Company: ADPT
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030913
Chunk: 63

Company: Adaptive Biotechnologies Corp
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 63
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 not result in a commercial agreement. Even if an agreement is reached, the resulting relationship may not be successful, and any products and services developed as part of the collaboration may not produce successful outcomes. Speculation in the industry about our existing or potential collaborations can be a catalyst for adverse speculation about us or our products, which can adversely affect our reputation and our business. 

Significant additional research and development and, in certain instances, clinical trials or validation will be required before we or our collaborators can potentially seek regulatory clearance, authorization or approval for, or commercialize any of our products or services in development. 

We are developing a pipeline of immune-based diagnostics and therapeutics, including TCR-based cellular therapies in oncology and antibodies in autoimmunity. However, significant additional research and development activities, validations, and clinical trials are required before we and, as pertinent, our collaborators will have a chance to achieve additional commercially viable products. Our research and development efforts remain subject to all of the risks associated with drug development in general and specific to products that we pursue on our own or in collaboration. Development of the underlying technology may be affected by unanticipated technical or other problems, among other research and development issues, and the possible lack of funds needed to complete development of these products. Safety, regulatory and efficacy issues, clinical hurdles or other challenges may result in delays and cause us to incur additional expenses that would increase our losses. If we and our collaborators cannot complete, or if we experience significant delays in developing, our clinical diagnostics or therapeutics, including T-cell based cellular therapies and antibodies, particularly after incurring significant expenditures, our business may fail and investors may lose the entirety of their investment. 

Prior to obtaining regulatory clearances, authorizations or approvals for the commercial sale of any new therapeutic products or services, we must demonstrate that our products are both safe and effective for use in each target disease indication. Clinical studies will be necessary to demonstrate that a product is safe and effective. Research and development, clinical testing and validation are expensive, can take many years to complete and the outcomes are inherently uncertain. Failure can occur at any time. For therapeutics, the results of preclinical studies and early clinical trials of products and services in development may not be predictive of the results of later-stage clinical trials, and initial success in clinical trials may not be indicative of results obtained when clinical trials are completed. There is typically an extremely high rate of failure as therapeutic products in development proceed through clinical trials. Products in later stages of clinical trials or validation also may fail to