Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 41

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 41
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Summary of Risk Factors

Our business is subject to a number of risks and uncertainties. The following is a summary of the principal risk factors described in this section:

Risks Related to Our Financial Position and Need for Additional Capital

•We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

•If we fail to raise additional capital, we would be forced to delay, reduce, or eliminate certain projects.

•Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies.

•Our short history as an independent company may make it difficult to evaluate the success of our business and to assess our future viability.

•Our future ability to utilize certain tax attributes may be limited.

•Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and its financial condition and results of operations.

•Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.

Risks Related to Discovery, Development and Commercialization of Our Allogeneic iNKT Cells and Other Product Candidates

•Our business is highly dependent on the success of our lead product candidate, agenT-797, and we may fail to develop agenT-797 successfully or be unable to obtain regulatory approval for it.

•Allogeneic iNKT cells represent a novel approaches to immunotherapy, which may result in significant challenges to the development, regulatory approval, and commercialization of product candidates.

•Our business is highly dependent on our iNKT cell platform, and our product candidates will require significant additional testing before we can seek regulatory approval.

•Serious adverse events, undesirable side effects or unexpected characteristics caused by our product candidates could delay or prevent regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.

•The data produced in our clinical trials is at an early stage and future data may not show responses in patients treated or support continued development. 

•We may not be able to submit INDs or the foreign equivalent to commence additional clinical trials for cell therapies on the timeframes we expect.

•Even if any product candidates we may develop receive marketing approval, they may fail to achieve commercial success.

•We face significant competition and there is a possibility that our competitors may achieve regulatory approval before us or develop adoptive cell therapies that are safer or more advanced or effective than ours. 

•Any product candidates we develop may be complex