Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 47

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 47
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 on, and expect to continue to rely on, third-party contract development and manufacturing organizations and other suppliers to support process validation and manufacture of our product candidates at a commercial scale. This helps ensure that all products supplied to us are produced in accordance with relevant regulatory requirements and approvals, including those product materials intended for use in our preclinical and clinical testing, as well as potential commercial supply. 

We believe that our strategy and workforce allow us to maintain an efficient infrastructure and ensure we do not need to invest in expensive manufacturing facilities and equipment. Our personnel within the organization enable us to focus our expertise and resources on the development of our product candidates and the management of third-party vendors.

To date, we have obtained active pharmaceutical ingredients (“APIs”) from qualified facilities with the relevant expertise to manufacture our drug substances. Likewise, suitably qualified facilities with relevant experience have been used to manufacture our drug products. All third parties are assessed under our quality system and appropriate quality agreements to ensure compliance are in place. We maintain agreements with our manufacturers and ensure that confidentiality and intellectual property provisions to protect our proprietary rights related to our product candidates are in place. 

We have determined our supply chain for our lead product candidate to help ensure continuity of supply and capacity for intended commercialization. 

41

Commercialization 

We hold worldwide development and commercialization rights to our pipeline of therapeutic cancer vaccine programs, and we intend to commercialize our product candidates, if approved, in key markets. We have not currently built our own launch infrastructure, nor the functions needed for launch, including but not limited to, marketing, market access, insights and analytics, field organization, or distribution capabilities. To commercialize Cylembio®, we would have to establish broad commercial capabilities internally or through collaborators, including third-party vendors.

Contingent on receiving health authority approvals, we plan to commence commercialization activities by building a focused commercial organization including, but not limited to, marketing, market access, insights and analytics and field organization. The commercial organization would be responsible for setting the go-to-market strategies, launch planning and execution across various functions. We may selectively enter into distribution or other commercial arrangements with third parties for any of our product candidates that obtain marketing approval, if we believe these collaborations could maximize the value of our product candidates. 

Intellectual Property 

We strive to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to our business, including seeking, maintaining, and defending patent rights, whether developed internally or assigned from third parties. We own the issued patents and patent applications