Allogene signals pivotal ALPHA3 interim data and ALLO-329 proof-of-concept in first half 2026 while maintaining cash runway into H2 2027

Earnings Call Insights: Allogene Therapeutics (ALLO) Q3 2025

MANAGEMENT VIEW

* CEO David Chang emphasized conviction in the company’s allogeneic platform, stating the focus is on “delivering what patients need now” and making “the promise of curative onetime off-the-shelf cell therapy a reality today.” He highlighted that Allogene is preparing for “a defining moment with pivotal interim data from cema-cel in the ALPHA3 trial in first-line consolidation and proof of concept from ALLO-329 in autoimmune disease, both milestones that we believe will shape the next era of cell therapy.”
* Zachary Roberts, EVP of R&D and CMO, reported that the ALPHA3 pivotal trial for cema-cel is now a 2-arm randomized study and that the futility analysis is on track for the first half of 2026. He described the trial as a “unified demonstration of the strength and versatility of our allogeneic platform.” Roberts also pointed to the expansion of ALPHA3 to over 50 active sites in the U.S. and Canada, with Australia and South Korea expected to join early next year.
* Roberts indicated that the TRAVERSE trial with ALLO-316 showed durable responses in nearly 1/3 of patients with metastatic kidney cancer and high CD70 expression, informing the design of the dual CD19/CD70 construct in autoimmune disease.
* On ALLO-329, Roberts described it as “a first-in-class allogeneic CD19, CD70 dual CAR T product” intended to simplify administration, improve tolerability, and “extend the reach of CAR-T therapy to a much broader patient population.”
* Geoffrey Parker, CFO, stated, “As of September 30, 2025, we had $277.1 million in cash, cash equivalents and investments. Our disciplined approach to resource management continues to support a cash runway that extends into the second half of 2027.” Parker added, “R&D expenses for the third quarter were $31.2 million, including $2.8 million of noncash stock-based compensation. G&A expenses for Q3 2025 were $13.7 million, including $5.9 million in noncash stock-based compensation. Net loss for third quarter was $41.4 million or $0.19 per share, including noncash stock-based compensation expense of $8.7 million.”

OUTLOOK

* The company maintained guidance for “2025 cash burn of approximately $150 million and full year GAAP operating expenses of approximately $230 million, which includes an estimated noncash stock-based compensation expense of approximately $45 million.” Management confirmed a cash runway into the second half of 2027 and expects interim futility data from ALPHA3 and proof-of-concept results from ALLO-329 in the first half of 2026.
* Roberts reiterated that the futility analysis for ALPHA3 remains on track for the first half of 2026, focusing on MRD conversion. Expansion into Australia and South Korea is planned for early next year.

FINANCIAL RESULTS

* As of September 30, 2025, Allogene reported $277.1 million in cash, cash equivalents, and investments. R&D expenses for Q3 were $31.2 million and G&A expenses were $13.7 million. Net loss for the quarter was $41.4 million or $0.19 per share. Guidance for 2025 cash burn and operating expenses remains unchanged from the previous quarter.
* The company highlighted its ability to manufacture product in advance and at scale, supporting a more efficient and sustainable business model for allogeneic therapies.

Q&A

* Salveen Richter, Goldman Sachs: Asked if data beyond MRD conversion would be available at the futility analysis and about enrollment trends. Roberts responded that only MRD conversion will be shared at the interim, with “no primary endpoints for efficacy” included, and indicated enrollment is “on track” with a “slight uptick” after moving to a 2-arm design.
* Tyler Van Buren, TD Cowen: Inquired about the percentage of sites actively enrolling. Roberts replied that “close to all” of the 50+ sites are actively screening and enrolling patients.
* Jack Allen, Baird: Sought details on the size and breadth of the ALLO-329 dataset expected next year. Chang said there will be “a handful of patients” with biomarker and early clinical responses presented.
* Samantha Corwin, William Blair: Asked about MRD consent rates and expected MRD positivity. Roberts said the pace “has at least held steady” and the MRD positive rate “is holding steady to our assumptions.”
* Karina Rabayeva, Truist: Queried about donor material impact. Chang stated they “have a good way to identify the exciting materials that will result in very potent and consistent products.”
* Samantha Semenkow, Citi: Asked about lymphodepletion in autoimmune programs. Chang expressed confidence in ALLO-329’s approach and noted the ongoing study will test both reduced and no lymphodepletion cohorts.
* John Newman, Canaccord: Asked if the phenotype of remaining T cells post-ALLO-329 would be analyzed. Chang confirmed this is being considered and will be addressed in future data releases.
* Reni Benjamin, Citizens JMP: Queried if biomarker data would indicate B-cell reset and its robustness for selecting future indications. Chang said biomarker data will be “very meaningful” and that indications could extend broadly based on the dual-target approach.
* Lut Ming Cheng, JPMorgan: Asked about confidence in MRD conversion predicting event-free survival and the timing for reaching a 30% bar. Roberts expressed “pretty confident, high confidence actually” and indicated MRD is assessed soon after infusion, though no exact time point was shared.
* Luca Issi, RBC: Sought clarification on whether the futility analysis could require more time if MRD is insufficient. Chang said assumptions are “well grounded” and supported by various data, expressing comfort with the analysis plan.
* Robert Burns, H.C. Wainwright: Asked about FDA interactions. Chang described them as “very timely and very productive,” noting the FDA’s openness to single-arm approaches.
* Unknown Analyst, Jefferies: Asked about MRD assay consistency. Roberts confirmed all MRD tests are centrally conducted by Foresight Diagnostics, minimizing technical variability.

SENTIMENT ANALYSIS

* Analysts’ questioning was generally constructive but often pressed for details on trial design, enrollment, biomarker robustness, and regulatory pathways, indicating a neutral to slightly positive tone. There was focus on operational clarity and data expectations.
* Management’s responses were confident, emphasizing “conviction,” “confidence,” and “clarity” in both prepared remarks and Q&A. Chang closed with, “We are entering 2026 with conviction, clarity and momentum and are excited for what the coming months may hold.”
* Compared to the previous quarter, management’s tone remained steadily confident, with slightly more emphasis on upcoming milestones and operational readiness.

QUARTER-OVER-QUARTER COMPARISON

* Guidance for cash burn and operating expenses remains unchanged. Cash position declined from $302.6 million to $277.1 million, reflecting expected spend. The company continues to project a cash runway into the second half of 2027.
* Strategic focus is consistent, but the current quarter emphasizes the approaching futility analysis for ALPHA3 and the initial proof-of-concept for ALLO-329 as “defining moments.”
* Management’s confidence remains high, with repeated references to conviction and clarity in both quarters.
* Analysts’ focus shifted toward specifics of enrollment, data breadth, biomarker reliability, and regulatory engagement, compared to broader operational questions previously.

RISKS AND CONCERNS

* Management acknowledged challenges in patient competition, scientific and operational hurdles, especially in autoimmune indications. Roberts stated, “Clinical development is complex. We compete for patients, particularly in autoimmune indications and face both scientific and operational challenges.”
* No new or unexpected risks were highlighted versus prior quarters. Regulatory clarity was reinforced as a positive, with Chang describing FDA interactions as “very timely and very productive.”
* Site setup and patient enrollment were emphasized but reported as progressing well, with most sites actively enrolling.

FINAL TAKEAWAY

Allogene Therapeutics is advancing toward two significant clinical milestones in the first half of 2026: interim futility data from ALPHA3 in first-line consolidation and proof-of-concept results from ALLO-329 in autoimmune disease. With a solid financial position supporting operations into the second half of 2027, the company remains confident in its allogeneic platform, streamlined clinical execution, and its ability to deliver meaningful advances in cell therapy for both oncology and autoimmune conditions.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/allo/earnings/transcripts]

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