Atara Biotherapeutics Reports Q2 2024 Financials, Operational Progress, Leadership Update

Atara Biotherapeutics, Inc., based in Thousand Oaks, California, has recently shared its financial outcomes for the second quarter of 2024, alongside notable business advancements and anticipated milestones for the year. The company's president and CEO, Pascal Touchon, expressed significant progress in their operations, especially following the acceptance of the Biologics License Application (BLA) for their treatment tab-cel, which now has a Priority Review status with a target action date of January 15, 2025. This milestone indicates a forward movement towards the U.S. launch of tab-cel, primarily aimed at treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

During the quarter, Atara also advanced its lead CAR T program, ATA3219, with upcoming key milestones expected within the next year. Initial data from their non-Hodgkin’s lymphoma study is anticipated in the first quarter of 2025, which could shed light on ATA3219's potential in addressing autoimmune diseases. Moreover, the company plans to commence its ATA3219 trial for Systemic Lupus Erythematosus (SLE) later this year, with initial data expected by mid-2025.

Touchon also announced his transition to the role of Chairman of the Board, allowing him to dedicate more time to his family while continuing to contribute strategically to Atara. His successor, Cokey Nguyen, Ph.D., will take over as President and CEO. Nguyen, previously the company's Chief Scientific and Technical Officer, is recognized for his expertise and commitment to cell therapy advancements. He expressed his enthusiasm for continuing the company's journey toward U.S. approval for tab-cel and exploring the potential of their allogeneic CAR-T platform.

The U.S. FDA has accepted Atara’s BLA for tabelecleucel (tab-cel), a treatment for EBV+ PTLD in patients who have undergone prior therapies. The BLA has been granted Priority Review, with a decision expected by mid-January 2025. The filing includes data from over 430 patients, demonstrating a significant Objective Response Rate and a favorable safety profile. Atara received a $20 million milestone payment from its partner, Pierre Fabre Laboratories, following the BLA acceptance, with an additional $60 million contingent on FDA approval.

Atara is also progressing with ATA3219, a CD19-targeted CAR T-cell therapy for lupus nephritis (LN). A Phase 1 study is set to start in late 2024, focusing on safety, efficacy, pharmacokinetics, and biomarkers. Initial data from this study is anticipated by mid-2025. The company plans to expand this study to include severe SLE without lymphodepletion, aiming to simplify treatment and improve safety without compromising efficacy.

Atara's advancements extend to non-Hodgkin’s lymphoma (NHL) with ongoing enrollment for a Phase 1 trial of ATA3219. Initial data from this trial is expected in early 2025. Preclinical data has shown superior persistence and anti-tumor efficacy for ATA3219 compared to benchmark autologous CAR T therapies.

Additionally, Atara is developing ATA3431, a bispecific CAR targeting CD19 and CD20 for B-cell malignancies, with preclinical data showing promising antitumor activity and tumor growth inhibition. An Investigational New Drug (IND) submission for ATA3431 is planned for the second half of 2025.

Financially, Atara reported cash and equivalents totaling $35.3 million as of June 30, 2024, with additional expected receipts from Pierre Fabre bolstering this figure. The company’s net cash used in operating activities significantly decreased, and total revenues for the quarter were $28.6 million, a substantial increase from the previous year. Research and development expenses also saw a reduction compared to 2023, contributing to a narrower net loss.

Atara's robust pipeline, strategic leadership changes, and strong financial management underscore its commitment to advancing innovative cell therapies for cancer and autoimmune diseases. With significant milestones on the horizon, the company is poised for continued progress in the biotherapeutics field.

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