Company: IMRX
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001790340-25-000061
Chunk: 29

Company: Immuneering Corp
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 3
Chunk 29
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 and completion on a timely basis of our ongoing and any future clinical trials that we may initiate, despite any delays including those arising out of ongoing or future pandemics, or other widespread adverse health events;

•maintaining and establishing relationships with CROs and clinical sites for clinical development, both in the United States and internationally;

•the frequency and severity of adverse events in the clinical trials;

•the efficacy, safety and tolerability profiles that are satisfactory to the FDA or any comparable foreign regulatory authority for marketing approval;

•the timely receipt of marketing approvals from applicable regulatory authorities;

•the extent of any required post-marketing approval commitments to applicable regulatory authorities;

•the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development;

•the maintenance of existing, or the establishment of new, scaled production arrangements with third-party manufacturers to obtain finished products that are appropriate for commercial sale of our product candidates, if approved;

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•obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

•the protection of our rights in our intellectual property portfolio;

•the successful launch of commercial sales following any marketing approval;

•a continued acceptable safety profile following any marketing approval;

•commercial acceptance by patients, the medical community and third-party payors; and

•our ability to compete with other therapies.

We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize the product candidates we develop, which would materially harm our business. If we do not receive marketing approvals for IMM-1-104 or any other product candidate we develop, we may not be able to continue our operations.

We are substantially dependent on our platform, including our proprietary technologies, which are supported by our information technology systems. Any failure of these or other elements of our platform will materially harm our business.

We are substantially dependent on our platform, including our proprietary technologies, which are supported by our information technology systems, for significant elements of our drug discovery process, bioinformatics and computational biology software systems, database of information relating to our product candidates and their role in the targeted disease process, amongst others. Although we invest substantially in the backup/restore,