ALLO

A month has gone by since the last earnings report for Allogene Therapeutics (ALLO). Shares have lost about 11.1% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Allogene Therapeutics due for a breakout? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Allogene Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Allogene incurred a second-quarter 2026 loss of 13 cents per share, narrower than the Zacks Consensus Estimate of a loss of 16 cents. Lower R&D spending supported the narrower loss. In the year-ago period, the company reported a loss of 23 cents.The company recorded $4.6 million in collaboration revenues from related parties. It did not record any sales in the year-ago period. R&D expenses were $30.7 million, down 23.5% year over year. In contrast, general and administrative (G&A) expenses rose 45.9% to $20.8 million. As of June 30, 2026, cash, cash equivalents and investments totaled $423.6 million compared to $266.9 million in the previous quarter. This uptick was due to the completion of a public offering in April that generated gross proceeds of $200.4 million. Based on its June-end liquidity, management expects a cash runway into 2029.The company maintained operating expenses guidance for full-year 2026 at about $225 million, including non-cash stock-based compensation expense of nearly $35 million. In the past month, investors have witnessed a upward trend in fresh estimates. The consensus estimate has shifted 22.89% due to these changes. At this time, Allogene Therapeutics has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. However, the stock was allocated a score of F on the value side, putting it in the lowest quintile for value investors. Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Allogene Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Allogene Therapeutics belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Rocket Pharmaceuticals (RCKT), has gained 4.2% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Rocket Pharmaceuticals reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.15 for the same period compares with -$0.59 a year ago. Rocket Pharmaceuticals is expected to post a loss of $0.38 per share for the current quarter, representing a year-over-year change of +15.6%. Over the last 30 days, the Zacks Consensus Estimate has changed +5.9%. Rocket Pharmaceuticals has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report Rocket Pharmaceuticals, Inc. (RCKT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 5 p.m. ET Chief Corporate Affairs and Brand Strategy Officer - Christine Cassiano President and Chief Executive Officer - Zachary Roberts Chief Financial Officer - Geoff Parker Operator: Hello. Thank you for standing by and welcome to Allogene Therapeutics second quarter 2026 conference call. [Operator Instructions] 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: 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 second quarter of 2026. This press release and today's webcast are available on our website. Following brief prepared remarks from Dr. Zachary Roberts, President and Chief Executive Officer, we will open the call for questions. Geoff Parker, Chief Financial Officer, will also join the Q&A. To help us conclude within 45 minutes, we ask that each analyst limit themselves to one question. 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, the potential treatment setting, 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'm going to turn the call over to Zach. Zachary Roberts: Thanks, Christine, and good afternoon, everyone. This is my first quarterly call as CEO, and it marks the beginning of a new chapter for Allogene, one made possible by the foundation David Chang helped build. David has been my mentor and one of the people who has most shaped how I think about cell therapy and drug development. More than that, he co-founded and built this company, led the field in the generation of clinical data in patients with relapsed cancer, and created the framework we needed to take Allogene into its next chapter. When I joined Allogene, my mandate was clear. Challenge the conventional thinking about how allogeneic CAR-T should be developed. That meant starting with the patient and working backward. Understand what patients and their care teams need, then design products and clinical programs that meet those needs. That work led to a deliberate strategic shift announced in 2024, designing programs and products that leverages features of the allogeneic cell therapy into a clinical advantage. We focused on settings that demand the unique attributes of off-the-shelf CAR T, ready availability, consistent product quality that is independent of the patient's immune status, and crucially, the ability to treat patients locally. Allogeneic CAR T is not a stepping stone between autologous therapy and whatever may come next. It is a distinct platform capable of filling gaps existing modalities cannot and progress across ALPHA3, ALLO-316 and ALLO-329 is beginning to demonstrate those advantages in practice. I will start with ALPHA3 because it is the clearest expression of this strategy. ALPHA3 arose from a simple premise. Can we identify patients at high risk of relapse after first-line treatment and intervene with CAR-T before the disease returns clinically? By treating earlier, the study aims to prevent relapse while avoiding much of the toxicity associated with standard second-line therapies, including autologous CAR-T. The trial is also designed to prove that we can overcome longstanding access barriers by enabling patients to receive CAR-T where they already received their first-line care in the community with the same doctors who gave them their first-line treatment. Testing this required a more precise way to identify patients at high risk of relapse. Standard methods used at diagnosis, such as disease stage and IPI, lack sufficient specificity because many patients classified as high risk by those methods are still cured with R-CHOP. That new tool emerged just weeks before I joined Allogene. When I saw the Foresight now Natera CLARITY data presented at ASH 2022, the design of ALPHA3 came into focus. When ALPHA3 began, MRD in large B-cell lymphoma was viewed largely as an academic research tool. We believed it could become far more a standard marker patient's prognosis and, if properly validated, a new treatment decision point. That view is gaining traction not only in LBCL but across oncology. In May, the FDA approved Tecentriq as adjuvant therapy for patients with bladder cancer who are in radiographic remission but remain MRD positive by circulating tumor DNA. The approval, based on the IMvigor011 study, is the first where patient selection was based solely on a ctDNA MRD test. IMvigor011 closely parallels ALPHA3's design and this approval, as well as a new Category 1 NCCN recommendation, signals a broader shift toward using MRD as a treatment decision trigger rather than waiting for clinical relapse. Fast forward to our first look at data from the ALPHA3 trial in April, the interim futility analysis, which provided an important early test of ALPHA3's hypothesis. Cema-Cel drove rapid MRD clearance in a majority of patients and did so with no treatment-related hospitalizations. Most patients were treated and followed entirely in the outpatient setting. And importantly, Cema-Cel was successfully delivered in community practices with no prior CAR-T experience. Together, those findings support ALPHA3's potential to change the lymphoma landscape by offering CAR-T earlier with less logistical burden and greater access across more treatment settings. At the end of July, the FDA granted both RMAT and Fast Track designations for Cema-Cel in first-line consolidation. These designations are based on two critical points. First, FDA acknowledges that MRD positivity at the end of first-line treatment is an unmet medical need. And second, Cema-Cel has the potential to meet that need. need. We interpret this action by FDA as validation for the ALPHA3 program. Additionally, RMAT creates an important opportunity for more frequent and focused engagement as we advance the trial. That engagement will be central to how we move forward. Our objective is clear. Execute the study well, protect its integrity, and work with the FDA toward the most efficient development and regulatory path. As enrollment continues, we expect opportunities in 2027 to update investors on the program, including enrollment progress and potential data such as the planned interim EFS analysis. The timing and scope of these updates will of course be guided by our regulatory discussions and the independent data monitoring committee. In the meantime, we will communicate meaningful operational and regulatory progress. Today we are proud to provide one such operational update. We entered the year with a goal of activating over 80 clinical sites by year end. With strong execution by the team and increased investigator interest following the interim futility analysis, we reached that goal in July. New academic and community-based investigators have asked to join the trial, citing enthusiasm for the initial MRD clearance data and safety profile and growing momentum of MRD testing in lymphoma. As a result, we now expect to have approximately 100 sites active by year end with the significant majority in the United States and additional sites in Canada, Australia, and South Korea. This expansion reflects growing investigator conviction in MRD and the ALPHA3 strategy, supports enrollment momentum, and gives more sites hands-on experience with Cema-Cel's ease of use ahead of a potential commercial launch. Turning to ALLO-316, the publication of the TRAVERSE results in the Journal of Clinical Oncology was an important milestone for the program and the Dagger platform. Solid tumors have been CAR T's hardest test. In patients with CD70 high renal cell carcinoma, ALLO-316 produced a 31% confirmed overall response rate the optimized regimen. At the data cutoff, none of the five confirmed responders had experienced disease progression, with follow-up ranging from eight months to more than 18 months after a single dose of ALLO-316. The data set is small, and the program has faced real safety challenges. We've been direct about both. But consistently, confirmed responses with this degree of durability in a solid tumor are notable. Just as important, the translational work gives us a much clearer view of the underlying biology of these responses using CAR T-cell expansion, persistence, tumor infiltration, and the contribution of Dagger. TRAVERSE also demonstrates how we operate. There were moments when the conventional decision would have been to stop development of ALLO-316. When toxicity emerged, our team brought in outside experts, engaged with the FDA, developed the management algorithm and continued learning. That work gave us a pathway to manage the most serious events while advancing understanding of an increasingly recognized immunotherapy toxicity and allowed us to generate the foundational clinical evidence for our Dagger technology pipeline. We are still far from declaring victory in solid tumors, but these results provide encouragement to keep pushing. They move the field forward and reinforce the principle that is central to allergy. When the biology is sound, we stay focused, learn from the data, and continue advancing the science. That same focus on thoughtful program design brings me to ALLO-329 and the RESOLUTION trial in autoimmune disease, where the core message is execution. Enrollment has moved quickly across cohorts, dose levels, and lymphodepletion strategies, even in a highly competitive field. We believe that momentum reflects a program designed with patients as the focus rather than one that asks them to adapt to the technology. ALLO-329 was designed with Dagger from the outset. Rather than designing another CAR-T product that requires chemotherapy-based lymphodepletion to work, the product is designed to function better when confronted by the biology of allo rejection by targeting the activated host T cells that contribute to it. Our objective is to both identify the optimal dose regimen for ALLO-329 and to understand how its cell dose, lymphodepletion, and Dagger work together. Strong enrollment and execution are keeping us on track to report a clinical and translational update by year end. Across all three programs, the through line is clear. We embrace the features of allogeneic CAR-T as unique strengths and have designed programs to allow us to meet the demands of patients when and where they arise. Over the next 12 months, we expect the value of that work to become increasingly visible, beginning with an ALLO-329 update by year-end and opportunities to update investors on ALPHA3 throughout 2027. Those milestones will help define our progress, but the standard we are working toward is simpler. Innovation only matters if patients can actually access it. We'll now open the call for questions. Operator: [Operator Instructions] Our first question comes from Michael Yee of UBS. Unknown Analyst: Hey, good afternoon, guys. This is Matt on for Mike. Thank you so much for taking your questions. I wanted to add, I saw you guys added an observational cohort to the ALPHA3 study, and I just wanted to ask about kind of the design of this cohort, maybe what the goal of it is, and kind of the questions you're helping to answer. It looks like it's an MRD negative patient. So just to kind of expand on kind of what the goals are. I'm wondering how we could just show what that observational cohort might be. Zachary Roberts: Thank you so much. Matt, thanks for the question. So it's pretty straightforward. We added this cohort to help provide context for the overall results of ALPHA3 looking at the MRD-positive patients. Of course, those are the ones that we randomized now into ALPHA3, so having a paired MRD-negative cohort using essentially the same patient population as this is coming into ALPHA3 itself, will give that ability to compare outcomes in the observational cohort of the MRD positive patients as ALPHA3 with the MRD negative patients as well. So really it will give us the ability to further characterize the test itself in a prospective manner. Operator: Our next question comes from Tyler Van Buren of TD Cowen. Tyler Van Buren: Congratulations on your first call as CEO, Zach, and I appreciate the efficient prepared remarks. I guess given the acceleration of site activation by six months, is it possible that the interim EFS analysis could occur earlier than the guided mid-2027 timeline? Zachary Roberts: Thanks for the question, Tyler, and thanks for the congratulations. It's a thrill to be CEO and it's an honor. So getting to your question, so we are currently maintaining guidance that the EFS should occur at roughly the same time as previously guided. We are just moving to try to accelerate the enrollment of the study and of course working very hard to bring on as many sites for the reasons stated in the prepared remarks. But at this time we're not making any adjustments to the expectation of data availability. Operator: Our next question comes from Salveen Richter of Goldman Sachs. Unknown Analyst: Hey, this is Mark on for Salveen. Thanks so much for taking our question and congrats on the progress. It was good to see the enrollment for ALPHA3 post the interim data. Could you give us a breakdown of enrollment cadence across academic versus community sites? Is the expectation still that it's going to be 1/3 community and 2/3 academic and what feedback are you hearing from the community physicians? Zachary Roberts: Without getting too specific here, I would say that the interest continues to be very high and growing in both the academic corners as well as the community corners. I would say that, that the surge of interest that we did see after the interim data really was pretty balanced between the two. We had some pretty big names centers reach out to try to join. And then we've got quite a number of community practices that also ask to join. So as far as how the patients break down in terms of where they come from, we actually have, I don't know if we've stated previously that it's about a third is expected. That's what we did see in the interim futility analysis. analysis, which was a very great outcome for us. I think that if we can maintain that or even bring it closer to parity in the final analysis, that would be something that we would be interested in doing. And that really does, I think, capture the last part of your question, which I believe was around what we're hearing from the various docs about the program. I think everything that we heard early on when we launched the study and even before that when we were just talking about it with sites is that the community practices view this as really the best and first true opportunity to access CAR-T for their patient populations. And the academicians, on the other hand, you know, are very excited about, you know, cutting edge technologies, serving their patients in ways that improve the benefit-risk profile, ideally preventing relapse, which everybody universally agrees is a bad outcome. So, across the board, we continue to hear very strong conviction that this strategy is excellent for patients, and then from the community practices specifically, enthusiasm around gaining access to CAR T, which has been out of their reach from the beginning. Operator: Our next question comes from Samantha Semenkow of Citi. Samantha Semenkow: Zach, let me add my congratulations on your first call as CEO. So just another one on ALPHA3. As we look forward to the interim EFS analysis mid-next year. Just wondering how we should think about that analysis in terms of the potential for overwhelming benefit to be demonstrated. If the interim MRD assessment that we saw is repeatable for with more patients. How likely is that to translate into a stat-sig benefit on EFS at the interim analysis? Thank you. Zachary Roberts: Thanks, Samantha, and it's a great question. So, as we went into some detail when we released the data in April, the strong MRD clearance data that we observed we did think was quite positive and gave us some very positive views on the potential outcome of the study, either at the interim EFS or at the primary analysis. We also detailed that because of the way that we've allocated the alpha between those two EFS analyses, that it would require overwhelming efficacy to achieve statistical significance at the midway point there at the EFS, the interim EFS analysis. You know, we can't really go into further detail around, you know, whether about how we're thinking about the likelihood of that statistical significance, except I will reiterate that prior studies such as the, the TRANSFORM study of Breyanzi illustrated that a 24% MRD clearance differential between the CAR T and the transplant arm translated into a greater than 60% improvement in the EFS between those two arms. So a very, very positive outcome there on a comparatively lesser differential in the MRD clearance rate. So we remain very excited about the potential for a positive outcome here, but going into any further detail around how that might play out at the EFS analysis that is currently planned for middle of next year. I don't want to get too far ahead of myself on that one. Operator: Thank you. And our next question comes from Matt Phipps of William Blair. Unknown Analyst: Hey team, this is Josh on for Matt. Thanks for taking my question and congrats on such a good quarter. So I had a question on the RESOLUTION readout as it approaches. We were wondering what kind of data and the level of granularity that we should expect from the readout later this year. Zachary Roberts: Thanks, Josh. So for the RESOLUTION trial, the data that is -- the data readout that we're currently planning for quarter 4 of this year, we expect to share clinical and translational data. I'll reiterate what was contained in the prepared remarks that we continue to be very pleased with the way enrollment is going. At the last call last quarter, we announced that we had treated nine patients in both the LD and non-LD containing arms. We have continued to see very robust demands to put patients into the study, so we should have a nice number of patients by the time we share that data in quarter 4, and then that will feature, of course, safety and efficacy outcomes as well as the translational findings. Operator: Thank you. And our next question comes from Cha Yang of Jefferies. Cha Cha Yang: This is Cha on for Roger. Congrats on the quarter as well. Just a question on the 329 trial with the data coming in fourth quarter. Just wondering if your guidance has changed in terms of the dose groups that you're going to announce. Are we still expecting the 20 million, 40 million and 80 million doses or is there any change? Zachary Roberts: Thank you, Cha. So those are indeed the first three dose levels or the first two dose levels. We also will be dosing patients with 80 million. And this, you know, there are additional doses above that are contemplated within the protocol. So as far as we get in that dose escalation, that will be the day. data that we share, but at least those three dose cohorts, 20 million, 40 million and 80 million, will be included. Operator: Our next question comes from Jack Allen of Baird. Your line is open. Jack Allen: Congrats on the progress over the quarter. I want to extend my congratulations to Zach on the new role. Really great to see you on the quarterly call here. My question is around the RMAT and Fast Track designations that you were able to secure over the course of the quarter. My understanding is that for RMAT specifically, there's a need to share clinical data when available with the FDA, and I'm just curious if you could provide any more context around what data was shared with the FDA. Was it really the April MRD data? Or were there additional clinical data that were shared with the FDA? And then also kind of in the same vein, what aspects of the data set were most intriguing from the FDA's perspective? Was it the efficacy? Was it the safety? Or was it a combination of the two? Any context you can provide would be very helpful. Zachary Roberts: Thanks, Jack. Yes, we were thrilled to receive those designations. RMAT, as you point out, is it does in fact require clinical data. It's very similar to breakthrough therapy designation. And so the clinical data that we provided was derived from that interim analysis that we shared back in April. And of course, what we share with regulators, generally speaking, is quite a bit more extensive than what is shared publicly outside of the company. And so this was a complete briefing package that went into all the information. available detail that we had. Again, EFS at the time, the actual events were blinded and they remained blinded to us. So this was really focused on the MRD results, but additional detail around the MRD was provided to the FDA and of course, an exhausted safety package also. In the FDA's decision, to award RMAT or not, they generally don't go into details about which aspect of the package was most enticing to them or most influential in their decision, but just generally that number one, that the disease under study, in our case MRD-positive large B-cell lymphoma represents an unmet medical need, which I really want to highlight as a pretty important thing for them to have pointed out, that this trial and this data set was even eligible for RMAT designation was predicated on that very fact, that MRD positivity is an unmet need. And then critically, of course, that MRD... Based on the data that they reviewed, Cema-Cel has the potential to meet that unmet medical need. So for those reasons, they decided to give us RMAT, but any further granularity, they did not provide. Operator: And our next question comes from John Newman of Canaccord, who line is open. John Newman: Congrats on the excellent progress. The question is, given the very impressive pace of enrollment for ALPHA3 and the increased target of enrollment sites to 100 by the end of the year. Are you open to the possibility of enrolling additional patients beyond the current target? Zachary Roberts: Thanks, John. The short answer is we are going to try to find as many ways that we can in the context of an ongoing study to offer enrollment to patients who meet the eligibility criteria for ALPHA3. Within the confines of ALPHA3 as written, the target is the target, 220 patients randomized into the two arms and generally speaking you don't want to go much above that until data is available to suggest a benefit-risk ratio that is permissive of over-enrollment. However, if additional opportunities along the way present themselves to add cohorts or explore other nuances within this broader field. those things will be considered in due time. But as the time sits right now, our target is 220. Operator: Our next question comes from Luca Issi of RBCCM. Unknown Analyst: Adding our congrats to Zach and team on successful transition This is Cassie for Luca. Quick question on the 329. As Zach, you mentioned that dosing started for the lymphodepletion arm. Are you hearing any early anecdotes for CAR T expansion or persistence in patients treated with cyclophosphamide? And what positive signs are you looking for here at the 4Q update for this specific arm? Should we be thinking non-inferior or any specific benchmark. Any color, they're much appreciated. Zachary Roberts: Thanks, Cassie. So, you know, we were, as all phase one, first in human studies are, they are primarily a safety trial. So this is why we started a low dose and go up, and really we're monitoring most closely the safety outcomes and then making decisions about whether the dose escalate, dose expand. at additional cohorts, what have you. So we are collecting all of the safety information and we meet as a team with outside advisors prior to dose escalation. So that is the most important and comprehensive data package that we review in real time. We obviously are in close contact with the investigators around the efficacy and so, you know, as in previous statements, we've talked about encouraging signs of activity in that program and so, you know, I'll reiterate that now here is that we continue to have very robust interest and demand from investigators and patients to come in. on what we're seeing so far. As far as the translational data goes, those data are developed sort of in parallel and typically in batches. But so we do not, you know, we're not in a position to comment on the translational findings here today, just that we will be including those findings in the upcoming fourth quarter data release. Operator: Our next question comes from Reni Benjamin of Citizens. Reni Benjamin: Zach, congratulations on the new role. I guess I jumped in late. I hope this hasn't already been asked, but I'm interested in the competitive landscape as it continues to evolve and how you guys are kind of thinking about things and managing it, in particular, you know, not just the frontline study for autology CAR-T's that are being evaluated but also the recent Legend in vivo CAR-T data. I would love to kind of get your thoughts as to how you manage these things. Zachary Roberts: Thanks, Reni, for the question and for the congrats. So, great question. Thanks for asking it. It had not been asked prior to you joining, so good opportunity for me to dive in a little bit on that. So, obviously, we monitor the competitive landscape across our portfolio very, very carefully. And one of the things that we've enjoyed and continue to enjoy, I believe, is a pretty well protected place within this first line consolidation for ALPHA3. Nobody else has entered this space explicitly in that way yet. And the upfront, the first line studies that are ongoing, you mentioned CAR-T, but of course there's other specific pivotal studies as well. You know, we've looked at this very carefully both through conversations with PIs and investigators that are involved in the studies and those that are not. And then we've also performed some fairly extensive blinded market research. And our conclusion from that, those ongoing frontline studies is that they'll actually have a fairly minimal impact on the overall rate of MRD positivity in the immediate post-frontline setting. And that's primarily because both the CAR T cells and the bispecifics tend to carry a fairly significant toxicity profile. They're a bit cumbersome. some for patients and with some of them needing step-up dosing and even prospective hospitalization just to administer the therapy. So this is largely, in my view and in the view of the respondents to our study, will probably be reserved for select patients and select centers. So by and large, being that most patients, 80% or more, are treated in the community practices, the MRD rate is likely to stay pretty much where it is, primarily driven by outcomes following R-CHOP and R-Pola-CHP. With respect to the question around in vivo, And my view on this, and I think this has been validated through several conversations I've had, is that obviously an extremely exciting platform for the field and for patients, but likely I believe it will primarily suffice to replace autologous CAR T in the relapsed refractory setting, again pointing primarily to the toxicity profile, at least in the early days here, unless that gets markedly better, most community oncologists are not going to be enthusiastic about administering a large dose of active viral particles into patients during a busy clinic afternoon. So, it feels like this is an opportunity for really, an off the shelf CAR T being available to community oncologists. They can give it in their infusion clinics over five minutes and the patients can be reasonably assured to go home without having much toxicity. At least that's the intention of ALPHA3. So clearly a lot of activity both upstream from us as well as downstream from us with the in vivo, but we think we're pretty well protected here right in the middle. Operator: Thank you. That concludes our question-and-answer session. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may now log off and disconnect. Before you buy stock in Allogene Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Allogene Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* Now, it’s worth noting Stock Advisor’s total average return is 966% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 19, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Allogene (ALLO) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Allogene Therapeutics ALLO incurred a second-quarter 2026 loss of 13 cents per share, narrower than the Zacks Consensus Estimate of a loss of 16 cents. Lower research and development (R&D) spending supported the narrower loss. In the year-ago period, the company reported a loss of 23 cents. Allogene recorded $4.6 million in collaboration revenues from related parties. It did not record any sales in the year-ago period. Shares of Allogene were up in after-market trading yesterday, likely due to the better-than-expected results. Year to date, the stock has risen 51% compared with the industry’s nearly 6% growth. Image Source: Zacks Investment Research R&D expenses were $30.7 million, down 23.5% year over year. In contrast, general and administrative (G&A) expenses rose 45.9% to $20.8 million. Total operating expenses declined 9.3% to $51.6 million. As of June 30, 2026, cash, cash equivalents and investments totaled $423.6 million compared with $266.9 million in the previous quarter. This uptick was due to the completion of a public offering in April that generated gross proceeds of $200.4 million. Based on its June-end liquidity, management expects a cash runway into 2029. The company maintained operating expenses guidance for full-year 2026 at about $225 million, including non-cash stock-based compensation expense of nearly $35 million. Allogene’s main focus is the pivotal phase II ALPHA3 study, which evaluates the lead drug cema-cel as a potential first-line treatment for patients with newly diagnosed large B-cell lymphoma (LBCL) who are likely to relapse and require further therapy. In April, the company reported an interim futility analysis from the study, showing 58.3% MRD negativity at day 45 in patients treated with cema-cel versus 16.7% with observation. Management reported no treatment-related serious adverse events at the cutoff and said most patients were managed on an outpatient basis. The company surpassed its 2026 goal of activating more than 80 ALPHA3 sites about six months early. It now expects approximately 100 sites to be active by year-end, with most in the United States and additional locations in Canada, Australia and South Korea. Despite faster site activation, Allogene still expects to provide an interim analysis on the primary endpoint of event-free survival (EFS) in mid-2027. The ALPHA3 study is expected to randomize about 220 participants, with enrollment anticipated to be completed by year-end 2027. The company is also exploring the potential of allogeneic CAR T cell therapies in autoimmune diseases. It is enrolling patients in the phase I basket study (called RESOLUTION) evaluating ALLO-329 across autoimmune indications, including systemic lupus erythematosus, idiopathic inflammatory myopathies and systemic sclerosis. With enrollment remaining brisk, Allogene expects a clinical and translational data update in the fourth quarter of 2026. Management said the readout should include at least the 20-million, 40-million and 80-million cell-dose cohorts, along with safety, efficacy and translational findings. Allogene currently carries a Zacks Rank #3 (Hold). Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote Some better-ranked stocks in the biotech sector are Anika Therapeutics ANIK and Repligen Corporation RGEN, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 30 days, earnings per share (EPS) estimates for Anika Therapeutics have risen from 41 cents to $1.05 for 2026. Over the same period, EPS estimates have increased from 46 cents to 95 cents for 2027. ANIK shares have skyrocketed 129% year to date. Anika Therapeutics missed on earnings in each of the trailing four quarters, delivering an average surprise of 950%. Over the past 30 days, estimates for Repligen’s 2026 EPS have increased to $2.06 from $1.99. Over the same period, EPS estimates for 2027 have risen from $2.57 to $2.62. RGEN shares have gained 1% so far this year. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is transitioning from a 'stepping stone' view of allogeneic CAR-T to a distinct platform strategy focused on settings where off-the-shelf availability and local community treatment provide a clinical advantage. The ALPHA3 program is built on the premise that identifying high-risk patients via Minimal Residual Disease (MRD) allows for intervention before clinical relapse, potentially avoiding the toxicity of standard second-line therapies. The FDA's recent approval of an MRD-based adjuvant therapy in bladder cancer is cited as a critical regulatory precedent that validates using circulating tumor DNA as a treatment decision trigger. Interim futility data for Cema-Cel demonstrated rapid MRD clearance with zero treatment-related hospitalizations, supporting the feasibility of a purely outpatient, community-based CAR-T model. The company reached its year-end goal of 80 active clinical sites by July, driven by increased investigator interest following the interim safety and efficacy results. Management attributes the success of the TRAVERSE trial in solid tumors to a management algorithm that allowed them to navigate serious toxicities while generating foundational evidence for their Dagger technology. The company increased its year-end site activation target to approximately 100 sites, with a significant majority located in the United States to support enrollment momentum. A clinical and translational update for the ALLO-329 program in autoimmune disease is on track for the fourth quarter of 2026, covering at least three dose cohorts. Management expects the planned interim Event-Free Survival (EFS) analysis for ALPHA3 to occur in mid-2027, maintaining previous timelines despite accelerated site activation. The RMAT designation for Cema-Cel is expected to facilitate more frequent FDA engagement to define the most efficient regulatory path for MRD-positive large B-cell lymphoma. Future updates for the ALPHA3 program throughout 2027 will be guided by regulatory discussions and the independent data monitoring committee to protect study integrity. The FDA granted RMAT and Fast Track designations for Cema-Cel, which management interprets as formal validation that MRD-positivity at the end of first-line treatment is an unmet medical need. The TRAVERSE results for ALLO-316 in renal cell carcinoma showed a 31% confirmed overall response rate, though management acknowledged the program has faced 'real safety challenges' and serious toxicity events. Management noted that while in vivo CAR-T platforms are emerging, they believe these will primarily compete with autologous CAR-T in relapsed settings rather than the frontline consolidation space targeted by Allogene. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The cohort was added to provide prospective context by comparing outcomes of MRD-negative patients against the randomized MRD-positive patients in the main study. This will allow the company to further characterize the predictive value of the Natera CLARITY test within the specific ALPHA3 patient population. Management clarified that achieving statistical significance at the interim point would require 'overwhelming efficacy' due to the specific alpha allocation in the study design. They referenced the TRANSFORM study, noting that even a 24% MRD clearance differential previously translated into a 60% improvement in EFS, providing a benchmark for their optimism. Management expects minimal impact on their target market because existing frontline CAR-T and bispecifics have high toxicity and logistical burdens (e.g., step-up dosing) that limit community adoption. Since 80% of patients are treated in community practices, Allogene believes their five-minute infusion profile maintains a 'well-protected' position in the treatment landscape. The current randomization target remains 220 patients; management stated they generally do not over-enroll until data suggests a permissive benefit-risk ratio. However, they expressed openness to exploring additional cohorts or nuances in the field as the study progresses.

This article first appeared on GuruFocus. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Allogene Therapeutics Inc (NASDAQ:ALLO) received FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for its lead candidate, stemmacel, in first-line consolidation for large B-cell lymphoma, validating the Alpha 3 program's approach. The Alpha 3 trial exceeded its site activation goal, now expecting approximately 100 active sites by year-end, reflecting strong investigator interest and supporting enrollment momentum. Interim data from the Alpha 3 trial showed stemmacel drove rapid MRD clearance in a majority of patients with no treatment-related hospitalizations, demonstrating its potential for outpatient and community-based administration. ALLO316's TRAVERSE results, published in the Journal of Clinical Oncology, showed a 31% confirmed overall response rate in CD70-high renal cell carcinoma, with durable responses lasting over 18 months in some patients. Enrollment for the ALLO329 RESOLUTION trial in autoimmune disease is progressing quickly across multiple dose levels and lympho-depletion strategies, keeping the program on track for a clinical and translational update by year-end. The interim EFS analysis for the Alpha 3 trial is still expected around mid-2027, with no acceleration despite faster site activation, and it would require overwhelming efficacy to achieve statistical significance at that point. The ALLO316 solid tumor data set is small, and the program has faced real safety challenges, including serious toxicity events that required management algorithms and FDA engagement. The company acknowledges it is 'still far from declaring victory in solid tumors,' indicating significant uncertainty remains for the ALLO316 program. Management is not open to enrolling additional patients beyond the current target of 220 in the Alpha 3 trial, limiting potential to capitalize on the high enrollment interest. The company faces a competitive landscape with autologous CAR-T and in-vivo therapies, which could impact the adoption and differentiation of its allogeneic approach in the future. Warning! GuruFocus has detected 3 Warning Signs with ALLO. Is ALLO fairly valued? Test your thesis with our free DCF calculator. Q: Given the acceleration of site activation by 6 months, is it possible that the interim EFS analysis could occur earlier than the guided mid-2027 timeline?A: Zachary Roberts, President and CEO, stated that the company is maintaining its guidance that the EFS analysis will occur at roughly the same time as previously guided. While they are working to accelerate enrollment and activate more sites, they are not making any adjustments to the expectation of data availability at this time. Q: Could you provide a breakdown of enrollment cadence across academic versus community sites? Is the expectation still 1/3 community and 2/3 academic, and what feedback are you hearing from community physicians?A: Zachary Roberts noted that interest is high and growing in both academic and community settings, with the surge in interest after the interim data being balanced between the two. The breakdown from the interim futility analysis was about 1/3 community, which they view as a great outcome. Community practices see this as the first true opportunity to access CAR T for their patients, while academicians are excited about the cutting-edge technology and improved benefit-risk profile. Q: As we look forward to the interim EFS analysis mid-next year, how should we think about the potential for overwhelming benefit if the interim MRD assessment is repeatable with more patients? How likely is that to translate into a statistical benefit on EFS at the interim analysis?A: Zachary Roberts explained that the strong MRD clearance data from April gave them positive views on the potential outcome. However, due to the alpha allocation between the two EFS analyses, it would require overwhelming efficacy to achieve statistical significance at the interim. He referenced the TRANSFORM study, where a 24% MRD clearance differential translated into a greater than 60% improvement in EFS, suggesting a positive outcome is possible but declined to provide further detail on the likelihood of statistical significance. Q: I saw you added an observational cohort to the Alpha 3 study. What is the design and goal of this cohort, and what questions is it helping to answer?A: Zachary Roberts explained that the observational cohort was added to provide context for the overall results of Alpha 3. By including MRD-negative patients using essentially the same patient population as those entering Alpha 3, the cohort will allow for a comparison of outcomes between MRD-positive patients in Alpha 3 and MRD-negative patients, further characterizing the test in a prospective manner. Q: Regarding the RMAT and Fast Track designations secured for cemacabtagene ansegedleucel (cema-cel), what data was shared with the FDA, and what aspects of the data set were most intriguing from the FDA's perspective?A: Zachary Roberts stated that the clinical data provided was derived from the April interim analysis, with a complete briefing package including extensive MRD results and an exhaustive safety package. The FDA's decision to award RMAT was based on two critical points: MRD positivity at the end of first-line treatment represents an unmet medical need, and cema-cel has the potential to meet that need. The FDA did not provide further granularity on which specific aspects were most influential. Q: Given the impressive pace of enrollment for Alpha 3 and the increased target of 100 sites by year-end, are you open to enrolling additional patients beyond the current target?A: Zachary Roberts confirmed the target remains 220 patients randomized into the two arms. He noted that generally, you don't want to over-enroll until data suggests a permissive benefit-risk ratio. However, if additional opportunities arise to add cohorts or explore other nuances, those will be considered in due time. Q: As the RESOLUTION trial readout approaches, what kind of data and level of granularity should we expect from the update later this year?A: Zachary Roberts stated that the data readout planned for Q4 2026 will include clinical and translational data. Enrollment has been robust, with 9 patients treated in both the lymphodepletion (LD) and non-LD containing arms as of the last quarter. The update will feature safety and efficacy outcomes as well as translational findings. Q: For the ALLO-329 trial with data coming in Q4, has your guidance changed in terms of the dose groups you will announce? Are we still expecting the 20 million, 40 million, and 80 million doses?A: Zachary Roberts confirmed that the first three dose levels are 20 million, 40 million, and 80 million cells, with additional doses above that contemplated within the protocol. At least those three dose cohorts will be included in the data shared, depending on how far dose escalation progresses. Q: As the competitive landscape evolves, particularly with frontline studies for autologous CAR T and recent in vivo CAR T data, how are you thinking about managing these competitive threats?A: Zachary Roberts noted that Allogene is well-protected in the first-line consolidation space, as no one else has entered it explicitly. Frontline studies with CAR T and bispecifics are likely to have minimal impact on MRD positivity rates due to their significant toxicity profiles and logistical burdens. Regarding in vivo CAR T, he believes it will primarily replace autologous CAR T in relapsed/refractory settings due to toxicity concerns, leaving a clear opportunity for off-the-shelf CAR T like cema-cel to be administered in community infusion clinics over 5 minutes with minimal toxicity. Q: For ALLO-329, are you hearing any early anecdotes for CAR T expansion or persistence in patients treated with cyclophosphamide, and what positive signs are you looking for at the Q4 update for this specific arm?A: Zachary Roberts emphasized that as a Phase 1 first-in-human study, safety is the primary focus. The team is monitoring safety outcomes closely and meeting with outside advisers prior to dose escalation. While there have been encouraging signs of activity, translational data are developed in parallel and in batches, so they are not in a position to comment on those findings today. The translational findings will be included in the Q4 data release. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Allogene Therapeutics, Inc.? Here are five stocks we like better. ALPHA3 enrollment infrastructure is expanding: Allogene Therapeutics activated more than 80 sites ahead of schedule and expects roughly 100 active sites by year-end 2026, while maintaining its target of an interim event-free survival analysis around mid-2027. Cema-cel received FDA RMAT and Fast Track designations for first-line consolidation treatment in MRD-positive large B-cell lymphoma, potentially enabling closer regulatory discussions as the pivotal trial progresses. Pipeline updates are expected across other programs: ALLO-316 showed a 31% confirmed response rate in CD70-high renal cell carcinoma, while initial safety, efficacy and translational data from the ALLO-329 autoimmune study are planned for the fourth quarter. 3 Stocks With Sky-High Short Interest Levels Allogene Therapeutics (NASDAQ:ALLO) outlined progress across its clinical pipeline during its second-quarter 2026 conference call, highlighting expanded enrollment infrastructure for its pivotal ALPHA3 lymphoma study, recent FDA designations for cema-cel, published renal cell carcinoma data for ALLO-316, and plans to report initial data from the ALLO-329 autoimmune program by year-end. President and Chief Executive Officer Zachary Roberts, speaking on his first quarterly call in the role, said the company’s strategy centers on using the off-the-shelf availability, consistent manufacturing and potential community-based administration of allogeneic CAR T therapies to address settings where those characteristics may provide an advantage. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat 2 Downgrades in Healthcare You Might Want to Buy Roberts described ALPHA3 as the company’s principal expression of that strategy. The trial is evaluating cema-cel as first-line consolidation treatment for patients with large B-cell lymphoma who remain minimal residual disease, or MRD, positive after initial therapy. The study aims to intervene before a clinical relapse occurs. Allogene had set a goal to activate more than 80 trial sites by year-end, but reached that milestone in July. The company now expects to have approximately 100 active sites by the end of 2026, with most located in the United States and additional sites in Canada, Australia and South Korea. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Roberts said the expanded network includes academic and community-based investigators. He said interest after the trial’s interim futility analysis was balanced between academic centers and community practices, and that community physicians view the study as an opportunity to offer CAR T treatment locally. The company’s April interim analysis found that cema-cel cleared MRD rapidly in a majority of patients, according to Roberts. He said there were no treatment-related hospitalizations, most patients were managed entirely in outpatient settings, and the therapy was administered successfully at community practices without prior CAR T experience. → First Solar’s Profit Engine Faces a New Policy Test in Washington Allogene also added an observational cohort of MRD-negative patients to ALPHA3. Roberts said the cohort will provide a prospective reference population to help contextualize outcomes for the randomized MRD-positive patients and further characterize the MRD test. Despite faster site activation, Allogene maintained its expectation for the trial’s planned interim event-free survival, or EFS, analysis around mid-2027. Roberts said the company is focused on accelerating enrollment but is not changing its timeline for data availability. The trial’s current randomized enrollment target remains 220 patients. Roberts noted that statistical significance at the interim EFS analysis would require what he called “overwhelming efficacy” because of how the trial’s statistical alpha is allocated between the interim and primary analyses. He cited the prior TRANSFORM study of Breyanzi as an example in which a 24% MRD-clearance difference corresponded with more than a 60% improvement in EFS, while cautioning that Allogene could not provide further estimates on ALPHA3’s likelihood of meeting statistical significance at the interim analysis. At the end of July, the FDA granted regenerative medicine advanced therapy, or RMAT, and Fast Track designations to cema-cel in first-line consolidation. Roberts said the agency’s action reflects its view that MRD-positive large B-cell lymphoma after first-line treatment represents an unmet medical need and that cema-cel may have the potential to address it. He said the RMAT submission was supported by clinical information from the April interim analysis, including more extensive MRD details and a safety package than the company disclosed publicly. EFS data remained blinded at that point and remain blinded to the company, he said. Roberts added that RMAT status could facilitate more frequent and focused interactions with the FDA as the ALPHA3 trial advances. Allogene expects potential opportunities to update investors on ALPHA3 enrollment and data in 2027, subject to regulatory discussions and guidance from the independent data monitoring committee. Allogene also discussed the recent publication of results from the TRAVERSE study of ALLO-316 in the Journal of Clinical Oncology. In patients with CD70-high renal cell carcinoma treated using the optimized regimen, ALLO-316 produced a 31% confirmed overall response rate. At the data cutoff, none of the five confirmed responders had progressed, with follow-up ranging from eight months to more than 18 months after a single dose. Roberts said the data set was small and acknowledged that the program has faced safety challenges. He said the company worked with outside experts and the FDA to develop a management algorithm for serious events, while continuing to study CAR T expansion, persistence, tumor infiltration and the role of its Dagger technology. For ALLO-329, which is being evaluated in the RESOLUTION autoimmune trial, Allogene expects to report clinical and translational data in the fourth quarter. The company previously disclosed that nine patients had been treated across lymphodepletion-containing and non-lymphodepletion arms, and Roberts said enrollment has continued to be robust. The planned update is expected to include safety, efficacy and translational findings. Roberts said the initial dose cohorts of 20 million, 40 million and 80 million cells will be included, while the protocol also contemplates higher dose levels. Asked about early findings in the lymphodepletion arm, Roberts said the phase 1 study is primarily focused on safety and dose escalation decisions. He said Allogene has observed encouraging signs of activity but was not prepared to discuss translational findings before the fourth-quarter update. Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic, or “off-the-shelf,” chimeric antigen receptor T-cell (CAR T) therapies to treat a range of hematologic malignancies and solid tumors. The company leverages gene-editing technologies to generate universally compatible engineered T cells, aiming to overcome the limitations of patient-specific CAR T approaches such as manufacturing delays, variable product quality and treatment resistance. The company's pipeline includes multiple allogeneic CAR T candidates targeting key antigens in blood cancers. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Allogene Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Pivotal Phase 2 ALPHA3 Program in 1L Large B-cell Lymphoma (LBCL): Phase 1 RESOLUTION Trial in Autoimmune Disease: Ended the Second Quarter of 2026 with $423.6 Million in Cash, Cash Equivalents and Investments Conference Call and Webcast Scheduled for Today at 2:00 PM PT/5:00 PM ET SOUTH SAN FRANCISCO, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today provided corporate updates and reported financial results for the quarter ended June 30, 2026. “When we reset our strategy in 2024, we started with the patient and focused on where the distinct attributes of allogeneic CAR T could create a clinical advantage,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “ALPHA3 is the clearest expression of that strategy: identifying patients at high risk of relapse, treating before disease returns clinically, and enabling CAR T delivery where patients already receive care. We took the same patient-first approach with ALLO-329, recognizing early that chemotherapy-based lymphodepletion and treatment interruptions associated with leukapheresis in autologous therapy could create meaningful burdens for patients with autoimmune disease. Together, these programs demonstrate that the value of allogeneic CAR T extends well beyond off-the-shelf availability, offering the flexibility to address clinical and practical barriers other approaches cannot. We believe the scale of that opportunity will become increasingly apparent as our programs continue to advance.” Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCLCemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized Phase 2 trial in LBCL designed to assess whether MRD-guided treatment following first-line therapy can delay or prevent clinical relapse. In July, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following review of the interim futility analysis. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity, with the majority clearing MRD by the first post-treatment assessment, compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature and cross-study benchmarks suggest that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion. Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common. Most patients were treated and followed entirely in the outpatient setting. Community cancer centers accounted for approximately one-third of screening activity and cema-cel infusions, including sites with limited or no prior CAR T experience. These findings support ALPHA3’s potential to bring CAR T earlier in the course of disease and closer to where patients receive care. The Company achieved its 2026 goal of activating more than 80 sites approximately six months ahead of schedule, driven by strong execution and increased investigator interest following the interim futility analysis. The Company now expects approximately 100 sites to be active by year-end, with the significant majority in the United States and additional sites in Canada, Australia and South Korea. This expansion is expected to support enrollment momentum, broaden access to the trial, and provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch. ALPHA3 is expected to randomize approximately 220 MRD+ patients to either cema-cel consolidation or close observation, with enrollment anticipated to be completed by year-end 2027. The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027. ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger® technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive host T cells, with the goal of supporting CAR T-cell expansion while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion. The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating cell dose of ALLO-329 and the role played by Dagger with and without lymphodepletion across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. Enrollment continues at a brisk pace across cohorts, dose levels and lymphodepletion strategies. The Company remains on track to provide a clinical and translational update in the fourth quarter of 2026. 2026 Second Quarter Financial Results Research and development expenses were $30.7 million for the second quarter of 2026, which includes $2.1 million of non-cash stock-based compensation expense. General and administrative expenses were $20.8 million for the second quarter of 2026, which includes $10.3 million of non-cash stock-based compensation expense. Net loss for the second quarter of 2026 was $42.7 million, or $0.13 per share, including non-cash stock-based compensation expense of $12.4 million. The Company had $423.6 million in cash, cash equivalents, and investments as of June 30, 2026. Based on its cash, cash equivalents, and investments as of June 30, 2026, the Company currently projects its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities. Conference Call and Webcast DetailsAllogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by cell therapy veterans applying proven CAR T experience, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In some cases, forward-looking statements may be identified by words such as “expect,” “believe,” “aim,” “plan,” “intend,” “seek,” “estimate,” “target,” “potential,” “may,” “could,” “will,” “would,” “should,” “anticipate,” “support,” “designed to,” “working to” and similar expressions. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing, design, conduct, and results of Allogene’s clinical trials and analyses (including the interim futility analysis and MRD clearance outcomes from the Phase 2 ALPHA3 trial of cema-cel and updates from the Phase 1 RESOLUTION trial of ALLO-329); the extent to which additional clinical trial sites may support enrollment momentum, broaden access to the ALPHA3 trial, or provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch; the rate and pace of enrollment in the RESOLUTION trial; the potential benefits and regulatory implications of the RMAT and Fast Track designations for cema-cel; the potential clinical benefits, safety, tolerability, durability, and efficacy of Allogene’s product candidates; the potential for MRD-guided first-line consolidation to improve outcomes in LBCL; the extent to which published literature, cross-study benchmarks, and observed or potential MRD clearance differences of 25-30% may translate into clinically meaningful improvement at study completion; the potential value and advantages of allogeneic CAR T, including its ability to address clinical and practical barriers presented by other therapies; the potential to deliver allogeneic CAR T therapy in outpatient and community care settings and expand access across academic and community care settings and the extent to which interim data and analysis is supportive thereof; the potential to reduce or eliminate conventional lymphodepletion; expectations regarding clinical trial execution and operational performance; and expectations regarding Allogene’s financial position, cash runway, and 2026 operating outlook. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, but not limited to, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results or clinical outcomes), patient enrollment and trial execution risks, uncertainties related to MRD testing and its clinical significance and whether observed differences in MRD clearance will translate into clinically meaningful benefit, the occurrence of adverse safety events, regulatory risks and uncertainties, manufacturing and CMC risks, reliance on third parties and licensors, competitive developments, intellectual property and contractual risks, and financial risks, including the need for additional capital. These and other risks and uncertainties are described more fully in Allogene’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, being filed with the SEC today. All forward-looking statements in this press release speak only as of the date of this press release, and Allogene undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Dagger® is a trademark of Allogene Therapeutics, Inc. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T program. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy [email protected]

Conference Call and Webcast Scheduled for August 12, 2026 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced that it will report second quarter 2026 financial results and provide a business update on August 12, 2026, after the close of the market. The announcement will be followed by a live audio webcast and conference call at 2:00 p.m. PT/5:00 p.m. ET. Listen-Only WebcastThe listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. A replay will be available on the Company's website for approximately 30 days. Conference Call RegistrationIf you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by cell therapy veterans applying proven CAR T experience, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements for AllogeneThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things Allogene’s ability to develop and deliver readily available allogeneic CAR T products for the treatment of cancer and autoimmune disease on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including risks and uncertainties related to our product candidates being based on novel technologies, which makes it difficult to predict the time and cost of product candidate development, the safety or efficacy of a product candidate, and whether a product candidate will receive regulatory approval, which could prevent or delay commercialization. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Form 10-Q filed for the quarter ended March 31, 2026. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy [email protected]

ALLO-316 Achieved a 31% Confirmed Response Rate with the Recommended Phase 2 Regimen in Patients with Stage IV Renal Cell Carcinoma (RCC) with High CD70 Expression Safety Profile was Manageable with Proactive Diagnostic and Management Strategies Effective in Mitigating IEC-HS ALLO-316 Demonstrated Robust Expansion and Tumor Infiltration Following Standard Lymphodepletion, Validating the Dagger® Technology as a Next-Generation Allogeneic CAR T Platform SOUTH SAN FRANCISCO, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology. TRAVERSE is being conducted as part of a strategic five-year collaboration with The University of Texas MD Anderson Cancer Center. ALLO-316, Allogene’s CD70-targeting AlloCAR T investigational therapy incorporating the Dagger® technology, achieved robust expansion, tumor infiltration, and durable antitumor activity in a solid tumor setting. “TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the Dagger® technology, our goal was to address two of the most persistent barriers in solid tumors – achieving robust CAR T expansion with standard lymphodepletion and translating that biology into durable responses. These results show that a well-designed allogeneic CAR T product, developed for a defined population, can expand, persist, and produce durable responses in metastatic, treatment refractory solid tumors. Importantly, the robust CAR T expansion and durable persistence in this trial provides clinical validation of our Dagger® technology platform and has direct read-through to our broader clinical and preclinical pipeline of next-generation AlloCAR T candidates.” Across the full Phase 1 TRAVERSE trial, 51 patients with Stage IV disease were enrolled, of whom 46 received ALLO-316 and had a median follow-up time of 28.8 months. The Phase 1b expansion cohort evaluated the safety and efficacy of the recommended Phase 2 regimen – ALLO-316 at a dose of 80M CAR T cells following a standard FC lymphodepletion regimen (fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days). The 22 patients in the Phase 1b safety population all had RCC resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had received ≥2 prior TKIs, and 41% had received prior belzutifan. Twenty of these patients received ALLO-316. Sixteen of the ALLO-316-treated patients in Phase 1b had a high CD70 Tumor Proportion Score (TPS ≥50%). The median time from enrollment to the start of therapy was four days. “Most patients in TRAVERSE had exhausted available therapies and faced a poor prognosis, with survival often measured in months,” said Samer A. Srour, MB ChB, MS, of The University of Texas MD Anderson Cancer Center. “In that context, the depth and durability of responses observed with a one-time ALLO-316 infusion are very promising, particularly in patients with high CD70-expressing tumors where all responders remained progression-free at the time of the published analysis. Taken together, these findings strongly support the continued clinical development of ALLO-316 and its evaluation as a potential new treatment approach for patients with advanced RCC.” A single dose of ALLO-316 produced disease control in half of patients in the Phase 1b cohort, with an overall confirmed response rate of 25% and a confirmed response rate of 31% in patients with CD70 TPS ≥50%. The median duration of response (mDOR) had not been reached (95% CI: 6.9 months to not estimable), with the longest ongoing response exceeding 18 months. Median overall survival in the Phase 1b population was 15.2 months (95% CI: 4.6 months to not estimable) and was not estimable in the CD70-high group (95% CI: 3.2 months to not estimable). RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product across the full Phase 1 trial. The most frequent Grade ≥3 events were hematologic. Three previously reported treatment related Grade 5 adverse events occurred in the Phase 1a portion (cardiogenic shock, failure to thrive and sepsis). There were no Grade 5 adverse events in Phase 1b. A higher incidence of IEC-HS was reported in Phase 1b relative to Phase 1a, likely due in part to improved diagnosis and coding implemented during Phase 1b. Most IEC-HS events were mild to moderate and were successfully managed utilizing a protocol-defined diagnostic and management algorithm. * Two patients received lymphodepletion but did not receive ALLO-316: one due to progression of disease (altered mental status during lymphodepletion found to be brain metastases on imaging), and one due to liver and kidney failure during lymphodepletion. IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis. ᵃ One patient experienced Grade 4 IEC-HS based on gastrointestinal bleeding with subsequent improvement; one patient experienced Grade 3 IEC-HS based on hypotension managed without vasopressors with subsequent improvement. The findings also underscore the broader strategic potential of the Dagger® technology, which addresses rejection by the patient’s immune system. By targeting CD70-expressing tumor cells as well as CD70-positive alloreactive host T cells, ALLO-316 is designed to support CAR T-cell expansion and persistence without requiring intensified lymphodepletion. In TRAVERSE, this design translated into robust expansion, durable persistence, and evidence of tumor infiltration – core attributes Allogene believes may be applicable across its next-generation clinical and pre-clinical allogeneic CAR T pipeline. About ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by cell therapy veterans applying proven CAR T experience, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements for Allogene This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding, among other things: the potential of ALLO-316 as a treatment approach for patients with advanced or metastatic renal cell carcinoma, including patients with high CD70-expressing tumors; the continued clinical development and future evaluation of ALLO-316; the potential significance of the Phase 1 TRAVERSE results, including with respect to durable responses, expansion, persistence, tumor infiltration, overall survival, duration of response and progression-free status; the potential of ALLO-316 and the Dagger® technology to address challenges associated with solid tumors and allogeneic CAR T therapies, including host immune recognition or rejection of allogeneic CAR T cells, selective targeting or elimination of CD70-positive alloreactive host T cells, CAR T-cell expansion and persistence, and the ability to achieve activity following standard lymphodepletion; the potential applicability of the Dagger® technology and ALLO-316 findings to Allogene’s broader clinical and preclinical allogeneic CAR T pipeline; the potential for ALLO-316 to be developed across additional cancers; and the potential benefits of off-the-shelf allogeneic CAR T therapies. Forward-looking statements are based on Allogene’s current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to: the limited nature of the Phase 1 data from the TRAVERSE trial, including the small number of patients treated and the early-stage nature of the study; the possibility that clinical results, including response rates, duration of response, overall survival, progression-free status, safety, expansion, persistence and tumor infiltration, may not be replicated or may change as additional patients are treated or additional follow-up becomes available; the risk that ALLO-316 may not demonstrate sufficient safety, efficacy or durability in future clinical trials to support further development or regulatory approval; the risk that adverse events, including cytokine release syndrome, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, infections, cytopenias, neurotoxicity or other toxicities, may be more frequent, severe or difficult to manage than expected; risks associated with the use of lymphodepletion and allogeneic CAR T therapies; uncertainties regarding the relationship between CD70 expression and clinical outcomes; the risk that the Dagger® technology may not provide the anticipated benefits, including with respect to expansion, persistence, tumor infiltration, resistance to host immune recognition or rejection, selective elimination of CD70-positive alloreactive host T cells, or applicability across other product candidates or disease settings; uncertainties related to clinical trial design, patient enrollment, manufacturing, regulatory interactions and the timing or success of future development activities; and the risks and uncertainties described under the heading “Risk Factors” in Allogene’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements in this press release speak only as of the date of this press release. Allogene undertakes no obligation to update any forward-looking statements, except as required by law. Dagger® is a trademark of Allogene Therapeutics, Inc. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T program. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy [email protected]