Kodiak Sciences (KOD) risk factors, FY2025 10-K

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

1. 01We are in the clinical stage of drug development and have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability32% rewritten
2. 02Our prospects are heavily dependent on our ability to successfully develop, obtain regulatory approval for and successfully commercialize tarcocimab, KSI-501 and KSI-101, our product candidates. We cannot be certain that our product candidates will be successful in any of the planned or pending clinical trials
3. 03For example, in our Phase 2b/3 DAZZLE clinical trial evaluating the efficacy, durability and safety of tarcocimab in treatment-naïve subjects with neovascular wet AMD and in our Phase 3 GLEAM and GLIMMER studies, tarcocimab did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains59% rewritten
4. 04measure retinal fluid and individualize dosing, and this dosing may not be incorporated into labeling or may require separate FDA review of the AI-based toolNew
5. 05The failure of pivotal studies to meet their primary efficacy endpoints may lead us to pause, change or discontinue development of other product candidates based on our ABC Platform27% rewritten
6. 06Our plans for the development of tarcocimab, KSI-501 or KSI-101 may be unsuccessful49% rewritten
7. 07Preliminary, interim and ongoing data from our preclinical studies and clinical trials is subject to a number of risks and uncertainties and may change as more patient data become availableNew
8. 08Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory, including marketing, approval, which is necessary before they can be commercialized
9. 09a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable38% rewritten
10. 10one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdictions. If we are unable to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations could be negatively affectedNew
11. 11We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all
12. 12delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials and for use in regulatory filings or the inability to do any of the foregoing
13. 13Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in other significant negative consequences
14. 14our reputation may suffer
15. 15We may encounter difficulties enrolling patients in our clinical trials and our clinical development activities could thereby be delayed or otherwise adversely affected
16. 16the risk that patients enrolled in clinical trials will not complete such trials, for any reason
17. 17Our clinical trials may fail to demonstrate substantial evidence of the durability, efficacy and safety of our product candidates, which would prevent, delay or limit the scope of regulatory approval and commercialization
18. 18We may not be successful in our efforts to continue to create a pipeline of product candidates or to develop commercially successful products. If we fail to successfully identify and develop additional product candidates, our commercial opportunity may be limited
19. 19One of our strategies is to identify and pursue clinical development of product candidates based on our ABC Platform. Our ABC Platform may not produce a pipeline of viable product candidates, or our competitors may develop platform technologies that render our ABC Platform obsolete or less attractive
20. 20The manufacture of our product candidates is highly complex and requires substantial lead time to produce
21. 21Changes in methods of manufacturing or formulation of product candidates may result in additional costs or delay
22. 22The development program and timeline of tarcocimab may impact our ability to use the Ursus Facility as intended, which could be costly
23. 23If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved
24. 24unforeseen costs and expenses associated with creating an independent commercialization organization
25. 25Even if any product candidates we develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success
26. 26Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business
27. 27Our product candidates may face competition from biological products that are biosimilar to or interchangeable with our product candidates sooner than anticipated
28. 28If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
29. 29a decline in our share price

Risks Related to Regulatory Approval and Other Legal Compliance Matters

1. 30the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
2. 31We have conducted clinical trials for our product candidates outside the United States (or the respective jurisdictions of other regulatory authorities), and the FDA (or EMA and applicable foreign regulatory authorities) may not accept data from such trials
3. 32Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
4. 33Even if we obtain regulatory approval for a product candidate, our products will remain subject to extensive obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements
5. 34require a product recall53% rewritten
6. 35Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations78% rewritten
7. 36Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements or insider trading violations, which could significantly harm our business
8. 37If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions could be adversely affected35% rewritten
9. 38challenges for companies like ours that operate in the clinical trial space and impacts the ability to transfer data in connection with certain transactions or agreementsNew
10. 39If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
11. 40Our business activities may be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery and anti-corruption laws

Risks Related to Our Reliance on Third Parties

1. 41We expect to rely on third parties to conduct many aspects of our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing
2. 42We currently rely on a third-party manufacturer, Lonza, for the manufacture of our materials for preclinical studies and clinical trials and expect to continue to do so for preclinical studies, clinical trials and for commercial supply of any product candidates that we may develop
3. 43the inability to produce required volume in a timely manner and to quality standards
4. 44Any medicines that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us
5. 45We rely on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business
6. 46We may depend on collaborations with third parties for the research, development and commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to realize the market potential of those product candidates
7. 47collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all
8. 48Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

Risks Related to Our Intellectual Property

1. 49If any of our patent applications does not issue as a patent in any jurisdiction, we may not be able to compete effectively
2. 50If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected
3. 51We may not be able to protect our intellectual property and proprietary rights throughout the world
4. 52Obtaining 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
5. 53If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed
6. 54We may be subject to claims challenging the inventorship of our patents and other intellectual property
7. 55If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
8. 56We 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
9. 57Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the development and commercialization of our product candidates, the ABC Platform and other technologies
10. 58We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful
11. 59If 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
12. 60Intellectual property rights do not necessarily address all potential threats

Risks Related to Our Operations

1. 61We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
2. 62Developing and commercializing new medicines is a challenging exercise and requires diverse expertise in a variety of scientific, clinical, manufacturing, commercial, financial, people and legal functions. Failure to adequately develop these functions will hurt our ability to compete effectively
3. 63We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth
4. 64managing increasing operational and managerial complexity46% rewritten
5. 65Some of our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations or exclusions of liability in our contracts may not be enforceable or adequate or protect us from liability or damagesNew
6. 66Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
7. 67Our business is subject to economic, political, regulatory and other risks associated with international operations
8. 68business interruptions resulting from geo-political actions, including war and terrorism or natural disasters24% rewritten
9. 69International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
10. 70governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our businessNew
11. 71Our business could be materially and adversely affected by health epidemics in regions where we have concentrations of clinical trial sites or other business operations and could cause significant disruption in the operations of third parties upon whom we rely

Risks Related to Our Business, Financial Condition and Capital Requirements

1. 72We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur significant and increasing net losses for the foreseeable future
2. 73We have incurred net losses in each reporting period since our inception, including net losses of $230.0 million, $176.2 million and $260.5 million for the years ended December 31, 2025, 2024 and 2023, respectively. As of December 31, 2025, we had an accumulated deficit of $1,559 million
3. 74defend against any product liability claims or other lawsuits related to our products
4. 75We have no products approved for commercial sale and have not generated any revenue from product sales. We do not anticipate generating any revenue from product sales until after we have successfully completed clinical development and received regulatory approval for the commercial sale of a product candidate, if ever
5. 76attracting, hiring and retaining qualified personnel
6. 77Our financial condition raises substantial doubt about our ability to continue as a going concern
7. 78If we fail to obtain additional financing, we may be unable to complete the development and, if approved, commercialization of our product candidates
8. 79If we engage in acquisitions, in-licensing or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks
9. 80Unfavorable U.S. and global economic conditions could adversely affect our business, financial condition or results of operations
10. 81Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
11. 82Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
12. 83Foreign currency exchange rate risk may impact our financial position and results
13. 84As a public company, we are subject to reporting and other obligations under the Exchange Act, including the requirements of the Sarbanes-Oxley Act of 2002, or SOX, Section 404, which require annual management assessments of the effectiveness of our internal control over financial reporting

Risks Related to Ownership of Our Common Stock

1. 85The market price of our common stock may be volatile, which could result in substantial losses for investors purchasing shares
2. 86the other factors described in this “Risk Factors” section
3. 87Future sales of our common stock in the public market could cause our share price to decline, even if our business is doing well
4. 88If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline
5. 89Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
6. 90Our principal stockholders own a significant percentage of our common stock, which could limit your ability to affect the outcome of key transactions, including a change of control
7. 91Delaware law and provisions in our certificate of incorporation and bylaws might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock
8. 92require the affirmative vote of at least 66 2/3% or more of the outstanding shares of common stock to amend many of the provisions described above
9. 93Our bylaws further provide that the U.S. federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act