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NAMS 10-K & 10-Q changes, risk factors and insider trading

NewAmsterdam Pharma Co N.V. (also NAMSW) · Nasdaq · Pharmaceutical Preparations · CIK 1936258 · All filings on SEC.gov

Everything below is quoted or computed from NewAmsterdam Pharma Co N.V.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

21 / 22risk-factor paragraphs added / removed in latest 10-K
4new risk-factor headings
1Form 4 filings reporting open-market purchases (last 180 days)
6Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-02-18 (period ending 2025-12-31) with 10-K filed 2025-02-26 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

21new paragraphs
22removed paragraphs
47reworded paragraphs
44,214 → 43,886words in section

New heading “We are planning a dedicated trial evaluating obicetrapib as a preventative treatment for Alzheimer's disease. There has been limited success in drug development for Alzheimer's disease, which makes it difficult to predict the time and cost of development and regulatory approval for obicetrapib as a treatment for Alzheimer's disease. Further, obicetrapib's mechanism of action has not previously used for Alzheimer's disease treatment, which also makes it difficult to predict the time and cost of development and regulatory approval.”

New heading “If we fail to obtain or maintain regulatory exclusivity for our product candidates, our business may be materially harmed.”

New heading “Generic competition following the expiration or loss of exclusivity could significantly reduce our revenues, if our product candidates are approved.”

New heading “Changes in U.S. government policies including increased tariffs could adversely affect our business.”

Removed heading “We have identified material weaknesses in our internal control over financial reporting in the past. If we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and the price of our securities.”

Removed heading “As of January 1, 2024, we are no longer a foreign private issuer, and we are required to comply with the provisions of the Exchange Act and the rules of Nasdaq applicable to U.S. domestic issuers, which will continue to require us to incur significant expenses and expend time and resources. significant additional costs and expenses and subject us to increased regulatory requirements.”

Removed heading “We no longer qualify as an “emerging growth company” as of December 31, 2024 and, as a result, we are no longer able to avail ourselves of certain reduced disclosure requirements applicable to emerging growth companies.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: consent decree, investigation, fine, penalt
“The FDA, the EMA or other comparable regulatory authorities strictly regulate the promotional claims that may be made about prescription drug products, such as obicetrapib, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA, the EMA or other comparable regulatory authorities as reflected in the product’s approved labeling. …”
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New text topics: consent decree, investigation, fine, penalt
“Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The federal government in the United States has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would harm our business. …”
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Removed text topics: litigation, penalt, inflation, regulation
“Our operations will also be subject to the federal transparency requirements under the ACA, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to annually report to the CMS an agency within HHS information related to payments and other transfers of value provided to physicians, teaching hospitals, certain ownership and investment interests held by physicians and their immediate family members and certain non-physician providers …”
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Removed text topics: material weakness
“We have identified material weaknesses in our internal control over financial reporting in the past. If we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and the price of our securities.”
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Removed text topics: investigation, penalt, pandemic
“In addition, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted. For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, 2013. …”
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New text topics: tariff, china, supply chain
“In April 2025, the Administration imposed a baseline ten percent tariff on imports from all nations importing goods to the United States, with that baseline supplemented in certain cases by additional tariffs that vary by nation, product or industry. Retaliatory tariffs on U.S. goods have been imposed by, among others, China and Canada. On July 28, 2025, the Administration announced a trade agreement with the EU that included a 15% tariff on most imports from the EU. …”
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Full comparison: every changed paragraph (90)

Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We are a clinical-stage company with limited operating history, no approved products and no significant historical product revenues, which makes it difficult to assess our future prospects and financial results. We have incurred net losses since our inception, and anticipate that we will continue to incur significant losses for the foreseeable future. We may never generate anysignificant product revenue or become profitable or, if we achieve profitability, may not be able to sustain it.

Reworded

We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. Our operations to date have been limited to developing and undertaking clinical trials of our product candidate, obicetrapib. We are not profitable and have not generated significant product revenue from operations. We have historically incurred net losses since we commenced operations in October 2019. For the year ended December 31, 2024,2025, we incurred a net loss of $241.6$203.8 million and as of December 31, 2024,2025, we had an accumulated deficit of $558.6$762.4 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, considering the current research and development stage of our activities, as we do not have products approved for commercial sale. Our ability to ultimately achieve recurring product revenues and profitability is dependent upon our ability to successfully complete the development of obicetrapib and obtain necessary regulatory approvals for, and successfully manufacture, market and commercialize, our product together with our partners.

Reworded

the costs associated with being a public company, including additional costs associated with no longer qualifying as an emerging growth company;

Reworded

Since our inception, almost all of our resources have been dedicated to the clinical development of obicetrapib. While we have been successful in the past in obtaining financing, we expect to continue to spend substantial amounts to continue the clinical development of our product candidate and on commercial readiness and establishment of sufficient commercial manufacturing capacity. As of December 31, 2024,2025, we had cash andcash, cash equivalents and marketable securities of $771.7$728.9 million.

Reworded

We have invested almost all of our efforts and financial resources in the research and development of obicetrapib. Our future success, including our ability to generate revenue, depends on our ability to develop, commercialize, market and sell obicetrapib. However, obicetrapib has yet to receive marketing approval from the FDA, the EMA or other comparable regulatory authorities. We currently do not generate nosignificant revenue from the sale of any products, and we may never be able to develop or commercialize a marketable product.

Reworded

our ability to agree upon an initial pediatric study plan with the FDA and, unless we have received a deferral or waiver, our ability to complete successfully any pediatric clinical trials agreed pursuant to the PREA or its EU equivalent;

Reworded

As a company, we have never progressed a product candidate through to regulatory approval. WeOther than our submission to the EMA and the EMA’s acceptance of MAAs for review for obicetrapib in August 2025, we have not previously submitted an NDA, an MAA or any similar drug approval filing to the FDA, the EMA or any comparable regulatory authority for any product candidate, and we cannot be certain that obicetrapib will be successful in clinical trials or receive regulatory approval. Further, obicetrapib may not receive regulatory approval even if it is successful in clinical trials. Even if we successfully obtain regulatory approvals to market our product candidate, our revenues will be dependent, to a significant extent, upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights or share in revenues from the exercise of such rights. If the markets for patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, if approved. In addition, there are, in general, relatively limited sources that can provide commercial product supply. While we believe our existing suppliers are sufficient to support our estimated target commercial market, and that alternative sources of supply exist if needed, there is no guarantee that our current and projected supply would be sufficient to support our commercials needs, if approved, especially if the market for obicetrapib is larger than we expected.

Reworded

We may also encounter delays if a clinical trial is suspended or terminated by us or the IRBs or ECs of the institutions in which such trials are being conducted, the trial’s data safety monitoring board or data monitoring committee (the “DSMB”), the FDA, the EMA or other comparable regulatory authorities. Such authorities may suspend or terminate one or more of our clinical trials due to a number of factors, including our failure to conduct the clinical trial in accordance with relevant regulatory requirements or clinical protocols, inspection of the clinical trial operations or trial site by the FDA, the EMA or other comparable regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, a finding that the participants are being exposed to an unacceptable benefit-risk ratio, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Reworded

If we experience delays in the initiation, enrollment or completion of any clinical trial of obicetrapib, or if any clinical trials of obicetrapib are cancelled or fail to adequately demonstrate the safety and efficacy of obicetrapib, the commercial prospects of obicetrapib may be materially adversely affected, and our ability to generate significant product revenues will be delayed or not realized at all. In addition, any delays in completing our clinical trials may increase our costs and slow down our product candidate development and approval process. Any of these delays may significantly harm our business and financial condition. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of obicetrapib.

Reworded

the clinical site’s ability to obtain and maintain subject consents; and non-compliance of clinical trial participants may not comply with clinical trial protocol procedures and instructions.

Reworded

The research, development, testing, manufacturing, labeling, packaging, approval, promotion, advertising, storage, recordkeeping, marketing, distribution, post-approval monitoring and reporting, and export and import of drug products are subject to extensive regulation by the FDA, the EMA and other comparable regulatory authorities in other countries. These regulations differ from country to country. We have not yet obtained regulatory approval to market obicetrapib in the United States or any other country, but plan to seek approval of obicetrapib in the United States, the EU, the United Kingdom, Switzerland, Japan and China. To gain approval to market obicetrapib, we must provide clinical trial data that adequately demonstrate the safety and efficacy of the product for the intended indication.

Reworded

We and our collaborator(s) are not permitted to market or promote obicetrapib before we receive regulatory approval from the FDA, the EMA, the MHRA, the PMDA, the NMPA or comparable regulatory authorities in other countries, and we may never receive such regulatory approval for obicetrapib to allow us to successfully commercialize our product candidate. If we do not receive regulatory approval with the necessary conditions to allow successful commercialization, we will not be able to generate significant revenue from obicetrapib in the United States or other countries in the foreseeable future, or at all. Any delay in obtaining, or inability to obtain, applicable regulatory approval for obicetrapib would delay or prevent commercialization of our obicetrapib and could thus negatively impact our business, results of operations and prospects.

Reworded

In addition to our Phase 3 lipid-lowering clinical trials for obicetrapib, we are currently conducting a CVOT,CVOT in patients with ASCVD. The completion of these clinical trials or any of our other ongoing or future clinical trials may be delayed for a number of reasons, including:

Reworded

We mayare failsubject to complex requirements to report AEsAEs, and there is a risk that the FDA, the EMA and other comparable regulatory authority regulations requiremay determine that we failed to report certain information about adverse medical events if our product may have caused or contributed to those AEs. The timing of our obligation to report would be triggered by the date upon which we become aware of the AE as well as the nature and severity of the event. We may also fail to appreciate that we have become aware of a reportable AE, especially if it is not reported to us as an AE or if it is an AE that is unexpected or removed in time from the use of our product. If we fail to comply with our reporting obligations, the FDA, the EMA, the MHRA, the PMDA, the NMPA or other comparable regulatory authority could take action including enforcing a hold on or cessation of clinical trials, withdrawal of approved drugs from the market, criminal prosecution, the imposition of civil monetary penalties or seizure of our product.

Reworded

Our ongoing clinical trials are being conducted both within and outside the United States, and we intend to conduct portions of our future clinical trials outside the United States. The acceptance of clinical trial data by the FDA, EMA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions, or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice and (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations.requirements. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements. In cases where data from foreign clinical trials are intended to serve as the basis for marketing authorizations in the EU, the EMA and/or local regulatory authorities in EU member states require that such clinical trials follow the principles that are equivalent to the clinical trial requirements set out under relevant EU legislation, including with respect to ethical and GCP standards. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that any U.S. or foreign regulatory authority would accept data from clinical trials conducted outside of its applicable jurisdiction. If the FDA, EMA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional clinical trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

Reworded

The ability of the FDA to review and clear or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new products or modifications to be approved by government agencies, which would adversely affect our business. Over the last several years, including for 43 days beginning on October 1, 2025 and for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory authorities, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process its regulatory submissions or provide feedback with respect to our planned clinical trials, which could have a material adverse effect on our business. In 2025, the FDA also experienced significant reductions in force that have impacted, and may continue to impact, its ability to review applications in a timely manner.

Reworded

If a prolonged government shutdown occurs,or further reductions in force occur, or if global health crises prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Removed

In addition, the new presidential administration has indicated that it may pursue significant changes to the operation of the FDA and other agencies, including significantly reducing the size of the workforce at the FDA. The effect of these changes, if adopted, is not clear at this time. There is a risk that the changes will disrupt the functioning of the FDA in ways that effect the review of our submissions.

Reworded

If the FDA, the EMA or other comparable regulatory authority approves obicetrapib, the manufacturing processes, labeling, packaging, distribution, AE reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration requirements andrequirements, continued compliance with cGMPs and compliance with GCPs for any clinical trials that we conduct post-approval. For certain commercial prescription drug products, manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or other products that are otherwise unfit for distribution in the United States. The EU similarly has in force falsified medicines rules, which require appropriate packaging, labeling, registration and tracking of certain medicinal products to ensure the detection of counterfeit medicinal products, and associated reporting requirements. Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

Reworded

The FDA strictly regulates the promotional claims that may be made about drug products. In particular, the FDA prohibits the pre-approval promotion of drugs as safe and effective for the purposes for which they are under investigation. Similarly, the FDA prohibits the promotion of approved drugs for new or unapproved indications.use, and requires that claims of a product’s benefits be presented with balanced information about its risks and any limitations of use. Comparable restrictions apply in the EU, where, in addition, the advertising of prescription only medications to the general public is prohibited .prohibited. If we are found to have improperly engaged in pre-approval promotion or to have improperly promoted off-label and other uses of our product candidates, we may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions, which would materially adversely affect our business and financial condition. The FDA could issue a public untitled or warning letter to us. We could also be subject to FDA prohibition on the sale or marketing of our product candidates or significant fines and penalties. The imposition of these sanctions could affect our reputation and position within the industry. Additionally, if the FDA believes we have improperly promoted an investigational product pre-approval, it is possible that it could lead the FDA to be more strict in their review of our application, including our proposed labeling for a drug.

Added

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The federal government in the United States has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred and our reputation could be damaged. The U.S. government has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we are determined by the U.S. government to have engaged in the promotion of our products for off-label use, or otherwise not met applicable advertising and promotion requirements, we could be subject to prohibitions on the sale or marketing of our products or significant fines and penalties, and the imposition of these sanctions could also affect our reputation with physicians, patients and caregivers, and our position within the industry.

Removed

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize obicetrapib, and harm our business, financial condition and results of operations.

Removed

The FDA, the EMA or other comparable regulatory authorities strictly regulate the promotional claims that may be made about prescription drug products, such as obicetrapib, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA, the EMA or other comparable regulatory authorities as reflected in the product’s approved labeling. For example, if we receive marketing approval for obicetrapib for cardiometabolic disease, physicians, in their professional medical judgment, may nevertheless prescribe obicetrapib to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label use, we may become subject to significant liability under the FDCA and other statutory authorities, such as laws prohibiting false claims for reimbursement. The federal government in the United States has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. If we become the target of such an investigation or prosecution based on our marketing and promotional practices, we could face similar sanctions, which would harm our business. In addition, management’s attention could be diverted from our business operations, significant legal expenses could be incurred and our reputation could be damaged. The U.S. government has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we are deemed by the FDA to have engaged in the promotion of our products for off-label use, we could be subject to prohibitions on the sale or marketing of our products or significant fines and penalties, and the imposition of these sanctions could also affect our reputation with physicians, patients and caregivers, and our position within the industry.

Added

We are planning a dedicated trial evaluating obicetrapib as a preventative treatment for Alzheimer's disease. There has been limited success in drug development for Alzheimer's disease, which makes it difficult to predict the time and cost of development and regulatory approval for obicetrapib as a treatment for Alzheimer's disease. Further, obicetrapib's mechanism of action has not previously used for Alzheimer's disease treatment, which also makes it difficult to predict the time and cost of development and regulatory approval.

Added

We reported positive data from our Alzheimer's disease biomarker analysis in our BROADWAY trial and we are planning a dedicated trial evaluating obicetrapib as a preventative treatment for Alzheimer's disease. However, there has been limited success in drug development for Alzheimer's disease, and there are few FDA-approved disease modifying therapeutic options available for patients with Alzheimer's disease. The majority of drugs approved by the FDA to treat Alzheimer's disease to date only address the diseases’ symptoms, they do not reverse or cure the disease. There are no approved preventative treatments for Alzheimer's disease. Only a small number of new treatments have been approved for Alzheimer's disease since 2003. It has been reported that Alzheimer's disease drug candidates have a failure rate of over 95%, as compared to 50% to 80% for other drug candidates. As a result, the FDA has a limited set of products to rely on in evaluating obicetrapib, and no comparable products for the prevention of Alzheimer's disease. This could result in a longer than expected regulatory review process, increased expected development costs or the delay or prevention of commercialization of obicetrapib for the treatment of Alzheimer's disease.

Added

As a result, the design and conduct of clinical trials evaluating obicetrapib as a preventative treatment for Alzheimer's disease may take longer, be more costly or be less effective as a result of the novelty of development in this disease. We cannot be certain that our approach will lead to the development of an approvable or marketable product.

Added

Our Alzheimer's disease trial may use endpoints or methodologies that regulatory authorities may not consider to be clinically meaningful, and any such regulatory authority may require evaluation of additional or different clinical endpoints in our clinical trials or ultimately determine that these clinical endpoints do not support marketing approval. In addition, if we are required to use additional or different clinical endpoints by regulatory authorities, obicetrapib may not achieve or meet such clinical endpoints in our clinical trials. Even if a regulatory authority finds our clinical trial success criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoint to a degree of statistical significance in any pivotal or other clinical trials we may conduct for the treatment or prevention of Alzheimer's disease. Further, even if we do achieve the pre-specified criteria, our trials may produce results that are unpredictable or inconsistent with the results of other efficacy endpoints in the trial. Regulatory authorities also could give overriding weight to other efficacy endpoints over a primary endpoint even if we achieve statistically significant results on that primary endpoint if we do not do so on our secondary efficacy endpoints. Regulatory authorities also weigh the benefits of a product against its risks and may view the efficacy results in the context of safety as not being supportive of approval.We cannot be sure that obicetrapib as a treatment for Alzheimer's disease, or any other product candidate we develop for Alzheimer's disease, will ultimately prove to be safe and effective, scalable or profitable.

Added

The biopharmaceutical industry is characterized by intense competition and rapid innovation. Our potential competitors include large pharmaceutical companies, smaller biotechnology and specialty pharmaceutical companies and generic drug companies. Many of our potential competitors have greater financial and technical human resources than we do, as well as greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products, and the commercialization of those products. Accordingly, our potential competitors may be more successful than us in obtaining FDA-approved drugs and achieving widespread market acceptance. We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available. Finally, the development of new treatment methods for the diseases we are targeting could render our product candidates non-competitive or obsolete.

Added

If obicetrapib is approved, our main competition will come from currently approved LDL-C lowering therapies for use on top of maximally tolerated statins, such as ezetimibe, Nexletol/Nexlizet (Esperion) and injectable PCSK9 inhibitors such as Repatha (Amgen Inc.), Praluent (Regeneron Pharmaceuticals, Inc.) and Leqvio (Novartis International AG). We are also aware of two orally administered small molecule product candidates that target the PCSK9 protein as a mechanism to lower LDL-C and reduce the risk of ASCVD in various stages of clinical development. These consist of MK-0616 (Enlicitide) from Merck & Co., Inc, for which Merck released data from completed Phase 3 trials of adult patients with hypercholesterolemia in November 2025 and, if approved, could enter the U.S. market in 2026, and AZD0780 from AstraZeneca, which is being evaluated in an ongoing Phase 3 clinical trial. There are also a number of other product candidates in clinical development by third parties, such as Arrowhead Pharmaceuticals, CVI Pharmaceuticals, Innovent Biologics, Ionis Pharmaceuticals, Lib Therapeutics, Novartis, Novo Nordisk, Regeneron Pharmaceuticals, Verve Therapeutics and others, that are intended to treat ASCVD by lowering LDL-C and/or Lp(a). If approved, these products would pose additional competition for obicetrapib.

Removed

The biopharmaceutical industry is intensely competitive and subject to rapid and significant technological change. Our potential competitors include large and experienced companies that enjoy significant competitive advantages over us, such as greater financial, research and development, manufacturing, personnel and marketing resources, greater brand recognition and more experience and expertise in obtaining marketing approvals from the FDA, the EMA and other comparable regulatory authorities. These companies may develop new drugs to treat the indications that we target, or seek to have existing drugs approved for use for the treatment of the indications that we target.

Removed

If obicetrapib is approved, our main competition will come from current LDL-C lowering therapies on the market for use on top of maximally tolerated statins, such as PSCK9 inhibitor injectables from Amgen Inc., Regeneron Pharmaceuticals, Inc. and Novartis International AG. We may also face competition from oral therapeutics containing bempedoic acid from Esperion. We are aware that Merck has decided to advance its oral PSCK9 inhibitor, MK-0616, into Phase 3 development and AstraZeneca has advanced its oral PSCK9 inhibitor, AZD0780, into Phase 2 development. If approved, MK-0616 and/or AZD0780 could pose additional competition for obicetrapib.

Reworded

Although we have hired a chief commercial officer, we do not have a complete sales or marketing infrastructure and, as a Companycompany have limited experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any product candidate for which we may obtain marketing approval, we will need to establish a sales and marketing organization or enter into collaboration, distribution and other marketing arrangements with one or more third parties to commercialize such product candidate. In the United States, we intend to build a commercial organization to target areas with the greatest incidence of high cardiovascular risk with residual elevation of LDL-C and Alzheimer's disease and recruit experienced sales, marketing and distribution professionals. The development of sales, marketing, and distribution capabilities will require substantial resources, will be time-consuming and could delay any product launch. We may decide to work with regional specialty pharmacies, distributors and/or multi-national pharmaceutical companies to leverage their commercialization capabilities to commercialize any product candidate for which we may obtain regulatory approval outside of the United States or certain areas of Europe.

Reworded

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel. We believe that our future success is highly dependent upon the contributions of members of our senior management, as well as our senior scientists and other members of our management team, especially our Chief Executive Officer, Dr. Michael Davidson, our Chief Scientific Officer, Dr. John Kastelein, our Chief Operating Officer, Douglas Kling, and our Chief Financial Officer, Ian Somaiya.Davidson. We are not aware of any present intention of any of these individuals to leave our company. The loss of services of any of these individuals and certain other key employees, though, could delay or prevent the successful development of our product pipeline, completion of our planned clinical trials or the commercialization of obicetrapib. Although we have agreements with our officers and employees, these agreements do not prevent them from terminating their employment or service arrangement with us as described in the agreements.

Reworded

Our workers are classified as either employees or independent contractors, and if employees, as either exempt from overtime or non-exempt (and therefore overtime eligible). The tests governing whether a service provider is an independent contractor or an employee are typically highly fact sensitive and can vary by governing law. Laws and regulations that govern the status and misclassification of independent contractors are also subject to divergent interpretations by various authorities, which can create uncertainty and unpredictability. Regulatory authorities and private parties have recently asserted within several industries that some independent contractors should be classified as employees and that some exempt employees should be classified as nonexempt based upon the applicable facts and circumstances and their interpretations of existing rules and regulations. The Dutch (tax) authorities have intensified the supervision and enforcement of the classification as an employee or independent contractor as of 1 January 2025. If we are found to have misclassified employees as independent contractors or non-exempt employees as exempt, we could face penalties and have additional exposure under tax (including federal and state tax), social security contributions, workers’ compensation, unemployment benefits, labor, employment and tort laws, including for prior periods, as well as potential liability for employee overtime and benefitsbenefits, including pensions, and tax withholdings. Legislative, judicial or regulatory (including tax) authorities could also introduce proposals or assert interpretations of existing rules and regulations that would change the classification of a number of independent contractors doing business with us from independent contractor to employee and a number of exempt employees to non-exempt. A reclassification in either case could result in an increase in employment-related costs such as wages, benefits and taxes. The costs associated with employee misclassification, including any related regulatory action or litigation, could therefore have an adverse effect on our results of operations and our financial position.

Reworded

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Amendments”), which amended the FDCA, a company may file an ANDA seeking approval of a generic version of an approved innovator product. Depending upon the timing, duration and specifics of any FDA marketing approval of our product candidates and our technology, one or more of our U.S. patents that we may own in the future may be eligible for limited patent term extensionextension, underdepending Hatch-Waxmanupon Amendments.the timing, duration and specifics of any FDA marketing approval of our product candidates and our technology. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent may be extended and only those claims covering the approved product, a method for using it or a method for manufacturing it may be extended. The application for the extension must be submitted prior to the expiration of the patent for which extension is sought. A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. However, we may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Reworded

Furthermore, trade secret protection and confidentiality agreements do not prevent competitors from independently developing substantially equivalent information and techniques and we cannot guarantee that our competitors will not independently develop substantially equivalent information and techniques. TheWhile there are U.S. laws prohibiting the use or disclosure of trade secret information by government employees, the FDA, as part of its Transparency Initiative, ishas currentlytaken considering whethersteps to make additional information publicly available on a routine basis, including 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 future, if at all.future.

Added

If we fail to obtain or maintain regulatory exclusivity for our product candidates, our business may be materially harmed.

Added

We may be unable to obtain, or may not be able to maintain, regulatory exclusivity for our product candidates, including exclusivity under the Hatch-Waxman Act, orphan drug exclusivity, or pediatric exclusivity. Even if granted, such exclusivity may be limited in scope or duration and may not prevent competitors from developing or marketing competing products. The loss or expiration of any exclusivity period could allow competitors to introduce generic or other competing products, which could significantly reduce our revenues, if our product candidates are approved, and adversely affect our business, financial condition, and results of operations.

Added

Generic competition following the expiration or loss of exclusivity could significantly reduce our revenues, if our product candidates are approved.

Added

Our product candidates, if approved, may become subject to competition from generic or follow-on drug manufacturers who seek approval through the ANDA or 505(b)(2) application process. Manufacturers may file ANDAs or 505(b)(2) applications seeking approval to market follow-on versions of our products prior to the expiration of our patents or regulatory exclusivities, including by filing Paragraph IV certifications alleging that our patents are invalid, unenforceable, or not infringed. Such challenges could result in costly and time-consuming litigation, and if successful, could lead to earlier-than-anticipated generic competition, which would materially and adversely affect our revenues and profitability, if our product candidates are approved.

Reworded

Current and future legislation and executive actions affecting the healthcare industry, including healthcare reform, may impact our business generally and may increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations and/or how much or under what circumstances healthcare providers will prescribe or administer obicetrapib, if approved.

Reworded

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell obicetrapib profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.initiatives and executive actions.

Removed

For example, in March 2010, President Obama signed into law the ACA, a law intended, among other things, to broaden access to health insurance, improve quality of care, and reduce or constrain the growth of healthcare spending. The ACA, among other things, imposed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extended the rebate program to individuals enrolled in Medicaid managed care organizations, added a provision to increase the Medicaid rebate for line extensions or reformulated drugs, established annual fees on manufacturers and importers of certain branded prescription drugs and biologic agents, promoted a new Medicare Part D coverage gap discount program, expanded the entities eligible for discounts under the Public Health Service Act pharmaceutical pricing program; and imposed a number of substantial new compliance provisions related to pharmaceutical companies’ interactions with healthcare practitioners. The ACA also expanded eligibility for Medicaid programs and introduced a new Patient Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research and a new Center for Medicare & Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Removed

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. In December 2017, Congress repealed the tax penalty, effective January 1, 2019, for an individual’s failure to maintain ACA-mandated health insurance as part of the Tax Cuts and Jobs Act of 2017 (the “Tax Act”). President Biden issued an Executive Order that instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. Further, there have been a number of health reform initiatives by the Biden administration that have impacted the ACA. For example, on August 16, 2022, President Biden signed the IRA into law, which sets forth meaningful changes to drug product reimbursement by Medicare. Among other actions, the IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiation program, including for certain orphan designated drugs for which the only approved indication (or indications) is for the orphan disease or condition. Should our product candidates be approved and covered by Medicare Part B or Part D, and fail to fall within a statutory exclusion, such as that for an orphan drug, those products could, after a period of time, be selected for negotiation and become subject to prices representing a significant discount from average prices to wholesalers and direct purchasers. The IRA also establishes a rebate obligation for drug manufacturers that increase prices of Medicare Part B and Part D covered drugs at a rate greater than the rate of inflation. The inflation rebates may require us to pay rebates if we increased the cost of a covered Medicare Part B or Part D approved product faster than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. Our cost-sharing responsibility for any approved product covered by Medicare Part D could be significantly greater under the newly designed Part D benefit structure compared to the pre-IRA benefit design. Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.

Removed

In addition, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted. For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, 2013. This 2% reduction was temporarily suspended during the COVID-19 pandemic, but has since been reinstated and, unless Congress and/or the Executive Branch take additional action, will begin to increase gradually starting in April 2030, reaching 4% in April 2031, until sequestration ends in October 2031. Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments from providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015 also introduced a quality payment program under which certain individual Medicare providers will be subject to certain incentives or penalties based on new program quality standards. In November 2019, CMS issued a final rule finalizing the changes to the Medicare Quality Payment Program. On May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

Removed

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that attempt to implement several of the administration’s proposals. The FDA also released a final rule, effective November 30, 2020, implementing a portion of the importation executive order providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 30, 2020, HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The IRA delayed the implementation of the rule to January 1, 2032. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers; the implementation of these provisions has also been delayed by the IRA until January 1, 2032.

Reworded

OnFor March 11, 2021, President Biden signedexample, the AmericanIRA Rescuesets Planforth Actmeaningful ofchanges 2021 into law, which eliminates the statutory Medicaidto drug rebateproduct price cap, currently set at 100% of a drug’s average manufacturer price for single source and innovator multiple source products, beginning on January 1, 2024. Further, in July 2021, the Biden administration released an executive order that included multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug price reform. The plan sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actionsreimbursement by HHS.Medicare. No legislative or administrative actions have been finalized to implement these principles. In addition, Congress is considering drug pricing as part of the budget reconciliation process. Additionally, theThe IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part DD, startingeffective in 2026, followed by 15 Part D drugsdrugs, effective in 2027, 15 Part B or Part D drugsdrugs, effective in 2028, and 20 Part B or Part D drugsdrugs, effective in 2029 and beyond.each year thereafter. This provision applies to drug products that have been approved for at least 97 years and biologics that have been licensed for 1311 years, but it does not apply to drugs and biologics that have been approved only for a single rare diseasediseases or condition.conditions. Nonetheless, sincebecause CMS may establish a maximum price for these products in price negotiations, we wouldmay be fullyexposed at risk ofto government action if our productsproduct arecandidates, if approved, become the subject of Medicare price negotiations. Moreover, given the risk that could be the case, these provisions of the IRA may also further heighten the risk thatthat, if our product candidates are approved, we would not be able to achieve the expected return on oursuch drugproduct productscandidates or realize the full value of ourthe patents protecting ourthem, productsincluding if prices are set after such productsproduct candidates have been on the market for nineseven years.

Added

The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiation program, including for certain orphan designated drugs for which the only approved indication (or indications) is for the orphan disease or condition. Should our product candidates be approved and covered by Medicare Part B or Part D and fail to fall within a statutory exclusion, such as that for an orphan drug, those products could, after a period of time, be selected for negotiation and become subject to prices representing a significant discount from average prices to wholesalers and direct purchasers. The IRA also establishes a rebate obligation for drug manufacturers that increase prices of Medicare Part B and Part D covered drugs at a rate greater than the rate of inflation. The inflation rebates may require us to pay rebates if we increase the cost of a covered Medicare Part B or Part D approved product faster than the rate of inflation. In addition, the law eliminates the “donut hole” under Medicare Part D beginning in 2025, significantly lowers the beneficiary maximum out-of-pocket cost, and requires manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. Our cost-sharing responsibility for any approved product covered by Medicare Part D could be significantly greater under the newly designed Part D benefit structure compared to the pre-IRA benefit design. Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.

Added

In addition, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, 2013. This 2% reduction was temporarily suspended during the COVID-19 pandemic, but has since been reinstated and, unless Congress and/or the Executive Branch take additional action, will begin to increase gradually starting in April 2030, reaching 4% in April 2031, until sequestration ends in October 2031.

Added

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products. At the federal level, the Trump Administration has issued executive orders relating to prescription drug pricing and letters to pharmaceutical manufacturers that direct drug manufacturers to, among other things, offer MFN pricing in Medicaid, offer MFN pricing for all newly launched drugs; repatriate increased revenue from abroad to lower drug prices in the United States, and implement direct-to-consumer and direct-to-business distribution of their products at MFN pricing. The Trump Administration has warned that manufacturers that fail to make “significant progress” toward MFN pricing will face enumerated regulatory and enforcement consequences. In September 2025, the Administration began announcing deals with specific manufacturers to address the Administration’s MFN goals.

Added

The Administration has also proposed three payment models that would test MFN pricing in Medicaid, Medicare Part D, and Medicare Part B. Participation in the Medicaid model, announced in November 2025, is voluntary for pharmaceutical manufacturers. Under the proposed rules for the Medicare Part D and Medicare Part B models published in December 2025, participation would be mandatory, and pharmaceutical manufacturers would be required to pay MFN-based rebates on eligible products for 25% of eligible Medicare beneficiaries during the applicable testing period. If these models are finalized and we obtain regulatory approval and commence commercialization of obicetrapib or any of our future product candidates during the testing period, we may be required to participate in these models. Moreover, pursuant to the Menarini License, Menarini is responsible for the commercialization and local development of obicetrapib in certain areas of Europe, if approved, and has sole discretion to set the price of the products in certain European markets. Since these markets may serve as benchmarks for any mandatory MFN pricing models, we may be unable to control the MFN price that must be paid under the announced payment models or in any future efforts to adopt MFN pricing. As a result, these payment models and other efforts to impose MFN pricing could have a material adverse effect on our business, financial condition or results of operations including the net sales potential of obicetrapib, if approved.

Added

Further, on November 30, 2020, HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The IRA delayed the implementation of the rule to January 1, 2032. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers; the implementation of these provisions has also been delayed by the IRA until January 1, 2032.

Removed

These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. It is currently unclear how the IRA will be effectuated but is likely to have a significant impact on the pharmaceutical industry. If healthcare policies or reforms intended to curb healthcare costs are adopted, or if we experience negative publicity with respect to the pricing of obicetrapib, if approved, or any future product or the pricing of pharmaceutical drugs generally, the prices that we charge for any approved products may be limited, our commercial opportunity may be limited and/or our revenues from sales of our products may be negatively impacted.

Reworded

If we obtain regulatory approval and commence commercialization of obicetrapib or any of our future product candidates, these laws could have an adverse effect on the market opportunities for obicetrapib or any of our future product candidates and may result in additional reductions in healthcare funding, which could have an adverse effect on our customers and accordingly, our financial operations. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether additional executive actions will be taken, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of obicetrapib or our future product candidates may be.

Reworded

In AprilDecember 2023,2025, the EUEuropean CommissionParliament releasedand proposalsthe Council of the European Union reached a provisional agreement on legislation to amend the current EU pharmaceutical regulatory framework. The text of the new legislation is due to be released in early 2026. The potential reforms include shorteningaltering the conditions and periods of regulatory and/or marketing protections available for innovative products. Depending on the final wording of these reforms (if adopted),reforms, a reduction in the periodspotential period of regulatory and/or marketing protectionsprotection available for obicetrapib or any of our future product candidates may adversely affect the commercial viability of such products in the EU. These changes could adversely affect our business by reducing our protection against generic competitors entering the EU market. Depending on the progress of the EU Parliament and Council,Council to finalize the text of the legislation, changes to EU pharmaceutical legislation are not expected to come into force until 2025 orearly 2026 and additional transitional periods mean that the changes will most likely not take effect until 2027 or 2028.mid-2028.

Reworded

Many states have similar fraud and abuse statutes and regulations that may be broader in scope and may apply regardless of payor,payor in(i.e., addition tofor items and services reimbursed by private payors, as well as under Medicaid and other state programs.programs). State and federal authorities have aggressively targeted medical technology companies for, among other things, alleged violations of these anti-fraud statutes, based on improper research or consulting contracts with doctors, certain marketing arrangements that rely on volume-based pricing, off-label marketing schemes, and other improper promotional practices.

Added

Our operations will also be subject to the federal transparency requirements, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, to annually report to CMS information related to payments and other transfers of value provided to physicians, other prescribers, and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members.

Removed

Our operations will also be subject to the federal transparency requirements under the ACA, which require certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to annually report to the CMS an agency within HHS information related to payments and other transfers of value provided to physicians, teaching hospitals, certain ownership and investment interests held by physicians and their immediate family members and certain non-physician providers (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified-nurse midwives). On November 20, 2020, CMS issued an interim final rule implementing President Trump’s Most Favored Nation (“MFN”) executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021. As a result of litigation, challenging the MFN model on August 10, 2021, CMS published a proposed rule that seeks to rescind the MFN model interim rule. In addition, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate price cap, currently set at 100% of a drug’s average manufacturer price for single source and innovator multiple source products, beginning on January 1, 2024. Further, in July 2021, the Biden administration released an executive order that included multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug price reform. The plan sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions by HHS. No legislative or administrative actions have been finalized to implement these principles. In addition, Congress is considering drug pricing as part of the budget reconciliation process. Additionally, the IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges.

Reworded

EU data protection laws including the GDPR impose strict requirements relating to the processing of personal data, including special protections for “special categories of personal data” which includes, without limitation, health and genetic information of data subjects residing in the EU. The GDPR also generally prohibits the transfer of personal information from the EU to the United States and most other foreign jurisdictions unless the parties to the transfer have implemented specific safeguards to protect the transferred personal information. There isremains uncertaintypractical regardingcomplexity howin to ensureensuring that transfers of personal information from the EU to the United States comply with the GDPR. As such, any transfers by us, or our vendors, of personal information from the EU may not comply with EU data protection laws; may increase our exposure to the GDPR’s heightened sanctions for violations of its cross-border data transfer restrictions; and may reduce demand for our services from companies subject to EU data protection laws. Loss of our ability to transfer personal information from the EU may also require us to increase our data processing capabilities in those relevant jurisdictions at significant expense.

Reworded

Reimbursement may impact the demand for, and/or the price of, any product for which we obtain marketing approval. Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the cost of our products. Therefore, coverage and adequate reimbursement isare critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA, the EMA or other comparable regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

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Reworded

We are a late-stage biopharmaceutical company whose mission is to improve patient care in populations with cardiometabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well tolerated and convenient LDL-C lowering therapy. In multiple Phase 3 trials, we have investigated obicetrapib, an oral, low-dose, once-daily, highly selective CETP inhibitor, alone or as aan fixed-dose combinationFDC with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. WeAdditionally, we believe that CETP inhibition may also play a role in other indications by potentially mitigating the risk of developing diseases such as Alzheimer’s disease.

Reworded

Obicetrapib, is a next-generation, oral, low-dose, highly selective CETP inhibitor that we are developing to potentially overcome the limitations of current LDL-C lowering treatments. In addition to LDL-C, obicetrapib has shown significant reductions in Lp(a) and small LDL particles, all with safety comparable to placebo. We believe that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In each of our Phase 3 clinical trials, BROADWAY and BROOKLYN, evaluating obicetrapib as an adjunct to high-intensity statin therapy, obicetrapib met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In our Phase 3 TANDEM clinical trial, evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy, obicetrapib in combination with ezetimibe met its primary and secondary endpoints, with statistically significant reductions in LDL-C observed. In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C loweringlowering. withIn each of these trials, side effects were similar in frequency and severity to placebo including muscle-related side effects and drug-related TESAEs. We have observed obicetrapib to be well tolerated in an aggregate of over 3,500 patients with dyslipidemia in our clinical trials to date. Furthermore, we believe that obicetrapib’s oral delivery, demonstrated activity at low doses, chemical properties and tolerability make it well-suited for combination approaches.

Reworded

Lowering of LDL-C, has been associated with MACE benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor, anacetrapib. In our Phase 3 BROADWAY clinical trialtrial, we observed a positive21% trendreduction in the exploratory MACE endpoint (coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization) and we are performing a Phase 3 CVOTCVOT, PREVAIL trialPREVAIL, to reconfirm this relationship.

Reworded

Our goal is to develop and commercialize an LDL-C lowering monotherapy and aan fixed-dose combinationFDC therapy, which offers the advantage of a single, low dose, once-daily oral pill, and fulfills the significant unmet need for an effective and convenient LDL-C lowering therapy. If we obtain marketing approval, we intend to commercialize obicetrapib for patients with ASCVD and/or HeFH and elevated levels of LDL-C despite being treated with currently available optimal lipid lowering therapy.

Added

We have partnered with Menarini, providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in an FDC with ezetimibe, in the Menarini Territory, if approved. In August 2025, the EMA accepted for review the MAAs submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in the UK and Switzerland and accepted for review. The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials. We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026. If the MAAs are approved, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory.

Reworded

We have partnered with Menarini, providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Subject to receipt of marketing approval, ourOur current plan is to pursue development andand, subject to the receipt of marketing approval, commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the EU,Europe, including in Japan and China. In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications. We are also continuallyregularly evaluating the potential acquisition or license of new product candidates.

Added

In addition to our cardiometabolic program, we are exploring the potential application of CETP inhibition in other indications, including Alzheimer’s disease. Based on the lipid-modifying effects of CETP inhibition observed in our clinical trials for obicetrapib to date, we have conducted preclinical and early clinical evaluations of obicetrapib in this area. We initiated a Phase 2a clinical trial in patients with early Alzheimer’s disease to evaluate the pharmacodynamic and pharmacokinetic effects, safety and tolerability of obicetrapib, and announced initial data from this trial in September 2023. In July 2025, we announced data from the prespecified Alzheimer’s disease biomarker analysis in our BROADWAY clinical trial. Based on these results, we expect to initiate a new clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease in 2026.

Added

As of December 31, 2025, we had cash, cash equivalents and marketable securities of $728.9 million as compared to $834.2 million as of December 31, 2024.

Removed

As of December 31, 2024, we had cash and cash equivalents of $771.7 million as compared to $340.5 million as of December 31, 2023. The increase in cash is primarily driven by the proceeds of the February 2024 Offering (as defined below), the December 2024 Offering (as defined below), Warrant exercises, exercises of options and the achievement of a clinical development milestone, partially offset by cash outflows related to research and development costs as we continue development of obicetrapib and increased spending on selling, general and administrative expenses to support our growing organization.. As of December 31, 2024, we no longer qualify as an “emerging growth company,” and, as a result, we are no longer able to avail ourselves of certain reduced reporting requirements applicable to emerging growth companies, and we expect to incur increased expenses as a result.

Removed

Recent Developments

Removed

December 2024 Follow-On Offering

Removed

On December 13, 2024, the Company completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 14,667,347 Ordinary Shares issued and sold in the offering, 2,550,000 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Removed

Positive Topline Data from Pivotal Phase 3 BROADWAY Clinical Trial

Removed

On December 10, 2024, we announced positive topline data from our Phase 3 BROADWAY clinical trial. The primary endpoint was the least-squares mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo, using imputation for missing data. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001). As part of the safety analysis, the trial adjudicated MACE as an exploratory endpoint, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization. In addition, a 21% reduction in MACE favoring obicetrapib was observed. The observed changes in other biomarkers, including HDL-C, non-HDL-C, Lp(a), ApoB, and Apolipoprotein A1 (ApoA1) were consistent with data reported in our prior clinical trials. As part of the safety analysis, key AEs of special interests were monitored. Among these AEs, glycemic control and renal function were monitored and each of the events favored obicetrapib. Overall, obicetrapib was also observed to be well-tolerated, with safety results, including blood pressure, comparable to placebo.

Removed

Positive Topline Data from Pivotal Phase 3 TANDEM Clinical Trial

Removed

On November 20, 2024, we announced positive topline data from our Phase 3 TANDEM clinical trial. The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including Lp(a), non-HDL-C and ApoB. The TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to placebo.

Removed

Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial

Removed

On November 18, 2024, we announced additional positive data from our Phase 3 BROOKLYN clinical trial. The trial met its primary endpoint of percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days. The trial also met several of its prespecified secondary endpoints with statistical significance and observed results consistent with our prior clinical trials. Key secondary endpoints included percent changes from baseline of obicetrapib 10 mg compared to placebo after 84 days in Lp(a), ApoB, HDL-C and non-HDL-C. The p-value for the LS mean for all secondary endpoints compared to placebo was <0.0001 following 84 days of treatment with obicetrapib. Obicetrapib was also observed to be well tolerated, with safety results in the treatment arm comparable to placebo and no observed increase in blood pressure.

Reworded

To date, we have not generated anysignificant revenue from the sale of pharmaceutical products. Our revenue has been solelyprimarily derived from our license agreement with Menarini. Two performance obligations for the Menarini licenseLicense were identified at contract inception, comprising a license to use the Company's intellectual property (the "license performance obligation") and a promise to continue the development activities for the licensed compound (the "R&D performance obligation"). Pursuant to the Menarini License, we received a non-refundable, non-creditable upfront amount of $120.9 million (€115.0 million) from Menarini on July 7, 2022, of which $98.6 million (€93.5 million) was attributed to the license performance obligation and recognized as revenue upon the execution of the Menarini License on June 23, 2022. The remaining $22.3 million (€21.5 million) was attributed to the R&D performance obligation and initially recognized as deferred revenue. As of December 31, 2025, the R&D performance obligation had been deemed to be completely satisfied and all deferred revenue related to such performance obligation was recognized.

Reworded

Additionally, in partial contribution to our costs of development of the Licensed Products, Menarini may pay us €27.5 million, payable in two equal annual installments. Due to the scientific uncertainties around the commercialization of the Licensed Products based on the success of clinical trials, which is out of our control, the fixed €27.5 million was considered constrained at contract execution and is not initially recognized within the transaction price until it becomes highly probable of no significant revenue reversal. At the endAs of eachDecember reporting31, period,2025, weboth assessannual thedevelopment probabilitycost ofcontributions significanthad reversalsbeen for any amounts that become likely to be realized prior to recognizing the constrained amounts associated with these paymentsrecognized within the transaction price.

Added

In addition, we entered into the Menarini Supply Agreement to provide commercial supply of obicetrapib monotherapy and obicetrapib and ezetimibe fixed-dose combination finished products in bulk tablet form (the “Drug Products”) for distribution by Menarini in specified European territories.

Added

We recognize revenue from the sale of Drug Products, and from the sale of active pharmaceutical ingredients to Menarini for the manufacturer of such tablets. Our product supply revenue is recognized at a point in time when the performance obligation is satisfied by transferring control of the promised goods or services to the customer and it is probable that we will collect the consideration to which we are entitled. In accordance with the terms of the Menarini Supply Agreement, control of the product is transferred upon the conveyance of title, which occurs when the product is made available to Menarini. The transaction price is contractually fixed at a markup of the actual cost of goods sold. Due to the cost-based nature of the agreement, the pricing structure includes a variable component which is measured using the expected value method. At each reporting period end, we update our estimate of the transaction price using actual cost data and forecasted expenses. We state revenues net of any taxes collected from customers that are required to be remitted to various government agencies.

Reworded

We do not expect to generate any revenue from product sales for the foreseeable future. Any revenue generated from potential future collaborations or product sales may vary due to the many uncertainties in the development of obicetrapib and other factors.

Reworded

All such costs are for the purpose of advancing our product candidatecandidates to successfully complete clinical development, attain regulatory approval and, if approved, commercialize our product candidate.candidates. Much of our current focus in our ongoing trials is on patient recruitment and retention and data cleaning. Research and development expenses consist of the following:

Reworded

manufacturing expenses arising from investments in commercial manufacturing capabilities and API and drug product development as performed by our CMOs, which are used in our clinical trials and research and development activitiesCMOs;

Reworded

costs associated with obtaining potential regulatory approval of our product candidate,candidates, including preparation and submission of filings, ongoing monitoring and compliance with comments and recommendations provided by regulatory authorities, and regulatory-related advisory fees;

Reworded

preclinical and nonclinical research and development expenses of theour product candidatecandidates; and other clinical costs such as clinical trial insurance and other consultancy fees.

Reworded

We expect our research and development expenses to be significant as we advance obicetrapibour product candidates through clinical trials and pursue regulatory approval. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming. Clinical trials generally become larger and more costly to conduct as they advance into later stages and, in the future, we will be required to make estimates for expense accruals related to clinical trial expenses. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of obicetrapib.our product candidates. See the section entitledtitled “Risk Factors—Risks Related to Our Product Development, Regulatory Approval and Commercialization” for more information regarding the risks associated with clinical development.

Reworded

Interest income is recognized using the effective interest rate method. FinanceInterest income for the year ended December 31, 20242025 is related to interest earned on cash, cash equivalents and marketable securities.

Added

Revenue decreased by $23.1 million, or 50.6%, to $22.5 million for the year ended December 31, 2025 compared to $45.6 million for the year ended December 31, 2024. This decrease was largely due to the recognition of $27.3 million of revenue from the Menarini License related to a clinical development milestone which was earned in the year ended December 31, 2024 while there were no clinical milestones earned in the year ended December 31, 2025. The decrease in revenue related to clinical development milestones pursuant to the Menarini License was partially offset by an increase in the amount of revenue recognized in the current period related to the development cost contributions under the Menarini License.

Removed

Revenue increased by $31.5 million, or 223.4%, to $45.6 million for the year ended December 31, 2024 compared to $14.1 million for the year ended December 31, 2023. This change is largely due to $27.3 million of revenue recognized in the year ended December 31, 2024 related to the license performance obligation under the Menarini License for a clinical success milestone compared to $5.4 million of such revenue recognized in the year ended December 31, 2023. The remainder of the change is due to an increase of $9.5 million in the revenue recognized related to the R&D performance obligation in the year ended December 31, 2024 as compared to the year ended December 31, 2023. This increase in revenue related to the R&D performance obligation is composed of the following:

Removed

recognition of $11.9 million of revenue for a general development cost reimbursement in the year ended December 31, 2024 while no such cost reimbursement was recognized in the year ended December 31, 2023; and an offsetting decrease of $2.3 million in recognition of deferred revenues in the year ended December 31, 2024 as compared to the year ended December 31, 2023 due to differences in the percentage of completion achieved in each respective year related to the performance obligation.

Removed

a $10.2 million decrease in manufacturing costs;

Removed

a $1.1 million decrease in non-clinical expenses related to preclinical studies;

Reworded

a $0.9$30.5 million decrease in clinical expenses mainly due to the completion of several Phase 3 clinical trialtrials whichin arethe completesecond orhalf nearingof completion2024 and cost phasing in ongoing clinical trials;

Added

partially offset by:

Added

an $8.3 million increase in non-clinical expenses due to greater activity related to pipeline expansion and product lifecycle management;

Added

a $6.1 million increase in manufacturing expense driven by investments in commercial manufacturing capabilities;

Added

a $5.0 million increase in personnel expenses primarily driven by an increase in share-based compensation expense; and a $1.5 million increase in regulatory expenses primarily driven by the preparation and planned submission of regulatory applications for obicetrapib.

Removed

a partially offsetting $0.9 million increase in regulatory expenses; and a partially offsetting $3.1 million increase in personnel expenses.

Reworded

a $10.9$5.1 million increase in marketing and communication expenses related to startup costs as we beginbegan to build capabilities to support our planned commercial launch of obicetrapib, if approved; and a partially offsetting $3.5$1.5 million decreaseincrease in financecosts andrelated administrationto expensesour intellectual property primarily due to costs incurred in 2023 in connection with an underwritten public offering of Ordinary Sharesdriven by certainworldwide ofpatent our shareholders. We did not sell any Ordinary Shares in the offering and did not receive any proceeds from the offering.filings.

Added

Fair value change - earnout was a gain of $4.0 million for the year ended December 31, 2025 compared to a loss of $37.0 million for the year ended December 31, 2024. The earnout liability was settled in March 2025.

Removed

Fair value change - earnout was a loss of $37.0 million for the year ended December 31, 2024 compared to a loss of $0.3 million for the year ended December 31, 2023. The change is driven by changes in the market price during the period for Ordinary Shares and an increase in the estimated probability of achieving the earnout milestone from 40% as of December 31, 2023 to 100% as of December 31, 2024.

Reworded

Fair value change - warrants was a loss of $22.8 million for the year ended December 31, 2025 compared to a loss of $38.6 million for the year ended December 31, 2024 compared to a loss of $10.0 million for the year ended December 31, 2023.2024. The change is primarily driven by changes in the market price during the period for the Warrants, which trade under the symbol "NAMSW."

Reworded

Net foreign exchange gains/(losses) were a gain of $13.1 million for the year ended December 31, 2025 compared to a loss of $6.6 million for the year ended December 31, 2024 compared to a gain of $5.1 million for the year ended December 31, 2023.2024. This change was largely driven by amovements weakening ofin the Euroexchange againstrate thefor U.S.Euros Dollar.which is our primary foreign currency exposure.

Reworded

Loss for the year increaseddecreased by $64.7$37.8 million, to $203.8 million for the year ended December 31, 2025 compared to $241.6 million for the year ended December 31, 2024 compared to $176.9 million for the year ended December 31, 2023.2024. The individual components of the change are described above.

Reworded

We are a clinical-stage biopharmaceutical company and, since inception, we have incurred significant operating losses and expect to continue to do so for the foreseeable future. Since inception, we have not generated anysignificant product revenues or net positive cash flows from operating activities. We willdo not expect to receive anysignificant product revenues or achieve net positive cash flows from operating activities until we successfully develop a product candidate, obtain regulatory approval, and successfully commercialize it.

Reworded

the costs and timing of obtaining sufficient quantities of our product candidatecandidates for clinical trials by establishing production capacities through contracts with CMOs;

Reworded

the costs of preparing for launch and commercialization of our product candidatecandidates; and the costs of operating as a public company in the United States.

Removed

losing our status as an emerging growth company; and the costs of operating as a public company in the United States.

Reworded

We have historically funded our operations primarily through private placements and public offerings of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the Business Combination. As of December 31, 2024,2025, we had cash andcash, cash equivalents and marketable securities of $771.7$728.9 million.million which management believes is sufficient to fund operating activities for at least the twelve-month period following the issuance of the consolidated financial statements accompanying this Annual Report. Until we can generate substantial revenue, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, convertible loans, warrants, collaborations, or other means. We may consider raising additional capital to take advantage of favorable market conditions or for other strategic considerations even if we have sufficient funds for planned operations. In addition to our partnership with Menarini, we may in the future utilize a variety of types of collaboration, license, monetization, distribution and other arrangements with other third parties relating to the development or commercialization, once approved, of obicetrapib or future product candidates or indications. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or privately placed equity offerings of securities, the terms of these securities or offerings may include liquidation or other preferences that adversely affect our other shareholders’ rights. To the extent that we raise additional funds by issuing and selling equity or equity-linked securities, shareholders will experience dilution. If we raise additional capital through debt financing, we would likely be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, licensing or selling assets, making capital expenditures or declaring dividends. Capital may become difficult or impossible to obtain due to poor market or other conditions outside of our control. If we are unable to raise sufficient additional funds on favorable terms as and when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others any of our potential future product candidates that we would prefer to develop and commercialize ourselves. See the section titled “Risk Factors” for additional detail regarding these risks.

Added

Menarini License and Menarini Supply Agreement

Added

On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products, for any use in the Menarini Territory. Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, of which €13.8 million has been received to date, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, €30 million of which has been received to date. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. See the section titled “Business—Commercial” for a full description of the Menarini License.

Added

As of December 31, 2025, we have received a total of €30 million in milestone payments from Menarini, none of which was received in the year ended December 31, 2025.

Added

On August 12, 2025, we entered into a supply agreement with Menarini pursuant to which we will supply Menarini with the Drug Products. We will initially be Menarini’s exclusive supplier of the Drug Products and fulfill purchase orders based on periodic volume forecasts that Menarini is required to provide, a portion of which will be binding. The price to be paid by Menarini will be based on a specified mark-up to our “cost of goods sold” for the supplied Drug Products (as determined in accordance with the supply agreement), subject to periodic adjustments.

Reworded

On December 13, 2024, we completed an underwritten public offering (the “December 2024 Offering”) of 14,667,347 Ordinary Shares at a public offering price of $24.50 per Ordinary Share and, in lieu of Ordinary Shares to certain investors, Pre-Funded Warrants to purchase 4,882,653 Ordinary Shares at a public offering price of $24.4999 per Pre-Funded Warrant, which represents the per share public offering price for the Ordinary Shares, less the $0.0001 per share exercise price for each such Pre-Funded Warrant. Of the 14,667,347 Ordinary Shares issued and sold in the December 2024 Offering, 2,550,000 Ordinary Shares were issued and sold pursuant to the exercise of the underwriters’ option to purchase additional Ordinary Shares at the public offering price per share. The net proceeds to the Company from the December 2024 Offering were $453.4 million after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Added

At-the-Market Offering

Added

On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0% of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the year ended December 31, 2025, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Removed

Menarini License

Removed

On June 23, 2022, we entered into the Menarini License, pursuant to which we granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of our intellectual property and our regulatory documentation to undertake post approval development activities and commercialize the Licensed Products, for any use in the Menarini Territory. Pursuant to the Menarini License, Menarini made a non-refundable, non-creditable upfront payment to us of €115 million. Menarini has also committed to providing us €27.5 million in funding for the research and development activities related to the Licensed Products over two years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory. We are also eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, €30 million of which has been received to date. If obicetrapib is approved, and successfully commercialized by Menarini, we will be entitled to tiered royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party IP payments. See the section titled “Business—Commercial” for a full description of the Menarini License.

Showing the first 60 of 76 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-05 (period ending 2026-06-30) with 10-Q filed 2026-05-07 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

4new paragraphs
0removed paragraphs
12reworded paragraphs
4,861 → 5,048words in section

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Reworded topics: investigation, tariff

Paragraph as it now reads, with added and removed wording marked:

Recently, trade and tariff policies among the United States and other countries have been unsettled and are subject to frequent changes. In April 2025, the Administration imposed a baseline ten percent tariff on imports from all nations importing goods to the United States, with that baseline supplemented in certain cases by additional tariffs that vary by nation, product or industry. In February 2026, the U.S. Supreme Court ruled against the Administration’s use of tariffs under the International Emergency Economic Powers Act, but the Administration imposed a new worldwide tariff under other legal authority, effective for 150 days from February 24, 2026. While the baseline tariff has been temporarily reduced, the underlying trade tensions and the potential reimposition of elevated tariffs may continue to pose risks to global supply chains and economic relations. The Bureau of Industry and Security, U.S. Department of Commerce, has initiated an investigation to determine whether pharmaceutical ingredients, including finished drug products, manufactured outside the United States pose a national security risk and should be subject to additional tariffs. The imposition of tariffs generally has historically led to increased trade and political tensions between the United States and other countries in the international community. Retaliatory tariffs on U.S. goods have been imposed by, among others, China and Canada. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions could have a material adverse effect on our financial condition or results of operations. In addition, increased tariffs on critical raw materials, components, and finished goods could raise our production costs and disrupt our supply chain, which could adversely affect our clinical development activities. The actual impact of the new tariffs on our business is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, potential retaliatory tariffs imposed by other countries, and the extent to which tariffs are imposed on finished or unfinished pharmaceutical products.
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Reworded topics: european commission

Paragraph as it now reads, with added and removed wording marked:

In December 2025, the EU Parliament and Council reached political agreement on the proposals to amend the current EU pharmaceutical regulatory framework. As discussed above, the final agreed text is likely to be released in late 2026, but it is generally expected that it will contain provisions that may cause additional pressure on pricing issues across the EU. For example, it is expected that the legislation will give EU member states the power, within one year of marketing authorization, to request that the marketing authorization holder places a product benefiting from regulatory data exclusivity protection or extended orphan market protection on its market in sufficient quantities and in the presentations necessary to cover patient needs. The request must be “proportionate” and may include: submission of a valid pricing and reimbursement application; participating in public procurement procedures; and establishing a roll-out plan. Failure to comply with the request within three years of the member state request would mean that regulatory data protection no longer applies in that member state and that the member state or EMA are able to validate generic/biosimilar applications after six years. However, the regulator cannot grant the marketing authorization until regulatory exclusivityexclusivity, and, where applicable, orphan exclusivity, has expired. The new legislation also provides for the loss of market protection or orphan market exclusivityprotection prolongation in the member state, meaning that generics/biosimilars may launch earlier. A separate parallel mechanism allows member states to request that marketing authorization holders for centrally authorized products launch and supply medicinal products benefiting from patent, supplementary patent term, regulatory data and extended orphan market protection. A failure by the marketing authorization holder to ensure adequate supplies may result in member state escalation to the European Commission. It is possible that these provisions could result in companies being forced to engage with member states that may otherwise be lower priority markets, which may result in downward pressure on price. Any changes to EU pharmaceutical legislation are not expected to come into force until 2027. Additional transitional periods mean that, while some of these changes may take effect in early 2028, others will most likely not take effect until early 2029
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New text topics: european commission
“A separate parallel mechanism allows member states to request that marketing authorization holders for centrally authorized products launch and supply medicinal products benefiting from patent, supplementary patent term, regulatory data and extended orphan market protection. A failure by the marketing authorization holder to ensure adequate supplies may result in member state escalation to the European Commission. …”
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Reworded topics: regulation

Paragraph as it now reads, with added and removed wording marked:

For example, the IRA sets forth meaningful changes to drug product reimbursement by Medicare. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D.D (the "Negotiation Program"). Starting in 2029 and for all subsequent years, CMS may negotiate prices for ten20 high-cost drugs paid for by Medicare Part D, effective in 2026, followed by 15 Part D drugs, effective in 2027, 15 Part B or Part DD. drugs,The effectiveNegotiation in 2028, and 20 Part B or Part D drugs, effective in 2029 and each year thereafter. This provisionProgram applies to drug products that have been approved for at least 7 years at the time of selection and biologics that have been licensed for 11 years,years butat itthe doestime notof apply to drugs and biologics that have been approved only for rare diseases or conditions.selection. Nonetheless, because CMS may establish a "maximum fair price" for thesecertain products in price negotiations, we may be exposed to government action if our product candidates, if approved, become the subject of Medicare price negotiations. Moreover, these provisions of the IRA may further heighten the risk that, if our product candidates are approved, we would not be able to achieve the expected return on such product candidates or realize the full value of the patents protecting them, including if prices are set after such product candidates have been on the market for seven years.
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Reworded topics: inflation

Paragraph as it now reads, with added and removed wording marked:

The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiationNegotiation program,Program, including for certain orphan-designated drugs for which the only approved indication (or indications) is for the orphan disease or condition. Should our product candidates be approved and covered by Medicare Part B or Part D and fail to fall within a statutory exclusion, such as that for an orphan drug,drugs, those products could, after a period of time, be selected for negotiation and become subject to prices representing a significant discount from average prices to wholesalers and direct purchasers. The IRA also establishes a rebate obligation for drug manufacturers that increase prices of Medicare Part B and Part D covered drugs at a rate greater than the rate of inflation. The inflation rebatesIRA may require us to pay rebates if we increase the cost of a covered Medicare Part B or Part D approved product faster than the rate of inflation. In addition, the law eliminates the coverage gap or “donut hole” under Medicare Part D beginning in 2025, significantly lowers the beneficiary maximum out-of-pocket cost, and requires manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. Our cost-sharing responsibility for any approved product covered by Medicare Part D could be significantly greater under the newly designedredesigned Part D benefit structure compared to the pre-IRA benefit design. Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.
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New text
“Any changes to EU pharmaceutical legislation are not expected to come into force until 2027. Additional transitional periods mean that, while some of these changes, including the first mechanism for member states to request supplies, may take effect in early 2028, others will most likely not take effect until early 2029. Based on the available draft text of the legislation, however, we expect that the new legislation should not apply to products for which marketing authorization applications are filed and approved under the current rules.”
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Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

For example, we expect to conduct an interim analysis of our Phase 3 PREVAIL CVOT in the fourth quarter of 2026. The interim analysis will be conducted by the DSMB for the trial and will remain blinded to us. Based on certain pre-specified criteria that we have set, as well as other considerations for which the DSMB has discretion, the DSMB may recommend that the trial be stopped early for efficacy or for futility or that the trial continue until the full target number of MACE events has occurred. The interim analysis will be based on a lower number of total MACE events than the trial protocol for PREVAIL contemplates being available at the conclusion of the trial and may, as a result, fail to detect a statistically significant treatment benefit of obicetrapib, if one exists. If, as a result of the interim analysis,theanalysis, the DSMB recommends that PREVAIL is discontinued for futility, our business prospects may be substantially harmed. If the trial is not stopped early for efficacy or futility, we expect to complete the trial by the end of 2027. Any material difference between the final data and any interim data or results of analyses we disclose could materially negatively impact our likelihood of receiving regulatory approval or, along with any other delays in our ability to file for marketing approval, could require significant additional time and expenditure.

Reworded

The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell obicetrapib or any other commercialized product profitably. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major federal and state legislative initiatives and executive actions.

Reworded

For example, the IRA sets forth meaningful changes to drug product reimbursement by Medicare. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax for offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D.D (the "Negotiation Program"). Starting in 2029 and for all subsequent years, CMS may negotiate prices for ten20 high-cost drugs paid for by Medicare Part D, effective in 2026, followed by 15 Part D drugs, effective in 2027, 15 Part B or Part DD. drugs,The effectiveNegotiation in 2028, and 20 Part B or Part D drugs, effective in 2029 and each year thereafter. This provisionProgram applies to drug products that have been approved for at least 7 years at the time of selection and biologics that have been licensed for 11 years,years butat itthe doestime notof apply to drugs and biologics that have been approved only for rare diseases or conditions.selection. Nonetheless, because CMS may establish a "maximum fair price" for thesecertain products in price negotiations, we may be exposed to government action if our product candidates, if approved, become the subject of Medicare price negotiations. Moreover, these provisions of the IRA may further heighten the risk that, if our product candidates are approved, we would not be able to achieve the expected return on such product candidates or realize the full value of the patents protecting them, including if prices are set after such product candidates have been on the market for seven years.

Reworded

The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiationNegotiation program,Program, including for certain orphan-designated drugs for which the only approved indication (or indications) is for the orphan disease or condition. Should our product candidates be approved and covered by Medicare Part B or Part D and fail to fall within a statutory exclusion, such as that for an orphan drug,drugs, those products could, after a period of time, be selected for negotiation and become subject to prices representing a significant discount from average prices to wholesalers and direct purchasers. The IRA also establishes a rebate obligation for drug manufacturers that increase prices of Medicare Part B and Part D covered drugs at a rate greater than the rate of inflation. The inflation rebatesIRA may require us to pay rebates if we increase the cost of a covered Medicare Part B or Part D approved product faster than the rate of inflation. In addition, the law eliminates the coverage gap or “donut hole” under Medicare Part D beginning in 2025, significantly lowers the beneficiary maximum out-of-pocket cost, and requires manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. Our cost-sharing responsibility for any approved product covered by Medicare Part D could be significantly greater under the newly designedredesigned Part D benefit structure compared to the pre-IRA benefit design. Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.

Added

The One Big Beautiful Bill Act of 2025 (“OBBBA”) also included significant reforms to Medicaid, including an estimated $1 trillion in reduced federal Medicaid spending from 2025 through 2034 and the imposition of work requirements for certain enrollees. These changes are expected to reduce overall Medicaid enrollment and to reduce the services covered by Medicaid, which could adversely affect the sales of any product candidates that we commercialize.

Reworded

Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for products. At the federal level, the Trump Administration has issued executive orders relating to prescription drug pricing and sent letters to pharmaceutical manufacturers that direct drug manufacturers to, among other things, offer most favored nation (“MFN”) pricing in Medicaid, offer MFN pricing for all newly launched drugs, repatriate increased revenue from abroad to lower drug prices in the United States and implement direct-to-consumer and direct-to-business distribution of their products at MFN pricing. The Trump Administration has warned that manufacturers that fail to make “significant progress” toward MFN pricing will face enumerated regulatory and enforcement consequences. In September 2025, the Administration began announcing deals with specific manufacturers to address the Administration’s MFN goals.

Reworded

The Administration has also proposeddeveloped three payment models that would test MFN pricing in Medicaid, Medicare Part D, and Medicare Part B. Participation in the Medicaid model, announced in November 2025, is voluntary for pharmaceutical manufacturers. Under the proposed rules for the Medicare Part D and Medicare Part B models published in December 2025, participation would be mandatory, and pharmaceutical manufacturers would be required to pay MFN-based rebates on eligible products for 25% of eligible Medicare beneficiaries during the applicable testing period. If these Medicare models are finalized and we obtain regulatory approval and commence commercialization of obicetrapib or any of our future product candidates during the testing period, and these products qualify for inclusion under the models, we may be required to participatepay MFN-based rebates in these models.

Reworded

Moreover, pursuant to the Menarini License, Menarini is responsible for the commercialization and local development of obicetrapib in certain areas of Europe, if approved. In August 2025, the European Medicines Agency (the “EMA”) accepted for review the Marketing Authorization Applications (“MAAs”) submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in the United Kingdom (“UK”) and Switzerland and accepted for review. We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026. Pursuant to the Menarini License, Menarini has sole discretion to set the price of the products in the European markets covered by its license. The price for prescription drug products in European and other non-U.S. markets is generally less, and in many cases significantly less, than the pricing for the same products sold in the United States. We expect the price of obicetrapib, if approved, in the European markets in which MAAs are currently under review by regulators, as well as the other European markets covered by the Menarini license, will be lower, and in most cases significantly lower, than the expected price for obicetrapib, if approved, in the United States. Since prices in the European markets in which Menarini has sole discretion to set the price of obicetrapib may serve as benchmarks for any mandatory MFN pricing models, if adopted, we may be unable to control the MFN price that must be paidmade available under the announced payment models, if adopted, or in any future efforts to adopt MFN pricing. As a result, these payment models and other efforts to impose MFN pricing could have a material adverse effect on our business, financial condition or results of operations, including the net sales potential of obicetrapib, if approved.

Reworded

If we obtain regulatory approval and commence commercialization of obicetrapib or any of our future product candidates, these laws and regulatory requirements could have an adverse effect on the market opportunities for obicetrapib or any of our future product candidates and may result in additional reductions in healthcare funding, which could have an adverse effect on our customers and accordingly, our financial operations. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether additional executive actions will be taken, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of obicetrapib or our future product candidates may be.

Reworded

Although we cannot predict the full effect on our business of the implementation of existing legislation and regulations or the enactmentadoption of additional legislation or further regulatory requirements pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for, or restrict coverage of, obicetrapib, if approved, or any of our future products could adversely affect how much or under what circumstances healthcare providers will prescribe or administer our products. This could adversely affect our business by reducing our ability to generate revenues, raise capital, obtain licenses and market our products. In addition, we believe the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage of pharmaceutical products, which may adversely impact product sales.

Reworded

In December 2025, the European Parliament and the Council of the European Union reached a provisional agreement on legislation to amend the current EU pharmaceutical regulatory framework. The text of the new legislation is due to be released in late 2026 following formal adoption by both the Parliament and Council. The potential reforms include altering the conditions and periods of regulatory and/or marketing protections available for innovative products.products and also making some of these protections conditional on fulfilling certain criteria. Depending on the final wording of these reforms, a reduction in the potential period of marketing protection available for obicetrapib or any of our future product candidates may adversely affect the commercial viability of such products in the EU. These changes could adversely affect our business by reducing our protection against generic competitors entering the EU market. Depending on the progress of the EU Parliament and Council to finalize the text of the legislation, changes to EU pharmaceutical legislation are not expected to come into force until early 2027 and additional transitional periods mean that most changes will most likely not take effect until early 2029.

Reworded

Recently, trade and tariff policies among the United States and other countries have been unsettled and are subject to frequent changes. In April 2025, the Administration imposed a baseline ten percent tariff on imports from all nations importing goods to the United States, with that baseline supplemented in certain cases by additional tariffs that vary by nation, product or industry. In February 2026, the U.S. Supreme Court ruled against the Administration’s use of tariffs under the International Emergency Economic Powers Act, but the Administration imposed a new worldwide tariff under other legal authority, effective for 150 days from February 24, 2026. While the baseline tariff has been temporarily reduced, the underlying trade tensions and the potential reimposition of elevated tariffs may continue to pose risks to global supply chains and economic relations. The Bureau of Industry and Security, U.S. Department of Commerce, has initiated an investigation to determine whether pharmaceutical ingredients, including finished drug products, manufactured outside the United States pose a national security risk and should be subject to additional tariffs. The imposition of tariffs generally has historically led to increased trade and political tensions between the United States and other countries in the international community. Retaliatory tariffs on U.S. goods have been imposed by, among others, China and Canada. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions could have a material adverse effect on our financial condition or results of operations. In addition, increased tariffs on critical raw materials, components, and finished goods could raise our production costs and disrupt our supply chain, which could adversely affect our clinical development activities. The actual impact of the new tariffs on our business is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, potential retaliatory tariffs imposed by other countries, and the extent to which tariffs are imposed on finished or unfinished pharmaceutical products.

Reworded

In December 2025, the EU Parliament and Council reached political agreement on the proposals to amend the current EU pharmaceutical regulatory framework. As discussed above, the final agreed text is likely to be released in late 2026, but it is generally expected that it will contain provisions that may cause additional pressure on pricing issues across the EU. For example, it is expected that the legislation will give EU member states the power, within one year of marketing authorization, to request that the marketing authorization holder places a product benefiting from regulatory data exclusivity protection or extended orphan market protection on its market in sufficient quantities and in the presentations necessary to cover patient needs. The request must be “proportionate” and may include: submission of a valid pricing and reimbursement application; participating in public procurement procedures; and establishing a roll-out plan. Failure to comply with the request within three years of the member state request would mean that regulatory data protection no longer applies in that member state and that the member state or EMA are able to validate generic/biosimilar applications after six years. However, the regulator cannot grant the marketing authorization until regulatory exclusivityexclusivity, and, where applicable, orphan exclusivity, has expired. The new legislation also provides for the loss of market protection or orphan market exclusivityprotection prolongation in the member state, meaning that generics/biosimilars may launch earlier. A separate parallel mechanism allows member states to request that marketing authorization holders for centrally authorized products launch and supply medicinal products benefiting from patent, supplementary patent term, regulatory data and extended orphan market protection. A failure by the marketing authorization holder to ensure adequate supplies may result in member state escalation to the European Commission. It is possible that these provisions could result in companies being forced to engage with member states that may otherwise be lower priority markets, which may result in downward pressure on price. Any changes to EU pharmaceutical legislation are not expected to come into force until 2027. Additional transitional periods mean that, while some of these changes may take effect in early 2028, others will most likely not take effect until early 2029

Added

A separate parallel mechanism allows member states to request that marketing authorization holders for centrally authorized products launch and supply medicinal products benefiting from patent, supplementary patent term, regulatory data and extended orphan market protection. A failure by the marketing authorization holder to ensure adequate supplies may result in member state escalation to the European Commission. It is possible that these provisions could result in companies being forced to engage with member states that may otherwise be lower priority markets, which may result in downward pressure on price.

Added

Both these supply mechanisms mean that companies may find themselves under pressure to launch in jurisdictions earlier than they might otherwise do. Some of these may be associated with lower pharmaceutical pricing and may have the potential to serve as benchmarks for US MFN pricing models.

Added

Any changes to EU pharmaceutical legislation are not expected to come into force until 2027. Additional transitional periods mean that, while some of these changes, including the first mechanism for member states to request supplies, may take effect in early 2028, others will most likely not take effect until early 2029. Based on the available draft text of the legislation, however, we expect that the new legislation should not apply to products for which marketing authorization applications are filed and approved under the current rules.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

24new paragraphs
7removed paragraphs
28reworded paragraphs
6,823 → 7,713words in section

New heading “Fair Value Change - Warrants”

New heading “Foreign Exchange Gains/(Losses)”

New heading “Loss for the Period”

New heading “Comparison of the six months ended June 30, 2026 and 2025”

New heading “Explanatory Note to Aid Comparison”

New heading “Research and Development Expenses”

New heading “Selling, General and Administrative Expenses”

Removed heading “Interest Income”

Removed heading “Interest Income”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text
“Comparison of the six months ended June 30, 2026 and 2025”
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“Selling, General and Administrative Expenses”
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“Explanatory Note to Aid Comparison”
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“Research and Development Expenses”
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“Foreign Exchange Gains/(Losses)”
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“Fair Value Change - Warrants”
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Full comparison: every changed paragraph (59)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We have partnered with A. Menarini International Licensing S.A. (“Menarini”), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a FDC with ezetimibe (the “Licensed Products”), in the majority of European countries (the Menarini Territory), if approved. In August 2025, the European Medicines Agency (the “EMA”) accepted for review the Marketing Authorization Applications (“MAAs”) submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in the United Kingdom (“UK”) and Switzerland and accepted for review. The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials. In July 2026, we announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA has adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. We anticipate that Menarini will receive decisions on the MAAs from each of the regulators inlater thethis second half of 2026.year. If the MAAs are approved by the regulators, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory and could potentially launch these products in the fourth quarter of 2026 in Germany and the UK.

Removed

Interest Income

Reworded

Interest income is recognized using the effective interest rate method. Interest income for the three and six months ended MarchJune 31,30, 2026 and 2025 is related to interest earned on cash, cash equivalents, restricted cash and marketable securities.

Reworded

Our exchange gain/loss relates mainly to cash balances denominated in foreign currencies, but also to transactions denominated in foreign currencies. Our foreign currency exposure is mainly related to the Euro. As of MarchJune 31,30, 2026, our net exposure to foreign currency risk was $ 80.9$72.6 million, as compared to $95.6 million as of December 31, 2025.

Reworded

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

Reworded

In prior periods, including the three months ended MarchJune 31,30, 2025, costs related to medical affairs activities and personnel were classified within selling, general and administrative expenses. Due to changes in the nature of activities performed by our medical affairs function, certain such costs, including personnel costs, are classified in accordance with U.S. GAAP as research and development expenses in the three and six months ended MarchJune 31,30, 2026. Costs associated with our medical affairs function totaled $5.1$4.6 million in the three months ended MarchJune 31,30, 2025, of which $3.0$3.1 million were personnel costs, compared to total costs of $4.5$4.3 million in the three months ended MarchJune 31,30, 2026, of which $3.2$2.9 million were personnel costs.

Reworded

Revenue was $3.0$3.7 million for the three months ended MarchJune 31,30, 2026 compared to $3.0$19.1 million for the three months ended MarchJune 31,30, 2025.2025, Revenuea fordecrease theof three$15.4 monthsmillion, endedor March81%. 31,This 2025decrease wasis largely due to the recognition of deferred$16.1 million of revenue in the comparative period related to the R&Dsecond performanceinstallment obligation.of Revenuedevelopment forcost thecontributions three months ended March 31, 2026 was related tounder the Menarini SupplyLicense, Agreement.which did not recur in the current period.

Reworded

Research and development expenses were $38.0$41.7 million for the three months ended MarchJune 31,30, 2026 compared to $44.8$27.5 million for the three months ended MarchJune 31,30, 2025, aan decreaseincrease of $6.8$14.2 millionmillion, or 15%.52%. This was primarily driven by:

Added

an $11.1 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials, as well as credits received upon the close-out of trials in the comparative period that did not recur in the current period;

Removed

a $8.3 million decrease in clinical expenses primarily due to the completion of Phase 3 clinical trials in the first half of 2025;

Removed

a $2.9 million decrease in non-clinical expenses primarily due to reduced activity related to pipeline expansion and product lifecycle management;

Removed

partially offset by:

Reworded

a $2.7$3.3 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved within the research and development activities to support the growth of the organization, together with an offsetting $3.3$2.5 million decrease related to a payroll tax relief grant received in the Netherlands; and a $1.7$0.7 million increase in manufacturingnon-clinical expenses drivendue byto agreater $4.9 million increaseactivity related to initialpipeline supplyexpansion activities,and partiallyproduct offsetlifecycle by a $3.2 million decrease associated with commercial manufacturing capability investments made in the comparative period.management;

Added

a $1.5 million decrease in manufacturing expenses primarily attributable to commercial manufacturing capability investments made in the comparative period, which did not recur in the current period.

Reworded

Selling, general and administrative expenses were $23.5$26.9 million for the three months ended MarchJune 31,30, 2026 compared to $27.2$27.3 million for the three months ended MarchJune 31,30, 2025, a decrease of $3.7$0.4 million or 14%.1%. This was primarily driven by:

Reworded

a $3.8$3.0 million decrease in marketing and communication expenses. The decrease is primarily driven by the change in the nature of medical affairs related costs, as described above,above; together withand a $1.4$0.5 million reductiondecrease in intellectual property expenses primarily driven by lowercosts marketrelated researchto spendingworldwide patent filings incurred in the comparative period, which did not recur in the current period;

Removed

a $0.8 million decrease in legal expenses primarily due to the transition of legal advisory services in-house;

Removed

a $0.7 million decrease in intellectual property costs primarily driven by worldwide patent filings incurred in the comparative period, which did not recur in the current period; and partially offset by:

Reworded

a $1.7$2.7 million increase in personnelshare-based expenses related to selling, general and administrative activities, including the impact of excluding medical affairs related personnelcompensation costs in the current period, as discussed above. The remainder of the change is primarily driven byand increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company. These increases are partially offset by the reclassification of medical affairs costs, as discussed above.

Removed

Interest Income

Reworded

Interest income was $5.7$5.8 million for the three months ended MarchJune 31,30, 2026 compared to $7.4$7.1 million for the three months ended MarchJune 31,30, 2025, a decrease of $1.7$1.3 million or 23%.18%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest iswas earned.

Added

Fair Value Change - Warrants

Added

Fair value change - warrants was a loss of $4.6 million for the three months ended June 30, 2026 compared to a gain of $2.6 million for the three months ended June 30, 2025. Prior to 2026, the fair value of the Warrants was determined using the last reported trading price of the Public Warrants, which trade under the symbol “NAMSW.” Beginning in 2026, due to a decrease in the trading volume of the Public Warrants, the fair value of the Warrants is determined by utilizing the Black-Scholes option pricing model. The primary driver of the change in fair value of the Warrants derived by such pricing method is the change in the trading price of the Company's Ordinary Shares, which trade under the symbol “NAMS.”

Added

Foreign Exchange Gains/(Losses)

Added

Net foreign exchange gains/(losses) were a loss of $0.5 million for the three months ended June 30, 2026 compared to a gain of $8.6 million for the three months ended June 30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Added

Loss for the Period

Added

Loss for the period was $64.1 million for the three months ended June 30, 2026 compared to $17.4 million for the three months ended June 30, 2025, an increase of $46.7 million. The individual components of the change are described above.

Added

Comparison of the six months ended June 30, 2026 and 2025

Added

The following table summarizes our consolidated statements of operations for the periods indicated:

Added

Explanatory Note to Aid Comparison

Added

In prior periods, including the six months ended June 30, 2025, costs related to medical affairs activities and personnel were classified within selling, general and administrative expenses. Due to changes in the nature of activities performed by our medical affairs function, certain such costs, including personnel costs, are classified in accordance with U.S. GAAP as research and development expenses in the six months ended June 30, 2026. Costs associated with our medical affairs function totaled $9.7 million in the six months ended June 30, 2025, of which $6.1 million were personnel costs, compared to total costs of $8.8 million in the six months ended June 30, 2026, of which $6.1 million were personnel costs.

Added

Revenue was $6.7 million for the six months ended June 30, 2026 compared to $22.1 million for the six months ended June 30, 2025, a decrease of $15.4 million, or 70%. This decrease was largely due to the recognition of $16.1 million of revenue related to the second installment of development cost contributions under the Menarini License in the comparative period.

Added

Research and Development Expenses

Added

Research and development expenses were $79.7 million for the six months ended June 30, 2026 compared to $72.3 million for the six months ended June 30, 2025, an increase of $7.4 million, or 10%. This was primarily driven by a:

Added

a $2.7 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials, partially offset by the completion of Phase 3 clinical trials in the first half of 2025; and a $6.0 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment costs for individuals involved within the research and development activities to support the growth of the organization, together with an offsetting $5.7 million decrease related to a payroll tax relief grant received in the Netherlands;

Added

a $2.1 million decrease in non-clinical expenses due to reduced activity in the first quarter related to pipeline expansion and product lifecycle management.

Added

The following table summarizes our research and development expenses for the periods indicated:

Added

Selling, General and Administrative Expenses

Added

Selling, general and administrative expenses were $50.3 million for the six months ended June 30, 2026 compared to $54.4 million for the six months ended June 30, 2025, a decrease of $4.1 million or 8%. This was primarily driven by:

Added

a $6.7 million decrease in marketing and communication expenses. The decrease is primarily driven by the change in the nature of medical affairs related costs, as described above, together with a $1.4 million reduction driven by lower market research spending;

Added

a $1.2 million decrease in costs related to our intellectual property primarily driven by worldwide patent filings incurred in the comparative period, which did not recur in the current period; and a $0.9 million decrease in legal expenses primarily due to the transition of legal advisory services in-house;

Added

a $4.3 million increase in share-based compensation costs and increased recruitment and employment costs for individuals involved with administrative and commercial preparedness activities to support the growth of the organization and operation as a public company. These increases are partially offset by the reclassification of medical affairs costs, as discussed above.

Added

Interest income was $11.5 million for the six months ended June 30, 2026 compared to $14.4 million for the six months ended June 30, 2025, a decrease of $2.9 million or 20%. This decrease was largely driven by a decrease in the amount of cash, cash equivalents and marketable debt securities on which interest was earned.

Reworded

Fair value change - earnout was a nil for the threesix months ended MarchJune 31,30, 2026 compared to a gain of $4.0 million for the threesix months ended MarchJune 31,30, 2025. The earnout liability was settled in full in March 2025.

Reworded

Fair value change - warrants was a gain of $5.9$1.4 million for the threesix months ended MarchJune 31,30, 2026 compared to a gain of $13.8$16.4 million for the threesix months ended MarchJune 31,30, 2025. Prior to 2026, the fair value of the Warrants was determined using the last reported trading price of the Public Warrants, which trade under the symbol “NAMSW.” Beginning in 2026, due to a decrease in the trading volume of the Public Warrants, the fair value of the Warrants is determined by utilizing the Black-Scholes option pricing model. The primary driver of the change in fair value of the Warrants derived by such pricing method is the change in the trading price of the Company's Ordinary Shares, which trade under the symbol “NAMS.”

Reworded

Net foreign exchange gains/(losses) were a loss of $1.6$2.1 million for the six months ended June 30, 2026 compared to a gain of $12.9 million for the three months ended MarchJune 31, 2026 compared to a gain of $4.3 million for the three months ended March 31,30, 2025. This change was largely driven by movements in the exchange rate for Euros which is our primary foreign currency exposure.

Reworded

Loss for the period was $48.4$112.6 million for the threesix months ended MarchJune 31,30, 2026 compared to $39.5$56.9 million for the threesix months ended MarchJune 31,30, 2025.2025, an increase of $55.7 million. The individual components of the change are described above.

Reworded

To date, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, undertaking preclinical studies and conducting clinical trials of obicetrapib. As a result, we are not yet profitable and have incurred losses in each annual period since our inception. As of MarchJune 31,30, 2026, we had an accumulated loss of $810.8$875.0 million. We expect to continue to incur significant losses for the foreseeable future.

Reworded

We have historically funded our operations primarily through private and public placements of shares, the sale of convertible notes, proceeds from the Menarini License and the proceeds from the closing of the transactions contemplated by the Business Combination Agreement. As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $707.3$678.3 million.

Reworded

As of MarchJune 31,30, 2026, we have received a total of €30 million in milestone payments from Menarini, none of which was received in the threesix months ended MarchJune 31,30, 2026.

Reworded

On August 9, 2024, we entered into an amended and restated sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which we may issue and sell from time to time up to $250 million of our Ordinary Shares through or to TD Cowen as our sales agent or acting as principal in any method deemed to be an “at the market offering.” TD Cowen will receive a commission of up to 3.0% of the gross proceeds of any Ordinary Shares sold pursuant to the Sales Agreement. During the threesix months ended MarchJune 31,30, 2026, we did not sell any Ordinary Shares pursuant to the Sales Agreement.

Reworded

In the threesix months ended MarchJune 31,30, 2026, 56,61969,371 Warrants were exercised at an exercise price of $11.50 per Ordinary Share generating gross proceeds of $0.7$0.8 million. As of MarchJune 31,30, 2026, we had another 2,433,4852,420,733 outstanding Warrants to purchase 2,433,4852,420,733 Ordinary Shares, exercisable at an exercise price of $11.50 per share, which expire on November 23, 2027, at 5:00 p.m., Eastern Standard Time. Based on the exercise price of the Warrants, we may receive up to $28.0$27.8 million assuming the exercise of all Warrants outstanding as of MarchJune 31,30, 2026. The exercise of the Warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our Ordinary Shares and the spread between the exercise price of the Warrant and the price of an Ordinary Share at the time of exercise. For example, to the extent that the trading price of the Ordinary Shares exceeds $11.50 per share, it is more likely that holders of our Warrants will exercise their Warrants. If the trading price of the Ordinary Shares is less than $11.50 per share, it is unlikely that such holders will exercise their Warrants. The exercise price of the Warrants has at times exceeded the market price of the Ordinary Shares. To the extent that the price of our Ordinary Shares is below $11.50, we believe that the Warrant holders will be unlikely to cash exercise their warrants, resulting in little to no cash proceeds to us. There can be no assurance that our Warrants will be in the money prior to their expiration and, as such, certain unexercised Warrants may expire worthless. As such, it is possible that we may never generate any additional cash proceeds from the exercise of our Warrants. We have not included, and do not intend to include, any potential cash proceeds from the exercise of our Warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability that the Warrants are exercised over the life of our Warrants and the merit of including potential cash proceeds from the exercise thereof in our liquidity projections.

Reworded

The following is a summary of cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

Reworded

Net cash flows used in operating activities was $30.6$69.8 million in the threesix months ended MarchJune 31,30, 2026 compared to $36.5$74.1 million in the threesix months ended MarchJune 31,30, 2025, a decrease of $5.9$4.3 million. This change was primarily duedriven toby favorable working capital changes, including a reductiondecrease in prepayments and other receivables and an increase in accounts payable, partially offset by an increase in operating expenses for the period partially offset by a change in working capital resulting from a decrease in accrued expenses..

Reworded

Net Cash Flows (Used In)/Provided By Investing Activities

Reworded

Net cash flows (used in)/provided by investing activities was $11.5$16.3 million in the threesix months ended MarchJune 31,30, 2026 compared to $2.9$156.3 million in the threesix months ended MarchJune 31,30, 2025, a change of $14.4$140.0 million. The change is primarily attributable to the purchases and maturities of marketable securities.

Reworded

Net cash flows provided by financing activities was $11.1$22.1 million in the threesix months ended MarchJune 31,30, 2026 compared to $6.5$9.9 million in the threesix months ended MarchJune 31,30, 2025, an increase of $4.6$12.2 million. The increase primarily reflects an increase in proceeds received upon the exercise of options.

Reworded

We have entered into a variety of agreements and financial commitments in the normal course of business with CROs, CMOs, and other third parties for preclinical and clinical development and manufacturing services. The terms generally provide us with the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. Payments due upon cancellation generally consist only of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. However, some of our service providers also charge cancellation fees upon cancellation. The amount and timing of such payments are not known, but at MarchJune 31,30, 2026 they are estimated to be a maximum of $29.5$50.6 million due within one year and $8.9$11.4 million due in more than a year. As at MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $707.3$678.3 million which is sufficient to fund these obligations.

Reworded

We are party to a services agreement (the “"Naarden Lease”") pursuant to which an affiliate of Forbion leased us office space;space, and an office lease agreement with RenaissanceWeston AventuraCommon Area LLC, dated May 24, 2021, as amended April 9,16, 2024 and March 11, 2026 (as amended, the “Miami Lease”), and an office sublease agreement with GR8 People, Inc., dated April 2, 20242026, (the “YardleyWeston Lease”). Under the Naarden Lease, we are obligated to pay €40 thousand per year in rent. The Naarden Lease will continue until terminated by either us or the landlord. Pursuant to the MiamiWeston Lease, we wereare required to pay annual rent ranging from $75$31 thousand to $82$34 thousand, increasing from the low end of the range to the higher end of the range for each year of the lease. The MiamiWeston Lease expiredwill expire by its terms on April 30, 2026.2029, Pursuantunless terminated earlier by either party pursuant to the Yardley Lease, we were required to pay annual rent ranging from $189 thousand to $194 thousand, increasing from the low endterms of the rangeWeston to the higher end of the range for each year of the lease. The Yardley Lease expired by its terms on April 30, 2026.Lease.

NAMS insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 1 trade date, 10,000 shares, about $226.5K) and open-market sales in 6 filings (3 insiders, 6 trade dates, 386,846 shares, about $11.4M; 5 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -376,846 (purchases minus sales); net value about -$11.1M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-30Kastelein Johannes Jacob Pieter
Director, Chief Scientific Officer
Option exercise
10b5-1 plan
50,246— —119,548 SEC
2026-09-30Kastelein Johannes Jacob Pieter
Director, Chief Scientific Officer
Open-market sale
10b5-1 plan
50,246$25.03 $1.3M69,302 SEC
2026-09-14Davidson Michael H.
Director, Chief Executive Officer
Open-market purchase 10,000$22.65 $226.5K792,923 SEC
2026-09-04Smither John W
Director
Open-market sale 1,600$25.32 $40.5K8,760 SEC
2026-09-01Gunning Robert William
Vice President, Controller
Grant/award 3,200— —3,200 SEC
2026-08-24Kastelein Johannes Jacob Pieter
Director, Chief Scientific Officer
Open-market sale
10b5-1 plan
125,000$26.91 $3.4M69,302 SEC
2026-08-24Kastelein Johannes Jacob Pieter
Director, Chief Scientific Officer
Option exercise
10b5-1 plan
125,000— —194,302 SEC
2026-07-20Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
2,915$31.71 $92.4K24,353 SEC
2026-07-20Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
31,885$31.05 $990.0K27,268 SEC
2026-07-20Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
70,200$29.96 $2.1M59,153 SEC
2026-07-20Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
80,000$11.17 $893.6K129,353 SEC
2026-07-20Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
25,000$11.90 $297.5K49,353 SEC
2026-06-22Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
300$30.73 $9.2K24,353 SEC
2026-06-22Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
15,000$11.90 $178.5K64,353 SEC
2026-06-22Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
25,000$10.90 $272.5K49,353 SEC
2026-06-22Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
39,700$30.20 $1.2M24,653 SEC
2026-05-26Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
5,000$10.90 $54.5K89,353 SEC
2026-05-26Kooij Louise Frederika
Chief Accounting Officer
Open-market sale
10b5-1 plan
65,000$35.69 $2.3M24,353 SEC
2026-05-26Kooij Louise Frederika
Chief Accounting Officer
Option exercise
10b5-1 plan
60,000$10.00 $600.0K84,353 SEC

Well-known investors holding NAMS (13F)

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