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Allogene Therapeutics (ALLO) investor relations material
Allogene Therapeutics Citi's SMID Call Series 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Citi's SMID Call Series 2025 summary2 Oct, 2025
Pipeline overview and strategic focus
Three ongoing clinical programs: a pivotal CD19 allogeneic CAR T (SemiCell) for lymphoma, a solid tumor program (ALLO-316) for renal cell carcinoma, and a novel dual-targeting CAR (ALLO-329) for autoimmune diseases.
SemiCell is being developed for frontline consolidation in large B cell lymphoma, targeting MRD-positive patients post-remission.
ALLO-316 showed a 31% response rate in refractory metastatic RCC, with durable responses, marking a first for off-the-shelf cell therapies.
ALLO-329 incorporates Dagger technology for built-in lymphodepletion, aiming to treat autoimmune patients with minimal or no chemotherapy.
The company’s cash runway extends into 2027, with resource prioritization on the pivotal ALPHA-3 trial.
ALPHA-3 trial design and market opportunity
ALPHA-3 targets MRD-positive large B cell lymphoma patients after frontline therapy, using MRD as a sensitive blood-based marker for relapse risk.
The global market opportunity is estimated at $5 billion, as MRD testing adoption grows and captures most patients at risk of relapse.
The trial randomizes MRD-positive patients to observation or SemiCell treatment, with a futility analysis planned for the first half of 2026.
Enrollment challenges included educating physicians and patients on MRD utility and coordinating between lymphoma and transplant teams; mitigation strategies have improved enrollment rates.
The study is powered for a 30% improvement in MRD conversion, with 220 patients to be randomized.
Clinical data and rationale
Phase 1 data for SemiCell showed a 58% complete response rate in relapsed/refractory lymphoma, with even higher efficacy in patients with low disease burden.
MRD positivity is a strong predictor of relapse, and rapid progression is common, supporting the need for fast-acting, off-the-shelf therapies.
Off-the-shelf CAR T is positioned as superior to autologous options for rapid intervention in high-risk patients.
The trial’s design and endpoints are FDA-discussed and agreed upon, with event-free survival as the primary endpoint.
How will cema-cel achieve broad market adoption?
Dagger's impact on ALLO-329 competitive advantage?
What is the strategy for ALLO-316 advancement?
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Next Allogene Therapeutics earnings date
Q3 20256 Nov, 2025
Next Allogene Therapeutics earnings date
Q3 20256 Nov, 2025
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Frequently asked questions
Allogene Therapeutics Inc is a biotechnology company focused on developing allogeneic CAR T cell therapies for cancer treatment. The company’s approach uses gene-editing and cell engineering technologies to produce off-the-shelf immunotherapies designed to target various hematologic and solid tumors. Its operations span research, clinical trials, and manufacturing. Allogene Therapeutics Inc is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.
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