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Item 1B. Unresolved Staff Comments

2025-03-10 compared with 2024-03-28 · 27 added, 32 removed, 3 unchanged (95% of the section changed)

2 unchanged sentences

Cybersecurity

Risk management and strategy

We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential information that is proprietary, strategic or competitive in nature, information related to our clinical trials, and the personal information of our employees (Information Systems and Data).

The information technology, information security, and legal functions, with the assistance of third-party service providers, as well as our Chief Operating Officer, help identify, assess and manage our cybersecurity threats and risks.

Together, they identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment and our risk profile using various methods including, for example, manual tools, automated tools, subscriptions to certain reports and services that identify cybersecurity threats, analyzing certain reports of threats and actors, conducting scans of the threat environment, evaluating our and industry’s risk profile, evaluating threats reported to us, performing internal and external audits of certain systems, conducing threat assessment for internal and external threats, third party threats assessments, conducting vulnerability assessments to identify vulnerabilities and use of external intelligence feeds.

Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example:

cybersecurity incident response policy, incident detection and response mechanisms and policy, planned conformance with certain security standards (e.g., NIST CSF), encryption of certain data, network security controls and role-based data segregation for certain environments and systems, role and user-based access controls for certain environments and systems, physical security, asset management, tracking and decommissioning of Information Systems and Data, system monitoring for certain systems, regular and periodic employee training, penetration testing, and cybersecurity insurance.

Our assessment and management of material risks from cybersecurity threats are integrated into our overall risk management processes.

For example, our senior management evaluates material risks from cybersecurity threats against our overall business objectives and reports to the audit committee of the Board of Directors, which evaluates our overall enterprise risk.

We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including, for example, threat intelligence and cybersecurity software providers, penetration testing firms, dark web monitoring services and other professional services firms, including legal counsel.

We use third-party service providers to perform a variety of functions throughout our business, such as contract research organizations, clinical laboratories and other clinical trial support vendors, contract

manufacturing organizations, supply chain vendors (such as clinical drug supply vendors), application providers (including regulatory, clinical, finance and other software application vendors), and hosting companies (such as cloud-based document storage companies).

We have a vendor management program to manage cybersecurity risks associated with our use of these providers.

The program includes a risk assessment for vendors contracted for certain critical operations, utilization of security questionnaires during contracting, imposition of information security contractual obligations on certain vendors, security assessment due diligence calls and review of security reports, assessments, and/or certifications for certain vendors, and conducting audits for certain vendors.

Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, our vendor management process may involve different levels of assessment designed to help identify cybersecurity risks associated with a provider and impose contractual obligations related to cybersecurity on the provider.

For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see our risk factors under Part 1.

Risk Factors in this Annual Report on Form 10-K, including the risk captioned “If our information technology systems, or those of third parties upon which we rely, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions;

fines and penalties;

disruptions of our business operations;

reputational harm;

loss of revenue or profits;

loss of customers or sales;

and other adverse consequences.”

Our Board of Directors addresses our cybersecurity risk management as part of its general oversight function.

The Board of Directors’ audit committee is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats.

Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including the Chief Operating Officer, who has over 20 years of experience in information technology and information security operations.

The information technology and security function, as overseen by the Chief Operating Officer, is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel.

These individuals are also responsible for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.

Our cybersecurity incident reporting and cybersecurity incident response policies are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including to the information technology and security function, and as needed, to the Chief Operating Officer, the Head of Global Legal Affairs and the VP of Corporate Operations (the Incident Management Team).

The Incident Management Team works to help us investigate, mitigate, and remediate cybersecurity incidents of which they are notified.

In addition, our cybersecurity incident response policy includes reporting to the audit committee of the Board of Directors for certain cybersecurity incidents.

The audit committee of the Board of Directors receives periodic reports from the Chief Operating Officer concerning our significant cybersecurity threats and risk and the processes we have implemented to address them.

The audit committee of the Board of Directors also has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.

Cybersecurity Risk Management and Strategy

We recognize the critical importance of cybersecurity in safeguarding our information systems, data, and operations.

Our cybersecurity risk management framework is designed to identify, assess, mitigate, and respond to cybersecurity threats that could impact our business, financial condition, or operational results.

Cybersecurity Risk and Threat Landscape

As a company that relies on technology and digital assets, we are exposed to various cybersecurity risks, including unauthorized access to, or disruptions of, our systems and networks, and loss of, damage to, or unauthorized access to, or use, disclosure, or other processing of, data, cyberattacks such as ransomware and other malware, phishing and other forms of social engineering, and denial-of-service attacks, insider threats from employees or third-party service providers, supply chain vulnerabilities that may affect our software, hardware, or service providers, and other sources of security breaches and incidents.

A security breach or incident, or any other system failure or disruption could result in operational disruptions, financial losses, reputational damage, regulatory penalties, and legal liabilities.

Cybersecurity Risk Management and Governance

Our cybersecurity risk management approach is integrated into our overall enterprise risk management program.

We maintain a cybersecurity governance structure that includes oversight by executive leadership and our Board.

Our Board, through the Audit Committee, receives updates on cybersecurity risks, threats, and mitigation strategies on at least a semi-annual basis.

Our Chief Financial Officer (CFO) leads our cybersecurity initiatives, working closely with third-party cybersecurity service providers to implement security controls and response plans.

We conduct periodic risk assessments and vulnerability analyses to evaluate and strengthen our security posture.

Additionally, we maintain a cybersecurity incident response plan that defines procedures designed to identify, contain, mitigate, and recover from cybersecurity incidents.

We also evaluate and monitor the security practices of our third-party vendors , partners, and service providers with access to our systems or processing sensitive data on our behalf.

Cybersecurity Strategy and Mitigation Measures

We implement a comprehensive cybersecurity strategy to address cybersecurity risks.

We employ a multi-layered security approach that includes firewalls, intrusion prevention systems, endpoint protection, and network segmentation.

We utilize access controls, including multi-factor authentication and role-based access management.

To enhance employee awareness and reduce human error risks, we conduct regular cybersecurity training and phishing simulations.

We utilize encryption technologies and secure backup systems to protect sensitive data.

We adhere to certain frameworks such as the National Institute of Standards and Technology (NIST) Cybersecurity Framework.

Furthermore, we leverage advanced threat intelligence and monitoring solutions designed to detect and respond to cyber threats in real time.

Cybersecurity Incident Disclosure

As of the date of this report, we have not identified any cybersecurity incidents that have materially affected our financial condition or operations.

However, in light of the evolving nature of cyber threats, there is no assurance that we will not be subject to future cybersecurity incidents that could have a material impact on our business.

Our cybersecurity risk management efforts are subject to ongoing evaluation and adaptation in response to emerging threats and factors such as regulatory developments.

For additional information regarding whether any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1B. Unresolved Staff Comments