Company: RPID
Filing Date: 2025-05-09
Form Type: 10-Q
Source: 0001380106-25-000102
Chunk: 355

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-05-09
Form: 10-Q
Item: Part I, Item 8
Chunk 355
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 process and we may be unable to develop or commercialize products on a timely basis, or at all.

Products from our development programs will take time and considerable resources to develop, and may include improvements or changes to our systems, software and consumables. We may not be able to complete development and commercialize them on a timely basis, or at all. There can be no assurance that our development programs will produce commercial products and solutions and before we can commercialize any new products, we will need to expend significant funds in order to:

•conduct substantial research and development, which may include validation studies;

•further develop and scale our engineering and manufacturing processes to accommodate different products;

•further develop and scale our infrastructure to be able to analyze increasingly large amounts of data; and

•utilize data and analytical insights generated from existing Growth Direct platform in our research and development programs in order to advance these programs.

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Our product development processes involve a high degree of risk, and these efforts may be delayed or fail for many reasons, including:

•failure of the product to perform as expected;

•higher costs than anticipated; and

•failure to reliably demonstrate the advantages of our products.

In addition, if we are unable to generate additional data and insights from our existing Growth Direct platforms, then we may not be able to advance these programs as quickly, or at all, or without significant additional investment, all of which could have a material adverse effect on our product development efforts.

Even if we are successful in developing new products, it will require us to make significant additional investments in marketing and selling resources in order to commercialize any such products. For example, we recently made generally available for commercial sale our rapid sterility application for use on the Growth Direct system, for which we have expended significant time and resources to develop. We placed our first Growth Direct rapid sterility system with an existing customer in the second quarter of 2024. We are continuing to scale our manufacturing capabilities for the rapid sterility application. However, there can be no assurance that we will successfully commercialize this new sterility test, scale our manufacturing capabilities to support customer demand or that this product will achieve broad acceptance by customers. Furthermore, because this is a new application, we may encounter technical or other product challenges as customers adopt and implement Growth Direct rapid sterility into their workflows. We may be unsuccessful in commercializing new products that we develop, which could adversely affect our business, financial condition, results of operations and prospects.

Our customers use our Growth Direct