Atara Biotherapeutics (ATRA) Goldman Sachs 45th Annual Global Healthcare Conference summary

Platform overview and differentiation

• Utilizes donor-derived, allogeneic EBV T cells as the foundation for multiple immunotherapy products, including the only approved T cell therapy of its kind in Europe, with U.S. approval anticipated soon.

• ATA3219, an allogeneic CD19 CAR-T, is designed to closely mimic autologous CAR-T efficacy while being off-the-shelf, leveraging extensive safety data from over 600 treated patients.

• The platform avoids gene editing, favoring natural T cell biology, and incorporates a next-generation 1XX CD28-based CAR and memory-like T cell phenotype for enhanced potency and persistence.

• Partial HLA matching is used to improve response rates and durability, differentiating the approach from other gene-edited allogeneic CAR-Ts.

• Manufacturing is outsourced to CDMOs, allowing for inventory-based supply similar to monoclonal antibodies, reducing overhead and enabling scalable production.

Clinical pipeline and milestones

• ATA3219 is in clinical trials for lymphoma, with initial data expected in Q4 2024, and for lupus nephritis, with data anticipated in 2025 for both lymphodepletion and non-lymphodepletion cohorts.

• ATA3431, a dual CD19/CD20 CAR-T, has shown superior preclinical potency and is expected to enter IND in the second half of 2025.

• Tab-cel is approved in Europe for PTLD, with a U.S. BLA filed and potential approval targeted for Q1 2025; commercial partner Pierre Fabre is preparing for U.S. launch.

• Expansion studies (EB Vision) are ongoing, targeting label expansion into first-line PTLD, especially for CNS-involved cases, with strong response and survival data presented.

• The platform's safety is supported by long-term data in over 600 patients, including those with autoimmune diseases and multiple sclerosis, with no significant safety issues reported and no need for lymphodepletion.

Commercialization and partnerships

• Ebvallo's EU launch is progressing well, with significant pricing and accelerating demand; top country reimbursement is expected by end of 2024, with sales acceleration in 2025.

• Pierre Fabre is expanding its U.S. team for the anticipated launch, with a deal structure including up to $640 million in milestones and double-digit royalties.

• The company is open to partnerships for expanding the CAR-T platform to new targets, broader autoimmune indications, and for its EBV vaccine candidate.

• The business model is built around scalable, cost-effective manufacturing and inventory management, aiming for outpatient use and broad accessibility.

• Pierre Fabre will assume global development, manufacturing, and commercialization of tab-cel®, with Atara receiving milestone payments and royalties.