Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 74

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 74
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, even if these trials begin, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Any such delays in the commencement or completion of our ongoing or planned clinical trials for TYRA-300, TYRA-200, TYRA-430 or any other product candidate, could significantly affect our product development timelines and development costs.

We do not know whether our planned trials will begin on time or be completed on schedule, if at all. The commencement, data readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to:

•inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

•obtaining regulatory allowance or authorization to commence a trial or reaching a consensus with regulatory authorities on trial design;

•the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;

•any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•failure to reach an agreement with diagnostic companies for the development and use of liquid biopsy companion diagnostic tests in our clinical trials;

•obtaining approval from one or more institutional review boards (IRBs) (or ethics committees);

•IRBs (or ethics committees) refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional patients, or withdrawing their approval of the trial;

•changes to clinical trial protocol;

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•identifying sufficient appropriately qualified investigators and other professionals to conduct the clinical trials;

•clinical sites deviating from trial protocol or dropping out of a trial;

•manufacturing sufficient quantities of product candidates for use in clinical trials;

•patients failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up;

•patients choosing alternative treatments for the indications for which we are developing our product candidates, or participating in competing clinical trials;

•lack of adequate funding to continue the clinical trials;

•patients experiencing severe or unexpected drug-related adverse effects;

•occurrence of serious adverse events in clinical trials of the same class of agents conducted by other companies;

•selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data;

•a facility manufacturing our product candidates or any of their components suspending or limiting manufacturing due to violations of cGMP, or other