Allogene Therapeutics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 2, 2023

There are 19 speakers on the call.

Operator

Thank you for standing by and welcome to Allogene Therapeutics Second Quarter 2023 Conference Call. Please be aware that today's conference is being recorded. I would now like to turn the call over to Christine Casciano, Chief Communications Officer, Ms. Castellano, please go ahead.

Speaker 1

Thank you, operator, and welcome to our call. Today, after market close, Allogene issued a press release that provides a business update and financial results for the Q2 of 2023. This press release and today's webcast are both available on our website. Following our prepared remarks, we will host a Q and A session. We ask you to limit your questions to 1 per person as we will keep this call to an hour and do our best to get to as many questions as possible.

Speaker 1

Joining me today are Doctor. David Chang, President and Chief Executive Officer Doctor. Zachary Roberts, Executive Vice President of Research discussion, Development and Chief Medical Officer and Doctor. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward looking statements.

Speaker 1

These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, Future research and development efforts, manufacturing capabilities and 2023 financial guidance among other things. These forward looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward looking statements and Allogene disclaims I'll now turn the call over to David.

Speaker 2

Thank you, Christine, and thank you for those joining the call today. During the Q2, we presented updated Phase 1 data on our lead allogeneic CAR T program targeting CD19 for relapse We are immensely proud that our off the shelf product candidate has shown the ability to generate Durable complete responses that by all accounts appear to be similar to approved Othala's CAR T therapies. This is a significant milestone for the field and represents a great opportunity to reflect on the current state of CAR T, On the allogeneic CAR T field at large, I will then ask Zach to talk specifically about our CD19 program, Including reviewing the data presented in June at the American Society of Clinical Oncology, European Hematology Association During the Q and A, we will welcome questions on other programs within our pipeline. First, let's talk about the field of cell therapy. As Autonomous CAR T franchise report Increasing sales and detailed initiatives to address manufacturing constraints, some ask if there is a place for an allogeneic product.

Speaker 2

Indeed, as one of the early developers of Autolus CAR T therapy, I am proud that this modality has become a commercial success A fundamentally different modality with properties that are inherently more attractive than autologous CAR T therapy And therefore capable of actually changing and expanding the landscape of CAR T access. Perhaps the most fundamental difference between the OTOYS therapy and an allogeneic product is that the former represents an individualized As autologous CAR T therapies move into earlier lines, The potential patient population that is eligible for therapy will undergo dramatic expansion And companies producing therapies at linear scale will be hard pressed to keep up with accelerating demand. Today, in the market for refractory lymphoma and myeloma, we are seeing that only a fraction of eligible patients can Patients who cannot readily secure a manufacturing slot, patients with rapidly progressing disease For patients who cannot undergo successful collection of cells. Also, as CAR T therapies move to earlier lines, Patients now need to be referred from the community based oncology centers to specialized CAR T centers, Which leads to yet another potential delay. By 2,030, it is estimated To put this figure in perspective, it is estimated that approximately 10,000 patients will receive CAR T therapies in 2023.

Speaker 2

Several autologous providers are making large investments in manufacturing infrastructure and delivery that are designed to increase capacity. These companies are now forecasting the ability to perform as many as 10,000 individual manufacturing ones in a few years' time. But even if successful, the forecasted supply is dwarfed by the number of patients who could benefit from treatment. The unfortunate outcome is that even under more optimistic forecast for capacity expansion, There will be far more patients without access to this modality than those who can be treated. Adding more and more linear Manufacturing is simply not a viable model for serving an increasingly large addressable market, which will Most likely lead to a scented market and patients without access to a potentially life saving treatment.

Speaker 2

My next point of reflection focuses on the innovative nature of allogeneic CAR T product. The $1,000,000,000,000 biopharmaceutical industry is based on very few therapeutic modalities. Often new classes of drugs are met with skepticism or even disbelief. In 2012, KITE and National Cancer Institute entered into Cooperative Research and Development Agreement for CRADA that would ultimately lead to the approval of ESKATA. But what many forget or may not know is how many biopharmaceutical companies will first offer the same opportunity as Kite, The development of Autales CAR T therapies, now a multibillion dollar industry was a lonely endeavor.

Speaker 2

The cacophony of naysayers and the development challenges that needed to be overcome required an undoubted belief in the science. As the year progressed and wealth of data on this new modality accumulated, there was a shift In attitude towards Othala's CAR T therapies. History doesn't repeat itself, but it often rhymes. We are very excited to see progress not just from Allogene, but others who are developing allogeneic CAR T products. We view this as a sign that the viability of the modality is becoming increasingly evident.

Speaker 2

The more companies that enter the arena with promising approaches, the more investment we see from large pharma companies, The better it is for the field. The work we have done to progress our clinical trial has allowed us to accumulate The learnings that must come from the Phase I trial are often hard won, But the outcomes we have seen in our recent data set makes it clearly worthwhile and keep us excited for what is to come. They can start treatment within days and without the need to undergo leukapheresis or bridging therapy. An allogeneic CAR T product provides 1, if not the only way to broaden the use of CAR T therapy, Making the delivery of therapy much easier and convenient for patients and their treating physicians. Ultimately, I believe the convenience of an off the shelf allogeneic CAR T product is the only way to introduce While preserving the potential for a one time treatment, an off the shelf option that is free of the hassle With that, now I would like to turn the call over to Zach.

Speaker 3

Thank you, David. As we have noted in previous calls, some of the biggest questions facing allogeneic CAR T development Whether an off the shelf product can induce durable complete remissions. At the American Society of Clinical Oncology Annual Meeting, the European Hematology Association Congress and the International Conference on Malignant Lymphoma in Lugano, we shared long term durability data from our Phase 1 trials Answer these very important questions and substantially reinforce that our off the shelf CD19 AlloCAR T product candidates At ASCO, with an EHA, we presented an updated analysis The ALPHA and ALPHA II trials focused on patients who received the regimen that is being deployed in our potentially pivotal Phase II trial. These 12 CAR T naive patients with relapsed refractory LVCL received a single dose of ALLO-five zero one Standard low doses of fludarabine and cyclophosphamide plus 90 milligrams of ALLO-six forty seven. The median time from enrollment to the start of therapy was 3 days And as of the April 20, 2023 data cutoff, all 12 patients were followed through a minimum of 6 months.

Speaker 3

7 of 12 patients or 58 percent achieved a complete response and 5 patients or 42% maintained a CR through month 6. Of the 5 patients who are in CR at 6 months, 4 or 80 percent had an ongoing remission. The 5th patient had disease progression at 24 months. The median duration of response was 23.1 months with 3 patients remaining in remission for over 24 months And the longest remaining in remission for over 31 months. To put these data in context, our CR rate of 58% can be viewed in light of approved autologous CAR T therapy CR rates that range from 32% to 54% per label.

Speaker 3

Of course, the appeal of CAR T therapy is that complete responses can be durable. Our CR rate at month 6 of 42% compares favorably with autologous CAR T as their rates range from 29% to approximately 40%. At the meeting in Lugano, we presented data from all 33 patients with relapsed refractory LBCL who received ALLO-five zero one or 501A We received either lower doses of ALLO-six forty seven or 2 infusions of ALLO-five zero one or 5018 spaced approximately 1 month apart in our consolidation regimen. Across these 33 patients, 100 percent of patients received product per specifications. No patients received bridging therapy.

Speaker 3

In these 33 patients, ACR was achieved by 14 patients or 42% of whom 10 maintained a complete response at month 6. The median duration of response in these 33 patients was also 23.1 months, demonstrating that we could still achieve results within the parameters established by We also observed robust CAR T cell expansion and persistence in patients, Particularly in responders, arguably a first for an off the shelf allogeneic cell product. In all presentations, our safety analysis included all 33 CAR T naive LVCL patients who received alloy product. Treatment was generally well tolerated with no incidences of Grade 3 or greater CRS and no cases of ICANS or GvHD. Cytopenias and infections were manageable and comparable to the experience with autologous CAR T therapies in patients with relapsed refractory LBCL.

Speaker 3

We showed patients neutrophil and lymphocyte counts beginning to recover within the 1st month of infusion and achieving baseline levels with kinetics similar to autologous cell therapies, providing additional insight into our comparable infection rate. Our data are the first to demonstrate the potential of an allogeneic CD19 CAR T To induce durable complete remissions and set the stage for a potentially competitive profile to approved autologous CD19 CAR Ts. Our focus now turns to 2 important objectives for this program. The first being enrollment in the ongoing Phase II ALPHA-two trial, We hope to definitively establish the potential of this new modality. We are very pleased to have extended enrollment in this trial into Canada And expect to begin enrolling patients in Europe in Q3 and Australia before year end.

Speaker 3

We also continue to focus on enrollment in our Phase 2 EXPAND trial, Which is designed to demonstrate the superiority of ALLO-six forty seven containing lymphodepletion regimens over a regimen of flucyalone. In parallel, we are working through a trial design strategy that could support regulatory approval in earlier line LBCL. We believe our proposed approach may be particularly advantageous and look forward to sharing more detail on this strategy by the end of the year. We believe our success to date where others may have fallen short is attributable to our ability to support the expansion and assistance of our allogeneic CAR T cells necessary to achieve durable tumor elimination. The preponderance of data we've already presented from our CD19 program point to an improved clinical performance when we include ALLO-six forty seven, our anti CD52 monoclonal antibody with standard low doses of blue side.

Speaker 3

Our platform enabled by ALLO-six forty seven permits an extended window of CAR T cell expansion and persistence. What ALLO-six forty seven does cannot be reproduced even with high doses of chemotherapy that might be associated with severe toxicity. We are now focused on applying a rigorous approach to explore the boundaries of what works as a best practice to enrich our understanding of CAR T cell expansion and persistence As we investigate next generation technologies, including DAgger, which is currently being utilized in our ALLO-three sixteen anti CD70 solid tumor trial. I will now turn the call over to Eric.

Speaker 4

Thank you, Zach, and good afternoon, everyone. I'd like to begin by acknowledging that today is my last day at Allogene, a very bittersweet occasion. The past 5 years have been rewarding, exciting and fun. They provided new challenges, allowed me to build life changing relationships and perhaps most intriguingly opened my eyes to side of the industry that I could not have previously fathomed. I respect for what management teams must do and the complexity of decision making and drug development It has truly been a privilege to serve as the CFO of Allogene.

Speaker 4

I look forward to spending more time in New York with my family. Allogene will forever be a part of me. I am thankful to David and the team for the trust and the opportunity they have accorded me I look forward to following the company's progress as it turns the promise of AlloCAR T into a reality for patients. Now on to our financials. I am pleased to share that our balance sheet remains very healthy.

Speaker 4

We ended June 30, 2023 with 500 and $44,500,000 in cash, cash equivalents and investments. In addition to our efforts to ensure operational efficiency, We raised net proceeds of approximately $88,000,000 in the 2nd quarter from our at the market or ATM equity financing facility. Based on our current expectations, we believe we have extended our cash runway into the second half of twenty twenty five. In the Q2 of 2023, our research and development expenses were $62,000,000 which includes $6,900,000 of non cash stock based compensation expense. General and administrative expenses were $18,500,000 For the Q2 of 2023, which includes $9,700,000 of non cash stock based compensation expense.

Speaker 4

Our net loss for the Q2 of 2023 was $78,000,000 or $0.53 per share, including non cash stock based compensation expense of $16,600,000 We continue to expect a decrease in cash, cash equivalents and investments Approximately $230,000,000 in 2023. We expect our full year 2023 GAAP operating expenses to be approximately $340,000,000 which includes estimated non cash stock based compensation expense of approximately $80,000,000 This guidance excludes any impact from potential business development activities. With that, we will now open the call for your questions.

Operator

Our first question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open.

Speaker 5

Great. Good afternoon, guys. Thanks very much Congratulations, Eric, on all that you helped the company achieve during your tenure at Allogene. With that said, my question is, I'd like to ask you to elaborate on the pace of enrollment in Alpha-two And whether you've seen an increase in the pace of enrollment, especially with all the recent conference presentations?

Speaker 6

Hi, Tyler, it's Zach. Thanks for the question. So the guidance that we have provided is that we Going to change over time, we always expect to see enrollment pick up towards the end of the enrollment period. That is very standard for clinical trials. Additionally, we have gotten approval by the EMA to open sites In Europe and we expect to do that in the coming weeks and furthermore plan to add Australia to the roster of enrolling sites by the end of the year.

Speaker 6

So All signs are pointing in the direction of momentum building in terms of geographies coming online, and we expect to have the study enrolled by the end of first half.

Operator

Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Speaker 7

Good afternoon.

Speaker 8

This is Anna Mid on for Salveen. Just a 2 part question from us. As you clearly described

Speaker 9

in the prepared remarks, it

Speaker 8

seems like the supply situation with remarks in the prepared remarks, it seems like the supply situation with autologous CAR T is improving, especially with respect to BCMA CAR T. I guess in this context, how are you thinking about the competitive landscape given the ongoing optimization that's required for ALLO-seven fifteen? And then In the lymphoma space, I guess in the context of the recent data that was presented from Caribou's CD19 program, which is also starting to evaluate the asset in earlier line patients? Thank you.

Speaker 2

Yes. This is David Chang. Let me take the first question on the BCMA, and I'll ask Zach, to comment on the competitive data. In terms of the Otalis CAR T supply, I mean, we are definitely hearing what

Speaker 9

What you're hearing is

Speaker 2

that, pharma that are in this space is putting a lot of effort to increase the manufacturing capacity. And along with that, I think there has been some improvement in reducing the out of spec, which also leads to Not being able to provide commercial materials to patients. I mean, certainly, that is happening and we were expecting that to happen. But the pace of that is how it's happening as we are following is as expected. There will be a lot of ramp up time that's needed.

Speaker 2

Now that leads to, I think, what you are really asking about The manufacturing process, I mean, certainly, we always knew that manufacturing is one of the key components of Making the cell product viable and also maintaining the level of efficacy that we are hoping to do. So We're making a good progress and we are continuously reviewing what we will be doing with the BCMA program As we complete the manufacturing review. Zach, on

Speaker 6

the CD19? Yes. So, great question about the Caribou update. Overall, we were very pleased to see another sponsor present data supporting We see that this is a very validating milestone for the field and having been at this now for 5 years and arguably some of the most experience in this field, we are very Proud to see an additional person join this field, but we also stand very much by the data that we presented this summer as part of the overall and growing experience

Speaker 3

in off the shelf ALLO CAR T cells.

Operator

Thank you. Our next question comes from the line of Michael Yee with Jefferies. Your line is now open.

Speaker 7

Hey, guys. Thanks for the question. One of the things that comes up is the Use of CAR T after Yescarta and since there's uncertainties about that, one could Envision that your product would be an obvious fit earlier lines, particularly given off the shelf. To do that, you would need to run a second line study. You suggested you would give us some tidbits and some insight into how you would Are there things relevant to sort of having to make progress on 3rd line?

Speaker 9

Would you

Speaker 7

have the money to do that? Could a pharma company help you out a lot easier? Maybe just talk through the different challenges of second line, how you should think about that because I would think that's even more important than third line? Thank you. Mike,

Speaker 2

let me take the first Part of the question, you were asking all important and excellent questions. And I'll ask Zach to comment on the In a study design, which is very much on track. In terms of the earlier I think that's really the opportunity of the cell therapy to maximize the benefit one time treatment that can potentially lead to something that's similar to cure where Successfully treated patient no longer requires a second, third or subsequent lines of therapy. I mean that is really the In the Holy Grail of what we are trying to do in the oncology space. And when we think about how the patients are Not in the tertiary centers, but in the local oncology infusion clinics and local oncologists.

Speaker 2

So this is where we also see the benefit of off the shelf allogeneic CAR T really shining. And that's Where we are trying to march as we think about our CD19 program beyond the current refractory and relapse In the 3rd line setting, previously we've been guiding that we will work with the investigator to finalize the study design, Get regulatory input from the agencies and then look for launching the study sometime in 20 24, that plan still holds. In terms of study design, let me ask Zach to comment on that. It's very early, but

Speaker 6

yes, thanks Mike for the question. So I think the premise of it is spot on. I You look across CD19 and also BCMA and what we're learning is that for as powerful as these therapies are in relapsed Obviously, the numbers of patients are greater there. So we have been keenly focused on coming up with a study design in earlier lines that I think will Play to our strengths and also serve an unmet need that exists in that second line. And we're not quite ready yet to share A lot of details on this study.

Speaker 6

We hope to be able to do that by the end of this year. But suffice it to say, we think that this is a great opportunity for the field and for Allogene in particular.

Operator

Thank you. Our next question comes from the line of Brian Chiang with JPMorgan, your line is now open.

Speaker 10

Hey, guys. Thanks for taking my call. You mentioned that you're thinking of combining CARs with the DAKR technology in human solid tumors, just as you need to be efficient on resources, since most of your focus today is now on CD19, how does the potential exploration

Speaker 2

Brian, Dave Chang here. Today, I mean, you guys are really asking excellent questions. I mean, when we think about the allogeneic, Danae, I think this is something that we can say for the cell therapy as a whole. This is still very early stages of Cell therapy, we are in right now. And the potential of cell therapy is ability to engineer the CAR T cells, in this case, Through the available technology, whether it's a lentibiral gene transaction, and that's essentially what the autologous cell therapy players are doing How the field has evolved to include gene editing, possibly multistep Gene engineering, including site specific integrations, etcetera, etcetera.

Speaker 2

And that's really the Holy Grail of cell therapy that Not just us, everybody in the allogeneic cell field is trying to accomplish. So in that context, We don't necessarily see the programs that we are advancing as the answer to all the solution that we are trying to provide And Advance is Field. I mean, some of the things that we internally discuss is not just how to make the cells work better, but also And that's where the concept of next generation such as the DAGR technology comes in. The question about how much can we do in the current environment where the spending is highly scrutinized It's a very good one. I mean, Mike was asking the same question.

Speaker 2

And this is something that we are trying to address through the prioritization as well as Trying to do things as efficiently. And also in this is another in a situation where any kind of partnership

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.

Speaker 1

Hey, guys. This is Kelsey on for Michael. Congrats, Eric, on your last today, but sad to see you go. I just had a couple of quick questions. I guess, first, building on your prepared remarks, David, There's a small percentage of eligible patients actually getting CAR T and we hear a lot about capacity, specifically in myeloma, of course, are early in the launches, but I guess for DLBCL, is capacity still the biggest limiting factor or is it something else?

Speaker 1

And then maybe building on that last question, how does kind of the Notch partnership fit into, kind of the stricter capital allocation? Thanks so much.

Speaker 2

Yes. The question about what's happening in autologous, I think, truthfully, We follow what the large companies in this space release the information on the quarterly basis. Only about 30% of the eligible patients are receiving CAR T therapy. I mean that remark was made in 2022. Now in 2023, there may have been some uptick on the percentage of patient eligible patients who are getting the CAR T.

Speaker 2

And we are also looking in terms of the quarterly earnings release and how much the revenue has gone up and trying to triangulate How much of that is due to earlier line usage versus further penetration in the 3rd line? On top of that, we will talk not only with the CAR T experts but also other hematology oncologists, especially at the centers that do not have Be reminded CAR T is only used in the certified centers and the number of certified centers that can administer commercial supply It's still limited. So my comment as well as answer to your question is I mean, Natchez is doing something incredible, trying to differentiate the iPSC Leveraging the power of iPSC, we are sensitive in terms of time horizon, but that technology can really be scaled up And be realistic in terms of introducing the clinics. And this is an area that I'm always humbled by How difficult it is, I mean, back in 2015, 2016, I thought in next 7 to 10 years, iPSC will be more or less in the mainstay of the CAR T. We are about 10 years from That time and still I think it's several years before the iPS derived CAR T therapy can be in the clinics.

Speaker 2

I mean the future is definitely there, but I think it's just taking a time and we are definitely putting that into context of how we are partnering and working with the notch.

Operator

Thank you. Our next question comes from the line of John Newman with Canaccord. Your line is now open.

Speaker 11

Hi, guys. Thanks for taking my question. So you mentioned that you're going to be Enrolling patients in the pivotal study in Europe and Australia here. I think Europe shortly and Australia by the end of the year. I'm curious if you could talk about whether or not there's any difference in the availability of the autologous CAR T therapies there.

Speaker 11

The

Speaker 6

Yes. So we know that the utilization of CAR T generally in those regions is Significantly less common than it is in the United States. And obviously, we expect that over time that will change. And As additional pivotal data sets come to the table and regulators begin to Approve these therapies and payers get on board as well. The whole field is moving towards utilization of CAR T in third line and in second line.

Speaker 6

But these regions are significantly behind the United States. So there is plenty of patients in both of those regions Where the unmet need in third line is substantially higher than it is in the United States. So we feel that it And have felt for a long time that it's made a lot of sense to broaden the footprint and be able to bring on those patients that are Whose needs are not being met by current standards in those ex U. S. Regions.

Operator

Thank you. Our next question comes from the line of Jack Allen with Baird. Your line is now open.

Speaker 12

Great. Congratulations to the team on the progress. Eric, congratulations to you on all of your accomplishments over the last 5 years. I'm going to try to do my best to put you to work on your And I wanted to talk for a second about the Seviate relationship. Could you remind us maybe how things stand as it relates to Seviate?

Speaker 12

And I'm seeing in the 10 ks that or the 10 Q that you received very de minimis payments from Citi in the last couple

Speaker 6

of quarters here. Do Do you expect

Speaker 12

that those payments could be higher as you move into the European region with the ALPHA-two study? And what's baked in as it relates to the cash runway guidance surrounding Sevea

Speaker 4

Jack, thank you very much for the kind personal comments and the question. It's good to hear your voice. And I think you must have studied more French than I did in high school because your pronunciation of Servier is spot on. We continue to have a little bit of a challenging relationship with Servier as we've discussed previously and in our SEC filings. There are disputes over certain aspects of our collaboration, as you noted, there are disputes over cost recoveries, which we believe we're entitled to, As well as our ability to opt into ex U.

Speaker 4

S. Development in the future date. So At this point in time, rather than to delve into legal matters, I'll just leave it to what's going to be published in our 10 Q in terms of the update. And And hopefully, we'll be able to find an allocable solution going forward.

Operator

Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open.

Speaker 13

Hi, this is Karina for Asthika. I had a question on ALLO-seven fifteen. I know you guys are looking just wanted to know if you guys are looking to change the cytokines used to get more of a CARB Xuelike efficacy, if you can share some color on to give tighter guidance on the timing as well, that would be great.

Speaker 2

Yes. Karina, there are multiple things that we are doing with the manufacturing process review. And As your question has pointed out, cytokine is an important aspect of what we are reviewing Without going into further details and in terms of timeline of what we'll say about our BCMA program, Let's defer that till we complete the review and decide what we will when we will think about introducing back into the clinic.

Operator

Thank you. Our next question comes from the line of Talpreet Patel with B. Riley. Your line

Speaker 14

is now open. Yes. Hey, good afternoon. Thanks for taking the question.

Speaker 6

One more on the enrollment.

Speaker 14

Could you please Comment on how many additional clinical sites you expect to include for the EXPAND trial? And is the guidance still

Speaker 6

Yes. Thank you for the question. So we haven't gone into exacting detail on the number of sites for either Alpha 2 and Xpand. We are continuing to bring on sites in North America for Xpand, as you know, this is a relatively newer trial than ALPHA-two. So we didn't have the benefit of long standing relationships with Phase 1 sites there.

Speaker 6

So everything is starting from scratch. But sites are coming online as we speak. And similar to the plan for Alpha-two, we also intend to bring expand into Both EU and Australia. And the last point that you asked about is still correct. Yes, we do expect to have data for Xpand coming at roughly the same time as Alpha

Operator

Thank you. Our next question comes from the line of Sami Corwin with William Blair. Your line is now open.

Speaker 1

Hi, there. Thanks for taking my question. Given that the current commercial CAR T therapies are commercialized by Large pharma players are through partnerships with large pharma. I guess, how are you are you thinking about commercializing ALFA-five zero one alone? Or do you think you'll need Commercial Partner.

Speaker 2

Yes. Sami, let me take that great question. I mean, that's something that we are internally But I think it's a little bit too early for us to say one way or the other.

Operator

Thank you. Our next question comes from the line of Luca Izzi with RBC Capital. Your line is now open.

Speaker 15

Great. Thanks so much for taking my questions. Maybe Zach, if I may circle back on a prior question, can you just talk a little bit about your enrollment projections for ALPHA-two versus EXPAND? What gives you confidence if you can complete enrollment of both trials in the first half of twenty twenty four? It feels to me that enrolling, expanding much harder than enrolling out the 2.

Speaker 15

I would love to hear your thoughts on that. And then Eric, thanks again for all your help and all the best in your next chapter.

Speaker 6

Thanks, Luca, for the questions. This is Zach. So, we the enrollment of each study is ongoing currently, as we've said. We've guided to completion of enrollment of Alpha-two by the first half of next year. We actually haven't specified exactly when we expect to to complete enrollment, but based on the study designs of these two trials, we our current projections are that Between the fewer patients that are required to enroll and expand as well as our belief The endpoint will actually take less time to come about with that study that we do think that those data sets will be available at roughly the same time.

Operator

Thank you. Our next question comes from the line of Tony Butler with EF Hutton. Your line is now open.

Speaker 16

Thanks very much. David or Zach, I wanted to go back to DAGR, if I may. I understand that There is a diagnostic being employed at this time. The question is in Doctor. Srower's presentation And number 2 is the data for efficacy.

Speaker 16

I'm not asking about, but what I am asking if It's possible for you to make any statements because the data were so in my opinion, were so good and the side effect profile was Very consistent with other studies, but importantly, was there minimal fatigue and syncope and or minimal CRS As was demonstrated at the lower doses. And finally, Eric, thank you very much. And again,

Speaker 6

Thank you for the question. So, We are as we said at AACR and it's still true today, we are continuing with the dose finding, dose exploration Part of this trial, I don't want to get into details about how many patients have been treated at each dose beyond what has been shared publicly at AACR. We do expect to be able to share additional information from this trial later on and we're continuing the enrollment Now and other than that though, I very much agree with your assessment that the data that was shared at AACR certainly is compelling And superior to what these patients could expect from standard of care.

Operator

Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer. Your line is now open.

Speaker 7

Great. Thank you. Thanks for the question. And also good luck, Eric. I have not known you, but best of luck.

Speaker 7

The question I have is just when you read out Alpha 2 later in 2024, I was just wondering What's out there in terms of a comparison or what are you looking for that would give you comfort In your discussion with the FDA to sort of enable BLA looking activity BLA enabling activities, Whether it's response rates and duration of response, I mean, what's the sort of ballpark figures you're thinking about or that would make you comfortable? And then just a minor follow-up to a previous question, which is that are you dosing patients alpha-two from your commercial facility? Thank you. Thanks for the question.

Speaker 6

So maybe I'll take the first one. So I think Primarily what's giving us comfort about the Phase 2 program is all of the experience that we have from Phase 1, which was really again brought to the surface

Speaker 3

In June

Speaker 6

at the various conferences where we shared data, feedback there and since has been overwhelmingly positive from investigators, both Those that are involved in the trial and those that are not. And so those are in patients that meet the eligibility criteria for our Phase 2 program. And so that's sort of our view going forward. And I don't want to get into specifics about conversations with FDA, but

Speaker 2

Yes. So the second question is about patient dosing. And as we have previously communicated, the patients are currently being dosed From the materials that our contract manufacturer has produced and the way that we have treated

Operator

Thank you. Our next question comes from the line of Kishore Gengangari with JMP Securities. Your line is now open.

Speaker 9

Hey, this is Ren Benjamin. Can you hear me?

Speaker 4

Hi, Ren.

Speaker 9

Hey, thanks for taking the question. I don't know where they got cut short from, but Eric, all the best in your future endeavors. The question that I have has to do with ALLO-three sixteen. I view that as kind of like the next main value driver And driver of shareholder value, I'm kind of curious, as you're looking at the in vitro companion diagnostic, Can you talk provide a little bit more color regarding this? How invasive is the process?

Speaker 9

Are you identifying patients In the real world that's kind of different than what you might have predicted from epidemiological studies. And I guess finally you expect dose escalation complete by the end of 2023, but how many patients do you think you'll have by the end of the year? Thanks.

Speaker 6

So the first question on the companion diagnostic, I can tell you that it is not I mean it's a biopsy, but we're allowing Biopsies that were taken prior to study enrollment for evaluation. So some patients are requiring fresh biopsies if there's no prior material that is accessible, but many others are just giving us blocks from their original diagnosis or recent operation of biopsy. So In that regard, it's no more invasive than any other sort of tissue assessment that occurs every day in oncology. And then the second question the second part of that question was, are we seeing differences in the results of these tests What we would have expected from the literature, the answer to that question is no. What we're finding is very consistent with the literature.

Speaker 6

So there's been no surprises there. As far as the second question, the number of patients, again, I don't want to get too into the weeds here on what Setting expectations for the future updates, but we have the interest in this program is very high and that was again Spiked after the ACR presentation, it's remained high ever since. And so, there's been an abundance of patients who are interested and abundance of Investigators who are interested in putting patients on to the trial.

Operator

Thank you. Our next question comes from the line of Jason Gerberry with Bank of America Securities. Your line is now open.

Speaker 12

Hey guys, thanks for squeezing me in. So just had a question for David. Wanted to come back to earlier comments just about the challenges that Autologous Cartese faced in sort of linear scaling manufacturing And really wanted to get your perspective on what you see as like the biggest impediment to the autologous approaches moving forward with like decentralized point of sight model Like it's being explored by companies like Galapagos, like what do you see as sort of the biggest hurdle to operationalizing that and scaling? Thanks.

Speaker 2

Yes, great question. I do have same questions, exact questions that you are asking. I mean, obviously, I have to How different companies are thinking about to advance the autologous South Turk and the sort of Quick Manufacturing or Point of Care Manufacturing sometimes comes up. Obviously, these are early days and I don't have a clear picture about how that's going to play out. But when you think about autologous cell therapy, there are multiple dimensions.

Speaker 2

One is, It has to be manufactured 1 at a time. Patients have to undergo leukapheresis and as As well as the waiting for like any other products that are used in human, all the release test that has to be part of The manufacturing process before the product can be used in human. And I think all these things provides In my view, somewhat of a barrier to really realize the full potential of the CAR T therapy and that's where the value proposition of the allogeneic cell therapy is coming.

Operator

Thank you. Our next question comes from the line of William Pickering with Bernstein. Your line is now open.

Speaker 17

Good afternoon. Thanks so much for squeezing me in. In your ALPHA-two study, how much outpatient dosing have you seen so far in the trial? And what are your expectations for how common that might potentially be in a commercial setting. And if I can maybe just ask one more, What are your expectations for the time horizon for an allogeneic therapy to be rolled out at hospitals that don't administer autologous CAR T today, such as community hospital basically trying to understand when you might be able to access some of these market segments where you're not competing head to head with autologous?

Speaker 17

Thank you.

Speaker 2

Hey, Bill, great question. In terms of our patient dosing, the ongoing studies do allow that. I mean, at this point, as we treat more patient, we'll be able to provide more information, but I think it's relatively too early. And in terms of the second question about allogeneic in the patient setting and all that, I mean, I think that's a direction that we want to take our programs to. So at this point, it's still early, so stay tuned.

Operator

Thank you. Our next question comes from the line of Ben Burnett with Stifel. Your line is now open.

Speaker 18

Hi, this is Carolina Ibanez Ventoso on for Ben Burnett. Thank you for taking our question. A follow-up on the in vitro companion diagnostic you have designed for ALLO-three sixteen, You mentioned that this tissue based, is this IHC type assay? And Wondering if you are planning to conduct a centralized diagnostic assessment and would appreciate also if you can talk

Speaker 6

So it is an IHC based assay and so it does give us an opportunity to address and understand and score the heterogeneity, so we've taken that into account in the development of the assay.

Operator

Thank you. That concludes our question and answer session. I would like to turn

Speaker 1

the conference back over to

Operator

management for any additional comments.

Speaker 2

Thank you very much for joining our call today. We are thrilled that our off the shelf CD19 AlloCAR T data continues to demonstrate both great promise in Operator, you may now disconnect.

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Earnings Conference Call
Allogene Therapeutics Q2 2023
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