Company: ATRA
Filing Date: 2025-03-07
Form Type: 10-K
Source: 0000950170-25-035507
Chunk: 87

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-03-07
Form: 10-K
Item: Item 1A
Chunk 87
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 other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risk, or for any other reason; 

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•data that demonstrate an unacceptable benefit/risk profile, including a lack of efficacy, unforeseen safety issues or adverse side effects

•difficulties in manufacturing or obtaining from third parties sufficient quantities of clinical product and/or inability to supply a breadth of appropriate partially HLA matched cell lines from among the available T-cell lines to start or to use in clinical studies;

•lack of adequate funding to continue a study, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional studies or increased expenses associated with the services of our CROs and other third parties; 

•non-compliance with CTIS processes under the new EU Clinical Trial Regulation, including with the CTIS transparency rules, which became applicable on June 18, 2024 and which will require adapting business processes of clinical trial sponsors; or

•changes in governmental regulations or administrative actions or lack of adequate funding to continue a clinical study.

Patient enrollment, a significant factor in the timing of clinical studies, is affected by many factors including: 

•the size and nature of the patient population; 

•the possibility that the rare diseases that many of our product candidates address are under-diagnosed;

•changing medical practice patterns or guidelines related to the diseases or conditions we are investigating;

•the severity of the disease under investigation; 

•our ability to open clinical study sites;

•the proximity of subjects to clinical sites;

•the patient referral practices of physicians;

•the design and eligibility criteria of the clinical study;

•ability to obtain and maintain patient consents; 

•risk that enrolled subjects will drop out or die before completion; 

•competition for patients from other clinical studies;

•our or our partner’s ability to manufacture the requisite materials for a study;

•risk that we do not have appropriately matched HLA cell lines;

•clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the diseases or conditions we are investigating; and

•disruptions caused by man-made or natural disasters or public health pandemics or epidemics, including, for example, the COVID-19 pandemic.

As an example, we activated additional clinical sites for the ALLELE study of tab-cel over the course of 2018 and increased HLA coverage during this period. As a result, enrollment in