Shattuck Labs, Inc. (NASDAQ:STTK) Q4 2022 Earnings Call Transcript

Lini Pandite: Yes, with the Doxil we are expecting something in the order of 10 to 20 patients by the middle of the year. So based €“ we would be sharing data both on the safety, as well as the efficacy. It will be a mixture of that data, depending on the enrollment. And we expect that we would provide some guidance closer to the time as to what to expect by the middle of the year. But to answer your question in the Doxil it will be in the order of 10 to 20 patients. With the mirve, looking at the mirve data, so yes, I mean, with mirve approved in the high expresser group, 75% of weight and here we are enrolling patients with 25% or greater. So we will be looking at the response by subgroup in those subset. But at this stage, what we are doing with ImmunoGen is that we are partnering with ImmunoGen to see what would be an interesting response rate and durability of response based on their database, we will definitely be working with them to benchmark the data that we see against the datasets that they have.

And by the end of the year, we would hope to have or expect to have about 40 patients of worth of data.

Marc Frahm: Thank you, very helpful.

Operator: Thank you. We go next now to Yigal Nochomovitz at Citi.

Yigal Nochomovitz: Hi, thanks. I’m just trying to get a feeling for expectations for the combo study with 154 in aza both in the relapsed/refractory setting, as well as in the frontline setting. What do you generally believe is the efficacy bar for aza by itself and with the addition of 154 in both relapsed/refractory AML and MDS as well as in the frontline setting in TP53 mutant, what might you expect to see with the combo above aza?

Taylor Schreiber: Thanks, Yigal. As Lini said in the initial portion of the trial, we’re enrolling primarily venetoclax to an HMA experienced subject. So any activity in that relapsed/refractory setting, I think would be helpful and perhaps provide some guidance toward what you might expect in the frontline setting. The first two cohorts that we expect to have data from in the second half of this year in the frontline setting are number one in the TP53 mutant AML patients. There we believe that the expected effect in terms of complete responses for azacitidine alone, are in the range of 22%. And so we’re looking for a combination complete response rate in the neighborhood of 40% or so. And in the high-risk MDS cohort, this is where there continues to be a bit of blurriness, honestly, in the field as to what the expected effect size of azacitidine alone is.

Some of the older studies place that complete response rate in the high teens, the more recent Takeda study with Pevonedistat suggest that it could be as high as the low 30s. And so we think it’s best to cite the higher response rate as the benchmark. And so we’re looking for a combination response rate somewhere in the neighborhood of 50% for complete responses.

Yigal Nochomovitz: Okay, and then I’m not sure if you mentioned it in the prepared remarks, but just can you just kind of go through again the choice of the 3 mg/kg for 154 in combo with the liposomal doxorubicin. What was driving that decision?