouard. Go ahead.

Edouard Mullarky : Yes. Okay. Sorry. Yes, just another question on SADA. Maybe just some color on — you said you’re being more selective about the patients that you’re your screening. Maybe if you could — just any color on the screening failures or kind of how you’re — or the types of patients that you’re aiming for? And then as a follow-up just on the — for the dose imagery data, sort of what dose levels are or how many patients do you think you’ll need in order to be able to present that later at R&D Day?

Thomas Gad : Tough questions. Yes. So as I said, these are third or fourth line patients that have been exposed to a lot of chemotherapy. And with that, comes a ton of side effects, as you know. So we need to get through echos and all kinds of prescreening. And I think that’s always the challenge with first-in-class drugs. I don’t necessarily think we have any unusual challenges and I think you’ll see we’ll be successful in recruiting patients and dosing them in time. What kind of protein dose we have to reach in order to see something? That’s speculation. It’s a classic 3 plus 3. We’re starting at 0.3 milligrams and the second cohort is 1 milligram and we hope to see something as soon as possible. And what we initially are looking for, as I said before, is tumor uptake, the 30 millicurie lutetium imaging dose paints the tumor and we don’t see any off-target noise on the scan, which would validate the mechanism and each patient moves on to a therapeutic dose of 200 millicurie if the protein lights up.