On March 7, 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 fourth quarter and full year 2024, business updates, and key upcoming milestones for 2025 (Press release, Atara Biotherapeutics, MAR 7, 2025, View Source [SID1234651009]).
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"We will further narrow our focus on the future financial value of EBVALLO for the benefit of all stakeholders. Atara continues to productively engage with our partner Pierre Fabre Laboratories and the FDA to help the third-party manufacturer adequately address the GMP compliance issues as we continue to work toward an expeditious path to release the clinical hold and resubmit the EBVALLO BLA," said Cokey Nguyen, President and Chief Executive Officer of Atara. "With the focus on future EBVALLO value paramount, the Company has made the difficult decision to pause development of its allogeneic CAR-T cell programs and to discontinue all CAR-T operations including terminating the clinical trials evaluating ATA3219. The Company’s strategic review is ongoing."
"I would like to convey our gratitude to the patients, investigators, and collaborators for their participation in our CAR-T development efforts. Through this work, we have made important progress and advanced an innovative allogeneic CAR-T platform to the clinical stage, which will serve the scientific community well with key learnings as the field progresses. I also wish to sincerely thank the Atara team members who worked tirelessly on this program, and our stockholders for their commitment to our Company," added Dr. Nguyen.
Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)
In January 2025, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for EBVALLO as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen
The CRL only cited findings that arose during a pre-license inspection of a third-party manufacturing facility for EBVALLO; it did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data
Atara received a clinical hold notice from FDA on EBVALLO studies linked to the CRL in January 2025
Atara is currently undertaking efforts to support the third-party manufacturer in addressing the FDA’s requests in order to lift the hold and support BLA resubmission; the Company anticipates providing a regulatory update in the second quarter of 2025
A second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB), has been approved to manufacture EBVALLO by the European Medicines Agency (EMA), and is positioned to play a primary role in ensuring reliable supply for the U.S. market over the long term following FDA approval
Atara remains eligible for significant milestone payments from Pierre Fabre upon FDA approval of the EBVALLO BLA and related commercial sales of EBVALLO, as well as significant royalties as a percentage of net sales
ATA3219: Paused CD19 Program in Non-Hodgkin’s Lymphoma (NHL)
First patient successfully completed dosing in the Phase I dose escalation study, evaluating the safety and efficacy of ATA3219
The Phase 1 study was a multi-center, open label dose escalation trial aimed at treating patients with NHL. The study and associated clinical operations are being discontinued
The administration of two infusions of ATA3219 was well tolerated with no evidence of graft versus host disease or other safety events. B-cell depletion was observed up to 28 days after initial treatment with levels of key pro-inflammatory cytokines—IFN-γ, IL-8, MCP-1, and IL-18— peaking by Day 7 with no detection of IL-6
Corporate Updates
Strategic Option Evaluation: As previously communicated, Atara engaged a well known financial advisor to support a comprehensive process to explore and assess a range of potential strategic options for the Company. Alternatives may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. This process is ongoing. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated.
Organizational Restructuring: Atara has implemented a strategic restructuring to sharpen the Company’s focus on addressing the issues at a third party manufacturing facility outlined in the CRL, lifting the clinical hold, and resubmitting the EBVALLO BLA. This restructuring resulted in a company-wide workforce reduction of approximately 50% of our remaining workforce, retaining approximately 35 personnel essential to execute on its remaining transition responsibilities under the EBVALLO collaboration with Pierre Fabre Laboratories, including as the BLA holder until approval, and certain wind-down activities for the CAR-T programs.
EBVALLO Transition Activities: Atara is in active discussions with Pierre Fabre on accelerating the transfer of all operational activities related to EBVALLO, except the BLA sponsorship, to be completed as early as the end of the first quarter of 2025.
Financial Update: As previously announced, Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding through an equity line of credit, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval, assuming a successful transition of operational activities related to EBVALLO to Pierre Fabre. Atara is also exploring alternative financing options.
Fourth Quarter and Full Year 2024 Financial Results
Cash, cash equivalents and short-term investments as of December 31, 2024 totaled $42.5 million, as compared to $51.7 million as of December 31, 2023
Net cash used in operating activities was $24.5 million and $68.7 million for the fourth quarter and fiscal year 2024, as compared to $50.4 million and $193.0 million in the same periods in 2023
Atara reported net losses of $12.7 million, or $1.19 per share, and $85.4 million, or $11.41 per share, for the fourth quarter and fiscal year 2024, respectively, as compared to $60.5 million, or $14.00 per share, and $276.1 million, or $65.19 per share, for the same periods in 2023
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $6.9 million and $32.1 million for the fourth quarter and fiscal year 2024, respectively, as compared to $11.1 million and $50.2 million for the same periods in 2023
Total costs and operating expenses include restructuring expense of $0.0 million and $5.1 million for the fourth quarter and fiscal year 2024 related to the reduction in force Atara announced in January 2024 and which reduced its headcount at that time by approximately 25%. This reduction in force was substantially completed in March 2024. In the comparative periods, total costs and operating expenses include restructuring expense of $6.7 million for the fourth quarter and fiscal year 2023 related to the reduction in force Atara announced in November 2023 and which reduced its headcount at that time by approximately 30%. This reduction in force was substantially completed in December 2023.
Research and development expenses were $28.3 million and $151.5 million for the fourth quarter and fiscal year 2024, respectively, as compared to $49.6 million and $224.8 million for the same periods in 2023
Research and development expenses include $2.6 million and $13.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2024, respectively, as compared to $5.8 million and $26.5 million for the same periods in 2023
General and administrative expenses were $9.4 million and $39.9 million for the fourth quarter and fiscal year 2024, respectively, as compared to $11.5 million and $50.9 million for the same periods in 2023
General and administrative expenses include $3.3 million and $13.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2024, respectively, as compared to $4.1 million and $18.9 million for the same periods in 2023