Aadi Bioscience, Inc. (NASDAQ:AADI) Q4 2023 Earnings Call Transcript

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Dave Lennon: Thanks, Loretta. And just to add on to what Loretta was saying, what we saw so far, we have enrolled a very diverse tumor population within our trial, and I think you saw that even in the early results where we had a kind of broad distribution of tumor types that we shared back in December. Thanks, Liang, for the questions. And I think if there’s no follow-ups, we can move to the next.

Liang Cheng: Thank you. Thank you. Appreciate it.

Dave Lennon: Thank you.

Operator: Thank you. [Operator Instructions] And our next question coming from the line of Ahu Demir with Ladenburg. Your line is open.

Ahu Demir: Good morning. Thank you so much for taking my questions. I have two questions, a follow-up to Joe’s question regarding endometrial cancer. One, could you give us a sense of the sites open, how many sites are open and inclusion and exclusion criteria for the patients? And what are we expecting to see this year? How many patients are they heavily pretreated? If you can provide a little bit of color, that would be great.

Dave Lennon: Sure. I think — so Ahu, we’re happy to answer those questions. I’m going to turn it over to Loretta for some of the details. But at the same time, we probably wouldn’t discuss a number of sites or number of patients at this point just given where we are in the trial, and it is active, and we’re kind of continuing to build that story. But maybe just in the design of the trial and what we might expect to see later this year, I’ll let Loretta give you an update there. So, Loretta?

Loretta Itri: Good morning, Ahu. Always great questions, as usual, coming from you. So basically, this is an open-label Phase II study, looking to evaluate the combination of nab-sirolimus with letrozole in patients who have advanced and that would be advanced or unresectable Stage 3 or 4 or recurrent endometrioid endometrial carcinoma. Patients will have received either no or one prior line of chemotherapy. So this is a population of patients who are relatively early in their treatment course, which is somewhat differentiated, of course, from what we’re doing in PRECISION. So patients are treated with the same dose of nab-sirolimus as they were in PEComa that is a well-established and safe dose. And I think pretty much that this is a Simon 2-stage study, so we plan to enroll the first cohort, and we anticipate since this is an open label study being able to report out early results by the end of this year.

Does that address your question, Ahu, would you like more detail?

Ahu Demir: This is great. Thank you so much Loretta. This is very helpful. And thank you for your compliment as well. I have one more conceptual question for you, Loretta, if I may. So you mentioned mTOR sensitive tumors besides TSC1, 2, could you comment on what other mutational backgrounds are sensitive to mTOR inhibitors?

Loretta Itri: Well, I think that’s quite a difficult question because I think there are many mutations along the mTOR pathway that may provide — that may provide targets. However, I don’t think that any of those specifically has been identified as a specific mutational target for mTOR inhibition. There are suggestions that I don’t think is any of those are proven.

Ahu Demir: Very helpful. Thank you so much.

Loretta Itri: You’re most welcome.

Dave Lennon: Thanks, Ahu. Operator, are there any other questions?

Operator: And I see no further questions in the queue at this time. I’ll now turn the call back over to Dr. Dave Lennon for any closing remarks.

Dave Lennon: Thank you, operator. And thank you, everyone, for joining the call today. I think as you see, we are delivering on the operational goals we have set for both 2023 and looking ahead into 2024, we’re very confident on our ability to deliver against our number one priority, which is the PRECISION 1 trial. And we look forward to providing an update on that two-thirds interim later this year and finishing that trial within 2024. We’re also excited about the new programs we mentioned today and got to discuss a little bit in the Q&A and look forward to providing updates on both our NET and endometrial trials later this year. At the same time, we remain really confident in the continued progress we’re making in the PEComa market with FYARRO.

This is an ultra-orphan indication, and we’re highly penetrated within that market. And that continues to deliver solid sales for us as we go forward. Overall, otherwise, I thank you all for your time and attention today, and we look forward to the next update with you all. Thank you, and have a great day.

Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.

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