Caribou Biosciences Inc Clinical Updates on Caribou’s off-the-shelf CAR-T Cell Therapy Programs Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yigal Nochomovitz - CITI - Analyst : Great. Thank you very much for taking the questions and congrats on all the very good data. I have one for Dr. Hamadani, if I may. I'm just curious if you could talk a bit about the pent-up demand at your center, specifically, what fraction of your lymphoma patients that are not eligible for the auto CAR-T or transplant would you be putting on vispa-cel today assuming it were available? And also what are those patients getting today in the way of chemo immunotherapy? Thank you.

Question: Yigal Nochomovitz - CITI - Analyst : Yeah. Thank you very, very much. Is there time to ask Dr. Rossi a question or did she leave? Adriana Rossi - Mt Sinai - Center of Excellence for Multiple Myeloma - Assistant Professor of Medicine (Hematology and Medical Oncology), Director

Question: Yigal Nochomovitz - CITI - Analyst : Oh, hi. Thank you. So obviously, you made a lot of very important points related to the bispecifics and also, as you pointed out and the other KOLs pointed out that a lot of the allo products which Caribou are developing may be appropriate in the community center as opposed to just into the academic centers. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Yigal Nochomovitz - CITI - Analyst : Great. Thank you very much.

Question: Alec Stranahan - BofA Global Research - Analyst : Hey guys. Thanks for taking our questions and congrats on the really exceptional data here. First, maybe for the company, on PFS. It looks like you're seeing the expected curve shapes versus auto CAR-Ts, the patients that respond really well responded for a while and those that don't progress pretty quickly. I guess if the pivotal study goes through as you outlined, how should we be thinking about PFS on the comparator arm? And maybe you could just walk us through what the event-driven interim would look like and sort of the alpha that (inaudible) from the final readout.

Question: Alec Stranahan - BofA Global Research - Analyst : Okay. Great. And then maybe one for the doctors on the call. I appreciate you come from fairly large academic centers. But maybe you could just talk whether there was a learning curve as you got comfortable with the therapy. And if you see any potential hurdles or points that smaller community practices might need to come up the curve on. Thank you. Joseph McGuirk - University of Kansas Cancer Center - Professor of Hematology/Oncology, Division Director for Hematologic Malignancies and Cellular Therapeutics Yeah, I'll address this from our perspective. We are a large center, and we do over 200 CAR-T on a yearly basis here in Kansas City. But our catchment area is principally rural and with even out the wilderness areas out on the Colorado border, half of Missouri, a little bit of Nebraska, Iowa, Oklahoma, and Arkansas. And so we have a network, as I mentioned, Midwest Cancer Alliance, with a large swath of that area of hospitals, community hospitals. And we've chosen very wisely, I think, centers that have obviously an ICU, have a champion, local champion. And we have been in the process of meeting with this group of folks in this large swath of area. Docs, they want to do this, their teams want to do these therapies. And these docs will be provided with 24/7 access to treatment experts. So for that unusual patient who does have more advanced CRS or ICANS, for example, where they need to get further guidance or actually transfer the patient, that will all be arranged and set up. And we're used to this in our network because we have one of the largest acute leukemia programs in the nation, and 24/7. These folks don't do 9 to 5 when they have onset of acute leukemia. We're, yes sir, yes ma'am. Right away, we get them on a helicopter, and we have them up here from Oklahoma or from way out in the state of Kansas, et cetera. And so, we will be leveraging that. But obviously intensive education, algorithms of care that we provide for our patients, the understanding therapy for the grading, the side effects of therapy, et cetera. So there's a very intensive effort already under way to do this. Adriana Rossi - Mt Sinai - Center of Excellence for Multiple Myeloma - Assistant Professor of Medicine (Hematology and Medical Oncology), Director

Question: Alec Stranahan - BofA Global Research - Analyst : Okay. That's very helpful. Thank you so much.

Question: Mani Foroohar - Leerink Partners - Analyst : Thanks for taking the question. I want to dive in a little bit on timing and status of regulatory conversation, recognizing that's a little bit looking forward beyond the conversation we're having today. When should we, as investors and analysts, expect feedback regarding your next interaction with the FDA? And so what is the timing in which we can get more clarity, recognizing that some of this morning's news has sort of introduced more nervousness into investors around predictability of FDA feedback, et cetera?

Question: Mani Foroohar - Leerink Partners - Analyst : Great. And if I could hop off to a separate unrelated question, I guess, a little bit also off the media side of our conversation, but more about CB-011, separate disclosures that you guys have also had. How should we think about the expected dose response for an allo CAR-T, recognizing this is a roughly small (inaudible) patient population in treatment? And how should we expect the tempo of dose response across that population to emerge? And how should we think about analyzing that in future disclosures?

Question: Mani Foroohar - Leerink Partners - Analyst : Thanks. That's very helpful. Congrats again, guys.

Question: Asthika Goonewardene - Truist Securities - Analyst : Good morning, folks, and thanks for taking my questions. I'll also offer my congratulations on this positive update here. So Tina, just to start us off, vispa-cel cohort had patients with some pretty poor prognostic features. Can you maybe give us some clarity on what proportion of the patients treated with vispa-cel and the optimized profile or the confirmator profile would have been deemed transplant ineligible? And how did these patients perform versus the others?

Question: Asthika Goonewardene - Truist Securities - Analyst : Okay. It's encouraging to know that. Maybe a question for Dr. Rossi and in a similar vein here. It's interesting to note that CB-011 was administered at centers, all of which, if we do our checks, suggest that auto CAR-T was commercially available. We know that approved auto CAR-T like Carvykti may have a long vein to vein (inaudible). So maybe for Dr. Rossi I could ask this question, I know it's hard to maybe glean this out of the baseline characteristics, but could you give us an estimate of what proportion of the patients treated with CB-011 would have been also deemed ineligible for auto CAR-T, maybe they had rapidly progressing disease? Can you maybe talk to us a little bit about that? I'm just wondering if this cohort might have recruited some of those patients who were just not fit enough and had rapidly progressing disease who are going to wait around long enough to get that auto CAR-T. Adriana Rossi - Mt Sinai - Center of Excellence for Multiple Myeloma - Assistant Professor of Medicine (Hematology and Medical Oncology), Director

Question: Asthika Goonewardene - Truist Securities - Analyst : Great. Thanks for taking my questions.

Question: Jon Miller - Evercore ISI - Analyst : Hi, guys. Thanks for taking my question and congrats on all the data. I'd like to dive in a little bit deeper into the different ways that somebody could be CAR-T ineligible for the proposed Phase 3 definition. I mean, we've heard a lot about these patients in academic centers who are ineligible for a variety of reasons. But there's also this other population that some of the KOLs were referring to that are ineligible in the community because they can't travel or they don't want to leave their local center to go to an academic center where auto CAR might be available. Presumably, these patients have different baselines and different expected response to CAR-T. Can you talk a little bit about what proportion of the Phase 3 population you might expect to be, quote-unquote, geographically ineligible versus more strictly ineligible and how you might stratify for those characteristics?

Question: Jon Miller - Evercore ISI - Analyst : Makes sense. Thank you. One other question I've got is on cell persistence, the durability of the cell signal, which I know you guys have armored your CARs and you've gone to some trouble to try and extend cell viability and persistence in vivo. But it doesn't look like, at least in the CD-19, it doesn't look like your getting cell persistence that is dramatically extended certainly versus the auto CARs. Granted, the efficacy data you've got is very competitive, but do you expect that that cell persistence is going to be meaningful to an allo product in the way that it is to an auto product? Should the bars there be the same?

Question: Jon Miller - Evercore ISI - Analyst : That makes sense. Thank you so much.

Question: Luca Issi - RBC Capital Markets - Analyst : Great. Thanks so much for taking my question and congrats on the data. Maybe if I can circle back on the powering assumption, it looks like your trial is obviously 250 patients. It's actually a little bit smaller than the ZUMA-7. Can you just maybe talk about that? Is that because you anticipate the control arm to underperform what you've seen historically from ZUMA-7? Or are there any other drivers that actually can explain the difference? Again, any color there is much appreciated. And then maybe on manufacturing quickly, can you just expand a little bit more manufacturing? I find it remarkable that the FDA published 200 CRLs, and close to half of them are actually related to manufacturing. So can you just talk about what capabilities you have with your partner? And then maybe talk about whether any part of the supply chain are ex-US. Thanks so much.

Question: Luca Issi - RBC Capital Markets - Analyst : Okay. Thanks so much, guys.