Allogene Therapeutics, Inc. Q3 FY2025 earnings call

• David Chang emphasized the company's focus on allogeneic cell therapy as the foundation for curative therapies, highlighting programs like cema-cel, ALLO-329, and ALLO-316.
• Zachary Roberts discussed R&D progress, including updates on the ALPHA3 trial for cema-cel (streamlined to a 2-arm randomized study, over 50 active sites in U.S. and Canada, futility analysis on track for first half 2026), progress in autoimmune disease with ALLO-329 (first-in-class allogeneic CD19, CD70 dual CAR T product), and solid tumor work with ALLO-316 (durable responses in metastatic kidney cancer).
• Geoffrey Parker mentioned financials: $277.1 million in cash, cash equivalents, and investments as of September 30, 2025; Q3 2025 R&D expenses $31.2 million, G&A expenses $13.7 million, net loss $41.4 million; 2025 cash burn expected ~$150 million, full-year GAAP operating expenses ~$230 million.

No detailed breakdown of product segment financial performance with revenue contribution percentages provided in the transcript.

• Expected 2025 cash burn of approximately $150 million and full year GAAP operating expenses of approximately $230 million, excluding impact from potential business development activities.
• Anticipated pivotal interim data from cema-cel in the ALPHA3 trial in first-line consolidation and proof of concept from ALLO-329 in autoimmune disease in the first half of 2026.

• Forward-looking statements are based on current information, assumptions, and expectations subject to change.
• Risks detailed in press releases and latest SEC disclosure documents.

Q: For the futility analysis in the first half of next year, could you see any data beyond MRD conversion? And can you just expand on the 30% bar that you commented on? And then just remind us how enrollment is progressing for ALPHA3 and whether you've seen any changes post discontinuation of the FCA LD arm earlier in the year?

A: Zachary Roberts answered that they plan to focus on MRD conversion, explained the 30% bar reference to POLARIX data and IMvigor 11 trial, and said enrollment is on track for the interim analysis with a slight uptick in patient screening post study conduct change.

Q: This is Sam on for Tyler. Just for the over 50 U.S. and Canada active sites, what percent of these have made it through that initial internal setup period and are now able to start actively enrolling patients?

A: Zachary Roberts responded that close to all of the over 50 active sites are open to enrollment with only the most recently activated sites possibly having a few remaining things to do before switching on.

Q: Congrats to the team on the progress made over the course of the quarter. I guess I'll ask one on the autoimmune program with 329. It seems like that's starting to get off the ground here, and you're going to have an update in the first half of next year. I just wanted to hear any updated thoughts you have around the size and breadth of the data set we should expect next year from that program.

A: David Chang stated that there will be a handful of patients with biomarker and early clinical responses communicated in the first half of 2026 and that the biomarker data will be meaningful with broad potential indications.

Q: On the progress I'm curious how many patients have consented for MRD testing now in ALPHA3 and if you're seeing the expected rate of MRD positivity that you initially theorized you'd see?

A: Zachary Roberts replied that the pace of consenting has held steady since earlier in the year and the MRD positive rate is holding steady to assumptions.

Q: This is Karina. So Caribou recently reported that their allogeneic CAR T product derived from younger donors demonstrated improved durability. Have you observed similar associations in your experience?

A: David Chang mentioned they follow Caribou and have a good way to identify exciting materials for potent and consistent products.

Q: Another one on the autoimmune program. I'm wondering, there's some recent data in the autologous space in pemphigus where there was no lymphodepletion in that trial that showed some pretty encouraging results. I'm wondering if there's any read-through that you can take into your program. Obviously, you have the CD70 CAR as well. But I'm curious if this increases your optimism on showing pretty robust efficacy without lymphodepletion.

A: David Chang said the data gives higher confidence in ALLO-329's built-in lymphodepleting capability, and the ongoing study will test cohorts with reduced lymphodepletion and without lymphodepletion.

Q: So David, given that 329 is pretty unique in that it targets both B cells and activated T cells, I'm wondering, in the initial data readout, will you be able to get a look at the phenotype of the remaining T cells, just to see if perhaps there's anything left after you hopefully wipe out all the CD70-positive T cells.

A: David Chang stated they will be looking at CD70 positive and negative fractions, and the proof-of-concept data in first half 2026 will address relevant questions.

Q: Also for ALLO-329, -- when you talk about the biomarker data, David, are there any in particular that would alert you to achieving a B-cell reset? And when we get those results, will the results be robust enough that it can help you, help us as an analyst and decide which indications you might move forward with?

A: David Chang said biomarker data will be meaningful with early clinical responses, and the broad targeting of CD19 and CD70 suggests potential for various autoimmune indications from rheumatology to neurology and metabolic disorders.

Q: Can you talk about your level of confidence in the MRD conversion to event-free survival? And then when you said around 30% MRD conversion as the bar, can you clarify a bit on the time point that is going to be meaningful for LBCL? And then how soon dosing do you think we can reach that level of conversion?

A: Zachary Roberts responded with high confidence in MRD conversion's prognostic value, explained the 30% bar reference to previous data, and noted MRD is a dynamic test assessable relatively soon after CAR-T infusion but didn't specify exact time point.

Q: This is Catia on for Luca. Congrats on the progress this quarter. And if I can push on the last question on the timing of analysis for MRD. Is the futility study for stopping the trial as MRD is below your bar of 30%. And I think you mentioned the last time the 30% MRD bar is partially based on other autologous CAR-Ts objective response rate. And correct me here, if I'm not understanding this correctly, but that is from a potentially much longer follow-up. So is there a chance that you see insufficient MRD at your futility analysis first half next year, but we'll probably just have to give it more time. Any color there much appreciated.

A: David Chang stated they are well-grounded in assumptions supported by multiple data sources and feel comfortable with the futility analysis plan for first half 2026.

Q: This is Katie on for Rob. My question is more about your -- if you have any more recent interactions with the FDA and if you feel like the kind of move towards greater flexibility in CAR-T oversight might give you some accelerated pathways or reduce some friction for you guys to get to market.

A: David Chang said there are ongoing productive communications with FDA and a single-arm approach for CAR-T therapy is still an open path with positive CMC review outlook.

Q: [Technical Difficulty] I apologize for technical issues. And just one question from me. How are you controlling for variability in the MRD assay sensitivity, if any, across different sites? And what steps are you taking to ensure consistency in MRD conversion assessment for the futility analysis?

A: Zachary Roberts replied that the MRD test is done centrally by Foresight Diagnostics with sites collecting samples and sending to the central lab, so no expected technical variability in test performance.