Aadi Bioscience, Inc. (NASDAQ:AADI) Q4 2022 Earnings Call Transcript

Ahu Demir: Okay, thanks Scott. And my second question is on the SGO presentation on the relevance of TSC1 and TSC2 alterations in endometrial cancers, could you maybe elaborate more on the relevance, like the maybe percentage of patients who are, who had the TSC1 and TSC2 alterations in endometrial cancers? Is there any specific subtypes that TSC1 and TSC2 alterations are curing those endometrial cancer patients? And maybe the part of the followup question is, what have you shown in the expanded access program for the again, endometrial patients?

Scott Giacobello: Okay, so I’m going to do is, I’m going to turn that first part of your question on the SGO data over to Loretta. Loretta, do you want to handle that one?

Loretta Itri: Sure. Can you hear me?

Scott Giacobello: Yes.

Loretta Itri: Hi Ahu. So off the top of my head, I can’t recall the incidence rates of TSC1 and TSC2 mutations. It is — of the different tumor types it’s one of the higher, I would say, in the range of 3% to 4% of endometrial cancers expressed TSC1 and TSC2 alterations. This sub-analysis that we performed was a relatively small subset of the AMPECT study. But as you may be aware, there was literature to suggest that PEComa’s that occurred in patients with endometrial cancer had a relatively unfavorable response. Our data in fact showed a very favorable response of 43% in this population. So I think we have shown rather definitively or at least in the best collection of patients of this type, that the effect of FYARRO in PEComas occurring in endometrial cancer is quite good. Did I answer your question?

Ahu Demir: Yes, you did. And is there any subtype of endometrial cancer, low grade, high grade, that TSC1 and TSC2 alterations occur at a higher rate?

Loretta Itri: We — unfortunately the number of patients that we had data for would not allow us to say anything definitive in that regard.

Ahu Demir: I see. Thank you very much.

Neil Desai: Ahu maybe, this is Neil Desai. Hi, everyone. Maybe I can just jump in here. The — like Loretta said, we don’t have enough information at this point on the sort of copy number high versus low in the relative TSC1 and TSC2 incidents, but that is an area we continue to look. I think you had another question on the EAP and as it relates to endometrial. And if you would recall, we did have endometrial cancer patients and this was not PEComa, but endometrial cancer patients on the EAP data that we had disclosed in ASCO 2021. And at least one of them, I mean, it was a small number, but at least one of them after many lines of therapy had responded and done very well and went on for a long period of time when we did the cutoff for the ASCO data, which was I believe over six months.

Ahu Demir: Very helpful. Thanks for taking my questions.

Operator: We have a question from the line of with Cowen.

Unidentified Analyst: Hi thank you for taking my questions. This is on for Boris Peaker. My first question is regarding PRECISION 1. You mentioned you had some difficulty recruiting due to COVID or staffing shortage. Are we still expecting the final readout in 2024 or if you have any more precise timeline for that?

Scott Giacobello: Sure. Loretta, do you want to take that one?

Loretta Itri: Sure. Good morning. We as I believe I may have mentioned in my prepared remarks, we are very aware and our sites report that they are having continued problems relative to staffing related to the COVID pandemic. However, we have been able to continue accruing patients onto the trial as we planned. And we do at this point still believe that we will meet our stated goal of completing enrollment in the spring of 2024. So I don’t think that there’s anything different.

Unidentified Analyst: Thank you. My second question is regarding to the Mirati collaboration. Could you just give a little more color of like the data expectations?