Q3 2025 Allogene Therapeutics Inc Earnings Call and Business Update
Speaker #2: The .
Speaker #3: Ladies and gentlemen , please stand by your conference will begin shortly . Please continue to stand by and thank you for your patience .
Speaker #3: Hello , and thank you for standing by . Welcome to Allogene Therapeutics, Inc. Third Quarter 2025 conference Call . At this time , all participants are in a listen only mode .
Speaker #3: After the speakers presentation , there will be a question and answer session . To ask a question during the session , you will need to press star one on your telephone .
Speaker #3: You will then hear automated message advising your hand is raised . To withdraw your question , please press star one one again . Please be aware that today's conference call is being recorded .
Speaker #3: I would now like to turn the call over to Christine Cassiano chief Corporate Affairs and Brand Strategy Officer , Miss Castellano . Please go ahead .
Speaker #4: Thank you . Operator and welcome everyone to allergens . Third quarter 2025 Conference Call . After the market closed , Allogene issued a press release that provided a business update and financial results for the third quarter of 2025 .
Speaker #4: This press release and today's webcast are available on our website . Following our prepared remarks , we will host a Q&A session . We recognize that historically , questions have been multifaceted , but note that we will endeavor to keep this call to under an hour .
Speaker #4: I'm joined today by Doctor David Chang , President and Chief Executive Officer . Doctor Zachary Roberts , Executive Vice president of Research and Development and chief medical officer .
Speaker #4: And Jeff Parker , chief financial officer . During today's call , we will be making certain forward looking statements . These may include statements regarding the success and timing of our ongoing and planned clinical trials .
Speaker #4: Data presentations , regulatory filings , future research and development efforts , manufacturing capabilities , the safety and efficacy of our product candidates , commercial market forecasts , and financial guidance , among other things .
Speaker #4: These forward looking statements are based on current information , assumptions and expectations that are subject to change . A description of the potential risks can be found in our press release and latest SEC disclosure documents .
Speaker #4: You are cautioned not to place reliance on these forward looking statements , and disclaims any obligation to update these statements . I'll now turn the call over to David .
Speaker #4: Thank you . Christine quarter .
Speaker #5: Has been about conviction . Conviction in our science . In the past , we have chosen . And in the future we are building for patients .
Speaker #5: We are aware of
Speaker #5: the shifting conversation in the .
Speaker #5: field . This Every new modality brings excitement and speculation about what the future might hold . But true innovation isn't about chasing what's next .
Speaker #5: It is about delivering what patients need now . And if a platform can safely , effectively and at scale deliver curative therapies , it doesn't just shape the future .
Speaker #5: It redefines it and allergen . Our focus has never wavered . We are advancing the platform we believe is not only essential to making cell therapies accessible and scalable , but one that could fundamentally upend the current paradigm and even the one others are still imagining .
Speaker #5: By making the promise of curative . One time off the shelf cell therapy a reality . Today . And that's
Speaker #5: exactly what undue allogeneic cell therapy represents . It's not a bridge to something else . It is the foundation . Allogeneic technology delivers the scalable backbone needed to democratize access , reduce the overall cost of care and bring transformative and potentially curative treatment to far more patients than ever before .
Speaker #5: We expect allogeneic therapy to be essential across oncology and autoimmune disease because it combines the precision and power of autologous with a flexible , efficient and commercially viable model .
Speaker #5: No other approach can its capacity for multiplex gene engineering allows to creation of future platform products within a single cell , an advance that we believe will be critical for addressing complex cancers , including solid tumors .
Speaker #5: This is an incremental progress . It's a leap forward that reshapes what's possible . We have done the hard work to make the future real .
Speaker #5: Our leadership in manufacturing translational science and clinical development positions allergen to endure and lead , setting the standard for how cell therapy can be delivered at scale and with impact .
Speaker #5: Each of our programs summit cell , our three , two , nine and 316 reflects that strategy to make cell therapy scalable , practical , accessible and in some cases , curative .
Speaker #5: At allergen , we are not waiting for the future of cell therapy . We are creating it with conviction , with data , and with a platform built for lasting impact .
Speaker #5: As we move into next year , we are preparing for what we expect to be a defining moment with pivotal interim data from cell in the Alpha3 trial .
Speaker #5: In first line consolidation and peripheral concept from 329 . In autoimmune disease . Both milestones that we believe will shape the next era of cell therapy .
Speaker #5: With that , I'll now turn it to Zach to share updates on our R&D progress . Thanks , David . Our programs this quarter continue to demonstrate the conviction .
Speaker #5: David spoke of conviction in our science and our execution, and the discipline required to advance truly innovative medicines across alpha-three resolution and traverse.
Speaker #5: Were driving forward a portfolio that spans earlier line lymphoma , autoimmune disease and solid tumors . Each is a distinct challenge , but together , a unified demonstration of the strength and versatility of our allogeneic platform in Alpha three , our pivotal trial of Stemcell has now been streamlined into two arm randomized study comparing treatment after standard FC lymphodepletion versus observation .
Speaker #5: This structure balances efficacy , safety and scalability , which are critical for translating Car-T therapy into earlier lines of treatment . We are now at more than 50 active sites across the US and Canada , with expansion into Australia and South Korea expected early next year .
Speaker #5: The planned futility analysis focused on MRD conversion remains on track for the first half of 2026 , a positive outcome would not only demonstrate disease modification in earlier line lymphoma , it would also mark a key step toward a potential Bla submission .
Speaker #5: As we look ahead to the upcoming futility analysis and the questions we often get about what success looks like at this stage , there are two key benchmarks worth keeping in mind .
Speaker #5: The first is the pivotal Polaris study , and the second is the recent vigor 11 trial in bladder cancer , which is highly analogous to what we're doing with alpha three .
Speaker #5: The Polaris study , which evaluated Polatuzumab plus chemoimmunotherapy in frontline DLBCL , demonstrated a modest 7% improvement in progression free survival over standard treatment .
Speaker #5: That result alone underscores how much opportunity remains for meaningful progress . And the transformative potential of Alpha three . While Alpha three is the first study of its kind in lbcl , the concept of consolidating remission in patients at high risk of relapse has guided adjuvant trials in solid tumors for decades .
Speaker #5: Highly sensitive MRD tests are emerging as powerful tools to identify patients at greatest risk of progression . The recent data from the Imvigor211 trial in bladder cancer is a powerful illustration of this approach .
Speaker #5: Patients with no evidence of disease after definitive frontline treatment , in this case surgery , underwent a ctDNA based MRD test . Those who were ctDNA positive while in remission were randomized to immunotherapy or placebo .
Speaker #5: Notably , ctDNA clearance differed by only 11% between arms at cycles 3 or 5 , yet both the primary endpoint of disease free survival and the key secondary endpoint of overall survival were statistically significant , representing a potentially practice changing advance .
Speaker #5: While every study is different , the new and bigger 11 data provides a valuable analog for illustrating the potential impact of this kind of approach .
Speaker #5: Achieving an approximately 30% delta between stem cell and observation would represent the largest improvement in lymphoma outcomes since the approval of rituximab . Given these reference points , we believe our study is well positioned to deliver a highly meaningful difference and the potential for a successful trial outcome .
Speaker #5: Together , these insights reinforce our confidence in the strength of the Alpha three program and its potential to meaningfully advance lymphoma treatment . If we look beyond stemcell , our dagger technology continues to demonstrate its value across indications in the traverse trial , the dagger technology enabled Allo 306 produced durable responses in nearly one third of patients with metastatic kidney cancer and high cd70 expression .
Speaker #5: These responses , following standard flu Cy and a single infusion of Allo 306 , highlight the built in lymphodepletion advantage of the dagger technology , enabling best in class Car-T cell expansion in solid tumors .
Speaker #5: The traverse trial provided an important insights that helped shape the design of our dual Cd19 cd70 construct in autoimmune disease , rather than repurposing a construct from another indication , we set out to create something truly fit for purpose .
Speaker #5: Designed from the start with long term application in mind for autoimmune disease and the patients who would be treated . We were the first to engineer a car specifically for this setting , pairing dual targeting with our dagger technology to achieve intrinsic built in lymphodepletion through immune modulation .
Speaker #5: Allo 329 is a first in class allogeneic Cd19 cd70 dual car T product designed to target both Cd19 positive B cells and Cd70 positive activated T cells , which are key drivers of autoimmune disease .
Speaker #5: This approach is intended to simplify administration , improve tolerability , and extend the reach of car T therapy to a much broader patient population .
Speaker #5: If successful , it could represent a step change in the treatment of immune mediated diseases . That is what we aim to achieve in the resolution study .
Speaker #5: Our Phase One basket trial in autoimmune disease, which is now enrolling for lupus, myositis, and scleroderma, is expected to report translationally important biomarker and early proof of concept data in the first half of 2026.
Speaker #5: Dave and I spend a great deal of time in the field of investigators. Their enthusiasm remains strong because they see how these studies could fundamentally change the accessibility of cell therapy by enabling treatment delivery within community networks, where most patients receive care.
Speaker #5: We are aligning with how these institutions operate clinically and economically . This model reduces referral barriers , simplifies logistics and supports sustainable integration of advanced therapies into routine practice .
Speaker #5: Clinical development is complex . We compete for patients , particularly in autoimmune indications , and face both scientific and operational challenges . But each challenge strengthens our understanding and sharpens our execution .
Speaker #5: That is the nature of innovation . Iterative , demanding and grounded in data . Collectively , our programs underscore that allogeneic Car-T is not an iteration .
Speaker #5: We believe it is the foundation upon which the next generation of cell therapy will be built . The science continues to advance the early signals remain strong , and our focus is on turning that progress into real world impact for patients .
Speaker #5: With that, I'll hand the call over to Geoff. Thank you, Zach. The operational...
Speaker #6: And scientific progress that David and Zach described is backed by a strong financial foundation . And disciplined capital management . Our focus remains on advancing our clinical priorities while maintaining flexibility to capture long term value for shareholders .
Speaker #6: As of September 30th , 2025 , we had $277.1 million in cash . Cash equivalents and investments . Our disciplined approach to resource management continues to support a cash runway that extends into the second half of 2027 .
Speaker #6: R&D expenses for the third quarter were $31.2 million , including $2.8 million of non-cash stock based compensation . G&A expenses for Q3 2025 were $13.7 million , including $5.9 million in non-cash stock based compensation .
Speaker #6: Net loss for third quarter was $41.4 million , or $0.19 per share , including non-cash stock based compensation expense of $8.7 million . We continue to expect 2025 cash burn of approximately $150 million and full year GAAP operating expenses of approximately $230 million , which includes an estimated non-cash stock based compensation expense of approximately $45 million .
Speaker #6: This guidance excludes any impact from potential business development activities . The impact of our allogeneic platform extends well beyond our disciplined cost structure by manufacturing product in advance and at scale , we lay the groundwork for a more efficient and sustainable model for the broader healthcare system .
Speaker #6: Allogeneic We'll now open the call for questions .
Speaker #6: therapies have the potential to meaningfully lower the overall cost of care for cell therapy , expand access beyond specialized centers , and make transformative cell therapies available to patients in a way that is both clinically practical and economically viable , with important clinical catalysts on the horizon and a solid financial foundation , we remain confident in our ability to execute and deliver on the opportunities ahead .
Speaker #3: Thank you . Ladies and gentlemen , as a reminder to ask a question , please press star one one on your telephone . Then wait for your name to be announced .
Speaker #3: To withdraw your question , please press star one one again . Please stand by while we compile the Q&A roster . Our first question comes from the line of Salveen Richter with Goldman Sachs .
Speaker #3: Your line is open .
Speaker #7: Good afternoon . Thanks for taking my question . For that futility analysis in the first half of next year , could you see any data beyond MRD conversion ?
Speaker #7: And can you just expand on the 30% bar that you commented on ? And then just remind us how enrollment progress , enrollment is progressing for Alpha three .
Speaker #7: And whether you've seen any changes post of the FCA L-dm earlier in the year . Thank you .
Speaker #5: High . This is Zach . I'll go ahead and answer that one . So .
Speaker #6: For the first .
Speaker #5: Part of your question . will we be sharing anything additional besides the MRD conversion at this time ? We plan to really focus on the MRD conversion .
Speaker #5: We this is not an interim analysis in which we intend to allocate alpha . So we really are looking at this MRD conversion and not any of the primary endpoints for efficacy .
Speaker #5: As far as the 30% bar that we mentioned in the prepared remarks . I think we went into some detail as to why we think that that would be a pretty significant win for for MSL in that trial with the benchmarks of the Polaris .
Speaker #6: Data .
Speaker #5: Showing a 7% improvement in PFS and frontline lymphoma , and then sort of looping in some some recent data that was published for an analogous trial in bladder cancer , showing an 11% MRD clearance , and that clinical context .
Speaker #5: Yet still having a significant primary endpoint when on disease free survival , as well as an overall survival win there . So we think that 30% would be a pretty strong showing for MSL as it pertains to the MRD clearance rate .
Speaker #5: And then I think the third part of your question , Salveen was around enrollment . And we'll say I'll reiterate here that we're on track for our our the interim analysis , the futility analysis in the first half of next year , as far as impact of the study conduct change , when we had the grade five event over the summer and went to a two arm instead of a three arm , I think the the general view of the investigators is that they are pleased to be working with a regimen that they consider a standard in Car-T , and not having to use an additional component with the Cd52 antibody .
Speaker #5: So it appears as though that has had a slight uptick in terms of .
Speaker #6: The .
Speaker #5: Pace of screening for this . For this trial .
Speaker #8: Thank you .
Speaker #3: Please stand by for our next question . Our next question comes from the line of Tyler Van Buren with TD . Your line is open .
Speaker #9: Hello . This is Sam on for Tyler . Thanks for taking our question . Just for the fit over 50 US and Canada active sites .
Speaker #9: What percent of these have made it through that initial internal setup period and are now able to start actively enrolling patients? Thanks.
Speaker #5: Hey , Sam , this is Zach again . We have gotten a lot better at forecasting how long that internal setup takes . And as well as sort of incorporating that into our timelines .
Speaker #5: So I would say that of the over 50 that are active , you know , it's going to be close to all of them that are open to enrollment .
Speaker #5: Only the most recently activated sites might still have a few remaining things that they need to do before they switch on . But for the most part , all 50 of those 50 plus are actively screening and enrolling patients .
Speaker #5: .
Speaker #9: Very helpful . Thank you .
Speaker #8: Thank you .
Speaker #3: Our next question comes from the line of Jack Allen with Baird . Your line is open .
Speaker #10: Great . Thanks so much for taking the questions . And congrats to the team on the progress made over the course of the quarter .
Speaker #10: I guess I'll ask one on the autoimmune program with three two , nine . It seems like that started to get off the ground here , and you're going to have an update in the first half of next year .
Speaker #10: I just wanted to hear any updated thoughts you have around the size and breadth of the data set . We should expect next year from that program .
Speaker #5: Hey Jack , this is Dave Chung . Let me take that question . Giving Zach a little bit of a break in terms of the scope of that data communication as we have previously said , it will be a handful of patients where we can show biomarker as well as the early clinical responses .
Speaker #5: So that's the extent of it. And frankly, what we have seen with autologous programs is that a handful of patients are sufficient to really understand what's going on with the CAR-T therapy.
Speaker #5: So we are hoping that the initial communication early first half of next year will be very meaningful . Communication .
Speaker #10: Great .
Speaker #11: Thank you so much .
Speaker #8: Thank you .
Speaker #3: Our next question comes from the line of Sammy Corwin with William Blair. Your line is open.
Speaker #12: Hey , guys . Congrats on the progress . Thanks for taking my questions . I'm curious how many patients have consented for MRD testing now in alpha three ?
Speaker #12: And if you're seeing the expected rate of MRD positivity that you initially theorized , you'd see .
Speaker #5: Hey , Sammy . Zach . So , you know , I don't think we have since we made that update earlier this year around the number of patients who had consented .
Speaker #5: We haven't really been providing kind of a regular updates on that . I can say , generally speaking , that the that the pace of consenting has has at least held steady since that early part of the year .
Speaker #5: So we've really growing and numbers and as far as MRD positive rate goes , it is holding steady to our assumptions .
Speaker #8: Thank you .
Speaker #3: Our next question comes from the line of Astika with Truist . Your line is open .
Speaker #8: Hi .
Speaker #12: This is .
Speaker #4: Karina for . Thanks for taking my question .
Speaker #13: So terrible recently reported that their allogeneic Car-T product derived from younger donors , demonstrated improved durability . Have you observed similar associations in your experience ?
Speaker #5: Hi , Karina , let me take that question . Yeah , we follow caribou and in terms of their recent announcement of the result , looks pretty encouraging .
Speaker #5: But in terms of the , you know , the studying , you know , of , I mean , this is something that , you know , we have been following pretty closely .
Speaker #5: And , you know , we have a good way to , you know , identify the starting materials that will result in very important and consistent products .
Speaker #13: Okay . Thank you .
Speaker #8: Thank you .
Speaker #3: Our next question comes from the line of Samantha Scimeca with city . Your line is open .
Speaker #7: Hi . Good afternoon . Thank you very much for taking the question . Another one on the autoimmune program . I'm wondering , there's .
Speaker #7: some recent data on the autologous space in pemphigus where there was no lipid depletion in that trial that showed some pretty encouraging results .
Speaker #7: I'm wondering if there's any read through that you can take into your program . Obviously , if the CD 70 car as well .
Speaker #7: But I'm curious if this increases your optimism on showing pretty robust efficacy without Lymphodepletion . Thanks very much .
Speaker #5: Hi , Samantha David Chang here . Thanks for that great question . You know , I have to say that what we are seeing in both autologous Car-T therapy .
Speaker #5: So obviously autologous and allogeneic , there are different issues , but what we have seen just gives us even higher confidence that our 3 to 9 this is CD 70 Cd19 dual car that has a built in lymphodepleting capability that our 3 to 9 in the you know , in the low volume setting , such as in the autoimmune disease setting where the targets are essentially the resident B cells and activated T cells , you know , it .
Speaker #5: It will work well , you know , without the lymphoid depletion , obviously , we have to show that . And just as a reminder , in the ongoing study , you know , we will be testing two different cohorts .
Speaker #5: One with a reduced lymphodepletion . So this is just with a cyclophosphamide alone . And the second cohort will be without any lymphodepletion .
Speaker #7: Thanks very much .
Speaker #8: Thank you . Our next .
Speaker #3: Question comes from the line of John Newman with Canaccord . Your line is open .
Speaker #14: Hi there . Thanks for taking my question . So David , given that three , two , nine is pretty unique in that it targets both B cells and activated T cells , I'm wondering in the initial data readout , will you be able to get a look at the phenotype of the remaining T cells just to see if perhaps , is there anything left after you hopefully wipe out all the cd70 positive T cells ?
Speaker #14: Thanks , John .
Speaker #5: I think that's definitely , you know , something that we are looking we'll be looking at . But I think it will be , you know , the you know , not that it's also going into very nuanced questions about , you know , how the Cd70 is working .
Speaker #5: I mean , we certainly have looked at the fraction of Cd70 positive versus Cd70 negative T cells . And keep in mind , you know , most quiescent T cells are cd70 negative and are not affected by Al 329 .
Speaker #5: And there's a real benefit of just eliminating activated T cells . And activated T cells here , potentially those that are contributing to the autoimmune disease itself as well as our reactive T cells .
Speaker #5: So , you know , in terms of , you know , how much data we will be sharing , you know , when we announce the concept data in the first half of 2026 , let me not go too much into that , but , you know , the question is really very relevant .
Speaker #5: And we will certainly be looking at , you know , cd70 positive and Cd70 negative fractions .
Speaker #14: Thank you .
Speaker #8: Thank you .
Speaker #3: Our next question comes from the line of Clara Dong with Jefferies . Your line is open . Please check to see if you're on mute .
Speaker #3: Clara , your line is open . Please stand by for our next question . Our next question comes from the line of Benjamin with citizens Bank .
Speaker #3: The line is open .
Speaker #15: Hey , guys . Thanks for taking the questions . Also for Allo 329 when you talk about the biomarker data , David , are there any particular that would alert you to achieving a B cell reset ?
Speaker #15: And when we get those results , would it will the results be robust enough that it can help you help us as analysts decide which indications you might move forward with ?
Speaker #5: Yeah , great question . I mean , there are two parts to your question . One is what are the biomarker data will give us a lot of insight about how well creatinine is working .
Speaker #5: Having seen , you know , most of the data that's coming out in this space from those House party , I do believe that a biomarker data will be very meaningful .
Speaker #5: But , you know , also , we intend to show some early clinical responses , depending on how long the patient has been followed up .
Speaker #5: So , you know , when we communicate the a proof of concept data , the first half of 2026 , it will be more than just a biomarker .
Speaker #5: There will be early sort of clinical responses that may , you know , corroborate with what we are seeing in the biomarker data .
Speaker #5: The second question to me is probably the most fascinating one . And , you know , if anything , I believe that we have probably very broad , you know , indications that we can potentially consider the fact that 3 to 9 targets , both Cd19 and Cd70 , really allows us to not just think about those autoimmune disorders that are heavily , you know , B cell driven , but also the immune diseases that are very T cell dependent or has a big T cell component .
Speaker #5: So essentially from the rheumatology indications to neurology indications such as multiple sclerosis or even metabolic indications such as type one diabetes , and it could be considered .
Speaker #5: So stay tuned .
Speaker #15: Thanks guys .
Speaker #3: Thank you . Please stand by for our next question . Our next question comes from the line of Brian Chen with J.P. Morgan .
Speaker #3: Your line is open .
Speaker #16: Hey , guys . Thanks for taking our questions . This is for Brian . Can you talk about your level of confidence in MD conversion to event free survival , and then when you said around 30% conversion as the bar .
Speaker #16: Can you clarify a bit on the time point that is going to be meaningful for Lbcl ? And then how soon do you think we can reach that level of conversion ?
Speaker #16: Thanks .
Speaker #5: Yeah , I can take that question . So , Ron , I may need to have you repeat 1 or 2 of them , but I think the first question was how confident are we in the prognostic value of MRD conversion as it relates to the study endpoints ?
Speaker #5: I would say we're we're we're pretty confident , high confidence actually , given everything that we know about the performance of this assay .
Speaker #5: After frontline , which was recently published in JCO , as well as after Car-T , which has been shown at Ash a couple of years in a row .
Speaker #5: The test seems to be pretty good at actually correlating with with long term outcomes . Can you repeat the next two questions ? I heard the second one , but I didn't hear the third one .
Speaker #16: Yeah of course . Sorry , when you said the bar , you said of 30% conversion . Can you clarify a bit on the time point ?
Speaker #16: That's going to be meaningful for Lbcl ? And then how soon after dosing do you think we can reach that level ?
Speaker #5: I see okay , so yeah , the 30% that we've been talking about , I think we provided some context already on on this call , why we picked that number .
Speaker #5: I mean , another another way to look at that is , is , you know , that's equivalent or maybe even slightly better than what rituximab brought when it was added to chop .
Speaker #5: So if , if the MRD conversion is roughly predictive of , of of clinical endpoints , as I just described , I think it is , you know , that would be a pretty significant win .
Speaker #5: You know , you know , some might even call a home run as far as the time point goes , you know , we haven't gone into detail around what exactly what time we're drawing these MRD results .
Speaker #5: But what I can say is that this is a pretty dynamic test , meaning that it goes up fast and it goes down fast .
Speaker #5: And so , you know , we we are able to assess MRD relatively soon after the Car-T is infused . Again . We haven't specified exactly what that time point is , but are pretty confident that the time point that we've selected is going to be predictive for the for the clinical outcomes .
Speaker #16: Great. Thank you so much.
Speaker #3: Thank you . Next question comes from the line of Luca is with RBC Capital Markets . Your line is open .
Speaker #17: Hi team . Thanks for taking our question . This is for Luca . Congrats on the progress this quarter . And if I can push on the last question on the timing of analysis for EMD , the is the fertility study for stopping the trial .
Speaker #17: If MD is a bar of 30% , and I think you mentioned the last time , the 30% MRD bar is partially based on other autologous Car-T subjective response rate .
Speaker #17: And correct me here , if I'm not understanding this correctly , but that is from a potentially much longer follow up . So is there a chance that you see an insufficient MRD at your fertility analysis first half next year ?
Speaker #17: But we probably just have to give it a more time . Any color there much appreciated . Thanks .
Speaker #5: Yeah . Let me take that question . You know , I think , you know , there are some questions still around . You know , what would look good for the study .
Speaker #5: And in terms of the MRD conversion , which is the primary , you know , the the reference point that we'll be looking at , at the futility analysis , I think we are very well grounded with the assumptions that we are making .
Speaker #5: And , you know , that assumption is supported from many different angles . The data that's coming from the Car-T therapy , as well as more newer data coming from other MRD based studies .
Speaker #5: So , you know , we feel very comfortable about , you know , how we will be conducting the futility analysis in the first half of next year .
Speaker #3: Thank you . Our next question comes from the line of Robert Burns with H.C. Wainwright . Your line is open . Hi , this is Katie .
Speaker #7: On for Rob . My question is more about your if you have any more recent interactions with the FDA and if you feel like kind of move towards greater flexibility in car t oversight might give you some accelerated pathways or reduce some friction for you guys to get to market .
Speaker #5: Yeah , we have a lot of ongoing communications with FDA , and you know , so far it has been very timely and very productive .
Speaker #5: And you know , the question that you are raising , it is a very interesting one . I mean , I think , you know , we will have to see , you know , when the time comes .
Speaker #5: But all the indications are that we can make from what FDA has said is that single arm approach . You know , with car t therapy , you know , that path is is still wide open and FDA's carefully reviewing the other side of the , you know , the LA requirements .
Speaker #5: You know , what is needed on the CMC side . So we view this , you know , you know , in a to be very positive , you know , for what we are doing .
Speaker #7: Great . Thank you .
Speaker #3: Thank you . Our next question comes from the line of Clara Dong with Jefferies . Your line is open .
Speaker #13: Hi . Can you hear me ? Okay . Now .
Speaker #5: Yes .
Speaker #13: Okay . Apologize for technical issues . And just one question from me . How are you controlling for variability in the MRD assay ?
Speaker #13: Sensitivity . If any , across different sites and what steps are you taking to ensure consistency in MRD conversion assessment for the fertility analysis ?
Speaker #13: Thank you .
Speaker #5: So , Clara , that's that's an easy one . The MRD test is all being done centrally by foresight Diagnostics . So all the sites are doing is collecting the samples and then sending them in to the central lab .
Speaker #5: So we don't expect there to be any kind of technical variability in the test performance .
Speaker #13: Okay . That's good to hear . Thank you .
Speaker #3: Thank you . Ladies and gentlemen , that concludes our question and answer session . I would now like to turn the conference back over to David for any additional comments .
Speaker #5: Thank you . Operator . Let me close out by saying that everything we have built over the past seven and a half years has led to what's ahead in 2026 .
Speaker #5: There are many ideas about where cell therapy is headed , but progress depends on staying focused on what is real and achievable . At Allogene , we kept our focus on building therapies that are scalable , reproducible and ready for patients .
Speaker #5: In the first half of 2026, we expect to see major milestones in terms of utility data from Alpha Three with stem cell in first-line consolidation and proof of concept results from 3 to 9.
Speaker #5: In autoimmune disease , these will not be theoretical advances . If successful , they will mark true clinical validation of the allergenic platform shaping our company's trajectory and building broader confidence in the potential of allogeneic Car-T therapy .
Speaker #5: The opportunity ahead is significant . We are entering 2026 with conviction , clarity and momentum and are excited for what ? Excited for what ?
Speaker #5: The coming months may hold . Operator you may now disconnect .
Speaker #3: Thank you , ladies and gentlemen , thank you for your participation in today's conference . That does conclude the program . And you may now log off in disconnect .