Company: INKT
Filing Date: 2025-03-18
Form Type: 10-K
Source: 0000950170-25-041379
Chunk: 44

Company: MiNK Therapeutics, Inc.
Filing Date: 2025-03-18
Form: 10-K
Item: Item 1A
Chunk 44
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losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we: 

•continue our clinical and preclinical development of product candidates; 

•seek to develop our iNKT cell platform further and identify additional research programs and additional product candidates; 

•initiate preclinical testing and clinical trials for any product candidates we identify and develop from our current research programs; 

•maintain, expand, enforce, defend and protect our intellectual property portfolio; 

•seek marketing approvals for any of our product candidates that successfully complete clinical trials; 

•establish a sales, marketing, manufacturing and distribution infrastructure to commercialize any biologics for which we may obtain marketing approval; 

•hire additional research and development personnel; 

•hire clinical and commercial personnel; 

•add operational, financial and management information systems and personnel, including personnel to support our product development; and

•acquire or in-license product candidates, intellectual property and technologies.

We have initiated three Phase 1 clinical trials for our lead product candidate, agenT-797, and all of our other product candidates remain in preclinical development. We do not have any products approved for sale and have not generated any revenue from product supplies or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we obtain marketing approval for a product candidate. We expect that it will be many years, if ever, before we have a product candidate that receives such approval. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a medicine or medicines with significant market potential. This will require us to be successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those medicines for which we may obtain marketing approval, and satisfying any post-marketing requirements. Even if one or more of the product candidates we may develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations and, even if we do achieve profitability, we may not be able to sustain or increase