Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 69

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 69
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 TYRA-300, TYRA-200 and TYRA-430, identifying other potential product candidates and conducting preclinical studies. We are relatively early in our clinical trials of  our product candidates and will need to progress our other development programs through additional preclinical studies to enable us to submit INDs with the FDA and receive allowance from the FDA to proceed with initiating their clinical development. Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend on the successful development and eventual commercialization of our product candidates. The success of our product candidates will depend on several factors, including the following:

•successful completion of preclinical studies with favorable results, including those compliant with Good Laboratory Practice (GLP) such as toxicology studies, biodistribution studies and minimum effective dose studies in animals;

•acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates and our proposed design of future clinical trials;

•successful identification of appropriate patients eligible to enroll, and enrollment of such patients, in clinical trials and completion of clinical trials with favorable results;

•successful identification of new product candidates utilizing our SNÅP platform;

•demonstrating safety and efficacy to the satisfaction of applicable regulatory authorities;

•making arrangements with our third-party manufacturers for, or establishing, commercial manufacturing capabilities;

•receipt of marketing approvals from applicable regulatory authorities, including new drug applications (NDAs), from the FDA and maintaining such approvals;

•establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;

•establishing and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates;

•maintaining an acceptable safety profile of our products following marketing approval, including acceptable results from any post-approval studies or clinical trials agreed to by us or required by the FDA; and

•maintaining and growing an organization of people who can develop and commercialize our product candidates.

The FDA or comparable foreign regulatory authorities can refuse to accept INDs or similar regulatory submissions for many reasons, including negative or ambiguous results from our preclinical studies or disagreement with our interpretation of data from preclinical studies. If we are unable to develop, obtain marketing approval for, 

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or, if approved, successfully commercialize our product candidates, we may not be able to generate sufficient revenue to continue our business.

As an organization, we have never completed any clinical trials or submitted an