Atara Biotherapeutics (ATRA) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key program updates and milestones

• Off-the-shelf T-cell therapy platform approved in the EU as Ebvallo, with US BLA accepted for priority review and a PDUFA target action date of January 15, 2025.

• Pipeline includes CD19 CAR-T (ATA3219) for large B-cell lymphoma, lupus nephritis, and SLE, with initial NHL Phase 1 data expected Q1 2025 and lupus data mid-2025.

• Dual CD19/CD20 CAR-T (ATA3431) targets B-cell malignancies, with IND submission planned for the second half of 2025 and preclinical data showing strong tumor inhibition.

• Partnership with Pierre Fabre supports global commercialization and regulatory processes, with up to $640M in potential consideration and double-digit royalties.

• Next 12 months expected to bring key regulatory and clinical milestones, including potential first US approval for allogeneic T-cell therapy.

Differentiated technology and clinical approach

• Platform uses healthy donor EBV-specific T-cells, expanded without gene editing, requiring minimal HLA matching and no lymphodepletion, with proven safety in over 600 patients.

• Manufacturing enables rapid, off-the-shelf product delivery within three days, compared to 25–35 days for autologous CAR-Ts, and supports robust scalability.

• Engineered features include a next-generation costimulatory domain (1XX), memory-like phenotype, and retained TCR/MHC, optimizing persistence, potency, and safety.

• Clinical and preclinical data show high response rates, low toxicity, superior in vivo persistence, and reduced cytokine release compared to autologous CAR-Ts.

• Platform addresses graft-vs-host disease, allorejection, and T-cell exhaustion without extensive gene editing.

Market needs and strategic focus

• Addresses major limitations of autologous CAR-Ts: manufacturing scale, cost, access, and patient immune variability.

• Allogeneic platform aims to meet high unmet needs in oncology and autoimmune diseases, especially lupus, by enabling rapid treatment without lymphodepletion.

• Only 20-40% of eligible NHL patients receive CAR T therapy; durability of response remains a challenge for current therapies.

• Tab-cel targets ultra-rare EBV+ PTLD with no approved therapies and significant pricing potential (> $500M peak sales estimate).

• Platform could expand access beyond major clinical centers, potentially reaching community settings.