Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 166

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1B
Chunk 166
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 any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance our product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates and expand our pipeline, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel. 

Our future research and development expenses may vary significantly based on a wide variety of factors, such as: 

•the number and scope, rate of progress, expense and results of our discovery and preclinical development activities and clinical trials; 

•the number of trials required for approval; 

•the number of sites included in each of our trials; 

•the countries in which the trials are conducted; 

•the length of time required to enroll eligible patients; 

•the number of patients that participate in the trials; 

•the ability to identify appropriate patients eligible for our clinical trials; 

•the number of doses that patients receive; 

•the drop-out or discontinuation rates of patients; 

•potential additional safety monitoring requested by regulatory agencies; 

•the duration of patient participation in the trials and follow-up; 

•the phase of development of the product candidate; 

•the efficacy and safety profile of the product candidate; 

•the timing, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators; 

•maintaining a continued acceptable safety profile of our product candidates following approval, if any; 

•the cost and timing of manufacturing our product candidates; 

•significant and changing government regulation and regulatory guidance; 

•the ability to attract and retain personnel;

•the impact of any business interruptions to our operations or to those of the third parties with whom we work;

•geopolitical instability, such as the war and other conflicts in Ukraine and the Middle East;

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•adverse effects on the financial markets, the global economy, the supply chain and our expenses due to pandemic or epidemic diseases, geopolitical instability, inflation, interest rates and other factors; and

•the extent to which we establish additional strategic collaborations or other arrangements. 

A change in the outcome of any of these variables with respect