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

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Zachary Roberts: Thanks, Laura. So we don’t — we are not worried in the least about the patients who are going to be randomized to observation. That is the current standard of care. And that means that — these patients, there is no data anywhere, let alone an approved agent to direct the physicians to offer another line of therapy to patients who are in the observation arm. So we don’t think that there — in fact, we know for a fact based on the work that we’ve done already in — during the study start-up that there that there is a wide agreement that this is the most appropriate management for these patients, which is the current standard of care observation. These patients will be monitored very closely in the context of a clinical trial, probably as closely, if not more so, then they would be, were they not participating in a clinical trial.

That’s the nature of clinical investigation. And this is going to be part of why we think patients will be willing to sign up for this study. And as far as competition goes, there is a good chance that at some point, we will see some company in the development of agents for patients with MRD-only disease. We do think that we have a unique product profile with onetime administration, so there’s no need for a long period of treatment or maintenance therapy. This is, as we said, kind of a seventh cycle of treatment, these patients can get and just go home and move on. And number two, there’s — these patients can progress very quickly after they complete frontline therapy and they have MRD disease. So being able to act definitively and very rapidly, and I’ll remind you that we initiated treatment within two to three days after patients were enrolled in our third line study.

So we know that we can affect this treatment extremely quickly. So we think we have a built-in advantage with our modality, and that’s on top of the strong lead advantage that we have, having launched this study before any of our competitors.

Operator: [Operator Instructions] Our next question comes from the line of William Pickering of Bernstein. Please go ahead, William.

William Pickering: Hi, thank you for taking my question. In your ALPHA3 trial, you’ve talked about, including community centers, could you speak to the level of interest that you’re getting from these centers? Do you expect it to be a large or a small percent of total sites. And do these centers need to already be [indiscernible] to participate? Thank you.

Zachary Roberts: So I will say that the reception that we have gotten from these community practices has been very, very positive and very — there’s a high level of engagement and enthusiasm. Many of them are moving extremely quickly to be ready to open the study. There’s even a little bit of friendly competition among some of them to really be the first to open. So we’ve been very encouraged by the reception that we have gotten. As far as the percentage goes, it’s going to be — we’re going to — we’re definitely going to have some academic centers because they are as excited about this concept as the community oncologist. So there’s going to be a continuum. We don’t exactly know yet. We haven’t completed the full selection of the entire panel of programs, but I will say that there will be a substantial percentage of patients coming from these community practices in the overall study.

William Pickering: Thank you.

Operator: Thank you. I would now like to turn the conference back to David Chang for closing remarks. Sir?

David Chang: Thank you for joining on our call today and your continued support. We are more excited than ever about the potential for Allogene and the opportunity to fulfill the promise of allogeneic CAR T for patients with cancer and now extending the promise to patients with autoimmune disease with our CAR T 2.0 ALLO-329. As someone who has been involved in developing cell therapies, I’m particularly excited about what’s happening in the field today, thinking differently and putting innovation at the forefront. That is exactly what is needed to fuel this new resurgence in cell therapy. I look forward to providing updates to our exciting programs throughout the year. With that, goodbye.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

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