On May 15, 2025 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 financial results for the first quarter 2025 and business updates (Press release, Atara Biotherapeutics, MAY 15, 2025, View Source [SID1234653159]).

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"We are pleased that we have secured additional financing that is expected to extend our cash runway through the first quarter of 2026," said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. "This enables Atara to continue to work to reduce costs and liabilities while maintaining the required support to achieve potential BLA approval."

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

The FDA has lifted the clinical holds on EBVALLO studies. Atara plans to resume enrollment in the Phase 3 ALLELE clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) and the Phase 2 label-expansion multi-cohort clinical study.
The FDA has granted a date in the second quarter of 2025 for a Type A meeting to discuss the plan to address the issues raised by the FDA in the Complete Response Letter (CRL) issued in January 2025, and the path forward for resubmission of the EBVALLO BLA.
In March 2025, the Company completed the transfer of all worldwide manufacturing and supply responsibility, including all associated costs, to Pierre Fabre Laboratories, and the Company is in active discussions on accelerating the transfer of all remaining operational activities related to tab-cel to Pierre Fabre, except the BLA sponsorship, which the Company expects to be completed as early as June 2025.
Atara remains eligible for significant milestone payments from Pierre Fabre Laboratories upon FDA approval of the EBVALLO BLA and related commercial sales of EBVALLO, as well as significant royalties as a percentage of net sales. Pierre Fabre Laboratories holds worldwide Commercialization rights to EBVALLO.
CAR T Programs Discontinued

Atara has paused development of its CAR T programs (ATA3219 and ATA3431), with anticipated completion of wind-down activities in the second quarter of 2025.
Corporate Updates

Strategic Option Evaluation: As communicated in January and March, Atara engaged a well-known financial advisor to support the assessment of a range of strategic options, which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. In April 2025, Atara paused its review of strategic options, pending the Type A meeting with the FDA which is scheduled in the second quarter of 2025, to discuss the plan to address the issues raised by the FDA in the CRL and the path forward for resubmission of the EBVALLO BLA.

Organizational Restructuring: In May 2025, Atara implemented a strategic restructuring to further reduce operating expenses and due to the wind down of the CAR T programs. This restructuring resulted in a company-wide workforce reduction of approximately 30%, retaining approximately 23 personnel essential to execute on its remaining transition responsibilities under the EBVALLO collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval.

Financial Update: Atara has entered into an underwriting agreement for the issuance and sale of 834,237 shares of its common stock at a purchase price of $6.61 per share and the issuance and sale of pre-funded warrants to purchase up to 1,587,108 shares of its common stock at a purchase price of $6.6099 per share, representing fair market value based on closing, to entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group. The proceeds to Atara from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes. The offering is expected to close on May 16, 2025, subject to the satisfaction of customary closing conditions.

First Quarter 2025 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2025 totaled $13.8 million, as compared to $42.5 million as of December 31, 2024.
Net cash used in operating activities was $28.1 million for the first quarter 2025, as compared to $29.6 million in the same period in 2024.
Total revenues were $98.1 million for the first quarter 2025, as compared to $27.4 million for the same period in 2024. Total revenues increased by $70.7 million year over year, primarily due to revenue recognized as a result of the completion of certain performance obligations under our Pierre Fabre agreement following the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $6.0 million for the first quarter 2025, as compared to $9.8 million for the same period in 2024.
Research and development expenses were $27.4 million for the first quarter 2025, as compared to $45.5 million for the same period in 2024.
Research and development expenses include $8.3 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force.
Research and development expenses also include $1.4 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $4.7 million for the same period in 2024.
General and administrative expenses were $11.5 million for the first quarter 2025, as compared to $11.1 million for the same period in 2024.
General and administrative expenses include $1.5 million in restructuring charges comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act for the January and March 2025 reductions in force.
General and administrative expenses include $2.8 million of non-cash stock-based compensation expenses for the first quarter 2025, as compared to $3.7 million for the same period in 2024.
Atara reported net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the first quarter 2025, as compared to a net loss of $31.8 million, or $5.65 basic and diluted loss per share, for the same period in 2024.
2025 Outlook and Cash Runway

Atara transitioned all tab-cel manufacturing costs and responsibilities to Pierre Fabre in the first quarter of 2025. Pierre Fabre continues to reimburse Atara for costs related to the remaining tab-cel operation activities.
In addition to reducing its headcount by approximately 85% since December 31, 2024, Atara continues to pursue additional initiatives aimed at enhancing operational efficiency.
Following the recognition of most of the one-time restructuring costs in the first quarter of 2025, we anticipate operating expenses to decrease continuously throughout the remainder of the year, with the largest reduction expected in the second quarter of 2025. In total, we expect full year 2025 operating expenses to decrease by approximately 65% from 2024.
Atara projects that cash, cash equivalents and short-term investments as of March 31, 2025, combined with the $16M gross proceeds from the May 2025 offering, in total will enable funding of planned operations into the first quarter of 2026.