Autolus Therapeutics plc (NASDAQ:AUTL) Q2 2023 Earnings Call Transcript

So, first of all, I think a shorter vein to delivery time always helps because the disease can be quite explosive in growth. So, anytime you shave off between frankly identifying the patient and treating the patient, is going to be helpful. But I think what is really important is that you want to actually make sure ultimately that if you’re not running the patients to – or waiting with the patients until they’ve actually reached very, very high levels of tumor burden before you actually identify them and involve them for therapy with a CAR T therapy. That’s not a good idea. It’s obviously what can happen. And the beauty of the data is that we’re highly active across the entire range of tumor burden and disease state and severity of disease, which also gives us an awful lot of confidence around the program.

But just from a very practical perspective, if you have an opportunity to identify the patients earlier, again the patients relapse, and a lot of that is done by monitoring patients’ tumor burden based on the PCR or FACS or NGS, that actually gives you an opportunity to identify the recurrence of disease earlier, and that actually increases your chances of a successful therapy, and also gives you an ability to minimize toxicity of this. So, it’s clearly an aspect you look at, and I think the shorter vein to delivery time overall helps, also because a lot of these patients are very immune -suppressed and there’s always a risk that the patients could actually pick up an infection, which would then actually could delay the dosing because that infection needs de first be taken care of before you could dose the type therapy.

So, speed is helpful. I think we’re at an excellent spot in terms of the time and dose, which is a highly competitive position.

Asthika Goonewardene: Great. Thanks for taking my questions, guys.

Operator: Thank you very much. One moment for our next call. Our next call comes from the line Kelly Shi at Jefferies. Your line is open.

Kelly Shi: Thank you for taking my questions. I have two quick ones. The first is regarding the subgroup analysis at ASH of this year. What kind of patient stratification are you going to use for this analysis? And also, what is the reason for 30% of the patients receive transplant while still in remission? Thank you.

Dr. Christian Itin: Hi, Kelly. Thanks a lot for the questions. The first is with regards to kind of the subgroup analysis. I think there’s obviously quite a lot. It’s a very rich data set. And this is one of the larger studies that actually have been conducted. If we take the Phase 1 component, it’s one of the largest studies conducted in relapsed/refractory patients. So, we have a very rich data set and that allows us to look at aspects in more detail of impact of tumor burden, impact of risk parameters on outcome, both on efficacy and safety outcome. And those are clearly key areas of focus that we’re sort of looking, expecting to provide updates on. So, it’s a very rich data set. What we’ve seen at ASCO is obviously just scratching the surface of the data that we’ve collected.

And we’re looking forward to obviously providing these much more detailed views, which also I think are some of the key reasons for the level of confidence in the consistency of the data that we have sort of articulated in the last few months. The patients that we had in the study, 30% of the patients did receive a stem cell transplant. That is pretty much kind of the range you sort of would expect based on clinical practice. I think if you have a patient – as an example, you have a patient that’s a younger patient, still relatively fit, that has an ability or capacity to actually tolerate a stem cell transplant, or may not have had one before, I think in those cases, certainly until you have long-term follow up in the study. I think physicians will have to make a choice whether or not to follow the patient and follow the persistence, follow the dysplasia and indicators for continued pressure on the leukemia.

Or if they think they have a good match for the patient, how to make a decision whether or not to potentially transplant. This is truly a physician decision. As you can see, it is a low percentage of patients that where that actually was a decision that was chosen to be taken. But it is clearly one of the options that is available to physicians. And it’s very much a very specific and very, I think, detailed analysis that the physicians actually make for the particular patients on whether or not to consider a transplant. And what we also certainly did see in the UK also where the physicians have more experience with the product. And the longer experience with the product is that while the first patient on the ALLCAR study received a stem cell transplant, actually that user transplant decreased quite a bit after that.