On May 8, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported its financial results for the first quarter 2023, recent business highlights and key upcoming catalysts (Press release, Atara Biotherapeutics, MAY 8, 2023, View Source [SID1234631164]).

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"We are entering an important period of potential value-generating milestones for our prioritized pipeline assets and continue to have productive dialogue and senior level engagement with FDA regarding tab-cel," said Pascal Touchon, President and Chief Executive Officer of Atara. "In parallel, we continue to identify operational efficiencies and reduce cash burn with the goal of further extending our cash runway to best position Atara for future success."

Tabelecleucel (tab-cel or EBVALLOTM) for Post-Transplant Lymphoproliferative Disease (PTLD)

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Following a recent meeting with FDA on chemistry, manufacturing, and controls (CMC) matters, Atara and the FDA agreed to hold a subsequent meeting, anticipated in Q2, to discuss additional details requested by the FDA on CMC aspects related to a potential biologics license application (BLA) submission for tab-cel. We expect to provide an update on our plans for a BLA submission for tab-cel at our next earnings release
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Following the successful transfer of the European Commission (EC) Marketing Authorization of EBVALLO to Pierre Fabre, the first patients have received treatment. Pierre Fabre is progressively launching EBVALLO on a country-by-country basis
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Atara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023
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Atara is engaged in discussions with potential U.S. commercialization partners

ATA188 for Progressive Multiple Sclerosis (MS)

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The primary analysis data read out for the Phase 2 EMBOLD study is on track for October 2023

ATA3219: CD19 Program for B-Cell Malignancies

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Atara is advancing an Investigational New Drug Application (IND) for ATA3219, an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy that incorporates multiple clinically validated technologies designed for T-cell memory, robust expansion, and potent anti-tumor efficacy, that is anticipated for filing in Q2 2023

Leadership Changes

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Jakob Dupont M.D., who has served as the Company’s Head of Global Research & Development since 2020, will depart Atara to pursue an opportunity in venture capital effective May 12, 2023. Following this date, Dr. Dupont will consult for Atara until the end of the year in support of progressing a potential BLA for tab-cel, the Phase 2 EMBOLD primary analysis data readout for ATA188, and advancing an IND for ATA3219. AJ Joshi, M.D., Chief Medical Officer, Jill Henrich, Head of Global Regulatory Affairs, and Cokey Nguyen, Ph.D., Chief Scientific Officer, will assume Dr. Dupont’s responsibilities
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Separately, Charlene Banard, who has served as Atara’s Chief Technical Officer since 2022, will be departing the Company effective June 9, 2023. Dr. Cokey Nguyen and Ms. Jill Henrich will assume Ms. Banard’s responsibilities

First Quarter 2023 Financial Results

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Cash, cash equivalents and short-term investments as of March 31, 2023, totaled $205.4 million, as compared to $242.8 million as of December 31, 2022
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Atara believes that its cash and investments as of March 31, 2023, will be sufficient to fund the Company’s planned operations into Q2 2024
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Atara reported net losses of $74.8 million, or $0.72 per share for the first quarter 2023, as compared to $88.1 million, or $0.87 per share for the same period in 2022
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Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $13.0 million for the first quarter 2023, as compared to $15.9 million for the same period in 2022
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Research and development expenses were $62.2 million for the first quarter 2023, as compared to $75.0 million for the same period in 2022
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Research and development expenses include $6.8 million of non-cash stock-based compensation expenses for the first quarter 2023 as compared to $8.5 million for the same period in 2022
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General and administrative expenses were $13.9 million for the first quarter 2023, as compared to $20.6 million for the same period in 2022
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General and administrative expenses include $5.0 million of non-cash stock-based compensation expenses for the first quarter 2023, as compared to $5.8 million for the same period in 2022