Kite at RBC Capital Markets: Advancing Cell Therapy Innovation

On Wednesday, 21 May 2025, Gilead Sciences Inc (NASDAQ:GILD) presented at the RBC Capital Markets Global Healthcare Conference 2025. The company highlighted promising developments in Kite’s cell therapy pipeline, focusing on both the strengths and challenges faced by its CAR T-cell therapies. While showcasing advancements in manufacturing and treatment efficacy, Kite acknowledged competitive pressures in the market.

Key Takeaways

• Kite’s BCMA CAR T-cell therapy for myeloma shows a 97% response rate and potential for outpatient treatment.
• Financial results reveal a 22% decline in Tecartus franchise sales, while Yescarta sales grew by 2%.
• Next-generation products focus on faster manufacturing and bispecific CAR T-cells.
• Expansion into autoimmune diseases and solid tumor therapies is underway.
• Kite plans to expand its global footprint of authorized treatment centers.

Financial Results

• Tecartus Franchise (ALL, CLL): Sales decreased by 22% in Q1 due to competition from both in-class and out-of-class rivals.
• Yescarta (Lymphoma): Sales increased by 2% in Q1, maintaining a steady performance despite new competitors in the ALLMCL space.

Operational Updates

• Manufacturing:

- Targeting 96% reliability, similar to Yescarta and Tecartus.

- Seamless tech transfer from CELX to Maryland facility.

- Fully automated processes and improved sterility testing turnaround.

• Market Access:

- Addressing challenges with FACT accreditation.

- FACT piloting modular accreditation in large community practices starting late July or August.

• Authorized Treatment Centers:

- 555 centers globally, with plans to expand beyond 29 markets by 2026.

Future Outlook

• BCMA CAR T for Myeloma (a needle cell):

- Launching in 2026 for the fourth line plus population.

- Focus on outpatient therapy to increase community reach.

• Next-Generation Products:

- Developing lymphoma products with three-day manufacturing.

- Bispecific CAR T-cells targeting CD19 and CD20.

• Autoimmune Diseases:

- Testing bispecific CAR T-cells in rheumatoid arthritis, lupus, and more.

• Solid Tumors:

- Presenting dual CAR construct data at ASCO.

- Developing a version two with TGF beta armoring.

Q&A Highlights

• Efficacy and Safety of a needle cell:

- 97% overall response rate with 68% complete response rate.

- Low rates of severe side effects, enabling potential outpatient therapy.

• Manufacturing of a needle cell:

- Production for clinical trials at Maryland facility.

- Aiming for 96% reliability at launch.

• Commercial Performance of CAR T Franchise:

- Facing competitive headwinds; expanding reach to community centers.

• Bispecific CAR T-cells:

- Aiming for improved efficacy and safety compared to existing products.

• Expansion into Autoimmune Diseases:

- Testing in multiple autoimmune conditions.

• Solid Tumors:

- Dual CAR construct targeting glioblastoma.

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Unidentified speaker: Represented by, their executive vice president of Kite, Cindy Peretti, who’s in charge of running running their their CAR T franchise. So, Cindy, thanks so so much for joining us.

Cindy Peretti, Executive Vice President of Kite, Kite: For inviting me. So

Unidentified speaker: I’m gonna start with a multipart question of something I think is on a lot of people’s radars and minds lately with a needle cell, BCMA CAR T for myeloma. We just saw some updated data at EHA, and I’m curious how this frames your views on some of its potential advantages and differentiation from other BCMA CARs. First off, on efficacy, just, you know, some of the potential predictors of response there, extramedullary disease, number of prior lines, etcetera, what you think is most important that we should be looking for to compare your data set to other therapies? And then when we think about safety, what you think is the most likely reason why we’re not seeing as many neurotox events, we’re not seeing any Parkinsonism, you know, the degree to which this relates to better patient selection and prophylaxis and how and your expectations for how that’s going to hold up. So, I know that’s a lot, but really it’s about efficacy safety and how this compares.

Cindy Peretti, Executive Vice President of Kite, Kite: I think maybe we’ll start with the efficacy. So if you look at the efficacy and you’re maybe able to see the abstract that we’re gonna be sharing more data at DHA in about two and a half weeks, the efficacy that we’re seeing now, we’ve got about twelve point six months worth of average follow-up for those patients. So you’re seeing a more mature dataset, and we continue to see a nice high response rate at ninety seven percent for the overall response rate. We’re also seeing our CR rate mature from what you saw at ASH, and so we’re at sixty eight percent on the complete response rate, and we expect that to continue maturing. And then on MRD, we saw ninety three percent minimal residual disease, and we feel really great about this data.

You asked about how do you think about the various high risk subgroups, and I would say, take a look at our subgroups. We’ll be showing that data with extramedullary disease, cytogenetics, and what we’re seeing in those high risk patients is we’re also getting very consistent responses. And so we feel like the efficacy for this product is on par or better with what we see in the existing constructs in the marketplace today, and, of course, that data will keep maturing. The second piece was around safety. And so for our safety profile, for grade three or above CRS or ICANS, we’re at one percent or less.

And what excites me about that is that can become an outpatient therapy. So if you think about patients who end up being admitted to hospital, it’s usually from the grade three events that you see. And so how we’re looking at this is that we have an opportunity to reach more patients. We have not seen any of the delayed neurotoxicity that you see with some of the existing constructs. So no parkinsonism, no Guillain Barre.

We haven’t seen any of the cranial cranial nerve palsies. In addition, we haven’t seen any enterocolitis either, which is something that has been reported with some of the other constructs in this space. So we’re feeling great about the safety. We’re gonna keep looking. It’s early days.

We have about a 50 patients that have crossed over the four month mark where we would expect to have seen some of these things happening, and we haven’t. But, again, we’ll continue monitoring in IMGIGINE-one as well as in the IMGIGINE-three study that we’ve started. But that safety profile, coupled with the efficacy, is something, again, I’m gonna stress, could make a very nice outpatient therapy. And as we want to reach more patients where they are, that becomes really important. If you couple that with our manufacturing today so we have, three manufacturing facilities across our network, and we make our own viral vector.

So we’re moving the viral vector as well into our vector facility. But today, we’re producing a need to sell for our clinical trials out of our Maryland production facility, and that’s also where we’ll launch out of. And within the clinical trials, we now have more than a handful of patients on IMGINE three, and we’re seeing those turnaround times in line with our commercial products, in line with the ESTARTA and TACARTA’s timelines today. And our goal is to really meet that is to, at launch, have that 96% reliability that we see with Yescarta and TACARTIS to be able to get our turnaround times down so that it’s really meaningful for patients. So we’re excited we’re excited about that.

You asked kind of how do we think about the safety, and there’s certainly a number of hypotheses floating around. We’ve spent a lot of time with our translational teams. We’ve been able to make the other two constructs within our research organization and then looking at the imagine one translational data. And there’s a couple things that we noticed that are different. The first is, for those of you who’ve seen pictures of the binding domain of the d domain, the d domain on a nida cell is a small compact binder.

And when I say small compact, it’s helical in structure. And if you look at the the other constructs that are available on the market today, their binding domains are quite large proteins that have integral folding. And so what we found in mimicking cellular intracellular uptake of these, we we are we are not seeing the d domain change based on pH or temperature or any of the things that would change physiologically in the body. But what we did see on on some of the other constructs that we reproduced is we did see changes in the folds. And so when we look at binding in addition to that, we see a very fast on and off rate with the d domain, and we think that that, again, mimics more physiological conditions.

That fast on and off rate allows for really rapid killing and effective killing of the myeloma cells, but it also doesn’t hang on and create the immunotoxicity that you see when something has really strong binding. And so our today, our hypothesis that we’re testing is really around the binding domain and our ability to not create those inflammatory and and immunotoxic events that we’re seeing with others.

Unidentified speaker: Great. And what should we be looking for in this next set of data, and what’s your sense of what would be required from a regulatory standpoint for approval in terms of just the magnitude of benefit, amount of follow-up numbers of patients?

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. So we’re not commenting on the regulatory strategy per se, but I will say we continue to have engaging conversations with around the Imagine One filing, and we have all 17 patients now that we’ll be sharing in the EHA dataset. But, obviously, those patients would be maturing over time and would be part of the full regulatory submission in addition to the phase one study that was conducted by our colleagues at Arcellx. So we would become we would be filing both of those data sets with the agency for the IMGIGN-one fourth line approval. Got it.

Unidentified speaker: And you talked about manufacturing, and it sounds like you’ve been able to really leverage a lot of your tight manufacturing facilities and expertise in this. What was the tech transfer like? Is that still ongoing at all? And I guess, where would you it sounds like turnaround times are comparable to Yescarta. Where are you with regards to inspect rates?

Is that something you would expect to be comparable, or just because this is a different product and process, we should be kind of thinking about this differently?

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. Our our goal is obviously to continue to be leading in manufacturing and get to those places where we have the 96% reliability we have with the Ascarta and Takartis. And to do that, you obviously need high volumes. Right? So we’ve treated over 29,000 patients today with the with the two constructs that we have today.

So there’s also learnings that come from it. From the manufacturing standpoint, our tech transfer went really well. So part of a successful tech transfer we found is we have our research facility located near our Los Angeles production facility, so that continuity between your research and process development folks really matters. Good news for us is our CELX has their research facility located in Gaithersburg, Maryland, which is literally two exits from our Maryland production facility. So we had a really seamless, not just through the people, but also from transfer, and that went really well.

We had we literally had no hiccups, and I was waiting for something to come up, and we had none. And so the tech transfer is complete. Again, we’re producing today out of Maryland for the clinical trials, and that’s great that we’re doing that because it gets us used to producing. It allows us to put in some of the automation that we wanted to put into that. So we’re excited for launch.

Unidentified speaker: Excellent. And as as you think about launch, what do you where do you see the highest priority market role for for a needle cell? Is there I mean, you sort of alluded to the outpatient opportunity. And even kind of beyond that, is there a certain type of center or a certain type of patient whose needs are are not being met by the existing therapy? Where do you see this ultimately fitting in Mhmm.

I guess at launch and then down the line for earlier line patients?

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. So at launch so we’ll be launching into that fourth line plus population. We get the question a lot, are there are there fourth line patients today? And so I wanna remind folks that today, for myeloma, only one in ten out of patients one out of ten patients that are eligible are getting access to CAR T. So there’s still ample room for us to grow that, and we will.

In lymphoma, it’s two out of ten. And so we know that we now know some of the pieces that are gonna help move that market, which is how we get closer to patients in the community. Ninety percent of myeloma patients sit in the community, only ten percent in academic centers. Because it’s a more indolent disease, they don’t get referred till later. And so reaching them where they are is important.

So that goes back to my comment about having an outpatient therapy. So I just have spent about three weeks, meeting with various, authorized treatment centers and community practices across The US. And I know all of you meet with KOLs frequently, so I encourage you to ask the same questions that I’m asking. You when they look at the paradigm they have today for CAR T and their institutions, many of them are treating with Carvicti but treating inpatients. So in a certain number of days, the patient may be may be dosed, but they come back into the hospital.

What I found on average was four to five days they’re admitted. The conversations we’re having is they’re not sure you know, obviously, time will tell if they even will need to admit an Anita cell patient, and that’s something that they’re thinking through, and certainly our clinical trial data will determine that. But bed space can become a capacity issue, and so how we think about coming forward with an outpatient therapy and what that paradigm could look like is really important. We tested it in about ten percent of our imagine one patients. We’re looking at about twenty percent of our imagine three patients being treated in an outpatient setting, and so we’ll continue to collect data around that.

But, again, there is still a large unmet need. The great thing about myeloma is there’s been a lot of cool approvals in the last five to ten years, so there’s a lot of therapies that physicians can work with. And what we’re finding is you’re seeing the quads move under frontline, some into second line, and then the the three drug regimens into third line. So there’s still patients that have not received CAR T by fourth line, and we really think we have an opportunity to treat those patients. So a combination of the academic centers and our existing authorized treatment centers as well as really pushing this paradigm for outpatient.

Today, we have 555 authorized treatment centers around the globe, so we’ll obviously be able to use that footprint, and that footprint grows every year. So by the time we launch a need to sell in 2026, we’ll we’ll presumably be in more than just 29 markets and have more than the 555 authorized treatment centers we have today. Great. Well, maybe speaking a little bit more about that existing footprint and and the lymphoma space. Yes,

Unidentified speaker: CARD has been a miracle drug so far for for so many patients, but there were also some challenges growing its use to the next level, as you mentioned, only two of ten patients. Can you talk about CAR T franchise commercial performance as of late, particularly coming out of first quarter? What have been the key positives that you’ve seen and some of the key challenges and any kind of additional data you’d be looking at to help potentially reaccelerate growth?

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. No. Thanks for that question. So as a reminder, one of the reasons I came to KITE is that we’re actually providing curative potential for patients. So if I think about our second line data, we have four year overall survival in fifty five percent of patients.

That that’s unheard of. In sec in that second line and third line, it’s at forty three percent. We’ve shared five year overall survival data. And even in ALL, we’re gonna be sharing five year overall survival data at EHA, but our four year overall survival data in ALL is forty percent. So we know these drugs are active, and we know these drugs can have a profound impact on patients.

So like you were saying, it keeps me up at night that we’re at two out of ten patients, and so we have, taken on a number of things to say how can we make that look different. So I’ll talk about quarter one, and then I’ll go through sort of the activities we have. So in quarter one, we continue to face headwinds, both in class competitors as well as out of class competitors with the T cell engagers. In class, in the second half of last year, we saw a number of new approvals in the follicular lymphoma space, the CLL space, as well as ALL. And so in those more those smaller tumor types is where we saw a lot of the headwinds in in quarter one.

So our TACARTICE our TACARTICE franchise went down 22%, so we took a big hit there in class and out of class. In lymphoma, we we grew about two percent. So lymphoma, we’re seeing a little bit more steady, but with a new entrance of both bispecifics in in the ALLMCL space and in class competition, that’s where we’ve seen a lot of headwinds. We’re gonna continue to face those headwinds because we can imagine that you’ll you’ll see additional approvals, but some of the things that we’re doing to unlock that is then how do we reach more centers? How do we reach patients where they are?

I’ve talked about this previously. My hope when I joined KITE was that we’d be able to move those community practices in six to twelve months, And what we’ve discovered is it takes a little bit more time than that. They have to work through contracting with hospitals and a number of other things, but we’re starting to see some of that work go into motion where we’re seeing more community practices now taking on CAR T treatment and doing it either in collaboration with a hospital or one of our existing authorized treatment centers. The second piece is for our commercial payers. Commercial payment is often tied to FACT accreditation, and and FACT is an accreditation that goes along with transplant, and cell therapy was added to it.

What’s required to deliver a cell therapy is not the same as what’s required transplant, so holding that equal is really tough for a community practice who’s never gonna be a transplant center. So FACT has created a modular accreditation, and they will be piloting across three of the large integrated community practices the second half of this year. We hope those will start probably in the late July, August time frame, and we’ll have data from that. And I think it’s that type of work that will show that you can accredit a community practice that could apply more broadly. And I think having those large integrated showing it can happen, it’s gonna be hugely helpful.

We have a number of things going on on the policy side as well, but those are some examples. Excellent. And we need to move lymphoma because we need to make room for anetacel as well.

Unidentified speaker: Good. And then on lymphoma, on men on Yescarta and Takarta’s manufacturing, just maybe touch on the latest improvements that you’re seeing there in manufacturing and turnaround time and where this may go in the future, and maybe also touch on the idea of kind of low dose three day turnaround, Yescarta.

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. So so for the existing products we have today, the improvements in manufacturing, a lot of it comes from automation, so becoming fully automated. Our Maryland production facilities are state of the art, and they operate primarily in fully automated. And we’re bringing fully full automation versus semiautomation into in into some of the other production facilities. So that’s a way we can make improvements, and we can make improvements on the back end on sterility testing.

We learned so much during COVID. If you remember, we took sterility testing from seven day plating to, like, one day turnaround on sterility testing. So we’re applying a lot of the COVID technologies to the back end of our analytics and and testing side. The second piece you brought up, we’re super excited about. And so we have developed two products that look at a three day manufacturing.

So today, manufacturing is anywhere from five to seven days of the product. And when you look at three day manufacturing, you end up with more juvenile cells, so more naive cells, and these are more potent cells. And so one of the components of our next gen products in lymphoma is that we have two constructs, one that looks that’s just like Yescarta that has a three day manufacturing process, and then we have bisistronic, which is a c d 19 c d 20. So it’s two targets and two costimulatory domains, c d twenty eight and four one b b, and that’s in three day. We have one that’s six day and one that’s three day manufacturing.

We’re gonna show the six day data at ASCO in just a couple weeks and then again at EHA and ICML. But the three day manufacturing, it allows you to go in with anywhere from one tenth to one twentieth the dose. So really low doses, but showing very similar potent efficacy and much better safety. And so if you think about going from a six day manufacturing to a three day manufacturing, right there is a savings in in the manufacturing time. So we’re, we’re looking forward to sharing, data in

Unidentified speaker: the future on those on those products. Excellent. And and maybe speaking of the the the biocistronics, can you talk about maybe some I I I know it’s been tried before, but you guys have some unique elements with these, specific co stim domains that are, I guess, independent coupling with the c d 19 and c d 20. Can you talk a little bit about the the properties of the construct and then kind of what you’re seeing profile wise in terms of cell expansion and persistence relative to, the sort of the first gen c d 19?

Cindy Peretti, Executive Vice President of Kite, Kite: Look at you. You need to come to ASCO and be our our, press for us. So on the costimmit, the the dual targets that we have, the bisistronics, we have done these we call it a bisistronic construct. You really have two cars that are pulled together by a linker. You’ll also see in this space tandem constructs, so they’re one construct with two two targets.

And what we found in our own hands and others may find different is when you do tandem, you only have so much our research head always says you only have so much re sorry. You only have, essentially, so much that you can pack into a single car, so much real estate on that car. And so by doing a single car in tandem, it’s harder to get two targets in there most effectively and even harder to get great transduction efficiencies. So we went with Bisistronic, so c d nineteen and c d twenty. C d 19 has the c d 28, so it gives you the sort of punch that you get with Yescarta, which is the the rapid cell proliferation.

But it’s actually when I say rapid, it’s muted just slightly. You get to the same peak, but you get to it over time because of the four one b b costimulatory domain. You you end up with the same number of cells, but the growth comes over a three day period versus a twenty four hour period. And why is that important? It’s super important as it comes to safety.

So you wanna get to the efficacy level where you have the same number of cells being produced, but doing that persistence component of having it over time and having it hang around longer is what we’re seeing with the four one b b. So we get a little bit of the best of both worlds. If you have a chance at ASCO, we’re showing our bisistronic construct with our six day manufacturing. It’s called three six three. And the goal of the bisastronics for us have been we need to improve on efficacy versus Yescarta and existing products, and we need to improve on safety.

So we’re looking at both, improvements on both, and we’re looking forward to sharing all of that data with you.

Unidentified speaker: Excellent. You’ve talked a little bit more about potentially going into I and I with the with CAR Ts, and I know it’s been an area where, you know, it’s been tried. There was some initial initially, a lot of excitement, and then maybe the next rounds of data hadn’t necessarily lived up to the initial enthusiasm, and there’s been challenges enrolling patients and finding the the right patients and indications. So can you talk about your interest in expanding the Bisostronics to I and I indications? What your current plans are?

When we might see the readouts there? And how you maybe overcome some of the challenges? Like, do you have some data that you’re seeing on B cell depletion inhibition that gives you confidence you’re going to be at a level that’s more successful or or or and or are there certain indications that you will be going after that you think maybe others have not pursued that where where you think that’s the most opportunity?

Cindy Peretti, Executive Vice President of Kite, Kite: Yeah. And and similar to sort of hematologic landscape, if you think about rituximab, it’s used both in autoimmune that c d 20 target, I think about Ocrevus and multiple sclerosis. We know that c d twenty is active in autoimmune diseases, so that’s one of the main reasons we decided to look at the c d 19, c d 20 construct because we think having the opportunity to hit both, particularly if you have patients that end up having one or the other muted, you have a you have a second chance, and that applies to oncology as well. But, and then as as I look at the construct and I described, we’re putting our day manufacturing, the three sixty three, the data we’ll share in hematology at ASCO. We’re putting that into we filed the IND, and that’s going into the rheumatologic malignancies or rheumatologic malignancy rheumatology indications now.

And and our belief really is to test that hypothesis is what is c d twenty adding. The second piece is I described the two costimulatory domains about reaching the same peak number of cells but reaching it over a slower period, that matters in autoimmune disease. I mean, these are patients who are living with a chronic disease. We don’t wanna see safety signals in the line of what you would see in an oncology patient. It just won’t be tolerated.

And so that was another component of why why we wanted to look at our bisistronic our bisistronic compounds. Yeah. Okay. Yep. And so we started a rheumatoid.

We filed an IND. We’re starting a basket study where we’re looking at lupus, both SLE and lupus nephritis. We’re looking at myositis, and we’re looking at scleroderma. And we’re in the process of filing a second IND where we would have, we will look in neurological conditions, both myasthenia gravis and MS, and both of those we know have a c d twenty component to it, and that’s why it made sense to look at the bisistronics there. Great.

Unidentified speaker: And when might we see any initial hints of those data, do you think? Is that sort

Cindy Peretti, Executive Vice President of Kite, Kite: of a They’re just getting started, so we’ll keep you posted. As you said, it’s about, it’s become a crowded space, so we’re looking at running our trials, in a global setting in The US, Europe, and Asia just to make sure that we can get a diverse patient population and understand, not see differences, not end up having not seen differences early in

Unidentified speaker: the phase one. Good. Just in the last thirty seconds, anything that we didn’t touch on on the cell therapies that we should be keeping an eye on or that’s maybe under investors’ radars, but we should

Cindy Peretti, Executive Vice President of Kite, Kite: be I would love to put in a plug for solid tumors. So we have an oral coming up at ASCO in in a week in the glioblastoma space. So we have put together a construct with our colleagues at Penn that is looking at a dual CAR, which is an EGFR and an IL thirteen RA that we are testing in glioblastoma. I think we’ll be sharing somewhere between fifteen and eighteen patients worth of data there. These patients are heavily treated glioblastoma patients probably coming up on second and third line end of life, unfortunately.

But the patients the therapy is delivered through an myo port into the brain. You don’t have to lymphodeplete the patient. It stays within the CNS. And so, hopefully, you’ll have a chance to come see that data. We are working on a version two of that construct because we recognize from the data we see in phase one that we need a little more persistence.

We want it to hang around in the CNS and still not have to lymphodeplete the patients. So we’re putting armoring on that TGF beta armoring, and we’ll be testing that second construct in the coming year. But solid tumors are possible now.

Unidentified speaker: We’ll we’ll look we’ll look out for that data in the coming weeks for sure. Cindy, thanks again. Fantastic to have you here. Thanks. Thanks, everyone.

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