Content Detail

• Content META

  Title	Earnings call transcript: Allogene Therapeutics beats EPS expectations in Q1 2026 By Investing.com
  ID	31325515
  External ID	af5bffd8d69996d30db18a00a5218975
  Author
  Published Date	May 13, 2026, 5:04 p.m.
  Summary	Earnings call transcript: Allogene Therapeutics beats EPS expectations in Q1 2026
  Tags
  URL	https://www.investing.com/news/transcripts/earnings-call-transcript-allogene-therapeutics-beats-eps-expectations-in-q1-2026-93ch-4686825
  Sentiment	Negative: 0.01976    Neutral: 0.03446    Positive: 0.94578
  Relevance	0.10526

• Content Details

  Content ID	38274386
  Key	fb3cf697-f17a-4465-9c94-6d335823553d
  Content	Allogene Therapeutics Inc. (ALLO) slightly surpassed earnings expectations for the first quarter of 2026, reporting an EPS of -$0.18 against a forecast of -$0.19. This minor earnings beat, along with a stable cash position, resulted in a modest 0.87% increase in its stock price during aftermarket trading, closing at $2.32. Allogene Therapeutics demonstrated a stable financial performance in Q1 2026, with a slight improvement over expectations. The company's strategic focus on advancing its clinical pipeline is supported by a robust cash position, which extends its financial runway to Q1 2029. However, increased operating expenses signal heightened costs associated with its aggressive clinical development strategy. Allogene reported an EPS of -$0.18, beating the forecast of -$0.19 by 5.26%. This performance reflects effective financial management despite ongoing losses and increased expenses. Notably, 2 analysts have revised their earnings upwards for the upcoming period, according to InvestingPro Tips. For the last twelve months ending Q4 2025, the company posted a diluted EPS of -$0.87. Following the earnings announcement, Allogene's stock price increased by 0.87% in aftermarket trading, closing at $2.32. This movement reflects a cautiously optimistic investor sentiment, buoyed by the earnings beat and strong cash position. The stock has surged 70% year-to-date and 94% over the past six months, demonstrating strong momentum despite the biotech sector's volatility. The company revised its 2026 operating cash expenses guidance upward to $165 million, a 10% increase, and GAAP operating expenses to $225 million, a 7.1% increase. This reflects the accelerated execution of its ALPHA3 program and robust enrollment in the ALLO-329 RESOLUTION trial. Executives highlighted the company's strategic focus on advancing its clinical programs with a strong emphasis on expanding the ALPHA3 trial globally. They emphasized the favorable safety profile and outpatient administration capabilities of their lead program, cema-cel. During the earnings call, analysts inquired about the company's strategy to manage increased expenses and its plans for further expanding clinical trials. Executives reiterated their commitment to disciplined financial management and strategic partnerships to support their clinical pipeline. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Hello. Thank you for standing by, and welcome to Allogene Therapeutics first quarter 2026 conference call. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Cassiano, please go ahead. Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: Thank you, operator, and welcome everyone to Allogene's conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the first quarter of 2026. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session and will aim to keep the call to under an hour. I'm joined today by Dr. David Chang, President and Chief Executive Officer; Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer; and Geoffrey 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, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecasts, potential treatment settings, and 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 press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'll now turn the call over to David. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Thank you, Christine. As we move through 2026, next generation cell therapy is shifting from promise to proof. The field is increasingly being defined by differentiated clinical evidence rather than platform ambition alone. At Allogene, our lead program, cema-cel, is built around the clear objective to establish a differentiated development path. That strategy is now translating into data that provides support for our approach. Our second program, ALLO-329 in autoimmune indications, is built on the same principle of product differentiation enabled by our understanding of CAR T design and the biology of allogeneic rejection. While these two programs are at different stages of development, the evidence emerging to date is consistent and aligned with the design principles behind each. Starting with ALPHA3, we have taken an innovative approach of treating patients with cema-cel in the first-line consolidation setting for large B-cell lymphoma with a primary goal of improving the cure rates. The key to achieving this goal is democratizing access by breaking the barriers that have historically limited the use of CAR-T therapy and by enabling cema-cel to be delivered in the outpatient setting. We are very pleased with what we've seen in the recently announced interim futility analysis from the ALPHA3 trial. In this 24 patient analysis, cema-cel achieved a 58.3% MRD clearance rate compared with 16.7% in the observation arm, representing a 41.6% absolute difference. While preliminary, this differential exceeded threshold of MRD clearance reported in other trials that led to groundbreaking clinical outcomes. We also observed a rapid and substantial reduction in circulating tumor DNA or ctDNA in the cema-cel arm, while the opposite trend was seen in the observation arm, where the ctDNA levels increased. Together, these early findings provide evidence consistent with the biological activity of cema-cel in the first-line consolidation setting as we advance ALPHA3 towards the next key milestone, the interim EFS analysis in mid-2027. Importantly, as we consider use in the outpatient community setting, this early biomarker efficacy signal was accompanied by a favorable safety profile. We observed no CRS, ICANS, or treatment-related hospitalization, enabling the majority of patients to be managed in the outpatient setting. These results reflect the trial that was designed to lead, not follow. Under Zach's leadership, ALPHA3 was built around MRD testing as a point of intervention rather than passive observation, an approach that moved beyond conventional trial design. We set out to test that forward-looking thesis, and these early data reaffirm my conviction that we are not only in the right path but ahead of the curve. Taken together, we believe these data provide compelling support for a different paradigm. One where cema-cel can be used earlier, made readily available, delivered broadly, and potentially integrated into routine care beyond specialized centers. Turning to ALLO-329, the program is progressing through early clinical development in autoimmune indications with the RESOLUTION basket trial advancing efficiently through dose escalation. This progress embodies the same discipline and forward-looking development approach that underpins ALPHA3. ALLO-329 incorporates the Dagger technology, which is designed to overcome premature rejection of allogeneic CAR T cells. This technology has previously been validated as part of our ALLO-316 program in the metastatic solid tumor setting. However, autoimmune disease represents a fundamentally different clinical context with distinct biology and a different threshold for safety and tolerability. With that in mind, we designed a structured and stepwise clinical approach, beginning at a conservative dose level to establish clear understanding of tolerability before progressing to therapeutic dose levels. Patients treated to date are within this initial dosing range as we evaluate both dose and lymphodepletion strategy. Our focus is on characterizing how the therapy behaves in patients by establishing a tolerability profile that supports continued development while also assessing early signs of activity. Within this framework, we are very pleased with the pace of enrollment and are beginning to observe initial signs of clinical activity coupled with favorable tolerability. While still early, these findings are highly encouraging and have important implications for the overall dosing paradigm, which includes not only the dose of Dagger-enabled ALLO-329, but also the required lymphodepletion regimen. As the program progresses, we expect continued dose escalation and patient follow-up to further establish the activity, tolerability, and mechanistic profile of ALLO-329. We look forward to providing a further update in the fourth quarter. With that, I will turn it over to Zach to walk through the data in more detail. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Thanks, David. I'll start with ALPHA3 and then turn to ALLO-329. ALPHA3 was designed around a clear clinical hypothesis that intervening at the point of molecularly detectable disease before clinical relapse can meaningfully alter the course of disease. When we initiated the study, MRD was emerging as a prognostic tool in LBCL. Our objective was to move MRD beyond risk assessment and into a treatment decision point. Across oncology, we are now seeing the shift in approaching a potential breakout moment. A case in point is the IMvigor011 trial, which evaluated TECENTRIQ in muscle-invasive bladder cancer. In the trial, patients who were in remission but remained MRD positive after the standard first-line procedure of complete surgical resection were randomized to TECENTRIQ or placebo, with TECENTRIQ demonstrating improvement in both disease-free and overall survival. The results of this trial could establish MRD as a clinically actionable endpoint following standard first-line treatment. If approved for this indication, TECENTRIQ would become the first therapy for which treatment initiation is guided by an ultrasensitive ctDNA MRD assay rather than clinical progression, a defining moment for the field. Against this backdrop, ALPHA3 is positioned at the forefront of how this new paradigm could evolve in large B-cell lymphoma as the first pivotal trial designed to use MRD positivity as the trigger for CAR T therapy. The ALPHA3 study is enrolling patients who have responded to first-line therapy but remain MRD positive and therefore at high risk of relapse. Patients are randomized to treatment with cema-cel or observation. We partnered with Foresight, now a wholly owned subsidiary of Natera, to utilize their CLARITY MRD assay, enabling a highly sensitive and dynamic view of disease burden over time. This enhanced sensitivity, detecting disease at or even below 1 in 1 million or 10 to the minus 6, is central to the design of ALPHA3 study and how we interpreted our interim futility data. At the interim analysis, we evaluated the first 24 patients enrolled in the ongoing two arms, a single dose of cema-cel versus observation. We observed a 58.3% MRD clearance rate in the cema-cel arm compared to a 16.7% in the observation arm, representing a 41.6 percentage point absolute difference. We also saw a rapid and substantial reduction in circulating tumor DNA. At the day 45 time point, the median ctDNA level decreased by nearly 98% in the cema-cel arm, while the median ctDNA level increased by more than 26% in the observation arm. The ALPHA3 interim futility analysis rests on the assumption that MRD clearance foreshadows clinical benefit. This hypothesis is supported by a growing body of evidence in various clinical settings, including in LBCL, linking MRD clearance in the range of 25%-30% with meaningful reductions in EFS events. The magnitude of the difference we just announced exceeds that range. While these external data sets support the relationship between MRD clearance and clinical outcomes, the impact on EFS and durability will ultimately be determined through our planned interim and primary EFS analyses. From a safety and treatment administration perspective, we observed no CRS, ICANS, or treatment-related hospitalizations, enabling the majority of patients to be managed entirely in the outpatient setting. We believe this encouraging tolerability profile is a function of treating patients earlier when disease burden is low, which is inherent to the ALPHA3 design. If the safety profile observed in the interim futility analysis bears out in the study overall, it could mark an important shift towards outpatient CAR T administration and enable cema-cel treatment in community practices where most patients with LBCL receive care. As ALPHA3 progresses, interest in the study is growing. First and foremost, we are seeing robust engagement from existing clinical sites resulting in high rates of patient screening. At the same time, new sites are expressing significant interest in joining the study, further reinforcing its momentum. From an execution standpoint, the trial continues to scale. We are now enrolling across more than 60 sites with global expansion underway. We recently announced regulatory approval in Australia and South Korea, where site activations and patient screening have begun. We anticipate the Asia-Pacific region to expand the study footprint to over 80 sites worldwide. These are not incremental additions. Australia and South Korea offer established clinical research infrastructure, experienced investigators, and highly efficient healthcare systems. This expansion reflects both strong global investigator interest and the operational discipline required to execute at scale. We are also seeing meaningful participation from community cancer centers, which contributed approximately one-third of screening and semi-self treatments in our interim futility analysis. This is an important early proof point up for the feasibility of broader administration as we look to move beyond specialized centers and into broader clinical practice. Let me now turn to ALLO-329, which as a first-in-human phase I trial, has a different objective at this stage of development. The program is supported by robust preclinical data recently published in Nature Communications, supporting the design of ALLO-329. These data demonstrated an optimized CD70 CAR engineered to protect allogeneic CAR T cells from rejection by eliminating alloreactive host T cells. In those studies, co-expression of CD70 and CD19 CARs drove sustained CAR T cell persistence, elimination of pathogenic B cells, and activated CD70-positive T cells in humanized SLE models and corresponding reductions in autoantibody production. Importantly, the Dagger technology, which eliminates alloreactive host T cells, has been clinically validated by our third clinical program and first CD70 targeting program, ALLO-316, with recently reported outcome data further supporting the approach and reinforcing our plans to advance the program in the near future. At this stage of development, our focus for ALLO-329 is to define a tolerability profile that supports continued dose escalation while generating early evidence that ALLO-329 can achieve meaningful biological activity in autoimmune disease consistent with its differentiated dual targeting mechanism. The RESOLUTION Basket trial, which includes patients with systemic lupus erythematosus with and without nephritis, scleroderma, and inflammatory myositis, continues to progress through dose escalation. 9 patients have already been treated since the study started enrollment in November 2025, with 3 patients at dose level 1 of 20 million cells and 3 patients at dose level 2 of 40 million cells, both following lymphodepletion with cyclophosphamide, and 3 patients at dose level 1 with no lymphodepletion. Importantly, the doses evaluated so far are substantially lower than those being explored in other CAR-T approaches in autoimmune disease, including autologous programs testing approximately 100 million cells and some allogeneic approaches evaluating doses above 1 billion cells. Even at these lower doses of ALLO-329, both with and without cyclophosphamide, investigators have reported signs of clinical activity. While these observations are preliminary and dose exploration continues, investigators have been very encouraged by these early signals, facilitating strong patient interest in participating in the study. This reflects a consistent approach across our programs. In ALPHA3, we designed the study to intervene earlier in disease treatment based on MRD. With ALLO-329, we are applying that same forward-looking discipline to autoimmune disease, prioritizing mechanism, durability, scalability, and long-term usability from the outset. As we continue dose escalation and patient follow-up, our goal is to build a data set that integrates clinical activity with mechanistic understanding and supports a path towards durable outcomes. We expect to provide a comprehensive update in the 4th quarter. Across both programs, our focus remains consistent, designing studies with clear hypotheses, executing with discipline, and allowing the data to define the role of allogeneic CAR T. With that, I'll turn it over to Geoff. Geoffrey Parker, Chief Financial Officer, Allogene Therapeutics: Thank you, Zach. As we execute against our key clinical milestones in 2026, we remain focused on maintaining a strong financial position that supports continued progress across our portfolio. As of March 31st, we had $266.9 million in cash equivalents, and investments. In April, we strengthened that position through a public offering that generated approximately $200.4 million in gross proceeds, extending our cash runway into the first quarter of 2029. R&D expenses for the first quarter were $32 million, including $2.7 million of non-cash stock-based compensation, reflecting continued investment in our clinical programs. G&A expenses for the first quarter were $14.1 million, including $5.6 million in non-cash stock-based compensation. Net loss for the first quarter was $42.6 million or $0.18 per share, including non-cash stock-based compensation expense of $8.3 million. Based upon our current forecast for the overall timing of the ALPHA3 program, we are modestly increasing our guidance for operating cash expense in 2026 from approximately $150 million to $165 million. GAAP operating expenses are also expected to slightly increase. From approximately $210 million to $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities. Overall, we believe we are well-positioned to execute on our strategy with the capital and flexibility needed to reach our next set of milestones. We'll now open the call for questions. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile a Q&A roster. Our first question comes from Michael Yee of UBS. Your line is open. Michael Yee, Analyst, UBS: Hey, guys. Congrats on the progress to date and the updated autoimmune update. Maybe 2 quick ones. One is, can you talk a little bit more specifically about some of the initial signs of activity or B-cell reductions? What does that mean? To what degree, maybe there are differences in B-cell reductions for the lymphodepletion cohort compared to any of the different cohorts with different lymphodepletion. If I may get a question on, obviously, the lead DLBCL program. Since the announcement of your MRD negativity interim, how have you seen perhaps enrollment, engagement and feedback and things of that nature? Maybe just talk a little bit about how things have progressed since that positive interim. Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Hey, Mike, Zach here. Thanks for the questions. On the ALLO-329 question, we'll be saving the details pertinent to your question until the Q4 update, other than to say that the encouraging signs that we refer to are coming from the cohorts that we've highlighted in, both with and without LD. We will be continuing to enroll patients according to the protocol design with and without cyclophosphamide and expect to show a more complete update in Q4. So far so good, and we're really thrilled with the patients coming into the study very briskly. The second question around has the Phase 1a results stimulated increased activity in ALPHA3? I will say that they have. It in these early days, these first couple of weeks since the announcement went out, that has come in the form of new sites coming and asking to participate in ALPHA3. Even sites that said early on that they didn't have room in their portfolio before the Phase 1a data was available. They're coming back and saying that they really do wanna participate. That kind of qualitative change is already underway. We will be watching very carefully for a quantitative uptick in the screening and enrollment pace. Except, I will say that, you know, that has been going very well in the last few months. We're optimistic. So far we're pretty happy with the way things are going. Michael Yee, Analyst, UBS: Great. Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Tyler Van Buren of TD Cowen. Your line is open. Chacha (on behalf of Roger Song), Analyst, Jefferies4: Hey, guys. Congrats on the progress. I have a couple, ALLO-329 questions as well. Since you mentioned favorable tolerability, can you discuss conceptually what sort of safety profile you hope to achieve with ALLO-329 over the long term? With respect to the update in the fourth quarter, can you give us any sense of what that might entail and kind of help put goalposts around what we should expect with that update? Chacha (on behalf of Roger Song), Analyst, Jefferies5: Hey, Tyler, thanks for those questions. You know, the safety profile in autoimmune indications, I mean, you know, we want this to be, you know, as clean as, you know, one can get to. I mean, I think that's really the patient population that we're dealing with. I mean, you know, we have seen in ALPHA3 study, even in oncology, in the right clinical setting, you know, CAR T therapy can be well-tolerated. You know, that's kind of profile that we're trying to mirror, where, you know, the treatment can be given as an outpatient and patient can be managed as an outpatient. That's really the safety profile that we're looking for. So far, you know, after, you know, completing, you know, both 20 and 40 million cell dose levels with cyclophosphamide lymphodepletion, you know, I feel very encouraged that, you know, if the, if the safety profile, you know, holds out, this can be very interesting finding. With respect to your second question about, you know, how to set up the expectations for the fourth quarter. I mean, so far, let's keep in mind in terms of the pace of enrollment that Zach had talked about. We dosed first patient, back in, you know, November of last year and May, so, you know, within six months. You know, dose escalation study where we have to wait about 1 month, you know, after first patient is dosed before we can fill up the rest of the cohort. Even with that kind of, sort of, you know, preset barriers in how fast we can enroll, we enrolled 9 patients. That is a, you know, pretty remarkable support that we are getting from various, you know, physicians involved in the autoimmune trial. We are highly encouraged. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: You know, this, you know, autoimmune, obviously, you know, the way that the clinical responses are being measured is different than in oncology. When the investigators are calling us and telling us that they're seeing that they would not have expected to see, in any setting, I mean, that I would view as a highly encouraging early signs. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Biren Amin of Piper Sandler. Your line is open. Speaker 0: Yeah. Hi, guys. Thanks for taking my questions. Maybe just to stay on ALLO-329. Given your reporting data in Q4, should we expect data across the 20 and 40 million cell doses in the fourth quarter, or could we get higher cell doses? That's the first question. Second question, what would be the patient composition across SLE, inflammatory myositis, and scleroderma in the Q4 update? Lastly, on the trial itself, recently in April, I think there was a change that was recorded on ClinicalTrials.gov where you increased target enrollment to 66 patients from 54 patients. Could you maybe just talk about that change and what drove that? Thank you. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah, Biren, as to your first question, I'm also realizing that was Tyler Van Buren's question, which I did not fully answer. In the fourth quarter, obviously, at this point, we have completed in 20 million and 40 million, and we are continuing the dose escalation by the fourth quarter, you know, update comes, you know, included patient in that will be more than just 20 million and 40 million. We're hoping that we can include, certainly the next dose level and possibly even, you know, higher dose, depending on how the pace of enrollment is maintained. When I'm talking about the cell dose levels, certainly, I'm talking about both with Cy and without cyclophosphamide. Zach, maybe you can cover the patient composition. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Yeah. Biren, we're seeing patients come from all of the indications that I listed previously, lupus, inflammatory myositis, and scleroderma. It's still too early to say whether the early signs of efficacy that we're seeing is segregated to 1 patient group or another. We're not gonna be making any changes to the basket style design of the protocol. As we continue to enroll patients, we expect a mix, and that mix will be presented in Q4. The ClinicalTrials.gov change that occurred, I actually have to say, I don't know why we made that. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: It's a administrative change. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Administrative change. Sometimes we have to go through, and we have to make little clerical changes to ClinicalTrials.gov. There's not been any changes to the study design that would have warranted that change. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Salveen Richter of Goldman Sachs. Your line is open. Chacha (on behalf of Roger Song), Analyst, Jefferies2: Good afternoon. Thanks for taking my question. For cema-cel, could you speak to the feedback you're hearing from the community practices to date, post the recent data? For the ongoing ALLO-329 RESOLUTION study, can you expand upon progress on site activation and patient enrollment and how that's playing out, just given some competition in the field for other autoimmune CAR-T programs? Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Salveen, it's Zachary. As far as how the community practices are reacting to the interim data from cema-cel, I would echo what I said a moment ago that the feedback has been really overwhelmingly and uniformly positive. As just to give another little anecdote on that, in the couple of literal days after that announcement was made that same week, we were on the phone with a couple of large community network practices that have already a couple of sites on the study seeking to expand their footprint within their practices and add additional sites. We believe that the interim analysis data is being viewed by the community practices and academic practices alike as potentially something very interesting and practice-changing. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah. Also, I would say it makes a lot of sense. When you think about, you know, this is giving the community physician something to offer to patients rather than referring them to a tertiary or cell therapy centers. 2, I think, you know, during the course of treating patients, they are realizing that treatment is relatively hassle-free. You know, what we have shared, you know, with the interim futility findings is the early safety profile. It was very clean, which also makes, you know, managing patient after the CAR T infusion extremely smooth. I mean, these are definitely early findings, but these are the things that, you know, I believe is making the community physicians being quite interested in participating in the ALPHA3 study. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Your second question, Salveen, about site activation and enrollment in 329. We are approaching the target number of sites that we sought to activate for ALLO-329. I can't say exactly what the number is on ClinicalTrials.gov, but we expect that to be completed here very shortly within the next few weeks, maybe a couple of months. That's gone very well. We've actually ended up getting quite a bit more traction even in that competitive space that you highlighted. We've got some really excellent marquee sites already listed on ClinicalTrials.gov and a few more in the can ready to come out. They are really being super productive on the patient screening and enrollment as we highlighted previously. We could not be happier with how ALLO-329 is going operationally. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: The mixture of the patients in this basket study is, you know. essentially it, you know, is excellent. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Yeah. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Samantha Semenkow of Citigroup. Your line is open. Chacha (on behalf of Roger Song), Analyst, Jefferies3: Hi, good afternoon. Thank you very much for taking the question. Another one on ALLO-329. I'm wondering if you could just talk a little bit about your thoughts on dosing going forward. You know, you mentioned some early clinical signals that you're seeing in these first 9 patients. I'm wondering, do you think the 20 million dose is too low or subtherapeutic? Curious your thoughts there. How are you thinking about dosing going forward? Are there any adjustments you're planning to make to the dose escalation? Thanks very much. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Hey, Sam. So, with respect to the question around the doses that we've tried so far, you know, we in the tenets of a phase I dose escalation study, you're really gated by safety. I wanna echo what David said a moment ago, that safety is paramount here, and we wanna make sure that we maintain the safety profile that would make this therapy attractive to patients and doctors with autoimmune disease. We're gonna keep going up until we start to bump up against that, the toxicity that we think would be prohibitive. So whether you call it subtherapeutic or room to go, I'm more of a room to go type of guy. We're gonna keep dose escalating. Then your other question is, do we see any need to make any adjustments? At this point, we do not. We still have some doses to go up, and we're hopeful that we'll start to see, you know, really compelling activity here in these next dose or the dose after that, and we can maintain that safety profile. Look forward to that Q4 update. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Roger Song of Jefferies. Your line is open. Chacha (on behalf of Roger Song), Analyst, Jefferies: Hi, this is Chacha on for Roger. Thanks so much for taking our question. I have two. One is, can you just give us some more color on what your current cash runway covers? On my second question is on ALLO-329. Can you tell us more about the decision factors that are driving the optionality for the fludarabine addition? I know you mentioned with the option of adding this. Can you just explain the gating factors for why we add or why we don't? Thanks. Geoffrey Parker, Chief Financial Officer, Allogene Therapeutics: Hi, this is Jeff. On the cash runway, as we discussed in the script, our current cash runway, based on the addition of the capital added in the recent financing, the $200 million financing, takes us into the first quarter of 2029. During that time, you know, we intend to complete the ALPHA3 study. As you know, we anticipate finishing enrollment at the end of 2027. We anticipate an interim analysis on EFS in mid 2027, primary analysis in mid 2028 with the filing of the BLA as quickly as possible, based on the results of those interim or final analysis. It really is focused on covering ALPHA3, as well as completing this phase I RESOLUTION study for ALLO-329, as we indicated, having the comprehensive data set in the fourth quarter of this year. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah. Let me take the question on the optionality of fludarabine. I think this is just, you know, how, you know, we try to make the, you know, protocol as flexible as possible, you know, without, you know, predefined, you know, idea about when to kick in these optionality. I mean, it's really looking at the data and then, you know, making the decision. Right now, based on the data, our primary focus is continuing the dose escalation. Chacha (on behalf of Roger Song), Analyst, Jefferies5: I'll just add one other piece of color on that. Honestly, in part, this would be driven by the demand to come into the study. By opening additional cohorts, it would allow us to park some patients and to allow patients into the trial. That is another factor that could come into it. Nothing has changed at all about our belief in the psi or no psi possibility here. We are continuing with that primary goal. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Matthew Phipps of William Blair. Your line is open. Matthew Phipps, Analyst, William Blair: Good afternoon. Thanks for taking my question. You know it's going to be on ALLO-329 as well. There's obviously been a lot made about B cell reset after, you know, CAR T with CD19. I was wondering if from your experience with ALLO-316, what the T cell kind of repopulation might have looked like after treatment, if you looked at that. I guess, do you expect maybe some ability to have an immune autoreactive T cell reset following ALLO-329 treatment? Will you have any data on that by Q4? Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Matt, a great question. Really insightful and I think right on point in terms of our understanding of the mechanism of action of ALLO-329. We are really focused on how the B-cell and the T-cell repertoires will change, and, you know, whether we achieve the reset as defined as just absolute B-cells going all the way down to 0, or whether there's some editing of the repertoire on both the B-cell and the T-cell side. Now, obviously, B-cells, we expect the chances of those cells going very low or to 0 to be higher because, you know, we're targeting a pan-B-cell marker. In the case of CD70, you're absolutely correct. It's only a subset that are gonna be CD70 positive. Of course, there's going to be a population of alloreactive cells that we expect to be depleted through the Dagger effect. There is also known to be CD70 positive pathogenic AID-causing T-cells, so clonal populations with specific TCRs that also express CD70. That has actually been one of the main reasons that we designed ALLO-329 the way we did, was try to wipe out that set, that clone or set of clones that may be driving the pathogenesis. We will be analyzing the T-cell repertoire as part of the ALLO-329 study. If we've got something to share in Q4, we'll share it. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Jack Allen of Baird. Your line is open. Jack Allen, Analyst, Baird: Great. Thanks so much for taking the questions, and congrats on the progress. I'll keep the theme going with the ALLO-329 question to start, and then I have one on cema-cel as well. On ALLO-329, I was just hoping you'd provide some additional color as it relates to how many doses you could escalate the study in and, you know, what the next step up might be. I guess logically it looks like 60 million would be a realistic target for the next dose, but how high could you go in that trial? On cema-cel, I just wanted to ask about the interim EFS look in mid-2027 and any additional color you can provide around the powering there. Chacha (on behalf of Roger Song), Analyst, Jefferies5: Jack, great question. The next dose level that we're gonna be looking at is not 60, it's actually 80 million cells. That cohort is enrolling now, following Cy, and then the no Cy cohort is close behind. I'm gonna hold off on saying exactly how many cell doses that we plan to go up, and we'll sort of reveal that at Q4 'cause I do think that we'll be in that zone by the time we give that update, so stay tuned. Eighty million is the next dose cohort that we're working on now. As far as cema-cel, we talked quite a bit about this with the fundraising and the ALPHA3 allocation for the Phase II. You know, we have not gone into specific detail. The method that we used to allocate the alpha was the O'Brien-Fleming spending function, so that will give you some general understanding of the fraction of alpha that's allocated to the phase II. I will take the opportunity now to reiterate, though, that, you know, the results of the interim analysis one does give us the possibility of having a positive outcome in phase II. That is something we are looking forward to and, of course, working feverishly to enroll the study and deliver on those timelines. Jack Allen, Analyst, Baird: Awesome. Thanks so much for the color. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from John Newman of Canaccord Genuity. Your line is open. John Newman, Analyst, Canaccord Genuity: Hi, guys. Thank you for taking the question. Also have one on ALLO-329. The question is, do you expect that the Dagger technology that's targeting CD70 positive T cells could actually give you maybe differential efficacy in some of the cohorts that you're enrolling versus lupus, for example, scleroderma and myositis, where it's sort of theorized that there's more T-cell activity? Thanks. Chacha (on behalf of Roger Song), Analyst, Jefferies5: John, great question. As usual, thank you for the insight. The answer is yes. Not just within these rheumatologic disorders where T-cells are known to play a role, and there's literature on it, but of course, there are lots and lots of papers and understanding about other therapeutic areas which are even thought to be more dependent on T-cell biology. Just to throw out a couple, multiple sclerosis and type 1 diabetes are thought to be, you know, primarily driven by pathogenic T-cells. Not only within this initial set do we think we could have some differential efficacy, as you put it, but we also believe it will give us a more plausible pathway into other therapeutic areas where T-cells are known to play a larger role than just a straight CD19 product. John Newman, Analyst, Canaccord Genuity: Great. Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Reni Benjamin of Citizens. Your line is open. Chacha (on behalf of Roger Song), Analyst, Jefferies1: Hey, guys. Thanks for taking the questions. Maybe just starting off with the interim analysis. Now that you've been able to, you know, kind of sit on the data with the futility analysis, do you feel that this delta that you're seeing increases the chances of a successful interim mid-2027 versus, you know, what you were thinking when you first started the study? If so, does it make sense to potentially modify the trial design to allocate a little bit more alpha and increase your chances of success there? Then regarding ALLO-329, as we kind of look at the landscape, look at autologous therapies and bispecifics, can you just guide us as to what is the clinical sort of efficacy and safety benchmarks you're hoping to hit, hoping to meet so that you can move this program forward? Does this program move forward ideally with a partner, or do you think you do this on your own? Thanks. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Hey, Reni. On the interim analysis, you know, EFS analysis, you know, without a question, after looking at the MRD clearance differential, we believe the probability, I mean, or the powering for the interim analysis, you know, has gone up quite a bit. I mean, that really, you know, goes down to we have said that, you know, study was designed to demonstrate, you know, the hazard ratio of 0.5, but the MRD clearance, as we extrapolate, based on the existing data, you know, leads us to a potentially the hazard ratio being much lower than 0.5. If that turns out to be true as we continue to enroll the study, the probability of interim analysis, as Zach has pointed out, you know, leading to a statistical significance is very significant. We'll just have to wait and see. Your second question about, you know, you know, would we consider amending the protocol. You know, I think that probably is not something that would be, you know, that's needed or that would be good to do at this point. I mean, I think the best course is just us sticking with the original study plan. Chacha (on behalf of Roger Song), Analyst, Jefferies5: The question around where does this fit in the evolving landscape? We actually feel really good about that. Right now, that landscape in the front line is really been focused for a long time on increasing intensity of those regimens and looking directly at the bispecific-based regimens that are being studied, that really do add a lot of complexity and toxicity to those newly diagnosed regimen, the patient regimens. We actually feel really good that, you know, no matter what happens upfront, an MRD positive result at the end of frontline treatment could trigger a cema-cel infusion and to be able to administer that, even in centers that we believe actually may not ever engage fully in frontline bispecific regimens because of the complexity and toxicity, that those centers could administer cema-cel in a consolidation setting. We actually feel like we have threaded the needle very well with ALPHA3 and are somewhat insulated from all of that competition in the early lines. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Reni, does that answer your question, or was the question on ALLO-329? Chacha (on behalf of Roger Song), Analyst, Jefferies1: That last one that Zach answered was on ALLO-329 in particular. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Okay. That's what I thought. Chacha (on behalf of Roger Song), Analyst, Jefferies1: Just trying to get it clear. Yeah. Sorry about that. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Let me, let me just answer, you know, the question on the ALLO-329. The profile that we are looking for is something that can be administered as an outpatient and patient managed as an outpatient. You know, plus that on top of that, the nature of the, you know, cell, you know, CAR-T is that, you know, this will be a, you know, one-time treatment with a, you know, possibility of redosing, you know, several years down the line if the symptoms were to come back. You know, that is the, you know, profile that we believe will remain very competitive when you think about other emerging modalities that's coming, you know, in the T-cell approach towards the autoimmune indications. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Our next question comes from Lut Ming Cheng of J.P. Morgan. Your line is open. Lut Ming Cheng (Brian Cheng), Analyst, J.P. Morgan: Hi, guys. Thanks for taking our question this afternoon. Just a quick one from us. Can you talk about the rationale of updating the autoimmune RESOLUTION data updates from June to 4/2? Is that decision data-driven or are there other considerations? Thanks for taking our question. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah, Brian Cheng, let me take the question. I think our intent is provide data update in a very meaningful way. In terms of the maturity of the data and what we have now, I think what we can say is enrollment is very robust. Also there is, you know, very sort of interesting signs of clinical activity. I don't think, you know, definitely I think this is for now and as we dose escalate, I mean, keep in mind, we intentionally started the study with very conservative dose to ensure the patient safety. $20 million, I think there was an earlier question about whether that may be low. In my view, it probably was lower than what was necessary. As we dose escalate, and certainly we are going to the dose levels that in other programs that we have done, you know, 80 million or 120 million is sort of the range that we have seen activities in programs like ALLO-316 or cema-cel. We're getting to that dose range, and, you know, as we update the data in fourth quarter, we will have patients treated at the dose that may be more in the right range. You know, definitely, we are enrolling this study rather briskly, and we'll have a lot to talk about in fourth quarter. Lut Ming Cheng (Brian Cheng), Analyst, J.P. Morgan: Great. Thank you. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. That concludes our question and answer session. I would like to turn the conference back over to management for any additional comments. Dr. David Chang, President and Chief Executive Officer, Allogene Therapeutics: All right. Thank you. We said at the onset that this would be in a year of defining proof. The ALPHA3 interim analysis represents an important first step. The signal we see today must be validated through EFS. It provides early support for a fundamentally different approach to CAR-T, one that is earlier, more accessible, and potentially scalable. Our focus now is execution, completing ALPHA3 enrollment, advancing ALLO-329 through dose escalation, and continuing to generate the data needed to define the role of allogeneic CAR-T across oncology and autoimmune disease. We believe we are well-positioned to do that. Thank you for your continued support. Operator, you may now disconnect. Chacha (on behalf of Roger Song), Analyst, Jefferies0: Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may log off and disconnect. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
  Content Reference URL	None

• Publisher

  Publisher Name	Investing.com (#43)
  Publisher URL	https://www.investing.com
  Description	None
  Trust Flow Score	37
  Citation Flow Score	46

• Data Source

  Data Source Name	NewsCatcher (#303)
  Data Source Type	news
  Data Source URL	https://www.newscatcherapi.com/
  Description
  Weight	1