Allogene (ALLO) Q1 2026 Earnings Transcript

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DATE

Wednesday, May 13, 2026 at 5 p.m. ET

Call participants

• President and Chief Executive Officer — David D. Chang, M.D., Ph.D.
• Executive Vice President, Research and Development, and Chief Medical Officer — Zachary J. Roberts, M.D., Ph.D.
• Chief Financial Officer — Geoffrey Parker
• Chief Communications Officer — Christine Cassiano

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Takeaways

• ALPHA-3 SemiCell MRD Clearance -- 58.3% minimal residual disease (MRD) clearance for SemiCell compared to 16.7% in the observation arm in a 24-patient interim analysis, a 41.6% absolute difference.
• Circulating Tumor DNA (ctDNA) Reduction -- Median ctDNA decreased by nearly 98% in the SemiCell arm and increased by more than 26% in the observation arm at day 45, highlighting a marked biomarker response.
• Safety Profile (ALPHA-3) -- No cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or treatment-related hospitalization observed, facilitating outpatient management in most cases.
• Clinical Site Expansion -- ALPHA-3 now enrolling at over 60 sites with regulatory approval and activations in Australia and South Korea, targeting more than 80 total global sites.
• Community Practice Participation -- Roughly one-third of patients screened and treated with SemiCell in the interim analysis were from community cancer centers, supporting feasibility beyond specialized sites.
• Dose Escalation for ALLO-329 -- Nine patients treated to date: 3 at 20 million cells with cyclophosphamide, 3 at 40 million cells with cyclophosphamide, and 3 at 20 million cells without lymphodepletion; next dose escalation set at 80 million cells.
• Early Activity and Tolerability (ALLO-329) -- Initial signs of clinical activity observed at lower cell doses with a favorable tolerability profile in both lymphodepletion and non-lymphodepletion cohorts.
• Enrollment Pace (ALLO-329) -- Study enrolled nine patients since November 2025 despite dose-escalation gating protocols; expect site activations to reach targeted number within weeks to months.
• Cash, Cash Equivalents, and Investments -- $266.9 million as of March 31, further increased by $200.4 million gross proceeds from April public offering, extending runway into 2029.
• Financial Guidance Increases -- Operating cash expense guidance raised from approximately $150 million to approximately $165 million for 2026; GAAP operating expenses to rise from approximately $210 million to approximately $225 million, including estimated noncash stock-based compensation expense of approximately $35 million.

Summary

The interim analysis of ALPHA-3 demonstrated a 41.6% absolute improvement in MRD clearance for SemiCell versus observation, accompanied by a sizable median ctDNA reduction, and no cases of CRS, ICANS, or related hospitalizations, enabling outpatient care. Robust investigator and community practice interest has spurred expansion to over 60 sites globally, with momentum to surpass 80 as new geographies activate. Allogene Therapeutics (NASDAQ:ALLO)'s ongoing Phase 1 trial in autoimmune indications treated nine patients as of May with early activity at subtherapeutic cell doses, favorable tolerability, and ongoing dose escalation planned for higher activity cohorts. April's public financing extends Allogene Therapeutics' capital runway through planned ALPHA-3 completion, further dose escalation in ALLO-329, and key program readouts without near-term external financing needs.

• Allogene stated, "the probability or the powering for the interim analysis has gone up quite a bit" for ALPHA-3 based on the observed MRD clearance differential.
• Allogene expects a comprehensive update on ALLO-329 in the fourth quarter, which will include higher cell-dose cohorts and balanced patient recruitment across multiple autoimmune disease groups.
• The company confirmed that its cash resources will cover ALPHA-3 enrollment completion, EFS analyses through mid-2028, and primary Resolution data for ALLO-329, with no stated impact from potential business development activities.
• Community practice feedback post-interim SemiCell data has resulted in increased interest and site expansion, with several large networks adding locations or re-engaging to participate.
• No safety signals in the current ALLO-329 cohorts prompted protocol changes, and dose escalation will continue until clinically meaningful toxicity emerges.

Industry glossary

• SemiCell: Allogene's lead allogeneic CAR T product candidate evaluated in first-line consolidation for large B-cell lymphoma.
• Dagger Technology: Genetic engineering platform enabling CAR T cells to resist host rejection by targeting alloreactive T cells.
• MRD (Minimal Residual Disease): Trace cancer cells remaining post-treatment, measured via sensitive assays to inform prognosis and therapy decisions.
• ctDNA (Circulating Tumor DNA): Tumor-derived DNA fragments in the bloodstream used as a dynamic biomarker for tumor response.
• Lymphodepletion: Conditioning regimen (e.g., cyclophosphamide) to suppress native immune cells prior to CAR T therapy administration.
• ALPHA-3: Allogene's pivotal clinical trial of SemiCell in large B-cell lymphoma using MRD-directed intervention.
• Resolution Basket Trial: Allogene's Phase 1 clinical trial evaluating ALLO-329 in multiple autoimmune indications.

Full Conference Call Transcript

Christine Cassiano: 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 2026. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q and A session and will aim to keep the call to under an hour. I am joined today by doctor David D. Chang, president and chief executive officer doctor Zachary J. 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 of presentation, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecast, potential treatment settings, and financial guidance among other things. These forward looking statements are based on current information and assumptions 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 will now turn the call over to David Chang.

David D. Chang: 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, SemiCell, is built around a 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 2 programs are at different stages of development, the evidence emerging to date is consistent, and aligned with the design principles behind each.

Starting with ALPHA-3, we have taken an innovative approach of treating patients with SemiCell in the first line consolidation setting for large B cell lymphoma, with a primary goal of improving the cure rates. A 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 SemiCell to be delivered in the outpatient setting. We are very pleased with what we have seen in the recently announced interim futility analysis from the ALPHA-3 trial. In this 24 patient analysis, Semi Cell 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, ctDNA in the semicell 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 SemiCell in the first line consolidation setting as we advance ALPHA-3 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, ALPHA-3 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 1 where SemiCell 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 and forward looking development approach that underpins ALPHA 3. 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 the 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 evidence of tolerability before progressing to therapeutic dose levels. Patients treated to date are within this initial dosing range and 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 they are 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.

Zachary J. Roberts: Thanks, David Chang. I will start with ALPHA-3 and then turn to ALLO-329. Alpha 3 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 is 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. Tecentriq demonstrated 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, ALPHA-3 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 ALPHA-3 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 SemiCell 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 a million or 10 to the -6 is central to the design of ALPHA-3 study and how we interpreted our interim futility data. At the interim analysis, we evaluated the first 24 patients enrolled in the ongoing 2 arms, a single dose of Semi Cell versus observation. We observed that 58.3% MRV clearance rate in the SemiCell arm compared to a 16.7% in the observation arm representing a 41.6%age 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 semisil arm, while the median ctDNA level increased by more than 26% in the observation arm. The 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% to 30% with meaningful reductions in EFS events. The magnitude of the difference we just announced exceeds that range.

While these external datasets 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 ALPHA-3 design.

If the safety profile observed in the interim futility analysis bears out in the study overall, it could mark an important shift toward outpatient CAR T administration and enable SemiCell treatment in community practices where most patients with LBCL receive care. As ALPHA-3 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. 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 health care 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 1-third of screening and SemiCell treatments in our interim futility analysis.

This is an important early proof point 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 1 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 CD 70 CAR engineered to protect allogeneic CAR T cells from rejection by eliminating alloreactive host T cells.

In those studies, coexpression of CD70 and CD19 CARs drove sustained CAR T cell persistence, elimination of pathogenic B cells and activated CD 70 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 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 with other CAR T approaches in autoimmune disease including autologous programs testing approximately 100 million cells and 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 ALPHA-3, 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 dataset that integrates clinical activity with mechanistic understanding and supports a path towards durable outcomes. We expect to provide a comprehensive update in the fourth 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 will turn it over to Jeff.

Geoffrey Parker: 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 31, we had $266.9 million in cash, 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 2029. R&D expenses for the first quarter were $32 million including $2.7 million of noncash 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 noncash stock based compensation expense of $8.3 million. Based upon our current forecast for the overall timing of the Alpha 3 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 noncash 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 will now open the call for questions.

Operator: Thank you. As a reminder, to ask a question. To withdraw your question, please press *11 again. Our first question comes from Michael Yee of UBS. Your line is open.

Analyst (Michael Yee): Hey, guys. Congrats on the progress to date. And the updated autoimmune color. Maybe 2 quick ones. 1 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? And to what degree, maybe there are differences in B cell for the lymphodepletion cohort compared to any of the different cohorts with different lymphodepletion. And 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 Maybe just talk a little bit about how things have progressed since that positive interim. Thank you.

Hey, Mike.

Zachary J. Roberts: This is Zachary here. Thanks for the questions. So on the 29 question, we are-- we will be saving the details pertinent to your question until the Q4 update, other than to say that the encouraging signs that we referred to are coming from the cohorts that we have highlighted both with and without lymphodepletion. So 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. But so far, so good, and we are really thrilled with the patients coming into the study, very briskly. The second question around has the IA1 results stimulated increased activity in ALPHA-3, I will say that they have.

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 ALPHA-3 even sites that said early on that, they did not have room in their core portfolio before the IA1 data was available. Now they are coming back and saying that they really do want to participate. So 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 has been going very well in the last few months.

So we are optimistic, but so far, we are pretty happy with the way things are going. Great. Thank you.

Operator: Thank you. And our next question comes from Tyler Van Buren of TD Cowen. Your line is open.

Analyst (Tyler Van Buren): Hey, guys. Congrats on the progress. I have a couple of 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? And then 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?

David D. Chang: Hey, Tyler Van Buren. Thanks for those questions. The safety profile in autoimmune indications, I mean, we want this to be as clean as 1 can get to. I mean, I think that is really the patient population that we are dealing with. Mean, we have seen an ALPHA-3 study even in oncology in the right clinical setting, CAR T therapy can be well tolerated. And, you know, that is kind of profile that we are trying to mirror. Where the treatment can be given as an outpatient and patient can be managed as an outpatient. So that is really the safe profile that we are looking for.

And so far, after completing both 20 and 40 million cell dose levels with cyclophosphamide lymphodepletion. You know, I feel very encouraged that you know, if the safety profile, you know, holds out, this can be very interesting finding. With respect to your second question about 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 Zachary had talked about. We dosed first patient back in November. and it is May. So, within 6 months, dose escalation study where we have to wait about a month after first patient is dosed before we can fill up the rest of the cohort.

Would even with that kind of sort of preset barriers in how fast we can enroll. We enrolled 9 patients. That is a pretty remarkable support that we are getting from various physicians involved in the autoimmune trials. So we are highly encouraged And, you know, autoimmune, obviously, the way that the clinical responses are being measured is different than in oncology. But when the investigators are calling us and telling us that they are seeing that they would not have expected to see in any setting. I mean, that I would view as a highly encouraging early signs.

Operator: Thank you. And the next question comes from Biren Amin of Piper Sandler. Your line is open.

Analyst (Biren Amin): Yes, hi guys. Thanks for taking my question. Maybe just to stay on ALLO-329. Biren, you are reporting data in Q4, should we expect data across the 20 million cell doses in the fourth quarter? Or could we get higher cell doses? So that is the first question. Second question, what would be the patient composition across SLE, myositis, and sclerosis in the Q4 update? And then and then lastly, on the trial itself, recently in April, I think there was a change that was recorded on ct.gov where you increased target enrollment to 56 patients from 54 patients. Could you maybe just talk about that change and what drove that? Thank you.

David D. Chang: Yeah, Biren Amin. As your first question, I am also realizing that was Tyler Van Buren's last question, which I did not fully answer. So in the fourth quarter, obviously at this point, we have completed 20 million and 40 million and we are continuing the dose escalation by the fourth quarter you know, update comes, you know, included patients in that will be more than just 20 and 40 million. We are hoping that we can include certainly the next dose level and possibly even in a higher dose depending on how the pace of enrollment is maintained.

And also, when I am talking about the cell dose levels, certainly I am talking about both with Cy and without cyclophosphamide. And, Zachary, maybe you can cover the patient composition.

Zachary J. Roberts: Yeah. So, Biren, we are seeing patients come from all of the indications. That I listed previously. So lupus, inflammatory myopathies, and scleroderma. it is still too early to say whether early signs of efficacy that we are seeing as segregated to 1 patient group or another. So we are not gonna be making any changes to the basket style design of the protocol. So as we continue to enroll patients, We expect a mix, and that mix will be presented in Q4 and then the ct.gov change that occurred I actually have to say I do not know why we made that. it is an administrative change. Yeah. Administrative change.

Sometimes we have to go through and we have to make little clerical changes to the ct.gov. there is not been any changes to the study design that would have warranted that change.

Operator: Thank you. And our next question comes from Salveen Richter of Goldman Sachs. Your line is open.

Analyst (Salveen Richter): Good afternoon. Thanks for taking my question. For Semisel, could you speak to the feedback you are hearing from the community practices to date post the recent data. And then for the ongoing ALLO-329 resolution study, can you expand upon progress on site activation and patient enrollment and how that is playing out just given some competition in the field for other autoimmune CAR T programs? Thank you.

Zachary J. Roberts: Salveen, it is Zach. So as far as how the community practices are reacting to the interim data from SemiCell, I would echo what I said a moment ago that 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.

So we believe that the interim analysis data is being viewed by the community practices and academic practices alike as potentially something very, very interesting and practice-changing. And also I would say it makes a lot of sense.

David D. Chang: And when you think about that this is giving the community physicians something to offer to patients, rather than referring them to a tertiary or cell therapy centers. And then 2, I think during the course of treating patients, they are realizing that treatment is relatively hassle free. And, you know, what we have shared 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 I believe is making the community physicians quite interested in participating in the ALPHA-3 study.

Zachary J. Roberts: And then your second question, Salveen, about site activation and enrollment in ALLO-329. We are approaching the target number of sites that we sought to activate for ALLO-329. I cannot say exactly what the number is on ct.gov, but we expect that to be completed here very shortly within the next few weeks, maybe a couple of months. that is gone very well. We have actually ended up getting quite a bit more traction, even in that competitive space that you highlighted. We have got some really excellent marquee sites already listed on ct.gov and a few more in the can ready to come out.

And then they are really being super productive on the patient, screening and enrollment as we highlighted previously. So we could not be happier with how ALLO-329 is going operationally. And the mixture of the patients in this basket study is, you know, essentially excellent. Thank you.

Operator: And our next question comes from Samantha Semenkow of Citi. Your line is open.

Analyst (Samantha Semenkow): Good afternoon. Thanks very much for taking the question. Another 1 on ALLO-329. I am wondering if you could just talk a little bit about your thoughts on dosing going forward. You mentioned some early clinical signals that you are seeing in these first 9 patients. I am wondering, do you think the 20 million dose is too low or subtherapeutic? Curious your thoughts there. And how are you thinking about dosing going forward? Are there any adjustments you are planning to make to the dose escalation? Thanks very much.

Zachary J. Roberts: Hey, Samantha Semenkow. So with respect to the question around doses that we have tried so far, you know, we, in the tenets of a phase 1 dose escalation study, you are really gated by safety. And I want to echo what David Chang said a moment ago that safety is paramount here. We want to make sure that we maintain the safety profile that would make this therapy attractive to patients and doctors with autoimmune disease. And so we are going to keep going Up until we start to bump up against the toxicity that we think would be prohibitive.

So whether you call it subtherapeutic or room to go, I am more of a room to go type of guy. And so we are going to 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 are hopeful that we will 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. So look forward to that Q4 update. Thank you.

Operator: And our next question comes from Robert Song of Jefferies. Your line is open.

Analyst: This is Chad on for Robert. Thanks so much for taking our question. I have 2. So 1 is, can you just give us some more color on what your current cash runway covers? And then on my second question is on also ALLO-329. Can you tell us more about the decision factors that are driving the optionality for the fludarabine addition? Know you mentioned with the option of adding this, can you just explain the gating factors for why we would add or why we would not? Thanks.

Geoffrey Parker: Hi. This is Geoffrey Parker. 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 2029. And during that time, you know, we intend to complete the ALPHA-3 study. So as you know, we anticipate finishing enrollment at the end of 2027. We anticipate an interim analysis on EFS in mid 27. Primary analysis in mid 28, with the filing of the BLA as quickly as possible based on the results of those interim or final analysis. So it really is focused on covering ALPHA-3 as well as completing this phase 1 resolution study for ALLO-329.

As we indicated, having the comprehensive data set in the fourth quarter of this year.

David D. Chang: Yeah. And let me take the question on the optionality of fludarabine. I think this is just how we try to make the protocol as flexible as possible, you know, without predefined idea about when to kick in this optionality. Mean, it is really looking at the data and then making the decision.

Zachary J. Roberts: Right now, based on the data, primary focus is continuing the dose escalation. And I will just add 1 other piece of color on that. Honestly, there, 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. So that is another factor that could come into it. But nothing has changed at all about our belief in the Cy or no Cy possibility here. So we are continuing with that primary goal.

Operator: Thank you. And our next question comes from Matt Phipps of William Blair. Your line is open.

Analyst (Matthew Phipps): Good afternoon. Thanks for taking my question. A lot is going to be on for you tonight as well. there is 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. And I guess do you expect maybe some ability to have an immune auto reactive T cell reset. Following 03/2004? Thank you.

Zachary J. Roberts: 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 zero whether there is 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 zero to be higher because you know, we are targeting, a pan B cell marker.

The case of CD70, you are absolutely correct. it is only a subset that are gonna be CD 70 positive. Of course, there is going to be a population of alloreactive cells that we expect to be depleted through the dagger effect. But there is also known to be CD 70 positive pathogenic AID causing T cells So clonal populations with specific TCRs that also express CD70. And that has actually been 1 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. And so we will be analyzing the T cell repertoire as part of the ALLO-329 study.

And if we have got something to share in Q4, we will share it. Thank you.

Operator: And our next question comes from Jack Allen of Baird. Your line is open.

Analyst (Jack Allen): Great. Thanks so much for taking the questions and congrats on the progress. I will keep the theme going with the ALLO-329 questions to start, and then I have 1 on Semiso as well. On ALLO-329, I was just hoping you could provide some additional color as it relates to how many doses you could escalate the study in and 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?

And then on SemiCell, I just wanted to ask about the interim EFS look in mid 27 and any additional color you can provide around the powering there.

Zachary J. Roberts: So, Jack Allen, great question. The next dose level that we are going to be looking at is not 60, it is actually 80. 80 million cells. So that cohort is enrolling now. Following Cy, and then the no Cy cohort is close behind. I am gonna hold off on saying exactly how many cell doses that we plan to go up, and we will sort of reveal that at Q4 because I do think that we will be in that zone, by the time we get that update. So stay tuned. But 80 million is the next dose cohort that we are working on now.

As far as SemiCell, we talked quite a bit about this, with the fundraising and the alpha allocation for the IA2? Know, we have not gone into specific detail. The method that we used to allocate the alpha with the O'Brien-Fleming spending function. So that will give you some general understanding of the fraction of alpha that is allocated to the IA2. I will take the opportunity now to reiterate, though, that, you know, the results of the interim analysis, 1, does give us the possibility of having a positive outcome in IA2. And so that is something we are, looking forward to and, of course, working feverishly to enroll the study and deliver on those timelines. Awesome.

Thanks so much for the color.

Operator: Thank you. And our next question comes from John Newman of Canaccord Genuity. Your line is open.

Analyst (John Newman): Hi, guys. Thank you for taking the question. Also have 1 on ALLO-329. The question is, do you expect that the dagger technology that targeting CD70 positive T cells could actually give you maybe differential efficacy in some of the cohorts that you are enrolling versus lupus, for example, scleroderma and myositis where it is sort of theorized that there is more T cell activity. Thanks.

Zachary J. Roberts: John, great question. As usual, thank you for the insight. And the answer is yes. So not just within these rheumatologic disorders, where T cells are known to play a role and there is literature on it. But, of course, there are lots and lots of papers and understandings 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.

And so not only within this initial set do we think we 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. Great. Thank you.

Operator: Thank you. And our next question comes from Reni Benjamin of JMP Securities. Your line is open.

Analyst (Reni Benjamin): Guys, thanks for taking the questions. Maybe just starting off with the interim analysis. Now that you have been able to, you know, kind of sit on the data with the futility analysis, do you feel that this delta that you are seeing increases the chances of a successful interim mid 27 versus what you were thinking when you first started the study. And 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?

And then regarding ALLO-329, as we kind of look at the landscape, look at autologous therapies and bispecifics, can you maybe just guide us as to what is the clinical sort of efficacy and safety benchmarks you are hoping to hit, hoping to meet so that you can move the program forward. And does this program move forward ideally with a partner or do you think you do this on your own? Thanks.

David D. Chang: 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 or the powering for the interim analysis has gone up quite a bit. I mean, that really goes down to we have said that the study was designed to demonstrate a hazard ratio of 0.5 But the MRD clearance as we extrapolate based on the existing data, leads us to a potential hazard ratio of 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 Zachary has pointed out, leading to a statistical significance. Is very significant.

So, we will just have to wait and see. And your second question about would we consider amending the protocol? I think that probably is not something that would be you know, that is needed or that will be good to do at this point. I mean, I think the best course is just sticking with the original study plan.

Zachary J. Roberts: And then the question around where does this fit in the evolving landscape we actually feel really good about that. Mhmm. And 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 patient regimens.

So 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 semicell 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 Semi Cell in a consolidation setting. So we actually feel like we have threaded the needle very well with ALPHA-3, and are somewhat insulated from all of that competition in the early lines.

David D. Chang: So, Reni, does that answer your question, or was the question on ALLO-329?

Analyst (Reni Benjamin): That was that last 1 that Zachary answered was on ALLO-329. In particular, just trying to get 1.

David D. Chang: Yeah. Sorry about that. So let me just answer the question on the ALLO-329. The profile that we are looking for is something that can be administered as an outpatient. and the patient managed as an outpatient. And also, you know, And, you know, plus, on top of that, the nature of the CAR T is that this will be a 1-time treatment with a possibility of redosing several years down the line if the symptoms were to come back. So, that is the profile that we believe will remain very competitive when you think about other emerging modalities that are coming in the T cell approach towards the autoimmune indications. Thank you.

Operator: And our next question comes from Brian Cheng of JPMorgan. Your line is open.

Analyst (Brian Cheng): Hi, guys. Thanks for taking our question this afternoon. Just a quick 1 from us. Can you talk about the rationale of updating the autoimmune Resolution data updates from June to Q4? Is that a physician data-driven decision, or are there other considerations? Thanks for taking our question.

David D. Chang: Brian Cheng, let me take the question. I think our intent is to provide data update in a very--. In terms of the maturity of the data, and what we have now, I think what we can say is enrollment is very robust. And also there are, you know, very, you know, sort of interesting signs of clinical activity. I do not think-- you know, definitely, I think it is for now. And as we dose escalate, keep in mind, we intentionally started the study with very conservative dose to ensure the patient's safety. So you know, 20 million, I think there was an earlier question about whether they may have been low.

In my view, it probably was lower than what was necessary. And as we dose escalate and certainly we are going through those levels that in other programs that we have done, you know, 80 million or 1 hundred and 20 million is sort of the range that we have seen activities in programs like ALLO-316 and SemiCell. So, we are getting to that dose range and as we update the data in fourth quarter, we will have patients treated at the dose that may be more in the right range, but, you know, definitely we are enrolling this study rather briskly, and we will have a lot to talk about in fourth quarter. Great. Thank you.

Operator: Thank you. That concludes our question and answer session. I would like to turn the conference back over to management for any additional comments.

David D. Chang: All right. Thank you. We said at the onset that this would be the year of defining proof and ALPHA-3 interim analysis represents an important first step. The signal we see today must be validated through EFS but it provides early support for a fundamentally different approach to CAR T, 1 that is earlier, more accessible, and potentially scalable. Our focus now is execution, completing ALPHA-3 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.

Operator: 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.

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