Company: IMRX
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001790340-25-000135
Chunk: 572

Company: Immuneering Corp
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 2
Chunk 572
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 receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses as we discover, develop and market additional potential product candidates. 

We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially if and as we:

•advance the development of our current and future product candidates, including atebimetinib, through preclinical and clinical development, and, if approved by the FDA or other comparable foreign regulatory authorities, commercialization;

•incur manufacturing costs for our product candidates;

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

•increase our research and development activities to identify and develop new product candidates;

•hire additional personnel;

•expand our operational, financial and management systems;

•invest in measures to protect and expand our intellectual property;

•establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize;

•incur costs in connection with capital raising activities and potential business restructuring activities, if required; 

•expand our manufacturing and develop our commercialization efforts, if any; and

•operate as a public company.

The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital and our ability to achieve and maintain profitability.

To become and remain profitable, we must succeed in developing and eventually commercializing product candidates that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing and selling any products for which we may obtain regulatory approval, achieving market acceptance of any such approved products and receiving reimbursements in amounts above our costs. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, we may never generate revenue that is significant enough to achieve profitability. Because of the numerous risks and uncertainties associated with pharmaceutical product candidate development, we are unable to accurately predict the timing or amount of increased expenses or