Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 67

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 67
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•size of the patient population and process for identifying patients; 

•design of the trial protocol; 

•availability and efficacy of approved medications for the disease under investigation; 

•ability to obtain and maintain patient informed consent; 

•risk that enrolled patients will drop out before completion of the trial; 

•eligibility and exclusion criteria for the trial in question; 

•perceived risks and benefits of the product candidate under trial; 

•perceived risks and benefits of adoptive cell therapy as a therapeutic approach; 

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•efforts to facilitate timely enrollment in clinical trials; 

•patient referral practices of physicians; 

•ability to monitor patients adequately during and after treatment; and 

•proximity and availability of clinical trial sites for prospective patients, especially for those conditions which have small patient pools. 

As COVID-19 vaccination rates have increased in the general population, fewer patients have been hospitalized with ARDS secondary to COVID-19, which has slowed our ability to enroll patients in our clinical trial for ARDS secondary to COVID-19. We are preparing a protocol to expand this trial to include ARDS secondary to other life-threatening infectious diseases, including influenza. 

Our ability to successfully initiate, enroll and complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries, including: 

•difficulty in establishing or managing relationships with CROs and physicians; 

•different standards for the conduct of clinical trials; 

•different standard-of-care for patients with a particular disease; 

•difficulty in locating qualified local consultants, physicians and partners; and 

•potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatments and of cell-based immunotherapies. 

In addition, our clinical trials may also compete to recruit patients with other clinical trials for product candidates that are in a similar adoptive cell therapy area as our product candidates, and this competition could reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. 

Enrollment delays in our clinical trials may result in increased development costs for any product candidates we may