Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q4 2023 Earnings Call Transcript

David Chang: And, Brian, I would add, I like the question about your focus on enrolling the patient and execution of the study, which I think is the key. When you look at what we’re doing in ALPHA3, I mean, that’s built on all the data that we have generated from the ALPHA2 in relapse refractory large B-cell lymphoma setting. We shared that data before with all of you and this is really on par with autologous CAR T therapy, which I don’t think any of the other allogeneic CAR T companies can say that yet. From the technical perspective, we believe that this is highly de-risk. I mean, after all, this is comparing against observation, watch and wait. So we feel pretty good about that. Execution is the key, and frankly, I think study start and enrollment, I think that is a pretty significant, de-risking information about the ALPHA3 study. So, stay tuned. I mean, our team’s working really hard to make sure that we execute this study as quickly as possible.

Operator: Thank you. Our next question comes from the line of Jack Allen of Baird. Please go ahead, Jack.

Jack Allen: Great, thanks for taking the question and congratulations on the progress. On kind of same vein as the last question, I wanted to ask about that interim analysis in the middle of 2025. I understand that it sounds like you may not be planning to outwardly share the results, but any context you can provide around the number of patients you’re looking to have for that data set and is there an internal bar you’re thinking about that you’re looking to reach as it relates to pushing the study forward, pass that interim analysis? Thanks so much.

Zachary Roberts: Hey, Jack. Thanks for the question. So we haven’t gone into detail about how many patients are going to be included in that analysis. I’ll say that it’s sort of, maybe unhelpfully not too many, not too few. We want to have enough statistical power to make a good call. And with respect to the second part of your question, how are we going — is there an internal bar that we’re going to be looking for? So there’s really two parts to this, right? We want to make sure that we are improving upon the standard of care, which is watch and wait. And we think, as David pointed out, that we’ve largely derisked that question through our experience in Phase 1. We know that cema-cel is an active therapy. So we think that we will be able to clear that ball, but of course we’ll be paying attention to it.

And then, of course, we have an additional set of criteria that we’ll be using to make the selection of FCA versus FC. So this is a very well thought out, prospectively designed analysis that we think is going to lead us to the right answer.

Operator: Thank you. Our next question comes from the line of John Newman of Canaccord Genuity. Your line is open, John.

John Newman: Hi guys, thanks a lot for taking the question and thanks for all the updates. Just curious if you could comment a little bit more regarding the potential targets in autoimmune disease? So obviously your approach is dual targeting. Other companies out there are also looking at CD19, but some are looking at CD20. And we have additional companies with BCMA CAR Ts that are sort of considering treatment of autoimmune disease, namely lupus. Can you say which targets could be better and why, obviously, different targets sort of crop up at different times during the life cycle of B-cells. But just curious as to your thinking on that. Thank you.

David Chang: Yeah, so in terms of — John, great question. And frankly, I think this is a topic that we are sort of looking into. But ultimately, I believe that when you look at the oncogeny of these cells, the targets that you have mentioned, CD19, CD20, and BCMA, if you look at the coverage of our CD-19 expression, that’s probably most broad and probably better suited than other targets. But this is something that we also have to find out from the clinical data as different players test these different targets. The other question around the indications that we are interested in. We can sort of think about this from generating early proof of concept of not requiring a lymphodepletion. If that is the primary objective, and actually that is, indications where the proof of concept has been established with a [CD9] (ph) CAR T would be very good.

Also, lupus, nephritis is commercially a very attractive indication as well. So lupus is definitely in the play. I know it’s getting crowded, but remember, our ALLO-329 has a very distinct and differentiated approach. So if we can differentiate from others, I think we will have a good traction even in the crowded field. But also being able to go after the activated T cells potentially opens the door to other autoimmune diseases where going after CD19 alone may not be sufficient. And multiple sclerosis as a class of diseases, one, autoimmune diseases that affect the nervous system, I think that also falls in. So frankly, yes, we have to be focused and we have to go after certain indications, but right now I don’t think we have to decide and we have enough time to finalize that decision in the next three to four months.

So stay tuned.

Operator: Thank you. Our next question comes from the line of Sami Corwin of William Blair. Your question, please, Sami.

Unidentified Analyst: Hi. This is Caleb on for Sami Corwin. Thanks for taking the question. So, given the number of CAR T cell companies pursuing autoimmune disease indications, how are you guys thinking about competing for patients in future trials? Would you be more focused on enrolled patients in US or ex-US or a combination of both?