Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 42

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 42
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 and difficult to manufacture. 

Risks Related to Regulatory Review and Other Legal Compliance Matters

•If our clinical trials fail to demonstrate safety and efficacy, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of product candidates.

•We may experience delays or difficulties in the enrollment of patients in our clinical trials.

•The regulatory landscape that will govern any product candidates we may develop is uncertain and may change.

•Any failure to comply with laws and regulations could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

•Healthcare and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize any product candidates.

•Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, or we may fail to satisfy certain arrangements with governmental authorities.

•Laws and regulations governing our international operations may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us implement costly compliance programs.

•We are subject to stringent privacy and information security laws, regulations, policies and contractual obligations and changes in such laws, regulations, policies and contractual obligations could adversely affect our business.

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Risks Related to Our Relationship with Agenus

•We may experience difficulty in separating our resources from Agenus. 

•Agenus owns a majority of our common stock and will be able to exert control over specific matters subject to stockholder approval.

•Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Agenus.

Risks Related to Our Relationships with Third Parties

•We rely on third parties, which may not perform satisfactorily, including failing to meet deadlines for the completion of trials, research, or testing.

•Reliance on third parties increases the risk that we will not have sufficient quantities of materials, product candidates, or any medicines that we may develop and commercialize, or that it will not be available at an acceptable cost.

•If we are not able to establish collaborations, we may have to alter our development and commercialization plans.

Risks Related to Our Intellectual Property

•We may be unable to obtain and maintain satisfactory patent and other intellectual property protection for any product candidates we develop and for our cell-based immunotherapies.

•Our rights to develop and commercialize our cell-based immunother