Item 1C. 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, and sensitive personal data, including of our employees, consultants and clinical trial participants (Information Systems and Data).

The Chief Financial Officer, Chief Business Officer, Chief Accounting Officer, and Head of Legal form our Cybersecurity Risk Management Committee and help identify, assess and manage the Company’s cybersecurity threats and risks. This Cybersecurity Risk Management Committee, which reports to our overall risk management committee, identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment and the Company’s risk profile using various methods including, for example: manual and automated tools in certain environments and systems, subscribing to reports and services that identify certain cybersecurity threats, conducting scans of certain threat environments, analyzing reports of certain threats and actors, evaluating certain cybersecurity threats reported to us, and conducting internal and external audits of certain environments and systems.

Depending on the environment and system, 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: incident response plan; incident detection and response tools; risk assessments of certain environments and systems; encryption of certain data; network security for certain environments and systems; access controls for certain environments and systems; data segregation of certain data; access controls; physical security; asset management; third-party systems monitoring; employee cybersecurity training; and cybersecurity insurance.

Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. For example, our Cyber Security Risk Management Committee 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 professional services firms, such as legal counsel, threat intelligence service providers, and cybersecurity software providers.

We use third-party service providers to perform a variety of functions throughout our business, such as software application providers, hosting companies, contract research organizations, and contract manufacturing organizations. 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 the Company and how they may do so, see our risk factors under Part 1. Item 1A. Risk Factors in this Annual Report, including the section titled “Risk Factors—General risk factors—If our information technology systems or data, or those of any of our third-party partners (such as contract research organizations and clinical trial sites), 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; litigation; fines and penalties; disruptions of our business operations; reputational harm; additional costs; loss of revenue or profits; and other adverse consequences.”

 

Governance

Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The board of directors’ audit committee is responsible for overseeing the Company’s cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats.

Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our Chief Business Officer, Chief Accounting Officer, and Head of Legal, working closely with our third-party information technology team; the senior staff members of our third-party information technology team have been in business providing services to similarly situated companies in our industry for more than 27 years, including extensive experience addressing complex information technology and cybersecurity matters.

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In particular, the Chief Business Officer is responsible for hiring appropriate personnel and third-party vendors, communicating key priorities to relevant personnel, and, in concert with members of the Cybersecurity Risk Management Committee, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy. Our Chief Business Officer, Chief Accounting Officer, and Head of Legal, in consultation with our third-party information technology team, is responsible for maintaining cybersecurity-related budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.

Our incident response plan is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including the Cybersecurity Risk Management Committee. This group works with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified. In addition, the Company’s incident response plan includes reporting to the audit committee of the board of directors for certain cybersecurity incidents.

The audit committee receives regular reports concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented to address them, including during audit committee meetings and other periodic updates. These reports are provided by members of the Company’s management team responsible for such reporting, including the Cybersecurity Risk Management Committee. The audit committee also receives various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.