Tyra Biosciences (TYRA) risk factors, FY2025 10-K

Other

1. 01Summary of Risks Related to Our Business
2. 02We will require substantial additional capital to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations
3. 03As an organization, we have never completed any clinical trials or submitted an application for marketing approval and may be unable to do so for any of our product candidates
4. 04If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
5. 05We face significant competition, and, if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected100% rewritten

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

1. 06We are early in our development efforts, have a limited operating history, have not completed any clinical trials, and have no products approved for commercial sale, which may make it difficult for investors to evaluate our current business and likelihood of success and viability43% rewritten
2. 07successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industryNew
3. 08costs associated with any products or technologies that we may in-license or acquire
4. 09Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
5. 10Our portfolio of investments or bank deposits may be subject to market, interest and credit risk that may reduce their value and adversely affect our business, results of operations and financial condition

Risks Related to the Discovery, Development and Marketing Approval of Our Product Candidates

1. 11maintaining and growing an organization of people who can develop and commercialize our product candidates
2. 12Any difficulties or delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects79% rewritten
3. 13in the commencement or completion of our ongoing or planned clinical trials for dabogratinib, TYRA-430, TYRA-200 or any other product candidate, could significantly affect our product development timelines and development costsNew
4. 14third-party contractors not performing data collection or analysis in a timely or accurate manner; or
5. 15Our proprietary SNÅP platform is innovative and unproven, and we do not know whether we will be able to develop any product candidates that are successful in clinical development or products of commercial value
6. 16our ability to recruit clinical trial investigators with the appropriate competencies and experience; and
7. 17We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays in enrollment, which would result in the delay of completion of such trials beyond our expected timelines
8. 18Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates
9. 19Any delays in the marketing approval of our product candidates may negatively impact our ability to successfully position the product candidate in the market or the product candidate may face additional competition from other products
10. 20If we are unable to successfully develop companion diagnostics for biomarkers that enable patient selection, or experience significant delays in doing so, we may not be able to commercialize the product candidate and our ability to generate revenue will be materially impaired52% rewritten
11. 21approval or clearance of a companion diagnostic could delay or prevent approval, certification or continued marketing of our related product candidatesNew
12. 22We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
13. 23We may not be able to obtain or maintain orphan drug designations for any of our product candidates, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity
14. 24We have obtained a rare pediatric disease designation for dabogratinib for the treatment of ACH, however, there is no guarantee that any FDA approval of dabogratinib will result in issuance of a priority review voucher
15. 25the application is approved for a different adult indication than the RPD for which the product is designated63% rewritten
16. 26We have conducted, and may continue to conduct, clinical trials for certain of our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business
17. 27Interim, topline and preliminary data from our preclinical studies and clinical trials that we may announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data72% rewritten
18. 28conclusions reached, our ability to obtain approval for, and commercialize, any of our product candidates may be harmed, which could harm our business, financial condition, results of operations and prospectsNew
19. 29Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay

Risks Related to Our Reliance on Third Parties

1. 30in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product candidates or any other future product candidates
2. 31termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us31% rewritten
3. 32Our reliance on third parties requires us to share our confidential information, which increases the possibility that confidential information will be misappropriated or disclosed
4. 33We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships

Risks Related to Commercialization of Our Product Candidates

1. 34injunctions or the imposition of civil or criminal penalties
2. 35The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
3. 36We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad
4. 37The commercial success of our product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors and others in the medical community
5. 38unfavorable publicity relating to the product33% rewritten
6. 39the amount that we are able to charge for our products. Accordingly, in markets outside the United States, the reimbursement for our products, once approved, may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profitsNew
7. 40We face significant competition, and if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our business and our ability to develop and successfully commercialize products may be adversely affected100% rewritten
8. 41If the market opportunities for our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer
9. 42Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties

Risks Related to Our Business Operations and Industry

1. 43Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide
2. 44the timing and success or failure of preclinical studies or clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners
3. 45We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer
4. 46We will need to continue to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth21% rewritten
5. 47improving our operational, financial and management controls, reporting systems and procedures
6. 48We are subject to various federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition
7. 49Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition36% rewritten
8. 50As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct businessNew
9. 51Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and may affect the prices we may set70% rewritten
10. 52We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly
11. 53If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products57% rewritten
12. 54a decline in our stock price
13. 55Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities24% rewritten
14. 56Our business could be affected by litigation, government investigations and enforcement actions
15. 57Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
16. 58We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
17. 59Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business, financial condition and stock price
18. 60Changes in tax law may materially adversely affect our financial condition, results of operations and cash flows
19. 61Our ability to use net operating loss carryforwards and other tax attributes may be limited28% rewritten
20. 62U.S. federal NOLs generated in periods after December 31, 2017 may be carried forward indefinitely but may only be used to offset 80% of our taxable income in years beginning after December 31, 2020

Risks Related to Our Intellectual Property

1. 63to successfully commercialize our product candidates and other proprietary technologies we may develop may be adversely affectedNew
2. 64As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to oursNew
3. 65Substantive examination is just beginning on our pending patent applications, which makes it difficult to forecast the extent of any future patent right
4. 66We may not be able to protect our intellectual property and proprietary rights throughout the world
5. 67Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements21% rewritten
6. 68Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
7. 69Issued patents relating to our product candidates and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
8. 70Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
9. 71If we do not obtain patent term extension for our product candidates, our business may be materially harmed
10. 72We may be subject to claims challenging the inventorship of our patents and other intellectual property
11. 73If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
12. 74We may not be successful in obtaining necessary rights to any product candidate we may develop through acquisitions and in-licenses
13. 75We may be subject to claims that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
14. 76such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management
15. 77Third-party claims of intellectual property infringement, misappropriation or other violations against us or our collaborators may prevent or delay the development and commercialization of our product candidates and other proprietary technologies we may develop
16. 78We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful
17. 79Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
18. 80If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
19. 81Intellectual property rights do not necessarily address all potential threats
20. 82the patents of others may harm our business; and
21. 83We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses

Risks Related to Our Common Stock

1. 84The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses
2. 85intellectual property, product liability or other litigation against us
3. 86An active, liquid trading market for our common stock may not be maintained
4. 87Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval
5. 88We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock21% rewritten
6. 89Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall
7. 90We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
8. 91exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved
9. 92We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives
10. 93loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences
11. 94Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
12. 95Our business is subject to risks arising from pandemic and epidemic diseases
13. 96If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline
14. 97If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline
15. 98Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management
16. 99We could be subject to securities class action litigation
17. 100Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud