NewAmsterdam Pharma (NAMS) risk factors, FY2025 10-K

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

1. 01changes in reimbursement policies that could have a negative impact on our future revenue stream
2. 02We may require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations
3. 03delay, limit, reduce or terminate our other research and development activities; or
4. 04Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or current or future product candidates
5. 05We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”) and the Dutch Deposit Guarantee Scheme, the loss of which would have a severe negative affect on our operations and liquidity

Risks Related to Our Product Development, Regulatory Approval and Commercialization

1. 06We are dependent on the success of our only product candidate, obicetrapib, and cannot guarantee that obicetrapib will successfully complete clinical development, receive regulatory approval or, if approved, be successfully commercialized
2. 07our ability to obtain, protect and enforce our intellectual property rights with respect to obicetrapib; and
3. 08We have never obtained approval for, or commercialized, any product candidate, and may be unable to do so successfully
4. 09Clinical drug development involves a lengthy and expensive process with uncertain outcomes. Results of earlier studies and trials may not be predictive of future trial results and our clinical trials may fail to adequately demonstrate the safety and efficacy of obicetrapib
5. 10raise sufficient capital to fund a trial
6. 11additional clinical trials or preclinical studies. In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approval
7. 12non-compliance of clinical trial participants with clinical trial protocol procedures and instructions
8. 13Interim, “topline” and preliminary data from our clinical trials that we 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
9. 14The regulatory approval processes of the FDA, the EMA and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for obicetrapib, our business will be substantially harmed
10. 15resistance to approval from the FDA’s advisory committee for any reason including safety or efficacy concerns
11. 16Our ongoing clinical trials may be subject to delays or failures, which could result in increased costs to us and could delay, prevent or limit our ability to obtain regulatory approval for obicetrapib, which could have an adverse impact on our business
12. 17difficulties retaining patients who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the clinical trial, lack of efficacy, side effects, personal issues or loss of interest
13. 18lack of adequate funding to continue the clinical trial
14. 19our being sued and held liable for harm caused to patients97% rewritten
15. 20product-related AEs to the satisfaction of the FDA, the EMA or other comparable regulatory authority in a timely manner or ever, which could harm our business, prospects and financial conditionNew
16. 21injunctions or the imposition of civil or criminal penalties32% rewritten
17. 22We are developing obicetrapib in combination with other therapies, and safety or supply issues with combination products may delay or prevent development and approval of our combination product candidate
18. 23If we are not successful in our efforts to discover, in-license or acquire and develop additional product candidates, we may be unable to grow our business
19. 24We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success55% rewritten
20. 25Obicetrapib, if approved, will face significant competition from competing therapies and our failure to compete effectively may prevent us from achieving significant market penetration88% rewritten
21. 26Any approved products may fail to achieve the degree of market acceptance by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success
22. 27the effectiveness of our sales and marketing efforts

Risks Related to Our Collaboration With or Reliance on Third Parties

1. 28the failure to deliver our products under specified storage conditions and in a timely manner25% rewritten
2. 29to us under the Menarini License, a breakdown in collaboration between the parties or a complete or partial loss of this relationship could materially harm our business if obicetrapib is approved in the relevant jurisdictionsNew
3. 30We may not be able to meet our obligations under the Menarini License. Additionally, if we do not reach certain milestones as set forth in the Menarini License, we will not receive the milestone payments, which could require us to seek funding additional capital to complete clinical trials
4. 31Should the Menarini License be terminated, we will need to either build marketing, sales, distribution, managerial and other non-technical capabilities or contract with third parties to obtain these capabilities in Europe31% rewritten
5. 32hire a sales force in the United States that is sufficient in size or has adequate expertise to target the areas that we intend to target. If we are unable to establish a sales force and marketing and distribution capabilities, our operating results may be adversely affectedNew
6. 33unforeseen costs and limitations with regard to setting up a distribution network
7. 34collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates
8. 35Our 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, which could cause significant liability for us or harm our reputation
9. 36If we, or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business

Risks Related to Our Business and Strategy

1. 37If we fail to manage our growth effectively, our business could be disrupted
2. 38continue to improve our operational, financial and management controls, reporting systems and procedures
3. 39If obicetrapib or our future product candidates receive approval for marketing, and if physicians misuse our products, we may become subject to product liability claims, and our image and reputation within the industry and marketplace could be harmed
4. 40If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of obicetrapib or any future products we may develop
5. 41the inability to commercialize our product, if approved
6. 42If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop our product candidate, conduct our clinical trials and, if approved, commercialize our product candidate or any other products we may develop
7. 43Misclassification or reclassification of our independent contractors or employees could increase our costs and adversely impact our business
8. 44Under applicable employment laws, we may not be able to enforce covenants not to compete
9. 45We have expanded and expect to continue expanding our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
10. 46Inflation may adversely affect our operations, including increases in the prices of goods and services required for our operations
11. 47Our international operations subject us to various risks, and our failure to manage these risks could adversely affect our results of operations and we may be exposed to significant foreign exchange risk
12. 48tariffs, trade protection measures, import or export licensing requirements, trade embargoes and other trade barriers
13. 49We may undertake strategic acquisitions, in-licenses or other strategic transactions in the future and any difficulties from integrating such acquisitions could adversely affect our share price, operating results and results of operations
14. 50Global health crises may adversely affect our business and that of our suppliers, CROs or other third parties relevant to our business

Risks Related to Our Intellectual Property

1. 51While we have sought and continue to actively seek patent protection for obicetrapib, our patent coverage is limited, and we can provide no assurance that any of our current or future patent applications will result in issued patents or that any issued patents will provide us with any competitive advantage
2. 52duration of the patent protection of our technologies or product candidates, all of which could limit our ability to stop others from using or commercializing similar or identical product candidates or technology to compete directly with us, without payment to usNew
3. 53Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
4. 54Uncertainty and instability resulting from the conflict between Russia and Ukraine could negatively impact our ability to maintain our patents in Russia
5. 55We may receive only limited protection, or no protection, from our issued patents and patent applications and such patents could be narrowed, found invalid or unenforceable if challenged in court or before administrative bodies54% rewritten
6. 56applications, such patents or applications may be invalid and unenforceable. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our businessNew
7. 57If we do not obtain patent term extension for our product candidates, if needed, our business may be harmed
8. 58We may not be able to protect our intellectual property rights throughout the world, or we may choose not to pursue patent rights in jurisdictions that later become important to our business, thus harming our ability to compete in those jurisdictions
9. 59Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could harm our business, financial condition or results of operations
10. 60If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed70% rewritten
11. 61including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change further in the futureNew
12. 62If we fail to obtain or maintain regulatory exclusivity for our product candidates, our business may be materially harmedNew
13. 63Generic competition following the expiration or loss of exclusivity could significantly reduce our revenues, if our product candidates are approvedNew
14. 64We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors
15. 65We may not be able to build name recognition in our markets of interest if our trademarks and trade names are not adequately protected and our business may be adversely affected
16. 66Disputes over intellectual property subject to the Menarini License may materially impact our ability to commercialize obicetrapib
17. 67the ownership of inventions and know-how resulting from the joint creation or use of intellectual property

Risks Related to Government Regulation

1. 68We may currently be or may become subject to various federal, state and foreign healthcare laws, including those intended to prevent healthcare fraud and abuse92% rewritten
2. 69been broadly defined to include anything of value, including, but not limited to, cash, improper discounts, and free or reduced price items and servicesNew
3. 70We are subject to stringent privacy laws, information security policies and contractual obligations governing the use, processing, and cross-border transfer of personal information and our data privacy and security practices41% rewritten
4. 71Attorneys General are aggressive in reviewing privacy and data security protections for consumers. New laws also are being considered or have been implemented at both the state and federal levelsNew
5. 72Complying with the GDPR and other U.S. and foreign data protection laws and regulations may cause us to incur substantial operational costs or require us to change our business practices in a manner adverse to our business
6. 73Our marketing efforts may be subject to a variety of regulations
7. 74We could be adversely affected by violations of the FCPA and other worldwide anti-bribery laws, export and import controls, sanctions, embargoes, and anti-money laundering laws and regulations
8. 75It may be difficult for us to profitably sell obicetrapib or any future product candidate in the United States, if approved, if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies
9. 76neither experimental nor investigational
10. 77Marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in foreign jurisdictions46% rewritten
11. 78We are subject to changing law and regulations regarding regulatory matters, corporate governance and public disclosure that have increased both our costs and the risk of noncompliance65% rewritten
12. 79Legislative or regulatory healthcare reforms in the United States or abroad may make it more difficult and costly for us to obtain regulatory approval of obicetrapib or any of our future product candidates now or in the future and to produce, market and distribute our products after approval is obtainedNew
13. 80additional recordkeeping
14. 81Changes in U.S. government policies including increased tariffs could adversely affect our businessNew

Risks Related to Our Financial Position

1. 82Our ability to use our tax losses to offset future taxable income may be subject to certain limitations33% rewritten
2. 83We are a holding company that does not conduct any business operations of its own. As a result, we are largely dependent upon cash dividends and distributions and other transfers, including for dividends or payments in respect of any indebtedness we may incur, from our subsidiaries to meet its obligations
3. 84U.S. Holders generally will not be able to make a qualified electing fund election solely with respect to the Warrants
4. 85an estate the income of which is subject to U.S. federal income taxation regardless of its source; or

Risks Related to Ownership of Our Securities

1. 86Sales of a substantial number of our securities in the public market by certain of our securityholders pursuant to a registration statement we filed and/or by our existing securityholders could cause the price of our Ordinary Shares and Warrants to fall47% rewritten
2. 87We are a Dutch public limited liability company. The rights of our shareholders may be different from the rights of shareholders in companies governed by the laws of other jurisdictions and may not protect investors in a similar fashion afforded by incorporation in such other jurisdiction
3. 88The market price and trading volume of the Ordinary Shares and Public Warrants may be volatile and could decline significantly
4. 89other events or factors, including those resulting from infectious diseases, health epidemics and pandemics, natural disasters, war, acts of terrorism or responses to these events
5. 90There can be no assurance that the Ordinary Shares or the Public Warrants will be able to comply with the continued listing standards of Nasdaq
6. 91a decreased ability to issue additional securities or obtain additional financing in the future
7. 92If securities or industry analysts do not publish or cease publishing research or reports about the Company, our business, or the market in which we operate, or if they change their recommendations regarding the Ordinary Shares adversely, then the price and trading volume of the Ordinary Shares could decline
8. 93We do not intend to pay dividends for the foreseeable future. Accordingly, you may not receive any return on investment unless you sell your Ordinary Shares for a price greater than the price you paid for them28% rewritten
9. 94Our management team has limited experience managing a public company
10. 95Investors may have difficulty enforcing civil liabilities against the Company or the members of the Board of Directors
11. 96Also, service of process against non-residents of the United States can in principle (absent, for example, a valid choice of domicile) not be effected in the United States
12. 97Our principal shareholders and management own a significant percentage of our Ordinary Shares and have representation on the Board of Directors and will be able to control matters subject to shareholder approval22% rewritten
13. 98Inferior internal controls could also cause investors to lose confidence in our reported financial information, which is likely to negatively affect our business and the market price of the Ordinary Shares52% rewritten
14. 99We may redeem your unexpired warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless
15. 100Warrants and options to purchase Ordinary Shares will become exercisable for Ordinary Shares, which would increase the number of shares eligible for future resale in the public market and result in dilution to shareholders38% rewritten
16. 101There is no guarantee that the Warrants will be in the money, and they may expire worthless
17. 102The terms of the Public Warrants may be amended in a manner adverse to a holder if holders of at least 65% of the then outstanding Public Warrants approve of such amendment
18. 103Our shareholders may not have any preemptive rights in respect of future issuances of Ordinary Shares, and, as a result, may experience substantial dilution upon future issuances of Ordinary Shares or grants of rights to subscribe for such shares
19. 104We are not obligated to, and do not, comply with all best practice provisions of the Dutch Corporate Governance Code
20. 105Under Dutch law, various protective measures are possible and permissible within the boundaries set by Dutch law and Dutch case law
21. 106Dutch law also allows for, and we have adopted, staggered multi-year terms of our directors, as a result of which only part of the Board of Directors will be subject to appointment or re-appointment in any given year
22. 107the Board of Directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; orNew