Allogene Therapeutics, Inc. Q4 FY2025 earnings call

After closing 2025, Allogene is focused on 2026 delivering meaningful clinical milestones. In lymphoma, with semicell and alpha-3, aiming to redefine large B-cell lymphoma management by intervening earlier with CAR-Q. In autoimmune disease, with Allo 329, a dual CD19-CD70 CAR design, expecting proof-of-concept data in June 2026. Built broad clinical pipeline and has financial strength with $258.3 million in cash, etc. as of Dec 31, 2025, extended cash runway to Q1 2028. Concentrating resources on programs where allogeneic CAR T has greatest potential.

Guidance for operating cash expense in 2026 is approx $150 million. GAAP operating expenses expected to be approx $210 million including estimated non-cash stock-based comp of approx $35 million. Pivotal data from Alpha 3 approaching in April, proof of concept data for Allo 329 expected in June, cash runway extended into 2028 so well capitalized to execute through inflection points.

Q: Tyler Van Buren asks about safety parameters for Alpha 3 data update, bar for broad uptake in community, and community investigators' response to incorporating SemaCell.

A: Zach Roberts says will provide high-level safety info, safety needs to allow outpatient delivery, community use is ongoing.

Q: Byron Amin focuses on Zuma 7 MRD analysis, read-throughs from Zuma 7 data, confidence on stopping at interim EFS analysis, and when interim EFS data expected.

A: David Chang says Zuma 7 data consistent with MRD clearance and clinical outcome, stay tuned on interim EFS analysis.

Q: Michael Yee asks about defining interim analysis for EFS and target product profile for autoimmune program.

A: David Chang says interim EFS analysis is optional spending analysis, Allo329 is highly differentiated with dagger technology enabling low or no lymphodepletion.

Q: Salveen Richter asks about stem cell market opportunity and commercial positioning as CD3 bispecifics move to front line.

A: Zach Roberts says need to wait for final data on evolving LBCL landscape.

Q: Matt Phipps asks about patterns in high-risk baseline characteristics and Simicel's performance in subgroups.

A: Zach Roberts says differential MRD positivity rates by baseline risk, Alpha-3 offers upfront cure for all, Simicel saw good activity across risk spectrum.

Q: Samantha Semienko asks about expectations for observation arm in Alpha-3 study, expected rate of spontaneous MRD conversion.

A: Zach Roberts says long assumed non-zero spontaneous MRD conversion rate, modeled at about 20%, used data from publications.

Q: Matthew Begler asks about label expansions and validation work for MRD assays.

A: Zach Roberts says MRD as concept becoming standard of care, possibility of mixing and matching tests in commercial context.

Q: John Newman asks about data on CD70 positive T cells depletion in L329 Resolution 1 trial.

A: David Chang says study is ongoing, plans to analyze translational data, focus on dose level one data communication.

Q: Jack Allen asks about pace of enrollment in Alpha 3 study and MRD positivity following RCHOP.

A: Zach Roberts says expect to complete enrollment by end of 2027, rate of MRD positivity consistent with assumptions.

Q: Brian Chang asks about top line data on MRD clearance time points and variability of MRD clearance.

A: Zach Roberts says will share top line info on MRD clearance in treatment and observation arms, patients with large B-cell lymphoma tend to have fast disease progression, MRD is highly predictive.

Q: Luca Essie asks about statistical assumptions for CMSL futility analysis and confidence in 24-patient sample size.

A: David Chang says earlier unplanned analysis cleared futility bar, details on statistical powering better suited for study completion and publication