On August 8, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2022, an update to its corporate strategy, recent business highlights, and key upcoming catalysts (Press release, Atara Biotherapeutics, AUG 8, 2022, View Source [SID1234617783]).
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"We are excited about the transformative potential of ATA188 in MS and are pleased that as a result of our significant and constructive engagement, the FDA has recommended a possible path towards a tab-cel BLA filing without the need for a new clinical study," said Pascal Touchon, President and Chief Executive Officer of Atara. "Atara’s R&D-centered strategy, clear portfolio prioritization, and purposeful partnerships are positioning us for success in reaching critical value-generating milestones for our key pipeline assets. I would like to extend my sincere gratitude and thanks to Atara’s staff for their significant contributions and unwavering commitment to advancing truly innovative medicines for patients in need."
Corporate Strategy Update
Atara announced plans to focus its activities as a leaner organization centered on R&D to further advance the Company’s innovative pipeline, while reducing cash burn
Staff will be reduced by approximately 20% across the organization
Future annual cash burn is anticipated to be reduced by over 20%, extending Atara’s cash runway into Q1 2024
Leveraging its differentiated allogeneic T-cell therapy platform and unique clinical experience in over 500 patients treated, Atara will prioritize R&D activities over the next 18 months on three core priorities:
Clinical development of ATA188, our potentially transformative Phase 2 asset for progressive multiple sclerosis
EU and potential U.S. regulatory filings and approvals for tab-cel while seeking a commercial partner for tab-cel in the U.S., including all related activities and costs, which is expected to further extend the Company’s cash runway
Anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogeneic CD19 CAR T, with the potential to address the significant opportunity in the field for improving durable clinical response in hard-to-treat B-cell malignancies
These actions are part of a broader ongoing strategy to focus the organization on R&D, building on the previously announced manufacturing and commercialization collaborations with FUJIFILM Diosynth Biotechnologies (FDB) and Pierre Fabre, respectively, and continuing with the R&D-focused prioritization announced today
ATA188 for Progressive Multiple Sclerosis (MS)
Atara completed the Phase 2 EMBOLD study Interim Analysis (IA) in patients with progressive MS in June 2022 and the Company determined no sample size adjustment or modification would be made to the study
Based on enrollment at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement by EDSS at 12 months. Communication of these data is planned to occur at an appropriate forum in October 2023
Atara continues to plan for Phase 3 readiness, including interacting with the U.S. Food & Drug Administration (FDA) based on two Fast Track designations, and further developing its proprietary large-scale bioreactor manufacturing process
New Phase 1 MRI data providing further evidence of the potential clinical impact of ATA188 in progressive MS patients, as well as updated OLE data, are planned for presentation at an appropriate forum in Q4 2022
Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)
Based on constructive discussions with Atara, the FDA recommended a possible path to a Biologics License Application (BLA) submission that does not require a new clinical trial
Following planned interactions with FDA, Atara intends to provide further guidance on progress to a BLA submission at our next quarterly call
The European Medicines Agency (EMA) review of tab-cel is on-track and Atara anticipates European Commission (EC) approval in Q4 2022
Atara has successfully completed all six pre-approval inspections required to support the Marketing Authorization Application (MAA) for tab-cel in Europe
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
Following Bayer’s strategic review and asset-level prioritization of its pipeline, the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies ATA2271, an autologous version, and ATA3271, an armored allogeneic T-cell immunotherapy has been terminated
Accordingly, the IND for ATA3271 is paused pending funding for clinical development
Following the findings of the Memorial Sloan Kettering (MSK)-generated autopsy report and correlative data analyses, Atara intends to continue supporting the clinical development of ATA2271 through our collaboration with MSK and a protocol amendment to be discussed shortly with the FDA
ATA3219 (B-cell Malignancies)
Atara continues to make progress toward the anticipated IND filing for ATA3219 in Q4 2022. This allogeneic EBV CD19 CAR T program, using an optimized manufacturing process, is enriched for a memory T-cell phenotype and continues to show robust activity in preclinical studies
Second Quarter 2022 Financial Results
Cash, cash equivalents and short-term investments as of June 30, 2022 totaled $331.3 million, as compared to $301.8 million as of March 31, 2022. The increase includes the impact of net proceeds of $94.8 million from the sale of the ATOM facility during the second quarter
Atara believes that its cash and investments as of June 30, 2022, together with the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into the first quarter of 2024
Net cash used in operating activities was $64.0 million for the second quarter 2022, as compared to $61.6 million for the same period in 2021
Atara reported net income of $18.5 million, or $0.18 per share, for the second quarter 2022, as compared to a net loss of $83.8 million, or $0.91 per share, for the same period in 2021. Second quarter 2022 net income included a gain on the sale of the ATOM facility of $50.2 million.
License and collaboration revenue was $51.6 million for the second quarter 2022, primarily consisting of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements, as compared to $3.9 million for the same period in 2021. We anticipate that license and collaboration revenues will decrease substantially in future quarters due to the termination of the Bayer Agreements.
Total operating expenses include non-cash expenses of $15.6 million for the second quarter 2022, as compared to $16.1 million for the same period in 2021
Research and development expenses were $64.9 million for the second quarter 2022, as compared to $68.5 million for the same period in 2021
The decrease in the second quarter 2022 was primarily due to lower employee-related and overhead costs as a result of the FDB transaction, partially offset by increased spending on the Company’s ATA188 and CAR T programs
Research and development expenses include $7.9 million of non-cash stock-based compensation expenses for the second quarter 2022 as compared to $8.3 million for the same period in 2021
General and administrative expenses were $18.8 million for the second quarter 2022, as compared to $19.4 million for the same period in 2021
General and administrative expenses include $6.2 million of non-cash stock-based compensation expenses for the second quarter 2022, as compared to $5.5 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13730293. 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.