Tyra Biosciences (TYRA) risk factors, FY2024 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 affected

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 viability
2. 07connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts
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 prospects
3. 13third-party contractors not performing data collection or analysis in a timely or accurate manner; or
4. 14Our 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
5. 15our ability to recruit clinical trial investigators with the appropriate competencies and experience; and
6. 16We 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
7. 17Our 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
8. 18Any 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
9. 19If 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 impaired
10. 20modifications may make it more difficult and costly for us to obtain regulatory clearances, approvals or certification for our companion diagnostics or to manufacture, market or distribute our products after clearance, approval or certification is obtained
11. 21We 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
12. 22We 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
13. 23We have obtained a rare pediatric disease designation for TYRA-300 for the treatment of ACH, however, there is no guarantee that any FDA approval of TYRA-300 will result in issuance of a priority review voucher
14. 24the application is approved for a different adult indication than the RPD for which the product is designated
15. 25We 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
16. 26Interim, 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 data
17. 27Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points
18. 28Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay

Risks Related to Our Reliance on Third Parties

1. 29in 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. 30termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
3. 31Our reliance on third parties requires us to share our confidential information, which increases the possibility that confidential information will be misappropriated or disclosed
4. 32We 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. 33injunctions or the imposition of civil or criminal penalties
2. 34The 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. 35We 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. 36The 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. 37unfavorable publicity relating to the product
6. 38change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely
7. 39We 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 affected
8. 40If 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. 41Our 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. 42Our 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. 43the 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. 44We 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. 45We will need to continue to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth
5. 46improving our operational, financial and management controls, reporting systems and procedures
6. 47We 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. 48Actual 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 condition
8. 49Recently 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 set
9. 50included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects
10. 51We 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. 52If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products
12. 53using, administering or selling products that may be approved in the future. Claims could also be asserted under state consumer protection acts
13. 54a decline in our stock price
14. 55Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities
15. 56Our business could be affected by litigation, government investigations and enforcement actions
16. 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
17. 58We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
18. 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
19. 60Changes in tax law may materially adversely affect our financial condition, results of operations and cash flows
20. 61Our ability to use net operating loss carryforwards and other tax attributes may be limited
21. 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. 63Substantive examination is just beginning on our pending patent applications, which makes it difficult to forecast the extent of any future patent right
2. 64We may not be able to protect our intellectual property and proprietary rights throughout the world
3. 65Obtaining 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 requirements
4. 66Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
5. 67Issued 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
6. 68Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
7. 69If we do not obtain patent term extension for our product candidates, our business may be materially harmed
8. 70We may be subject to claims challenging the inventorship of our patents and other intellectual property
9. 71If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
10. 72We may not be successful in obtaining necessary rights to any product candidate we may develop through acquisitions and in-licenses
11. 73We 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
12. 74such 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
13. 75Third-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
14. 76We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful
15. 77Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
16. 78If 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
17. 79Intellectual property rights do not necessarily address all potential threats
18. 80the patents of others may harm our business; and
19. 81We 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. 82The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses
2. 83intellectual property, product liability or other litigation against us
3. 84An active, liquid and orderly market for our common stock may not be maintained
4. 85Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly control or influence all matters submitted to stockholders for approval
5. 86We 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 stock
6. 87Sales 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. 88We 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. 89exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved
9. 90We 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. 91substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences
11. 92Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
12. 93Our business is subject to risks arising from pandemic and epidemic diseases
13. 94If 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. 95If 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. 96Provisions 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. 97We could be subject to securities class action litigation
17. 98Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud