Company: ATRA
Filing Date: 2025-04-28
Form Type: DEF 14A
Source: 0000950170-25-059322
Chunk: 51

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-04-28
Form: DEF 14A
Chunk 51
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tain approval of PV3.3 in Europe in coordination with Pierre Fabre                       
 •Successfully release tab-cel PV3.2AT and PV3.3 vials per production plan with Pierre Fabre 
 •Satisfy transition obligations per agreement with Pierre Fabre                             | •Successfully filed BLA in Q2 2024                                                                              
 •Received FDA acceptance of BLA in Q3 2024                                                                      
 •Completed RTQs and PAI to support BLA approval in HCT and SOT                                                  
 •Received approval of PV3.3 in Europe in coordination with Pierre Fabre in Q4 2024                              | 45%    |
| CAR T           | •Treat first ATA3219 NHL patient in Q2 2024                                                 
 •Disclose initial ATA3219 clinical data in NHL by EOY 2024                                  
 •Submit ATA3219 lupus IND in Q1 2024 and treat first patient by EOY 2024                    
 •Complete ATA3431 non-GMP demo runs by EOY 2024 to enable IND filing in 2025                | •Treated first ATA3219 NHL patient in Q3 2024                                                                   
 •Submitted 3219 IND for systemic lupus erythematosus (SLE); received Safe to Proceed letter from FDA in Q1 2024 
 •Expanded Phase 1 study to include new cohort in extrarenal SLE without lymphodepletion in Q3 2024              | 45%    |
| Corporate       | •Manage expenses to stay within approved 2024 budget through financial stewardship          | •Successfully implemented several expense management initiatives to improve organization effectiveness          | 10%    |

As noted above, we achieved important progress with the FDA by filing the BLA in the second quarter of 2024 and received confirmation of FDA acceptance of the BLA in the third quarter of 2024. In addition, as noted above, during the course of 2024, we also advanced our CAR-T programs with treatment of our first ATA3219 NHL patient in the third quarter of 2024 and expanding the Phase 1 study to include a new cohort in extrarenal SLE without lymphodepletion in the third quarter of 2024. Despite these important achievements, we were disappointed by the Complete Response Letter to the tab-cel BLA from the FDA and clinical holds on our active INDs, which were solely related to observations as part of a standard pre-license inspection of a third-party manufacturing