Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 55

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 55
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, financial condition, results of operations and prospects. 

The data produced in our clinical trials of agenT-797 is at an early stage and future data may not show responses in patients treated or support continued development. In addition, the results ultimately obtained from our preclinical studies or other clinical trials for agenT-797 or any of our other product candidates may not be predictive of future results. 

In February 2024, we published data from our clinical trial for ARDS secondary to COVID-19; such interim data, and any future interim data from clinical trials that we may conduct, including the clinical trials for agenT-797 for the treatment of cancer and, potentially, other life-threatening infectious diseases, are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. We cannot provide any assurance that additional data will be provided frequently or that data updates will be available at any particular time. Furthermore, while patients with who have 

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been treated with our product candidates may have a positive response, there can be no assurance that their progress or recovery will be sustained.

Preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously announced. Negative differences between preliminary or interim data and final data could materially adversely affect the prospects of any product candidate that is impacted by such data updates. 

In addition, the results of any preclinical studies of agenT-797 or for our other product candidates may not be predictive of the results of clinical trials. For example, preclinical models as applied to cell therapy in oncology do not adequately represent the clinical setting, and thus cannot predict clinical activity nor all potential risks and may not provide adequate guidance as to appropriate dose or administration regimen of a given therapy. 

We may not be able to submit INDs or the foreign equivalent outside of the United States to commence additional clinical trials for cell therapies on the timeframes we expect, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all. 

We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the