Coya Therapeutics (COYA) risk factors, FY2024 10-K

Other

1. 01Summary of Risks Associated with our Business
2. 02We are a clinical-stage biopharmaceutical company with no product(s) approved for commercial sale
3. 03We will need to raise significant additional capital, which may not be available to us on acceptable terms, or at all. If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened
4. 04We may encounter substantial delays in our planned clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all
5. 05Any clinical trials that are planned or are conducted on our product candidates may fail. Clinical trials are lengthy, complex and extremely expensive processes with uncertain outcomes and results and frequent failures
6. 06Our business is subject to, and may be affected by, extensive and costly government regulation
7. 07We face competition from companies that have greater resources than we do, and we may not be able to effectively compete against these companies

Risks Related to Our Business, Financial Condition and Capital Requirements

1. 08We are a clinical-stage biotechnology company with limited resources, have a limited operating history and have no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability
2. 09We are a clinical-stage biotechnology company that commenced operations in 2020. In addition, we have no products approved for commercial sale and therefore all sources of capital have been obtained solely through financing
3. 10We have incurred significant losses since our inception and we expect to incur significant losses for the foreseeable future, and we will require sufficient additional funding to finance our operations, which may not be available
4. 11We have never generated revenue from product sales and may never achieve or maintain profitability
5. 12attracting, hiring and retaining qualified personnel
6. 13We will need to raise additional capital and if we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened
7. 14Any such required financing may not be available in amounts or on terms acceptable to us, and the failure to procure such required financing could have a material and adverse effect on our business, financial condition and results of operations, or threaten our ability to continue as a going concern
8. 15We may not be able to acquire additional funds on acceptable terms, or at all. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets or delay, reduce the scope of or eliminate some or all of our development programs
9. 16Any acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities or subject us to other risks
10. 17our inability to generate revenue from acquired drugs, intellectual property rights, technologies, and/or businesses sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs
11. 18Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have never generated any revenue from product sales, we may never generate any revenue from product sales, and we may fail to generate further revenue from grants or contracts or to be profitable
12. 19We face risks related to public health epidemics and pandemics, which could significantly disrupt our preclinical studies and clinical trials
13. 20Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations
14. 21Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock price
15. 22Adverse global conditions, including economic uncertainty, may negatively impact our financial results
16. 23Our ability to use our net operating loss carryovers and certain other tax attributes may be limited

Risks Related to Development and Regulatory Approval

1. 24Our business depends upon the success of our potential therapeutic modalities and product candidates
2. 25Utilizing Treg cells represents a novel approach to the treatment of neurodegenerative and auto immune diseases, and we must overcome significant challenges in order to develop, commercialize and manufacture our product candidates
3. 26Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control
4. 27failure of ourselves or any third-party manufacturers, contractors or suppliers to comply with regulatory requirements, maintain adequate quality controls, or be able to provide sufficient product supply to conduct and complete preclinical studies or clinical trials of our product candidates
5. 28Changes in the U.S. political and regulatory environment could affect availability of government funding that we or our third party collaborators may rely on, which could negatively impact the development of our product candidates
6. 29There is no assurance that we will develop our product candidates successfully or be able to obtain regulatory approval for them
7. 30delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing
8. 31We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. If we are unable to design, conduct and complete our planned clinical trials successfully, our product candidates will not be able to receive regulatory approval
9. 32Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control
10. 33our ability to manufacture the requisite materials for a patient and clinical trial
11. 34Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all
12. 35the FDA not allowing us to rely on previous findings of safety and efficacy for other similar but approved products and published scientific literature
13. 36If any of our product candidates, or any competing product candidates, demonstrate serious adverse events, including the development of severe or fatal cytokine release syndrome, neurotoxicity or graft-versus-host disease, we may be required to halt or delay further clinical development
14. 37approval by the FDA or comparable foreign regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics
15. 38Following the completion of the preclinical studies in different animal models of disease, we will evaluate the data to potentially conduct further preclinical studies and to select a potential clinical indication for human studies
16. 39Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements
17. 40We may seek special designations by the regulatory authorities to expedite regulatory approvals, but may not be successful in receiving such designations, and even if received, they may not benefit the development and regulatory approval process
18. 41We may seek Orphan Drug Designation for our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity
19. 42We may not identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success
20. 43a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors
21. 44If third parties that we rely on to conduct clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates
22. 45form relationships with other entities, some of which may be our competitors
23. 46We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates

Risks Related to Commercialization

1. 47If any of our product candidates are approved for marketing and commercialization and we have not developed or secured third- party marketing, sales and distribution capabilities, we will be unable to successfully commercialize such products and may not be able to generate product revenue
2. 48If we fail to compete effectively with academic institutions and other biotechnology companies that are developing similar or alternatives to cellular immunotherapy product candidates, our business will be materially adversely affected
3. 49If we are not able to establish pharmaceutical or biotechnology collaborations on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans
4. 50If we enter into collaborations with third parties to develop or commercialize our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations
5. 51collaboration agreements may restrict our right to independently pursue new product candidates
6. 52Our product candidates could be subject to regulatory limitations following approval, if and when such approval is granted
7. 53imposition of civil or criminal penalties
8. 54The commercial success of any of our product candidates will depend upon such product candidate’s degree of market acceptance by physicians, patients, third-party payors and others in the medical community
9. 55Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be fully known until after such product is launched. Our product candidates may not achieve broad market acceptance
10. 56The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market such products and to generate product revenue
11. 57Healthcare reform initiatives and other administrative and legislative proposals may harm our business
12. 58Obtaining and maintaining marketing approval or commercialization of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions
13. 59production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
14. 60Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable fraud and abuse and other healthcare laws and regulations, which could expose us to penalties
15. 61Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set
16. 62expansion of the entities eligible for discounts under the Public Health Service program; and a licensure framework for follow on biologic products

Risks Related to Our Employees, Managing Our Growth and Our Operations

1. 63We will need to increase the size of our organization, and we may experience difficulties in managing growth
2. 64If we fail to attract and retain senior management and clinical and key scientific personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates
3. 65Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop
4. 66Our insurance policies may be inadequate, may not cover all of our potential liabilities and may potentially expose us to unrecoverable risks
5. 67Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business
6. 68Computer system interruptions, cyber-attacks or security breaches could significantly disrupt our product development programs and our ability to operate our business

Risks Related to Manufacturing

1. 69Our manufacturing process is complex and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient supply of our product candidates for clinical trials or our products for patients, if approved
2. 70We rely on third parties to manufacture our product candidates, which increases the risk that we will not have sufficient quantities of such product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts
3. 71the possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us
4. 72plus a fusion protein, we have entered into the DRL License Agreement with DRL whereby will in-license DRL’s proposed Abatacept biosimilar to be used in the development and commercialization of COYA 302 in the United States, Canada, Mexico, South America, the European Union, the United Kingdom, and Japan
5. 73We are dependent on third parties to store our Treg cells and other products and any damage or loss would cause delays in replacement, and our business could suffer
6. 74We have not yet developed a validated methodology for freezing and thawing large quantities of Treg cells, which we believe will be required for the storage and distribution of our Treg product candidates

Risks Related to Our Intellectual Property

1. 75If our license agreement with The Methodist Hospital is terminated, we could lose our rights to key components enabling our Treg Modalities
2. 76Our development and commercialization rights to our current and future product candidates and technology are subject, in part, to the terms and conditions of licenses granted to us by others
3. 77expenses related to the prosecution, maintenance, enforcement and defense of patents and patent applications that we in-license from them
4. 78Duration of patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time, and the expiration of our patents may subject us to increased competition
5. 79We can provide no assurance that we will be able to file or receive additional patent protection for our product candidates
6. 80If any patent protection we obtain is not sufficiently robust, our competitors could develop and commercialize products and technology similar or identical to ours
7. 81We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which could materially adversely affect our ability to develop, manufacture and market our product candidates
8. 82Claims brought against us for infringing, misappropriating or otherwise violating intellectual property rights of third parties or engaging in unfair competition, would be costly and time-consuming and could prevent or delay us from successfully developing or commercializing our product candidates
9. 83We may not be able to effectively monitor unauthorized use of our intellectual property and enforce our intellectual property rights against infringement, and may incur substantial costs as a result of bringing litigation or other proceedings relating to our intellectual property rights
10. 84We may also, from time to time, seek to enforce our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of the intellectual property
11. 85We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection
12. 86Changes in U.S. patent law or the patent law of other jurisdictions could decrease the certainty of our ability to obtain patents and diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates
13. 87America Invents Act, or the America Invents Act, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention
14. 88We may fail to obtain or enforce assignments of intellectual property rights from our employees and contractors
15. 89If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be materially diminished

Risks Related to Our Securities

1. 90If we sell securities in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline
2. 91Our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change of corporate control
3. 92The market price for our common stock may be volatile, and your investment in our securities could decline in value
4. 93the loss of any of our key scientific or management personnel
5. 94We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices
6. 95We are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make our securities less attractive to investors
7. 96We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment
8. 97The rights of the holders of our securities may be impaired by the potential issuance of preferred stock
9. 98If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline
10. 99Anti-takeover provisions in our organizational documents and Delaware law might discourage or delay attempts to acquire us that you might consider favorable
11. 100These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management
12. 101Provisions in our organizational documents regarding exculpation and indemnification of our directors and officers may result in substantial expenditures by us and may discourage lawsuits against our directors and officers
13. 102We ratified certain actions pursuant to Section 204 of the Delaware General Corporation Law and filed Certificates of Validation with the Secretary of State of the State of Delaware