Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 56

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 56
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 timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin. 

Even if any product candidates we may develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success. 

The commercial success of any of the product candidates we may develop will depend upon its degree of market acceptance by physicians, patients, third-party payors and others in the medical community. Even if any product candidates we may develop receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including: 

•the efficacy and safety of such product candidates as demonstrated in clinical trials; 

•the potential and perceived advantages compared to alternative treatments; 

•the limitation to our targeted patient population and limitations or warnings contained in approved labeling by the FDA or other regulatory authorities; 

•the ability to offer our medicines for sale at competitive prices; 

•convenience and ease of administration compared to alternative treatments; 

•the clinical indications for which the product candidate is approved by the FDA, the EMA or other regulatory agencies; 

•the willingness of the target patient population to try novel therapies and of physicians to prescribe these therapies; 

•product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling; 

•relative convenience and ease of administration; 

•the timing of market introduction of competitive products; 

•publicity concerning our products or competing products and treatments; 

•the strength of marketing and distribution support; 

•sufficient third-party coverage or reimbursement; and 

•the prevalence and severity of any side effects. 

If any of the product candidates we develop are approved, but do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. 

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If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved. 

We do not have a sales or marketing infrastructure and have no experience in the sale