On November 1, 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 recent business highlights including an expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel), financial results for the third quarter 2023, and key upcoming catalysts (Press release, Atara Biotherapeutics, NOV 1, 2023, View Source [SID1234636625]).
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"We are proud to expand our global tab-cel partnership with Pierre Fabre Laboratories, who is committed to delivering this first-of-its-kind treatment to patients in need across the globe," said Pascal Touchon, President and Chief Executive Officer of Atara. "In light of our expanded tab-cel partnership and to strategically position the company going forward, we are also restructuring our operations to significantly reduce expenses, meaningfully extend our cash runway to nearly two years, and enable organizational focus on generating the greatest value from our transformative pipeline: ATA188 and our differentiated allogeneic CAR-T assets. I wish to personally thank the talented colleagues who will be departing Atara for their essential contributions in getting us to this critical point in our journey."
Expanded Global Partnership for Tabelecleucel (tab-cel or EBVALLO)
Atara has entered into an expanded partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel for up to USD 640 million and significant double-digit tiered royalties on net sales. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected tab-cel global development costs through Biologics License Application (BLA) transfer, and purchase current and future tab-cel inventory through the BLA transfer date. Near-term payments to Atara include:
Approximately USD 30 million in cash upfront and initial inventory purchase at closing
USD 100 million in potential regulatory milestones through BLA approval
Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer
Atara expects to submit the tab-cel post-transplant lymphoproliferative disease (PTLD) BLA in Q2 2024
"We are eager to progress tabelecleucel toward approval in the U.S. so that American patients can access this innovative treatment already approved and commercialized in Europe," said Eric Ducournau, CEO of Pierre Fabre Laboratories.
The closing of the transaction, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to occur in December 2023. PJT Partners served as the exclusive financial advisor to Atara and Fenwick & West LLP served as legal counsel to Atara.
Strategic Restructure and Financial Impacts
Concurrent with the execution of the global tab-cel partnership, Atara is undertaking a strategic restructuring and is reducing its current workforce by approximately 30 percent. This will enable Atara to execute its remaining responsibilities under the tab-cel collaboration with Pierre Fabre Laboratories, while focusing on the advancement of ATA188 and its differentiated allogeneic CAR T (AlloCAR-T) programs
The strategic restructuring, combined with certain anticipated payments from the expanded global partnership and the Company’s existing cash, cash equivalents and short-term investments as of September 30, 2023, is expected to fund the Company’s planned operations into Q3 2025
Pipeline Focus Moving Forward
The ATA188 Phase 2 EMBOLD study primary analysis and communication remains on track for early November with more than 90 patients to be included
To create the greatest value from its potentially transformative pipeline, Atara will focus capital resources on ATA188 development and to unlock the full promise of its growing and potential best-in-class oncology and autoimmune targeted AlloCAR-T portfolio
Atara will leverage its EBV T-cell biology expertise and novel CAR-T technologies for areas of significant unmet medical need by overcoming limitations of current or investigational autologous or allogeneic CAR-T approaches:
Initiation of Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) for ATA3219—an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy—expected in the coming months with preliminary clinical data anticipated H2 2024
Progressing efforts toward a potential clinical study evaluating ATA3219 in autoimmune disease in parallel with NHL development
Continued advancement of promising early AlloCAR-T development programs including ATA3431, an allogeneic, bispecific tandem CAR directed against both CD19 and CD20 built on the EBV T-cell platform with a 1XX costimulatory signaling domain. ATA3431 preclinical data has been accepted for poster presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2023
Third Quarter 2023 Financial Results (prior to Pierre Fabre Laboratories partnership expansion in October 2023)
Cash, cash equivalents and short-term investments as of September 30, 2023, totaled $102.4 million, as compared to $153.6 million as of June 30, 2023
Net cash used in operating activities was $51.3 million for the third quarter 2023, as compared to $65.1 million in the same period in 2022
Atara reported a net loss of $69.8 million, or $0.66 per share for the third quarter 2023, as compared to a net loss of $84.1 million, or $0.82 per share for the same period in 2022.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $12.4 million for the third quarter 2023, as compared to $15.4 million for the same period in 2022
Research and development expenses were $56.9 million for the third quarter 2023, as compared to $70.2 million for the same period in 2022
Research and development expenses include $6.8 million of non-cash stock-based compensation expenses for the third quarter 2023 as compared to $8.0 million for the same period in 2022
General and administrative expenses were $12.2 million for the third quarter 2023, as compared to $18.9 million for the same period in 2022
General and administrative expenses include $4.4 million of non-cash stock-based compensation expenses for the third quarter 2023, as compared to $6.0 million for the same period in 2022
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Wednesday, November 1, 2023, at 9:00 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.