Company: ATRA
Filing Date: 2025-03-07
Form Type: 10-K
Source: 0000950170-25-035507
Chunk: 75

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-03-07
Form: 10-K
Item: Item 1A
Chunk 75
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 to the Development of Our Product and Product Candidates

We have one approved product, Ebvallo, which is currently approved in the European Economic Area (EEA), the UK and Switzerland. In March 2025, we announced our decision to pause the development of our allogeneic CAR T programs and discontinue all CAR T development operations. All of our other product candidates are still in preclinical development. If we or our collaborators are unable to  successfully develop, manufacture and commercialize our product or product candidates or experience significant delays in doing so, our business may be materially harmed. 

We have one approved product, Ebvallo, which is currently approved in the EEA, the UK and Switzerland. We have invested substantial resources in identifying and developing potential product candidates, conducting preclinical and clinical studies, manufacturing activities, and preparing for the commercial launch of our product and product candidates. Our ability to generate revenues from the sale of our product and product candidates, if approved, will depend heavily on the successful development and manufacture, and our partners' eventual commercialization of our product and product candidates. 

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The success of our product and product candidates depends on many factors, including the following:

•completion of preclinical and clinical studies with positive results, including demonstrating the stability, safety, purity, and potency of our product candidates to the satisfaction of the FDA or other regulatory agencies;

•receipt of regulatory approvals from applicable authorities, including required authorizations for clinical trials and marketing authorizations;

•protecting our rights in our intellectual property portfolio, including by obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

•establishing or making successful arrangements with third party manufacturers and commercialization partners; 

•qualifying our and our CMOs’ manufacturing facilities for clinical and commercial manufacturing purposes;

•developing manufacturing and distribution processes for our novel T-cell product candidates and next-generation CAR T programs;

•contracting with third parties for the manufacture of our product candidates at an acceptable cost;

•contracting with third parties for commercialization of our products on terms favorable to us, if approved by applicable regulatory authorities;

•acceptance of our products, if approved by applicable regulatory authorities, by patients and the medical community;

•our partners’ ability to obtain and maintain coverage and adequate reimbursement by third-party payors, including government payors, for our products, if approved by applicable regulatory authorities;

•effectively competing with other therapies;

•maintaining a continued acceptable benefit/risk profile of the products following approval; and