Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 253

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part II, Item 1A
Chunk 253
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 proprietary methods have never been produced or implemented outside of our company, and we may therefore experience delays to our development programs if and when we attempt to establish new third-party manufacturing arrangements for these product candidates or methods. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third-party manufacture our product candidates. If we are required to or voluntarily change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines and that the product produced is equivalent to that produced in a prior facility. The delays associated with the verification of a new manufacturer and equivalent product could negatively affect our ability to develop product candidates in a timely manner or within budget.

Our, or a third-party’s, failure to execute on our manufacturing requirements, to do so on commercially reasonable terms and timelines, or to comply with cGMP requirements could adversely affect our business in a number of ways, including without limitation:

•inability to meet our product specifications and quality requirements consistently;

•inability to initiate or continue clinical trials of our product candidates under development;

•delays in submitting regulatory applications, or receiving marketing approvals, for our product candidates, if at all;

•inability to commercialize any product candidates that receive marketing approval on a timely basis;

• loss of the cooperation of future collaborators;

•subjecting third-party manufacturing facilities or our manufacturing facilities, if any, to additional inspections by regulatory authorities; 

•requirements to cease development or to recall batches of our product candidates;

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•in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product or any other future product candidates; and

•our future profit margins.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates progress through preclinical studies and clinical trials to potential marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials,